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The use of external consultants from private and not-for-profit providers in the National Health Service (NHS) is intended to improve the quality of commissioning. The aim of this study was to learn about the support offered to healthcare commissioners, how external consultants and their clients work together and the perceived impact on the quality of commissioning.
NHS commissioning organisations and private and not-for-profit providers.
Mixed methods case study of eight cases.
92 interviews with external consultants (n=36), their clients (n=47) and others (n=9). Observation of 25 training events and meetings. Documentation, for example, meeting minutes and reports.
Constant comparison. Data were coded, summarised and analysed by the research team with a coding framework to facilitate cross-case comparison.
In the four contracts presented here, external providers offered technical solutions (eg, software tools), outsourcing and expertise including project management, data interpretation and brokering relationships with experts. In assessing perceived impact on quality of commissioning, two contracts had limited value, one had short-term benefits and one provided short and longer term benefits. Contracts with commissioners actively learning, embedding and applying new skills were more valued. Other elements of success were: (1) addressing clearly agreed problems of relevance to managerial and operational staff (2) solutions co-produced at all organisational levels (3) external consultants working directly with clients to interpret data outputs to inform locally contextualised commissioning strategies. Without explicit knowledge exchange strategies, outsourcing commissioning to external providers resulted in the NHS clients becoming dependent.
NHS commissioning will be disadvantaged if commissioners both fail to learn in the short term from the knowledge of external providers and in the longer term lose local skills. Knowledge exchange mechanisms are a vital component of commissioning and should be embedded in external provider contracts.
To compare the difference between the China growth reference and the WHO growth standards in assessing malnutrition of children under 5 years.
The households selected from 31 provinces, autonomous regions and municipalities in mainland China (except Taiwan, Hong Kong and Macao).
Households were selected by using a stratified, multistage probability cluster sampling. Children under 5 years of age in the selected households were recruited (n=15 886).
Underweight, stunting, wasting, overweight and obesity.
According to the China growth reference, the prevalence of underweight (8.7% vs 4.8%), stunting (17.2% vs 16.1%) and wasting (4.4% vs 3%) was significantly higher than that based on the WHO growth standards, respectively (p<0.001); the prevalence of overweight was lower than that based on the WHO growth standards (9.4% vs 10.2%, p<0.001). In most cases, the prevalence of undernutrition assessed by using the China growth reference was significantly higher. However, the prevalence of overweight was significantly lower by using China charts for boys aged 3–4, 6, 8, 10, 12–18 and 24 months.
The WHO growth standards could be more conservative in undernutrition estimation and more applicable for international comparison for Chinese children. Future researches are warranted for using the WHO growth standards within those countries with local growth charts when there are distinct differences between the two.
To determine whether statin treatment is associated with increased risk of haemorrhagic stroke (HS) in older women. A secondary objective was to evaluate HS risk in users of combined statin and antiplatelet treatment.
Observational study: secondary data analysis from the Women's Health Initiative (WHI) clinical trials.
Women were recruited from 40 participating sites.
Cohort of 68 132 women followed through 2005 (parent study) and for an additional 5 years in the extension study.
Statin use was assessed at baseline and at follow-up visits (1, 3, 6 and 9 years). Women brought medications in original containers for inventory. Strokes were ascertained semiannually and centrally adjudicated. Risk of HS by statin use (time-varying covariate, with the 'no use' category as the referent) was estimated from Cox proportional hazard regression models adjusted for age (model 1); risk factors for HS (model 2); and possible confounders by indication (model 3). Prespecified subgroup analyses were conducted by use of antiplatelet medications.
Final models included 67 882 women (mean age, 63±7 years). Over a mean follow-up of 12 years, incidence rates of HS were 6.4/10 000 person-years among statin users and 5.0/10 000 person-years among non-users (p=0.11). The unadjusted risk of HS in statin users was 1.21 (CI 0.96 to 1.53); after adjusting for age and HS risk factors the HR was 0.98 (CI 0.76 to 1.26). Risk of HS was higher among women on statins and antiplatelet agents versus women on antiplatelet medications alone (HR=1.59; CI 1.03 to 2.47); p for interaction=0.011.
This retrospective analysis did not show an association between statin use and HS risk among older women. HS risk was higher among women taking statins with antiplatelet agents. These findings warrant further investigation, given potential implications for clinical decision-making.
A recent study reported a large increase in the number of meniscal procedures from 2000 to 2011 in Denmark. We examined the nation-wide distribution of meniscal procedures performed in the private and public sector in Denmark since different incentives may be present and the use of these procedures may differ from region to region.
We included data on all patients who underwent an arthroscopic meniscal procedure performed in the public or private sector in Denmark.
Data were retrieved from the Danish National Patient Register on patients who underwent arthroscopic meniscus surgery as a primary or secondary procedure in the years 2000 to 2011. Hospital identification codes enabled linkage of performed procedures to specific hospitals.
Yearly incidence of meniscal procedures per 100 000 inhabitants was calculated with 95% CIs for public and private procedures for each region.
Incidence of meniscal procedures increased at private and at public hospitals. The private sector accounted for the largest relative and absolute increase, rising from an incidence of 1 in 2000 to 98 in 2011. In 2011, the incidence of meniscal procedures was three times higher in the Capital Region than in Region Zealand.
Our study identified a large increase in the use of meniscal procedures in the public and private sector in Denmark. The increase was particularly conspicuous in the private sector as its proportion of procedures performed increased from 1% to 32%. Substantial regional differences were present in the incidence and trend over time of meniscal procedures.
Prostate cancer mortality (PCM) in the USA is among the lowest in the world, whereas PCM in England is among the highest in Europe. This paper aims to assess the association of variation in use of definitive therapy on risk-adjusted PCM in England as compared with the USA.
Observational study.
Cancer registry data from England and the USA.
Men diagnosed with non-metastatic prostate cancer (PCa) in England and the USA between 2004 and 2008.
Competing-risks survival analyses to estimate subhazard ratios (SHR) of PCM adjusted for age, ethnicity, year of diagnosis, Gleason score (GS) and clinical tumour (cT) stage.
222 163 men were eligible for inclusion. Compared with American patients, English patients were more likely to present at an older age (70–79 years: England 44.2%, USA 29.3%, p<0.001), with higher tumour stage (cT3-T4: England 25.1%, USA 8.6%, p<0.001) and higher GS (GS 8–10: England 20.7%, USA 11.2%, p<0.001). They were also less likely to receive definitive therapy (England 38%, USA 77%, p<0.001).
English patients were more likely to die of PCa (SHR=1.9, 95% CI 1.7 to 2.0, p<0.001). However, this difference was no longer statistically significant when also adjusted for use of definitive therapy (SHR=1.0, 95% CI 1.0 to 1.1, p=0.3).
Risk-adjusted PCM is significantly higher in England compared with the USA. This difference may be explained by less frequent use of definitive therapy in England.
The prevalence of sensory impairment at an early stage of amyotrophic lateral sclerosis (ALS) is still debated. The study aim was to investigate the anatomofunctional properties of sensory pathways in patients with ALS, combining spinal diffusion tensor imaging (DTI) and somatosensory evoked potentials (SEPs).
Case–control study.
ALS referral centre and laboratory of biomedical imaging (Paris, France).
Well-characterised group of 21 patients with ALS with moderate disability (mean amyotrophic lateral sclerosis Functional Rating Scale (ALSFRS) score 39.3±1.0) and no clinical sensory signs and control group of 21 gender and age-matched healthy subjects.
Fractional anisotropy and diffusivity of the dorsal columns at C5-T1 levels (DTI metrics) and SEPs after median and ulnar nerve stimulations (latency and amplitude of N9 and N20 components).
Abnormal DTI metrics indicated anatomical damages of ascending sensory fibres in ~60% of patients (p<0.05). Raw SEPs (μV) were smaller in ~40% of patients but the difference with healthy subjects was not significant (p>0.16). Their normalisation to prestimulus activity strengthened the difference between groups (p<0.05) and allowed identification of ~60% of patients with abnormal values. According to N9 latency, the peripheral conduction time was normal in patients (p>0.32) but based on N20 latency, the central conduction time (between spinal cord and parietal cortex) was found to be slower (p<0.05). Significant correlation was found between DTI metrics and N9 amplitude (p<0.05). Altered SEPs were also correlated with the disease duration (p<0.05). Taken together, spinal imaging and electrophysiology helped to identify ~85% of patients with subclinical sensory defect while separated methods revealed abnormal values in ~60%.
Sensory impairments have been underestimated at early stages of ALS. These results show for the first time the interest to combine electrophysiology and imaging to assess non-motor system involvement in ALS.
To test whether there is an association between abortion legislation and maternal mortality outcomes after controlling for other factors thought to influence maternal health.
Population-based natural experiment.
Official maternal mortality data from 32 federal states of Mexico between 2002 and 2011.
Maternal mortality ratio (MMR), MMR with any abortive outcome (MMRAO) and induced abortion mortality ratio (iAMR).
Abortion legislation grouped as less (n=18) or more permissive (n=14); constitutional amendment protecting the unborn (n=17); skilled attendance at birth; all-abortion hospitalisation ratio; low birth weight rate; contraceptive use; total fertility rates (TFR); clean water; sanitation; female literacy rate and intimate-partner violence.
Over the 10-year period, states with less permissive abortion legislation exhibited lower MMR (38.3 vs 49.6; p<0.001), MMRAO (2.7 vs 3.7; p<0.001) and iAMR (0.9 vs 1.7; p<0.001) than more permissive states. Multivariate regression models estimating effect sizes (β-coefficients) for mortality outcomes showed independent associations (p values between 0.001 and 0.055) with female literacy (β=–0.061 to –1.100), skilled attendance at birth (β=–0.032 to –0.427), low birth weight (β=0.149 to 2.166), all-abortion hospitalisation ratio (β=–0.566 to –0.962), clean water (β=–0.048 to –0.730), sanitation (β=–0.052 to –0.758) and intimate-partner violence (β=0.085 to 0.755). TFR showed an inverse association with MMR (β=–14.329) and MMRAO (β=–1.750) and a direct association with iAMR (β=1.383). Altogether, these factors accounted for (R2) 51–88% of the variance among states in overall mortality rates. No statistically independent effect was observed for abortion legislation, constitutional amendment or other covariates.
Although less permissive states exhibited consistently lower maternal mortality rates, this finding was not explained by abortion legislation itself. Rather, these differences were explained by other independent factors, which appeared to have a more favourable distribution in these states.
To assess the effect of experienced stigma on depth of multidimensional poverty of persons with severe mental illness (PSMI) in Delhi, India, controlling for gender, age and caste.
Matching case (hospital)–control (population) study.
University Hospital (cases) and National Capital Region (controls), India.
A case–control study was conducted from November 2011 to June 2012. 647 cases diagnosed with schizophrenia or affective disorders were recruited and 647 individuals of same age, sex and location of residence were matched as controls at a ratio of 1:2:1. Individuals who refused consent or provided incomplete interview were excluded.
Higher risk of poverty due to stigma among PSMI.
38.5% of PSMI compared with 22.2% of controls were found poor on six dimensions or more. The difference in multidimensional poverty index was 69% between groups with employment and income of the main contributors. Multidimensional poverty was strongly associated with stigma (OR 2.60, 95% CI 1.27 to 5.31), scheduled castes/scheduled tribes/other backward castes (2.39, 1.39 to 4.08), mental illness (2.07, 1.25 to 3.41) and female gender (1.87, 1.36 to 2.58). A significant interaction between stigma, mental illness and gender or caste indicates female PSMI or PSMI from 'lower castes' were more likely to be poor due to stigma than male controls (p<0.001) or controls from other castes (p<0.001).
Public stigma and multidimensional poverty linked to SMI are pervasive and intertwined. In particular for low caste and women, it is a strong predictor of poverty. Exclusion from employment linked to negative attitudes and lack of income are the highest contributors to multidimensional poverty, increasing the burden for the family. Mental health professionals need to be aware of and address these issues.
The relationship between inflammatory markers and depressive symptoms has been reported inconsistently. Moreover, there were only a few studies conducted in an Asian population. The purpose of this study was to examine the association between C reactive protein (CRP) and depressive symptoms in an elderly Korean population.
This study used data from the Korean Social Life, Health and Aging Project Health Examination Cohort, which started in 2011. Among participants aged 60 or over recruited from a rural community, 569 (224 men and 345 women) without a history of stroke, angina pectoris, myocardial infarction or CRP≥20 mg/L were employed for cross-sectional analyses. As a marker of systemic inflammation, CRP was measured. Depressive symptoms were measured with the Center for Epidemiologic Studies Depression (CES-D) scale. Multiple linear regression analysis was used to investigate the relationship between CRP and depressive symptoms.
In men, CRP levels had significant associations with depressive symptoms before (β=0.420, p=0.010) and after (β=0.336, p=0.025) adjusting for age, body mass index, systolic blood pressure, number of comorbidities, smoking status, alcohol intake, marital status, education and sleep duration. However, in women, the association between CRP and depressive symptoms was not significant before (p=0.250) and after (p=0.256) adjustment.
Our findings suggest that elevated CRP levels are independently associated with the presence of depressive symptoms in elderly Korean men.
Haemophilus influenzae type b (Hib) vaccine has been available in India's private sector market since 1997. It was not until 14 December 2011 that the Government of India initiated the phased public sector introduction of a Hib (and DPT, diphtheria, pertussis, tetanus)-containing pentavalent vaccine. Our objective was to investigate the state-specific coverage and behaviour of Hib vaccine in India when it was available only in the private sector market but not in the public sector. This baseline information can act as a guide to determine how much coverage the public sector rollout of pentavalent vaccine (scheduled April 2015) will need to bear in order to achieve complete coverage.
16 of 29 states in India, 2009–2012.
Retrospective descriptive secondary data analysis.
(1) Annual sales of Hib vaccines, by volume, from private sector hospitals and retail pharmacies collected by IMS Health and (2) national household surveys.
State-specific Hib vaccine coverage (%) and its associations with state-specific socioeconomic status.
The overall private sector Hib vaccine coverage among the 2009–2012 birth cohort was low (4%) and varied widely among the studied Indian states (minimum 0.3%; maximum 4.6%). We found that private sector Hib vaccine coverage depends on urban areas with good access to the private sector, parent's purchasing capacity and private paediatricians' prescribing practices. Per capita gross domestic product is a key explanatory variable. The annual Hib vaccine uptake and the 2009–2012 coverage levels were several times higher in the capital/metropolitan cities than the rest of the state, suggesting inequity in access to Hib vaccine delivered by the private sector.
If India has to achieve high and equitable Hib vaccine coverage levels, nationwide public sector introduction of the pentavalent vaccine is needed. However, the role of private sector in universal Hib vaccine coverage is undefined as yet but it should not be neglected as a useful complement to public sector services.
Individuals with autism spectrum disorder (ASD) have difficulties in communication and social interaction resulting from atypical perceptual and cognitive information processing, leading to an accumulation of anxiety. Extreme overloading experienced internally may not be externally visible. Identifying stressful situations at an early stage may avoid socially problematic behaviour from occurring, such as self-injurious behaviour. Activation of the autonomous nervous system (ANS) is involved in the response to anxiety, which can be measured through heart rate variability and skin conductance with the use of portable devices, non-intrusively and pain-free. Thus, developing innovative analysis of signal perception and reaction is necessary, mainly for non-communicative individuals with autism.
The protocol will take place in real life (home and social environments). We aim to associate modifications of the ANS with external events that will be recorded in a synchronous manner through a specific design (spy glasses with video/audio recording). Four phases will be carried out on ASD participants and aged-matched controls: (1) 24-hour baseline pre-experiment (physical activity, sleep), (2) 2 h in a real life situation, (3) 30 min in a quiet environment, interrupted by a few seconds of stressful sound, (4) an interview to record feelings about events triggering anxiety. ASD and control participants will be together for phases 2 and 3, revealing different physiological responses to the same situations, and thus identifying potentially problematic events. The novelty will be to apply time-series analyses (which led to several Nobel Prizes in quantitative finance) on ANS series (heart rate, heart rate variability, skin conductance) and wrist motion.
Ethical approval has been obtained from Ethics Committee of Clermont-Ferrand (South-East I), France (2014-A00611–46). Trial findings will be disseminated via open-access peer-reviewed publications, conferences, clinical networks, public lectures and our websites.
ClinicalTrials identifier NCT02275455.
To compare health-related and cost-related outcomes of consultations for symptoms suggestive of minor ailments in emergency departments (EDs), general practices and community pharmacies.
Observational study; prospective cohort design.
EDs (n=2), general practices (n=6) and community pharmacies (n=10) in a mix of rural/urban and deprived/affluent areas across North East Scotland and East Anglia. Participants Adults (≥18 years) presenting between 09:00 and 18:00 (Monday–Friday) in general practices and 09:00–18:00 (Monday–Saturday) in pharmacies and EDs with ≥1 of the following: musculoskeletal pain; eye discomfort; gastrointestinal disturbance; or upper respiratory tract-related symptoms.
Participants completed three questionnaires: baseline (prior to index consultation); satisfaction with index consultation and follow-up (2 weeks after index consultation).
Symptom resolution, quality of life, costs, satisfaction and influences on care-seeking behaviour.
377 patients participated, recruited from EDs (81), general practices (162) and community pharmacies (134). The 2-week response rate was 70% (264/377). Symptom resolution was similar across all three settings: ED (37.3%), general practice (35.7%) and pharmacy (44.3%). Mean overall costs per consultation were significantly lower for pharmacy (£29.30 (95% CI £21.60 to £37.00)) compared with general practice (£82.34 (95% CI £63.10 to £101.58)) and ED (£147.09 (95% CI £125.32 to £168.85)). Satisfaction varied across settings and by measure used. Compared with pharmacy and general practice use, ED use was significantly (p<0.001) associated with first episode and short duration of symptom(s), as well as higher levels of perceived seriousness and urgency for seeking care. Convenience of location was the most common reason for choice of consultation setting.
These results suggest similar health-related outcomes and substantially lower costs with pharmacy consultations for minor ailments. Effective strategies are now needed to shift demand for minor ailment management away from EDs and general practices to the community pharmacy setting.
A bibliometric analysis of the UK National Institute for Health Research (NIHR) Health Technology Assessment (HTA) monographs and their related journal articles by: (1) exploring the differences in citations to the HTA monographs in Google Scholar (GS), Scopus and Web of Science (WoS), and (2) comparing Scopus citations to the monographs with their related journal articles.
A study of 111 HTA monographs published in 2010 and 2011, and their external journal articles.
Citations to the monographs in GS, Scopus and WoS, and to their external journal articles in Scopus.
The number of citations varied among the three databases, with GS having the highest and WoS the lowest; however, the citation-based rankings among the databases were highly correlated. Overall, 56% of monographs had a related publication, with the highest proportion for primary research (76%) and lowest for evidence syntheses (43%). There was a large variation in how the monographs were cited, compared to journal articles, resulting in more frequent problems, with unlinked citations in Scopus and WoS. When comparing differences in the number of citations between monograph publications with their related journal articles from the same project, we found that monographs received more citations than their journal articles for evidence syntheses and methodology projects; by contrast, journal articles related to primary research monographs were more highly cited than their monograph.
The numbers of citations to the HTA monographs differed considerably between the databases, but were highly correlated. When a HTA monograph had a journal article from the same study, there were more citations to the journal article for primary research, but more to the monographs for evidence syntheses. Citations to the related journal articles were more reliably recorded than citations to the HTA monographs.
Skin biopsies from local sites of herpes simplex virus 2 (HSV-2)-induced ulcers can show infiltrates of inflammatory cells several months after macroscopic healing. We hypothesise that foreskin tissue samples of asymptomatic HSV-2 seropositive men had remaining signs of inflammation at the molecular level. Even in the absence of clinical lesions, genital inflammation may contribute to increased HIV susceptibility on sexual exposure to the virus.
Foreskin tissue samples were collected from men undergoing elective circumcision in Kisumu, Kenya.
The foreskin tissue samples (n=86) were stratified into study groups based on HSV-2 serology and assessed for mRNA expression of inflammatory markers. Markers of interest were further assessed by immunohistochemical staining within the tissue samples.
The two study groups had comparable levels of all molecular markers (CD3, CD4, CD8, CD69, CCR5, HLA-DR, Langerin, DC-SIGN, Mannose Receptor 1, IL-1, IL-6, TNF-α, β7, IgA, IFN-α, CCL5, E-cadherin, ZO-1 and occludin), except for lower mRNA levels of the epithelial junction protein claudin-1 in the HSV-2 seropositive group (p=0.008). Although mRNA levels of claudin-1 were lower in HSV-2 seropositive individuals, the corresponding protein could be visualised in the foreskin epithelium of all samples tested.
Whereas no general inflammation was demonstrated in the foreskin of asymptomatic HSV-2 seropositive individuals, a decreased expression of claudin-1 indicates a less robust genital epithelial barrier. An intact epithelial barrier is essential for blocking mucosal entry of genital infections, including HIV.
Providers and patients are most likely to use and benefit from guidelines accompanied by implementation support. Guidelines published in 2007 and earlier assessed with the Appraisal of Guidelines, Research and Evaluation (AGREE) instrument scored poorly for applicability, which reflects the inclusion of implementation instructions or tools. The purpose of this study was to examine the applicability of guidelines published in 2008 or later and identify factors associated with applicability.
Systematic review of studies that used AGREE to assess guidelines published in 2008 or later.
MEDLINE and EMBASE were searched from 2008 to July 2014, and the reference lists of eligible items. Two individuals independently screened results for English language studies that reviewed guidelines using AGREE and reported all domain scores, and extracted data. Descriptive statistics were calculated across all domains. Multilevel regression analysis with a mixed effects model identified factors associated with applicability.
Of 245 search results, 53 were retrieved as potentially relevant and 20 studies were eligible for review. The mean and median domain scores for applicability across 137 guidelines published in 2008 or later were 43.6% and 42.0% (IQR 21.8–63.0%), respectively. Applicability scored lower than all other domains, and did not markedly improve compared with guidelines published in 2007 or earlier. Country (UK) and type of developer (disease-specific foundation, non-profit healthcare system) appeared to be associated with applicability when assessed with AGREE II (not original AGREE).
Despite increasing recognition of the need for implementation tools, guidelines continue to lack such resources. To improve healthcare delivery and associated outcomes, further research is needed to establish the type of implementation tools needed and desired by healthcare providers and consumers, and methods for developing high-quality tools.
Physicians are a commonly targeted group in health research surveys, but their response rates are often relatively low. The goal of this paper was to evaluate the effect of unconditional incentives in the form of a coffee card on physician postal survey response rates.
Following 13 key informant interviews and eight cognitive interviews a survey questionnaire was developed.
A random sample of 534 physicians, stratified by physician group (geriatricians, family physicians, emergency physicians) was selected from a national medical directory.
Using computer generated random numbers; half of the physicians in each stratum were allocated to receive a coffee card to a popular national coffee chain together with the first survey mailout.
The intervention was a $10 Tim Hortons gift card given to half of the physicians who were randomly allocated to receive the incentive.
265 (57.0%) physicians completed the survey. The response rate was significantly higher in the group allocated to receive the incentive (62.7% vs 51.3% in the control group; p=0.01).
Our results indicate that an unconditional incentive in the form of a coffee gift card can substantially improve physician response rates. Future research can look at the effect of varying amounts of cash on the gift cards on response rates.
To construct and internally validate a risk score, the '80+ score', for revisits to hospital and mortality for older patients, incorporating aspects of pharmacotherapy. Our secondary aim was to compare the discriminatory ability of the score with that of three validated tools for measuring inappropriate prescribing: Screening Tool of Older Person's Prescriptions (STOPP), Screening Tool to Alert doctors to Right Treatment (START) and Medication Appropriateness Index (MAI).
Two acute internal medicine wards at Uppsala University hospital. Patient data were used from a randomised controlled trial investigating the effects of a comprehensive clinical pharmacist intervention.
Data from 368 patients, aged 80 years and older, admitted to one of the study wards.
Time to rehospitalisation or death during the year after discharge from hospital. Candidate variables were selected among a large number of clinical and drug-specific variables. After a selection process, a score for risk estimation was constructed. The 80+ score was internally validated, and the discriminatory ability of the score and of STOPP, START and MAI was assessed using C-statistics.
Seven variables were selected. Impaired renal function, pulmonary disease, malignant disease, living in a nursing home, being prescribed an opioid or being prescribed a drug for peptic ulcer or gastroesophageal reflux disease were associated with an increased risk, while being prescribed an antidepressant drug (tricyclic antidepressants not included) was linked to a lower risk of the outcome. These variables made up the components of the 80+ score. The C-statistics were 0.71 (80+), 0.57 (STOPP), 0.54 (START) and 0.63 (MAI).
We developed and internally validated a score for prediction of risk of rehospitalisation and mortality in hospitalised older people. The score discriminated risk better than available tools for inappropriate prescribing. Pending external validation, this score can aid in clinical identification of high-risk patients and targeting of interventions.
To develop a nomogram for estimating the glycated haemoglobin (HbA1c) response to different dipeptidyl peptidase-4 (DPP-4) inhibitors in type 2 diabetes.
A systematic review and meta-analysis of randomised controlled trials (RCTs) of DPP-4 inhibitors (vildagliptin, sitagliptin, saxagliptin, linagliptin and alogliptin) on HbA1c were conducted. Electronic searches were carried out up to December 2013. Trials were included if they were carried out on participants with type 2 diabetes, lasted at least 12 weeks, included at least 30 participants and had a final assessment of HbA1c. A random effect model was used to pool data. A nomogram was used to represent results of the metaregression model.
Adults with type 2 diabetes.
Any DPP-4 inhibitor (vildagliptin, sitagliptin, saxagliptin, linagliptin or alogliptin).
The HbA1c response to each DPP-4 inhibitor within 1 year of therapy.
We screened 928 citations and reviewed 98 articles reporting 98 RCTs with 100 arms in 24 163 participants. There were 26 arms with vildagliptin, 37 with sitagliptin, 13 with saxagliptin, 13 with linagliptin and 11 with alogliptin. For all 100 arms, the mean baseline HbA1c value was 8.05% (64 mmol/mol); the decrease of HbA1c from baseline was –0.77% (95% CI –0.82 to –0.72%), with high heterogeneity (I2=96%). Multivariable metaregression model that included baseline HbA1c, type of DPP-4 inhibitor and fasting glucose explained 58% of variance between studies, with no significant interaction between them. Other factors, including age, previous diabetes drugs and duration of treatment added low predictive power (<1%). The nomogram estimates the absolute HbA1c reduction from baseline using the type of DPP-4 inhibitor, baseline values of HbA1c and fasting glucose.
Baseline HbA1c level and fasting glucose explain most of the variance in HbA1c change in response to DPP-4 inhibitors: each increase of 1.0% units HbA1c provides a 0.4–0.5% units greater fall.
The concept of 'resilience' is of increasing interest in studies of mental health in populations facing adversity. However, lack of longitudinal data on the dynamics of resilience and non-usage of resilience-specific measurements have prevented a better understanding of resilience-mental health interactions. Hence, the present study was conducted to investigate the stability of levels of resilience and its associations with sociodemographic and mental health exposures in a conflict-affected internal-migrant population in Sri Lanka.
A prospective follow-up study of 1 year.
Puttalam district of North Western province in postconflict Sri Lanka (baseline in 2011, follow-up in 2012).
An ethnic Muslim population internally displaced 20 years ago (in 1990) from Northern Sri Lanka, aged 18 or above and currently in the process of return migration.
It was hypothesised that levels of resilience would be associated with mental health outcomes. Resilience was measured on both occasions using the 14-item Resilience Scale (RS-14), social support by the Multidimensional Social Support Scale and Lubben Social Network Scale and common mental disorders by the Patient Health Questionnaire (PHQ).
Of 450 participants interviewed at baseline in 2011, 338 (75.1%) were re-interviewed in 2012 after a 1-year follow-up. The mean resilience scores measured by RS-14 were 80.2 (95% CI 78.6 to 81.9) at baseline and 84.9 (83.5 to 86.3) at follow-up. At both time points, lower resilience was independently associated with food insecurity, lower social support availability and social isolation. At both time points, there were significant associations with common mental disorders (CMDs) in unadjusted analyses, but they only showed independence at baseline. The CMD prevalence, maintenance and incidence at follow-up was 8.3%, 28.2% and 2.2%, respectively.
In this displaced population facing a potential reduction in adversity, resilience was more strongly and robustly associated with economic and social factors than with the presence of mental disorder.
The skill set required for junior doctors to work efficiently and safely Out of Hours (OoH) in hospitals has not been established. This is despite the OoH period representing 75% of the year and it being the time of highest mortality. We set out to explore the expectations of medical students and experiences of junior doctors of the non-technical skills needed to work OoH.
Survey-based cross-sectional study informed by focus groups.
Online survey with participants from five large teaching hospitals across the UK.
300 Medical Students and Doctors
Participants ranked the importance of non-technical skills, as identified by literature review and focus groups, needed for OoH care.
The focus groups revealed a total of eight non-technical skills deemed to be important. In the survey 'Task Prioritisation' (mean rank 1.617) was consistently identified as the most important non-technical skill. Stage of training affected the ranking of skills, with significant differences for 'Communication with Senior Doctors', 'Dealing with Clinical Isolation', 'Task Prioritisation' and 'Communication with Patients'. Importantly, there was a significant discrepancy between the medical student expectations and experiences of doctors undertaking work.
Our findings suggest that medical staff particularly value task prioritisation skills; however, these are not routinely taught in medical schools. The discrepancy between expectations of students and experience of doctors reinforces the idea that there is a gap in training. Doctors of different grades place different importance on specific non-technical skills with implications for postgraduate training. There is a pressing need for medical schools and deaneries to review non-technical training to include more than communication skills.
Sexually transmitted infections (STI) are a major public health problem. Condoms provide effective protection but there are many barriers to use. Face-to-face health promotion interventions are resource-intensive and show mixed results. Interactive digital interventions may provide a suitable alternative, allowing private access to personally tailored behaviour change support. We have developed an interactive digital intervention (the Men's Safer Sex (MenSS) website) which aims to increase condom use in men. We describe the protocol for a pilot trial to assess the feasibility of a full-scale randomised controlled trial of the MenSS website in addition to usual sexual health clinical care.
Participants: Men aged 16 or over who report female sexual partners and recent unprotected sex or suspected acute STI. Participants (N=166) will be enrolled using a tablet computer in clinic waiting rooms. All trial procedures will be online, that is, eligibility checks; study consent; trial registration; automated random allocation; and data submission. At baseline and at 3, 6 and 12 months, an online questionnaire will assess condom use, self-reported STI diagnoses, and mediators of condom use (eg, knowledge, intention). Reminders will be by email and mobile phone. The primary outcome is condom use, measured at 3 months. STI rates will be recorded from sexual health clinic medical records at 12 months. The feasibility of a cost-effectiveness analysis will be assessed, to calculate incremental cost per STI prevented (Chlamydia or Gonorrhoea), from the NHS perspective.
Ethical approval: City and East NHS Research Ethics Committee (reference number 13 LO 1801). Findings will be made available through publication in peer-reviewed journals, and to participants and members of the public via Twitter and from the University College London eHealth Unit website. Raw data will be made available on request.
Current Controlled Trials. ISRCTN18649610. Registered 15 October 2013 http://www.controlled-trials.com/ISRCTN18649610.
Hip fractures are a leading cause of mortality and disability worldwide, and the number of hip fractures is expected to rise to over 6 million per year by 2050. The optimal approach for the surgical management of displaced femoral neck fractures remains unknown. Current evidence suggests the use of arthroplasty; however, there is lack of evidence regarding whether patients with displaced femoral neck fractures experience better outcomes with total hip arthroplasty (THA) or hemiarthroplasty (HA). The HEALTH trial compares outcomes following THA versus HA in patients 50 years of age or older with displaced femoral neck fractures.
HEALTH is a multicentre, randomised controlled trial where 1434 patients, 50 years of age or older, with displaced femoral neck fractures from international sites are randomised to receive either THA or HA. Exclusion criteria include associated major injuries of the lower extremity, hip infection(s) and a history of frank dementia. The primary outcome is unplanned secondary procedures and the secondary outcomes include functional outcomes, patient quality of life, mortality and hip-related complications—both within 2 years of the initial surgery. We are using minimisation to ensure balance between intervention groups for the following factors: age, prefracture living, prefracture functional status, American Society for Anesthesiologists (ASA) Class and centre number. Data analysts and the HEALTH Steering Committee are blinded to the surgical allocation throughout the trial. Outcome analysis will be performed using a 2 test (or Fisher's exact test) and Cox proportional hazards modelling estimate. All results will be presented with 95% CIs.
The HEALTH trial has received local and McMaster University Research Ethics Board (REB) approval (REB#: 06-151).
Outcomes from the primary manuscript will be disseminated through publications in academic journals and presentations at relevant orthopaedic conferences. We will communicate trial results to all participating sites. Participating sites will communicate results with patients who have indicated an interest in knowing the results.
The HEALTH trial is registered with clinicaltrials.gov (NCT00556842).
To investigate the relationship between self-rated health, adjusted for standard risk factors, and myocardial infarction.
Population-based prospective cohort study.
Enrolment took place between 1990 and 2004 in Västerbotten County, Sweden
Every year, persons in the total population, aged 40, 50 or 60 were invited. Participation rate was 60%. The cohort consisted of 75 386 men and women. After exclusion for stroke or myocardial infarction before, or within 12 months after enrolment or death within 12 months after enrolment, 72 530 persons remained for analysis. Mean follow-up time was 13.2 years.
Cox regression analysis was used to estimate HRs for the end point of first non-fatal or fatal myocardial infarction. HR were adjusted for age, sex, systolic blood pressure, total cholesterol, smoking, diabetes, body mass index, education, physical activity and self-rated health in the categories very good; pretty good; somewhat good; pretty poor or poor.
In the cohort, 2062 persons were diagnosed with fatal or non-fatal myocardial infarction. Poor self-rated health adjusted for sex and age was associated with the outcome with HR 2.03 (95% CI 1.45 to 2.84). All categories of self-rated health worse than very good were statistically significant and showed a dose–response relationship. In a multivariable analysis with standard risk factors (not including physical activity and education) HR was attenuated to 1.61 (95% CI 1.13 to 2.31) for poor self-rated health. All categories of self-rated health remained statistically significant. We found no interaction between self-rated health and standard risk factors except for poor self-rated health and diabetes.
This study supports the use of self-rated health as a standard risk factor among others for myocardial infarction. It remains to demonstrate whether self-rated health adds predictive value for myocardial infarction in combined algorithms with standard risk factors.
In order to improve antimicrobial (AM) use, a policy of providing technical and financial support to AM management teams (AMTs) was rolled out in all Belgian hospitals between 2002 and 2008. We aimed to analyse the association of this policy with AM use for the two indications accounting for the largest number of patients receiving AM: prophylaxis for major lower limb orthopaedic surgery and pneumonia.
We used patient-level data routinely collected in all Belgian acute care hospitals between 1999 and 2010. We modelled trends for selected quality indicators (QIs) using the year of AMT implementation in each hospital as the main 'change point', with fine-tuned case-mix adjustment. Of all admissions for lower limb orthopaedic surgery, and pneumonia between 1999 and 2010, 90% (325 094) and 95% (327 635), respectively, were found eligible for analyses.
The surgery QI was defined as: cefazolin, dose in the expected range, and no use of other AM. For pneumonia, QIs were: ratio of oral/parenteral defined daily doses (DDD, O/P QI), and mean number of DDD minus penicillin, per 100 days of hospitalisation (DDD QI).
Between 1999 and 2010, the surgery QI improved from 59% to 71%, the O/P QI from 0.72 to 0.97, and the DDD QI from 96 to 64. Heterogeneity between hospitals was high. Overall, no association was found with the year of implementation of the AMT.
Improvements have been observed but could not be related at the national level to the policy under study. However, these results cannot be extrapolated to other QIs for AM use in hospitals. Our findings do not question the need for AMT, nor the need for continuation of AMT funding. Several recommendations can be made in order to make the best of Belgium's unique political and financial commitments in that field.
Depression is common among children and adolescents and is associated with significantly negative effects. A number of structured psychosocial treatments are administered for depression in children and adolescents; however, evidence of their effectiveness is not clear. We describe the protocol of a systematic review and network meta-analysis to evaluate the efficacy, quality of life, tolerability and acceptability of the use of psychological intervention for this young population.
We will search PubMed, EMBASE, CENTRAL (the Cochrane Central Register of Controlled Trials), Web of Science, PsycINFO, CINAHL, LiLACS, Dissertation Abstracts, European Association for Grey Literature Exploitation (EAGLE) and the National Technical Information Service (NTIS) from inception to July 2014. There will be no restrictions on language, publication year or publication type. Only randomised clinical trials (RCTs) with psychosocial treatments for depression in children and adolescents will be considered. The primary outcome of efficacy will be the mean overall change of the total score in continuous depression severity scales from baseline to end point. Data will be independently extracted by two reviewers. Traditional pairwise meta–analyses will be performed for studies that directly compared different treatment arms. Then we will perform a Bayesian network meta–analyses to compare the relative efficacy, quality of life, tolerability and acceptability of different psychological intervention. Subgroup analyses will be performed by the age of participants and the duration of psychotherapy, and sensitivity analyses will be conducted to assess the robustness of the findings.
No ethical issues are foreseen. The results will be published in a peer–reviewed journal and disseminated electronically and in print. The meta–analysis may be updated to inform and guide management of depression in children and adolescents.
Increasing evidence suggests that water, sanitation and hygiene (WASH) practices affect linear growth in early childhood. We determined the association between household access to water, sanitation and personal hygiene practices with stunting among children aged 0–23 months in rural India.
A total of 10 364, 34 639 and 1282 under-2s who participated in the 2005–2006 National Family Health Survey (NFHS-3), the 2011 Hunger and Malnutrition Survey (HUNGaMA) and the 2012 Comprehensive Nutrition Survey in Maharashtra (CNSM), respectively, were included in the analysis.
The association between WASH indicators and child stunting was assessed using logistic regression models.
The prevalence of stunting ranged from 25% to 50% across the three studies. Compared with open defecation, household access to toilet facility was associated with a 16–39% reduced odds of stunting among children aged 0–23 months, after adjusting for all potential confounders (NHFS-3 (OR=0.84, 95% CI 0.71 to 0.99); HUNGaMA (OR=0.84, 95% CI 0.78 to 0.91); CNSM (OR=0.61, 95% CI 0.44 to 0.85)). Household access to improved water supply or piped water was not in itself associated with stunting. The caregiver's self-reported practices of washing hands with soap before meals (OR=0.85, 95% CI 0.76 to 0.94) or after defecation (OR=0.86, 95% CI 0.80 to 0.93) were inversely associated with child stunting. However, the inverse association between reported personal hygiene practices and stunting was stronger among households with access to toilet facility or piped water (all interaction terms, p<0.05).
Improved conditions of sanitation and hygiene practices are associated with reduced prevalence of stunting in rural India. Policies and programming aiming to address child stunting should encompass WASH interventions, thus shifting the emphasis from nutrition-specific to nutrition-sensitive programming. Future randomised trials are warranted to validate the causal association.
The aim of the study was to explore the associations between the dyad's (person with stroke and informal caregiver) perception of the person with stroke's rehabilitation needs and stroke severity, personal factors (gender, age, sense of coherence), the use of rehabilitation services, amount of informal care and caregiver burden. Further, the aim was to explore the personal experience of everyday life changes among persons with stroke and their caregivers and their strategies for handling these 1 year after stroke.
A mixed methods design was used combining quantitative and qualitative data and analyses.
Data were mainly collected in the participants' homes.
Data were collected through established instruments and open-ended interviews. The dyad's perceptions of the person with stroke's rehabilitation needs were assessed by the persons with stroke and their informal caregivers using a questionnaire based on Ware's taxonomy. The results were combined and classified into three groups: met, discordant (ie, not in agreement) and unmet rehabilitation needs. To assess sense of coherence (SOC) in persons with stroke, the SOC-scale was used. Caregiver burden was assessed using the Caregiver Burden Scale. Data on the use of rehabilitation services were obtained from the computerised register at the Stockholm County Council.
86 persons with stroke (mean age 73 years, 38% women) and their caregivers (mean age 65 years, 40% women).
Fifty-two per cent of the dyads perceived that the person with stroke's need for rehabilitation was met 12 months after stroke. Met rehabilitation needs were associated with less severe stroke, more coping strategies for solving problems in everyday activities and less caregiver burden.
Rehabilitation interventions need to focus on supporting the dyads' process of psychological and social adaptation after stroke. Future studies need to explore and evaluate the effects of using a dyadic perspective throughout rehabilitation.
Most pneumonia treatment guidelines recommend that prior outpatient antibiotic treatment should be considered when planning inpatient antibiotic regimen. Our purpose was to study in patients admitted for community-acquired pneumonia the mode of continuing antibiotic treatment at the outpatient to inpatient transition and the subsequent clinical course.
Retrospective cohort study.
Dutch PHARMO Record Linkage System.
7323 patients aged >18 years and hospitalised with pneumonia in the Netherlands between 2004 and 2010.
We identified all prescribed antibiotics prior to, during and after hospitalisation. In case of prior outpatient treatment, the continuation of antibiotic treatment on admission was categorised as: no atypical coverage > no atypical coverage; atypical coverage > atypical coverage; no atypical coverage > atypical coverage; and atypical coverage > no atypical coverage.
Length of hospital stay, in-hospital mortality and readmission within 30 days.
Twenty-two per cent of the patients had received prior outpatient treatment, of which 408 (25%) patients were switched on admission to antibiotics with atypical coverage. There were no differences in length of hospital stay, in-hospital mortality or readmission rate between the four categories of patients with prior outpatient treatment. The adjusted HR for adding atypical coverage versus no atypical coverage was 0.91 (95% CI 0.55 to 1.51) for time to discharge. For in-hospital mortality and readmission within 30 days, the adjusted ORs were 1.09 (95% CI 0.85 to 1.34) and 0.59 (95% CI 0.30 to 1.18), respectively.
This study found no association between mode of continuing antibiotic treatment at the outpatient to inpatient transition and relevant clinical outcomes. In particular, adding atypical coverage in patients without prior atypical coverage did not influence the outcome.
Cancer is an important and growing public health burden in South Africa (SA). Over the past few decades, there has been considerable scientific activity in cancer in SA. However, there has been limited analysis of cancer scientific publications. In this paper, we present a protocol for bibliometric analysis of cancer research conducted in SA.
A comprehensive search of the journal databases PubMed, SCOPUS, Web of Science and EBSCO will be conducted to identify and retrieve data from primary peer-reviewed cancer research articles using a set of consensus search words. Articles that involve cancer research conducted in SA or using biological or clinical data from South African participants and published between 2004 and 2014 will be included in the study. Two independent researchers will screen the articles for eligibility. Bibliometric indicators and study characteristics will be extracted, entered into a database and analysed. The cancer disease site will be recorded and research will be classified using the Common Scientific Outline system. Data obtained will be analysed to determine SA's publication productivity index in cancer research. Annual trends in bibliometric indicators and the type of cancer research will be determined. The degree of collaboration in research conducted in SA will be analysed using co-authorship matrix software. A publication to disease type ratio will be used to assess scientific production relative to disease burden.
As this analysis will draw on publicly available data and does not directly involve human participants, ethical review is not required. We anticipate that the bibliometric analysis will identify the trends in cancer research productivity and the extent to which cancer research is aligned to the local burden of disease. Results will be published in peer-reviewed journals and presented in a user-friendly format to relevant policymakers and funders.
To determine the association between the side of the hip fracture and the subsequent occurrence of symptomatic lower limb DVT.
Single tertiary trauma centre, Wales.
All 3657 patients presenting with hip fracture between 2007 and 2013 were identified from our unit's National Hip Fracture Database. We excluded 404 patients (11.0%) resident outside our catchment area, leaving a total of 3253. Median age was 83 years (±12.4).
We cross-linked patient details with Medical Physics records, to identify 634 (19.5%) who had undergone one or more lower-limb Doppler-ultrasound scans at some point during the study period. The distribution rates of DVT were calculated from this resulting data set.
Many of the total 634 scans were unrelated to the hip fracture, including 225 (35.5%) performed prior to the fracture. We calculated a baseline rate of DVT of 3.7/1000 patients per year, for the 3-month period immediately before the hip fracture. Scans performed following hip fracture showed DVT risk to be highest in the 3-month period after fracture (35.7/1000 patients per year). This resulted from a six-fold increase in DVTs on the side of the fracture (29.5/1000 patients per year, p<0.01). We found only a very small non-significant increase in DVT on the contralateral leg (6.1/1000 patients per year)
The additional risk of DVT after hip fracture is essentially confined to the fractured limb—the leg to which it is most painful to apply stockings. There appears little justification for the cost and potential risk of using stockings on the contralateral leg.
Chest pain is common in emergency department (ED) patients and represents a considerable burden for rural health services. Health services reforms to improve access to care need appropriately skilled and supported clinicians in the delivery of safe and effective care, including the use of emergency nurse practitioners (ENPs). Despite increasing use of ENPs, little is known about the safety and quality of the service in the rural ED context. The aims of this study are (1) to examine the safety and quality of the ENP service model in the provision of care in the rural environment and (2) to evaluate the effectiveness of the service in the management of patients presenting with undifferentiated chest pain.
This is the protocol for a prospective longitudinal nested cohort study to compare the effectiveness of ENP service with that of standard care. Adults presenting to three rural EDs in Queensland, Australia with a primary presenting complaint of atraumatic chest pain will be eligible for enrolment. We will measure (1) clinician's use of evidence-based guidelines (2) diagnostic accuracy of ECG interpretation for the management of patients with suspected or confirmed ACS (3) service indicators of waiting times, length-of-stay and did-not-wait rates and (4) clinician's diagnostic accuracy as measured by rates of unplanned representation within 7 days (5) satisfaction with care, (6) quality-of-life and (7) functional status. To assess these outcomes we will use a combination of measures collected from routinely collected data, medical record review and questionnaires (with 30-day follow-up).
Queensland Health Human Research Ethics Committee (HREC) has approved this protocol. The results will be published in peer-reviewed scientific journals and presented at one or more scientific conferences.
Diabetes mellitus (DM) is the most common cause of end-stage renal disease (ESRD). Patients with diabetes on dialysis have worse clinical outcomes and increased psychological burden. The need to manage the combined treatment demands for both conditions is particularly challenging yet there is paucity of data of the barriers preventing optimal management to combined therapy for diabetes and kidney failure. The study aims to explore needs of patients and develop an intervention to enable people with diabetes and ESRD to better manage both their conditions.
A two-phase study comprising a mixed method observational study (phase I) and a feasibility trial (phase II). Phase I will seek to document outcomes and needs of the population (patients with DM-ESRD) and seek input on preferred delivery/implementation for the programme. Data will be collected with in-depth interviews with patients, caregivers and healthcare providers (N=50), and from a questionnaire-based survey (N=170). Phase 2 will build on these data to design and test the feasibility of a practical, low-intensity, clinic-integrated intervention using a self-management paradigm. The intervention will primarily seek to support behavioural change so as to improve adherence and clinical outcomes for DM as well as for ESRD. For the feasibility trial, we will be evaluating acceptability, retention and completion rates of the programme.
The study protocol has been approved by the local ethics committee and written informed consent is required from every participant. Findings will be disseminated through journals, conferences and will be used to create a fully manualised intervention (materials) and training course for facilitators.
Epidemiological studies suggest that exercise has a tremendous preventative effect on morbidity and premature death, but these findings need to be confirmed by randomised trials. Generation 100 is a randomised, controlled study where the primary aim is to evaluate the effects of 5 years of exercise training on mortality in an elderly population.
All men and women born in the years 1936–1942 (n=6966), who were residents of Trondheim, Norway, were invited to participate. Between August 2012 and June 2013, a total of 1567 individuals (790 women) were included and randomised to either 5 years of two weekly sessions of high-intensity training (10 min warm-up followed by 4x4 min intervals at ~90% of peak heart rate) or, moderate-intensity training (50 min of continuous work at ~70% of peak heart rate), or to a control group that followed physical activity advice according to national recommendations. Clinical examinations, physical tests and questionnaires will be administered to all participants at baseline, and after 1, 3 and 5 years. Participants will also be followed up by linking to health registries until year 2035.
The study has been conducted according to the SPIRIT statement. All participants signed a written consent form, and the study has been approved by the Regional Committee for Medical Research Ethics, Norway. Projects such as this are warranted in the literature, and we expect that data from this study will result in numerous papers published in world-leading clinical journals; we will also present the results at international and national conferences.
Clinical trial gov NCT01666340.
Unilateral haemodynamically significant large-vessel intracranial stenosis may be associated with reduced blood-oxygen-level-dependent (BOLD) cerebrovascular reactivity (CVR), an indicator of autoregulatory reserve. Reduced CVR has been associated with ipsilateral cortical thinning and loss in cognitive function. These effects have been shown to be reversible following revascularisation. Our aim was to study the effects of unilateral revascularisation on CVR in the non-intervened hemisphere in bilateral steno-occlusive or Moyamoya disease.
A retrospective observational study.
A routine follow-up assessment of CVR after a revascularisation procedure at a research teaching hospital in Toronto (Journal wants us to generalise).
Thirteen patients with bilateral Moyamoya disease (age range 18 to 52 years; 3 males), seven patients with steno-occlusive disease (age range 18 to 78 years; six males) and 27 approximately age-matched normal control subjects (age range 19–71 years; 16 males) with no history or findings suggestive of any neurological or systemic disease.
Participants underwent BOLD CVR MRI using computerised prospective targeting of CO2, before and after unilateral revascularisation (extracranial–intracranial bypass, carotid endarterectomy or encephaloduroarteriosynangiosis). Pre-revascularisation and post-revascularisation CVR was assessed in each major arterial vascular territory of both hemispheres.
As expected, surgical revascularisation improved grey matter CVR in the middle cerebral artery (MCA) territory of the intervened hemisphere (0.010±0.023 to 0.143±0.010%BOLD/mm Hg, p<0.01). There was also a significant post-revascularisation improvement in grey matter CVR in the MCA territory of the non-intervened hemisphere (0.101±0.025 to 0.165±0.015%BOLD/mm Hg, p<0.01).
Not only does CVR improve in the hemisphere ipsilateral to a flow restoration procedure, but it also improves in the non-intervened hemisphere. This highlights the potential of CVR mapping for staging and evaluating surgical interventions.
To estimate the incidence of serious suicide attempts (SSAs, defined as suicide attempts resulting in either death or hospitalisation) and to examine factors associated with fatality among these attempters.
A surveillance study of incidence and mortality. Linked data from two public health surveillance systems were analysed.
Three selected counties in Shandong, China.
All residents in the three selected counties.
Incidence rate (per 100 000 person-years) and case fatality rate (%).
Records of suicide deaths and hospitalisations that occurred among residents in selected counties during 2009–2011 (5 623 323 person-years) were extracted from electronic databases of the Disease Surveillance Points (DSP) system and the Injury Surveillance System (ISS) and were linked by name, sex, residence and time of suicide attempt. A multiple logistic regression model was developed to examine the factors associated with a higher or lower fatality rate.
The incidence of SSAs was estimated to be 46 (95% CI 44 to 48) per 100 000 person-years, which was 1.5 times higher in rural versus urban areas, slightly higher among females, and increased with age. Among all SSAs, 51% were hospitalised and survived, 9% were hospitalised but later died and 40% died with no hospitalisation. Most suicide deaths (81%) were not hospitalised and most hospitalised SSAs (85%) survived. The fatality rate was 49% overall, but was significantly higher among attempters living in rural areas, who were male, older, with lower education or with a farming occupation. With regard to the method of suicide, fatality was lowest for non-pesticide poisons (7%) and highest for hanging (97%).
The incidence of serious suicide attempts is substantially higher in rural areas than in urban areas of China. The risk of death is influenced by the attempter's sex, age, education level, occupation, method used and season of year.
To examine the relation between the protein:carbohydrate (P/C) ratio and added sugar intake in pregnancy and gestational weight gain (GWG).
A prebirth cohort including 103 119 pregnancies enrolled between 1996 and 2003.
All women in Denmark were eligible to participate if they spoke Danish and were planning to carry to term.The pregnant women were recruited and enrolled during their first antenatal visit (6–10 weeks of gestation).
Participants included women with live-born singletons and complete data on dietary intake and GWG, leaving 46 262 women for the analysis.
Macronutrient intake was quantified using a validated food frequency questionnaire administered in the 25th week of gestation. The P/C ratio and added sugar intake were examined in quintiles.
GWG was based on self-reported weight in gestational weeks 12 and 30 and defined as gain in g/week. We used multivariable linear regression, including adjusting for pre-pregnancy body mass index, to calculate relative change in GWG and 95% CI.
Average GWG was 471(224) g/week. The adjusted weight gain was 16 g/week lower (95% CI 9 to 22, p for trend <0.001) in the highest (Q5) versus lowest (Q1) quintile of the P/C ratio (~3% average reduction across the entire pregnancy). Weight gain for those with >20%E vs <12%E from protein was 36 g/week lower (95% CI 20 to 53, p for trend <0.0001; ~8% average reduction). A high P/C ratio was inversely related to intake of added sugars. Added sugar consumption was strongly associated with GWG (Q5 vs Q1: 34, 95% CI 28 to 40 g/week, p for trend <0.0001).
A high P/C ratio was associated with reduced GWG. This association appeared to be partly driven by a decrease in intake of added sugar. These results are consistent with randomised trials in non-pregnant participants. A dietary intervention targeting an increased P/C ratio with emphasis on reducing added sugar can contribute to reducing excessive GWG.
We examined abruption risk in relation to change in paternity, and evaluated if birth interval confounds this association.
Population-based study of singleton births in Norway between 1967 and 2009.
Women who had their first two (n=747 566) singleton births in the Norwegian Medical Birth Registry. The associations between partner change between pregnancies and birth interval were examined in relation to abruption in a series of logistic regression models.
Risk, as well as unadjusted and adjusted OR of placental abruption in relation to change in paternity and interval between births.
Among women without abruption in their first pregnancy, the risks of abruption in the second pregnancy were 4.7 and 6.5 per 1000 in women who had the same and different partners, respectively (OR=1.39, 95% CI 1.26 to 1.53). After adjustments for confounders including birth interval and smoking, partner change was not associated with abruption (OR=1.01, 95% CI 0.79 to 1.32). Among women with abruption in the first pregnancy, the association between partner change and abruption in the second pregnancy was 0.98 (95% CI 0.75 to 1.28). Interval <1 year was associated with increased abruption risk in the second pregnancy among women with the same as well as different partners, but interval over 4 years was only associated with increased risk among women with the same partner. No such patterns were seen for recurrent abruption.
We find no evidence that a change in partner is associated with increased abruption risk. Theories supporting an immune maladaptation hypothesis afforded by change in paternity are not supported insofar as abruption is concerned.
Of adolescents in the general population in England, we aimed to determine (1) the proportion that has an emergency admission to hospital for injury related to adversity (violence, self-harm or drug or alcohol misuse) and (2) the risk of recurrent emergency admissions for injury in adolescents admitted with adversity-related injury compared with those admitted with accident-related injury only.
We used longitudinally linked administrative hospital data (Hospital Episode Statistics) to identify participants aged 10–19 years with emergency admissions for injury (including day cases lasting more than 4 h) in England in 1998–2011. We used the Office for National Statistics mid-year estimates for population denominators.
Approximately 4.3% (n=141 248) of adolescents in the general population (n=3 254 046) had one or more emergency admissions for adversity-related injury (girls 4.6%, boys 4.1%), accounting for 50% of all emergency admissions for injury in girls and 29.1% in boys. Admissions for self-harm or drug or alcohol misuse commonly occurred in the same girls and boys. Recurrent emergency admissions for injury were more common in adolescents with adversity-related injury (girls 17.3%, boys 16.5%) than in those with accident-related injury only (girls 4.7%, boys 7.4%), particularly for adolescents with adversity-related injury related to multiple types of adversity (girls 21.1%, boys 24.2%).
Hospital-based interventions should be developed to reduce the risk of future injury in adolescents admitted for adversity-related injury.
To investigate patients' experiences of the choice of general practitioner (GP) practice pilot.
Mixed-method, cross-sectional study.
Patients in the UK National Health Service (NHS) register with a general practice responsible for their primary medical care and practices set geographic boundaries. In 2012/2013, 43 volunteer general practices in four English NHS primary care trusts (PCTs) piloted a scheme allowing patients living outside practice boundaries to register as an out of area patient or be seen as a day patient.
Analysis of routine data for 1108 out of area registered patients and 250 day patients; postal survey of out of area registered (315/886, 36%) and day (64/188, 34%) patients over 18 years of age, with a UK mailing address; comparison with General Practice Patient Survey (GPPS); semistructured interviews with 24 pilot patients.
Pilot patients were younger and more likely to be working than non-pilot patients at the same practices and reported generally more or at least as positive experiences than patients registered at the same practices, practices in the same PCT and nationally, despite belonging to subgroups of the population who typically report poorer than average experiences. Out of area patients who joined a pilot practice did so: after moving house and not wanting to change practice (26.2%); for convenience (32.6%); as newcomers to an area who selected a practice although they lived outside its boundary (23.6%); because of dissatisfaction with their previous practice (13.9%). Day patients attended primarily on grounds of convenience (68.8%); 51.6% of the day patient visits were for acute infections, most commonly upper respiratory infections (20.4%). Sixty-six per cent of day patients received a prescription during their visit.
Though the 12-month pilot was too brief to identify all costs and benefits, the scheme provided a positive experience for participating patients and practices.
Accurate assessment of cartilage status is increasingly becoming important to clinicians for offering joint preservation surgeries versus joint replacements. The goal of this study was to evaluate the validity of three-dimensional (3D), gradient-echo (GRE)-based T2* and T1Gd mapping for the assessment of various histological severities of degeneration in knee joint cartilage with potential implications for clinical management.
MRI and histological assessment were conducted in 36 ex vivo lateral femoral condyle specimens. The MRI protocol included a 3D GRE multiecho data image combination sequence in order to assess the T2* decay, a 3D double-echo steady-state sequence for assessment of cartilage morphology, and a dual flip angle 3D GRE sequence with volumetric interpolated breathhold examination for the T1Gd assessment. The histological sample analysis was performed according to the Mankin system. The data were then analysed statistically and correlated.
We observed a significant decrease in the T2* and T1Gd values with increasing grades of cartilage degeneration (p<0.001) and a moderate correlation between T2* (r=0.514)/T1Gd (r=0.556) and the histological grading of cartilage degeneration (p<0.001). In addition, we noted a zonal variation in the T2* and T1Gd values reflecting characteristic zonal differences in the biochemical composition of hyaline cartilage.
This study outlines the potential of GRE-based T2* and T1Gd mapping to identify various grades of cartilage damage. Early changes in specific zones may assist clinicians in identifying methods of early intervention involving the targeted joint preservation approach versus moving forward with unicompartmental, bicompartmental or tricompartmental joint replacement procedures.
Frailty is a major concern due to its costly and widespread consequences, yet evidence of effective interventions to delay or reduce frailty is lacking. Our previous study found that a multifactorial intervention was feasible and effective in reducing frailty in older people who were already frail. Identifying and treating people in the pre-frail state may be an effective means to prevent or delay frailty. This study describes a randomised controlled trial that aims to evaluate the effectiveness of a multifactorial intervention on development of frailty in older people who are pre-frail.
A single centre randomised controlled trial with concealed allocation, assessor blinding and intention-to-treat analysis. Two hundred and thirty people aged above 70 who meet the Cardiovascular Health Study frailty criteria for pre-frailty, reside in the community and are without severe cognitive impairment will be recruited. Participants will be randomised to receive a multifactorial intervention or usual care. The intervention group will receive a 12-month interdisciplinary intervention targeting identified characteristics of frailty and problems identified during geriatric assessment. Participants will be followed for a 12-month period. Primary outcome measures will be degree of frailty measured by the number of Cardiovascular Health Study frailty criteria present, and mobility measured with the Short Physical Performance Battery. Secondary outcomes will include measures of mobility, mood and use of health and community services.
The study was approved by the Northern Sydney Local Health District Health Research Ethics Committee (1207-213M). The findings will be disseminated through scientific and professional conferences, and in peer-reviewed journals.
Australian New Zealand Clinical Trials Registry: ACTRN12613000043730.
To develop a conceptual model for effective use of telehealth in the management of chronic health conditions, and to use this to develop and evaluate an intervention for people with two exemplar conditions: raised cardiovascular disease risk and depression.
The model was based on several strands of evidence: a metareview and realist synthesis of quantitative and qualitative evidence on telehealth for chronic conditions; a qualitative study of patients' and health professionals' experience of telehealth; a quantitative survey of patients' interest in using telehealth; and review of existing models of chronic condition management and evidence-based treatment guidelines. Based on these evidence strands, a model was developed and then refined at a stakeholder workshop. Then a telehealth intervention ('Healthlines') was designed by incorporating strategies to address each of the model components. The model also provided a framework for evaluation of this intervention within parallel randomised controlled trials in the two exemplar conditions, and the accompanying process evaluations and economic evaluations.
Primary care.
The TElehealth in CHronic Disease (TECH) model proposes that attention to four components will offer interventions the best chance of success: (1) engagement of patients and health professionals, (2) effective chronic disease management (including subcomponents of self-management, optimisation of treatment, care coordination), (3) partnership between providers and (4) patient, social and health system context. Key intended outcomes are improved health, access to care, patient experience and cost-effective care.
A conceptual model has been developed based on multiple sources of evidence which articulates how telehealth may best provide benefits for patients with chronic health conditions. It can be used to structure the design and evaluation of telehealth programmes which aim to be acceptable to patients and providers, and cost-effective.
Jian Ling Decoction (JLD) is often prescribed to improve hypertension-related symptoms in China. However, this treatment has not been systematically reviewed for its efficacy against essential hypertension (EH). This review aims to assess the current clinical evidence of JLD in the treatment of EH.
Seven electronic databases, including the Cochrane Central Register of Controlled Trials, PubMed, EMBASE, the Chinese National Knowledge Infrastructure (CNKI), the Chinese Scientific Journal Database (VIP), the Chinese Biomedical Literature Database (CBM) and the Wanfang Database, were searched up to March 2014. Randomised control trials (RCTs) comparing JLD or combined with antihypertensive drugs versus antihypertensive drugs were included. We assessed the methodological quality, extracted the valid data and conducted the meta-analysis according to criteria from the Cochrane group. The primary outcome was categorical or continuous blood pressure (BP), and the secondary outcome was quality of life (QOL).
Ten trials (655 patients) with unclear-to-high risk of bias were identified. Meta-analysis showed that JLD used alone showed no BP reduction effect; however, improvement on QOL was found in the JLD group compared to antihypertensive drugs. A significant reduction in systolic and diastolic BP was observed for JLD plus antihypertensive drugs when compared with antihypertensive drugs alone. No serious adverse effects were reported.
Owing to insufficient clinical data, it is difficult to draw a definite conclusion regarding the effectiveness and safety of JLD for EH, and better trials are needed.
To evaluate the impact of the GOALS (Getting Our Active Lifestyles Started) family-based childhood obesity treatment intervention during the first 3 years of implementation.
Single-group repeated measures with qualitative questionnaires.
Community venues in a socioeconomically deprived, urban location in the North-West of England.
70 overweight or obese children (mean age 10.5 years, 46% boys) and their parents/carers who completed GOALS between September 2006 and March 2009.
GOALS was a childhood obesity treatment intervention that drew on social cognitive theory to promote whole family lifestyle change. Sessions covered physical activity (PA), diet and behaviour change over 18 2 h weekly group sessions (lasting approximately 6 months). A Template for Intervention Description and Replication (TIDieR) checklist of intervention components is provided.
The primary outcome measure was child body mass index (BMI) z-score, collected at baseline, post-intervention and 12 months. Secondary outcome measures were child self-perceptions, parent/carer BMI and qualitative changes in family diet and PA (parent/carer questionnaire).
Child BMI z-score reduced by 0.07 from baseline to post-intervention (p<0.001) and was maintained at 12 months (p<0.05). There was no change in parent/carer BMI or child self-perceptions, other than an increase in perceived social acceptance from baseline to post-intervention (p<0.05). Parents/carers reported positive changes to family PA and dietary behaviours after completing GOALS.
GOALS completion was associated with small improvements in child BMI z-score and improved family PA and dietary behaviours. Several intervention modifications were necessary during the implementation period and it is suggested childhood obesity treatment interventions need time to embed before a definitive evaluation is conducted. Researchers are urged to use the TIDieR checklist to ensure transparent reporting of interventions and facilitate the translation of evidence to practice.
Although successful airway management is essential for emergency trauma care, comprehensive studies are limited. We sought to characterise current trauma care practice of airway management in the emergency departments (EDs) in Japan.
Analysis of data from a prospective, observational, multicentre registry—the Japanese Emergency Airway Network (JEAN) registry.
13 academic and community EDs from different geographic regions across Japan.
723 trauma patients who underwent emergency intubation from March 2010 through August 2012.
ED characteristics, patient and operator demographics, methods of airway management, intubation success or failure at each attempt and adverse events.
A total of 723 trauma patients who underwent emergency intubation were eligible for the analysis. Traumatic cardiac arrest comprised 32.6% (95% CI 29.3% to 36.1%) of patients. Rapid sequence intubation (RSI) was the initial method chosen in 23.9% (95% CI 21.0% to 27.2%) of all trauma patients and in 35.5% (95% CI 31.4% to 39.9%) of patients without cardiac arrest. Overall, intubation was successful in ≤3 attempts in 96% of patients (95% CI 94.3% to 97.2%). There was a wide variation in the initial methods of intubation; RSI as the initial method was performed in 0–50.9% of all trauma patients among 12 EDs. Similarly, there was a wide variation in success rates and adverse event rates across the EDs. Success rates varied between 35.5% and 90.5% at the first attempt, and 85.1% and 100% within three attempts across the 12 EDs.
In this multicentre prospective study in Japan, we observed a high overall success rate in airway management during trauma care. However, the methods of intubation and success rates were highly variable among hospitals.
To test the effectiveness of a non-pharmaceutical programme for obese participants in a rural Eastern Canadian Province using certified health professionals.
A prospective quasi-experimental design with repeated premeasure and postmeasure.
146 participants with obesity (body mass index >30 kg/m2) from rural and urban communities in an Eastern Canadian Province were divided into four groups.
A 6-month intensive active community-based lifestyle intervention (InI) delivered by Certified Exercise Physiologists, Certified Personal Trainers and Registered Dietitians, followed by 6 months of self-management. A second intervention (InII) was nested in InI and consisted of group-mediated cognitive–behavioral intervention (GMCBI) delivered by an exercise psychologist to two of the four InI groups.
(1) Improving health outcomes among the participants' preactive and postactive 6-month intervention and self-management period, (2) Documenting the impact of InII (GMCBI) and location of the intervention (urban vs rural).
The 6-month active InI significantly improved cardiovascular health for participants who completed the intervention. InII (GMCBI) significantly lowered the attrition rate among the participants. The self-management period was challenging for the participants and they did not make further gains; however, most were able to maintain the gains achieved during the active intervention. The location of the intervention, urban or rural, had little impact on outcomes.
A community-based programme utilising healthcare professionals other than physicians to treat obese patients was effective based on premeasure and postmeasure. During the self-management phase, the participants were able to maintain the gains. Psychological support is essential to participant retention.
The present study assesses the relationship between contents of GD1 (glycerol dehydratase)-positive Lactobacillus, presence of Lactobacillus and the inflammatory response measured in host lung tissue in mild to moderate chronic obstructive pulmonary disease (COPD). We hypothesise that there will be a loss of GD1 producing Lactobacillus with increasing severity of COPD and that GD1 has anti-inflammatory properties.
Secondary care, 1 participating centre in Vancouver, British Columbia, Canada.
74 individuals who donated non-cancerous portions of their lungs or lobes removed as treatment for lung cancer (normal lung function controls (n=28), persons with mild (GOLD 1) (n=21) and moderate (GOLD 2) COPD (n=25)).
Primary outcome measure was GD1 positivity within each group and whether or not this impacted quantitative histological measures of lung inflammation. Secondary outcome measures included Lactobacillus presence and quantification, and quantitative histological measurements of inflammation and remodelling in early COPD.
Total bacterial count (p>0.05) and prevalence of Lactobacillus (p>0.05) did not differ between groups. However, the GD1 gene was detected more frequently in the controls (14%) than in either mild (5%) or moderate (0%) COPD (p<0.05) samples. Macrophage and neutrophil volume fractions (0.012±0.005 (mean±SD) vs 0.026±0.017 and 0.005±0.002 vs 0.015±0.014, respectively) in peripheral lung tissue were reduced in samples positive for the GD1 gene (p<0.0035).
A reduction in GD1 positivity is associated with an increased tissue immune inflammatory response in early stage COPD. There is potential for Lactobacillus to be used as a possible therapeutic, however, validation of these results need to be completed before an anti-inflammatory role of Lactobacillus in COPD can be confirmed.
This literature review examined research into the impact of a previous 'all-clear' or non-cancer diagnosis following symptomatic presentation ('false alarm') on symptom attribution and delays in help seeking for subsequent possible cancer symptoms.
The comprehensive literature review included original research based on quantitative, qualitative and mixed data collection methods. We used a combination of search strategies, including in-depth searches of electronic databases (PubMed, EMBASE, PsychInfo), searching key authors and articles listed as 'related' in PubMed, and reference lists. We performed a narrative synthesis of key themes shared across studies.
The review included studies published after 1990 and before February 2014 reporting information on adult patients having experienced a false alarm following symptomatic presentation. We excluded false alarms in the context of screening.
We evaluated the effect of a 'false alarm' on symptom attribution and help seeking for new or recurrent possible cancer symptoms.
Overall, 1442 papers were screened and 121 retrieved for full-text evaluation. Among them, 19 reported on false alarms and subsequent symptom attribution or help seeking. They used qualitative (n=14), quantitative (n=3) and mixed methods (n=2). Breast (n=7), gynaecological (n=3), colorectal (n=2), testicular (n=2), and head and neck cancers (n=2) were the most studied. Two broad themes emerged underlying delays in help seeking: (1) over-reassurance from the previous 'all-clear' diagnosis leading to subsequent symptoms being interpreted as benign, and (2) unsupportive healthcare experiences in which symptoms were dismissed, leaving patients concerned about appearing hypochondriacal or uncertain about the appropriate next actions. The evidence suggested that the effect of a false alarm can persist for months and even years.
In conclusion, over-reassurance and undersupport of patients after a false alarm can undermine help seeking in the case of new or recurrent potential cancer symptoms, highlighting the need for appropriate patient information when investigations rule out cancer.
Recurrent or persistent low back pain is common after back surgery but is typically not well controlled. Previous randomised controlled trials on non-acute pain after back surgery were flawed. In this article, the design and protocol of a randomised controlled trial to treat pain and improve function after back surgery are described.
This study is a pilot randomised, active-controlled, assessor-blinded trial. Patients with recurring or persistent low back pain after back surgery, defined as a visual analogue scale value of ≥50 mm, with or without leg pain, will be randomly assigned to an electroacupuncture-plus-usual-care group or to a usual-care-only group. Patients assigned to both groups will have usual care management, including physical therapy and patient education, twice a week during a 4-week treatment period that would begin at randomisation. Patients assigned to the electroacupuncture-plus-usual-care group will also have electroacupuncture twice a week during the 4-week treatment period. The primary outcome will be measured with the 100 mm pain visual analogue scale of low back pain by a blinded evaluator. Secondary outcomes will be measured with the EuroQol 5-Dimension and the Oswestry Disability Index. The primary and secondary outcomes will be measured at 4 and 8 weeks after treatment.
Written informed consent will be obtained from all participants. This study was approved by the Institutional Review Board (IRB) of Pusan National University Korean Hospital in September 2013 (IRB approval number 2013012). The study findings will be published in peer-reviewed journals and presented at national and international conferences.
This trial was registered with the US National Institutes of Health Clinical Trials Registry: NCT01966250.
One in six children who have been admitted to hospital with an injury develop persistent stress symptoms that put their development at risk. Parents play a crucial role in children's psychological recovery, however, it is unknown how specific parenting behaviours can help or hinder. We aim to describe the nature and quantity of parent–child communication after a child has been injured, and to examine how these interactions are related to children's psychological recovery.
We are conducting a prospective observational study among children aged 3–16 years, who have been admitted to a tertiary children's hospital with a serious injury. Data collection involves a naturalistic observation of spontaneous, everyday parent–child communication at home, shortly after discharge, and an assessment of children's psychological recovery at 6 weeks and 3 months post-injury. Main analyses comprise descriptive statistics, cluster analysis and analyses of variance.
This study has been approved by the Human Research Ethics Committee of the Royal Children's Hospital Melbourne (33103) and Monash University Human Research Ethics Committee (CF13/2515—2013001322). We aim to disseminate the findings through international peer-reviewed journals, international conferences and social media. Participants will be sent a summary of the overall study findings.
Engaging in teamwork requires a clear understanding of positive and negative behaviours that act as facilitators and barriers to collegial workplace relationships. Identifying and correcting underlying barriers, while promoting facilitators, is fundamental to improving care delivery and, ultimately, clinical outcomes. Despite a considerable amount of literature in this area, there is a lack of clarity of the different behaviours as several parallel literatures address similar questions about antecedents, processes and outcomes. The purpose of this study is to synthesise the current state of literature reporting on behaviours in workplace relationships. Using a scoping review methodology, the following research question will be addressed: "What is known about positive and negative behaviours in workplace relationships?"
We will employ the methodological frameworks used by Arksey and O'Malley and Levac et al. The search strategy will include numerous electronic databases, grey literature sources and hand-searching of reference lists from 1990 to present with a limit to English language. Search strategies will be developed using controlled vocabulary and keyword terms related to various components of workplace relationships. Two reviewers will independently screen titles and abstracts for inclusion, followed by screening of the full text of potential articles to determine final inclusion. A descriptive numerical analysis will describe characteristics of included studies. A thematic analysis will provide an overview of the literature, including definitions, conceptual frameworks, antecedents, outcomes and interventions.
In reviewing a wide range of positive and negative behaviours, then integrating into a manageable, meaningful whole, this study is a critical step in helping policymakers, leaders and healthcare professionals effectively use what is known thus far. Knowledge translation activities will occur throughout the study with dissemination of findings to local, national, and international stakeholders, including a wide range of clinicians, leaders and administrators in all sectors.
To determine whether older age at graduation is associated with any difference in outcomes from the annual specialty training progression assessment.
An open cohort of 38 308 doctors who graduated from a UK medical school with annual assessments of progression in their specialty training programme with data centrally collected by the General Medical Council between 5 August 2009 to 31 July 2012.
Mature junior doctors (≥29 years at graduation) were more likely to have problems with progression on their annual review of competence progression record of in training assessment (ARCP/RITA) than their younger colleagues (OR 1.34, 95% CI 1.22 to 1.49, p<0.001). This association was, if anything, even stronger (OR 1.57, 95% CI 1.41 to 1.74, p<0.001) after adjustment for gender, ethnicity, type of University and specialty. The same was true when only looking at the most extreme ARCP outcome (4) which is being asked to leave their specialist programme (OR 1.81, 95% CI 1.34 to 2.44, p<0.001).
Mature doctors are a growing part of the medical workforce and they are likely to broaden the spectrum of doctors by bring different life experience to the profession. These results suggest that they are more likely to have problems with progressing through their specialist training programme. More research is required to determine the reasons behind these associations and how mature doctors can be supported both in choosing the best training programme and in coping with the complex demands of higher training at a later stage in their lives.
To investigate the safety and efficacy of QMF149, a once-daily, fixed-dose combination of the long-acting β2-agonist (LABA) indacaterol maleate and inhaled corticosteroid (ICS) mometasone furoate (MF) for the treatment of persistent asthma. The hypothesis was that QMF149 would not increase the risk of serious asthma exacerbations.
174 research centres in nine countries.
1519 adolescents and adults with persistent asthma who were treated or qualified for treatment with combination LABA/ICS were randomised, and 1508 were included in the intention-to-treat analysis.
Patients were randomised to QMF149 (indacaterol maleate 500 µg/MF 400 µg) or MF (400 µg) once daily via Twisthaler inhalation device in a double-blind, parallel-group study for 6–21 months.
The primary end point was time to first serious asthma exacerbation (resulting in hospitalisation, intubation or death). The key secondary end point was annual rate of exacerbations requiring systemic corticosteroids.
Treatment with QMF149 resulted in no significant difference in time to first serious exacerbation compared to MF (2 (0.3%) vs 6 events (0.8%); difference –0.52 percentage point; 95% CI –1.25 to 0.21, p=0.160, HR=0.31; 95% CI 0.06 to 1.54, p=0.151). QMF149 significantly reduced the annual rate of exacerbations requiring systemic corticosteroids (rate ratio=0.71; 95% CI 0.55 to 0.90, p=0.005). Proportions of patients experiencing adverse events were similar across groups (74.0% in the QMF149 group and 73.4% in the MF group). Serious adverse events occurred in 4% and 5.8% of patients in the QMF149 and MF groups, respectively.
No significant difference was observed in the primary outcome of time to first serious asthma exacerbation in patients treated with QMF149 compared with patients treated with MF. Long-term treatment with QMF149 once daily had a favourable safety/efficacy profile in adolescent and adult patients with persistent asthma.
ClinicalTrials.gov; NCT00941798.
To study the incidence of de novo multimorbidity across all ages in a geographically defined population with an emphasis on sex and ethnic differences.
Historical cohort study.
All persons residing in Olmsted County, Minnesota, USA on 1 January 2000 who had granted permission for their records to be used for research (n=123 716).
We used the Rochester Epidemiology Project medical records-linkage system to identify all of the county residents. We identified and removed from the cohort all persons who had developed multimorbidity before 1 January 2000 (baseline date), and we followed the cohort over 14 years (1 January 2000 through 31 December 2013).
Incident multimorbidity was defined as the development of the second of 2 conditions (dyads) from among the 20 chronic conditions selected by the US Department of Health and Human Services. We also studied the incidence of the third of 3 conditions (triads) from among the 20 chronic conditions.
The incidence of multimorbidity increased steeply with older age; however, the number of people with incident multimorbidity was substantially greater in people younger than 65 years compared to people age 65 years or older (28 378 vs 6214). The overall risk was similar in men and women; however, the combinations of conditions (dyads and triads) differed extensively by age and by sex. Compared to Whites, the incidence of multimorbidity was higher in Blacks and lower in Asians.
The risk of developing de novo multimorbidity increases steeply with older age, varies by ethnicity and is similar in men and women overall. However, as expected, the combinations of conditions vary extensively by age and sex. These data represent an important first step toward identifying the causes and the consequences of multimorbidity.
We aimed to conduct culturally-based participatory research to assess cultural and belief contexts for smoking behaviours within Mandarin and Cantonese communities. Outcome variables were smoking-related knowledge, smoking patterns, attitudes and beliefs, and perceived barriers and facilitators to successful cessation.
A community-based approach was applied involving smokers, community key-informants and professionals in study design and implementation. Initially, focus groups were conducted and findings were used to develop study instrument. Participants responded once to study questionnaire after informed consent.
Community based in the Greater Vancouver Area, Canada.
16 Chinese smokers participated in focus groups and subsequently, 167 current Chinese immigrant (137 males and 30 females) smokers from Mandarin and Cantonese communities, recruited with the help of community agencies and collaborating physicians, were enrolled in a cross-sectional study.
We found that a majority believed smoking was harmful on their health. Younger smokers (<35 years of age) did not mind smoking in front of young children compared to older smokers (≥35 years of age) (p<0.001). People with high school or lower levels of education believed that they would benefit more from smoking than suffering from withdrawal symptoms compared to better educated smokers (p<0.05). Mandarin smokers were significantly more likely to encourage others to quit than Cantonese smokers (p<0.05). Many indicated not receiving adequate support from care providers and lack of access to culturally and linguistically appropriate cessation programmes impacted on their ability to quit smoking.
Our study highlighted the importance of tobacco beliefs and perceptions among Mandarin and Cantonese speaking immigrants with limited access to healthcare information and for younger smokers whose attention to health consequences of smoking may be limited as well. Study participants were generally aware of the health risks and were willing to quit. Access to appropriate cessation programmes would fulfil their willingness.
To assess HIV/AIDS research productivity in the 27 countries of the European Union (EU), and the structural level factors associated with levels of HIV/AIDS research productivity.
A bibliometric analysis was conducted with systematic search methods used to locate HIV/AIDS research publications (period of 1 January 2002 to 31 December 2011; search databases: MEDLINE (Ovid, PubMed), EMBASE, ISI-Thomson Web of Science; no language restrictions).
The publication rate (number of HIV/AIDS research publications per million population in 10 years) and the rate of articles published in HIV/AIDS journals and selected journals with moderate to very high (IF ≥3) 5-year impact factors were used as markers for HIV research productivity. A negative binomial regression model was fitted to assess the impact of structural level factors (sociodemographic, health, HIV prevalence and research/development indicators) associated with the variation in HIV research productivity.
The total numbers of HIV/AIDS research publications in 2002–2011 by country ranged from 7 to 9128 (median 319). The median publication rate (per million population in 10 years) was 45 (range 5–150) for all publications. Across all countries, 16% of the HIV/AIDS research was published in HIV/AIDS journals and 7% in selected journals with IF ≥3. Indicators describing economic (gross domestic product), demographic (size of the population) and epidemiological (HIV prevalence) conditions as well as overall scientific activity (total research output) in a country were positively associated with HIV research productivity.
HIV research productivity varies noticeably across EU countries, and this variation is associated with recognisable structural factors.
To investigate the effectiveness of tonsillectomy in reducing acute throat infection (ATI) consultation rates over 6 years' follow-up among children with low baseline ATI consultation rates.
Retrospective cohort study.
UK general practices from the Clinical Practice Research Datalink.
Children aged 4–15 years with ≤3 ATI consultations during the 3 years prior to 2001 (baseline). 450 children who underwent tonsillectomy (tonsillectomy group) and 13 442 other children with an ATI consultation (comparison group) in 2001.
Mean differences in ATI consultation rates over the first 3 years' and subsequent 3 years' follow-up compared with 3 years prior to 2001 (baseline); odds of ≥3 ATI consultations at the same time points.
Among children in the tonsillectomy group, the 3-year mean ATI consultation rate decreased from 1.31 to 0.66 over the first 3 years' follow-up and further declined to 0.60 over the subsequent 3 years' follow-up period. Compared with children who had no operation, those who underwent tonsillectomy experienced a reduction in 3-year mean ATI consultations per child of 2.5 (95% CI 2.3 to 2.6, p<0.001) over the first 3 years' follow-up, but only 1.2 (95% CI 1.0 to 1.4, p<0.001) over the subsequent 3 years' follow-up compared with baseline, respectively. This equates to a mean reduction of 3.7 ATI consultations over a 6-year period and approximates to a mean annual reduction of 0.6 ATI consultations per child, per year, over 6 years' follow-up. Children who underwent tonsillectomy were also much less likely to experience ≥3 ATI consultations during the first 3 years' follow-up (adjusted OR=0.12, 95% CI 0.08 to 0.17) and the subsequent 3 years' follow-up (adjusted OR=0.24, 95% CI 0.14 to 0.41).
Among children with low baseline ATI rates, there was a statistically significant reduction in ATI consultation rates over 6 years' follow-up. However, the relatively modest clinical benefit needs to be weighed against the potential risks and complications associated with surgery.
Vascular access devices (VADs), such as peripheral or central venous catheters, are vital across all medical and surgical specialties. To allow therapy or haemodynamic monitoring, VADs frequently require administration sets (AS) composed of infusion tubing, fluid containers, pressure-monitoring transducers and/or burettes. While VADs are replaced only when necessary, AS are routinely replaced every 3–4 days in the belief that this reduces infectious complications. Strong evidence supports AS use up to 4 days, but there is less evidence for AS use beyond 4 days. AS replacement twice weekly increases hospital costs and workload.
This is a pragmatic, multicentre, randomised controlled trial (RCT) of equivalence design comparing AS replacement at 4 (control) versus 7 (experimental) days. Randomisation is stratified by site and device, centrally allocated and concealed until enrolment. 6554 adult/paediatric patients with a central venous catheter, peripherally inserted central catheter or peripheral arterial catheter will be enrolled over 4 years. The primary outcome is VAD-related bloodstream infection (BSI) and secondary outcomes are VAD colonisation, AS colonisation, all-cause BSI, all-cause mortality, number of AS per patient, VAD time in situ and costs. Relative incidence rates of VAD-BSI per 100 devices and hazard rates per 1000 device days (95% CIs) will summarise the impact of 7-day relative to 4-day AS use and test equivalence. Kaplan-Meier survival curves (with log rank Mantel-Cox test) will compare VAD-BSI over time. Appropriate parametric or non-parametric techniques will be used to compare secondary end points. p Values of <0.05 will be considered significant.
Relevant ethical approvals have been received. CONSORT Statement recommendations will be used to guide preparation of any publication. Results will be presented at relevant conferences and sent to the major organisations with clinical practice guidelines for VAD care.
Australian New Zealand Clinical Trial Registry (ACTRN 12610000505000).
The burden of chronic disease is a global phenomenon, particularly among people aged 65 years and older. More than half of older adults have more than one chronic disease and their care is not optimal. Chronic disease management (CDM) tools have the potential to meet this challenge but they are primarily focused on a single disease, which fails to address the growing number of seniors with multiple chronic conditions.
We will conduct a systematic review alongside a realist review to identify effective CDM tools that integrate one or more high-burden chronic diseases affecting older adults and to better understand for whom, under what circumstances, how and why they produce their outcomes. We will search MEDLINE, EMBASE, CINAHL, AgeLine and the Cochrane Library for experimental, quasi-experimental, observational and qualitative studies in any language investigating CDM tools that facilitate optimal disease management in one or more high-burden chronic diseases affecting adults aged ≥65 years. Study selection will involve calibration of reviewers to ensure reliability of screening and duplicate assessment of articles. Data abstraction and risk of bias assessment will also be performed independently. Analysis will include descriptive summaries of study and appraisal characteristics, effectiveness of each CDM tool (meta-analysis if appropriate); and a realist programme theory will be developed and refined to explain the outcome patterns within the included studies.
Ethics approval is not required for this study. We anticipate that our findings, pertaining to gaps in care across high-burden chronic diseases affecting seniors and highlighting specific areas that may require more research, will be of interest to a wide range of knowledge users and stakeholders. We will publish and present our findings widely, and also plan more active dissemination strategies such as workshops with our key stakeholders.
Our protocol is registered with PROSPERO (registration number CRD42014014489).
To complete a 30-year interrupted time-series analysis of the impact of austerity-related and prosperity-related events on the occurrence of suicide across Greece.
Greece from 1 January 1983 to 31 December 2012.
A total of 11 505 suicides, 9079 by men and 2426 by women, occurring in Greece over the study period.
National data from the Hellenic Statistical Authority assembled as 360 monthly counts of: all suicides, male suicides, female suicides and all suicides plus potentially misclassified suicides.
In 30 years, the highest months of suicide in Greece occurred in 2012. The passage of new austerity measures in June 2011 marked the beginning of significant, abrupt and sustained increases in total suicides (+35.7%, p<0.001) and male suicides (+18.5%, p<0.01). Sensitivity analyses that figured in undercounting of suicides also found a significant, abrupt and sustained increase in June 2011 (+20.5%, p<0.001). Suicides by men in Greece also underwent a significant, abrupt and sustained increase in October 2008 when the Greek recession began (+13.1%, p<0.01), and an abrupt but temporary increase in April 2012 following a public suicide committed in response to austerity conditions (+29.7%, p<0.05). Suicides by women in Greece also underwent an abrupt and sustained increase in May 2011 following austerity-related events (+35.8%, p<0.05). One prosperity-related event, the January 2002 launch of the Euro in Greece, marked an abrupt but temporary decrease in male suicides (–27.1%, p<0.05).
This is the first multidecade, national analysis of suicide in Greece using monthly data. Select austerity-related events in Greece corresponded to statistically significant increases for suicides overall, as well as for suicides among men and women. The consideration of future austerity measures should give greater weight to the unintended mental health consequences that may follow and the public messaging of these policies and related events.
Adolescents spend increasingly more time on electronic devices, and sleep deficiency rising in adolescents constitutes a major public health concern. The aim of the present study was to investigate daytime screen use and use of electronic devices before bedtime in relation to sleep.
A large cross-sectional population-based survey study from 2012, the youth@hordaland study, in Hordaland County in Norway.
Cross-sectional general community-based study.
9846 adolescents from three age cohorts aged 16–19. The main independent variables were type and frequency of electronic devices at bedtime and hours of screen-time during leisure time.
Sleep variables calculated based on self-report including bedtime, rise time, time in bed, sleep duration, sleep onset latency and wake after sleep onset.
Adolescents spent a large amount of time during the day and at bedtime using electronic devices. Daytime and bedtime use of electronic devices were both related to sleep measures, with an increased risk of short sleep duration, long sleep onset latency and increased sleep deficiency. A dose–response relationship emerged between sleep duration and use of electronic devices, exemplified by the association between PC use and risk of less than 5 h of sleep (OR=2.70, 95% CI 2.14 to 3.39), and comparable lower odds for 7–8 h of sleep (OR=1.64, 95% CI 1.38 to 1.96).
Use of electronic devices is frequent in adolescence, during the day as well as at bedtime. The results demonstrate a negative relation between use of technology and sleep, suggesting that recommendations on healthy media use could include restrictions on electronic devices.
Local government concerns over expenditure on social and healthcare are growing. The aim of the present study was to explore the association between a weak 'sense of coherence' (SOC) in teens and their subsequent risk of receiving social and healthcare benefits during young adulthood, and to monitor how SOC developed during this period.
Prospective cohort study.
North Denmark Region.
773 Pupils from seventh and eighth forms who answered a questionnaire in 1998.
Different social benefits (from the Danish DREAM database embracing disbursed public social benefits). Change in SOC score from 1998 to 2010.
722 had answered seven items of the original SOC-13 questionnaire (denoted by SOC-7). Girls with a weak SOC-7 (the lowest 1st quartile) in 1998 had a significantly increased risk of receiving unemployment benefits (RR 1.3 (1.1 to 1.6)), social assistance (RR 1.8 (1.3 to 2.5)) and sickness benefits (RR 1.5 (1.2 to 2.0)) compared with girls with a strong SOC-7. For boys, only minor protective and non-significant differences were found. The SOC answers from 1998 and 2010 were compared (n=394). SOC increased significantly and mostly in girls.
SOC-7 may serve as a predictor for social life event outcomes and hence facilitate an early identification and a selective approach to support teenage girls with a weak SOC. From adolescence to young adulthood, SOC-7 was of a relatively unstable nature.
This study aimed to summarise the current evidence from randomised control trials (RCTs) concerning treatment of patients with resistant hypertension with Chinese herbal medicine (CHM).
Seven databases, including the Cochrane Library, PubMed, EMBASE, CNKI, VIP, CBM and Wanfang, were systematically searched from their inception to March 2014 for RCTs investigating treatment of resistant hypertension in which CHM was used either as a monotherapy or in combination with conventional medicine versus placebo, no intervention or conventional medicine.
Five trials containing 446 hypertensive patients were identified. The methodological quality of most trials was evaluated as generally low. All included trials compared CHM plus antihypertensive drugs with antihypertensive drugs alone for resistant hypertension. Formulations of CHM included tablet, decoction and injection. It was found that, compared with antihypertensive drugs alone, CHM (tablet) plus antihypertensive drugs resulted in clinically, but not statistically, significant reductions in systolic blood pressure (SBP; weighted mean difference (WMD)=–10.32 mm Hg; 95% CI –21.10 to 0.46; p=0.06) and diastolic blood pressure (DBP; WMD=–3.30 mm Hg; 95% CI –7.66 to 1.06; p=0.14). CHM (decoction) plus antihypertensive drugs also produced a clinically meaningful, but not statistically significant, reduction in SBP (WMD=–12.56 mm Hg; 95% CI –26.83 to 1.71; p=0.08), and did significantly decrease DBP (WMD=–7.89 mm Hg; 95% CI –11.74 to –4.04; p<0.0001). There were no significant differences in SBP (WMD=–3.50 mm Hg; 95% CI –8.95 to 1.95; p=0.21) and DBP (WMD=1.00 mm Hg; 95% CI –1.39 to 3.39; p=0.41) between CHM (injection) plus the antihypertensive drugs group and antihypertensive drugs alone. The safety of CHM remained uncertain.
No definite conclusions about the effectiveness and safety of CHM for resistant hypertension could be drawn. More rigorously designed trials are warranted.
Describe the incidence, prevalence and survival of patients needing renal replacement therapy (RRT) for end-stage renal disease (ESRD) due to diabetes mellitus (DM)-related glomerulosclerosis or nephropathy (diabetic nephropathy, DN) in the Netherlands.
Using the national registry for RRT (RENINE-registry), data of all Dutch individuals initiating RRT for ESRD and having DN as primary diagnosis in the period 2000–2012 were obtained.
Observational study in the Netherlands.
Patients with ESRD needing RRT for DN.
Age and gender adjusted incidence and prevalence of RRT for DN in the period 2000–2012. In addition, trends in time and patient's survival were examined.
The prevalence of DM in the general population increased from approximately 466 000 in 2000 to 815 000 in 2011. The number of individuals who started RRT with DN as primary diagnosis was 17.4 per million population (pmp) in 2000 and 19.1 pmp in 2012, with an annual percentage change (APC) of 0.8% (95% CI –0.4 to 2.0). For RRT due to type 1 DN, the incidence decreased from 7.3 to 3.5 pmp (APC –4.8%, 95% CI –6.5 to –3.1) while it increased for type 2 DN from 10.1 to 15.6 pmp (APC 3.1%, 95% CI 1.3 to 4.8). After 2009, the prevalence of RRT for DN remained stable (APC 1.0%, 95% CI –0.4 to 2.5). Compared to the period 2000–2004, patients initiating RRT and dialysis in 2005–2009 had better survival, HRs 0.8 (95% CI 0.7 to 0.8) and 0.8 (95% CI 0.7 to 0.9), respectively, while survival after kidney transplantation remained stable, HR 0.8, 95% CI 0.5 to 1.1).
Over the last decade, the incidence of RRT for DN was stable, with a decrease in RRT due to type 1 DN and an increase due to type 2 DN, while survival increased.
To assess the association of socioeconomic deprivation (SED) with survival after stroke in China.
A systematic literature review and a new population-based cohort study.
In urban and rural communities in Anhui, China, 2978 residents aged ≥60 years took part in baseline investigation and were followed up for 5 years; five published studies were identified for a systematic review.
167 of 2978 participants (5.6%) had doctor-diagnosed stroke at baseline or 1 year later. All-cause mortality in the follow-up.
In the Anhui cohort follow-up of 167 patients with stroke, 64 (38.3%) died. Multivariate adjusted hazard ratio (HR) of mortality in patients with educational level of less than or equal to primary school was 1.88 (95% CI 1.05 to 3.36) compared to those having more than primary school education. Increased HR of mortality in patients living in a rural area was at borderline significant (1.64, 0.97 to 2.78), but the HR in patients with lower levels of occupation and income was not significant. Published studies showed a significant increase in stroke mortality in relation to some SED indicators. Pooled relative risk (RR) of mortality in patients with low education was 3.07 (1.27 to 7.34), in patients with low income 1.58 (1.50 to 1.65) and in patients living in rural areas 1.47 (1.37 to 1.58).
The evidence suggests the presence of a mortality gradient after stroke for material as well as social forms of deprivation in China. Inequalities in survival after stroke persist and need to be taken into account when implementing intervention programmes.
Methamphetamine abuse affects brain structure and function. Although methamphetamine and cannabis are commonly abused together, few studies have investigated the differential neurocognitive consequences of methamphetamine abuse with or without cannabis. Furthermore, the effects of drug use on the developing adolescent brain remain poorly understood. We compared neurocognitive function between adolescents with 'pure' methamphetamine abuse, those with comorbid methamphetamine and cannabis abuse, and healthy controls at baseline and follow-up.
Individuals residing in the greater Cape Town region, between the ages of 13 and 18 years, were recruited into either Methamphetamine only group (Meth-only; n=10), Methamphetamine and cannabis group (Meth-cann; n=10) or healthy control (n=20) groups using a quasi-experimental design. All participants underwent a comprehensive neurocognitive assessment. Substance-use variables and psychiatric symptom counts were also recorded. A portion of the Meth-only and control participants completed 12-month follow-up assessments.
While the Meth-cann group demonstrated widespread neurocognitive deficits at baseline, these deficits were restricted to the self-monitoring domain in the Meth-only group at baseline and at follow-up.
Methamphetamine abuse with cannabis abuse is associated with significantly more neurocognitive impairment than methamphetamine abuse alone, and such deficits may be enduring.
In resource-poor settings, the standard of care to inform labour management is the partograph plus Pinard stethoscope for intermittent fetal heart rate (FHR) monitoring. We compared FHR monitoring in labour using a novel, robust wind-up handheld Doppler with the Pinard as a primary screening tool for abnormal FHR on perinatal outcomes.
Prospective equally randomised clinical trial.
The labour and delivery unit of a teaching hospital in Kampala, Uganda.
Of the 2042 eligible antenatal women, 1971 women in active term labour, following uncomplicated pregnancies, were randomised to either the standard of care or not.
Intermittent FHR monitoring using Doppler.
Incidence of FHR abnormality detection, intrapartum stillbirth and neonatal mortality prior to discharge.
Age, parity, gestational age, mode of delivery and newborn weight were similar between study groups. In the Doppler group, there was a significantly higher rate of FHR abnormalities detected (incidence rate ratio (IRR)=1.61, 95% CI 1.13 to 2.30). However, in this group, there were also higher though not statistically significant rates of intrapartum stillbirths (IRR=3.94, 0.44 to 35.24) and neonatal deaths (IRR=1.38, 0.44 to 4.34).
Routine monitoring with a handheld Doppler increased the identification of FHR abnormalities in labour; however, our trial did not find evidence that this leads to a decrease in the incidence of intrapartum stillbirth or neonatal death.
Clinical Trails.gov (1000031587).
Small increases in smoking restrictions in cars and homes were reported after legislation prohibiting smoking in public places. Few studies examine whether these changes continued in the longer term. This study examines changes in restrictions on smoking in cars and homes, and child exposure to secondhand smoke (SHS) in these locations, since 2008 postlegislation surveys in Wales.
State-maintained primary schools in Wales (n=75).
Children aged 10–11 years (year 6) completed CHETS (CHild exposure to Environmental Tobacco Smoke) Wales surveys in 2007 (n=1612) and 2008 (n=1605). A replication survey (CHETS Wales 2) was conducted in 2014, including 1601 children.
Children's reports of whether smoking was allowed in their car or home and exposure to SHS in a car or home the previous day.
The percentage of children who reported that smoking was allowed in their family vehicle fell from 18% to 9% in 2014 (OR=0.42; 95% CI 0.33 to 0.54). The percentage living in homes where smoking was allowed decreased from 37% to 26% (OR=0.30; 95% CI 0.20 to 0.43). Among children with a parent who smoked, one in five and one in two continued to report that smoking was allowed in their car and home. The percentage reporting SHS exposure in a car (OR=0.52; 95% CI 0.38 to 0.72) or home (OR=0.44; 95% CI 0.36 to 0.53) the previous day also fell. Children from poorer families remained less likely to report smoking restrictions.
Smoking in cars and homes has continued to decline. Substantial numbers of children continue to report that smoking is allowed in cars and homes, particularly children from poorer families. A growing number of countries have legislated, or plan to legislate, banning smoking in cars carrying children. Attention is needed to the impact of legislation on child health and health inequalities, and reducing smoking in homes.
To analyse the impact of placebo effects on outcome in trials of selected minimally invasive procedures and to assess reported adverse events in both trial arms.
A systematic review and meta-analysis.
We searched MEDLINE and Cochrane library to identify systematic reviews of musculoskeletal, neurological and cardiac conditions published between January 2009 and January 2014 comparing selected minimally invasive with placebo (sham) procedures. We searched MEDLINE for additional randomised controlled trials published between January 2000 and January 2014.
Effect sizes (ES) in the active and placebo arms in the trials' primary and pooled secondary end points were calculated. Linear regression was used to analyse the association between end points in the active and sham groups. Reported adverse events in both trial arms were registered.
We included 21 trials involving 2519 adult participants. For primary end points, there was a large clinical effect (ES≥0.8) after active treatment in 12 trials and after sham procedures in 11 trials. For secondary end points, 7 and 5 trials showed a large clinical effect. Three trials showed a moderate difference in ES between active treatment and sham on primary end points (ES ≥0.5) but no trials reported a large difference. No trials showed large or moderate differences in ES on pooled secondary end points. Regression analysis of end points in active treatment and sham arms estimated an R2 of 0.78 for primary and 0.84 for secondary end points. Adverse events after sham were in most cases minor and of short duration.
The generally small differences in ES between active treatment and sham suggest that non-specific mechanisms, including placebo, are major predictors of the observed effects. Adverse events related to sham procedures were mainly minor and short-lived. Ethical arguments frequently raised against sham-controlled trials were generally not substantiated.
There is considerable evidence of a cultural shift towards heavier alcohol consumption among university students, especially women. The aim of this study is to investigate the prevalence and correlates of hazardous alcohol consumption (HAC) among university students with particular reference to gender and to compare different modes of data collection in this population.
A large Irish university.
A cross-sectional study using a classroom distributed paper questionnaire.
A total of 2275 undergraduates completed the classroom survey, 84% of those in class and 51% of those registered for the relevant module.
Prevalence of HAC measured using the Alcohol Use Disorders Identification Test for Consumption (AUDIT-C) and the proportion of university students reporting 1 or more of 13 adverse consequences linked to HAC. HAC was defined as an AUDIT-C score of 6 or more among males and 5 or more among females.
In the classroom sample, 66.4% (95% CI 64.4 to 68.3) reported HAC (65.2% men and 67.3% women). In women, 57.4% met HAC thresholds for men. Similar patterns of adverse consequences were observed among men and women. Students with a hazardous consumption pattern were more likely to report smoking, illicit drug use and being sexually active.
The findings highlight the high prevalence of HAC among university students relative to the general population. Public policy measures require review to tackle the short-term and long-term risks to physical, mental and social health and well-being.
To explore factors influencing poor glycaemic control in people with type 2 diabetes using insulin.
A qualitative method comprising in-depth individual interviews. A semistructured interview guide was used. The interviews were audiorecorded, transcribed verbatim and analysed using a thematic approach.
Seventeen people with type 2 diabetes using insulin with glycated haemoglobin (HbA1c) ≥9% for >1 year.
The Primary Care Clinic and Diabetes Clinic in the University of Malaya Medical Centre (UMMC), Malaysia.
Data analysis uncovered four themes: lifestyle challenges in adhering to medical recommendations; psychosocial and emotional hurdles; treatment-related factors; lack of knowledge about and self-efficacy in diabetes self-care.
Factors that explain the poor glycaemic control in people with type 2 diabetes using insulin were identified. Healthcare providers could use these findings to address patients' concerns during consultations and help to improve glycaemic control.
Non-steroidal anti-inflammatory drugs (NSAIDs), proton pump inhibitors (PPIs), low-dose aspirin and statins may decrease the risk of oesophageal adenocarcinoma (OAC) among patients with Barrett's oesophagus (BO). However, previous studies did not adequately address bias and confounding. Our objective was to estimate the risk of OAC among patients with BO exposed to NSAIDs, statins and PPIs.
Case–control study nested within a BO cohort.
Two primary care databases (the UK and the Netherlands (NL)).
Cases were adults ≥18 years of age with OAC or high-grade dysplasia (HGD) diagnosis ≥1 year after BO diagnosis. Controls were matched on age, sex, year of BO diagnosis and database.
Drug use was assessed from BO diagnosis until matching date.
Adjusted ORs with 95% CI were calculated by conditional logistic regression.
Within the BO cohort (n=15 134), 45 OAC (UK: 40, NL: 5) and 12 HGD cases (NL: 12) were identified. ORa for OAC during NSAID use was 1.2 (95% CI 0.6 to 2.5) and during statin use for >3 years 0.5 (95% CI 0.1 to 1.7). When including HGD cases (n=57), ORa for NSAID use was 0.9 (95% CI 0.5 to 1.8) and for statin use >3 years 0.5 (95% CI 0.1 to 1.7). Higher doses of statins showed lower estimates for OAC and HGD, though not statistically significant. Low-dose aspirin and PPIs did not significantly decrease the risk of OAC and HGD.
In this population-based nested case–control study, use of NSAIDs, PPIs, low-dose aspirin or statins did not reduce the risk of HGD and OAC among patients with BO. These findings indicate that for an unselected group of patients with BO chemoprevention by use of drugs to reduce progression to HGD and OAC should not be directly considered as routine care.
Hyperglycaemia is very common during exacerbations of asthma and chronic obstructive pulmonary disease (COPD). However, its clinical significance is not clear. The objective of the present study was to assess whether exacerbation-associated hyperglycaemia affects long-term mortality in these patients.
A prospective, observational cohort study.
A single hospital in eastern Finland.
153 consecutive patients who were hospitalised due to mild to moderate obstructive lung disease exacerbation (110 with asthma and 43 with COPD) and who survived at least 30 days.
Plasma glucose levels were recorded seven times during the first day on the ward. Several possible confounders were also recorded. The median follow-up time was 6 years and 2 months.
During the follow-up, 57 (37%) of the patients died. Previously diagnosed diabetes was strongly associated with elevated mortality (adjusted HR (aHR) 3.03 (1.28 to 7.18). The highest fasting glucose value (aHR 1.10 (1.01 to 1.20) per 1 mmol/L) and the highest postprandial glucose value ((aHR 1.07 (1.00 to 1.16)) were also associated with late mortality. However, the associations between highest glucose values and mortality vanished when the diagnosis of diabetes was included in the same model. Within the patients without diabetes, neither fasting (aHR 0.92 (0.42 to 2.02)) nor postprandial ((aHR 1.04 (0.50 to 2.12)) hyperglycaemia was associated with late mortality. There were no statistically significant differences in the underlying causes of death between the patients with and without diabetes.
A history of diabetes but not hyperglycaemia during exacerbation of obstructive lung disease has impact on long-term mortality.
Stimulating physical activity behaviour in persons with a physical disability is important, especially after discharge from rehabilitation. A tailored counselling programme covering both the period of the rehabilitation treatment and the first months at home seems on the average effective. However, a considerable variation in response is observed in the sense that some patients show a relevant beneficial response while others show no or only a small response on physical activity behaviour. The Rehabilitation, Sports and Active lifestyle (ReSpAct) study aims to estimate the associations of patient and programme characteristics with patients' physical activity behaviour after their participation in a tailored counselling programme.
A questionnaire-based nationwide longitudinal prospective cohort study is conducted. Participants are recruited from 18 rehabilitation centres and hospitals in The Netherlands. 2000 participants with a physical disability or chronic disease will be followed during and after their participation in a tailored counselling programme. Programme outcomes on physical activity behaviour and patient as well as programme characteristics that may be associated with differences in physical activity behaviour after programme completion are being assessed. Data collection takes place at baseline and 14, 33 and 52 weeks after discharge from rehabilitation.
The study protocol has been approved by the Medical Ethics Committee of the University Medical Centre Groningen and at individual participating institutions. All participants give written informed consent. The study results will provide new insights into factors that may help explain the differences in physical activity behaviour of patients with a physical disability after they have participated in the same physical activity and sports stimulation programme. Thereby, it will support healthcare professionals to tailor their guidance and care to individual patients in order to stimulate physical activity after discharge in a more efficient and effective way.
Cigarette smoke contributes to a diverse range of diseases including chronic obstructive pulmonary disease (COPD), cardiovascular disorders and many cancers. There currently is a need for human challenge models, to assess the acute effects of a controlled cigarette smoke stimulus, followed by serial sampling of blood and respiratory tissue for advanced molecular profiling. We employ precision sampling of nasal mucosal lining fluid by absorption to permit soluble mediators measurement in eluates. Serial nasal curettage was used for transcriptomic analysis of mucosal tissue.
Three groups of strictly defined patients will be studied: 12 smokers with COPD (GOLD Stage 2) with emphysema, 12 matched smokers with normal lung function and no evidence of emphysema, and 12 matched never smokers with normal spirometry. Patients in the smoking groups are current smokers, and will be given full support to stop smoking immediately after this study. In giving a controlled cigarette smoke stimulus, all patients will have abstained from smoking for 12 h, and will smoke two cigarettes with expiration through the nose in a ventilated chamber. Before and after inhalation of cigarette smoke, a series of samples will be taken from the blood, nasal mucosal lining fluid and nasal tissue by curettage. Analysis of plasma nicotine and metabolites in relation to levels of soluble inflammatory mediators in nasal lining fluid and blood, as well as assessing nasal transcriptomics, ex vivo blood platelet aggregation and leucocyte responses to toll-like receptor agonists will be undertaken.
Development of acute cigarette smoke challenge models has promise for the study of molecular effects of smoking in a range of pathological processes.
This study was approved by the West London National Research Ethics Committee (12/LO/1101). The study findings will be presented at conferences and will be reported in peer-reviewed journals.
To develop and validate a new algorithm to identify patients with rheumatoid arthritis (RA) and estimate disease prevalence using administrative health databases (AHDs) of the Italian Lombardy region.
Case–control and cohort diagnostic accuracy study.
In a randomly selected sample of 827 patients drawn from a tertiary rheumatology centre (training set), clinically validated diagnoses were linked to administrative data including diagnostic codes and drug prescriptions. An algorithm in steps of decreasing specificity was developed and its accuracy assessed calculating sensitivity/specificity, positive predictive value (PPV)/negative predictive value, with corresponding CIs. The algorithm was applied to two validating sets: 106 patients from a secondary rheumatology centre and 6087 participants from the primary care. Alternative algorithms were developed to increase PPV at population level. Crude and adjusted prevalence estimates taking into account algorithm misclassification rates were obtained for the Lombardy region.
The algorithms included: RA certification by a rheumatologist, certification for other autoimmune diseases by specialists, RA code in the hospital discharge form, prescription of disease-modifying antirheumatic drugs and oral glucocorticoids. In the training set, a four-step algorithm identified clinically diagnosed RA cases with a sensitivity of 96.3 (95% CI 93.6 to 98.2) and a specificity of 90.3 (87.4 to 92.7). Both external validations showed highly consistent results. More specific algorithms achieved >80% PPV at the population level. The crude RA prevalence in Lombardy was 0.52%, and estimates adjusted for misclassification ranged from 0.31% (95% CI 0.14% to 0.42%) to 0.37% (0.25% to 0.47%).
AHDs are valuable tools for the identification of RA cases at the population level, and allow estimation of disease prevalence and to select retrospective cohorts.
To engage young people, parent carers and clinicians in a systematic process to identify and prioritise research questions regarding ways to improve the health and well-being of children and young people with neurodisability.
British Academy of Childhood Disability (BACD)-James Lind Alliance research priority setting partnership bringing together patients, carers and clinicians as equal stakeholders.
UK health service and community.
The BACD Strategic Research Group formed the partnership. A Steering Group was established; charity and professional partner organisations were recruited. Suggestions were gathered in an open survey and from research recommendations for statutory guidance. Items were aggregated to formulate indicative research questions and verified as uncertainties from research evidence. An interim survey was used to rank the questions to shortlist topics. A mixed group of stakeholders discussed the top 25 questions at the final priority setting workshop agreeing a final rank order and the top 10 research priorities.
Partner organisations were 13 charities and 8 professional societies. 369 people submitted suggestions (40% non-clinicians). 76 people participated in the interim prioritisation (26 parents, 1 young person, 10 charity representatives, 39 clinicians); 22 took part in the final workshop (3 young people, 7 parents, 3 charity representatives, 9 professionals).
The top three research priorities related to (1) establishing the optimal frequency and intensity (dose) for mainstream therapies, (2) means for selecting and encouraging use of communication strategies and (3) ways to improve children's attitudes towards disability. The top 10 included evaluating interventions to promote mobility, self-efficacy, mental health, continence, physical fitness, educational inclusion and reduce impacts of sleep disturbance.
The methodology provided a systematic and transparent process to identify research priorities that included stakeholders that have typically not contributed to setting the research agenda. The top 10 and other topics identified provide a resource for researchers and agencies that fund research
To evaluate the evidence on the efficacy of psychosocial interventions for improving pregnancy rates and reducing distress for couples in treatment with assisted reproductive technology (ART).
Systematic review and meta-analysis.
PsycINFO, PubMed, EMBASE, CINAHL, Web of Science and The Cochrane Library between 1978 and April 2014.
Studies were considered eligible if they evaluated the effect of any psychosocial intervention on clinical pregnancy and/or distress in infertile participants, used a quantitative approach and were published in English.
Study characteristics and results were extracted and the methodological quality was assessed. Effect sizes (ES; Hedges g) were pooled using a random effects model. Heterogeneity was assessed using the Q statistic and I2, and publication bias was evaluated using Egger's method. Possible moderators and mediators were explored with meta-analyses of variances (ANOVAs) and meta-regression.
We identified 39 eligible studies (total N=2746 men and women) assessing the effects of psychological treatment on pregnancy rates and/or adverse psychological outcomes, including depressive symptoms, anxiety, infertility stress and marital function. Statistically significant and robust overall effects of psychosocial intervention were found for both clinical pregnancy (risk ratio=2.01; CI 1.48 to 2.73; p<0.001) and combined psychological outcomes (Hedges g=0.59; CI 0.38 to 0.80; p=0.001). The pooled ES for psychological outcomes were generally larger for women (g: 0.51 to 0.73) than men (0.13 to 0.34), but the difference only reached statistical significance for depressive symptoms (p=0.004). Meta-regression indicated that larger reductions in anxiety were associated with greater improvement in pregnancy rates (Slope 0.19; p=0.004). No clear-cut differences were found between effects of cognitive–behavioural therapy (CBT; g=0.84), mind–body interventions (0.61) and other intervention types (0.50).
The present meta-analysis suggests that psychosocial interventions for couples in treatment for infertility, in particular CBT, could be efficacious, both in reducing psychological distress and in improving clinical pregnancy rates.
The Health Information Technology for Economic and Clinical Health (HITECH) Act created incentives for adopting electronic health records (EHRs) for some healthcare organisations, but long-term care (LTC) facilities are excluded from those incentives. There are realisable benefits of EHR adoption in LTC facilities; however, there is limited research about this topic. The purpose of this systematic literature review is to identify EHR adoption factors for LTC facilities that are ineligible for the HITECH Act incentives.
We conducted systematic searches of Cumulative Index of Nursing and Allied Health Literature (CINAHL) Complete via Ebson B. Stephens Company (EBSCO Host), Google Scholar and the university library search engine to collect data about EHR adoption factors in LTC facilities since 2009.
Search results were filtered by date range, full text, English language and academic journals (n=22).
Multiple members of the research team read each article to confirm applicability and study conclusions.
Researchers identified common themes across the literature: specifically facilitators and barriers to adoption of the EHR in LTC.
Results identify facilitators and barriers associated with EHR adoption in LTC facilities. The most common facilitators include access to information and error reduction. The most prevalent barriers include initial costs, user perceptions and implementation problems.
Similarities span the system selection phases and implementation process; of those, cost was the most common mentioned. These commonalities should help leaders in LTC facilities align strategic decisions to EHR adoption. This review may be useful for decision-makers attempting successful EHR adoption, policymakers trying to increase adoption rates without expanding incentives and vendors that produce EHRs.
Tobacco dependence and smoke exposure have been global epidemics with health consequences recognised by the US Surgeon General since the 1960s and 1970s, respectively. During this period, a vast body of research evidence has emerged including many reviews of primary research studies targeting various tobacco control strategies. Published review studies synthesise primary evidence, providing a rich source for mapping the broad range of topics and research foci along with revealing areas of evidence deficits. In this paper, we outline our scoping review protocol to systematically review published review articles specific to tobacco control and primary prevention over the last 10 years.
Using Arksey and O'Malley's scoping review methodology as a guide, our scoping review of published reviews begins by searching several databases: PubMed, Scopus, the Cochrane Library, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycInfo and the Educational Resources Information Centre (ERIC). Our multidisciplinary team has formulated search strategies and two reviewers will independently screen eligible studies for final study selection. Bibliographic data and abstract content will be collected and analysed using a tool developed iteratively by the research team.
A scoping review of published review articles is a novel approach for examining the breadth of literature regarding tobacco control strategies and, as a secondary analysis, does not require ethics approval. We anticipate results will identify research gaps as well as novel ideas for primary prevention research specific to tobacco control strategies concerning intervention, programming and policy. Although this is our first step in establishing a foundation for a research agenda, we will be disseminating results through journals and conferences targeting primary care providers and tobacco control.
To identify the factors associated with 12-month mental health service use in primary care patients with depressive symptoms.
Cross-sectional followed by 12-month cohort study.
10 179 adult patients were recruited from the waiting rooms of 59 primary care clinics across Hong Kong to complete a questionnaire which screened for depression. 518 screened-positive participants formed the cohort and were telephoned at 3, 6 and 12 months to monitor mental health service use.
Help-seeking preferences;
Intention to seek help from a healthcare professional;
12-month mental health service use.
At baseline, when asked who they would seek help from if they thought they were depressed, respondents preferred using friends and family (46.5%) over a psychiatrist (24.9%), psychologist (22.8%) or general practitioner (GP; 19.9%). The presence of depressive symptoms was associated with a lower intention to seek help from family and friends but had no effect on intention to seek help from a healthcare professional. Over 12 months, 24.3% of the screened-positive cohort reported receiving services from a mental health professional. Factors associated with service use included identification of depression by the GP at baseline, having a past history of depression or other mental illness, and being a public sector patient. Having a positive intention to seek professional help or more severe depressive symptoms at baseline was not associated with a greater likelihood of receiving treatment.
Mental health service use appears to be very low in this setting with only one in four primary care patients with depressive symptoms receiving treatment from a psychiatrist, GP or psychologist over a year. To help reduce the burden of illness, better detection of depressive disorders is needed especially for patients who may be undertreated such as those with no prior diagnosis of depression and those with more severe symptoms.
The recruitment of community health volunteers to support the delivery of health programmes is a well-established approach in many countries, particularly where health services are not readily available. However, studies on management of volunteers are scarce and current research on human resource management of volunteers faces methodological challenges. This paper presents the protocol of a realist evaluation that aims at identifying the factors influencing the performance of community health volunteers involved in the delivery of a Red Cross immunisation programme in Kampala (Uganda) with a specific focus on motivation.
The realist evaluation cycle structures the protocol. To develop the theoretical basis for the evaluation, the authors conducted interviews and reviewed the literature on community health volunteers' performance, management and organisational behaviour. This led to the formulation of the initial programme theory, which links the intervention inputs (capacity-building strategies) to the expected outcomes (positive work behaviour) with mechanisms that point in the direction of drivers of motivation. The contextual elements include components such as organisational culture, resource availability, etc. A case study design will be adopted. We define a case as a Red Cross branch, run by a programme manager, and will select two cases at the district level in Kampala. Mixed methods will be used in data collection, including individual interviews of volunteers, participant observation and document review. The thematic analysis will be based on the initial programme theory and will seek for context-mechanism-outcome configurations. Findings from the two cases will be compared.
We discuss the scope for applying realist evaluation and the methodological challenges we encountered in developing this protocol.
The study was approved by the Ethical Committee at Rennes University Hospital, France. Results will be published in scientific journals, and communicated to respondents and relevant institutions.
Opioid prescribing is increasing in many countries. In Australia, there is limited research on patterns of prescribing and access, or the outcomes associated with this use. The aim of this research programme is to use national dispensing data to estimate opioid use and costs, including problematic or extramedical use in the Australian population.
In a cohort of persons dispensed at least one opioid in 2013, we will estimate monthly utilisation and costs of prescribed opioids, overall and according to individual opioid formulations and strengths. In a cohort of new opioid users, commencing therapy between 1 July 2009 and 31 December 2013, we will examine patterns of opioid use including initiation of therapy, duration of treatment and concomitant use of opioids and other prescribed medicines. We will also examine patterns of extramedical opioid use based on indicators including excess dosing, use of more than one opioid concomitantly, doctor/pharmacy shopping and accelerated time to prescription refill.
This protocol was approved by the NSW Population and Health Services Ethics Committee (March 2014) and data access approved by the Department of Human Services External Review Evaluation Committee (June 2014). This will be one of the first comprehensive Australian studies with the capability to investigate individual patterns of use and track extramedical use. In the first instance our analysis will be based on 5 years of dispensing data but will be expanded with ongoing annual data updates. This research has the capability to contribute significantly to pharmaceutical policy within Australia and globally. In particular, the trajectory of extramedical prescription-opioid use has been the subject of limited research to date. The results of this research will be published widely in general medical, pharmacoepidemiology, addiction and psychiatry journals.
Acute chest pain (ACP) is a leading cause of hospital emergency unit consultation. As there are various underlying conditions, ranging from musculoskeletal disorders to acute coronary syndrome (ACS), thorough clinical diagnostics are warranted. The aim of this prospective study was to assess whether reproducible chest wall tenderness (CWT) on palpation in patients with ACP can help to rule out ACS.
In this prospective, double-blinded diagnostic study, all consecutive patients assessed in the emergency unit at the University Hospital Zurich because of ACP between July 2012 and December 2013 were included when a member of the study team was present. Reproducible CWT on palpation was the initial step and was recorded before further examinations were initiated. The final diagnosis was adjudicated by a study-independent physician.
121 patients (60.3% male, median age 47 years, IQR 34–66.5 years) were included. The prevalence of ACS was 11.6%. Non-reproducible CWT had a high sensitivity of 92.9% (95% CI 66.1% to 98.8%) for ACS and the presence of reproducible CWT ruled out ACS (p=0.003) with a high negative predictive value (98.1%, 95% CI 89.9% to 99.7%). Conversely non-reproducible CWT ruled in ACS with low specificity (48.6%, 95% CI 38.8% to 58.5%) and low positive predictive value (19.1%, 95% CI 10.6% to 30.5%).
This prospective diagnostic study supports the concept that reproducible CWT helps to rule out ACS in patients with ACP in an early stage of the evaluation process. However, ACS and other diagnoses should be considered in patients with a negative CWT test.
ClinicalTrial.gov: NCT01724996.
Accurately predicting the prognosis of young patients with breast cancer (<40 years) is uncertain since the literature suggests they have a higher mortality and that age is an independent risk factor. In this cohort study we considered two prognostic tools; Nottingham Prognostic Index and Adjuvant Online (Adjuvant!), in a group of young patients, comparing their predicted prognosis with their actual survival.
North East England
Data was prospectively collected from the breast unit at a Hospital in Grimsby between January 1998 and December 2007. A cohort of 102 young patients with primary breast cancer was identified and actual survival data was recorded. The Nottingham Prognostic Index and Adjuvant! scores were calculated and used to estimate 10-year survival probabilities. Pearson's correlation coefficient was used to demonstrate the association between the Nottingham Prognostic Index and Adjuvant! scores. A constant yearly hazard rate was assumed to generate 10-year cumulative survival curves using the Nottingham Prognostic Index and Adjuvant! predictions.
Actual 10-year survival for the 92 patients who underwent potentially curative surgery for invasive cancer was 77.2% (CI 68.6% to 85.8%). There was no significant difference between the actual survival and the Nottingham Prognostic Index and Adjuvant! 10-year estimated survival, which was 77.3% (CI 74.4% to 80.2%) and 82.1% (CI 79.1% to 85.1%), respectively. The Nottingham Prognostic Index and Adjuvant! results demonstrated strong correlation and both predicted cumulative survival curves accurately reflected the actual survival in young patients.
The Nottingham Prognostic Index and Adjuvant! are widely used to predict survival in patients with breast cancer. In this study no statistically significant difference was shown between the predicted prognosis and actual survival of a group of young patients with breast cancer.
The impact of schizophrenia on vital diseases, such as chronic kidney disease (CKD), has not as yet been verified. This study aims to establish whether there is an association between schizophrenia and CKD.
A nationwide matched cohort study.
Taiwan's National Health Insurance Research Database.
A total of 2338 patients with schizophrenia, and 7014 controls without schizophrenia (1:3), matched cohort for sex, age group, geography, urbanisation and monthly income, between 1 January 2003 and 31 December 2007, based on the International Classifications of Disease Ninth Edition (ICD-9), Clinical Modification codes.
After making adjustments for confounding risk factors, a Cox proportional hazards model was used to compare the risk of developing CKD during a 3-year follow-up period from the index date.
Of the 2338-subject case cohort, 163 (6.97%) developed a CKD, as did 365 (5.20%) of the 7014 control participants. Cox proportional hazards regression analysis revealed that patients with schizophrenia were more likely to develop CKD (HR=1.36, 95% CI 1.13 to 1.63; p<0.001). After adjusting for gender, age group, hypertension, diabetes mellitus, hyperlipidaemia, heart disease and non-steroid anti-inflammatory drugs (NSAIDs) usage, the HR for patients with schizophrenia was 1.25 (95% CI 1.04 to 1.50; p<0.05). Neither typical nor atypical antipsychotics was associated an increased risk of CKD in patients with schizophrenia.
The findings from this population-based retrospective cohort study suggest that schizophrenia is associated with a 25% increase in the risk of developing CKD within only a 3-year follow-up period.
Non-pharmacological therapies for common chronic medical conditions in older patients are underused in clinical practice. We propose a protocol for the assessment of the evidence of non-pharmacological interventions to prevent or treat relevant outcomes in several prevalent geriatric conditions in order to provide recommendations.
The conditions of interest for which the evidence about efficacy of non-pharmacological interventions will be searched include delirium, falls, pressure sores, urinary incontinence, dementia, heart failure, orthostatic hypotension, sarcopaenia and stroke. For each condition, the following steps will be undertaken: (A) prioritising clinical questions; (B) retrieving the evidence (MEDLINE, the Cochrane Library, CINAHL and PsychINFO will be searched to identify systematic reviews); (C) assessing the methodological quality of the evidence (risk of bias according to the Cochrane method will be applied to the primary studies retrieved from the systematic reviews); (D) developing recommendations based on the evidence (Grading of Recommendations Assessment, Development and Evaluation (GRADE) items—risk of bias, imprecision, inconsistency, indirectness and publication bias—will be used to rate the overall evidence and develop recommendations).
For each target condition, at least one systematic overview concerning the evidence of non-pharmacological interventions will be produced and published in peer-reviewed journals.
To assess the current health of the Deaf community in the UK and compare with the general population.
A quota sample of adult Deaf British Sign Language (BSL) users underwent a health assessment and interview in 2012–2013. Comparative data were obtained from the Health Survey for England (HSE) 2011 and the Quality Outcomes Framework (QOF) 2012.
Participants completed a structured interview and health assessment at seven Bupa centres across the UK, supported in BSL by Deaf advisers and interpreters.
298 Deaf people, 20–82 years old, 47% male, with 12% from ethnic minorities.
Self–reported health conditions, medication usage, tobacco and alcohol consumption; measured blood pressure (BP), body mass index, fasting blood sugar and lipid profile.
Rates of obesity in the Deaf sample were high, especially in those over 65 years, and 48% were in a high risk group for serious illness. High BP readings were obtained in 37% of Deaf people (21% in HSE): 29% were unaware of this (6% in HSE). Only 42% of Deaf people being treated for hypertension had adequate control, compared with 62% of the general population. Deaf people with self-reported cardiovascular disease (CVD) were significantly less than the general population. One-third of Deaf participants had total cholesterol >5 mmol/L but although control rates were high compared with HSE, treatment rates for self-reported CVD were half the general population rate. Eleven per cent of Deaf participants had blood sugar at prediabetic or diabetic levels, and 77% of those at prediabetic levels were unaware of it. Deaf respondents self-reported more depression (31% of women, 14% of men), but less smoking (8%) and alcohol intake (2–8 units/week).
Deaf people's health is poorer than that of the general population, with probable underdiagnosis and undertreatment of chronic conditions putting them at risk of preventable ill health.
To gain an understanding of the views of women with false-positive screening mammograms of screening recall services, their ideas for service improvements and how these compare with current UK guidelines.
Inductive qualitative content analysis of semistructured interviews of 21 women who had false-positive screening mammograms. These were then compared with UK National Health Service (NHS) guidelines.
Participants' concerns about mammography screening recall services focused on issues of communication and choice. Many of the issues raised indicated that the 1998 NHS Breast Screening Programme guidelines on improving the quality of written information sent to women who are recalled, had not been fully implemented. This included being told a clear reason for recall, who may attend with them, the length of appointment, who they will see and what tests will be carried out. Additionally women voiced a need for: reassurance that a swift appointment did not imply they had cancer; choice about invasive assessment or watchful waiting; the offer of a follow-up mammogram for those uncertain about the validity of their all-clear and an extension of the role of the clinical nurse specialist, outlined in the 2012 NHS Breast Screening Programme (NHSBSP) guidelines, to include availability at the clinic after the all-clear for women with false-positive mammograms.
It is time the NHSBSP 1998 recall information guidelines were fully implemented. Additionally, the further suggestions from this research, including extending the role of the clinical nurses from the 2012 NHSBSP guidelines, should be considered. These actions have the potential to reduce the anxiety of being recalled.
Open Access This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 3.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/3.0/
The amended funding statement is:
Funding This work is supported by the European Commission under the Framework Programme (grant number 278901). Professor Smeeth's contribution was supported by the Wellcome Trust, grant number WT082178.
The corrected article is available online.
]]>Stress-induced hyperglycaemia, which has been shown to be associated with an unfavourable prognosis, is common among critically ill patients. Additionally, it has been reported that hypoglycaemia and high glucose variabilities are also associated with adverse outcomes. Thus, continuous glucose monitoring (CGM) may be the optimal method to detect severe hypoglycaemia, hyperglycaemia and decrease glucose excursion. However, the overall accuracy and reliability of CGM systems and the effects of CGM systems on glucose control and prognosis in critically ill patients remain inconclusive. Therefore, we will conduct a systematic review and meta-analysis to clarify the associations between CGM systems and clinical outcome.
We will search PubMed, EMBASE and the Cochrane Library from inception to October 2014. Studies comparing CGM systems with any other glucose monitoring methods in critically ill patients will be eligible for our meta-analysis. The primary endpoints include the incidence of hypoglycaemia and hyperglycaemia, mean glucose level, and percentage of time within the target range. The second endpoints include intensive care unit (ICU) mortality, hospital mortality, duration of mechanical ventilation, length of ICU and hospital stay, and the Pearson correlation coefficient and the results of error grid analysis. In addition, we will record all complications (eg, acquired infections) in control and intervention groups and local adverse events in intervention groups (eg, bleeding or infections).
Ethics approval is not required as this is a protocol for a systematic review. The findings will be disseminated in a peer-reviewed journal and presented at a relevant conference.
PROSPERO registration number: CRD42014013488.
To analyse the falls in coronary heart disease (CHD) mortality in England between 2000 and 2007 and quantify the relative contributions from preventive medications and population-wide changes in blood pressure (BP) and cholesterol levels, particularly by exploring socioeconomic inequalities.
A modelling study.
Sources of data included controlled trials and meta-analyses, national surveys and official statistics.
English population aged 25+ in 2000–2007.
Number of deaths prevented or postponed (DPPs) in 2007 by socioeconomic status. We used the IMPACTSEC model which applies the relative risk reduction quantified in previous randomised controlled trials and meta-analyses to partition the mortality reduction among specific treatments and risk factor changes.
Between 2000 and 2007, approximately 20 400 DPPs were attributable to reductions in BP and cholesterol in the English population. The substantial decline in BP was responsible for approximately 13 000 DPPs. Approximately 1800 DPPs came from medications and some 11 200 DPPs from population-wide changes. Reduction in population BP prevented almost twofold more deaths in the most deprived quintile compared with the most affluent. Reduction in cholesterol resulted in approximately 7400 DPPs; approximately 5300 DPPs were attributable to statin use and approximately 2100 DPPs to population-wide changes. Statins prevented almost 50% more deaths in the most affluent quintile compared with the most deprived. Conversely, population-wide changes in cholesterol prevented threefold more deaths in the most deprived quintile compared with the most affluent.
Population-wide secular changes in systolic blood pressure (SBP) and cholesterol levels helped to substantially reduce CHD mortality and the associated socioeconomic disparities. Mortality reductions were, in absolute terms, greatest in the most deprived quintiles, mainly reflecting their bigger initial burden of disease. Statins for high-risk individuals also made an important contribution but maintained socioeconomic inequalities. Our results strengthen the case for greater emphasis on preventive approaches, particularly population-based policies to reduce SBP and cholesterol.
Breast cancer incidence rates are rising in Qatar. Although the Qatari government provides subsidised healthcare and screening programmes that reduce cost barriers for residents, breast cancer screening (BCS) practices among women remain low. This study explores the influence of socioeconomic status on BCS among Arab women in Qatar.
A multicentre, cross-sectional quantitative survey was conducted with 1063 Arab women (87.5% response rate) in Qatar from March 2011 to July 2011. Women who were 35 years or older and had lived in Qatar for at least 10 years were recruited from seven primary healthcare centres and women's health clinics in urban and semiurban regions of Qatar. Associations between socioeconomic factors and BCS practice were estimated using 2 tests and multivariate logistic regression analyses.
Findings indicate that less than one-third of the participants practised BCS appropriately, whereas less than half of the participants were familiar with recent BCS guidelines. Married women and women with higher education and income levels were significantly more likely to be aware of and to practise BCS than women who had lower education and income levels.
Findings indicate low levels of awareness and low participation rates in BCS among Arab women in Qatar. Socioeconomic factors influence these women's participation in BCS activities. The strongest predictors for BCS practice are higher education and higher income levels.
Additional research is needed to explore the impact of economic factors on healthcare seeking behaviours in the Middle Eastern countries that have a high national gross domestic product where healthcare services are free or heavily subsidised by the government; promotion of BCS and intervention strategies in these countries should focus on raising awareness about breast cancer, the cost and benefit of early screening for this disease, particularly among low-income women.
MicroRNA-205 (miRNA-205) was revealed as an attractive prognostic tumour biomarker in recent studies. However, the results of different studies have been inconsistent. We conducted a meta-analysis to elucidate the precise predictive value of miRNA-205 in various human malignant neoplasms.
Qualified studies were identified up to 5 June 2014 by performing online searches in PubMed, EMBASE and Web of Science, and additional quality evaluations.
Seventeen eligible studies with 4827 patients were ultimately enrolled in this meta-analysis.
The heterogeneity between studies was assessed using I2 statistics. Pooled HRs with 95% CIs for patient survival and disease recurrence were calculated to investigate the correlation between miRNA-205 expression and cancer prognosis.
Our results indicate that elevated miRNA-205 was significantly associated with enhanced overall survival in the breast cancer subgroup (HR=0.78, 95% CI 0.67 to 0.91) and superior disease-free survival/recurrence-free survival in the adenocarcinoma subgroup (HR=0.68, 95% CI 0.49 to 0.94).
miRNA-205 is a promising biomarker for predicting the recurrence and progression of patients with adenocarcinomas or breast cancer. Owing to its complex roles, further relevant studies are warranted.
Contributors Each of the listed authors made substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data; drafting the article or revising it critically for important intellectual content; and to the final approval of the version to be published as set out in the Uniform Requirements for Manuscripts Submitted to Biomedical Journals. MW, CJ, EM, RI, JSM & PK conceived and designed the research idea. All authors contributed to the drafting the article or revising it critically and gave final...]]>
Malondialdehyde-modified low-density lipoprotein (MDA-LDL) level is a marker of oxidative stress and is linked to progression of arteriosclerosis; however, the clinical factors affecting the oxidised LDL level have not been elucidated. We investigate various factors to identify correlation with MDA-LDL level in high-risk patients requiring catheter intervention.
Secondary care (cardiology), single-centre study.
600 patients who were admitted to our hospital and underwent cardiac catheterisation.
Blood samples were obtained to measure lipid profiles and MDA-LDL level.
With regard to smoking status, MDA-LDL level was significantly higher in ex-smokers/current smokers compared with non-smokers. Of note, there was no improvement of MDA-LDL level even in patients who had quit smoking. Multiple regression analysis showed that MDA-LDL level was positively correlated with LDL-cholesterol (LDL-C) level, Brinkman index and male gender. The correlation between smoking status and either MDA-LDL or LDL-C level was investigated in two groups: namely, patients with and patients without statin treatment. In the non-statin group, MDA-LDL level and MDA-LDL/LDL-C ratio were significantly higher in ex-smokers/current smokers compared with non-smokers, while no significant correlation was observed between smoking status and LDL-C level. In contrast, in the statin group, there were no significant correlations between smoking status and any of the cholesterol parameters.
We found that MDA-LDL level was affected by multiple factors, such as smoking status, LDL-C level and male gender. The present findings give additional evidence that smoking should be prohibited from a MDA-LDL standpoint. Furthermore, statin therapy might have a beneficial effect on the reduction of MDA-LDL level.
To systematically review the evidence for the impact of study design and setting on the interpretation of tuberculosis (TB) transmission using clustering derived from Mycobacterial Interspersed Repetitive Units-Variable Number Tandem Repeats (MIRU-VNTR) strain typing.
MEDLINE, EMBASE, CINHAL, Web of Science and Scopus were searched for articles published before 21st October 2014.
Studies in humans that reported the proportion of clustering of TB isolates by MIRU-VNTR were included in the analysis. Univariable meta-regression analyses were conducted to assess the influence of study design and setting on the proportion of clustering.
The search identified 27 eligible articles reporting clustering between 0% and 63%. The number of MIRU-VNTR loci typed, requiring consent to type patient isolates (as a proxy for sampling fraction), the TB incidence and the maximum cluster size explained 14%, 14%, 27% and 48% of between-study variation, respectively, and had a significant association with the proportion of clustering.
Although MIRU-VNTR typing is being adopted worldwide there is a paucity of data on how study design and setting may influence estimates of clustering. We have highlighted study design variables for consideration in the design and interpretation of future studies.
To identify multilevel correlates of former smoking in patients with cerebrovascular disease.
Secondary data analysis of the Canadian Community Health Survey.
We used data from the 2007–2008 Canadian Community Health Survey (CCHS). Smoking status (former smoking vs smoker) was described by multilevel correlates of former smoking. A multilevel approach for variable selection for this study was used to understand how multiple levels in society can have an impact on former smoking. The study sample was selected from those respondents of the CCHS that reported they suffered from stroke symptoms. Logistic regression was used to predict former smoking in patients with cerebrovascular disease while controlling for multilevel confounders. Proportions were weighted to reflect the Canadian population.
There were 172 355 respondents who reported to suffer from stroke. From this sample, 36.5% were smokers and 63.5% were former smokers. Age groups 55–69 and 70–80 and higher education (secondary education +) were positively related to former smoking. Household and vehicle smoking restrictions significantly predicted former smoking. Counselling advice from a physician and having access to a general practitioner were correlates of former smoking. Finally, the use of buproprion was positively related to former smoking.
There are multilevel correlates of former smoking in smokers with reported stroke symptoms. These correlates include older age groups, higher education, household and vehicle smoking restrictions, pharmacotherapy use (bupropion), access to a general practitioner and counselling advice from a physician.
The reference numbers are correctly displayed throughout the manuscript and all the tables. However, the figures were published with incorrect reference numbers. The findings of the study and data presented are all correct, but the figures could be misleading/confusing in their current form. The correct figures are below.
Mortality—by pre-AKI baseline (AKI, acute kidney injury; CKD, chronic kidney disease; eGFR, estimated glomerular filtration rate; w/o rec, without recovery; with rec, with recovery).
Mortality—by post AKI recovery (AKI, acute kidney injury; CKD, chronic kidney disease; w/o rec, without recovery; with rec, with recovery).
Success in the treatment of young people with cancer, as measured conventionally by survival rates, is mitigated by late effects of therapy that impose a burden of morbidity and limit life expectancy. Among these adverse sequelae are altered body composition, especially obesity, and compromised bone health in the form of osteoporosis and increased fragility. These outcomes are potentially reversible and even preventable. This study will examine measures of body composition and bone health in long-term survivors of acute lymphoblastic leukaemia (ALL) in childhood and adolescence. These measures will be complemented by measures of physical activity and health-related quality of life (HRQL).
Survivors of ALL who are at least 10 years from diagnosis, following treatment on uniform protocols, will undergo measurements of body mass index; triceps skin fold thickness and mid-upper arm circumference; fat mass, lean body mass, skeletal muscle mass and bone mineral density by dual energy X-ray absorptiometry; trabecular and cortical bone indices and muscle density by peripheral quantitative CT; physical activity by the Habitual Activity Estimation Scale; and HRQL by Health Utilities Index instruments. Descriptive measures will be used for continuous variables and number (percent) for categorical variables. Associations between variables will be assessed using Fisher's exact t test and the 2 test; correlations will be tested by the Pearson correlation coefficient.
The study is approved by the institutional research ethics board and is supported by a competitive funding award. Dissemination of the results will occur by presentations to scientific meetings and publications in peer-reviewed journals, and by posting summaries of the results on websites accessed by adolescent and young adult survivors of cancer.
To describe patients' perceived value and use of quality measures in evaluating and choosing community pharmacies.
Focus group methodology was combined with a survey tool. During the focus groups, participants assessed the value of the Pharmacy Quality Alliance's quality measures in evaluating and choosing a pharmacy. Also, participants completed questionnaires rating their perceived value of quality measures in evaluating a pharmacy (1 being low value and 5 being high) or choosing a pharmacy (yes/no). Thematic analysis and descriptive statistics were used to analyse the focus groups and surveys, respectively.
Semistructured focus groups were conducted in a private meeting space of an urban and a rural area of a Mid-western State in the USA.
Thirty-four adults who filled prescription medications in community pharmacies for a chronic illness were recruited in community pharmacies, senior centres and public libraries.
While comments indicated that all measures were important, medication safety measures (eg, drug-drug interactions) were valued more highly than others. Rating of quality measure utility in evaluating a pharmacy ranged from a mean of 4.88 ('drug-drug interactions') to a mean of 4.0 ('absence of controller therapy for patients with asthma'). Patients were hesitant to use quality information in choosing a pharmacy (depending on the participant's location) but might consider if moving to a new area or having had a negative pharmacy experience. Use of select quality measures to choose a pharmacy ranged from 97.1% of participants using 'drug-drug interactions' (medication safety measure) to 55.9% using 'absence of controller therapy for patients with asthma'.
The study participants valued quality measures in evaluating and selecting a community pharmacy, with medication safety measures valued highest. The participants reported that the quality measures would not typically cause a switch in pharmacy but might influence their selection in certain situations.
Despite a growing body of literature, uncertainty regarding the influence of physician dress on patients' perceptions exists. Therefore, we performed a systematic review to examine the influence of physician attire on patient perceptions including trust, satisfaction and confidence.
We searched MEDLINE, Embase, Biosis Previews and Conference Papers Index. Studies that: (1) involved participants ≥18 years of age; (2) evaluated physician attire; and (3) reported patient perceptions related to attire were included. Two authors determined study eligibility. Studies were categorised by country of origin, clinical discipline (eg, internal medicine, surgery), context (inpatient vs outpatient) and occurrence of a clinical encounter when soliciting opinions regarding attire. Studies were assessed using the Downs and Black Scale risk of bias scale. Owing to clinical and methodological heterogeneity, meta-analyses were not attempted.
Of 1040 citations, 30 studies involving 11 533 patients met eligibility criteria. Included studies featured patients from 14 countries. General medicine, procedural (eg, general surgery and obstetrics), clinic, emergency departments and hospital settings were represented. Preferences or positive influence of physician attire on patient perceptions were reported in 21 of the 30 studies (70%). Formal attire and white coats with other attire not specified was preferred in 18 of 30 studies (60%). Preference for formal attire and white coats was more prevalent among older patients and studies conducted in Europe and Asia. Four of seven studies involving procedural specialties reported either no preference for attire or a preference for scrubs; four of five studies in intensive care and emergency settings also found no attire preference. Only 3 of 12 studies that surveyed patients after a clinical encounter concluded that attire influenced patient perceptions.
Although patients often prefer formal physician attire, perceptions of attire are influenced by age, locale, setting and context of care. Policy-based interventions that target such factors appear necessary.
When used appropriately, transfusion of red blood cells (RBCs) is a necessary life-saving therapy. However, RBC transfusions have been associated with negative outcomes such as infection and organ damage. Seeking explanations for the beneficial and deleterious effects of RBC transfusions is necessary to ensure the safe and optimal use of this precious resource. This study will create a framework to analyse the influence of blood donor characteristics on recipient outcomes.
We will conduct a multisite, longitudinal cohort study using blood donor data routinely collected by Canadian Blood Services, and recipient data from health administrative databases. Our project will include a thorough validation of primary data, the linkage of various databases into one large longitudinal database, an in-depth epidemiological analysis and a careful interpretation and dissemination of the results to assist the decision-making process of clinicians, researchers and policymakers in transfusion medicine. Our primary donor characteristic will be age of blood donors and our secondary donor characteristics will be donor–recipient blood group compatibility and blood donor sex. Our primary recipient outcome will be a statistically appropriate survival analysis post-RBC transfusion up to a maximum of 8 years. Our secondary recipient outcomes will include 1-year, 2-year and 5-year mortality; hospital and intensive care unit length of stay; rehospitalisation; new cancer and cancer recurrence rate; infection rate; new occurrence of myocardial infarctions and need for haemodialysis.
Our results will help determine whether we need to tailor transfusion based on donor characteristics, and perhaps this will improve patient outcome. Our results will be customised to target the different stakeholders involved with blood transfusions and will include presentations, peer-reviewed publications and the use of the dissemination network of blood supply organisations. We obtained approval from the Research Ethics boards and privacy offices of all involved institutions.
The aim of this study was to develop and test, for the first time, a multivariate diagnostic classifier of attention deficit hyperactivity disorder (ADHD) based on EEG coherence measures and chronological age.
The participants were recruited in two specialised centres and three schools in Reykjavik.
The data are from a large cross-sectional cohort of 310 patients with ADHD and 351 controls, covering an age range from 5.8 to 14 years. ADHD was diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders fourth edition (DSM-IV) criteria using the K-SADS-PL semistructured interview. Participants in the control group were reported to be free of any mental or developmental disorders by their parents and had a score of less than 1.5 SDs above the age-appropriate norm on the ADHD Rating Scale-IV. Other than moderate or severe intellectual disability, no additional exclusion criteria were applied in order that the cohort reflected the typical cross section of patients with ADHD.
Diagnostic classifiers were developed using statistical pattern recognition for the entire age range and for specific age ranges and were tested using cross-validation and by application to a separate cohort of recordings not used in the development process. The age-specific classification approach was more accurate (76% accuracy in the independent test cohort; 81% cross-validation accuracy) than the age-independent version (76%; 73%). Chronological age was found to be an important classification feature.
The novel application of EEG-based classification methods presented here can offer significant benefit to the clinician by improving both the accuracy of initial diagnosis and ongoing monitoring of children and adolescents with ADHD. The most accurate possible diagnosis at a single point in time can be obtained by the age-specific classifiers, but the age-independent classifiers are also useful as they enable longitudinal monitoring of brain function.
Mechanical ventilation is a cornerstone in the management of critically ill patients worldwide; however, less is known about the clinical management of mechanically ventilated patients in low and middle income countries where limitation of resources including equipment, staff and access to medical information may play an important role in defining patient-centred outcomes. We present the design of a prospective, longitudinal study of mechanically ventilated patients in Peru that aims to describe a large cohort of mechanically ventilated patients and identify practices that, if modified, could result in improved patient-centred outcomes and lower costs.
Five Peruvian intensive care units (ICUs) and the Medical ICU at the Johns Hopkins Hospital were selected for this study. Eligible patients were those who underwent at least 24 h of invasive mechanical ventilation within the first 48 h of admission into the ICU. Information on ventilator settings, clinical management and treatment were collected daily for up to 28 days or until the patient was discharged from the unit. Vital status was assessed at 90 days post enrolment. A subset of participants who survived until hospital discharge were asked to participate in an ancillary study to assess vital status, and physical and mental health at 6, 12, 24 and 60 months after hospitalisation, Primary outcomes include 90-day mortality, time on mechanical ventilation, hospital and ICU lengths of stay, and prevalence of acute respiratory distress syndrome. In subsequent analyses, we aim to identify interventions and standardised care strategies that can be tailored to resource-limited settings and that result in improved patient-centred outcomes and lower costs.
We obtained ethics approval from each of the four participating hospitals in Lima, Peru, and at the Johns Hopkins School of Medicine, Baltimore, USA. Results will be disseminated as several separate publications in different international journals.
In spite of accumulating evidences suggesting an inverse association between insulin resistance and plasma B-type natriuretic peptide (BNP) levels, the effect of daily physical activity on plasma BNP in individuals with glucose intolerance remains unknown. We investigated the association of physical activity level (PAL) with plasma BNP in patients with impaired fasting glucose, impaired glucose tolerance and type 2 diabetes.
Cross-sectional study.
Outpatients visiting the National Center for Global Health and Medicine Kohnodai Hospital.
A total of 60 patients with glucose intolerance who did not take any hypoglycaemic agents, cholesterol-lowering agents and antihypertensive agents were recruited. Patients who were diagnosed as having heart failure and renal impairment, engaged in sports-like exercise and resistance training were excluded.
PAL was objectively measured by a triaxial accelerometer. The association between PAL and plasma BNP levels was assessed by multiple regression analysis.
PAL was positively correlated with plasma BNP levels (r=0.296, p=0.021). PAL was still significantly correlated with plasma BNP levels after adjustment for age (β=0.290, p=0.014), and adjustment for age and body mass index (β=0.282, p=0.018). Plasma BNP levels were inversely correlated with serum insulin levels (r=–0.350, p=0.006) and homeostasis model assessment-estimated insulin resistance (HOMA-IR; r=–0.363, p=0.004). Serum insulin levels (mean±SD, 8.1±6.4 μU/mL) and HOMA-IR (2.4±1.9) in the high-BNP group were significantly lower than those (11.2±7.4 μU/mL and 3.7±3.0, respectively) in the low-BNP group.
Our findings propose the possibility that plasma BNP may be increased by daily physical activity and BNP is associated with insulin resistance.
The present study aimed to combine observational evidence with randomised controlled trials (RCTs) by using the Bayesian approach.
Electronic databases, including PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), ISI Web of Science, EMBASE and EBSCO were searched from inception to January 2014.
RCTs and observational studies (OS) investigating the effectiveness of activated protein C (aPC) on mortality reduction were included for analysis.
Patients with sepsis.
Observational evidence was incorporated into the analysis by using power transformed priors in a Bayesian. Trial sequential analysis was performed to examine changes over time and whether further studies need to be conducted.
a total of 7 RCTs and 12 OS were included for the analysis. There was moderate heterogeneity among included RCTs (I2=48.6%, p=0.07). The pooled OR for mortality from RCTs was 1.00 (95% CI 0.84 to 1.19). In OS, there was potential publication bias as indicated by the funnel plot and the pooled OR for mortality with the use of aPC was 0.67 (95% CI 0.62 to 0.72). The pooled effect sizes of RCTs were changed by using different power transform priors derived from observational evidence. When observational evidence was used at its 'face value', the treatment effect of aPC was statistically significant in reducing mortality.
while RCT evidence showed no beneficial effect of aPC on sepsis, observational evidence showed a significant treatment effect of aPC. By using power transform priors in Bayesian model, we explicitly demonstrated how RCT evidence could be changed by observational evidence.
The protocol for the current study was registered in PROSPERO (registration number: CRD42014009562).
Identification of pathway effects responsible for specific diseases has been one of the essential tasks in systems epidemiology. Despite some advance in procedures for distinguishing specific pathway (or network) topology between different disease status, statistical inference at a population level remains unsolved and further development is still needed. To identify the specific pathways contributing to diseases, we attempt to develop powerful statistics which can capture the complex relationship among risk factors.
Acute myeloid leukaemia (AML) data obtained from 133 adults (98 patients and 35 controls; 47% female).
Simulation studies indicated that the proposed Pathway Effect Measures (PEM) were stable; bootstrap-based methods outperformed the others, with bias-corrected bootstrap CI method having the highest power. Application to real data of AML successfully identified the specific pathway (Treg->TGFβ->Th17) effect contributing to AML with p values less than 0.05 under various methods and the bias-corrected bootstrap CI (–0.214 to –0.020). It demonstrated that Th17–Treg correlation balance was impaired in patients with AML, suggesting that Th17–Treg imbalance potentially plays a role in the pathogenesis of AML.
The proposed bootstrap-based PEM are valid and powerful for detecting the specific pathway effect contributing to disease, thus potentially providing new insight into the underlying mechanisms and ways to study the disease effects of specific pathways more comprehensively.
To analyse the clinical features, inflammatory markers and radiographs of community-acquired pneumonia (CAP) cases with lobe or multi foci infiltration; with a special focus on factors which allow the differential diagnosis of viral and mycoplasma pneumonia.
Retrospective chart review of CAP cases in a large university teaching hospital.
126 paediatric CAP cases, with lobe or multi foci infiltration, presenting between May 2012 and April 2013. Demographic data, clinical presentation on admission or referral, laboratory tests, prior history, and radiography were collected for each case if available.
We used univariate and multivariate logistic regression to determine the significant factors which allow the differential diagnosis of viral and mycoplasma CAP with lobe or multi foci infiltration.
There were 71 (56%) male and 55 (44%) female CAP cases with lobar or multi foci infiltration. 70 pneumonia cases were caused by Mycoplasma pneumoniae and 18 by viruses. Univariate analysis of the mycoplasma and viral causes of the CAP revealed that increased respiratory rate, wheeze, male gender and lymphocyte percentage were the factors associated with the differentiation of mycoplasma and viral aetiologies of pneumonia (p<0.05). A stepwise logistic regression analysis was performed to assess independent factors which allow the differential diagnosis of viral and mycoplasma pneumonia. Increased respiratory rate, wheeze, and lymphocyte percentage were reliable independent factors which allow the differential diagnosis of viral and mycoplasma CAP with lobar or multi foci infiltration.
Whether the CAP with lobar or multi foci infiltration was caused by mycoplasma species or viruses could not be inferred from the radiological patterns. Wheeze, lymphocyte percentage and respiratory rate were independent factors which allowed the differential diagnosis of viral and mycoplasma CAP with lobar or multi foci infiltration.
To examine if streamlining a medical research funding application process saved time for applicants.
Cross-sectional surveys before and after the streamlining.
The National Health and Medical Research Council (NHMRC) of Australia.
Researchers who submitted one or more NHMRC Project Grant applications in 2012 or 2014.
Average researcher time spent preparing an application and the total time for all applications in working days.
The average time per application increased from 34 working days before streamlining (95% CI 33 to 35) to 38 working days after streamlining (95% CI 37 to 39; mean difference 4 days, bootstrap p value <0.001). The estimated total time spent by all researchers on applications after streamlining was 614 working years, a 67-year increase from before streamlining.
Streamlined applications were shorter but took longer to prepare on average. Researchers may be allocating a fixed amount of time to preparing funding applications based on their expected return, or may be increasing their time in response to increased competition. Many potentially productive years of researcher time are still being lost to preparing failed applications.
Otitis media (OM) starts within weeks of birth in almost all Indigenous infants living in remote areas of the Northern Territory (NT). OM and associated hearing loss persist from infancy throughout childhood and often into adulthood. Educational and social opportunities are greatly compromised. Pneumococcus and non-typeable Haemophilus influenzae (NTHi) are major OM pathogens that densely colonise the nasopharynx and infect the middle ear from very early in life. Our hypothesis is that compared to current single vaccine schedules, a combination of vaccines starting at 1 month of age, may provide earlier, broadened protection.
This randomised outcome assessor, blinded controlled trial will recruit 425 infants between 28 and 38 days of age and randomly allocate them (1:1:1) to one of three pneumococcal conjugate vaccine (PCV) schedules: Synflorix at 2, 4, 6 months of age, Prevenar13 at 2, 4 and 6 months of age, or an investigational schedule of Synflorix at 1, 2 and 4 months plus Prevenar13 at 6 months of age. The blinded primary outcomes at 7 months of age are immunogenicity of specific vaccine antigens (geometric mean concentration (GMC) and proportion of participants with above threshold GMC of 0.35 µg/L). Secondary outcomes at all timepoints are additional immunogenicity measures and proportion of participants with nasopharyngeal carriage of vaccine-type pneumococci and NTHi, and any OM, including any tympanic membrane perforation. Parental interviews will provide data on common risk factors for OM.
Ethical approval has been obtained from NT Department of Health and Menzies HREC (EC00153), Central Australian HREC (EC00155) and West Australian Aboriginal Health Ethics Committee (WAAHEC- 377-12/2011). Final trial results, data analyses, interpretation and conclusions will be presented in appropriate written and oral formats to parents and guardians, participating communities, local, national and international conferences, and published in peer-reviewed open access journals.
ACTRN12610000544077 and NCT01174849.
The primary aim was to investigate the impact of complaints on doctors' psychological welfare and health. The secondary aim was to assess whether doctors report exposure to a complaints process is associated with defensive medical practise.
This was a cross-sectional anonymous survey study. Participants were stratified into recent/current, past, no complaints. Each group completed tailored versions of the survey.
95 636 doctors were invited to participate. A total of 10 930(11.4%) responded, 7926 (8.3%) completed the full survey and were included in the complete analysis.
Anxiety and depression were assessed using the standardised Generalised Anxiety Disorder scale and Physical Health Questionnaire. Defensive practise was evaluated using a new measure. Single-item questions measured stress-related illnesses, complaints-related experience, attitudes towards complaints and views on improving complaints processes.
16.9% of doctors with current/recent complaints reported moderate/severe depression (relative risk (RR) 1.77 (95% CI 1.48 to 2.13) compared to doctors with no complaints (9.5%)). Fifteen per cent reported moderate/severe anxiety (RR=2.08 (95% CI 1.61 to 2.68) compared to doctors with no complaints (7.3%)). Distress increased with complaint severity, with highest levels after General Medical Council (GMC) referral (26.3% depression, 22.3% anxiety). Doctors with current/recent complaints were 2.08 (95% CI 1.61 to 2.68) times more likely to report thoughts of self-harm or suicidal ideation. Most doctors reported defensive practise: 82–89% hedging and 46–50% avoidance. Twenty per cent felt victimised after whistleblowing, 38% felt bullied, 27% spent over 1 month off work. Over 80% felt processes would improve with transparency, managerial competence, capacity to claim lost earnings and action against vexatious complainants.
Doctors with recent/current complaints have significant risks of moderate/severe depression, anxiety and suicidal ideation. Morbidity was greatest in cases involving the GMC. Most doctors reported practising defensively, including avoidance of procedures and high-risk patients. Many felt victimised as whistleblowers or reported bullying. Suggestions to improve complaints processes included transparency and managerial competence.
We conducted a retrospective review of patients with extrapulmonary small cell carcinomas (EPSCCs) to explore the distribution, treatments, patterns of relapse and outcomes by primary site.
We have reviewed the outcomes of one of the largest data sets of consecutive patients with EPSCC identified from two major cancer centres.
Consecutive patients with a histopathological diagnosis of EPSCC from the two institutions were retrospectively identified.
Outcomes were evaluated including stage at presentation, treatments given, sites of relapse, time to distant relapse, progression-free survival and overall survival (OS).
From a total 159 patients, 114 received first-line chemotherapy, 80.5% being platinum-based. Response rate was 48%. Commonest primary sites were genitourinary and gynaecological. 44% of patients presented with metastatic disease. 55.9% relapsed with liver the commonest site, whereas only 2.5% developed brain metastases. Median OS was 13.4 months for all patients, 7.6 months and 19.5 months for those with metastatic and non-metastatic disease, respectively. Gynaecological and head and neck patients had significantly better OS compared to gastrointestinal patients.
EPSCCs demonstrate high response rates to chemotherapy and high rates of distant metastases. Primary sites may influence prognosis, and survival is optimal with a radical strategy. Brain metastases are rare and we therefore do not recommend prophylactic cranial irradiation.
The primary objective was to estimate the national prevalence of psoriasis and palmoplantar pustulosis (PPP) in Japan. Secondary objectives were to determine (1) whether psoriasis and PPP disease activity varies by season, and (2) whether disease severity is associated with concurrent diabetes mellitus, hyperlipidaemia and hypertension.
Patients with a psoriasis or PPP diagnosis code between April 2010 and March 2011 were identified using a Japanese national database.
565 903 patients with psoriasis or PPP were identified. No patient was excluded.
National prevalence was calculated using census data. We estimated the difference in the proportion of patients who used healthcare services, as a proxy for disease activity, between the hot and cold seasons and the difference in the standardised prevalence of comorbidities between severe and mild disease. The measures were estimated separately for the two broad disease categories of psoriasis and PPP but not in all patients as planned because the two disease categories had major differences.
The national prevalence of psoriasis and PPP was 0.34% (95% CI 0.34% to 0.34%) and 0.12% (0.12% to 0.12%), respectively. The difference in the proportion of patients who used healthcare services in the hot compared to the cold season was –0.3% (–0.5% to –0.1%) for psoriasis and 10.0% (9.8% to 10.3%) for PPP. The difference in the standardised prevalence between severe and mild psoriasis was 3.1% (2.7% to 3.4%), 3.2% (2.8% to 3.6%) and 5.1% (4.7% to 5.6%) for concurrent diabetes mellitus, hyperlipidaemia and hypertension, respectively. No significant difference in the prevalence of comorbidity was observed for PPP.
The national prevalence, seasonal variation in disease activity and prevalence of comorbidities in Japanese patients with psoriasis and PPP estimated in this descriptive study may be used as basic information for future studies.
To estimate the efficacy of a probiotic yogurt compared to a pasteurised yogurt for the prevention of antibiotic-associated diarrhoea in children.
This was a multisite, randomised, double-blind, placebo-controlled clinical trial conducted between September 2009 and 2012. The study was conducted through general practices and pharmacies in Launceston, Tasmania, Australia.
Children (aged 1–12 years) prescribed antibiotics, were randomised to receive 200 g/day of either yogurt (probiotic) containing Lactobacillus rhamnosus GG (LGG), Bifidobacterium lactis (Bb-12) and Lactobacillus acidophilus (La-5) or a pasteurised yogurt (placebo) for the same duration as their antibiotic treatment.
Stool frequency and consistency were recorded for the duration of treatment plus 1 week. Primary outcome was stool frequency and consistency, classified at different levels of diarrhoea severity. Due to the small number of cases of diarrhoea, comparisons between groups were made using Fisher's exact analysis.
72 children commenced and 70 children (36 placebo and 34 probiotic) completed the trial. There were no incidents of severe diarrhoea (stool consistency ≥6, ≥3 stools/day for ≥2 consecutive days) in the probiotic group and six in the placebo group (Fisher's exact p=0.025). There was also only one episode of minor diarrhoea (stool consistency ≥5, ≥2 stools/day for ≥2 days in the probiotic group compared to 21 in the placebo group (Fisher's exact p<0.001). The probiotic group reported fewer adverse events (1 had abdominal pain, 1 vomited and 1 had headache) than the placebo group (6 had abdominal pain, 4 had loss of appetite and 1 had nausea).
A yogurt combination of LGG, La-5 and Bb-12 is an effective method for reducing the incidence of antibiotic-associated diarrhoea in children.
Australian New Zealand Clinical Trials Registry ACTRN12609000281291
This paper reports on a qualitative exploration of the reasons for differences in pathways to care and duration of untreated psychosis (DUP) in the African, Caribbean and European (ACE) Pathways to Care study from the perspective of respondents to the study and their families.
Ontario, Canada.
Thirty-four participants in total. Twenty-five young people who had experienced a first episode of psychosis and nine family members. Participants were part of the ACE Pathways to Care study.
We implemented six focus groups. Furthermore, we implemented four in-depth interviews with two African-origin young women, one Caribbean-origin woman, and one European-origin woman with lived experience of psychosis.
Factors that influenced help-seeking delays across the three groups were: personal awareness of symptoms, family members' knowledge of psychotic symptoms and knowledge of mental health services. Youth and their family members described how stigma played a key role in pathways to care by stopping them from asking for help. The way in which stigma operated on the three groups' members, from feeling ashamed to feeling guilty for their mental illnesses, helped to explain differences in DUP between the groups. Guilt feelings emerged as a prominent theme among members from the African and Caribbean groups and it was not discussed in the European focus group. Delay in entering into first-episode psychosis programmes was also influenced by the stigma perceived by young people in healthcare settings. This had an impact on the therapeutic relationships, disclosure of symptoms and overall trust in the healthcare system.
The findings of this paper suggest that stigma, especially internalised stigma, may operate in different ways in European-origin, African-origin and Caribbean-origin groups. These findings could inform the development of more equitable services for people in early stages of psychosis.
Heavy menstrual bleeding (HMB) diminishes individual quality-of-life and poses substantial societal burden. In HMB endometrium, inactivation of cortisol (by enzyme 11β hydroxysteroid dehydrogenase type 2 (11βHSD2)), may cause local endometrial glucocorticoid deficiency and hence increased angiogenesis and impaired vasoconstriction. We propose that 'rescue' of luteal phase endometrial glucocorticoid deficiency could reduce menstrual bleeding.
DexFEM is a double-blind response-adaptive parallel-group placebo-controlled trial in women with HMB (108 to be randomised), with active treatment the potent oral synthetic glucocorticoid dexamethasone, which is relatively resistant to 11βHSD2 inactivation. Participants will be aged over 18 years, with mean measured menstrual blood loss (MBL) for two screening cycles ≥50 mL. The primary outcome is reduction in MBL from screening. Secondary end points are questionnaire assessments of treatment effect and acceptability. Treatment will be for 5 days in the mid-luteal phases of three treatment menstrual cycles. Six doses of low-dose dexamethasone (ranging from 0.2 to 0.9 mg twice daily) will be compared with placebo, to ascertain optimal dose, and whether this has advantage over placebo. Statistical efficiency is maximised by allowing randomisation probabilities to 'adapt' at five points during enrolment phase, based on the response data available so far, to favour doses expected to provide greatest additional information on the dose–response. Bayesian Normal Dynamic Linear Modelling, with baseline MBL included as covariate, will determine optimal dose (re reduction in MBL). Secondary end points will be analysed using generalised dynamic linear models. For each dose for all end points, a 95% credible interval will be calculated for effect versus placebo.
Dexamethasone is widely used and hence well-characterised safety-wise. Ethical approval has been obtained from Scotland A Research Ethics Committee (12/SS/0147). Trial findings will be disseminated via open-access peer-reviewed publications, conferences, clinical networks, public lectures, and our websites.
ClinicalTrials.gov NCT01769820; EudractCT 2012-003405-98.
Increasing evidence suggests obesity has its origins prior to birth. There is clear correlation between maternal obesity, high birthweight and offspring risk of obesity in later life. It is also clear that women who are obese during pregnancy are at greater risk of adverse outcomes, including gestational diabetes and stillbirth. The mechanism(s) by which obesity causes these problems is unknown, although hyperglycaemia and insulin resistance are strongly implicated. We present a protocol for a study to test the hypothesis that metformin will improve insulin sensitivity in obese pregnant women, thereby reducing the incidence of high birthweight babies and other pregnancy complications.
The Efficacy of Metformin in Pregnant Obese Women, a Randomised controlled (EMPOWaR) trial is a double-masked randomised placebo-controlled trial to determine whether metformin given to obese (body mass index >30 kg/m2) pregnant women from 16 weeks' gestation until delivery reduces the incidence of high birthweight babies. A secondary aim is to test the mechanism(s) of any effect. Obese women with a singleton pregnancy and normal glucose tolerance will be recruited prior to 16 weeks' gestation and prescribed study medication, metformin or placebo, to be taken until delivery. Further study visits will occur at 28 and 36 weeks' gestation for glucose tolerance testing and to record anthropometric measurements. Birth weight and other measurements will be recorded at time of delivery. Anthropometry of mother and baby will be performed at 3 months postdelivery. As of January 2014, 449 women had been randomised across the UK.
The study will be conducted in accordance with the principles of Good Clinical Practice. A favourable ethical opinion was obtained from Scotland A Research Ethics Committee, reference number 10/MRE00/12. Results will be disseminated at conferences and published in peer-reviewed journals.
In this work, we have compared uniprofessional and interprofessional versions of a simulation education intervention, in an attempt to understand more about whether it improves trainees' self-efficacy.
Interprofessionalism has been climbing the healthcare agenda for over 50 years. Simulation education attempts to create an environment for healthcare professionals to learn, without potential safety risks for patients. Integrating simulation and interprofessional education can provide benefits to individual learners.
The intervention took place in a high-fidelity simulation facility located on the campus of a large urban hospital. The centre provides educational activities for an Academic Health Sciences Centre. Approximately 2500 staff are trained at the centre each year.
One hundred and fifteen nurses and midwives along with 156 doctors, all within the early years of their postgraduate experience participated. All were included on the basis of their ongoing postgraduate education.
Each course was a one-day simulation course incorporating five clinical and one communication scenarios. After each a facilitated debriefing took place. A mixed methods approach utilised precourse and postcourse questionnaires measuring self-efficacy in managing emergency situations, communication, teamwork and leadership.
Thematic analysis of qualitative data showed improvements in communication/teamwork and leadership, for doctors and nurses undergoing simulation training. These findings were confirmed by statistical analysis showing that confidence ratings improved in nurses and doctors overall (p<0.001). Improved outcomes from baseline were observed for interprofessional versus uniprofessional trained nurses (n=115; p<0.001). Postcourse ratings for doctors showed that interprofessional training was significantly associated with better final outcomes for a communication/teamwork dimension (n=156; p<0.05).
This study provides evidence that simulation training enhances participants' self-efficacy in clinical situations. It also leads to increases in their perceived abilities relating to communication/teamwork and leadership/management of clinical scenarios. Interprofessional training showed increased positive effects on self-efficacy for nurses and doctors.
To investigate the association of the duration of use of prescription medications and nicotine replacement therapy (NRT) with smoking cessation using a national sample of the general population in the USA, controlling for nicotine dependence and sociodemographic variables.
We used data from the 2010–2011 Tobacco Use Supplement to the US Current Population Survey. We limited the analysis to current daily smokers who made a quit attempt in the past year and former smokers who were a daily smoker 1 year prior to the survey (n=8263). Respondents were asked about duration of use of prescription medication (varenicline, bupropion, other) and NRT (nicotine patch, gum/lozenges, nasal spray and inhaler) for smoking cessation.
Successful smoking cessation. Individuals who reported to have smoked at least 100 cigarettes in their lifetime but were not smoking at all at the time of the interview and were a daily smoker 1 year prior to the interview were considered to have successfully quit smoking.
After adjusting for daily cigarette consumption and sociodemographic covariates, we found evidence for an association between duration of pharmacotherapy use and smoking cessation (p<0.001). Adjusted cessation rates for those who used prescription medication or NRT for 5+ weeks were 28.8% and 27.8%, respectively. Adjusted cessation rates for those who used prescription medication or NRT for less than 5 weeks varied from 6.2% to 14.5%. Adjusted cessation rates for those who used only behavioural counselling and those who attempted to quit smoking unassisted were 16.1% and 16.4%, respectively.
Use of pharmacotherapy for at least 5 weeks is associated with increased likelihood of successful smoking cessation. Results suggest that encouraging smokers who intend to quit to use pharmacotherapy and to adhere to treatment duration can help improve chances of successful cessation.
An expectation of research is that participants should give fully informed consent. However, there is also a need to maximise recruitment to ensure representativeness. We explored the impact of passive or active parental consent on consent, completion rates and on dietary data quality in a survey among children aged 11–12 years.
Six middle schools in North-East England.
All children aged 11–12 years attending the six middle schools were eligible to participate (n=1141).
Primary outcomes: whether or not each eligible child's parent gave consent and provided a complete dietary diary; whether or not a child completed their dietary diary but only among children who agreed to participate, and whether or not children providing diaries were classified as an under-reporter or not.
Parents were more likely to consent passively than actively. This difference was greater among the more deprived: OR 16.9 (95% CI 5.7 to 50.2) in the least and 129.6 (95% CI 39.9 to 420.6) in the most deprived quintile (test for interaction: method of consent by level of deprivation, p=0.02). For all children eligible, completion was more likely if passive consent was used (OR 2.8, 95% CI 2.2 to 3.7). When only children who gave consent are considered, completion was less likely when passive rather than active consent was used (OR 0.6, 95% CI 0.4 to 0.9). Completion rate decreased as level of deprivation increased; we found no evidence that the OR for the method of consent varied by level of deprivation. There was no evidence that the quality of dietary data, as measured by an assessment of under-reporting, differed by method of consent (OR 0.8, 95% CI 0.5 to 1.2).
Passive consent led to a higher participation rate and a more representative sample without compromising data quality.
To explore Do Not Attempt Cardiopulmonary Resuscitation (DNACPR) policies from English acute, community and ambulance service Trusts for evidence of consistency and variation in implementation of national guidelines between healthcare organisations.
Acute, community or ambulance National Health Service (NHS) Trusts in England.
48 NHS Trusts.
Freedom of information requests for adult DNACPR policies were sent to a random sample of Trusts.
DNACPR policies were assessed on aspects identified from national guidelines including documentation, ethical and legal issues, decision-makers and involvement of others in DNACPR decisions as well as practical considerations such as validity, review and portability of decisions.
Policies from 26 acute, 12 community and 10 ambulance service Trusts were reviewed. There was variation in terminology used (85% described documents as policies, 6% procedures and 8% guidelines). Only one quarter of Trusts used the recommended Resuscitation Council (UK) record form (or a modification of the form). There was variation in the terminology used which included DNAR, DNACPR, Not for CPR and AND (allow natural death). Accountability for DNACPR decisions rested with consultants at all acute Trusts and the most senior clinician at community Trusts. Most Trusts (74%) recommended discussion of decisions with a multidisciplinary team. Compliance with guidance requiring clinical staff to assess the patient for capacity and when to consult a lasting power of attorney or independent mental capacity advocate occurred less commonly. There was wide variation in the duration of time over which a DNACPR decision was considered valid as well as in the Trusts' approach to reviewing DNACPR decisions. The level of portability of DNACPR decisions between healthcare organisations was one of the greatest sources of variation.
There is significant variation in the translation of the national DNACPR guidelines into English healthcare Trusts' DNACPR policies.
To clarify the pathophysiological basis of persistent geotropic positional nystagmus (PGN) in patients with the horizontal canal type of benign paroxysmal positional vertigo (H-BPPV), the time constant (TC) of nystagmus and the relationship between its slow phase eye velocity (SPV) and the angle of head rotation in supine were defined.
Geotropic or apogeotropic positional nystagmus was recorded by video-oculography and analysed three-dimensionally.
Geotropic positional nystagmuses in patients with H-BPPV were classified as transient geotropic positional nystagmus with a TC of ≤35 s or PGN with a TC of >35 s. Alternatively, the TC of persistent apogeotropic positional nystagmus (AN) in patients with H-BPPV was >35 s. The direction of the SPV of patients with PGN was opposite to that of patients with AN at each head position across the range of neutral head positions. The relationship between the SPV of patients with PGN and the angle of head rotation was linearly symmetrical against that of patients with AN with respect to a line drawn on the neutral head position.
Since its TC was >35 s, it is suggested that PGN is induced by cupula deviation in response to gravity at each head position. It is also suggested that the direction of cupula deviation in patients with PGN is opposite to that of patients with AN across the neutral head positional range with no nystagmus where the long axis of cupula is in alignment with the axis of gravity. Since the pathophysiological basis of AN is considered a heavy cupula, it is suggested that PGN is conversely induced by a light cupula.
This study aimed to test the hypothesis that the i-gel supraglottic airway device would fit the larynx and provide better sealing pressure if prewarmed to 42°C relative to the device kept at room temperature in non-paralysed, sedated patients.
A total of 74 adult patients were assigned to the warm (i-gel prewarmed to 42°C; W group; 37 patients) or the control (i-gel kept at room temperature; C group; 37 patients) groups. Anaesthesia was induced with propofol and fentanyl. The i-gel was prewarmed to 42°C for 30 min before insertion in the W group, but kept at room temperature (approximately 23°C) for the C group. The number of attempts made until successful insertion and sealing pressure were compared between the two groups.
Insertion was successful with one attempt in 35 cases each for the W and C groups. Two attempts were needed in two cases for the W group and one case for the C group. There was one failed attempt in the C group, but none in the W group. None of the differences between the two groups were significant (p=0.51). Sealing pressure was slightly, but not significantly, higher in the W group than in the C group (W group 22.6±6.1 cm H2O; C group 20.7±6.1 cm H2O; p=0.15).
Prewarming of the i-gel to 42°C did not increase the success rate of insertion, nor did it significantly increase sealing pressure in anaesthetised, non-paralysed patients. Our data suggest that we can keep the i-gel at room temperature for emergency airway management for non-paralysed, sedated patients.
University Medical Information Network, Japan 000012287.
Postoperative atrial fibrillation (AF) occurs in 30–40% of patients after cardiac surgery. Identification of recurrent postoperative AF is required to initiate evidence-based management to reduce the risk of subsequent stroke. However, as AF is often asymptomatic, recurrences may not be detected after discharge. This study determines feasibility and impact of a self-surveillance programme to identify recurrence of postoperative AF in the month of posthospital discharge.
This is a feasibility study, using a cross-sectional study design, of self-screening for AF using a hand-held single-lead iPhone electrocardiograph device (iECG). Participants will be recruited from the cardiothoracic surgery wards of the Royal North Shore Hospital and North Shore Private Hospital, Sydney, Australia. Cardiac surgery patients admitted in sinus rhythm and experiencing a transient episode of postoperative AF will be eligible for recruitment. Participants will be taught to take daily ECG recordings for 1 month posthospital discharge using the iECG and will be provided education regarding AF, including symptoms and health risks. The primary outcome is the feasibility of patient self-monitoring for AF recurrence using an iECG. Secondary outcomes include proportion of patients identified with recurrent AF; estimation of stroke risk and patient knowledge. Process outcomes and qualitative data related to acceptability of patient's use of the iECG and sustainability of the screening programme beyond the trial setting will also be collected.
Primary ethics approval was received on 25 February 2014 from Northern Sydney Local Health District Human Resource Ethics Committee, and on 17 July 2014 from North Shore Private Hospital Ethics Committee. Results will be disseminated via forums including, but not limited to, peer-reviewed publications and presentation at national and international conferences.
To investigate access to weight management interventions for overweight and obese patients in primary care.
UK primary care electronic health records.
A cohort of 91 413 overweight and obese patients aged 30–100 years was sampled from the Clinical Practice Research Datalink (CPRD). Patients with body mass index (BMI) values ≥25 kg/m2 recorded between 2005 and 2012 were included. BMI values were categorised using WHO criteria.
Interventions for body weight management, including advice, referrals and prescription of antiobesity drugs, were evaluated.
The rate of body weight management interventions and time to intervention were the main outcomes.
Data were analysed for 91 413 patients, mean age 56 years, including 55 094 (60%) overweight and 36 319 (40%) obese, including 4099 (5%) with morbid obesity. During the study period, 90% of overweight patients had no weight management intervention recorded. Intervention was more frequent among obese patients, but 59% of patients with morbid obesity had no intervention recorded. Rates of intervention increased with BMI category. In morbid obesity, rates of intervention per 1000 patient years were: advice, 60.2 (95% CI 51.8 to 70.4); referral, 75.7 (95% CI 69.5 to 82.6) and antiobesity drugs 89.9 (95% CI 85.0 to 95.2). Weight management interventions were more often accessed by women, older patients, those with comorbidity and those in deprivation. Follow-up of body weight subsequent to interventions was infrequent.
Limited evidence of weight management interventions in primary care electronic health records may result from poor recording of advice given, but may indicate a lack of patient access to appropriate body weight management interventions in primary care.
Cholecystectomy is one of the most common general surgical operations performed. Despite level one evidence supporting the role of cholecystectomy in the management of specific gallbladder diseases, practice varies between surgeons and hospitals. It is unknown whether these variations account for the differences in surgical outcomes seen in population-level retrospective data sets. This study aims to investigate surgical outcomes following acute, elective and delayed cholecystectomies in a multicentre, contemporary, prospective, population-based cohort.
UK and Irish hospitals performing cholecystectomies will be recruited utilising trainee-led research collaboratives. Two months of consecutive, adult patient data will be included. The primary outcome measure of all-cause 30-day readmission rate will be used in this study. Thirty-day complication rates, bile leak rate, common bile duct injury, conversion to open surgery, duration of surgery and length of stay will be measured as secondary outcomes. Prospective data on over 8000 procedures is anticipated. Individual hospitals will be surveyed to determine local policies and service provision. Variations in outcomes will be investigated using regression modelling to adjust for confounders.
Research ethics approval is not required for this study and has been confirmed by the online National Research Ethics Service (NRES) decision tool. This novel study will investigate how hospital-level surgical provision can affect patient outcomes, using a cross-sectional methodology. The results are essential to inform commissioning groups and implement changes within the National Health Service (NHS). Dissemination of the study protocol is primarily through the trainee-led research collaboratives and the Association of Upper Gastrointestinal Surgeons (AUGIS). Individual centres will have access to their own results and the collective results of the study will be published in peer-reviewed journals and presented at relevant surgical conferences.
[18F] Fluorodeoxyglucose positron emission tomography (FDG PET), a standard tool for evaluating malignancies, can also detect inflammatory lesions. However, its usefulness in evaluating muscle lesions in polymyositis and dermatomyositis syndromes (PM/DM) has not been established.
33 patients with PM/DM who had undergone FDG PET were retrospectively analysed. FDG uptake was visually evaluated (visually identified FDG uptake, vFDG) in 16 regions of the body using mediastinum blood vessels as a positivity criterion. We also calculated the maximum standardised uptake value (SUVmax) in all four limbs of the patients with PM/DM as well as in 22 patients with amyotrophic lateral sclerosis (ALS) with similar disabilities. In 24 patients with PM/DM, MRI and FDG PET findings were compared.
vFDG was observed in multiple muscle lesions with varying distributions in two-thirds of the patients with PM/DM, with most lesions being symmetrical. The number of vFDG-positive regions strongly correlated with the mean SUVmax in all four limbs (p<0.0001). Histological grades of biopsied muscles correlated with both the mean SUVmax and number of vFDG-positive regions. Serum creatine kinase levels were higher in patients with more than two vFDG-positive regions than in those with two or less regions (p<0.05). While the inflamed muscles showed diffused, patchy or marginal signal abnormalities on MRI, FDG uptake was most prominent inside the muscles. Compared with ALS, the mean SUVmax was significantly higher in the patients with PM/DM (p<0.0001) and showed a striking correlation in the bilateral muscles, reflecting symmetrical muscle involvement in PM/DM.
The visual assessment of FDG uptake as well as calculation of SUV enabled us to comprehensively evaluate skeletal muscle. This method can improve clinical practices and provide insights into pathomechanisms of PM/DM.
Effective government policies are essential to increase the healthiness of food environments. The International Network for Food and Obesity/non-communicable diseases (NCDs) Research, Monitoring and Action Support (INFORMAS) has developed a monitoring tool (the Healthy Food Environment Policy Index (Food-EPI)) and process to rate government policies to create healthy food environments against international best practice. The aims of this study were to pilot test the Food-EPI, and revise the tool and process for international implementation.
New Zealand.
Thirty-nine informed, independent public health experts and non-governmental organisation (NGO) representatives.
Evidence on the extent of government implementation of different policies on food environments and infrastructure support was collected in New Zealand and validated with government officials. Two whole-day workshops were convened of public health experts and NGO representatives who rated performance of their government for seven policy and seven infrastructure support domains against international best practice. In addition, the raters evaluated the level of difficulty of rating, and appropriateness and completeness of the evidence presented for each indicator.
Inter-rater reliability was 0.85 (95% CI 0.81 to 0.88; Gwet's AC2) using quadratic weights, and increased to 0.89 (95% CI 0.85 to 0.92) after deletion of the problematic indicators. Based on raters' assessments and comments, major changes to the Food-EPI tool include strengthening the leadership domain, removing the workforce development domain, a stronger focus on equity, and adding community-based programmes and government funding for research on obesity and diet-related NCD prevention, as good practice indicators.
The resulting tool and process will be promoted and offered to countries of varying size and income globally. International benchmarking of the extent of government policy implementation on food environments has the potential to catalyse greater government action to reduce obesity and NCDs, and increase civil society's capacity to advocate for healthy food environments.
Patients with malignant pleural mesothelioma (MPM) may develop painful 'procedure tract metastasis' (PTM) at the site of previous pleural interventions. Prophylactic radiotherapy has been used to minimise this complication; however, three small randomised trials have shown conflicting results regarding its effectiveness. The surgical and large bore procedures in malignant pleural mesothelioma and radiotherapy trial (SMART Trial) is a suitably powered, multicentre, randomised controlled trial, designed to evaluate the efficacy of prophylactic radiotherapy within 42 days of pleural instrumentation in preventing the development of PTM in MPM.
203 patients with a histocytologically proven diagnosis of MPM, who have undergone a large bore pleural intervention (thoracic surgery, large bore chest drain, indwelling pleural catheter or local anaesthetic thoracoscopy) in the previous 35 days, will be recruited from UK hospitals. Patients will be randomised (1:1) to receive immediate radiotherapy (21 Gy in 3 fractions over 3 working days within 42 days of the pleural intervention) or deferred radiotherapy (21 Gy in 3 fractions over 3 working days given if a PTM develops). Patients will be followed up for 12 months. The primary outcome measure is the rate of PTM until death or 12 months (whichever is sooner), as defined by the presence of a clinically palpable nodule of at least 1 cm diameter felt within 7 cm of the margins of the procedure site as confirmed by two assessors. Secondary outcome measures include chest pain, quality of life, analgaesic requirements, healthcare utilisation and safety (including radiotherapy toxicity).
The trial has received ethical approval from the Southampton B Research Ethics Committee (11/SC/0408). There is a Trial Steering Committee, including independent members and a patient and public representative. The trial results will be published in a peer-reviewed journal and presented at international conferences.
To calculate the short-term risk–benefit effect of occasional and regular use of low-dose aspirin (≤100 mg/day) in primary prevention.
Two retrospective cohort studies.
63 788 and 24 910 patients of two nationwide population-based studies were examined.
Two databases of 1 000 000 patients were randomly sampled from data of Taiwan's National Health Insurance (NHI) for years 1997–2000 (NHI 2000) and 2005 (NHI 2005). In NHI 2000, 63 788 patients 30–95 years of age were found not to have previously been prescribed aspirin before 1 January 2000, but to have first been prescribed low-dose aspirin after that date. They were also found to be at risk of first hospitalisation for any major vascular diseases including haemorrhage (major gastrointestinal haemorrhage or cerebral haemorrhage) and ischaemia (acute myocardial infarction or ischaemic stroke) after their first prescription. We also applied it to NHI 2005, and the number of eligible patients was 24 910. Patients prescribed low-dose aspirin for <20% of the days of a 60-day follow-up period were considered to be occasional users, and those prescribed low-dose aspirin for ≥80% of the days were considered to be regular users. Differences in rate of haemorrhage and ischaemia between these users were used to calculate their net clinical risk.
Vascular diseases.
In NHI 2000, the overall unadjusted rates of haemorrhage and ischaemia were 0.09% and 0.21%, respectively, for occasional users and 0.32% and 2.30%, respectively, for regular users. Adjusted net clinical risk of low-dose aspirin use between the two groups was 2.24% (95% CI 2.03% to 2.48%; p<0.001). Similar results were also found in NHI 2005.
Short-term regular use of low-dose aspirin might not be better than occasional use for preventing major vascular diseases in primary prevention. Prescribing regular low-dose aspirin for primary prevention should be done with caution. Future studies should explore the risk–benefit effect of long-term low-dose aspirin use in primary prevention.
Recent studies have suggested that stress in a pregnant mother may affect the future health of the unborn child negatively. An excellent proxy for health problems is the use of healthcare resources. Using nationwide data, we examined whether persons born to mothers who lost a close relative during pregnancy have more contacts to general practice.
Population-based cohort study.
We included all children born in Denmark from 1973 to 2002 (N=2 032 528). Exposure of prenatal stress was defined as maternal bereavement by the death of a close relative during the antenatal period. The outcome of interest was contact with general practice between 2003 and 2009 when the participants were between 1 and 35 years of age. Poisson regression was used to assess the association between exposure and outcome.
Contacts to general practitioner.
Overall, persons exposed to prenatal stress had 2% more GP contacts than those not exposed, primarily due to increased utilisation of healthcare services during late adolescence and early adulthood. The exposed persons born to mothers who had lost a spouse had a higher risk (relative risk (RR) 1.12, 95% CI 1.10 to 1.14) and so did those born to mothers who had lost a close relative due to unexpected death (RR 1.06, 95% CI 1.05 to 1.06). Exposed persons had more contacts to general practice in daytime and more psychometric tests, talk therapies and C reactive protein tests than unexposed persons.
Prenatal stress following maternal bereavement was associated with a slightly increased utilisation of primary healthcare, mainly due to increased healthcare needs related to mental health and infections. Understanding how stress during pregnancy influences the future health of the child is an important aspect of prenatal care.
Methadone maintenance treatment (MMT) has been implemented in China since 2004 and has expanded into a nationwide programme. This study aims to evaluate changes in social functioning, family relations and drug-related criminal behaviour among MMT clients in China.
Systematic review and meta-analysis.
Both English and Chinese literature databases, including PubMed, Chongqing VIP Chinese Science and Technology Journals Database (CQVIP), China National Knowledge Infrastructure (CNKI) and Wanfang Data, were comprehensively searched over the period 2004–2014 for studied indicators. Study selection, quality assessment and data extraction were conducted according to the PRISMA (preferred reporting items for systematic reviews and meta-analyses) Statement. Meta-analyses were conducted using Comprehensive Meta-Analysis Biostat software.
Thirty-eight articles were included in this review (1 in English and 37 in Chinese). The self-reported arrest rate decreased from 13.1% (95% CI 9.1% to 18.5%) at baseline to 3.4% (95% CI 1.5% to 7.7%) and 4.3% (95% CI 1.6% to 11.4%) after 6 and 12 months of MMT intervention, respectively. The rate of drug selling decreased from 7.6% (95% CI 3.8% to 14.8%) at baseline to 1.9% (95% CI 0.6% to 6.2%) and 3.0% (95% CI 1.0% to 8.9%) after 6 and 12 months of intervention, respectively. Similarly, the rates of selling sex for drugs and drug-related crime decreased from 5.3% (95% CI 2.4% to 11.1%) and 9.9% (95% CI 6.8% to 14.2%) at baseline to 1.1% (95% CI 0.5% to 2.3%) and 3.4% (95% CI 2.5% to 4.5%) at 6 months, then to 0.8% (95% CI 0.3% to 1.9%) and 3.4% (95% CI 0.8% to 13.1%) at 12 months after treatment initiation, respectively. In contrast, the rate of employment of clients and the proportion of clients having a good relationship with their family increased substantially from 26.4% (95% CI 22.9% to 30.1%) and 37.9% (95% CI 32.0% to 44.2%) to 41.6% (95% CI 36.6% to 48.0%) and 59.6% (95% CI 48.1% to 70.2%) at 6 months, then to 59.8% (95% CI 52.4% to 66.8%) and 75.0% (95% CI 69.0% to 80.2%) at 12 months after treatment initiation, respectively.
MMT has significantly reduced criminal activity, and improved employment rate and social well-being, of clients of the MMT programme. MMT is an effective measure to help drug users to resume societal and familial functions in China.
Rhabdomyosarcoma (RMS) management depends on risk stratification at diagnosis and treatment response. Assessment methods include CT, MRI, bone scintigraphy, histological analysis and bone marrow biopsy. Advanced functional imaging (FI) has potential to improve staging accuracy and management strategies.
We conducted a systematic review (PROSPERO 2013:CRD42013006128) of diagnostic accuracy and clinical effectiveness of FI in histologically proven paediatric RMS. PRISMA guidance was followed. We searched 10 databases to November 2013. Studies with ≥10 patients with RMS which compared positron emission tomography (PET), PET-CT or diffusion-weighted imaging (DWI) MRI to conventional imaging at any treatment stage were included. Study quality was assessed. Limited, heterogeneous effectiveness data required narrative synthesis, illustrated by plotting sensitivity and specificity in receiver operating curve (ROC) space.
Eight studies (six PET-CT, two PET) with 272 RMS patients in total were included. No DWI-MRI studies met inclusion criteria. Pooled estimates were not calculated due to sparseness of data. Limited evidence indicated initial PET-CT results were predictive of survival. PET-CT changed management of 7/40 patients. Nodal involvement PET-CT: sensitivity ranged from 80% to 100%; specificity from 89% to 100%. Distant metastatic involvement: PET-CT sensitivity ranged from 95% to 100%; specificity from 80% to100%. Data on metastases in different sites were sparse. Limited data were found on outcome prediction by PET-CT response.
PET/PET-CT may increase initial staging accuracy in paediatric RMS, specifically in the detection of nodal involvement and distant metastatic spread. There is a need to further assess PET-CT for this population, ideally in a representative, unbiased and transparently selected cohort of patients.
To investigate associations of giving birth with morbidity in terms of hospitalisation and social consequences of morbidity in terms of sickness absence (SA), while taking familial (genetics and shared environmental) factors into account.
Prospective register-based cohort study. Estimates of risk of hospitalisation and SA were calculated as HRs with 95% CIs.
All female twins, that is, women with a twin sister, born in Sweden.
5118 Swedish female twins (women with a twin sister), born during 1959–1990, where at least one in the twin pair had their first childbirth (T0) during 1994–2009 and none gave birth before 1994.
Hospitalisation and SA during year 3–5 after first delivery or equivalent.
Preceding the first childbirth, the mean annual number of SA days increased for mothers, and then decreased again. Hospitalisation after T0 was associated with higher HRs of short-term and long-term SA (HR for short-term SA 3.0; 95% CI 2.5 to 3.6 and for long-term SA 2.3; 95% CI 1.6 to 3.2). Hospitalisation both before and after first childbirth was associated with a higher risk of future SA (HR for long-term SA 4.2; 95% CI 2.7 to 6.4). Familial factors influenced the association between hospitalisation and long-term SA, regardless of childbirth status.
Women giving birth did not have a higher risk for SA than those not giving birth and results indicate a positive health selection into giving birth. Mothers hospitalised before and/or after giving birth had higher risks for future SA, that is, there was a strong association between morbidity and future SA.
(1)To describe the prevalence and severity of tremor in patients with multiple sclerosis (MS) registered within a large North American MS registry; (2) to provide detailed descriptions on the characteristics and severity of tremor in a subset of registrants and (3) to compare several measures of tremor severity for strength of agreement.
The North American Research Committee on MS (NARCOMS) registry.
Registrants of NARCOMS reporting mild or greater tremor severity.
We determined the cross-sectional prevalence of tremor in the NARCOMS registry over three semiannual updates between fall 2010 and fall 2011. A subset of registrants (n=552) completed a supplemental survey providing detailed descriptions of their tremor. Outcomes included descriptive characteristics of their tremors and correlations between outcome measures to determine the strength of agreement in assessing tremor severity.
The estimated prevalence of tremor in NARCOMS ranged from 45% to 46.8%, with severe tremor affecting 5.5–5.9% of respondents. In the subset completing the supplemental survey, mild tremor severity was associated with younger age of MS diagnosis and tremor onset than those with moderate or severe tremor. However, tremor severity did not differ by duration of disease or tremor. Respondents provided descriptions of tremor symptoms on the Clinical Ataxia Rating Scale, which had a moderate to good (=0.595) correlation with the Tremor Related Activities of Daily Living (TRADL) scale. Objectively scored Archimedes' spirals had a weaker (=0.358) correlation with the TRADL. Rates of unemployment, disability and symptomatic medication use increased with tremor severity, but were high even among those with mild tremor.
Tremor is common among NARCOMS registrants and severely disabling for some. Both ADL-based and symptom-descriptive measures of tremor severity can be used to stratify patients.
Overactive bladder (OAB) is a symptom syndrome defined by the International Continence Society (ICS) as 'the presence of urinary urgency (both daytime and nighttime), usually accompanied by increased frequency and nocturia with or without urge urinary incontinence in the absence of a urinary tract infection or other obvious pathology'. Clinical studies indicate that acupuncture could reduce micturition over 24 h, urgency episodes over 24 h, and improve quality of life among people with OAB. This systematic review protocol details the proposed methods for evaluating the effectiveness and safety of acupuncture for OAB.
The following databases will be searched for relevant studies: the Cochrane Central Register of Controlled Trials (CENTRAL), the Cochrane Incontinence Group Trials Register, MEDLINE, EMBASE, Chinese Biomedical Literature Database (CBM), Chinese Medical Current Content (CMCC), Chinese Scientific Journal Database (VIP database), Wan-Fang Data, and China National Knowledge Infrastructure (CNKI) and will hand search a list of medical journals as a supplement. Any randomised controlled trials in English or Chinese without restriction of publication status will be included with treatment of OAB. Outcomes will mainly include number of micturition episodes over 24 h, number of urgency episodes over 24 h and number of incontinence episodes over 24 h. Two reviewers will independently screen the titles, abstracts or even full texts, and extract data. Two other reviewers will assess study quality. Revman 5.1 software will be used to conduct meta-analysis and calculate the risk ratio for dichotomous data. Weighted mean difference or standard mean difference will be calculated for continuous data. The Cochrane collaboration's tool will be used to assess the risk of bias.
This systematic review protocol will provide information on acupuncture therapy for OAB. The results will be disseminated through peer-reviewed publication or conference presentations.
To evaluate and provide a real-life view of the operation of the Healthy Start vitamins scheme.
The study took place in primary care and community settings that served rural, urban and ethnically diverse populations, in two sentinel sites: London, and Yorkshire and the Humber. An online consultation and stakeholder workshops elicited views from across England.
669 health and social care practitioners including health visitors, midwives, public health practitioners, general practitioners, paediatricians and support staff participated in focus group discussions (n=49) and an online consultation (n=620). 56 participants representing health and social care practitioners, policymakers, service commissioners, and voluntary and independent sectors took part in stakeholder workshops.
Three-phase multimethod study comprising focus group discussions, an online consultation and stakeholder workshops. Qualitative data were analysed thematically and quantitative data from the online survey were analysed using descriptive statistics.
Study participants were concerned about the low uptake of Healthy Start vitamin supplements and the consequences of this for health outcomes for women and young children. They experienced Healthy Start vitamin distribution as logistically complex, requiring the time, resources and creative thinking of a range of local and regional practitioners from senior strategists to administrative support workers. In the light of this, many participants argued that moving to universal provision of vitamin supplements would be more cost-effective than the current system.
There is consistency of views of health practitioners that the current targeted system of providing free vitamin supplements for low-income childbearing women and young children via the Healthy Start programme is not fulfilling its potential to address vitamin deficiencies. There is wide professional and voluntary sector support for moving from the current targeted system to provision of free vitamin supplements for all pregnant and new mothers, and children up to their fifth birthday.
Polyneuropathy, organomegaly, endocrinopathy, M-protein and skin changes (POEMS) syndrome is a fatal systemic disorder associated with plasma cell dyscrasia and the overproduction of the vascular endothelial growth factor (VEGF). Recently, the prognosis of POEMS was substantially improved by introduction of therapeutic intervention for myeloma. However, no randomised clinical trial has been performed because of the rarity and severity of the disease.
The Japanese POEMS syndrome with Thalidomide (J-POST) Trial is a phase II/III multicentre, double-blinded, randomised, controlled trial that aims to evaluate the efficacy and safety of a 24-week treatment with thalidomide in POEMS syndrome, with an additional 48-week open-label safety study. Adults with POEMS syndrome who have no indication for transplantation are assessed for eligibility at 12 tertiary neurology centres in Japan. Patients who satisfy the eligibility criteria are randomised (1:1) to receive thalidomide (100–300 mg daily) plus dexamethasone (12 mg/m2 on days 1–4 of a 28-day cycle) or placebo plus dexamethasone. Both treatments were administered for 24 weeks (six cycles; randomised comparative study period). Patients who complete the randomised study period or show subacute deterioration during the randomised period participate in the subsequent 48-week open-label safety study (long-term safety period). The primary end point of the study is the reduction rate of serum VEGF levels at 24 weeks.
The protocol was approved by the Institutional Review Board of each hospital. The trial was notified and registered at the Pharmaceutical and Medical Devices Agency, Japan (No. 22-1716). The J-POST Trial is currently ongoing and is due to finish in August 2015. The findings of this trial will be disseminated through peer-reviewed publications and conference presentations and will also be disseminated to participants.
UMIN000004179 and JMA-IIA00046.
The treatment of chronic obstructive pulmonary disease (COPD) involves different care providers across care sites. This fragmentation of care increases the morbidity and mortality burden, as well as acute health services use. The COPD-Integrated Care Pathway (ICP) was designed and implemented to integrate the care across different sites from primary care to acute hospital and home. It aims to reduce the prevalence of COPD among the population in the catchment, reduce risk of hospital admissions, delay or prevent the progression of the disease and reduce mortality rate by adopting a coordinated and multidisciplinary approach to the management of the patients' medical conditions. This study on the COPD-ICP programme is undertaken to determine the impact on processes of care, clinical outcomes and acute care utilisation.
This will be a retrospective, pre-post, matched-groups study to evaluate the effectiveness of the COPD-ICP programme in improving clinical outcomes and reducing healthcare costs. Programme enrolees (intervention group) and non-enrolees (comparator group) will be matched using propensity scores. Administratively, we set 30% as our target for proportion admission difference between programme and non-programme patients. A sample size of 62 patients in each group will be needed for statistical comparisons to be made at 90% power. Adherence with recommended care elements will be measured at baseline and quarterly during 1-year follow-up. Risk of COPD-related hospitalisations as primary outcome, healthcare costs, disease progression and 1-year mortality during 1-year follow-up will be compared between the groups using generalised linear regression models.
This protocol describes the implementation and proposed evaluation of the COPD-ICP programme. The described study has received ethical approval from the NHG Domain Specific Review Board (DSRB Ref: 2013/01200). Results of the study will be reported through peer-review publications and presentations at healthcare conferences.
Prehospital care provided by specially trained, physician-based emergency services (P-EMS) is an integrated part of the emergency medical systems in many developed countries. To what extent P-EMS increases survival and favourable outcomes is still unclear. The aim of the study was thus to investigate ambulance runs initially assigned 'life-saving missions' with emphasis on long-term outcome in patients treated by the Mobile Emergency Care Unit (MECU) in Odense, Denmark
All MECU runs are registered in a database by the attending physician, stating, among other parameters, the treatment given, outcome of the treatment and the patient's diagnosis. Over a period of 80 months from May 1 2006 to December 31 2012, all missions in which the outcome of the treatment was registered as 'life saving' were scrutinised. Initial outcome, level of competence of the caretaker and diagnosis of each patient were manually established in each case in a combined audit of the prehospital database, the discharge summary of the MECU and the medical records from the hospital. Outcome parameters were final outcome, the aetiology of the life-threatening condition and the level of competences necessary to treat the patient.
Of 25 647 patients treated by the MECU, 701 (2.7%) received prehospital 'life saving treatment'. In 596 (2.3%) patients this treatment exceeded the competences of the attending emergency medical technician or paramedic. Of these patients, 225 (0.9%) were ultimately discharged to their own home.
The present study demonstrates that anaesthesiologist administrated prehospital therapy increases the level of treatment modalities leading to an increased survival in relation to a prehospital system consisting of emergency medical technicians and paramedics alone and thus supports the concept of applying specialists in anaesthesiology in the prehospital setting especially when treating patients with cardiac arrest, patients in need of respiratory support and trauma patients.
To explore what patients consider important when evaluating their recovery from hip fracture and to consider how these priorities could be used in the evaluation of the quality of hip fracture services.
Semistructured interviews exploring the experience of recovery from hip fracture at two time points—4 weeks and 4 months postoperative hip fixation. Two approaches to analysis: thematic analysis of data specifically related to recovery from hip fracture; summarising the participant's experience overall.
31 participants were recruited, of whom 20 were women and 12 were cognitively impaired. Mean age was 81.5 years. Interviews were provided by 19 patients, 14 carers and 8 patient/carer dyad; 10 participants were interviewed twice.
Single major trauma centre in the West Midlands of the UK.
Stable mobility (without falls or fear of falls) for valued activities was considered most important by participants who had some prefracture mobility and were able to articulate what they valued during recovery. Mobility was important for managing personal care, for day-to-day activities such as shopping and gardening, and for maintenance of mental well-being. Some participants used assistive mobility devices or adapted to their limitations. Others maintained their previous limited function through increased care provision. Many participants were unable to articulate what they valued as hip fracture was perceived as part of their decline with age. The fracture and problems from other health conditions were an inseparable part of one health experience.
Prefracture mobility, adaptations to reduced mobility before or after fracture, and whether or not patients perceive themselves to be declining with age influence what patients consider important during recovery from hip fracture. No single patient-reported outcome measure could evaluate quality of care for all patients following hip fracture. General health-related quality of life tools may provide useful information within clinical trials.
It has been suggested that statins have an effect on the modulation of the cytokine cascade and on the outcome of patients with community-acquired pneumonia (CAP). The aim of this prospective, randomised, double-blind, placebo-controlled trial was to determine whether statin therapy given to hospitalised patients with CAP improves clinical outcomes and reduces the concentration of inflammatory cytokines.
A tertiary teaching hospital in Barcelona, Spain.
Thirty-four patients were randomly assigned and included in an intention-to-treat analysis (19 to the simvastatin group and 15 to the placebo group).
Patients were randomly assigned to receive 20 mg of simvastatin or placebo administered in the first 24 h of hospital admission and once daily thereafter for 4 days.
Primary end point was the time from hospital admission to clinical stability. The secondary end points were serum concentrations of inflammatory cytokines and partial pressure of arterial oxygen/fractional inspired oxygen (PaO2/FiO2) at 48 h after treatment administration.
The trial was stopped because enrolment was much slower than originally anticipated. The baseline characteristics of the patients and cytokine concentrations at the time of enrolment were similar in the two groups. No significant differences in the time from hospital admission to clinical stability were found between study groups (median 3 days, IQR 2–5 vs 3 days, IQR 2–5; p=0.47). No significant differences in PaO2/FiO2 (p=0.37), C reactive protein (p=0.23), tumour necrosis factor-α (p=0.58), interleukin 6 (IL-6; p=0.64), and IL-10 (p=0.61) levels at 48 h of hospitalisation were found between simvastatin and placebo groups. Similarly, transaminase and total creatine kinase levels were similar between study groups at 48 h of hospitalisation (p=0.19, 0.08 and 0.53, respectively).
Our results suggest that the use of simvastatin, 20 mg once daily for 4 days, since hospital admission did not reduce the time to clinical stability and the levels of inflammatory cytokines in hospitalised patients with CAP.
To summarise the evidence from studies of acute kidney injury (AKI) with regard to the effect of pre-AKI renal function and post-AKI renal function recovery on long-term mortality and renal outcomes, and to assess whether these factors should be taken into account in future prognostic studies.
A systematic review of observational studies listed in Medline and EMBASE from 1990 to October 2012.
All AKI studies in adults with data on baseline kidney function to identify AKI; with outcomes either stratified by pre-AKI and/or post-AKI kidney function, or described by the timing of the outcomes.
Long-term mortality and worsening chronic kidney disease (CKD).
Of 7385 citations, few studies met inclusion criteria, reported baseline kidney function and stratified by pre-AKI or post-AKI function. For mortality outcomes, three studies compared patients by pre-AKI renal function and six by post-AKI function. For CKD outcomes, two studies compared patients by pre-AKI function and two by post-AKI function. The presence of CKD pre-AKI (compared with AKI alone) was associated with doubling of mortality and a fourfold to fivefold increase in CKD outcomes. Non-recovery of kidney function was associated with greater mortality and CKD outcomes in some studies, but findings were inconsistent varying with study design. Two studies also reported that risk of poor outcome reduced over time post-AKI. Meta-analysis was precluded by variations in definitions for AKI, CKD and recovery.
The long-term prognosis after AKI varies depending on cause and clinical setting, but it may also, in part, be explained by underlying pre-AKI and post-AKI renal function rather than the AKI episode itself. While carefully considered in clinical practice, few studies address these factors and with inconsistent study design. Future AKI studies should report pre-AKI and post-AKI function consistently as additional factors that may modify AKI prognosis.
To investigate whether common infection foci (pulmonary, intra-abdominal and primary bacteraemia) are associated with variations in mortality risk in patients with sepsis.
Prospective, observational cohort study.
Three surgical intensive care units (ICUs) at a university medical centre.
A total of 327 adult Caucasian patients with sepsis originating from pulmonary, intra-abdominal and primary bacteraemia participated in this study.
The patients were followed for 90 days and mortality risk was recorded as the primary outcome variable. To monitor organ failure, sepsis-related organ failure assessment (Sequential Organ Failure Assessment, SOFA) scores were evaluated at the onset of sepsis and throughout the observational period as secondary outcome variables.
A total of 327 critically ill patients with sepsis were enrolled in this study. Kaplan-Meier survival analysis showed that the 90-day mortality risk was significantly higher among patients with primary bacteraemia than among those with pulmonary and intra-abdominal foci (58%, 35% and 32%, respectively; p=0.0208). To exclude the effects of several baseline variables, we performed multivariate Cox regression analysis. Primary bacteraemia remained a significant covariate for mortality in the multivariate analysis (HR 2.10; 95% CI 1.14 to 3.86; p=0.0166). During their stay in the ICU, the patients with primary bacteraemia presented significantly higher SOFA scores than those of the patients with pulmonary and intra-abdominal infection foci (8.5±4.7, 7.3±3.4 and 5.8±3.5, respectively). Patients with primary bacteraemia presented higher SOFA-renal score compared with the patients with other infection foci (1.6±1.4, 0.8±1.1 and 0.7±1.0, respectively); the patients with primary bacteraemia required significantly more renal replacement therapy than the patients in the other groups (29%, 11% and 12%, respectively).
These results indicate that patients with sepsis with primary bacteraemia present a higher mortality risk compared with patients with sepsis of pulmonary or intra-abdominal origins. These results should be assessed in patients with sepsis in larger, independent cohorts.
Despite the strong relationship between smoking and health-related consequences, very few smokers quit. Heavy drinking is a significant risk factor for health consequences, and is implicated in persistent smoking and less success at quitting smoking. Self-efficacy (SE) to abstain from smoking is an important determinant of smoking outcomes and may link alcohol use to poor quit rates. Even though research has demonstrated a strong association between drinking and smoking, and the multiplicative effect of these substances on cancer-related, heavy-drinking smokers has been largely ignored in the literature. Further, research has not taken advantage of innovative methods, such as ecological momentary assessment, to capture the impact of daily factors on smoking cessation outcomes in this particular group. The proposed study identifies daily changing factors that impede or promote SE and future smoking cessation efforts in risky-drinking smokers.
This is an observational study of 84 regular smokers (≥10 cigarettes per day) who drink at risky levels, report a desire to quit in the next 6 months, and show no evidence of psychiatric disturbance, severe history of alcohol withdrawal or drug dependence (excluding nicotine and caffeine). Participants report on their smoking, alcohol consumption and SE related to smoking twice a day for 28 days using interactive voice response (IVR) surveys. Multilevel regression and path models will examine within-person daily associations among drinking, smoking and SE, and how these variables predict the likelihood of future smoking behaviour at 1 and 6 months follow-up.
This protocol was approved by an accredited Institutional Review Board. The findings will help us understand the factors that promote or impede smoking cessation among a high-risk group of smokers (heavy-drinking smokers) and will be disseminated through peer-reviewed journal articles and presentations at national conferences.
During the past decades, smoking prevalence in Greece was estimated to be near or over 40%. Following a sharp fall in cigarette consumption, as shown in current data, our objective is to assess smokers' sensitivity to cigarette price and consumer income changes as well as to project health benefits of an additional tax increase.
Cigarette consumption was considered as the dependent variable, with Weighted Average Price as a proxy for cigarette price, gross domestic product as a proxy for consumers' income and dummy variables reflecting smoking restrictions and antismoking campaigns. Values were computed to natural logarithms and regression was performed. Then, four scenarios of tax increase were distinguished in order to calculate potential health benefits.
Short-run price elasticity is estimated at –0.441 and short-run income elasticity is estimated at 1.040. Antismoking campaigns were found to have a statistically significant impact on consumption. Results indicate that, depending on the level of tax increase, annual per capita consumption could fall by at least 209.83 cigarettes; tax revenue could rise by more than 0.74 billion, while smokers could be reduced by up to 530 568 and at least 465 smoking-related deaths could be averted.
Price elasticity estimates are similar to previous studies in Greece, while income elasticity estimates are far greater. With cigarettes regarded as a luxury good, a great opportunity is presented for decisionmakers to counter smoking. Increased taxation, along with focused antismoking campaigns, law reinforcement (to ensure compliance with smoking bans) and intensive control for smuggling could invoke a massive blow to the tobacco epidemic in Greece.
To evaluate the potential determinants of forced expiratory volume in 1 s (FEV1) decline in workers with occupational asthma (OA) still exposed to the causative agent. We hypothesised that sputum eosinophilia might be a predictor of poor asthma outcome after diagnosis.
In a specialistic clinical centre of the University Hospital of Pisa, we studied 39 participants (28 M, 11 F) diagnosed as having OA, routinely followed up between 1990 and 2009. They were a subgroup of 94 participants diagnosed as affected by OA in that period: 9 had been removed from work at the diagnosis, 21 were excluded for having ceased occupational exposure after few months from diagnosis, and 25 were lost at the follow-up or had no acceptable sputum measurements at the diagnosis. Estimates of the decline in FEV1 were obtained by means of simple regression analysis during the period of occupational exposure after diagnosis. Logistic regression was used to analyse the effects of factors (baseline FEV1 and sputum inflammatory cells, duration and type of exposure) that may potentially influence FEV1 decline.
At follow-up (5.7+3.7 years), most participants were still symptomatic despite inhaled corticosteroids (ICS) treatment and had their occupational exposure reduced. Participants with higher sputum eosinophils (>3%) at baseline had a significantly greater decline of FEV1 (–52.5 vs –18.6 mL/year, p=0.012). Logistic regression showed that persistent exposure and sputum eosinophilia were significantly associated with a greater decline in FEV1 (OR 11.5, 95% CI 1.8 to 71.4, p=0.009 and OR 6.7, 95% CI 1.1 to 41.7, p= 0.042, respectively).
Sputum eosinophilia at diagnosis, together with the persistence of occupational exposure during follow-up, may contribute to a greater decline in FEV1 in patients with OA still at work. Further long-term studies are required as to whether intensive ICS treatment may be beneficial for patients with OA and increase ad eosinophilic inflammation.
Cancer is the leading cause of death among Asian Americans. Chinese Americans comprise the largest Asian American ethnic group. Low health literacy (LHL) is associated with lower cancer screening rates, but this association has not been studied in Chinese Americans. We examined the relationship between LHL and meeting US Preventive Service Task Force (USPSTF) guidelines for cervical, colorectal and breast cancer screening among Chinese Americans.
Observational study of Chinese respondents in the 2007 California Health Interview Survey, a population-based survey. Interview languages included English, Cantonese and Mandarin.
California, USA
Chinese respondents in age/gender groupings appropriate for USPSTF cancer screening guidelines (cervical: women ages 21–65, n=632; colorectal: men or women ages 50–75, n=488; and breast: women ages 50–74, n=326).
Relationships were tested using multivariable logistic regression models controlling for healthcare access and demographic factors, including limited English proficiency (LEP). The combined effects of having both LHL and LEP were specifically examined. LHL was measured by 2-items on perceived ease-of-use of written medical materials. All study variables were self-reported.
Cancer screening percentages among Chinese Americans were 77.8% for cervical, 50.9% for colorectal (47.9% for women and 54.2% for men), and 85.5% for breast. LHL was associated with lower odds of meeting breast cancer screening guidelines (OR 0.41; 95% CI 0.20 to 0.82). Respondents with both LHL and LEP were significantly less likely to have up-to-date colorectal (OR 0.49; 95% CI 0.25 to 0.97) and breast cancer screening (OR 0.21; 95% CI 0.08 to 0.54) than those with neither health communication barrier. In all multivariable models, having seen a physician in the past year was a significant predictor of an up-to-date screening.
In Chinese Americans, LHL and LEP were negatively associated with up-to-date breast and colorectal cancer screening, independent of a recent physician visit. Efforts to promote cancer screening among Chinese Americans should consider and address LHL, LEP and physician access barriers.
The c.2268dup mutation in the thyroid peroxidase (TPO) gene is the most common TPO alteration reported in Taiwanese patients with thyroid dyshormonogenesis. The ancestors of these patients are believed to originate from the southern province of China. Our previous study showed that this mutation leads to reduced abundance of the TPO protein and loss of TPO enzyme activity in a Malaysian–Chinese family with goitrous hypothyroidism. The aim of our study was to provide further data on the incidence of the c.2268dup mutation in a cohort of Malaysian–Chinese and its possible phenotypic effects.
Cohort study.
Twelve biologically unrelated Malaysian–Chinese patients with congenital hypothyroidism were recruited in this study. All patients showed high thyrotropin and low free thyroxine levels at the time of diagnosis with proven presence of a thyroid gland.
Screening of the c.2268dup mutation in the TPO gene in all patients was carried out using a PCR–direct DNA sequencing method.
Further screening for mutations in other exonic regions of the TPO gene was carried out if the patient was a carrier of the c.2268dup mutation.
The c.2268dup mutation was detected in 4 of the 12 patients. Apart from the c.2268dup and a previously documented mutation (c.2647C>T), two novel TPO alterations, c.670_672del and c.1186C>T, were also detected in our patients. In silico analyses predicted that the novel alterations affect the structure/function of the TPO protein.
The c.2268dup mutation was detected in approximately one-third of the Malaysian–Chinese patients with thyroid dyshormonogenesis. The detection of the novel c.670_672del and c.1186C>T alterations expand the mutation spectrum of TPO associated with thyroid dyshormonogenesis.
To investigate healthcare professional perceptions of local implementation of a national clinical governance policy in New Zealand.
Respondent comments written at the end of a national healthcare professional survey designed to assess implementation of core components of the clinical governance policy.
The written comments were provided by respondents to a survey distributed to over 41 000 registered healthcare professionals employed in 19 of New Zealand's government-funded District Health Boards. Comments were analysed and categorised within emerging themes.
3205 written comments were received. Five key themes illustrating barriers to clinical governance implementation were found, representing problems with: developing management–clinical relations; clinicians stepping up into clinical governance and leadership activities; interprofessional relations; training needs for governance and leadership; and having insufficient time to get involved.
Despite a national policy on clinical governance which New Zealand's government launched in 2009, this study found that considerable effort is required to build clinical governance at the local level. This finding parallels with other studies in the field. Two areas demand attention: building systems for organisational governance and leadership; and building professional governance arrangements.
This paper aimed to systematically evaluate the mental health and well-being outcomes observed in previous community-based obesity prevention interventions in adolescent populations.
Systematic review of literature from database inception to October 2014. Articles were sourced from CINAHL, Global Health, Health Source: Nursing and Academic Edition, MEDLINE, PsycARTICLES and PsycINFO, all of which were accessed through EBSCOhost. The Cochrane Database was also searched to identify all eligible articles. PRISMA guidelines were followed and search terms and search strategy ensured all possible studies were identified for review.
Intervention studies were eligible for inclusion if they were: focused on overweight or obesity prevention, community-based, targeted adolescents (aged 10–19 years), reported a mental health or well-being measure, and included a comparison or control group. Studies that focused on specific adolescent groups or were treatment interventions were excluded from review. Quality of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) guidelines.
Primary outcomes were measures of mental health and well-being, including diagnostic and symptomatic measures. Secondary outcomes included adiposity or weight-related measures.
Seven studies met the inclusion criteria; one reported anxiety/depressive outcomes, two reported on self-perception well-being measures such as self-esteem and self-efficacy, and four studies reported outcomes of quality of life. Positive mental health outcomes demonstrated that following obesity prevention, interventions included a decrease in anxiety and improved health-related quality of life. Quality of evidence was graded as very low.
Although positive outcomes for mental health and well-being do exist, controlled evaluations of community-based obesity prevention interventions have not often included mental health measures (n=7). It is recommended that future interventions incorporate mental health and well-being measures to identify any potential mechanisms influencing adolescent weight-related outcomes, and equally to ensure interventions are not causing harm to adolescent mental health.
There is some debate as to what extent epidemiological data for the prevalence of childhood tinnitus can be relied on. While indications are that the prevalence is relatively high, referral numbers for children with tinnitus are reported to be low and many of the studies have a number of methodological difficulties. We describe the protocol of a systematic review aimed at assessing the prevalence of tinnitus and/or hyperacusis in children and young people.
We will include studies of any design (except case reports or case series) comparing the prevalence of tinnitus and/or hyperacusis in children and young people with and without hearing loss, any known external exposure and psychological disorders. We will search the following databases: PubMed, EMBASE and Scopus. No restrictions of language will be applied in the search strategy but during the article selection language is limited to English, German and Scandinavian languages. Primary and additional outcomes will be the prevalence of tinnitus/hyperacusis and the severity, respectively.
No ethical issues are foreseen. The results will be published in a peer-reviewed journal and presented at national and international conferences of audiology and paediatrics.
This review protocol is registered in the PROSPERO International Prospective Register of Systematic Reviews, registration number CRD42014013456.
To examine the relationship between cycling injury severity and personal, trip, route and crash characteristics.
Data from a previous study of injury risk, conducted in Toronto and Vancouver, Canada, were used to classify injury severity using four metrics: (1) did not continue trip by bike; (2) transported to hospital by ambulance; (3) admitted to hospital; and (4) Canadian Triage and Acuity Scale (CTAS). Multiple logistic regression was used to examine associations with personal, trip, route and crash characteristics.
Of 683 adults injured while cycling, 528 did not continue their trip by bike, 251 were transported by ambulance and 60 were admitted to hospital for further treatment. Treatment urgencies included 75 as CTAS=1 or 2 (most medically urgent), 284 as CTAS=3, and 320 as CTAS=4 or 5 (least medically urgent). Older age and collision with a motor vehicle were consistently associated with increased severity in all four metrics and statistically significant in three each (both variables with ambulance transport and CTAS; age with hospital admission; and motor vehicle collision with did not continue by bike). Other factors were consistently associated with more severe injuries, but statistically significant in one metric each: downhill grades; higher motor vehicle speeds; sidewalks (these significant for ambulance transport); multiuse paths and local streets (both significant for hospital admission).
In two of Canada's largest cities, about one-third of the bicycle crashes were collisions with motor vehicles and the resulting injuries were more severe than in other crash circumstances, underscoring the importance of separating cyclists from motor vehicle traffic. Our results also suggest that bicycling injury severity and injury risk would be reduced on facilities that minimise slopes, have lower vehicle speeds, and that are designed for bicycling rather than shared with pedestrians.
To assess the prevalence of awareness and use of massive open online courses (MOOCs) among medical undergraduates in Egypt as a developing country, as well as identifying the limitations and satisfaction of using these courses.
A multicentre, cross-sectional study using a web-based, pilot-tested and self-administered questionnaire.
Ten out of 19 randomly selected medical schools in Egypt.
2700 undergraduate medical students were randomly selected, with an equal allocation of participants in each university and each study year.
Primary outcome measures were the percentages of students who knew about MOOCs, students who enrolled and students who obtained a certificate. Secondary outcome measures included the limitations and satisfaction of using MOOCs through five-point Likert scale questions.
Of 2527 eligible students, 2106 completed the questionnaire (response rate 83.3%). Of these students, 456 (21.7%) knew the term MOOCs or websites providing these courses. Out of the latter, 136 (29.8%) students had enrolled in at least one course, but only 25 (18.4%) had completed courses earning certificates. Clinical year students showed significantly higher rates of knowledge (p=0.009) and enrolment (p<0.001) than academic year students. The primary reasons for the failure of completion of courses included lack of time (105; 77.2%) and slow Internet speed (73; 53.7%). Regarding the 25 students who completed courses, 21 (84%) were satisfied with the overall experience. However, there was less satisfaction regarding student–instructor (8; 32%) and student–student (5; 20%) interactions.
About one-fifth of Egyptian medical undergraduates have heard about MOOCs with only about 6.5% actively enrolled in courses. Students who actively participated showed a positive attitude towards the experience, but better time-management skills and faster Internet connection speeds are required. Further studies are needed to survey the enrolled students for a better understanding of their experience.
Thyroid cancer incidence in Korea is the highest in the world and has recently increased steeply. However, factors contributing to this sudden increase have not been fully elucidated, and few studies have explored the postoperative prognosis. The Thyroid Cancer Longitudinal Study (T-CALOS) was initiated with three aims: (1) to identify factors predicting quality of life, recurrence, and incidence of other diseases after thyroid cancer treatments; (2) to investigate environmental exposure to radiation, toxicants and molecular factors in relation to tumour aggressiveness; and (3) to evaluate gene–environment interactions that increase thyroid cancer in comparison with healthy participants from a pool of nationwide population-based healthy examinees.
T-CALOS enrols patients with incident thyroid cancer from three general hospitals, Seoul National University Hospital, Seoul National University Bundang Hospital and National Medical Center, Korea. The study is an ongoing project expecting to investigate 5000 patients with thyroid cancer up until 2017. Healthy examinees with a normal thyroid confirmed by sonography have been enrolled at the Healthy Examination Center at Seoul National University Hospital. We are also performing individual matching using two nationwide databases that are open to the public. Follow-up information is obtained at patients' clinical visits and by linkage to the national database. For statistical analysis, we will use conditional logistic regression models and a Cox proportional hazard regression model. A number of stratifications and sensitivity analyses will be performed to confirm the results.
Based on a large sample size, a prospective study design, comprehensive data collection and biobank, T-CALOS has been independently peer-reviewed and approved by the three hospitals and two funding sources (National Research Foundation of Korea and Korean Foundation for Cancer Research). The results of T-CALOS will be published according to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) criteria.
We compared the automated non-treponemal reagin (rapid plasma reagin (RPR)) test with the conventional RPR card test for usefulness in clinical applications.
A comparative study of laboratory methods using clinical specimens in a single institute.
A total of 112 serum samples including 59 Treponema pallidum particle agglutination (TPPA)-positive and 53 TPPA-negative specimens were evaluated.
HiSens Auto RPR LTIA (HBI, Anyang, Korea) was compared with Macro-Vue RPR Card Tests (Becton Dickinson BD Microbiology Systems, Sparks, Maryland, USA). Treponemal-specific tests were performed by Serodia TPPA assay (Fujirebio, Tokyo, Japan). The percentage agreement, value and overall sensitivity and specificity of the two RPR tests were compared. Seroconversion rates after treatment were also compared for each RPR test.
The percentage agreement between the two RPR tests was 78.6% ( 0.565; 95% CI 0.422 to 0.709). Sensitivity and specificity of the automated RPR test relative to the TPPA test was 52.5% (95% CI 39.1% to 65.7%) and 94.3% (95% CI 84.3% to 98.8%), respectively, while the same values for the conventional RPR card test were 86.4% (95% CI 75% to 93.9%) and 94.3% (95% CI 84.3% to 98.8%), respectively. The conventional RPR card test showed overall higher positivity than the automated RPR test, whereas the automated RPR test showed higher seroconversion (43.5%, 10/23) than the conventional RPR card test (4.3%, 1/23) in treated patients.
The automated RPR test showed overall lower sensitivity than the conventional RPR test based on the treponemal test, but higher seroconversion after treatment. The automated RPR test could be used to monitor treatment response, especially in the reverse screening algorithm in syphilis testing.
Exercise has been shown to improve clinical measures of strength, balance and mobility, and in some cases, has improved symptoms of tremor and rigidity in people with Parkinson's disease (PD). However, to date, no research has examined whether improvements in trunk control can remedy deficits in dynamic postural stability in this population. The proposed randomised controlled trial aims to establish whether a 12-week exercise programme aimed at improving dynamic postural stability in people with PD; (1) is more effective than education; (2) is more effective when training frequency is increased; and (3) provides greater long-term benefits than education.
Forty-five community-dwelling individuals diagnosed with idiopathic PD with a falls history will be recruited. Participants will complete baseline assessments including tests of cognition, vision, disease severity, fear of falling, mobility and quality of life. Additionally, participants will complete a series of standing balance tasks to evaluate static postural stability, while dynamic postural control will be measured during walking using head and trunk-mounted three-dimensional accelerometers. Following baseline testing, participants will be randomly-assigned to one of three intervention groups, who will receive either exercise once per week, exercise 3 days/week, or education. Participants will repeat the same battery of tests conducted at baseline after the 12-week intervention and again following a further 12-week sustainability period.
This study has the potential to show that low-intensity and progressive trunk exercises can provide a non-invasive and effective means for maintaining or improving postural stability for people with PD. Importantly, if the programme is noted to be effective, it could be easily performed by patients within their home environment or under the guidance of available allied health professionals.
The protocol for this study is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12613001175763).
Vitamin D is related to resistance to chronic diseases, physiological parameters and functional measures. All of these relationships underscore the potential benefits of cholecalciferol or D3 (nutritional vitamin D) in cancer. This is the first study designed to obtain conclusive evidence on the effect of cholecalciferol in advanced patients with cancer. The main goal is to assess its effects on the patient's perceived quality of life. Cholecalciferol's impact on fatigue and physical performance, as well as its cost utility, will also be assessed.
A randomised triple-blind phase II/III placebo-controlled multicentre trial has been designed. Patients satisfying the inclusion and exclusion criteria will be randomly assigned to receive cholecalciferol or placebo. Eligible patients will be adults with a locally advanced or metastatic or inoperable solid cancer in palliative care, who have given signed informed consent and have matched inclusion and exclusion criteria. The randomisation will be based on a computer-generated procedure and centralised by the pharmacy service of the coordinating centre. The assigned treatment will be administered by the hospital's pharmacy to conceal group allocation for patients and healthcare providers. Cholecalciferol (4000 IU/day) or placebo, starting at day 15 and continuing up to day 42, will be added to palliative care treatment. Outpatient visits will be scheduled every 14 days.
Ethical approval was received from the Medical Ethical Commitee of the HUAV (CEIC-1169). Participants and their families will receive the research findings which will also be disseminated on local and national media, presented at national and international meetings of the specialty, and published in peer-reviewed scientific journals.
EudraCT: 2013-003478-29.
Factors that are important to the competence of healthcare providers have important consequences for quality of healthcare. Although some previous research has discussed risks or supports to the competence of clinicians, a thorough exploration is currently lacking. The purpose of this review is to examine the literature examining risks and supports to clinical competence of healthcare practitioners and trainees engaged in field-based education. In this study, field-based education refers to teaching or training in a real-world/work-based setting.
We will employ an established scoping review methodology. Eligible studies will include those that mention (1) a healthcare professional, (2) competence from field-based education throughout the lifespan/career and (3) a risk or support to competence. Four authors will independently apply the inclusion criteria to all studies, regardless of study design. Our data extraction will include information on study design, location and type of study and we will develop a comprehensive list of risks and supports that are discussed in the literature.
Since this is a review of the literature, ethics approval is not indicated. We will disseminate the findings from this study in publications in peer-reviewed journals as well as presentations at relevant national and international conferences.
To examine the nature of media coverage of vitamin D in relation to its role in health and the need for supplements.
Media content analysis.
Print articles from elite newspapers in the UK, the USA and Canada.
294 print newspaper articles appearing over 5 years (2009–2014).
Newspaper coverage of vitamin D generally supported supplementation. The most common framing of vitamin D in print articles was "adequate vitamin D is necessary for good health." Articles also framed vitamin D as difficult to obtain from food supply and framed vitamin D deficiency as a widespread concern. In discussions of supplementation, 80% articles suggested supplementation is or may be necessary for the general population, yet almost none of the articles discussed the potential harms of vitamin D supplementation in any detail.
Print articles named 40 different health conditions in relationship to vitamin D. The most commonly cited conditions included bone health, cancer and cardiovascular health. Although print articles referred to a wide range of scholarly research on vitamin D with varying degrees of endorsement for supplementation, a general tone of support for vitamin D supplementation in media coverage persisted.
Newspaper articles conveyed overall support for vitamin D supplementation. News articles linked vitamin D to a wide range of health conditions for which there is no conclusive scientific evidence. Media coverage downplayed the limitations of existing science and overlooked any potential risks associated with supplementation.
Countries around the world have increasingly adopted pictorial health warning labels (HWLs) for tobacco packages to warn consumers about smoking-related risks. Research on how pictorial HWLs work has primarily analysed self-reported responses to HWLs; studies at the neural level comparing the brain's response to different types of HWLs may provide an important complement to prior studies, especially if self-reported responses are systematically biased. In this study we characterise the brain's response to three types of pictorial HWLs for which prior self-report studies indicated different levels of efficacy.
Current smokers rated pictorial HWLs and then observed the same HWLs during functional MRI (fMRI) scanning. Fifty 18–50-year-old current adult smokers who were free from neurological disorders were recruited from the general population and participated in the study. Demographics, smoking-related behaviours and self-reported ratings of pictorial HWL stimuli were obtained prior to scanning. Brain responses to HWLs were assessed using fMRI, focusing on a priori regions of interest.
Pictorial HWL stimuli elicited activation in a broad network of brain areas associated with visual processing and emotion. Participants who rated the stimuli as more emotionally arousing also showed greater neural responses at these sites.
Self-reported ratings of pictorial HWLs are correlated with neural responses in brain areas associated with visual and emotional processing. Study results cross-validate self-reported ratings of pictorial HWLs and provide insights into how pictorial HWLs are processed.
To explore the factors influencing doctors' job satisfaction and morale in China, in the context of the ongoing health system reforms and the deteriorating doctor–patient relationship.
Cross-sectional survey using self-completion questionnaires.
The survey was conducted from March to May 2012 among doctors at the provincial, county and primary care levels in Zhejiang Province, China.
The questionnaire was completed by 202 doctors. Factors which contributed most to low job satisfaction were low income and long working hours. Provincial level doctors were most dissatisfied while primary care doctors were the least dissatisfied. Three per cent of doctors at high-level hospitals and 27% of those in primary care were satisfied with the salary. Only 7% at high-level hospitals were satisfied with the work hours, compared to 43% in primary care. Less than 10% at high levels were satisfied with the amount of paid vacation time (3%) and paid sick leave (5%), compared with 38% and 41%, respectively, in primary care. Overall, 87% reported that patients were more likely to sue and that patient violence against doctors was increasing. Only 4.5% wanted their children to be doctors. Of those 125 who provided a reason, 34% said poor pay, 17% said it was a high-risk profession, and 9% expressed concerns about personal insecurity or patient violence.
Doctors have low job satisfaction overall. Recruitment and retention of doctors have become major challenges for the Chinese health system. Measures must be taken to address this, in order to ensure recruitment and retention of doctors in the future. These measures must first include reduction of doctors' workload, especially at provincial hospitals, partly through incentivisation of appropriate utilisation of primary care, increase in doctors' salary and more effective measures to tackle patient violence against doctors.
Patients with transient ischaemic attack (TIA) or stroke are at risk for cognitive impairment and dementia. Currently, there is no known effective strategy to prevent this cognitive decline. Increasing evidence exists that physical exercise is beneficial for cognitive function. However, in patients with TIA or stroke who are at risk of cognitive impairment and dementia, only a few trials have been conducted. In this study, we aim to investigate whether a physical exercise programme (MoveIT) can prevent cognitive decline in patients in the acute phase after a TIA or minor ischaemic stroke.
A single-blinded randomised controlled trial will be conducted to investigate the effect of an aerobic exercise programme on cognition compared with usual care. 120 adult patients with a TIA or minor ischaemic stroke less than 1 month ago will be randomly allocated to an exercise programme consisting of a 12-week aerobic exercise programme and regular follow-up visits to a specialised physiotherapist during the period of 1 year or to usual care. Outcome measures will be assessed at the baseline, and at the 1-year and 2-year follow-up. The primary outcome is cognitive functioning measured with the Montreal Cognitive Assessment (MoCA) test and with additional neuropsychological tests. Secondary outcomes include maximal exercise capacity, self-reported physical activity and measures of secondary prevention.
The study received ethical approval from the VU University Amsterdam Ethics committee (2011/383). The results of this study will be published in peer-reviewed journals and presented at international conferences. We will also disseminate the main results to our participants in a letter.
The Nederlands Trial Register NTR3884.
Early identification (EI) and brief interventions (BIs) for risky drinkers are effective tools in primary care. Lack of time in daily practice has been identified as one of the main barriers to implementation of BI. There is growing evidence that facilitated access by primary healthcare professionals (PHCPs) to a web-based BI can be a time-saving alternative to standard face-to-face BIs, but there is as yet no evidence about the effectiveness of this approach relative to conventional BI. The main aim of this study is to test non-inferiority of facilitation to a web-based BI for risky drinkers delivered by PHCP against face-to-face BI.
A randomised controlled non-inferiority trial comparing both interventions will be performed in primary care health centres in Catalonia, Spain. Unselected adult patients attending participating centres will be given a leaflet inviting them to log on to a website to complete the Alcohol Use Disorders Identification Test (AUDIT-C) alcohol screening questionnaire. Participants with positive results will be requested online to complete a trial module including consent, baseline assessment and randomisation to either face-to-face BI by the practitioner or BI via the alcohol reduction website. Follow-up assessment of risky drinking will be undertaken online at 3 months and 1 year using the full AUDIT and D5-EQD5 scale. Proportions of risky drinkers in each group will be calculated and non-inferiority assessed against a specified margin of 10%. Assuming reduction of 30% of risky drinkers receiving standard intervention, 1000 patients will be required to give 90% power to reject the null hypothesis.
The protocol was approved by the Ethics Commmittee of IDIAP Jordi Gol i Gurina P14/028. The findings of the trial will be disseminated through peer-reviewed journals, national and international conference presentations.
ClinicalTrials.gov NCT02082990.
Preventable adverse drug events (ADEs) are closely related to administration processes of parenteral medication. The Dutch Patient Safety Program provided a protocol for administering parenteral medication to reduce the amount of ADEs. The execution of the protocol was evaluated and a cost estimation was performed to provide insight in the associated costs of protocol compliance.
A longitudinal evaluation study was performed in secondary care. A total of 2154 observations of the administration process of parenteral medication were carried out within 10 measurements in 19 hospitals between November 2011 and December 2012. The total time needed for the process was measured in a sample of five hospitals. Multilevel linear and logistic regression analyses were used to analyse the trend over time of the implementation and to assess the association between hospital and administration characteristics, and compliance of the protocol. A cost estimation provided insight into the costs of performing a complete administration process and the costs at department level for 1 year.
The complete protocol was performed in 19% of the observations. The proceeding 'check by a second nurse' was least performed. Large differences were found between individual hospitals in performing the administration protocol. The compliance of the protocol was negatively influenced in case of disturbance of the administrator. The overall trend over time of completion of the protocol fluctuated during the study period. On average, 3 min 26 s were needed to perform the complete protocol, which costs 2.42. Extrapolating the costs to department level, including cost for clinical lessons, the difference in costs in performing the complete protocol and an incomplete protocol was 7.891 for 1 year.
The protocol for administering parenteral medication is still not implemented completely, therefore an investment in time and Euros is needed.
We analysed potential differences in incidence, type, nature, impact and preventability of adverse events (AEs) during hospitalisation between ethnic Dutch and ethnic minority patients, and the role of patient-related determinants. We hypothesised an increased AE incidence for ethnic minority patients.
We conducted a prospective cohort study in four urban hospitals.
763 Dutch patients and 576 ethnic minority patients aged between 45 and 75, admitted for at least one night, were included in the study. All patients completed a questionnaire on patient-related determinants (eg, language proficiency).
Incidence, type (eg, diagnostic AEs), impact and nature of AEs were assessed with a two-stage medical record review. Logistic regression analysis was used to adjust for patient and admission characteristics, and to investigate the contribution of patient-related determinants to AE risk.
There was no significant difference in the incidence of AEs: 11% (95% CI 9% to 14%) in Dutch patients and 10% (95% CI 7% to 12%) in ethnic minority patients. Also, there was no significant difference in the incidence of preventable AEs: 3% (95% CI 1% to 4%) in Dutch patients and 1% (95% CI 0% to 2%) in ethnic minority patients. Low language proficiency, inadequate health literacy and low educational level did not increase the risk of an AE.
Compared with Dutch patients, ethnic minority patients were not at increased risk of AEs while receiving care in Dutch hospitals. Healthcare providers seem to have responded effectively to specific patient care needs, but we do not know whether this occurred in an ad hoc or in a systematic way.
Several studies have shown that smoking may confer a greater excess risk for chronic diseases in women compared with men. The reasons for this excess risk of smoking in women are unclear, yet sex differences in smoking habits may play a role. We, thus, characterised sex differences in smoking habits in a contemporary Western population.
Cross-sectional population-based study.
UK Biobank Resource.
499 797 (54% women) individuals with data on smoking habits.
Women-to-men prevalence ratios in smoking status, and the women-minus-men mean difference in age at smoking initiation, number of cigarettes smoked daily and age at smoking cessation in 5-year birth cohort bands.
The women-to-men ever-smoking ratio ranged from 0.57 in the oldest to 0.87 in the youngest birth cohort. In the oldest cohort, born 1935–1939, women started smoking 1.9 years (95% CI 1.7 to 2.1) later than did men, but in those born after 1959 there was no difference in the age at initiation. The oldest women smoked 5.3 (95% CI 4.7 to 5.9) cigarettes per day fewer than did the oldest men, compared with 2.0 (95% CI 1.7 to 2.3) fewer cigarettes smoked per day in the youngest, born 1965–1969. Among quitters, women born before 1945 were, on average, 1.5 years older than their male contemporaries, but this differential was 1 year or less among people born after 1949.
Differences in smoking behaviour between women and men have decreased over time. Even past differentials are unlikely to explain the increased susceptibility to smoking-related chronic disease in women compared with men that has previously been observed. Future studies are required to determine whether sex differences in the physiological and biological effects of smoking are responsible for the differential impact of smoking on health in women and men.
To study the influence of healthy lifestyle behaviour on the prognosis of occasional low back pain among men and women in a general population.
Cohort study with a 4-year follow-up.
General population in Stockholm County, Sweden.
The study sample comprised 3938 men and 5056 women aged 18–84 from the Stockholm Public Health Cohort reporting occasional low back pain in the baseline questionnaire 2006.
Lifestyle factors and potential confounders were assessed at baseline. The lifestyle factors smoking habits, alcohol consumption, leisure physical activity and consumption of fruit and vegetables were dichotomised using recommendations for a health-enhancing lifestyle and combined to form the exposure variable 'healthy lifestyle behaviour'. The exposure was categorised into five levels according to the number of healthy lifestyle factors met. The follow-up questionnaire in 2010 gave information about the outcome, long duration troublesome low back pain. Crude and adjusted binomial regression models were applied to estimate the association between the exposure and the outcome analysing men and women separately.
The risk of developing long duration troublesome low back pain among women with occasional low back pain decreased with increasing healthy lifestyle behaviour (trend test: p=0.006). 21% (28/131) among women with no healthy lifestyle factor (reference) experienced the outcome compared to 9% (36/420) among women with all four factors. Compared to the reference group, the risk was reduced by 35% (RR 0.65, 95% CI 0.44 to 0.96) for women with one healthy lifestyle factor and 52% (RR 0.48, 95% CI 0.31 to 0.77) for women with all four healthy lifestyle factors. There were no clear associations found among men.
Healthy lifestyle behaviour seems to decrease the risk of developing long duration troublesome low back pain among women with occasional low back pain and may be recommended to improve the prognosis.
To describe the prevalence and determinants of births by caesarean section in private and public health facilities in underserved communities in South Asia.
Cross-sectional study.
81 community-based geographical clusters in four locations in Bangladesh, India and Nepal (three rural, one urban).
45 327 births occurring in the study areas between 2005 and 2012.
Proportion of caesarean section deliveries by location and type of facility; determinants of caesarean section delivery by location.
Institutional delivery rates varied widely between settings, from 21% in rural India to 90% in urban India. The proportion of private and charitable facility births delivered by caesarean section was 73% in Bangladesh, 30% in rural Nepal, 18% in urban India and 5% in rural India. The odds of caesarean section were greater in private and charitable health facilities than in public facilities in three of four study locations, even when adjusted for pregnancy and delivery characteristics, maternal characteristics and year of delivery (Bangladesh: adjusted OR (AOR) 5.91, 95% CI 5.15 to 6.78; Nepal: AOR 2.37, 95% CI 1.62 to 3.44; urban India: AOR 1.22, 95% CI 1.09 to 1.38). We found that highly educated women were particularly likely to deliver by caesarean in private facilities in urban India (AOR 2.10; 95% CI 1.61 to 2.75) and also in rural Bangladesh (AOR 11.09, 95% CI 6.28 to 19.57).
Our results lend support to the hypothesis that increased caesarean section rates in these South Asian countries may be driven in part by the private sector. They also suggest that preferences for caesarean delivery may be higher among highly educated women, and that individual-level and provider-level factors interact in driving caesarean rates higher. Rates of caesarean section in the private sector, and their maternal and neonatal health outcomes, require close monitoring.
Despite the increasing burden of acute heart failure (AHF) on healthcare systems, the association between centralised cardiovascular specialist care and the quality of AHF care remains unknown. We examine the relationship between the number of cardiologists per hospital and hospital practice variations.
In a retrospective observational study, we analysed 38 668 patients with AHF admitted to 546 Japanese acute care hospitals between 2010 and 2011 using the Diagnosis Procedure Combination administrative claims database. Sample hospitals were categorised into four groups according to the number of cardiologists per facility (none, 1–4, 5–9 and ≥10). To confirm the capability of administrative data to identify patients with AHF, the ≥10 cardiologists group was compared with two recent clinical registries in Japan.
Using multivariable logistic regression models, patient risk-adjusted in-hospital mortality rates and age-sex-adjusted ORs of various AHF therapies were calculated and compared among four hospital groups.
The ≥10 cardiologists group of hospitals from the administrative database had similar major underlying disease incidence and therapeutic practices to those of the clinical registry hospitals. Age-adjusted and sex-adjusted ORs of various AHF therapies in the four hospital groups revealed wide practice variations associated with the number of cardiologists. Adjusted in-hospital mortality demonstrated a negative association with the number of cardiologists. In addition, the different hospital-level distribution patterns of specific therapeutic practices illustrated the diffusion process of therapies across facilities.
Wide practice variations in AHF care were associated with the number of cardiologists per facility, indicating a possible relationship between the quality of AHF care and manpower resources. The provision of recommended therapies increased together with the number of cardiologists.
Previous studies have found social cognitive theory (SCT)-framed interventions are successful for improving condom use and reducing sexually transmitted infections (STIs). We conducted a secondary analysis of behavioural data from the Safe in the City intervention trial (2003–2005) to investigate the influence of SCT constructs on study participants' self-reported use of condoms at last intercourse.
The main trial was conducted from 2003 to 2005 at three public US STI clinics. Patients (n=38 635) were either shown a 'safer sex' video in the waiting room, or received the standard waiting room experience, based on their visit date. A nested behavioural assessment was administered to a subsample of study participants following their index clinic visit and again at 3 months follow-up. We used multivariable modified Poisson regression models to examine the relationships among SCT constructs (sexual self-efficacy, self-control self-efficacy, self-efficacy with most recent partner, hedonistic outcome expectancies and partner expected outcomes) and self-reported condom use at last sex act at the 3-month follow-up study visit.
Of 1252 participants included in analysis, 39% reported using a condom at last sex act. Male gender, homosexual orientation and single status were significant correlates of condom use. Both unadjusted and adjusted models indicate that sexual self-efficacy (adjusted relative risk (RRa)=1.50, 95% CI 1.23 to 1.84), self-control self-efficacy (RRa=1.67, 95% CI 1.37 to 2.04), self-efficacy with most recent partner (RRa=2.56, 95% CI 2.01 to 3.27), more favourable hedonistic outcome expectancies (RRa=1.83, 95% CI 1.54 to 2.17) and more favourable partner expected outcomes (RRa=9.74, 95% CI 3.21 to 29.57) were significantly associated with condom use at last sex act.
Social cognitive skills, such as self-efficacy and partner expected outcomes, are an important aspect of condom use behaviour.
clinicaltrials.gov (#NCT00137370).
Pressure ulcers are common in the elderly and immobile. Currently, there are few proven effective treatments for pressure ulcers. This trial aims to evaluate the feasibility, efficacy and safety of moxibustion for pressure ulcers.
This is a multicentre, two-armed, parallel-design randomised controlled trial (RCT). 30 eligible patients with pressure ulcers will be randomised in a ratio of 1:1 to the treatment group and control group. The participants in the treatment group will undergo indirect moxibustion for 30 min before application of a dressing, one session daily, five sessions weekly for 4 weeks. The patients in the control group will only receive a dressing, applied in the same way as in the treatment group. Both groups will be followed up for 3 months. The primary outcome measures will be wound surface area (WSA) and proportion of ulcers healed within trial period (PUHTP). The secondary outcomes will be the Pressure Ulcer Scale for Healing (PUSH Tool), visual analogue scale (VAS) and adverse events. All outcomes will be evaluated at the beginning of the study, at the end of the second week, at 4 weeks after randomisation and at 1 and 3 months after treatment cessation.
This trial has undergone ethical scrutiny and been approved by the ethics review boards of First Affiliated Hospital of Heilongjiang University of Chinese Medicine and Second Affiliated Hospital of Heilongjiang University of Chinese Medicine (Permission number: HZYEYLP2014). The results of this study will provide clinical evidence for the feasibility, efficacy and safety of moxibustion for pressure ulcers.
Exercise is integral to health across the lifespan and important for people with chronic health conditions. A systematic review of exercise trials for chronic conditions reported suboptimal descriptions of the evaluated interventions and concluded that this hinders interpretation and replication. The aim of this project is to develop a standardised method for reporting essential exercise programme details being evaluated in clinical trials.
A modified Delphi technique will be used to gain consensus among international exercise experts. We will use three sequential rounds of anonymous online questionnaires to refine a standardised checklist. A draft checklist of potentially relevant items was developed based on the results of a systematic review of exercise systematic reviews. An international panel of experts was identified by exercise systematic review authorship, established international profile in exercise research and practice and by peer referral. In round 1, the international panel of experts will be asked to rate the importance of each draft item and provide additional suggestions for revisions or new items. Consensus will be considered reached if at least 70% of the panel strongly agree/disagree that an item should be included or excluded. Where agreement is not reached or there are suggestions for altered or new items, these will be taken to round 2 together with an aggregated summary of round 1 responses. Following the second round, a ranking of item importance will be made to rationalise the number of items. The final template will be distributed to panel members for approval.
Ethics approval was received from The Cabrini Institute Ethics Committee, Melbourne, Australia (HREC 02-07-04-14). We plan to use a stepwise process to develop and refine a standardised and internationally agreed template for explicit reporting of exercise programmes. The template will be generalisable across all types of exercise interventions. The findings will be disseminated through peer-reviewed publications and conference presentations.
Prostate-specific antigen (PSA) screening is controversial. A community jury allows presentation of complex information and may clarify how participants view screening after being well-informed. We examined whether participating in a community jury had an effect on men's knowledge about and their intention to participate in PSA screening.
Random allocation to either a 2-day community jury or a control group, with preassessment, postassessment and 3-month follow-up assessment.
Participants from the Gold Coast (Australia) recruited via radio, newspaper and community meetings.
Twenty-six men aged 50–70 years with no previous diagnosis of prostate cancer.
The control group (n=14) received factsheets on PSA screening. Community jury participants (n=12) received the same factsheets and further information about screening for prostate cancer. In addition, three experts presented information on PSA screening: a neutral scientific advisor provided background information, one expert emphasised the potential benefits of screening and another expert emphasised the potential harms. Participants discussed information, asked questions to the experts and deliberated on personal and policy decisions.
Our primary outcome was change in individual intention to have a PSA screening test. We also assessed knowledge about screening for prostate cancer.
Analyses were conducted using intention-to-treat. Immediately after the jury, the community jury group had less intention-to-screen for prostate cancer than men in the control group (effect size=–0.6 SD, p=0.05). This was sustained at 3-month follow-up. Community jury men also correctly identified PSA test accuracy and considered themselves more informed (effect size=1.2 SD, p<0.001).
Evidence-informed deliberation of the harms and benefits of PSA screening effects men's individual choice to be screened for prostate cancer. Community juries may be a valid method for eliciting target group input to policy decisions.
Australian and New Zealand Clinical Trials Registry (ACTRN12612001079831).
To examine the effect of the new legislation on partial sickness benefit on subsequent work participation of Finns with long-term sickness absence. Additionally, we investigated whether the effect differed by sex, age or diagnostic category.
A register-based quasi-experimental study compared the intervention (partial sick leave) group with the comparison (full sick leave) group regarding their pre-post differences in the outcome. The preintervention and postintervention period each consisted of 365 days.
Nationwide, individual-level data on the beneficiaries of partial or full sickness benefit in 2008 were obtained from national sickness insurance, pension and earnings registers.
1738 persons in the intervention and 56 754 persons in the comparison group.
Work participation, measured as the proportion (%) of time within 365 days when participants were gainfully employed and did not receive either partial or full ill-health-related or unemployment benefits.
Although work participation declined in both groups, the decline was 5% (absolute difference-in-differences) smaller in the intervention than in the comparison group, with a minor sex difference. The beneficial effect of partial sick leave was seen especially among those aged 45–54 (5%) and 55–65 (6%) and in mental disorders (13%). When the groups were rendered more exchangeable (propensity score matching on age, sex, diagnostic category, income, occupation, insurance district, work participation, sickness absence, rehabilitation periods and unemployment, prior to intervention and their interaction terms), the effects on work participation were doubled and seen in all age groups and in other diagnostic categories than traumas.
The results suggest that the new legislation has potential to increase work participation of the population with long-term sickness absence in Finland. If applied in a larger scale, partial sick leave may turn out to be a useful tool in reducing withdrawal of workers from the labour market due to health reasons.
To assess the effect of awareness and advice to seek care on blood pressure (BP) control among patients with hypertension in Bangladesh.
Longitudinal study.
The study was carried out in icddr,b surveillance sites at rural Matlab in Chandpur district and semi-urban Kamalapur in Dhaka, Bangladesh.
Randomly selected men and non-pregnant women aged 20 years or older without any acute illness or history of any vascular events such as stroke or acute myocardial infarction.
Hypertension was defined as systolic BP (SBP) ≥140 and/or diastolic BP (DBP) ≥90 mm Hg or as self-reported hypertension under medication. We advised patients to seek care from a qualified provider and to adopt a healthy lifestyle. We compared changes in BP from baseline to follow-up at around 6 months.
Overall, 17.1% (n=287) of participants had hypertension at baseline with significantly higher prevalence in the semi-urban than in the rural population (23.6% vs 10.8%; p<0.001); half were unaware of their condition. At follow-up, 83% (n=204) reported a visit to any healthcare provider. In the semi-urban area, a higher proportion of patients visited medically qualified practitioners than in the rural area (76.7% vs 36.6%, p<0.000). SBP (–3.3±20.7 mm Hg; p<0.01) and DBP (–2.0±13.0 mm Hg; p<0.02) were lower at follow-up. Those who visited medically qualified practitioners had significant SBP (–3.9±22.4 mm Hg; p<0.03) and DBP (–2.7±14.1 mm Hg; p<0.02) reduction. BP reduction did not reach statistical significance among those visiting a pharmacist or their village doctors. Overall, half of the patients with hypertension achieved the BP control goal (BP<140/90 mm Hg).
Awareness and simple health messages increase provider visit, reduce blood pressure and improve BP control in hypertensive Bangladeshis. Longer-term follow-up is required to verify the sustainability.
To evaluate the effectiveness and safety of dipeptidyl peptidase-4 (DPP-4) inhibitors versus intermediate-acting insulin for adults with type 2 diabetes mellitus (T2DM) and poor glycaemic control despite treatment with two oral agents.
Studies were multicentre and multinational.
Ten studies including 2967 patients with T2DM.
Studies that examined DPP-4 inhibitors compared with each other, intermediate-acting insulin, no treatment or placebo in patients with T2DM.
Primary outcome was glycosylated haemoglobin (HbA1c). Secondary outcomes were healthcare utilisation, body weight, fractures, quality of life, microvascular complications, macrovascular complications, all-cause mortality, harms, cost and cost-effectiveness.
10 randomised clinical trials with 2967 patients were included after screening 5831 titles and abstracts, and 180 full-text articles. DPP-4 inhibitors significantly reduced HbA1c versus placebo in network meta-analysis (NMA; mean difference (MD) –0.62%, 95% CI –0.93% to –0.33%) and meta-analysis (MD –0.61%, 95% CI –0.81% to –0.41%), respectively. Significant differences in HbA1c were not observed for neutral protamine Hagedorn (NPH) insulin versus placebo and DPP-4 inhibitors versus NPH insulin in NMA. In meta-analysis, no significant differences were observed between DPP-4 inhibitors and placebo for severe hypoglycaemia, weight gain, cardiovascular disease, overall harms, treatment-related harms and mortality, although patients receiving DPP-4 inhibitors experienced less infections (relative risk 0.72, 95% CI 0.57 to 0.91).
DPP-4 inhibitors were superior to placebo in reducing HbA1c levels in adults with T2DM taking at least two oral agents. Compared with placebo, no safety signals were detected with DPP-4 inhibitors and there was a reduced risk of infection. There was no significant difference in HbA1c observed between NPH and placebo or NPH and DPP-4 inhibitors.
The aim of this study was to evaluate the usability of two formats of a shortened systematic review for clinicians.
Usability of the prototypes was assessed using three cycles of iterative testing. 10 participants were asked to complete tasks of locating information or items within two prototypes and 'think aloud' while being audio taped. Interviews were also audio recorded and participants completed a systematic usability scale.
Revisions were made between each iteration in order to address issues identified by participants. Finding information relating to the number of studies in the meta-analysis, and locating the number of studies in the entire systematic review were revealed as areas needing attention during the usability evaluation.
Iterative testing combined with a multifaceted approach to usability testing offered essential insight into aspects of the prototypes that required modifications. Alterations were made in order to create finalised versions of the two shortened systematic review formats.
To investigate the relationship between neighbourhood greenspace and type 2 diabetes.
3 diabetes screening studies conducted in Leicestershire, UK in 2004–2011. The percentage of greenspace in the participant's home neighbourhood (3 km radius around home postcode) was obtained from a Land Cover Map. Demographic and biomedical variables were measured at screening.
10 476 individuals (6200 from general population; 4276 from high-risk population) aged 20–75 years (mean 59 years); 47% female; 21% non-white ethnicity.
Screen-detected type 2 diabetes (WHO 2011 criteria).
Increased neighbourhood greenspace was associated with significantly lower levels of screen-detected type 2 diabetes. The ORs (95% CI) for screen-detected type 2 diabetes were 0.97 (0.80 to 1.17), 0.78 (0.62 to 0.98) and 0.67 (0.49 to 0.93) for increasing quartiles of neighbourhood greenspace compared with the lowest quartile after adjusting for ethnicity, age, sex, area social deprivation score and urban/rural status (Ptrend=0.01). This association remained on further adjustment for body mass index, physical activity, fasting glucose, 2 h glucose and cholesterol (OR (95% CI) for highest vs lowest quartile: 0.53 (0.35 to 0.82); Ptrend=0.01).
Neighbourhood greenspace was inversely associated with screen-detected type 2 diabetes, highlighting a potential area for targeted screening as well as a possible public health area for diabetes prevention. However, none of the risk factors that we considered appeared to explain this association, and thus further research is required to elicit underlying mechanisms.
This study uses data from three studies (NCT00318032, NCT00677937, NCT00941954).
The use of acupuncture has been suggested for the treatment of acute neck pain caused by stiff neck in China. However, current evidence is insufficient to draw any conclusions about its efficacy. Therefore this pilot study was designed to evaluate the feasibility and efficacy of acupuncture at the Houxi (SI3) acupoint for treatment of acute neck pain.
This pilot study will be a two-parallel-group, assessor-blinded, randomised controlled trial. Thirty-six stiff neck participants with acute neck pain will be recruited and randomly divided into two groups in a 1:1 ratio. Participants in the control group will receive massage on the local neck region (5 min each session, three times a day for 3 days). In addition to massage, patients in the treatment group will receive acupuncture (one session a day for 3 days). Measures will be taken at 0, 3 and 15 days. The primary outcome is the Northwick Park Neck Pain Questionnaire (NPQ). The secondary outcome is the Short Form of the McGill Pain Questionnaire (SF-MPQ).
The protocol for this pilot randomised clinical trial has undergone ethics scrutiny and been approved by the ethics review boards of the First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine (Permission number: HZYLL201303502). The findings of this study will provide important clinical evidence on the feasibility and efficacy of acupuncture treatment for stiff neck patients with acute neck pain. In addition, it will explore the feasibility of further acupuncture research.
Youth with mental health problems often have difficulties engaging in education and employment. In Australia, youth mental health services have been widely established with a key aim of improving role functioning; however, there is little knowledge of those who are not engaged in employment, education or training (NEET) and the factors which may influence this. This study aimed to examine NEET status and its correlates in a sample of such youth.
Cross-sectional data from a longitudinal cohort study.
Between January 2011 and August 2012, young people presenting to one of the four primary mental health centres in Sydney or Melbourne were invited to participate.
Young adults (N=696) aged between 15 and 25 years (M=19.0, SD=2.8), 68% female, 58% (n=404) attended headspace in Sydney.
Individuals 'Not in any type of Education, Employment or Training' in the past month were categorised as NEET. Demographic, psychological and clinical factors alongside disability and functioning were assessed using clinical interview and self-report.
A total of 19% (n=130/696) were NEET. NEETs were more likely to be male, older, have a history of criminal charges, risky cannabis use, higher level of depression, poorer social functioning, greater disability and economic hardship, and a more advanced stage of mental illness than those engaged in education, training or work. Demographics such as postsecondary education, immigrant background and indigenous background, were not significantly associated with NEET status in this sample.
One in five young people seeking help for mental health problems were not in any form of education, employment and training. The commonly observed risk factors did not appear to influence this association, instead, behavioural factors such as criminal offending and cannabis use appeared to require targeted intervention.
Obesity, hypertension and diabetes are on a dramatic rise in low-income and middle-income countries, and this foretells an overwhelming increase in chronic disease burden from cardiovascular disease. Therefore, rapid action should be taken through preventive population-based programmes. However, in these regions, data on the population distribution of cardiovascular risk factors, and of intermediate and final end points for cardiovascular disease are scarce. The Healthy Life in Suriname (HELISUR) study is a cardiovascular population study in Suriname, which is part of the Caribbean Community. The HELISUR study is dedicated to provide data on risk factors and prevalent cardiovascular disease in the multiethnic population, which is mainly of African and Asian descent.
In a cross-sectional, observational population-based setting, a random representative sample of 1800 citizens aged between 18 and 70 years will be selected using a cluster household sampling method. Self-reported demographic, socioeconomic and (cardiovascular) health-related data will be collected. Physical examination will include the assessment of cardiovascular risk factors and prevalent cardiovascular disease. In addition, we will study cardiovascular haemodynamics non-invasively, as a novel intermediate outcome. Finally, fasting blood and overnight urine samples will be collected to monitor cardiometabolic risk factors. The main outcome will be descriptive in reporting the prevalence of risk factors and measures of (sub) clinical end organ damage, stratified for ethnicity and sex-age groups.
Ethical approval has been obtained from the State Secretary of Health. Data analysis and manuscript submission are scheduled for 2016. Findings will be disseminated in peer-reviewed journals, and at national, regional and international scientific meetings. Importantly, data will be presented to Surinamese policymakers and healthcare workers, to develop preventive strategies to combat the rapid rise of cardiovascular disease.
To create and validate a frailty assessment tool for community-dwelling adults aged ≥75 years.
Longitudinal, population-based study.
The Survey of Health, Ageing and Retirement in Europe (SHARE).
4001 women and 3057 men aged ≥75 years from the second wave of SHARE. 3325 women and 2587 men had complete information for the frailty indicators: fatigue, low appetite, weakness, observed gait (walking without help, walking with help, chairbound/bedbound, unobserved) and low physical activity.
The internal validity of the frailty indicators was tested with latent class analysis, by modelling an underlying variable with three ordered categories. The predictive validity of the frailty classification was tested against 2-year mortality and 4-year disability. The mortality prediction of SHARE-FI75+ was compared with that of previously operationalised frailty scales in SHARE (SHARE-FI, 70-item index, phenotype, FRAIL).
In both genders, all frailty indicators significantly aggregated into a three-category ordinal latent variable. After adjusting for baseline age, comorbidity and basic activities of daily living (BADL) disability, the frail had an OR for 2-year mortality of 2.2 (95% CI 1.2 to 3.8) in women and 4.2 (2.6 to 6.8) in men. The mortality prediction of SHARE-FI75+ was similar to that of the other SHARE frailty scales. By wave 4, 49% of frail women (78 of 159) had at least one more limitation with BADL (compared with 18% of non-frail, 125 of 684; p<0.001); in men, these proportions were 39% (26 of 66) and 18% (110 of 621), respectively (p<0.001). A calculator is supplied for point-of-care use, which automatically replicates the frailty classification for any given measurements.
SHARE-FI75+ could help frailty case finding in primary care and provide a focus for personalised community interventions. Further validation in trials and clinical programmes is needed.
This review aims to evaluate the effectiveness and safety of acupuncture for patients with postoperative pain after laparoscopic surgery.
We will search the following databases from their inception to October 2014: MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), the Cumulative Index to Nursing and Allied Health Literature (CINAHL), the Allied and Complementary Medicine Database (AMED), three Chinese databases (China National Knowledge Infrastructure (CNKI), the Chongqing VIP Chinese Science and Technology Periodical Database (VIP) and the Wanfang database), one Japanese database (Japan Science and Technology Information Aggregator, Electronic (J-STAGE)) and eight Korean databases (Korean Association of Medical Journal Edition, Korean Medical Database, Korean Studies Information Service System, National Discovery for Science Leaders, Database Periodical Information Academic, Korean National Assembly Digital Library, Oriental Medicine Advanced Searching Integrated System and Korean Traditional Knowledge Portal). All randomised controlled trials of acupuncture for postoperative pain after laparoscopic surgery will be considered for inclusion. The risk of bias and reporting quality will be assessed using the Cochrane risk of bias tool, the Consolidated Standards of Reporting Trials (CONSORT) and the revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA). The risk ratio for dichotomous data and mean difference or standard mean difference for continuous data will be calculated with 95% CIs.
The results of this review will be disseminated through peer-reviewed publication or conference presentation. Our findings will summarise the current evidence of acupuncture to treat postoperative pain after laparoscopic surgery, and may provide important guidance for acupuncture usage after laparoscopic surgery for clinicians and patients.
Antibiotic resistance has risen dramatically over the past years. For individual patients, adequate initial antibiotic therapy is essential for clinical outcome. Computer-assisted decision support systems (CDSSs) are advocated to support implementation of rational anti-infective treatment strategies based on guidelines. The aim of this study was to evaluate long-term effects after implementation of a CDSS.
This prospective 'before/after' cohort study was conducted over four observation periods within 5 years. One preinterventional period (pre) was compared with three postinterventional periods: directly after intensive implementation efforts (post1), 2 years (post2) and 3 years (post3) after implementation.
Five anaesthesiological-managed intensive care units (ICU) (one cardiosurgical, one neurosurgical, two interdisciplinary and one intermediate care) at a university hospital.
Adult patients with an ICU stay of >48 h were included in the analysis. 1316 patients were included in the analysis for a total of 12 965 ICU days.
Implementation of a CDSS.
The primary end point was percentage of days with guideline adherence during ICU treatment. Secondary end points were antibiotic-free days and all-cause mortality compared for patients with low versus high guideline adherence.
Adherence to guidelines increased from 61% prior to implementation to 92% in post1, decreased in post2 to 76% and remained significantly higher compared with baseline in post3, with 71% (p=0.178). Additionally, antibiotic-free days increased over study periods. At all time periods, mortality for patients with low guideline adherence was higher with 12.3% versus 8% (p=0.014) and an adjusted OR of 1.56 (95% CI 1.05 to 2.31).
Implementation of computerised regional adapted guidelines for antibiotic therapy is paralleled with improved adherence. Even without further measures, adherence stayed high for a longer period and was paralleled by reduced antibiotic exposure. Improved guideline adherence was associated with reduced ICU mortality.
A timely initiation of treatment is crucial to better control tuberculosis (TB). The aim of this study is to describe treatment delay among migrant patients with TB and to identify factors associated with treatment delay, so as to provide evidence for strategy development and improvement of TB control among migrants in China.
A cross-sectional study was conducted in Shandong province of China. A total of 314 confirmed smear positive migrant patients with pulmonary TB were included. Univariate logistic regression was used to analyse the association of variables with treatment delay among migrant patients with TB. A multilogistic regression model was developed to further assess the effect of variables on treatment delay.
Of 314 migrant patients with TB, 65.6% experienced treatment delay (>1 day). Household income level, diagnosis symptom severity, understanding of whether TB is curable or not and knowledge about the free TB treatment policy are factors significantly associated with treatment delay.
Economic status and knowledge about TB are key barriers to accessing TB treatment. An integrated policy of carrying out TB-related health education and publicising the free TB treatment policy among migrants is needed. Health insurance schemes for migrants should be modified to make them transferrable and pro-poor.
Since conflicting results have been published on the role of tobacco smoking on the risk of endometriosis, we provide an up-to-date summary quantification of this potential association.
We performed a PubMed/MEDLINE search of the relevant publications up to September 2014, considering studies on humans published in English. We searched the reference list of the identified papers to find other relevant publications. Case–control as well as cohort studies have been included reporting risk estimates on the association between tobacco smoking and endometriosis. 38 of the 1758 screened papers met the inclusion criteria. The selected studies included a total of 13 129 women diagnosed with endometriosis.
Academic hospitals.
Risk of endometriosis in tobacco smokers.
We obtained the summary estimates of the relative risk (RR) using the random effect model, and assessed the heterogeneity among studies using the 2 test and quantified it using the I2 statistic. As compared to never-smokers, the summary RR were 0.96 (95% CI 0.86 to 1.08) for ever smokers, 0.95 (95% CI 0.81 to 1.11) for former smokers, 0.92 (95% CI 0.82 to 1.04) for current smokers, 0.87 (95% CI 0.70 to 1.07) for moderate smokers and 0.93 (95% CI 0.69 to 1.26) for heavy smokers.
The present meta-analysis provided no evidence for an association between tobacco smoking and the risk of endometriosis. The results were consistent considering ever, former, current, moderate and heavy smokers, and across type of endometriosis and study design.
To identify barriers that are common and unique to six selected vulnerable groups: low socioeconomic status; Indigenous; mental illness and substance abuse; homeless; prisoners; and at-risk youth.
A systematic review was carried out to identify the perceived barriers to smoking cessation within six vulnerable groups.
MEDLINE, EMBASE, CINAHL and PsycInfo were searched using keywords and MeSH terms from each database's inception published prior to March 2014.
Studies that provided either qualitative or quantitative (ie, longitudinal, cross-sectional or cohort surveys) descriptions of self-reported perceived barriers to quitting smoking in one of the six aforementioned vulnerable groups were included.
Two authors independently assessed studies for inclusion and extracted data.
65 eligible papers were identified: 24 with low socioeconomic groups, 16 with Indigenous groups, 18 involving people with a mental illness, 3 with homeless groups, 2 involving prisoners and 1 involving at-risk youth. One study identified was carried out with participants who were homeless and addicted to alcohol and/or other drugs. Barriers common to all vulnerable groups included: smoking for stress management, lack of support from health and other service providers, and the high prevalence and acceptability of smoking in vulnerable communities. Unique barriers were identified for people with a mental illness (eg, maintenance of mental health), Indigenous groups (eg, cultural and historical norms), prisoners (eg, living conditions), people who are homeless (eg, competing priorities) and at-risk youth (eg, high accessibility of tobacco).
Vulnerable groups experience common barriers to smoking cessation, in addition to barriers that are unique to specific vulnerable groups. Individual-level, community-level and social network-level interventions are priority areas for future smoking cessation interventions within vulnerable groups.
A protocol for this review has been registered with PROSPERO International Prospective Register of Systematic Reviews (Identifier: CRD42013005761).
To evaluate epidemiological characteristics of out-of-hospital cardiac arrests (OHCAs) by detailed non-cardiac cause and factors associated with the outcomes after OHCAs of non-cardiac origin.
A prospective, population-based observational study.
The Utstein Osaka Project.
14 164 adult patients aged ≥20 years old with OHCAs due to non-cardiac origin who were resuscitated by emergency-medical-service personnel or bystanders, and then were transported to medical institutions from January 2005 to December 2011.
One-month survival after OHCA. Multiple logistic regression analysis was used to assess factors that were potentially associated with the outcome.
During the study period, the 1-month survival rate was 5.3% (755/14 164). The proportion of 1-month survival was 6.2% (510/8239) in external causes, 6.5% (94/1148) in respiratory diseases, 0.8% (11/1309) in malignant tumours, 4.9% (55/1114) in strokes and 4.1% (85/2054) in others. As for external causes, the proportion of 1-month survival was 14.3% (382/2670) in asphyxia, 4.2% (84/1999) in hanging, 0.7% (9/1300) in fall, 1.1% (12/1062) in drowning, 1.6% (12/765) in traffic injury, 3.7% (7/187) in drug overuse and 1.6% (4/256) in unclassified external causes. In a multivariate analysis, adults aged <65 years old with arrests witnessed by bystanders, with normal activities of daily living before the arrests, having ventricular fibrillation arrests, having arrests in public places, intravenous fluid levels and early Emergency Medical Service response time were significant predictors for 1-month outcome after OHCAs of non-cardiac origin. The proportion of 1-month survival of all OHCAs of non-cardiac origin did not significantly increase (from 4.3% (86/2023) in 2005 to 4.9% (105/2126) in 2011) and the adjusted OR for one-increment of year was 1.01 (95% CI 0.97 to 1.06).
From a large OHCA registry in Osaka, we demonstrated that 1-month survival after OHCAs of non-cardiac origin was poor and stable.
The government of China has introduced a National Essential Medicines Policy (NEMP) in the new round of health system reform. The objective of this paper is to analyse whether the NEMP can play a role in curbing the rise of medical expenditures without disrupting the availability of healthcare services at township hospitals in China.
This study adopted a pre–post treatment-control study design. A difference-in-differences method and fixed-effects model for panel data were employed to estimate the effect of the NEMP.
Chongqing, Jiangsu and Henan Province, in China, in 2009 and 2010.
296 township health centres.
Outcomes for health expenditures were average outpatient drug expenses per visit, average inpatient drug expenses per discharged patient, average outpatient expenses per visit and average inpatient expenses per discharged patient. Outcomes for care delivery were the numbers of visits per certified doctor per day and the numbers of hospitalised patients per certified doctor per day.
The township health centres that were enrolled in the NEMP reported 26% (p<0.01) lower drug expenditures for inpatient care. An 11% (p<0.05) decrease in average inpatient expenditures per discharged patient was found following the implementation of the NEMP. The impacts of the NEMP on average outpatient expenditures and outpatient drug expenditures were not statistically significant at the 5% level. No statistically significant associations were found between the NEMP and reduction in quantity of health service delivery.
The NEMP was significant in its effect in reducing inpatient medication and health service expenditures. This study shows no evidence that the quantity of healthcare service declined significantly after introduction of the NEMP over the study period, which suggests that if appropriate matching policies are introduced, the side effects of the NEMP can be counteracted to some degree. Further research including a long-term follow-up study is needed.
Concern has been raised that the occurrence of cancer may be increased in neighbourhoods around a former manufactured gas plant in Champaign, Illinois, USA. Thus, we compared historical rates of cancer in this area to comparison communities as well as with nationally standardised rates.
Retrospective population-based community cancer assessment during 1990–2010.
Champaign County, Illinois, USA, and zip codes encompassing the location of the former manufactured gas plant to counties that were similar demographically.
Residents of the counties and zip codes studied between 1990 and 2010.
The relative risk (RR) and 95% CI were used to compare cancer incidence and mortality in the areas near the gas compression site to the comparison counties. Standardised incidence ratios (SIRs) were calculated to compare rates in the areas near the gas compression site to expected rates based on overall US cancer rates.
Total cancer mortality (RR=0.91, 95% CI 0.88 to 0.94) and incidence (RR=0.95, 95% CI 0.94 to 0.97) were reduced significantly in Champaign County versus the comparison counties. Similarly, a reduced rate of total cancer was observed in analyses by zip code (proximal to the former gas plant) when compared with either similar counties (RR=0.89, 95% CI 0.86 to 0.93) or national standardised rates of cancer (SIR=0.88, 95% CI 0.85 to 0.91).
This historical cancer assessment did not find an increased risk of total cancer or specific cancer types in communities near a former manufactured gas plant site.
Sepsis is the leading cause of mortality in non-cardiological critically ill patients. There are as many as 20 million cases of sepsis annually worldwide, with a mortality rate of around 35%. It has been reported that the dysregulation of haemostatic system due to the interaction between coagulation system and inflammatory response is a strong predictor of mortality in patients with severe sepsis. In this context, several anticoagulants have been evaluated in recent years. However, the results of these studies were inconsistent and even contradictory. In addition, there is insufficient evidence comparing the efficacy and safety of different anticoagulants. The purpose of our study is to carry out a systematic review and network meta-analysis comparing the efficacy and safety of different anticoagulants for severe sepsis based on existing randomised controlled trials (RCTs) and ranking these anticoagulants for practical consideration.
PubMed, EMBASE and Cochrane Library databases will be systematically searched for eligible studies. Randomised controlled trials (RCT) on anticoagulant therapy for severe sepsis with multiple outcome measures will be included. The Cochrane Risk of Bias Tool will be used to assess the quality of included studies. The primary outcomes are mortality and bleeding events. The secondary outcomes include the length of intensive care stay, the length of hospital stay and duration of mechanical ventilation. Direct pairwise meta-analysis (DMA), indirect treatment comparison meta-analysis (ITC) and network meta-analysis (NMA) will be conducted to compare different anticoagulants.
Ethical approval is not required given that this is a protocol for a systematic review. The protocol of this systematic review will be disseminated in a peer-reviewed journal and presented at a relevant conference.
This protocol has been registered in PROSPERO (http://www.crd.york.ac.uk/PROSPERO/) under registration number CRD42014013886.
To assess the diagnostic accuracy of three personal breathalyser devices available for sale to the public marketed to test safety to drive after drinking alcohol.
Prospective comparative diagnostic accuracy study comparing two single-use breathalysers and one digital multiuse breathalyser (index tests) to a police breathalyser (reference test).
Establishments licensed to serve alcohol in a UK city.
Of 222 participants recruited, 208 were included in the main analysis. Participants were eligible if they were 18 years old or over, had consumed alcohol and were not intending to drive within the following 6 h.
Sensitivity and specificity of the breathalysers for the detection of being at or over the UK legal driving limit (35 µg/100 mL breath alcohol concentration).
18% of participants (38/208) were at or over the UK driving limit according to the police breathalyser. The digital multiuse breathalyser had a sensitivity of 89.5% (95% CI 75.9% to 95.8%) and a specificity of 64.1% (95% CI 56.6% to 71.0%). The single-use breathalysers had a sensitivity of 94.7% (95% CI 75.4% to 99.1%) and 26.3% (95% CI 11.8% to 48.8%), and a specificity of 50.6% (95% CI 40.4% to 60.7%) and 97.5% (95% CI 91.4% to 99.3%), respectively. Self-reported alcohol consumption threshold of 5 UK units or fewer had a higher sensitivity than all personal breathalysers.
One alcohol breathalyser had sensitivity of 26%, corresponding to false reassurance for approximately one person in four who is over the limit by the reference standard, at least on the evening of drinking alcohol. The other devices tested had 90% sensitivity or higher. All estimates were subject to uncertainty. There is no clearly defined minimum sensitivity for this safety-critical application. We conclude that current regulatory frameworks do not ensure high sensitivity for these devices marketed to consumers for a decision with potentially catastrophic consequences.
To evaluate the effects of the glucagon-like peptide-1 receptor agonist lixisenatide on elevated liver blood tests in patients with type 2 diabetes.
Systematic review.
Electronic and manual searches were combined.
Randomised controlled trials (RCTs) on lixisenatide versus placebo or active comparators for type 2 diabetes were included.
Individual patient data were retrieved to calculate outcomes for patients with elevated liver blood tests.
Normalisation of alanine aminotransferase (ALT) and aspartate aminotransferase (AST).
The results of included trials were combined in meta-analyses. Sequential, subgroup and regression analyses were performed to evaluate heterogeneity and bias.
We included 12 RCTs on lixisenatide versus placebo and 3 RCTs with the active comparators liraglutide, exenatide or sitagliptin. The mean treatment duration was 29 weeks. Lixisenatide increased the proportion of patients with normalisation of ALT (risk difference: 0.07; 95% CI 0.01 to 0.14; number needed to treat: 14 patients, p=0.042). The effect was not confirmed in sequential analysis. No effects of lixisenatide were identified on AST, alkaline phosphatase or bilirubin. No evidence of bias was identified. Mixed effect multilevel meta-regression analyses suggest that the benefit of lixisenatide on ALT was limited to patients who were overweight or obese.
This review suggests that lixisenatide increases the proportion of obese or overweight patients with type 2 diabetes who achieve normalisation of ALT. Additional research is needed to determine if the findings translate to clinical outcome measures.
The measurement of disability in low-income countries is recognised as a major deficiency in health information systems, especially in Africa. The Iganga and Mayuge Demographic Surveillance System (IM-DSS) in Uganda provides a special opportunity to develop population-based data to inform national health policies and evaluate innovations in assessing the burden of disability in Uganda. In this study, we apply a new instrument to screen for physical disabilities at the IM-DSS. The study utilised a modified version of the short set of questions proposed by the Washington Group on Disability Statistics. The instrument was applied at the household level and information was collected on all individuals over the age of 5, who were residents of the IM-DSS.
The study was based at the IM-DSS, which covers the parts of Iganga and Mayuge districts in Eastern Uganda.
57 247 individuals were included in the survey, with 51% of the study population being women.
Activity limitations
The overall prevalence of physical disability at the IM-DSS was 9.4%, with vision being the most common type of difficulty reported in this population, and communication being least prevalent. Disability was less likely to be observed among males than their female counterparts (OR 0.75; 95% CI 0.71 to 0.81; p<0.001). Statistically significant associations were found between disability and increasing age, as well as disability and decreasing household wealth status.
This study shows that the modified short set of questions can be readily applied in a DSS setting to obtain estimates on the prevalence and types of disability at the population level. This instrument could be adapted for use to screen for disability in other LMIC settings, providing estimates that are comparable across different global regions and populations.
Studies from western countries show that dentists are vulnerable to work-related musculoskeletal disorders (WMSDs) of the neck and upper extremities, but little is known about their epidemiology among members of this rapidly growing profession in China. This study aims to investigate the prevalence of WMSDs and identify potential risk factors associated with their occurrence in the dental profession in China.
A cross-sectional survey was carried out in 52 different hospitals in a large metropolitan city in China. A total of 304 questionnaires were distributed to respondents identified via stratified random sampling and 272 dentists (121 females and 151 males) completed the survey. The response rate was 89.5%.
Visual analogue score was used to record neck and upper limb musculoskeletal symptoms on a body chart. Work-related risk factors, including physical and psychosocial factors, were accounted for in the regression analysis.
88% of the dentists reported at least one musculoskeletal disorder and 83.8% suffered from neck pain. In the multivariate analyses, working hours per day were associated with neck pain (OR=1.43; 95% CI 1.03 to 1.98). Inability to select the appropriate size of dental instrument was associated with shoulder (OR=2.07; 95% CI 1.00 to 4.32) and wrist/hand (OR=2.47; 95% CI 1.15 to 5.32) pain. As for psychosocial factors, high job demand was associated with symptoms in the shoulder (OR=1.09; 95% CI 1.00 to 1.18), elbow (OR=1.11; 95% CI 1.03 to 1.19) and wrist/hand (OR=1.09; 95% CI 1.02 to 1.17). Regular physical exercise was associated with decreased neck pain (OR=0.37; 95% CI 0.14 to 1.00).
The prevalence of WMSDs among Chinese dentists is high. Specifically, long working hours, inability to select the appropriate size of dental instrument and high job demand are the most significant risk factors.
To examine the association between exacerbation frequency and mortality following an acute exacerbation of chronic obstructive pulmonary disease (AECOPD).
Cohort study using medical databases.
Northern Denmark.
On 1 January 2005, we identified all patients with prevalent hospital-diagnosed chronic obstructive pulmonary disease (COPD) who had at least one AECOPD during 1 January 2005 to 31 December 2009. We followed patients from the first AECOPD during this period until death, emigration or 31 December 2009, whichever came first. We flagged all AECOPD events during follow-up and characterised each by the exacerbation frequency (0, 1, 2 or 3+) in the prior 12-month period.
Using Cox regression, we computed 0–30-day and 31–365-day age-adjusted, sex-adjusted, and comorbidity-adjusted mortality rate ratios (MRRs) with 95% CIs entering exacerbation frequency as a time-varying exposure.
We identified 16 647 eligible patients with prevalent COPD, of whom 6664 (40%) developed an AECOPD and were thus included in the study cohort. The 0–30-day MRRs were 0.97 (95% CI 0.80 to 1.18), 0.90 (95% CI 0.70 to 1.15) and 1.03 (95% CI 0.81 to 1.32) among patients with AECOPD with 1, 2 and 3+ AECOPDs versus no AECOPD within the past 12 months, respectively. The corresponding MRRs were 1.47 (95% CI 1.30 to 1.66), 1.89 (95% CI 1.59 to 2.25) and 1.59 (95% CI 1.23 to 2.05) for days 31–365.
Among patients with AECOPD, one or more exacerbations in the previous year were not associated with 30-day mortality but were associated with an increased 31–365-day mortality.
To examine the recorded indication for antipsychotic prescriptions in UK primary care.
Cohort study.
Primary care.
Individuals prescribed antipsychotics between 2007 and 2011.
The proportion of individuals prescribed antipsychotics with a diagnosis of (1) psychosis and bipolar disorder, (2) other diagnoses including depression, anxiety and dementia and (3) none of these diagnoses.
We identified 47 724 individuals prescribed antipsychotic agents. 13 941 received first-generation agents and 27 966 received second-generation agents. The rates of prescribing were higher in females (incidence rate ratio (IRR) 1.092 (95% CI 1.088 to 1.095), older people (80+ vs 40–49; IRR 2.234 (2.222 to 2.246)) and in those from the most deprived areas (most deprived vs least deprived IRR 3.487 (3.567 to 3.606). Of those receiving first-generation antipsychotics, less than 50% had a diagnosis of psychosis/bipolar disorder. For the second-generation agents, the numbers ranged from 4824 (36%) for quetiapine to 7094 (62%) for olanzapine. In patients without psychosis/bipolar disorder, common diagnoses included anxiety, depression, dementia, sleep and personality disorders. For example, in risperidone users, 14% had an anxiety code, 22% depression, 12% dementia, 11% sleep disorder and 4% personality disorder. The median daily doses and duration of treatment were greater in those with schizophrenia (eg, risperidone median daily dose 4 mg; IQR 2–6: median duration 1.2 years) than in those with non-psychotic/bipolar disorders such as depression or anxiety (eg, risperidone 1 mg; IQR 1–2: 0.6 years). A relatively large proportion (between 6% and 17%) of people receiving individual antipsychotics had none of the diagnoses stated above.
In UK primary care, a large proportion of people prescribed antipsychotics have no record of psychotic or bipolar disorder. They are often older people with conditions including dementia, non-psychotic depression, anxiety and sleep disorders.
To investigate the impact of Australia's plain tobacco packaging policy on two stated purposes of the legislation—increasing the impact of health warnings and decreasing the promotional appeal of packaging—among adult smokers.
Serial cross-sectional study with weekly telephone surveys (April 2006–May 2013). Interrupted time-series analyses using ARIMA modelling and linear regression models were used to investigate intervention effects.
15 745 adult smokers (aged 18 years and above) in New South Wales (NSW), Australia. Random selection of participants involved recruiting households using random digit dialling and selecting the nth oldest smoker for interview.
The introduction of the legislation on 1 October 2012.
Salience of tobacco pack health warnings, cognitive and emotional responses to warnings, avoidance of warnings, perceptions regarding one's cigarette pack.
Adjusting for background trends, seasonality, antismoking advertising activity and cigarette costliness, results from ARIMA modelling showed that, 2–3 months after the introduction of the new packs, there was a significant increase in the absolute proportion of smokers having strong cognitive (9.8% increase, p=0.005), emotional (8.6% increase, p=0.01) and avoidant (9.8% increase, p=0.0005) responses to on-pack health warnings. Similarly, there was a significant increase in the proportion of smokers strongly disagreeing that the look of their cigarette pack is attractive (57.5% increase, p<0.0001), says something good about them (54.5% increase, p<0.0001), influences the brand they buy (40.6% increase, p<0.0001), makes their pack stand out (55.6% increase, p<0.0001), is fashionable (44.7% increase, p<0.0001) and matches their style (48.1% increase, p<0.0001). Changes in these outcomes were maintained 6 months postintervention.
The introductory effects of the plain packaging legislation among adult smokers are consistent with the specific objectives of the legislation in regard to reducing promotional appeal and increasing effectiveness of health warnings.
Infliximab (IFX), a monoclonal chimeric antibody against tumour necrosis factor (TNF) α, is effective for induction and maintenance of remission in moderate to severe Crohn's disease. Discontinuation of IFX maintenance therapy in patients in remission should be considered in order to reduce the potential long-term side effects and lower costs.
This is a prospective, double-blind, randomised, placebo-controlled, multicentre study of patients with luminal Crohn's disease who have been treated with IFX for at least 1 year and are in sustained complete clinical, biochemical and endoscopic remission (ie, Crohn's Disease Activity Index (CDAI) score <150, complete mucosal healing and biochemical markers of inflammation within the normal range). These patients are randomised to receive placebo infusions or continue IFX maintenance therapy. The primary end point is the proportion of patients in maintained remission after 48 weeks (def. CDAI <150).
It is estimated that the knowledge gained about how to optimally handle patients with Crohn's disease in complete long-term sustained remission on IFX is proportionate to the risks and inconveniences related to participation in this study. Prolonged exposure to IFX may cause severe side effects and increased risk of malignancies. Conversely, IFX discontinuation should not unnecessarily create a high risk of relapse. Thus, empirical evidence is needed concerning the safety of discontinuing IFX once a patient exhibits sustained remission. Study results will be published in an English language scientific medical journal. The study is approved by the Danish Medicines Agency (EudraCT-number: 2012-002702-51) and the Regional Ethics Committee of Region Hovedstaden Denmark (Approval-number: H-4-2012-099). The project is reported to the Danish Data Protection Agency (ID-number: 2007-58-0015/HEH.750.89-27), registered at Clinicaltrials.gov, and monitored by independent GCP units for the University of Copenhagen, Odense and Aarhus. The current approved protocol is V.3.2, dated 1 June 2014.
To evaluate risk factors associated with exacerbation frequency in primary care. Information on exacerbations of chronic obstructive pulmonary disease (COPD) has mainly been generated by secondary care-based clinical cohorts.
Retrospective observational cohort study.
Electronic medical records database (England and Wales).
58 589 patients with COPD aged ≥40 years with COPD diagnosis recorded between 1 April 2009 and 30 September 2012, and with at least 365 days of follow-up before and after the COPD diagnosis, were identified in the Clinical Practice Research Datalink. Mean age: 69 years; 47% female; mean forced expiratory volume in 1s 60% predicted.
Data on moderate or severe exacerbation episodes defined by diagnosis and/or medication codes 12 months following cohort entry were retrieved, together with demographic and clinical characteristics. Associations between patient characteristics and odds of having none versus one, none versus frequent (≥2) and one versus frequent exacerbations over 12 months follow-up were evaluated using multivariate logistic regression models.
During follow-up, 23% of patients had evidence of frequent moderate-to-severe COPD exacerbations (24% one; 53% none). Independent predictors of increased odds of having exacerbations during the follow-up, either frequent episodes or one episode, included prior exacerbations, increasing dyspnoea score, increasing grade of airflow limitation, females and prior or current history of several comorbidities (eg, asthma, depression, anxiety, heart failure and cancer).
Primary care-managed patients with COPD at the highest risk of exacerbations can be identified by exploring medical history for the presence of prior exacerbations, greater COPD disease severity and co-occurrence of other medical conditions.
To explore access to primary healthcare and drug therapy by refugee children in the East Midlands region of England.
Interviews with refugees with children and a control group of British parents with children.
East Midlands region of England.
50 refugees with children and a control group of 50 parents with children.
Number of medicines used by children in the last month and the past 6 months. Health of parents and children. Registration with a general practitioner (GP).
All families in both groups were registered with a GP. There was no difference in the number of children in the two groups experiencing illnesses .In the last month, 30 refugee children received 60 medicines and 31 control children 63 medicines. In the past 6 months, 48 refugee children received 108 medicines and 43 control children 96 medicines. There was no difference between the two groups of children in relation to the likelihood of receiving any medicines in either the last month (P=0.839) or the past 6 months (p=0.81). Children in the refugee group were more likely to receive prescribed medicines for the last month (p=0.008) and the past 6 months (p<0.001). They were also less likely to receive over the counter (OTC) medicines in the past 6 months (p=0.009).
The refugee children in this study in the East Midlands had access to primary healthcare, medicines and a family doctor. They were more likely to receive prescribed medicines and less likely to receive OTC medicines, especially paracetamol.
Overweight and obesity is a problem in children in particular and determining pathways of transmission is important in prevention. We aimed to examine associations for body mass index (BMI) across three generations of the same families.
Members of 556 families in the Lifeways Cross-Generation Cohort Study 2001–2014.
Community-based study with linkage to health records in the Republic of Ireland.
Employing a novel mixed-method approach which adjusts for age and familial group, BMI correlations were estimated at three ages of the index child, that is, at birth and at ages 5 and 9. Height was also examined for comparative purposes.
Correlation of offspring's BMI with that of the mother increased with age (correlation coefficient 0.15 increasing to 0.28, p value <0.001 in all cases) while no consistent pattern was seen with offspring and fathers. There was an association also with each parent and their own mother. Offspring's BMI was correlated to a lesser extent with that of the maternal grandmother while for girls only there was an association with that of the paternal grandmother at ages 0 and 5 (correlation coefficients 0.25, 0.28, p values 0.02, 0.01, respectively). In contrast, height of the child was strongly associated with those of all family members at age 5, but at birth and at age 9 only there was an association with those of the parents and the paternal grandfather. Correlation of offspring's height with those of the mother and father increased with age.
The results suggest that BMI is predominantly associated with the maternal line, possibly either with intrauterine development, or inherited through the X chromosome, or both, while height is a more complex trait with genetic influences of the parents and that of the paternal grandfather predominating.
Alcohol overuse and poverty, each associated with premature death, often exist within disadvantaged neighbourhoods. Cheque cashing places (CCPs) may be opportunistically placed in disadvantaged neighbourhoods, where customers abound. We explored whether neighbourhood density of CCPs and alcohol outlets are each related to premature mortality among adults.
Retrospective population-based study.
140 neighbourhoods in Toronto, Ontario, 2005–2009.
Adults aged 20–59 years.
Our primary outcome was premature all-cause mortality among adults aged 20–59 years. Across neighbourhoods we explored neighbourhood density, in km2, of CCPs and alcohol outlets, and the relation of each to premature mortality. Poisson regression provided adjusted relative risks (aRRs) and 95% CIs, adjusting for material deprivation quintile (Q), crime Q and number of banks.
Intentional self-harm, accidental poisoning and liver disease were among the top five causes of premature death among males aged 20–59 years. The overall premature mortality rate was 96.3/10 000 males and 55.9/10 000 females. Comparing the highest versus lowest CCP density Q, the aRR for death was 1.25 (95% CI 1.15 to 1.36) among males and 1.11 (95% CI 0.99 to 1.24) among females. The corresponding aRR comparing the highest Q versus lowest Q alcohol outlet density in relation to premature mortality was 1.36 (95% CI 1.25 to 1.48) for males and 1.11 (95% CI 1.00 to 1.24) for females. The pattern of the relation between either CCPs or alcohol outlet density and premature mortality was typically J shaped.
There is a J-shaped relation between CCP or alcohol outlet density and premature mortality, even on controlling for conventional measures of poverty. Formal banking and alcohol reduction strategies might be added to health promotion policies aimed at reducing premature mortality in highly affected neighbourhoods.
Falls and fall-related injuries are a serious cause of morbidity and cost to society. Foot problems and inappropriate footwear may increase the risk of falls; therefore podiatric interventions may play a role in reducing falls. Two Cochrane systematic reviews identified only one study of a podiatry intervention aimed to reduce falls, which was undertaken in Australia. The REFORM trial aims to evaluate the clinical and cost-effectiveness of a multifaceted podiatry intervention in reducing falls in people aged 65 years and over in a UK and Irish setting.
This multicentre, cohort randomised controlled trial will recruit 2600 participants from routine podiatry clinics in the UK and Ireland to the REFORM cohort. In order to detect a 10% point reduction in falls from 50% to 40%, with 80% power 890 participants will be randomised to receive routine podiatry care and a falls prevention leaflet or routine podiatry care, a falls prevention leaflet and a multifaceted podiatry intervention. The primary outcome is rate of falls (falls/person/time) over 12 months assessed by patient self-report falls diary. Secondary self-report outcome measures include: the proportion of single and multiple fallers and time to first fall over a 12-month period; Short Falls Efficacy Scale—International; fear of falling in the past 4 weeks; Frenchay Activities Index; fracture rate; Geriatric Depression Scale; EuroQoL-five dimensional scale 3-L; health service utilisation at 6 and 12 months. A qualitative study will examine the acceptability of the package of care to participants and podiatrists.
The trial has received a favourable opinion from the East of England—Cambridge East Research Ethics Committee and Galway Research Ethics Committee. The trial results will be published in peer-reviewed journals and at conference presentations.
Current Controlled Trials ISRCTN68240461assigned 01/07/2011.
To evaluate the reproducibility of first-pass contrast-enhanced cardiac MR (CMR) myocardial perfusion imaging in patients with non-ischaemic dilated cardiomyopathy (NIDCM).
Prospective observational study.
Single centre, tertiary care hospital.
6 outpatient participants with NIDCM.
Reproducibility of semiquantitative myocardial perfusion analysis by CMR.
6 patients with NIDCM were studied twice using first-pass of contrast transit through the left ventricular (LV) myocardium with a saturation-recovery gradient echo sequence at rest and during adenosine-induced hyperaemia. The anterior wall was divided into endocardial (Endo) and epicardial (Epi) segments. The Myocardial Perfusion Index (MPI) was calculated as the myocardial signal augmentation rate normalised to the LV cavity rate. The Myocardial Perfusion Reserve Index (MPRI) was calculated as hyperaemic/resting MPI.
Between study 1 and 2, median MPI was similar for resting Endo (0.076 vs 0.077), hyperaemic Endo (0.143 vs 0.143), resting Epi (0.073 vs 0.074), and hyperaemic Epi (0.135 vs 0.134). Median MPRI was similar for Endo (1.84 vs 1.87) and Epi (1.90 vs 2.00). Combining Endo and Epi MPI (N=12), there was excellent agreement between Study 1 and 2 for resting MPI (r=0.998, intraclass correlation coefficient (ICC) 0.998, coefficients of variation (CoV) 1.4%), hyperaemic MPI (r=0.979, ICC 0.963, CoV 3.3%) and MPRI (r=0.989, ICC 0.94, CoV 3.8%).
Resting and hyperaemic myocardial perfusion using a normalised upslope analysis during adenosine CMR is a highly reproducible technique in patients with NIDCM.
Clinical Trials.Gov ID NCT00574119.
Multiple sclerosis (MS) impacts the health-related quality of life (HRQL) in partners, but knowledge on the longitudinal perspective is needed. The aim was to analyse HRQL in partners of persons with MS living in Sweden a decade ago and after 10 years.
Partners were identified through a population-based study of persons with MS in Stockholm. Information on HRQL (the Sickness Impact profile), personal factors and disease-specific factors, and measures of functioning of persons with MS was collected at both time points mainly by home visits.
Some 64 of 102 identified partners (63%) agreed to participate at baseline, and at 10 years 40 of 54 eligible partners were included (74%). HRQL in partners was worse than in a Swedish, aged-grouped reference population at both baseline and follow-up. Depressive symptoms in persons with MS were independently associated with worse HRQL in partners.
Depressive symptoms in persons with MS were associated with worse HRQL in their partners, and HRQL of partners was continuously impacted in the longitudinal perspective. This knowledge needs to be accounted for in the planning of MS care, together with the development of evidence-based support for depressive symptoms, and engagement in recreational life in both partners and persons with MS.
This study involved the development of a question prompt list (QPL) booklet designed to facilitate communication and shared decision-making between parents/carers of children diagnosed with attention-deficit/hyperactivity disorder (ADHD) and their clinicians; and user-testing of the QPL to assess its usability.
Best practice in information writing and design was used to format the QPL content into a 16-page booklet. We then applied user-testing, which uses mixed methods to assess document performance with small cohorts of participants and then improves it in an iterative process. Individual interviews assessed the ability of QPL users to locate and understand key points of information, followed by a semistructured questionnaire, to ascertain their general views about the booklet.
Testing was undertaken with two cohorts of 10 parents/carers of children with ADHD (n=20); matched on age, gender and educational attainment.
In round 1, we tested 15 key points of information related to the QPL. Participant responses and feedback from round 1 informed a revised version of the booklet, tested in a subsequent round.
The target was for 8/10 of the participants to be able to find and demonstrate an understanding of all key information points, in accordance with European guidelines for medicine leaflet testing.
After round 1, problems related to 4/15 information points were identified (booklet purpose; preparing for appointments; asking about a second medical opinion; selecting which questions to ask). Participants also made suggestions regarding the booklet's layout and design. After round 2, all information points were located and understood by at least 8/10 participants.
This is the first study to have developed a usable ADHD-specific QPL for use by parents/carers of children with ADHD during clinical consultations, and the first demonstration of the utility of user-testing methods in ensuring QPL usability.
Multiplexed point-of-care (POC) devices can rapidly screen for HIV-related co-infections (eg, hepatitis C (HCV), hepatitis B (HBV), syphilis) in one patient visit, but global evidence for this approach remains limited. This study aimed to evaluate a multiplex POC testing strategy to expedite screening for HIV-related co-infections in at-risk populations.
A multiplex strategy was developed with two subsequent versions of an investigational device Miriad. It was evaluated in two non-comparable settings and populations in two countries for feasibility of conduct, detection of new infections, preference and accuracy. Version 1 was evaluated in 375 sexually transmitted disease clinic attendees in Mumbai, India; version 2 was evaluated in 119 injection drug users in Montreal, Canada.
Feasibility (completion rate) of the multiplex strategy was high (86.1% Mumbai; 92.4% Montreal). A total of 170 new infections were detected in Mumbai (56 HIV, 75 HBV, 37 syphilis, 2 HCV) versus 2 in Montreal. Preference was 60% in Mumbai and 97% in Montreal. Miriad version 1 specificities were high: HIV 99.7% (98.3% to 100%), HBV 99.3% (97.6% to 99.9%), HCV 99.7% (98.5% to 99.9%), syphilis 85.2% (80.9% to 88.8%); sensitivities were as follows: HIV 100% (94.8% to 100%), HBV 13.3% (6.6% to 23.2%), HCV 50% (1.3% to 98.7%), syphilis 86.1% (70.5% to 95.3%). With version 2, specificities improved: HIV 100% (97.2% to 100%), HBV 100% (97.3% to 100%), HCV 85.3% (73.8% to 93.0%), syphilis 98.1% (93.3% to 99.8%); sensitivities were: HIV 100% (47.3% to 100%), HCV 80.4% (66.1% to 90.6%), syphilis 100% (22.4% to 100%).
A quad multiplex POC strategy for HIV and co-infections was feasible to operationalise and preferred by patients in both settings. Many new infections were identified in Mumbai and accuracy improved with version 2 of the assay. Such a strategy will help expedite screening for co-infections, particularly where baseline screening is low. These findings are valuable to practitioners, researchers, policymakers and funders involved in initiatives for all four diseases with implications for scale-up.
There has been very little description of the health and social outcomes at pregnancy and early motherhood of girls who were previously looked after by local authorities. The objectives of this study were to compare the sociodemographic and health profiles of mothers who had spent time in a children's home or with foster parents as a child to mothers who had not. In particular, to examine associations between being looked after and the likelihood of smoking during pregnancy, birth weight, the presence of symptoms of maternal depression and the initiation of breastfeeding.
A retrospective cross-sectional study using the baseline questionnaire of the Millennium Cohort Study.
The UK.
A nationally representative study of 18 492 mothers of babies born in the UK during 2000–2002.
A history of spending time in a children's home or with foster parents.
(1) Smoking during pregnancy; (2) low birth weight; (3) symptoms of maternal depression and (4) initiation of breastfeeding.
In univariable analyses, women who had been looked after by local authorities were significantly less likely to be of a higher social class, live in a high-income household or have achieved a high level of education. They were more likely to have a low-birthweight baby and be a single parent. In multivariable analyses, women who had been looked after by local authorities were more likely to smoke during pregnancy (adjusted OR 3.0 95% CI 2.14 to 4.3) and were more likely to have symptoms of depression (adjusted OR 1.98 95% CI 1.4 to 2.7) compared with women who had not been looked after.
Our results suggest that these women carry social disadvantage into motherhood, with the potential of continuing the cycle of deprivation. There is a case for increasing our attention on this group, which can be readily accessed by maternity and early years' services.
To examine the experiences of patients, health professionals and screeners; their interactions with and understandings of diabetic retinopathy screening (DRS); and how these influence uptake.
Purposive, qualitative design using multiperspectival, semistructured interviews and thematic analysis.
Three UK Screening Programme regions with different service-delivery modes, minority ethnic and deprivation levels across rural, urban and inner-city areas, in general practitioner practices and patients' homes.
62 including 38 patients (22 regular-screening attenders, 16 non-regular attenders) and 24 professionals (15 primary care professionals and 9 screeners).
Antecedents to attendance included knowledge about diabetic retinopathy and screening; antecedents to non-attendance included psychological, pragmatic and social factors. Confusion between photographs taken at routine eye tests and DRS photographs was identified. The differing regional invitation methods and screening locations were discussed, with convenience and transport safety being over-riding considerations for patients. Some patients mentioned significant pain and visual disturbance from mydriasis drops as a deterrent to attendance.
In this, the first study to consider multiperspectival experiential accounts, we identified that proactive coordination of care involving patients, primary care and screening programmes, prior to, during and after screening is required. Multiple factors, prior to, during and after screening, are involved in the attendance and non-attendance for DRS. Further research is needed to establish whether patient self-management educational interventions and the pharmacological reformulation of shorter acting mydriasis drops, may improve uptake of DRS. This might, in turn, reduce preventable vision loss and its associated costs to individuals and their families, and to health and social care providers, reducing current inequalities.
We investigated incidence and risk factors for postextraction bleeding in patients receiving warfarin and those not receiving anticoagulation therapy.
Cross-sectional, multicentre, observational study.
26 hospitals where an oral surgeon is available.
Data on 2817 teeth (from 496 patients receiving warfarin, 2321 patients not receiving warfarin; mean age (SD): 62.2 (17.6)) extracted between 1 November 2008 and 31 March 2010, were collected. Warfarin-receiving patients were eligible when prothrombin time–international normalised ratio (PT-INR) measured within 7 days prior to the extraction was less than 3.0.
Simple dental extraction was performed, and incidence of postextraction bleeding and comorbidities were recorded.
Postextraction bleeding not controlled by basic haemostasis procedure was clinically significant.
Bleeding events were reported for 35 (7.1%) and 49 (2.1%) teeth, of which 18 (3.6%) and 9 (0.4%) teeth were considered clinically significant, in warfarin and non-warfarin groups, respectively, the difference between which was 3.24% (CI 1.58% to 4.90%). The incidence rates by patients were 2.77% and 0.39%, in warfarin and non-warfarin groups, respectively (incidence difference 2.38%, CI 0.65% to 4/10%). Univariate analyses showed that age (OR 0.197, p=0.001), PT-INR (OR 3.635, p=0.003), mandibular foramen conduction anaesthesia (OR 4.854, p=0.050) and formation of abnormal granulation tissue in extraction socket (OR 2.900, p=0.031) significantly correlate with bleeding incidence. Multivariate analysis revealed that age (OR 0.126, p=0.001), antiplatelet drugs (OR 0.100, p=0.049), PT-INR (OR 7.797, p=0.001) and history of acute inflammation at extraction site (OR 3.722, p=0.037) were significant risk factors for postextraction bleeding.
Our results suggest that there is slight but significant increase in the incidences of postextraction bleeding in patients receiving warfarin. Although absolute incidence was low in both groups, the bleeding risk is not negligible.
Conducting health surveys with community-based random samples are essential to capture an otherwise unreachable population, but these surveys can be biased if the effort to reach participants is insufficient. This study determines the desirable amount of effort to minimise such bias.
A household-based health survey with random sampling and face-to-face interviews. Up to 11 visits, organised by canvassing rounds, were made to obtain an interview.
Single-family homes in an underserved and understudied population in North Miami-Dade County, Florida, USA.
Of a probabilistic sample of 2200 household addresses, 30 corresponded to empty lots, 74 were abandoned houses, 625 households declined to participate and 265 could not be reached and interviewed within 11 attempts. Analyses were performed on the 1206 remaining households.
Each household was asked if any of their members had been told by a doctor that they had high blood pressure, heart disease including heart attack, cancer, diabetes, anxiety/ depression, obesity or asthma. Responses to these questions were analysed by the number of visit attempts needed to obtain the interview.
Return per visit fell below 10% after four attempts, below 5% after six attempts and below 2% after eight attempts. As the effort increased, household size decreased, while household income and the percentage of interviewees active and employed increased; proportion of the seven health conditions decreased, four of which did so significantly: heart disease 20.4–9.2%, high blood pressure 63.5–58.1%, anxiety/depression 24.4–9.2% and obesity 21.8–12.6%. Beyond the fifth attempt, however, cumulative percentages varied by less than 1% and precision varied by less than 0.1%.
In spite of the early and steep drop, sustaining at least five attempts to reach participants is necessary to reduce selection bias.
With the introduction of MRI in diagnosis and tumour necrosis factor inhibitors for treatment, the field of ankylosing spondylitis (AS) has undergone significant changes. We carried out a population-based study of the trends in incidence and prevalence of AS over the past 15 years.
This is a retrospective analysis of provincial health administrative databases. Residents of Ontario, Canada aged 15 years or older diagnosed with AS between 1995 and 2010 were included in the study. Crude as well as age-standardised and sex-standardised incidence and prevalence of AS between 1995 and 2010 were calculated. Trends in prevalence and incidence of male and female patients with AS were separately analysed.
We identified 24 976 Ontarians with AS. Age/sex-standardised AS prevalence increased from 79/100 000 in 1995 to 213/100 000 in 2010. Men had higher prevalence than women, but the male/female prevalence ratio decreased from 1.70 in 1995 to 1.21 by 2010. A higher proportion of male compared with female patients with AS were diagnosed in the 15–45 age group. Annual incidence rates revealed increasing diagnosis of AS among women after 2003.
The prevalence of AS in Ontario has nearly tripled over the past two decades. The proportion of women with new diagnosis of AS is increasing, a trend that began around the year 2003. A higher proportion of male compared with female patients with AS are diagnosed at an earlier age.
To assess the effects of rapid voluntary counselling and testing (VCT) for HIV on HIV incidence and uptake of HIV/AIDS services in people at high risk for HIV exposure.
Cochrane systematic review and meta-analysis.
We searched PubMed, EMBASE, AIDSearch, LILACS, Global Health, Medline Africa, PsychInfo, CINAHL, Cochrane CENTRAL, Cochrane HIV/AIDS Group Specialized Register and grey literature from 1 January 2001 to 5 June 2014 without language restriction.
We included controlled studies that compared rapid VCT with conventional testing among people at risk for HIV exposure.
Two reviewers extracted data. We used Cochrane risk of bias tool and GRADE criteria: risk of bias, inconsistency, indirectness, imprecision and publication bias. For observational studies we used the Newcastle-Ottawa Scale. We used the PRISMA-Equity reporting guideline.
From 2441 articles, we included 8 randomised controlled trials and 5 observational studies. Rapid VCT was associated with a threefold increase in HIV-testing uptake (relative risk (RR)=2.95 95% CI 1.69 to 5.16) and a twofold increase in the receipt of test results (RR=2.14, 95% CI 1.08 to 4.24). Women accepted testing more often than men in rapid VCT arm, but no differences in effect for age or socioeconomic status. Observational studies also showed rapid VCT led to higher rates of uptake of testing. Heterogeneity was high. A cluster-randomised trial reported an 11% reduction in HIV incidence in intervention communities (RR=0.89, 95% CI=0.63 to 1.24) over 3 years trial.
Rapid VCT in health facilities and communities was associated with a large increase in HIV-testing uptake and receipt of results. This has implications for WHO guidelines. The routine use of rapid VCT may also help avoid human rights violations among marginalised populations where testing may occur without informed consent and where existing stigma may create barriers to testing.
This priority setting partnership was commissioned by Parkinson's UK to encourage people with direct and personal experience of the condition to work together to identify and prioritise the top 10 evidential uncertainties that impact on everyday clinical practice for the management of Parkinson's disease (PD).
The UK.
Anyone with experience of PD including: people with Parkinson's (PwP), carers, family and friends, healthcare and social care professionals. Non-clinical researchers and employees of pharmaceutical or medical devices companies were excluded. 1000 participants (60% PwP) provided ideas on research uncertainties, 475 (72% PwP) initially prioritised them and 27 (37% PwP) stakeholders agreed a final top 10.
Using a modified nominal group technique, participants were surveyed to identify what issues for the management of PD needed research. Unique research questions unanswered by current evidence were identified and participants were asked to identify their top 10 research priorities from this list. The top 26 uncertainties were presented to a consensus meeting with key stakeholders to agree the top 10 research priorities.
1000 participants provided 4100 responses, which contained 94 unique unanswered research questions that were initially prioritised by 475 participants. A consensus meeting with 27 stakeholders agreed the top 10 research priorities. The overarching research aspiration was an effective cure for PD. The top 10 research priorities for PD management included the need to address motor symptoms (balance and falls, and fine motor control), non-motor symptoms (sleep and urinary dysfunction), mental health issues (stress and anxiety, dementia and mild cognitive impairments), side effects of medications (dyskinesia) and the need to develop interventions specific to the phenotypes of PD and better monitoring methods.
These research priorities identify crucial gaps in the existing evidence to address everyday practicalities in the management of the complexities of PD.
To determine whether socioeconomic inequalities are correlated to dental caries experience and decayed teeth of Indian adolescents, and assess whether behavioural and psychosocial factors mediate this association.
Cross-sectional study of 1386 adolescents living in three diverse areas of New Delhi. Caries experience and number of decayed teeth were assessed clinically and a questionnaire was used to gather sociodemographic and psychosocial data. Zero Inflated Negative Binomial regression models were used to assess the relationship between the outcomes (caries experience and decayed teeth) and area of residence, adjusting for covariates.
Significant inequalities in caries experience and number of decayed teeth were observed. Odds of an adolescent being caries free decreased by 66% (OR 0.34, 95% CI 0.23 to 0.49) and 70% (OR 0.30, 95% CI 0.21 to 0.43) in adolescents living in resettlement communities or urban slums, respectively, when compared with the middle class group. No difference was observed among those with caries experience/decayed teeth. Adjusting for covariates did not affect the inequalities.
Area of residence appears to be a very strong and significant determinant for an adolescent to be caries/decay free in India. Psychosocial and behavioural factors do not mediate the association between area of residence and oral health.
Data have indicated low to non-existent increased mortality risk for individuals with prediabetes, but it is unclear if the risk is increased when the patient has elevated iron markers. Our purpose was to examine the mortality risk among adults with prediabetes in the context of coexisting elevated transferrin saturation (TS) or serum ferritin.
Data collected by the third National Health and Nutrition Examination Survey 1988–1994 (NHANES III) in the USA and by the National Center for Health Statistics for the National Death Index from 1988 to 2006.
Individuals age 40 and older who participated in the NHANES and provided a blood sample.
Mortality was measured as all-cause mortality.
Adjusted analyses show that prediabetes has a small increased mortality risk (HR=1.04; 95% CI 1.00 to 1.08). Persons who had prediabetes and elevated serum ferritin had an increased HR for death (HR=1.14; 95% CI 1.04 to 1.24) compared with those who had normal ferritin and normal glucose. Among persons with prediabetes who had elevated TS, they had an increased mortality risk (HR=1.88; 95% CI 1.06 to 3.30) compared with those with normal TS levels and normal glucose.
The mortality risk of prediabetes is low. However, among individuals who have coexisting elevated iron markers, particularly TS, the risk rises substantially.
Parents' difficulties in perceiving children's weight status accurately pose a barrier for family-based obesity interventions; however, the factors underlying weight misinterpretation still need to be identified. This study's objective was to examine parents and grandparents' perceptions of preschoolers' body sizes. Interview questions also explored perceptions of parental responsibility for childhood obesity and appropriate contexts in which to discuss preschoolers' weights.
Semistructured interviews, which were videotaped, transcribed and analysed qualitatively.
Eugene and the Springfield metropolitan area, Oregon, USA
Families of children aged 3–5 years were recruited in February—May 2011 through advertisements about the study, published in the job seekers' sections of a classified website (Craigslist) and in a local newspaper. 49 participants (22 parents and 27 grandparents, 70% women, 60% with overweight/obesity) from 16 low-income families of children aged 3–5 years (50% girls, 56% with overweight/obesity) were interviewed.
There are important gaps between clinical definitions and lay perceptions of childhood obesity. While parents and grandparents were aware of their preschoolers' growth chart percentiles, these measures did not translate into recognition of children's overweight or obesity. The participants spoke of obesity as a problem that may affect the children in the future, but not at present. Participants identified childhood obesity as being transmitted from one generation to the next, and stigmatised it as resulting from 'lazy' parenting. Parents and grandparents avoided discussing the children's weights with each other and with the children themselves.
The results suggest that clinicians should clearly communicate with parents and grandparents about the meaning and appearance of obesity in early childhood, as well as counteract the social stigma attached to obesity, in order to improve the effectiveness of family-based interventions to manage obesity in early childhood.
Headaches are a common medical problem, yet few studies, particularly trials, have evaluated therapies that might prevent or control headaches. We, thus, investigated the effects on the occurrence of headaches of three levels of dietary sodium intake and two diet patterns (the Dietary Approaches to Stop Hypertension (DASH) diet (rich in fruits, vegetables and low-fat dairy products with reduced saturated and total fat) and a control diet (typical of Western consumption patterns)).
Randomised multicentre clinical trial.
Post hoc analyses of the DASH-Sodium trial in the USA.
In a multicentre feeding study with three 30 day periods, 390 participants were randomised to the DASH or control diet. On their assigned diet, participants ate food with high sodium during one period, intermediate sodium during another period and low sodium during another period, in random order.
Occurrence and severity of headache were ascertained from self-administered questionnaires, completed at the end of each feeding period.
The occurrence of headaches was similar in DASH versus control, at high (OR (95% CI)=0.65 (0.37 to 1.12); p=0.12), intermediate (0.57 (0.29 to 1.12); p=0.10) and low (0.64 (0.36 to 1.13); p=0.12) sodium levels. By contrast, there was a lower risk of headache on the low, compared with high, sodium level, both on the control (0.69 (0.49 to 0.99); p=0.05) and DASH (0.69 (0.49 to 0.98); p=0.04) diets.
A reduced sodium intake was associated with a significantly lower risk of headache, while dietary patterns had no effect on the risk of headaches in adults. Reduced dietary sodium intake offers a novel approach to prevent headaches.
To objectively measure the amount of intensity-specific physical activity by gender and age with respect to body mass index (BMI) during workdays and days off among Finnish employees.
A cross-sectional study.
Primary care occupational healthcare units.
A sample of 9554 Finnish employees (4221 men and 5333 women; age range 18–65 years; BMI range 18.5–40 kg/m2) who participated in health assessments related to occupational health promotion.
The amount of moderate-to-vigorous (MVPA) and vigorous (VPA) physical activity (≥3 and ≥6 metabolic equivalents, respectively) was assessed by estimating the minute-to-minute oxygen consumption from the recorded beat-to-beat R-R interval data. The estimation method used heart rate, respiration rate and on/off response information from R-R interval data calibrated by age, gender, height, weight and self-reported physical activity class. The proportion of participants fulfilling the aerobic physical activity recommendation of ≥150 min/week was calculated on the basis of ≥10 min bouts, by multiplying the VPA minutes by 2.
Both MVPA and VPA were higher among men and during days off, and decreased with increasing age and BMI (p<0.001 for all). Similar results were observed when the probability of having a bout of MVPA or VPA lasting continuously for ≥10 min per measurement day was studied. The total amount of VPA was low among overweight (mean ≤2.6 min/day), obese (mean ≤0.6 min/day) and all women in the age group 51–65 years (mean ≤2.5 min/day) during both types of days. The proportion of participants fulfilling the aerobic physical activity recommendation was highest for normal weight men (65%; 95% CI 62% to 67%) and lowest for obese women (10%; 95% CI 8% to 12%).
Objectively measured physical activity is higher among men and during days off, and decreases with increasing age and BMI. The amount of VPA is very low among obese, overweight and older women.
To describe radiologist's attitudes and perspectives on evidence-based medicine (EBM) and their practice.
Face-to-face semistructured interviews, thematic analysis.
24 institutions across six Australian states and New Zealand. Transcripts were imported into HyperRESEARCH software and thematically analysed.
25 radiologists.
Six themes were identified: legitimising decisions (validated justification, prioritising patient preferences, reinforcing protocols), optimising outcomes (ensuring patient safety, maximising efficiency), availability of access (requiring immediacy, inadequacy of evidence, time constraints, proximity of peer networks, grasping information dispersion), over-riding pragmatism (perceptibly applicability, preserving the art of medicine, technical demands), limited confidence (conceptual obscurity, reputation-based trust, demands constant practice, suspicion and cynicism), and competing powers (hierarchical conflict, prevailing commercial interests).
Radiologists believe EBM can support clinical decision-making for optimal patient outcomes and service efficiency but feel limited in their capacities to assimilate and apply EBM in practice. Improving access to evidence, providing ongoing education and training supplemented with practical tools for appraising evidence; and developing evidence-based guidelines and protocols may enhance feasibility and promote the confidence and skills among radiologists in applying EBM in radiology practice for better patient care.
The aim of this study is to describe trends in the consumption of manufactured and roll-your-own cigarettes between 1991 and 2012 in Spain, and to project these trends up to 2020.
We estimated daily consumption per capita during 1991–2012 using data on sales of manufactured cigarettes (20-packs) and rolling tobacco (kg) from the Tobacco Market Commission, and using data of the Spanish adult population from the National Statistics Institute. We considered different weights (0.5, 0.8 and 1 g) to compute the number of rolled cigarettes per capita. We computed the annual per cent of change and assessed possible changes in trends using joinpoint regression, and projected the consumption up to 2020 using Bayesian methods.
Daily consumption per capita of manufactured cigarettes decreased on average by 3.0% per year in 1991–2012, from 7.6 to 3.8 units, with three trend changes. However, daily consumption per capita of roll-your-own cigarettes increased on average by 14.1% per year, from 0.07 to 0.92 units of 0.5 g, with unchanged trends. Together, daily consumption per capita decreased between 2.9% and 2.5%, depending on the weight of the roll-your-own cigarettes. Projections up to 2020 indicate a decrease of manufactured cigarettes (1.75 units per capita) but an increase of roll-your-own cigarettes (1.25 units per capita).
While the consumption per capita of manufactured cigarettes has decreased in the past years in Spain, the consumption of roll-your-own cigarettes has increased at an annual rate around 14% over the past years. Whereas a net decrease in cigarette consumption is expected in the future, use of roll-your-own cigarettes will continue to increase.
Sideroblastic cardiomyopathy secondary to repeated blood transfusions is a feared complication in thalassaemia. Control of myocardial iron is thus becoming the cornerstone of thalassaemia management. Recent evidence suggests a role for L-type Ca2+ channels in mediating iron uptake by the heart. Blocking the cellular iron uptake through these channels may add to the benefit of therapy to standard chelation in reducing myocardial iron. We aim to determine the efficacy of amlodipine (a calcium channel blocker) as an adjunct to standard aggressive chelation in retarding myocardial iron deposition in thalassaemics with or without cardiomyopathy.
The primary outcome is to compare the efficacy of amlodipine+chelation (intervention) versus standard chelation (control) in retarding myocardial iron deposition. Secondary outcomes include the effect of amlodipine therapy on systolic and diastolic function, strain and strain rate and liver iron content.
This is a single-centre, parallel-group, prospective randomised control trial. Twenty patients will be randomised in a 1:1 allocation ratio into the intervention and control arms. In addition to conventional echocardiography, MRI T2* values for assessment of cardiac and liver iron load will be obtained at baseline and at 6 and 12 months. Cardiac T2* will be reported as the geometric mean and per cent coefficient of variation, and an increase in cardiac T2* values from baseline will be used as an end point to compare the efficacy of therapy. A p Value of <0.05 will be considered significant.
Department of Pediatric and Child Health, Aga Khan University Hospital, Karachi, Pakistan.
This study has been approved by the Ethics Review Committee and Clinical Trials Unit at The Aga Khan University with respect to scientific content and compliance with applicable research and human subjects regulations. Findings will be reported through scientific publications and research conferences and project summary papers for participants.
ClinicalTrials.Gov. Registration no: NCT02065492.
This study draws on baseline data from the At Home/Chez Soi demonstration project to examine the association between parenting status and mental health among homeless women and whether the association varies by duration of homelessness.
Structured interviews were conducted with participants in five cities across Canada including Moncton, Montreal, Toronto, Vancouver and Winnipeg.
Eligibility criteria included those with legal adult status, with a mental illness, and who lacked a regular, fixed shelter. All 713 women who participated in the larger project were selected for inclusion in this analysis.
The mental health conditions of interest include depression, post-traumatic stress disorder (PTSD), alcohol dependence and substance dependence.
The relationship between parenting status and depression, as well as PTSD, varied by duration of homelessness. Among women who had been homeless for less than 2 years, no relationship was found between parenting status and depression, or PTSD. However, among women who had been homeless for 2 or more years, the odds of depression was twice as high among parenting women compared with others (aOR=2.05, p≤0.05). A similar relationship was found between parenting status and PTSD (aOR=2.03, p≤0.05). The odds of substance dependence was found to be 2.62 times greater among parenting women compared with others and this relationship did not vary by duration of homelessness (aOR=2.62; 95% CI 1.86 to 3.69). No relationship was found between parenting and alcohol dependence.
Overall, the findings from this study suggest that there is a relationship between long-term homelessness and mothers' risk of poor mental health. Given the multiple demands mothers face, a failure to recognise their unique needs is likely to contribute to intergenerational legacies of homelessness and mental health problems.
World Health Organization's International Clinical Trials Registry Platform (ISRCTN66721740 and ISRCTN57595077).
To identify and compare sociocultural features of pandemic influenza with reference to illness-related experience, meaning and behaviour in urban and rural areas of India.
Cross-sectional, mixed-methods, cultural epidemiological survey with vignette-based interviews. Semistructured explanatory model interviews were used to study community ideas of the 2009 influenza pandemic. In-depth interviews elaborated respondents' experience during the pandemic.
Urban and rural communities, Pune district, western India.
Survey of urban (n=215) and rural (n=221) residents aged between 18 and 65 years. In-depth interviews of respondents with a history of 2009 pandemic influenza (n=6).
More urban (36.7%) than rural respondents (16.3%, p<0.001) identified the illness in the vignette as 'swine flu'. Over half (56.7%) believed the illness would be fatal without treatment, but with treatment 96% predicted full recovery. Worry ('tension') about the illness was reported as more troubling than somatic symptoms. The most common perceived causes—'exposure to a dirty environment' and 'cough or sneeze of an infected person'–were more prominent in the urban group. Among rural respondents, climatic conditions, drinking contaminated water, tension and cultural ideas on humoral imbalance from heat-producing or cold-producing foods were more prominent. The most widely reported home treatment was herbal remedies; more rural respondents suggested reliance on prayer, and symptom relief was more of a priority for urban respondents. Government health services were preferred in the urban communities, and rural residents relied more than urban residents on private facilities. The important preventive measures emphasised were cleanliness, wholesome lifestyle and vaccines, and more urban respondents reported the use of masks. In-depth interviews indicated treatment delays during the 2009 pandemic, especially among rural patients.
Although the term was well known, better recognition of pandemic influenza cases is needed, especially in rural areas. Improved awareness, access to treatment and timely referrals by private practitioners are also required to reduce treatment delays.
To explore the characteristics, motivations, ideologies, experience and perspectives of experienced medical humanitarian workers.
We applied a qualitative descriptive approach and conducted in-depth semistructured interviews, containing open-ended questions with directing probes, with 44 experienced international medical aid workers from a wide range of humanitarian organisations. Interviews were coded and analysed, and themes were developed.
International non-governmental organisations (INGOs) and United Nations (UN).
61% of participants were female; mean age was 41.8 years with an average of 11.8 years of humanitarian work experience with diverse major INGOs. Significant core themes included: population's rights to assistance, altruism and solidarity as motives; self-identification with the mission and directives of INGOs; shared personal and professional morals fostering collegiality; accountability towards beneficiaries in areas of programme planning and funding; burnout and emotional burdens; uncertainties in job safety and security; and uneasiness over changing humanitarian principles with increasing professionalisation of aid and shrinking humanitarian access. While dissatisfied with overall aid operations, participants were generally satisfied with their work and believed that they were well-received by, and had strong relationships with, intended beneficiaries.
Despite regular use of language and ideology of rights, solidarity and concepts of accountability, tension exists between the philosophy and practical incorporation of accountability into operations. To maintain a humanitarian corps and improve aid worker retention, strategies are needed regarding management of psychosocial stresses, proactively addressing militarisation and neo-humanitarianism, and nurturing individuals' and organisations' growth with emphasis on humanitarian principles and ethical practices, and a culture of internal debate, reflection and reform.
The objective of this study was to assess the prevalence of risk factors for coronary artery disease (CAD) in government employees across India.
The study population consisted of government employees in different parts of India ({n=10 642 men and n=1966 women; age 20–60 years}) and comprised various ethnic groups living in different environmental conditions. Recruitment was carried out in 20 cities across 14 states, and in one union territory. All selected individuals were subjected to a detailed questionnaire, medical examinations and anthropometric measurements. Blood samples were collected for blood glucose and serum lipid profile estimation, and resting ECG was recorded. Results were analysed using appropriate statistical tools.
The study revealed that 4.6% of the study population had a family history of premature CAD. The overall prevalence of diabetes was 16% (5.6% diagnosed during the study and the remaining 10.4% already on medication). Hypertension was present in 21% of subjects. The prevalence of dyslipidemia was significantly high, with 45.6% of study subjects having a high total cholesterol/high density lipoprotein ratio. Overall, 78.6% subjects had two or more risk factors for CAD.
The present study demonstrates a high prevalence of CAD risk factors in the Indian urban population. Therefore, there is an immediate need to initiate measures to raise awareness of these risk factors so that individuals at high risk for future CAD can be managed.
To investigate whether reported fast-food consumption over the previous year is associated with higher childhood or adolescent body mass index (BMI).
Secondary analysis from a multicentre, multicountry cross-sectional study (International Study of Asthma and Allergies in Children (ISAAC) Phase Three).
Parents/guardians of children aged 6–7 completed questionnaires which included questions about their children's asthma and allergies, fast-food consumption, height and weight. Adolescents aged 13–14 completed the same questionnaire. The questionnaire asked "In the past 12 months, how often on average did you (your child) eat fast-food/burgers?" The responses were infrequent (never/only occasionally), frequent (once/twice a week) or very frequent (three or more times per week). A general linear mixed model was used to determine the association between BMI and fast-food consumption, adjusting for Gross National Income per capita by country, measurement type (whether heights/weights were reported or measured), age and sex.
72 900 children (17 countries) and 199 135 adolescents (36 countries) provided data. Frequent and very frequent fast-food consumption was reported in 23% and 4% of children, and 39% and 13% of adolescents, respectively. Children in the frequent and very frequent groups had a BMI that was 0.15 and 0.22 kg/m2 higher than those in the infrequent group (p<0.001). Male adolescents in the frequent and very frequent groups had a BMI that was 0.14 and 0.28 kg/m2 lower than those in the infrequent group (p<0.001). Female adolescents in the frequent and very frequent groups had a BMI that was 0.19 kg/m2 lower than those in the infrequent group (p<0.001).
Reported fast-food consumption is high in childhood and increases in adolescence. Compared with infrequent fast-food consumption, frequent and very frequent consumption is associated with a higher BMI in children. Owing to residual confounding, reverse causation and likely misreporting, the reverse association observed in adolescents should be interpreted with caution.
To synthesise qualitative studies that explore prescribers' perceived barriers and enablers to minimising potentially inappropriate medications (PIMs) chronically prescribed in adults.
A qualitative systematic review was undertaken by searching PubMed, EMBASE, Scopus, PsycINFO, CINAHL and INFORMIT from inception to March 2014, combined with an extensive manual search of reference lists and related citations. A quality checklist was used to assess the transparency of the reporting of included studies and the potential for bias. Thematic synthesis identified common subthemes and descriptive themes across studies from which an analytical construct was developed. Study characteristics were examined to explain differences in findings.
All healthcare settings.
Medical and non-medical prescribers of medicines to adults.
Prescribers' perspectives on factors which shape their behaviour towards continuing or discontinuing PIMs in adults.
21 studies were included; most explored primary care physicians' perspectives on managing older, community-based adults. Barriers and enablers to minimising PIMs emerged within four analytical themes: problem awareness; inertia secondary to lower perceived value proposition for ceasing versus continuing PIMs; self-efficacy in regard to personal ability to alter prescribing; and feasibility of altering prescribing in routine care environments given external constraints. The first three themes are intrinsic to the prescriber (eg, beliefs, attitudes, knowledge, skills, behaviour) and the fourth is extrinsic (eg, patient, work setting, health system and cultural factors). The PIMs examined and practice setting influenced the themes reported.
A multitude of highly interdependent factors shape prescribers' behaviour towards continuing or discontinuing PIMs. A full understanding of prescriber barriers and enablers to changing prescribing behaviour is critical to the development of targeted interventions aimed at deprescribing PIMs and reducing the risk of iatrogenic harm.
To explore the purpose/s for which people with chronic conditions and their carers use Australian community pharmacies, and compare this to what pharmacy services they consider important, from the perspectives of both consumers and pharmacists.
An exploratory study involving a survey, which asked participants to indicate the pharmacy services they had ever used, and rate the importance of 22 pharmacy services to them, or the person they care for, or for their consumers if a pharmacist.
Four regions of Australia: Logan-Beaudesert and Mt Isa/North West region, Queensland, Northern Rivers, New South Wales, and the Greater Perth area, Western Australia.
Surveys were undertaken with 602 consumers and 91 community pharmacists.
Community pharmacy is predominantly used to obtain advice about medication and whether a doctor's visit is necessary, as well as for monitoring and screening services. Pharmacy services that were patient centric were important, such as individualised medication advice and respectful care, as well as tools or procedures to facilitate streamlined medication access. Less important services included adult vaccinations and health and wellness programmes. Carers identified services that assisted them with their specific role/s to be important. Overall, community pharmacists had a good understanding of the services that were important to people with chronic conditions and their carers.
People with chronic conditions and their carers not only care about what services are delivered, but how they are delivered; they sought services that generally improved their access to medication and information, but in a way that was patient centred. Ultimately, pharmacists understood the importance of patient-centred care for people with chronic conditions and their carers, perhaps indicating a greater acceptance of integrating patient-centred care into their everyday practice.
Considering equity into guidelines presents methodological challenges. This study aims to qualitatively synthesise the methods for incorporating equity in clinical practice guidelines (CPGs).
Content analysis of methodological publications.
Methodological publications were included if they provided checklists/frameworks on when, how and to what extent equity should be incorporated in CPGs.
We electronically searched MEDLINE, retrieved references, and browsed guideline development organisation websites from inception to January 2013. After study selection by two authors, general characteristics and checklists items/framework components from included studies were extracted. Based on the questions or items from checklists/frameworks (unit of analysis), content analysis was conducted to identify themes and questions/items were grouped into these themes.
The primary outcomes were methodological themes and processes on how to address equity issues in guideline development.
8 studies with 10 publications were included from 3405 citations. In total, a list of 87 questions/items was generated from 17 checklists/frameworks. After content analysis, questions were grouped into eight themes ('scoping questions', 'searching relevant evidence', 'appraising evidence and recommendations', 'formulating recommendations', 'monitoring implementation', 'providing a flow chart to include equity in CPGs', and 'others: reporting of guidelines and comments from stakeholders' for CPG developers and 'assessing the quality of CPGs' for CPG users). Four included studies covered more than five of these themes. We also summarised the process of guideline development based on the themes mentioned above.
For disadvantaged population-specific CPGs, eight important methodological issues identified in this review should be considered when including equity in CPGs under the guidance of a scientific guideline development manual.
The aim was to study the cause-specific mortality of users of the emergency department (ED) who received a diagnosis of alcohol use disorder (AUD) in comparison with mortality of other users of the department.
A population-based prospective cohort study.
All patients aged 18 years and above who were subsequently discharged home from the ED during the years 2002–2008. A total of 107 237 patients were followed by record linkage to a nationwide cause-of-death registry: 1210 patients with AUD as the main discharge diagnosis and 106 027 patients in the comparison group. HR and 95% CIs were calculated.
ED at Landspitali—the National University Hospital of Iceland, Reykjavik, Iceland. The hospital offers tertiary care and is the number one trauma centre and community hospital for the greater Reykjavik area. According to the population registry, 78% of the inhabitants of the area attended the ED during the study period.
72 patients died in the AUD group and 4807 in the comparison group. The adjusted HR for all causes of death was 1.91 (95% CI 1.51 to 2.42). The HR for AUDs was 47.68 (95% CI 11.56 to 196.59) while for alcohol liver disease the HR was 19.06 (95% CI 6.07 to 59.87). The HR was also elevated for diseases of the circulatory system: HR 2.52 (95% CI 1.73 to 3.68); accidental poisoning: HR=13.64, (95% CI 3.98 to 46.73); suicide: HR=2.72 (95% CI 1.08 to 6.83); and event of undetermined intent: HR=10.89 (95% CI 4.53 to 26.16).
AUD as the discharge diagnosis at the ED, among patients who were not admitted to a hospital ward but discharged home, predicts increased mortality. As the results conclusively show the vulnerability of these patients, one can question whether their needs are adequately met at the ED.
To incorporate behavioural insights into the user-centred design of an inpatient prescription chart (Imperial Drug Chart Evaluation and Adoption Study, IDEAS chart) and to determine whether changes in the content and design of prescription charts could influence prescribing behaviour and reduce prescribing errors.
A mixed-methods approach was taken in the development phase of the project; in situ simulation was used to evaluate the effectiveness of the newly developed IDEAS prescription chart.
A London teaching hospital.
A multimodal approach comprising (1) an exploratory phase consisting of chart reviews, focus groups and user insight gathering (2) the iterative design of the IDEAS prescription chart and finally (3) testing of final chart with prescribers using in situ simulation.
Substantial variation was seen between existing inpatient prescription charts used across 15 different UK hospitals. Review of 40 completed prescription charts from one hospital demonstrated a number of frequent prescribing errors including illegibility, and difficulty in identifying prescribers. Insights from focus groups and direct observations were translated into the design of IDEAS chart. In situ simulation testing revealed significant improvements in prescribing on the IDEAS chart compared with the prescription chart currently in use in the study hospital. Medication orders on the IDEAS chart were significantly more likely to include correct dose entries (164/164 vs 166/174; p=0.0046) as well as prescriber's printed name (163/164 vs 0/174; p<0.0001) and contact number (137/164 vs 55/174; p<0.0001). Antiinfective indication (28/28 vs 17/29; p<0.0001) and duration (26/28 vs 15/29; p<0.0001) were more likely to be completed using the IDEAS chart.
In a simulated context, the IDEAS prescription chart significantly reduced a number of common prescribing errors including dosing errors and illegibility. Positive behavioural change was seen without prior education or support, suggesting that some common prescription writing errors are potentially rectifiable simply through changes in the content and design of prescription charts.
Patient and public involvement (PPI) in research is increasingly required, although evidence to inform its implementation is limited.
Inform the evidence base by describing how plans for PPI were implemented within clinical trials and identifying the challenges and lessons learnt by research teams.
We compared PPI plans extracted from clinical trial grant applications (funded by the National Institute for Health Research Health Technology Assessment Programme between 2006 and 2010) with researchers' and PPI contributors' interview accounts of PPI implementation. Analysis of PPI plans and transcribed qualitative interviews drew on the Framework technique.
Of 28 trials, 25 documented plans for PPI in funding applications and half described implementing PPI before applying for funding. Plans varied from minimal to extensive, although almost all anticipated multiple modes of PPI. Interview accounts indicated that PPI plans had been fully implemented in 20/25 trials and even expanded in some. Nevertheless, some researchers described PPI within their trials as tokenistic. Researchers and contributors noted that late or minimal PPI engagement diminished its value. Both groups perceived uncertainty about roles in relation to PPI, and noted contributors' lack of confidence and difficulties attending meetings. PPI contributors experienced problems in interacting with researchers and understanding technical language. Researchers reported difficulties finding 'the right' PPI contributors, and advised caution when involving investigators' current patients.
Engaging PPI contributors early and ensuring ongoing clarity about their activities, roles and goals, is crucial to PPI's success. Funders, reviewers and regulators should recognise the value of preapplication PPI and allocate further resources to it. They should also consider whether PPI plans in grant applications match a trial's distinct needs. Monitoring and reporting PPI before, during and after trials will help the research community to optimise PPI, although the need for ongoing flexibility in implementing PPI should also be recognised.
Infant colic, or excessive crying of unknown cause in infants less than 3 months old, is common and burdensome. Its aetiology is undetermined, and consensus on its management is still lacking. Recent studies suggest a possible link between infant colic and gut microbiota, indicating probiotics to be a promising treatment. However, only a few strains have been tested, and results from randomised controlled trials are conflicting. It is important to clarify whether probiotics are effective for treating infant colic in general, and to identify whether certain subgroups of infants with colic would benefit from particular strains of probiotics.
Through an individual participant data meta-analysis (IPDMA), we aim to identify whether the probiotic Lactobacillus reuteri DSM 17938 is effective in the management of infant colic, and to clarify whether its effects differ according to feeding method (breast vs formula vs combined), proton pump inhibitor exposure, and antibiotic exposure. The primary outcomes are infant crying duration and treatment success (at least 50% reduction in crying time from baseline) at 21 days postintervention. Individual participant data from all studies will be modelled simultaneously in multilevel generalised linear mixed-effects regression models to account for the nesting of participants within studies. Subgroup analyses of participant-level and intervention-level characteristics will be undertaken on the primary outcomes to assess if the intervention effect differs between certain groups of infants.
Approved by the Royal Children's Hospital Human Research Ethics Committee (HREC 34081). Results will be reported in a peer-reviewed journal in 2015.
Heart failure (HF) continues to be a leading cause of hospital admissions, particularly in underserved patients. We hypothesised that providing individualised self-management support to patients and feedback on use of evidence-based HF therapies (EBT) to physicians could lead to improvements in care and decrease hospitalisations. To assess the feasibility of conducting a larger trial testing the efficacy of this dual-level intervention, we conducted the Congestive Heart failure Adherence Redesign Trial Pilot (CHART-P), a proof-of-concept, quasi-experimental, feasibility pilot study.
A large tertiary care medical centre in Chicago.
Low-income patients (<US$30 000/year) hospitalised for exacerbation of systolic HF (ejection fraction ≤50%) and their physicians. Twenty physicians and 33 patients were enrolled, of whom 23 patients completed the study.
Physicians received HF guidelines and periodic individualised feedback on their adherence to EBT. Patients received HF education, support and self-management training for diet and medication adherence by a trained nurse through 11 interactive sessions over a 4-month period. Evaluations were conducted pre-enrolment and 1 month postintervention completion.
Feasibility was assessed by the ability to deliver intervention to patients and physicians. Exploratory outcomes included changes in medication and sodium intake for patients and adherence to EBT for physicians.
Eighty-seven per cent and 82% of patients received >80% of interventions at 1 month and by study completion, respectively. Median sodium intake declined (3.5 vs 2.0 g; p<0.01). There was no statistically significant change in medication adherence based on electronic pill cap monitoring or the Morisky Medication Adherence Scale (MMAS); however, there was a trend towards improved adherence based on MMAS. All physicians received timely intervention.
This pilot study demonstrated that the protocol was feasible. It provided important insights about the need for intervention and the difficulties in treating patients with a variety of psychosocial problems that undercut their effective care.
Adverse events (AEs), defined as unintended patient harm related to healthcare provided rather than an underlying medical condition, represent a significant threat to patient safety and public health. The emergency department (ED) is a high-risk patient safety setting for many reasons including presentation 'outside of regular hours', high patient volumes, and a chaotic work environment. Children have also been identified as particularly vulnerable to AEs. Despite the identification of the ED as a high-risk setting and the vulnerability of the paediatric population, little research has been conducted regarding paediatric patient safety in the ED. The study objective is to generate an estimate of the risk and type of AEs, as well as their preventability and severity, for children seen in Canadian paediatric EDs.
This multicentre, prospective cohort study will enrol patients under 18 years of age from nine paediatric EDs across Canada. A stratified cluster random sampling scheme will be used to ensure patients recruited are representative of the overall ED population. A rigorous, standardised two-stage process will be used for AE identification. The primary outcome will be the proportion of children with AEs associated with ED care in the 3 weeks following the ED visit. Secondary outcomes will include the proportion of children with preventable AEs and the types and severity of AEs. We will aim to recruit 5632 patients over 1 year and this will allow us to detect a proportion of patients with an AE of 5% (to within an absolute margin of error of 0.6%).
Ethics approval has been obtained from participating sites. Results will be disseminated through presentations, peer review publications, linkages with emergency research network and a webinars for key knowledge user groups.
This study is registered at Clinicaltrials.gov (NCT02162147; https://clinicaltrials.gov/ct2/show/NCT02162147).
Many patients with stroke receive integrative medicine in China, which includes the basic treatment of Western medicine and routine rehabilitation, in conjunction with acupuncture and Chinese medicine. The question of whether integrative medicine is efficacious for stroke rehabilitation is still controversial and very little research currently exists on the integrated approach for this condition. Consequently, we will conduct a multicentre, randomised, controlled, assessor-blinded clinical trial to assess the effectiveness of integrative medicine on stroke rehabilitation.
360 participants recruited from three large Chinese medical hospitals in Zhejiang Province will be randomly divided into the integrative medicine rehabilitation (IMR) group and the conventional rehabilitation (CR) group in a 1:1 ratio. Participants in the IMR group will receive acupuncture and Chinese herbs in addition to basic Western medicine and rehabilitation treatment. The CR group will not receive acupuncture and Chinese herbal medicine. The assessment data will be collected at baseline, 4 and 8 weeks postrandomisation, and then at 12 weeks' follow-up. The primary outcome is measured by the Modified Barthel Index. The secondary outcomes are the National Institutes of Health Stroke Scale (NIHSS), Fugl-Meyer Assessment, the mini-mental state examination and Montreal Cognitive, Hamilton's Depression Scale and Self-Rating Depression Scale, and the incidence of adverse events.
Ethical approval was obtained from ethics committees of three hospitals. The results will be disseminated in a peer-reviewed journal and presented at international congresses. The results will also be disseminated to patients by telephone, during follow-up calls inquiring on patient's post-study health status.
Chinese Clinical Trial Register: ChiCTR-TRC-12001972, http://www.chictr.org/en/proj/show.aspx?proj=2561
This study aimed to establish the clinical characteristics of patients with glaucoma attending eye care facilities in Botswana, and management of glaucoma among patients who received care in these facilities. The study also aimed to calculate the number of new diagnoses of glaucoma within the glaucoma service.
A prospective, hospital-based, observational study.
A multicentre study was undertaken in government-run eye departments in Botswana from June to August 2012.
All patients with a diagnosis of glaucoma attending clinics at seven study sites were invited to participate.
Examination findings, diagnosis and management were extracted from individual patient-held medical charts. Sociodemographic characteristics, patient knowledge and understanding of glaucoma were assessed through face-to-face interviews. In addition, details of outpatient attendances for 2011 were collected from 21 government-run hospitals.
The majority of the 366 patients interviewed had a diagnosis of primary glaucoma (86.6%). The diagnoses were mainly made by ophthalmologists (48.6%) and ophthalmic nurses (44.0%). Many patients (38.5%) had been symptomatic for over 6 months before visiting an eye clinic. The mean presenting intraocular pressure was 28.2 mm Hg (SD 11.9 mm Hg). Most follow-up patients (79.2%) had not received surgery, however, many (89.5%) would accept surgery. Only 11.5% of participants had heard of glaucoma prior to diagnosis. Many participants (35.9%) did not understand glaucoma after being diagnosed. The majority (94.9%) of living first-degree relatives had never been examined. The number of newly diagnosed glaucoma cases for 2011 in the south of the country was 14.1/100 000; 95% CI (12.0 to 16.5), in the north it was 16.2/100 000; 95% CI (13.8 to 19.0).
Glaucoma is a significant burden that presents challenges to ophthalmic services in Botswana. Many patients have limited understanding of the condition and poor access to services. There is a need to develop a treatment infrastructure to include safe surgery and a reliable supply of effective medication.
To identify risk factors for ovarian pregnancy (OP) and compare clinical features between OP and tubal pregnancy (TP) patients.
Case–control study.
University hospital.
A case–control study was conducted from January 2005 to May 2014. Women diagnosed with OP were recruited as the case group (n=71), 145 women with TP and 146 with intrauterine pregnancy (IUP) were matched as controls at a ratio of 1:2:2. Women who refused interviews or provided incomplete information were excluded.
OP risk was lower than TP risk in women with serological evidence of Chlamydia trachomatis infection (adjusted OR1 0.17, 95% CI 0.06 to 0.52), previous adnexal surgery (adjusted OR1 0.25, 95% CI 0.07 to 0.95), and current levonorgestrel emergency contraceptive use (adjusted OR1 0.24, 95% CI 0.07 to 0.78). In vitro fertilisation-embryo transfer (IVF-ET) carried a higher risk of OP (adjusted OR1 12.18, 95% CI 2.23 to 66.58) than natural conception. When Controlled by IUP women, current users of intrauterine devices (IUDs) carried a higher risk of OP than non-users of any contraceptives (adjusted OR2 9.60, 95% CI 1.76 to 42.20). β-Human chorionic gonadotropin (hCG) levels on the day of surgery were higher in OP patients than in TP patients (p<0.01). Women with OP were less likely to initially present with vaginal bleeding than those with TP (p=0.02). Moreover, shock (p=0.02), rupture (p<0.01), haemoperitoneum (p<0.01) and emergency laparotomy (p<0.01) were more common in the OP group than in the TP group.
IVF-ET and IUD use may be risk factors for OP, and OP patients tend to have high β-hCG levels and a poor clinical outcome (shock, rupture, haemoperitoneum and need for emergency laparotomy). Our findings may contribute to the prevention and early diagnosis of OP.
To develop a new model for patient recruitment that harnessed the full potential of Electronic Health Records (EHRs). Gaining access to potential participants' health records to assess their eligibility for studies and allow an approach about participation ('consent for contact') is ethically, legally and technically challenging, given that medical data are usually restricted to the patient's clinical team. The research objective was to design a model for identification and recruitment to overcome some of these challenges as well as reduce the burdensome (and/or time consuming) gatekeeper role of clinicians in determining who is appropriate or not to participate in clinical research.
Large secondary mental health services context, UK.
2106 patients approached for 'consent for contact'. All patients in different services within the mental health trust are gradually and systematically being approached by a member of the clinical care team using the 'consent for contact' model. There are no exclusion criteria.
Provision of 'consent for contact'.
A new model (the South London and Maudsley NHS Trust Consent for Contact model (SLaM C4C)) for gaining patients' consent to contact them about research possibilities, which is built around a de-identified EHR database. The model allows researchers to contact potential participants directly. Of 2106 patients approached by 25 October 2013, nearly 3 of every 4 gave consent for contact (1560 patients; 74.1%).
The SLaM C4C model offers an effective way of expediting recruitment into health research through using EHRs. It reduces the gatekeeper function of clinicians; gives patients greater autonomy in decisions to participate in research; and accelerates the development of a culture of active research participation. More research is needed to assess how many of those giving consent for contact subsequently consent to participate in particular research studies.
To map using geospatial modelling techniques the morbidity and mortality caused by heart failure within Warwickshire to characterise and quantify any influence of air pollution on these risks.
Warwickshire, UK.
Data from all of the 105 current Warwickshire County wards were collected on hospital admissions and deaths due to heart failure.
In multivariate analyses, the presence of higher mono-nitrogen oxide (NOx) in a ward (3.35:1.89, 4.99), benzene (Ben) (31.9:8.36, 55.85) and index of multiple deprivation (IMD; 0.02: 0.01, 0.03), were consistently associated with a higher risk of heart failure morbidity. Particulate matter (Pm; –12.93: –20.41, –6.54) was negatively associated with the risk of heart failure morbidity. No association was found between sulfur dioxide (SO2) and heart failure morbidity. The risk of heart failure mortality was higher in wards with a higher NOx (4.30: 1.68, 7.37) and wards with more inhabitants 50+ years old (1.60: 0.47, 2.92). Pm was negatively associated (–14.69: –23.46, –6.50) with heart failure mortality. SO2, Ben and IMD scores were not associated with heart failure mortality. There was a prominent variation in heart failure morbidity and mortality risk across wards, the highest risk being in the regions around Nuneaton and Bedworth.
This study showed distinct spatial patterns in heart failure morbidity and mortality, suggesting the potential role of environmental factors beyond individual-level risk factors. Air pollution levels should therefore be taken into account when considering the wider determinants of public health and the impact that changes in air pollution might have on the health of a population.
The fundus examination is a non-invasive evaluation of the microcirculation of the retina. The aim of the present study is to develop and validate (reliability and validity) the ALTAIR software platform (Automatic image analyser to assess retinal vessel calibre) in order to analyse its utility in different clinical environments.
A cross-sectional study in the first phase and a prospective observational study in the second with 4 years of follow-up. The study will be performed in a primary care centre and will include 386 participants. The main measurements will include carotid intima-media thickness, pulse wave velocity by Sphygmocor, cardio-ankle vascular index through the VASERA VS-1500, cardiac evaluation by a digital ECG and renal injury by microalbuminuria and glomerular filtration. The retinal vascular evaluation will be performed using a TOPCON TRCNW200 non-mydriatic retinal camera to obtain digital images of the retina, and the developed software (ALTAIR) will be used to automatically calculate the calibre of the retinal vessels, the vascularised area and the branching pattern. For software validation, the intraobserver and interobserver reliability, the concurrent validity of the vascular structure and function, as well as the association between the estimated retinal parameters and the evolution or onset of new lesions in the target organs or cardiovascular diseases will be examined.
The study has been approved by the clinical research ethics committee of the healthcare area of Salamanca. All study participants will sign an informed consent to agree to participate in the study in compliance with the Declaration of Helsinki and the WHO standards for observational studies. Validation of this tool will provide greater reliability to the analysis of retinal vessels by decreasing the intervention of the observer and will result in increased validity through the use of additional information, especially in the areas of vascularisation and vessel branching patterns.
Clinical Trials.gov Identifier: NCT02087605.
Antipsychotics are commonly used for management of behavioural symptoms in dementia, among people in residential care. This continues to occur despite their modest effectiveness, potential harms including increased risk of death and stroke, and absence of detrimental effect when people with dementia were randomised to antipsychotic withdrawal. This study aims to test the hypothesis that the multifaceted REducing Anti-Psychotic use in residential care-Huntington Disease (REAP-HD) programme is more effective than standard staff education (SSE) in reducing antipsychotic use for people with HD in residential care facilities (RCF).
this is a cluster randomised controlled trial with blinded outcome assessment. The study population is healthcare professionals looking after people with HD in individual RCF, in the state of New South Wales. Each RCF will be centrally randomised to the REAP-HD programme or the comparator, SSE. Blinded outcome assessment will be performed by examining drug charts and using the Neuropsychiatric Inventory-Q (NPI-Q). Primary outcome is the proportion of people with HD who have had a reduction in antipsychotic use 4 months after the intervention. Secondary outcome measures are (1) change in severity of behavioural symptoms, as measured by the NPI-Q at 4 months (to ensure antipsychotic reduction has not lead to worsening behavioural symptoms), and (2) proportion of people with HD who have had a reduction in antipsychotic dosage at 4 months for each strategy, compared to 4 months prior to enrolment (to capture the possibility that both arms reduced antipsychotic use). Analysis will be by Intention-To-Treat and take into account the clustering. Recruitment is ongoing, as of July 2014.
This protocol has been approved by the Western Sydney Local Health District Human Research Ethics Committee, trial registration ACTRN12614000083695. Study results will be disseminated through peer-reviewed publication in an anonymous manner.
ACTRN12614000083695, the Australian New Zealand Clinical Trials Registry.
To explore healthcare policy and system improvements that would more proactively respond to future penetration of counterfeit cancer medications in the USA drug supply chain using geospatial analysis.
A statistical and geospatial analysis of areas that received notices from the Food and Drug Administration (FDA) about the possibility of counterfeit Avastin penetrating the US drug supply chain. Data from FDA warning notices were compared to data from 44 demographic variables available from the US Census Bureau via correlation, means testing and geospatial visualisation. Results were interpreted in light of existing literature in order to recommend improvements to surveillance of counterfeit medicines.
This study analysed 791 distinct healthcare provider addresses that received FDA warning notices across 30 431 zip codes in the USA.
Statistical outputs were Pearson's correlation coefficients and t values. Geospatial outputs were cartographic visualisations. These data were used to generate the overarching study outcome, which was a recommendation for a strategy for drug safety surveillance congruent with existing literature on counterfeit medication.
Zip codes with greater numbers of individuals age 65+ and greater numbers of ethnic white individuals were most correlated with receipt of a counterfeit Avastin notice. Geospatial visualisations designed in conjunction with statistical analysis of demographic variables appeared more capable of suggesting areas and populations that may be at risk for undetected counterfeit Avastin penetration.
This study suggests that dual incorporation of statistical and geospatial analysis in surveillance of counterfeit medicine may be helpful in guiding efforts to prevent, detect and visualise counterfeit medicines penetrations in the US drug supply chain and other settings. Importantly, the information generated by these analyses could be utilised to identify at-risk populations associated with demographic characteristics. Stakeholders should explore these results as another tool to improve on counterfeit medicine surveillance.
There is insufficient evidence on which to base a recommendation for optimal antiplatelet therapy following a stroke while on aspirin. The objective was to compare clopidogrel initiation vs aspirin reinitiation for vascular risk reduction among patients with ischaemic stroke on aspirin at the time of their index stroke.
We conducted a nationwide cohort study by retrieving all hospitalised patients (≥18 years) with a primary diagnosis of ischaemic stroke between 2003 and 2009 from Taiwan National Health Insurance Research Database.
Among 3862 patients receiving aspirin before the index ischaemic stroke and receiving either aspirin or clopidogrel after index stroke during follow-up period, 1623 were excluded due to a medication possession ratio <80%. Also, 355 were excluded due to history of atrial fibrillation, valvular heart disease or coagulopathy. Therefore, 1884 patients were included in our final analysis.
Patients were categorised into two groups based on whether clopidogrel or aspirin was prescribed during the follow-up period. Follow-up was from time of the index stroke to admission for recurrent stroke or myocardial infarction, death or the end of 2010.
The primary end point was hospitalisation due to a new-onset major adverse cardiovascular event (MACE: composite of any stroke or myocardial infarction). The leading secondary end point was any recurrent stroke.
Compared to aspirin, clopidogrel was associated with a lower occurrence of future MACE (HR=0.54, 95% CI 0.43 to 0.68, p<0.001, number needed to treat: 8) and recurrent stroke (HR=0.54, 95% CI 0.42 to 0.69, p<0.001, number needed to treat: 9) after adjustment of relevant covariates.
Among patients with an ischaemic stroke while taking aspirin, clopidogrel initiation was associated with fewer recurrent vascular events than aspirin reinitiation.
Equitable health financing remains a key health policy objective worldwide. In low and middle-income countries (LMICs), there is evidence that many people are unable to access the health services they need due to financial and other barriers. There are growing calls for fairer health financing systems that will protect people from catastrophic and impoverishing health payments in times of illness. This study aims to assess equity in healthcare financing in Fiji and Timor-Leste in order to support government efforts to improve access to healthcare and move towards universal health coverage in the two countries.
The study employs two standard measures of equity in health financing increasingly being applied in LMICs—benefit incidence analysis (BIA) and financing incidence analysis (FIA). In Fiji, we will use a combination of secondary and primary data including a Household Income and Expenditure Survey, National Health Accounts, and data from a cross-sectional household survey on healthcare utilisation. In Timor-Leste, the World Bank recently completed a health equity and financial protection analysis that incorporates BIA and FIA, and found that the distribution of benefits from healthcare financing is pro-rich. Building on this work, we will explore the factors that influence the pro-rich distribution.
The study is approved by the Human Research Ethics Committee of University of New South Wales, Australia (Approval number: HC13269); the Fiji National Health Research Committee (Approval # 201371); and the Timor-Leste Ministry of Health (Ref MS/UNSW/VI/218).
Study outcomes will be disseminated through stakeholder meetings, targeted multidisciplinary seminars, peer-reviewed journal publications, policy briefs and the use of other web-based technologies including social media. A user-friendly toolkit on how to analyse healthcare financing equity will be developed for use by policymakers and development partners in the region.
Case management allows us to respond to the complex needs of a vulnerable clientele through a structured approach that promotes enhanced interaction between partners. Syntheses on the subject converge towards a need for a better description of the relationships between programmes and their local context, as well as the characteristics of the clienteles and programmes that contribute to positive impacts. The purpose of this project is thus to describe and evaluate the case management programmes of four health and social services centres in the Saguenay-Lac- Saint-Jean region of Québec, Canada, in order to inform their improvement while creating knowledge on case management that can be useful in other contexts.
This research relies on a multiple embedded case study design based on a developmental evaluation approach. We will work with the case management programme for high users of hospital services of each centre. Three different units of analysis will be interwoven to obtain an in-depth understanding of each case, that is: (1) health and social services centre and local services network, (2) case management programme and (3) patients who are high users of services. Two strategies for programme evaluation (logic models and implementation analysis) will guide the mixed data collection based on qualitative and quantitative methods. This data collection will rely on: (1) individual interviews and focus groups; (2) participant observation; (3) document analysis; (4) clinical and administrative data and (5) questionnaires. Description and comparison of cases, and integration of qualitative and quantitative data will be used to guide the data analysis.
The study protocol was approved by the Ethics Research Boards of the four health and social services centres (HSSCs) involved. Findings will be disseminated by publications in peer-reviewed journals, conferences, and policy and practice partners in local and national government.
The National Institute for Health and Care Excellence (NICE) guidelines for attention deficit/hyperactivity disorder (ADHD) state that young people need to have access to the best evidence-based care to improve outcome. The current 'gold standard' ADHD diagnostic assessment combines clinical observation with subjective parent, teacher and self-reports. In routine practice, reports from multiple informants may be unavailable or contradictory, leading to diagnostic uncertainty and delay. The addition of objective tests of attention and activity may help reduce diagnostic uncertainty and delays in initiating treatment leading to improved outcomes. This trial investigates whether providing clinicians with an objective report of levels of attention, impulsivity and activity can lead to an earlier, and more accurate, clinical diagnosis and improved patient outcome.
This multisite randomised controlled trial will recruit young people (aged 6–17 years old) who have been referred for an ADHD diagnostic assessment at Child and Adolescent Mental Health Services (CAMHS) and Community Paediatric clinics across England. Routine clinical assessment will be augmented by the QbTest, incorporating a continuous performance test (CPT) and infrared motion tracking of activity. The participant will be randomised into one of two study arms: QbOpen (clinician has immediate access to a QbTest report): QbBlind (report is withheld until the study end). Primary outcomes are time to diagnosis and diagnostic accuracy. Secondary outcomes include clinician's diagnostic confidence and routine clinical outcome measures. Cost-effective analysis will be conducted, alongside a qualitative assessment of the feasibility and acceptability of incorporating QbTest in routine practice.
The findings from the study will inform commissioners, clinicians and managers about the feasibility, acceptability, clinical utility and cost-effectiveness of incorporating QbTest into routine diagnostic assessment of young people with ADHD. The results will be submitted for publication in peer-reviewed journals. The study has received ethical approval.
To evaluate the current provision and outcome of community-based education (CBE) in UK medical schools.
An online survey of UK medical school websites and course prospectuses and a systematic review of articles from PubMed and Web of Science were conducted. Articles in the systematic review were assessed using Rossi, Lipsey and Freeman's approach to programme evaluation.
Publications from November 1998 to 2013 containing information related to community teaching in undergraduate medical courses were included.
Out of the 32 undergraduate UK medical schools, one was excluded due to the lack of course specifications available online. Analysis of the remaining 31 medical schools showed that a variety of CBE models are utilised in medical schools across the UK. Twenty-eight medical schools (90.3%) provide CBE in some form by the end of the first year of undergraduate training, and 29 medical schools (93.5%) by the end of the second year. From the 1378 references identified, 29 papers met the inclusion criteria for assessment. It was found that CBE mostly provided advantages to students as well as other participants, including GP tutors and patients. However, there were a few concerns regarding the lack of GP tutors' knowledge in specialty areas, the negative impact that CBE may have on the delivery of health service in education settings and the cost of CBE.
Despite the wide variations in implementation, community teaching was found to be mostly beneficial. To ensure the relevance of CBE for 'Tomorrow's Doctors', a national framework should be established, and solutions sought to reduce the impact of the challenges within CBE.
This is the first study to review how community-based education is currently provided throughout Medical Schools in the UK. The use of Rossi, Lipsey and Freeman's method of programme evaluation means that the literature was analysed in a consistent and comprehensive way. However, a weakness is that data from the online survey was obtained from online medical school prospectuses. This means the data may be incomplete or out of date. Data in the literature review may also be skewed by publication bias.
To investigate the reliability and an aspect of validity of a modified version of the long International Physical Activity Questionnaire (Hausa IPAQ-LF) in Nigeria.
Cross-sectional study, examining the reliability and construct validity of the Hausa IPAQ-LF compared with anthropometric and biological variables.
Metropolitan Maiduguri, the capital city of Borno State in Nigeria.
180 Nigerian adults (50% women) with a mean age of 35.6 (SD=10.3) years, recruited from neighbourhoods with diverse socioeconomic status and walkability.
Domains (domestic physical activity (PA), occupational PA, leisure-time PA, active transportation and sitting time) and intensities of PA (vigorous, moderate and walking) were measured with the Hausa IPAQ-LF on two different occasions, 8 days apart. Outcomes for construct validity were measured body mass index (BMI), systolic blood pressure (SBP) and diastolic blood pressure (DBP).
The Hausa IPAQ-LF demonstrated good test–retest reliability (intraclass correlation coefficient, ICC>75) for total PA (ICC=0.79, 95% CI 0.65 to 0.82), occupational PA (ICC=0.77, 95% CI 0.68 to 0.82), active transportation (ICC=0.82, 95% CI 0.75 to 0.87) and vigorous intensity activities (ICC=0.82, 95% CI 0.76 to 0.87). Reliability was substantially higher for total PA (ICC=0.80), occupational PA (ICC=0.78), leisure-time PA (ICC=0.75) and active transportation (ICC=0.80) in men than in women, but domestic PA (ICC=0.38) and sitting time (ICC=0.71) demonstrated more substantial reliability coefficients in women than in men. For the construct validity, domestic PA was significantly related mainly with SBP (r=–0.27) and DBP (r=–0.17), and leisure-time PA and total PA were significantly related only with SBP (r=–0.16) and BMI (r=–0.29), respectively. Similarly, moderate-intensity PA was mainly related with SBP (r=–0.16, p<0.05) and DBP (r=–0.21, p<0.01), but vigorous-intensity PA was only related with BMI (r=–0.11, p<0.05).
The modified Hausa IPAQ-LF demonstrated sufficient evidence of test–retest reliability and may be valid for assessing context specific PA behaviours of adults in Nigeria.
There is a need to identify innovative, low-cost and broad-reaching strategies for promoting exercise and improving physical function in older adults with multiple sclerosis (MS).
This randomised controlled pilot trial will test the efficacy of a 6-month, DVD-delivered exercise intervention to improve functional performance and quality of life in older adults with MS. Participants will be randomised either into a DVD-delivered exercise condition or an attentional control condition. This novel approach to programme delivery provides participants with detailed exercise instructions which are presented in a progressive manner and includes a variety of modifications to better meet varying levels of physical abilities. The targeted exercises focus on three critical elements of functional fitness: flexibility, strength and balance. It is hypothesised that participants who are randomised to the exercise DVD condition will demonstrate improvements in physical function compared with participants assigned to the attentional control condition. Data analysis will include a 2 (condition)x2 (time) mixed factor analysis of variance (ANOVA) that follows intent-to-treat principles, as well as an examination of effect sizes. Participants will take part in qualitative interviews about perspectives on physical activity and programme participation.
The study protocol was approved by a university institutional review board and registered with a federal database. Participants will be asked to read and sign a detailed informed consent document and will be required to provide a physician's approval to participate in the study. The exercise DVDs include an overview of safety-related concerns and recommendations relative to exercise participation, as well as detailed instructions highlighting the proper execution of each exercise presented on screen. Following completion of this trial, data will be immediately analysed and results will be presented at scientific meetings and published in scholarly journals.
Clinical Trials NCT01993095.
Adherence to inhaled corticosteroids (ICS) is a major issue in asthma. This study aimed to estimate the accuracy of the days' supply and number of refills allowed, variables recorded in Québec claims databases and used to estimate adherence, and to develop correction factors, if required. We hypothesised that the accuracy of the days' supply for ICS would be low whereas the accuracy of the number of refills allowed would be high.
40 community pharmacies in Québec (Canada) and a medication registry.
We collected data for 1108 ICS original prescriptions stored in the 40 pharmacies (sample 1), and we obtained a second sample of 2676 ICS prescriptions selected from reMed, a medication registry (sample 2).
We estimated the concordance of the days' supply and number of refills between Québec claims databases and the original prescription from sample 1. We developed a correction factor for the days' supply in sample 1 and validated it in sample 2. Analyses were stratified by age: 0–11 and 12–64 years.
In sample 1, the concordance for the days' supply was 39.6% (95% CI 37.6% to 41.6%) in those aged 0–11 years and 56% (54.9% to 57.2%) in those aged 12–64 years. The concordance increased to 59.4% (58.2% to 60.5%) in those aged 0–11 years and 74.2% (73.5% to 74.9%) in those aged 12–64 years after applying the correction factors in sample 2. The concordance for the refills allowed was 92.1% (91% to 93.1%) in those aged 0–11 years and 93.1% (92.5% to 93.7%) in those aged 12–64 years in sample 1.
The accuracy of the days' supply was moderate among those aged 0–11 years and substantial among those aged 12–64 years after applying the correction factors. The accuracy of the number of refills was almost perfect in both groups.
To conduct a systematic review and meta-analysis examining the effectiveness of behavioural interventions targeting diet, physical activity or smoking in low-income adults.
Systematic review with random effects meta-analyses. Studies before 2006 were identified from a previously published systematic review (searching 1995–2006) with similar but broader inclusion criteria (including non-randomised controlled trials (RCTs)). Studies from 2006 to 2014 were identified from eight electronic databases using a similar search strategy.
MEDLINE, EMBASE, PsycINFO, ASSIA, CINAHL, Cochrane Controlled Trials, Cochrane Systematic Review and DARE.
RCTs and cluster RCTs published from 1995 to 2014; interventions targeting dietary, physical activity and smoking; low-income adults; reporting of behavioural outcomes.
Dietary, physical activity and smoking cessation behaviours.
35 studies containing 45 interventions with 17 000 participants met inclusion criteria. At postintervention, effects were positive but small for diet (standardised mean difference (SMD) 0.22, 95% CI 0.14 to 0.29), physical activity (SMD 0.21, 95% CI 0.06 to 0.36) and smoking (relative risk (RR) of 1.59, 95% CI 1.34 to 1.89). Studies reporting follow-up results suggested that effects were maintained over time for diet (SMD 0.16, 95% CI 0.08 to 0.25) but not physical activity (SMD 0.17, 95% CI –0.02 to 0.37) or smoking (RR 1.11, 95% CI 0.93 to 1.34).
Behaviour change interventions for low-income groups had small positive effects on healthy eating, physical activity and smoking. Further work is needed to improve the effectiveness of behaviour change interventions for deprived populations.
This study aimed to determine if the risk of adverse outcomes (in-hospital and 60-day mortality, intensive care unit (ICU) and total hospital length of stay (LOS)) was greater for medical ICU (MICU) or high dependency unit (HDU) patients indirectly admitted from the emergency department (ED) than for directly admitted patients.
This study was conducted at a large public acute care hospital in Singapore.
In this retrospective cohort study, hospital records of patients who were admitted directly from the ED, or initially admitted to the general wards from the ED and subsequently transferred to the MICU/HDU within 24 h, were reviewed. Patients were included if they were: (A) discharged from the MICU/HDU in 2009 and were admitted from the ED and (B) transferred to the MICU/HDU within 24 h of presentation at the ED. Data from 706 patients were analysed; 58.4% were men with a median age of 61 years.
The following outcomes were compared: in-hospital mortality, 60-day mortality, LOS at the MICU/HDU, as well as total hospital LOS.
Of the 706 patients, 491 (69.5%) were directly admitted to the MICU/HDU. After adjusting for demographics, comorbidities, interventions at the ED and clinical parameters at the ED (heart rate, respiration, oxygen saturation, mean arterial pressure), as well as the Apache II score on arrival at the MICU/HDU, indirectly admitted patients had a higher risk of in-hospital mortality (OR=3.07, 95% CI 1.39 to 6.80), death within 60 days (OR=3.09, 95% CI 1.40 to 6.83) and risk of staying >1 day at the MICU/HDU (OR=2.54, 95% CI 1.48 to 4.36). There was no significant difference in total in-hospital LOS.
Indirectly admitted MICU/HDU patients had generally poorer outcomes. As the magnitude of effect may vary across settings, context-specific studies may be useful for improving outcomes.
Heart failure (HF) is a leading reason for hospitalisation and readmissions to hospital, particularly among individuals older than 65 years of age. The prognosis of patients with HF is grim, with high rates of mortality risk and hospital readmissions. The transition period early after hospital discharge represents a window of opportunity to positively influence patient outcomes using quality improvement (QI) strategies. However, little is known about which QI interventions exist for early events of HF after discharge, so the main objective of our study is to conduct a scoping review of the literature to determine which QI strategies are effective for reducing hospital readmissions and mortality for patients with HF who transition from the hospital back into independent living. We will also investigate which elements contribute to effective QI strategies.
We will search the literature in MEDLINE, EMBASE, CINAHL and the Cochrane library for randomised controlled trials and systematic reviews evaluating QI interventions aimed at improving outcomes for patients with HF transitioning from the hospital back into the community. Two reviewers will independently apply our eligibility criteria at level 1 (abstract/title) and level 2 (full-text) screening; disagreements will be resolved through consensus. We will extract data in duplicate on study characteristics, population, setting, QI intervention and outcomes. We will synthesise results descriptively and explore QI elements to determine which aspect contributes to its impact. We will also consider synthesis of our data according to several conceptual frameworks such as Wagner's Chronic Care Model.
The findings of this scoping review will be used to determine which elements should comprise a QI intervention aimed at facilitating the transition of newly admitted patients with HF back into the community. We will disseminate our findings through publications, presentations as well as through a stakeholder meeting to generate key messages most relevant to each.
To evaluate clinicobiochemical factors predicting severe hepatic fibrosis in patients with chronic hepatitis C virus (HCV) infection.
Tertiary institution.
859 treatment-naïve Korean patients with HCV who underwent liver biopsy. Severe fibrosis was defined as fibrosis stage ≥3 based on the METAVIR system.
Clinicobiochemical factors predicting severe hepatic fibrosis.
The median serum alanine aminotransferase (ALT) level was 68 IU/L and body mass index (BMI) was 24.2 kg/m2. Severe fibrosis was observed in 326 (39.7%) of the 859 patients. The frequencies of severe fibrosis were 0%, 37.8%, 41.9% and 42% in patients with serum ALT concentrations (IU/L) of ≤20, 20–30, 30–40 and >40 (p<0.01), respectively, and 10.7%, 19.8%, 30.5%, 39.2% and 55.6% in patients <30, 30–40, 40–50, 50–60 and ≥60 years old, respectively (p<0.01). Categorised age in years (50–60 (OR 4.26, p=0.03) and ≥60 (OR 7.53, p<0.01) compared with <30), categorised ALT level in IU/L (20–30 (OR 16.76, p<0.01), 30–40 (OR 20.02, p<0.01) and >40 (OR 21.49, p<0.01) compared with ≤20) and BMI >27.5 kg/m2 (OR 1.65, p=0.03) were independently related to severe fibrosis in patients with chronic HCV. The severe fibrosis rate was 60.6% in patients aged ≥50 years with ALT >20 IU/L and BMI >27.5 kg/m2.
More advanced age (≥50 years), obesity and serum ALT>20 IU/L are associated with severe fibrosis in patients with chronic HCV. Anti-HCV therapy may be considered for these patients without histological confirmation, regardless of HCV genotype. A wait-and-see policy may be justified for patients with serum ALT ≤20 IU/L.
Although aware that smoking while pregnant presents serious risks to their unborn children, some women continue to smoke and rationalise their dissonance rather than quit. We explored metaphors women used to frame smoking and quitting, then developed cessation messages that drew on these metaphors and examined the perceived effectiveness of these.
We used a two-phase qualitative study. Phase one involved 13 in-depth interviews with women who were smoking (or who had smoked) while pregnant. Phase two comprised 22 in-depth interviews with a new sample drawn from the same population.
Data were analysed using thematic analysis, which promoted theme identification independently of the research protocol.
Participants often described smoking as a choice, a frame that explicitly asserted control over their behaviour. This stance allowed them to counter-argue messages to quit, and distanced them from the risks they created and faced. Messages tested in phase 2 used strong affective appeals as well as themes that stimulated cognitive reflection. Without exception, the messages depicting unwell or distressed children elicited strong emotional responses, were more powerful cessation stimuli, and elicited fewer counter-arguments.
Cessation messages that evoke strong affective responses capitalise on the dissonance many women feel when smoking while pregnant and stimulate stronger consideration of quitting. Given the importance of promoting cessation among pregnant women, future campaigns could make greater use of emotional appeals and place less emphasis on informational approaches, which often prompt vigorous counter-arguments.
Traditional Chinese medicine (TCM) has accumulated some experience in curing stable angina pectoris (SAP) and efficacy has been demonstrated. Chinese patent medicines, known as modern dosage forms of TCM, can attain the desired effect in clinical application only with the guidance of TCM syndrome theory. However, due to their use by a large number of persons with little knowledge of TCM theories and practices, their efficacy and reputation have been seriously affected.
Two common syndrome types of SAP in TCM, 'qi deficiency and blood stasis' and 'qi stagnation and blood stasis', will be studied in 144 subjects from four TCM hospitals in Tianjin in China using a partial crossover design. The two syndromes will be broken down into six symptom combinations; patients will select a combination of the most distressing to them, and then will be randomised into two groups. Each group, on the basis of routine medication, will be administered one kind of Chinese patent drug: Qishenyiqi Dripping Pills or Compound Danshen Dripping Pills. The treatment characteristics of the two medicines will be evaluated with the COME-PIO method developed by our research team.
This protocol has been approved by the medical ethics committee of Tianjin University of TCM (registration number TJUTCM-EC20130005). The study is safe and reliable.
Chinese clinical trials register ChiCTR-TTRCC-14004406.
Investigate factors associated with the onset of diabetes in women aged more than 49 years.
Cross-sectional, population-based study using self-reports with 622 women. The dependent variable was the age of occurrence of diabetes using the life table method. Cox multiple regression models were adjusted to analyse the onset of diabetes according to predictor variables. Sociodemographic, clinical and behavioural factors were evaluated.
Of the 622 women interviewed, 22.7% had diabetes. The mean age at onset was 56 years. The factors associated with the age of occurrence of diabetes were self-rated health (very good, good) (coefficient=–0.792; SE of the coefficient=0.215; p=0.0001), more than two individuals living in the household (coefficient=0.656, SE of the coefficient=0.223; p=0.003), and body mass index (BMI) (kg/m2) at 20–30 years of age (coefficient= 0.056, SE of the coefficient=0.023; p=0.014).
Self-rated health considered good or very good was associated with a higher rate of survival without diabetes. Sharing a home with two or more other people and a weight increase at 20–30 years of age was associated with the onset of type 2 diabetes.
To examine the effect of early clinical and demographic factors on occupational outcome, return to work or awarded permanent disability pension in young patients with chronic fatigue syndrome (CFS).
Longitudinal cohort study.
A written self-management programme including a description of active coping strategies for daily life was provided.
Patients with CFS after mononucleosis were evaluated at Department of Neurology, Haukeland University Hospital during 1996–2006 (contact 1). In 2009 self-report questionnaires were sent to all patients (contact 2).
Primary measure was employment status at contact 2. Secondary measures included clinical symptoms, and Fatigue Severity Scale (FSS) scores on both contacts, and Work and Social Adjustment Scale (WSAS) at contact 2.
Of 111 patients at contact 1, 92 (83%) patients returned the questionnaire at contact 2. Mean disease duration at contact 1 was 4.7 years and at contact 2 11.4 years. At contact 1, 9 (10%) were part-time or full-time employed. At contact 2, 49 (55%) were part-time or full-time employed. Logical regression analysis showed that FSS≥5 at contact 2 was associated with depression, arthralgia and long disease duration (all at contact 1).
About half of younger patients with CFS with long-term incapacity for work experienced marked improvement including full-time or part-time employment showing better outcomes than expected. Risk factors for transition to permanent disability were depression, arthralgia and disease duration.
Occupational and environmental exposures remain important modifiable risk factors of public health. Existing cohort studies are often limited by the level of detail of data collected on these factors and health. It is also often assumed that the more healthy group is over-represented in cohort studies, which is of concern for their external validity. In this cohort profile, we describe how we set up the population-based Occupational and Environmental Health Cohort Study (AMIGO) to longitudinally study occupational and environmental determinants of diseases and well-being from a multidisciplinary and life course point of view. Reviewed by the Medical Ethics Research Committee of the University Medical Center Utrecht (protocol 10-268/C). All cohort members participate voluntarily and gave informed consent prior to their inclusion.
14 829 adult cohort members (16% of those invited) consented and filled in the online baseline questionnaire. Determinants include chemical, biological, physical (eg, electromagnetic fields), and psychosocial factors. Priority health outcomes include cancer, neurological, cardiovascular and respiratory diseases and non-specific symptoms. Owing to the recruitment strategy via general practitioners of an established network, we also collect longitudinal data registered in their electronic medical records including symptoms, diagnosis and treatments. Besides the advantage of health outcomes that cannot be easily captured longitudinally by other means, this created a unique opportunity to assess health-related participation bias by comparing general practitioner-registered prevalence rates in the cohort and its source population.
We found no indications of such a systematic bias. The major assets of the AMIGO approach are its detailed occupational and environmental determinants in combination with the longitudinal health data registered in general practice besides linkage to cancer and mortality registries and self-reported health.
We are now in the phase of prospective follow-up, with the aim of continuing this for as long as possible (20+ years), pending future funding. Findings will be disseminated through scientific conferences and peer-reviewed journals, and through newsletters and the project website to participants, stakeholders and the wider public.
This research endeavours to identify the role of traditional birth attendants (TBAs) in supporting the maternal, newborn and child health (MNCH) care, partnership mechanism with a formal health system and also explored livelihood options for TBAs in the health system of Pakistan.
The study was conducted in district Chitral, Khyber Pakhtunkhwa province, covering the areas where the Chitral Child Survival programme was implemented.
A qualitative exploratory study was conducted, comprising seven key informant interviews with health managers, and four focus group discussions with community midwives (CMWs), TBAs, members of Community Based Saving Groups (CBSGs) and members of village health committees (VHCs).
The study identified that in the new scenario, after the introduction of CMWs in the health system, TBAs still have a pivotal role in health promotion activities such as breastfeeding promotion and vaccination. TBAs can assist CMWs in normal deliveries, and refer high-risk cases to the formal health system. Generally, TBAs are positive about CMWs' introduction and welcome this addition. Yet their livelihood has suffered after CMWs' deployment. Monetary incentives to them in recognition of referrals to CMWs could be one solution. The VHC is an active forum for strengthening co-ordination between the two service providers and to ensure an alternate and permanent livelihood support system for the TBAs.
TBAs have assured their continued support in provision of continuum of care for pregnant women, lactating mothers and children under the age of 5 years. The district health authorities must figure out ways to foster a healthy interface vis-à-vis roles and responsibilities of TBAs and CMWs. In time it would be worthwhile to do further research to look into the CMWs' integration in the system, as well as TBAs' continued role for provision of MNCH care.
The management of recurrent malignant pleural effusions (MPE) can be challenging. Various options are available, with the most efficacious and widely used being talc pleurodesis. Talc can either be applied via a chest drain in the form of slurry, or at medical thoracoscopy using poudrage. Current evidence regarding which method is most effective is conflicting and often methodologically flawed. The TAPPS trial is a suitably powered, multicentre, open-label, randomised controlled trial designed to compare the pleurodesis success rate of medical thoracoscopy and talc poudrage with chest drain insertion and talc slurry.
330 patients with a confirmed MPE requiring intervention will be recruited from UK hospitals. Patients will be randomised (1:1) to undergo either small bore (<14 Fr) Seldinger chest drain insertion followed by instillation of sterile talc (4 g), or to undergo medical thoracoscopy and simultaneous poudrage (4 g). The allocated procedure will be performed as an inpatient within 3 days of randomisation taking place. Following discharge, patients will be followed up at regular intervals for 6 months. The primary outcome measure is pleurodesis failure rates at 3 months. Pleurodesis failure is defined as the need for further pleural intervention for fluid management on the side of the trial intervention.
The trial has received ethical approval from the National Research Ethics Service Committee North West—Preston (12/NW/0467). There is a trial steering committee which includes independent members and a patient and public representative. The trial results will be published in a peer-reviewed journal and presented at international conferences, as well as being disseminated via local and national charities and patient groups. All participants who wish to know the study results will also be contacted directly on their publication.
Efforts to engage Traditional, Complementary and Alternative Medical (TCAM) practitioners in the public health workforce have growing relevance for India's path to universal health coverage. We used an action-centred framework to understand how policy prescriptions related to integration were being implemented in three distinct Indian states.
Health departments and district-level primary care facilities in the states of Kerala, Meghalaya and Delhi.
In each state, two or three districts were chosen that represented a variation in accessibility and distribution across TCAM providers (eg, small or large proportions of local health practitioners, Homoeopaths, Ayurvedic and/or Unani practitioners). Per district, two blocks or geographical units were selected. TCAM and allopathic practitioners, administrators and representatives of the community at the district and state levels were chosen based on publicly available records from state and municipal authorities. A total of 196 interviews were carried out: 74 in Kerala, and 61 each in Delhi and Meghalaya.
We sought to understand experiences and meanings associated with integration across stakeholders, as well as barriers and facilitators to implementing policies related to integration of Traditional, Complementary and Alternative (TCA) providers at the systems level.
We found that individual and interpersonal attributes tended to facilitate integration, while system features and processes tended to hinder it. Collegiality, recognition of stature, as well as exercise of individual personal initiative among TCA practitioners and of personal experience of TCAM among allopaths enabled integration. The system, on the other hand, was characterised by the fragmentation of jurisdiction and facilities, intersystem isolation, lack of trust in and awareness of TCA systems, and inadequate infrastructure and resources for TCA service delivery.
State-tailored strategies that routinise interaction, reward individual and system-level individual integrative efforts, and are fostered by high-level political will are recommended.
High levels of 'excess' mortality (ie, that seemingly not explained by deprivation) have been shown for Scotland compared to England and Wales and, especially, for its largest city, Glasgow, compared to the similarly deprived English cities of Liverpool and Manchester. It has been suggested that this excess may be related to differences in 'Sense of Coherence' (SoC) between the populations. The aim of this study was to ascertain whether levels of SoC differed between these cities and whether, therefore, this could be a plausible explanation for the 'excess'.
Three post-industrial UK cities: Glasgow, Liverpool and Manchester.
A representative sample of more than 3700 adults (over 1200 in each city).
SoC was measured using Antonovsky's 13-item scale (SOC-13). Multivariate linear regression was used to compare SoC between the cities while controlling for characteristics (age, gender, SES etc) of the samples. Additional modelling explored whether differences in SoC moderated city differences in levels of self-assessed health (SAH).
SoC was higher, not lower, among the Glasgow sample. Fully adjusted mean SoC scores for residents of Liverpool and Manchester were, respectively, 5.1 (–5.1 (95% CI –6.0 to –4.1)) and 8.1 (–8.1 (–9.1 to –7.2)) lower than those in Glasgow. The additional modelling confirmed the relationship between SoC and SAH: a 1 unit increase in SoC predicted approximately 3% lower likelihood of reporting bad/very bad health (OR=0.97 (95% CI 0.96 to 0.98)): given the slightly worse SAH in Glasgow, this resulted in slightly lower odds of reporting bad/very bad health for the Liverpool and Manchester samples compared to Glasgow.
The reasons for the high levels of 'excess' mortality seen in Scotland and particularly Glasgow remain unclear. However, on the basis of these analyses, it appears unlikely that a low SoC provides any explanation.
Rotavirus is the most common cause of severe gastroenteritis in infants and young children worldwide. Currently 67 countries include rotavirus vaccine in childhood immunisation programmes, but uptake in Western Europe has been slow. In July 2013, rotavirus vaccine was introduced into the UK's routine childhood immunisation programme. Prior to vaccine introduction in the UK, rotavirus was estimated to result in 750 000 diarrhoea episodes and 80 000 general practice (GP) consultations each year, together with 45% and 20% of hospital admissions and emergency department attendances for acute gastroenteritis, in children under 5 years of age. This paper describes a protocol for an ecological study that will assess rotavirus vaccine impact in the UK, to inform rotavirus immunisation policy in the UK and in other Western European countries.
In Merseyside, UK, we will conduct an ecological study using a 'before and after' approach to examine changes in gastroenteritis and rotavirus incidence following the introduction of rotavirus vaccination. Data will be collected on mortality, hospital admissions, nosocomial infection, emergency department attendances, GP consultations and community health consultations to capture all healthcare providers in the region. We will assess both the direct and indirect effects of the vaccine on the study population. Comparisons of outcome indicator rates will be made in relation to vaccine uptake and socioeconomic status.
The study has been approved by NHS Research Ethics Committee, South Central-Berkshire REC Reference: 14/SC/1140. Study outputs will be disseminated through scientific conferences and peer-reviewed publications. The study will demonstrate the impact of rotavirus vaccination on the burden of disease from a complete health system perspective. It will identify key areas that require improved data collection tools to maximise the usefulness of this surveillance approach and will provide a template for vaccine evaluations using ecological methods in the UK.
Prevention of suicide is a global public health challenge extending beyond mental health services. Linking routinely collected health and social care system data records for the same individual across different services and over time has enormous potential in suicide research. Most previous research linking suicide mortality data with routinely collected electronic health records involves only one or two domains of healthcare provision such as psychiatric inpatient care. This protocol paper describes the development of a population-based, routinely collected data linkage study: the Suicide Information Database Cymru (SID-Cymru). SID-Cymru aims to contribute to the information available on people who complete suicide.
SID-Cymru will facilitate a series of electronic case–control studies based in the Secure Anonymised Information Linkage (SAIL) Databank. We have identified 2664 cases of suicide in Wales between 2003 and 2011 from routinely collected mortality data using International Classification of Diseases, Tenth Revision, codes X60–X84 (intentional self-harm) and Y10–Y34 (undetermined intent). Each case will be matched by age and sex to at least five controls. Records will be collated and linked from routinely collected health and social data in Wales for each individual. Conditional logistic regression will be applied to produce crude and confounder (including general practice, socioeconomic status) adjusted ORs.
The SAIL Databank has the required ethical permissions in place to analyse anonymised data. Ethical approval has been granted by the Information Governance Review Panel (IGRP). Findings will be disseminated through peer-reviewed publications, consultations with stakeholders and national/international conference presentations. The improved understanding of the prior health, nature of previous contacts with services and wider social circumstances of those who complete suicide will assist in prevention policy, service organisation and delivery. SID-Cymru is funded through the National Institute for Social Care and Health Research, Welsh Government (RFS-12-25).
Cardiovascular admissions and atrial fibrillation readmissions for patients with or without atrial fibrillation. Data shown as admisions per 100 person years and stratified for age.
Noncardiovascular admissions for patients according to atrial fibrillation. Data shown as admisions per 100 person-years and stratified for age.
To evaluate whether dyspareunia is associated with HIV status in menopausal women and also to assess which factors are associated with dyspareunia in a group of HIV-positive menopausal women.
A cross-sectional study was conducted with 178 HIV-negative and 128 HIV-positive women aged 40–60 years. The Short Personal Experiences Questionnaire (SPEQ) was used to collect data. Sociodemographic, clinical, behavioural and reproductive factors were evaluated, as well as factors related to the HIV infection. Dyspareunia was defined as pain during intercourse. A bivariate analysis and Poisson multiple regression analysis were performed.
Overall, 41.4% of the HIV-positive women reported dyspareunia compared with 34.8% of the HIV-negative women (p=0.242). In the HIV-positive women, bivariate analysis revealed an association between dyspareunia and having a steady partner (p=0.047); the woman's partner having undergone HIV testing (p=0.020); vaginal dryness (p<0.001); muscle/joint pain (p=0.021); physical/emotional violence (p=0.049); urinary incontinence (p=0.004); and the use of lamivudine/zidovudine (p=0.048). The Poisson multiple regression analysis found an association between dyspareunia and vaginal dryness (prevalence ratio (PR)=1.96, 95% CI 1.10 to 3.50, p=0.023) and urinary incontinence (PR=1.86, 95% CI 1.06 to 3.27, p=0.031).
Dyspareunia was common in this group of HIV-positive women and was associated principally with vaginal dryness and urinary incontinence. The importance of treating dyspareunia within the context of sexual health in this group of women should be emphasised and appropriate management of this issue may reduce the likelihood of lesions on the vaginal wall, which may act as a portal of entry for other infections.
Lifestyle may be associated with risk behaviours. This study compares gym exercise and sexual risk behaviour between men who have sex with men (MSM) and heterosexual men. The research was based on the assumption that men who become muscular and physically attractive increase their number of sex partners and consequently their risk of HIV or other sexually transmitted infections (STIs).
Five gyms in central Tel Aviv, Israel.
In 2012, a sample of 182 (48%) MSM and 197 (52%) heterosexual men who train in gyms completed anonymous questionnaires regarding their training, health and sexual behaviours.
Participants in this cross-sectional study who exercised more than the median number of anaerobic training hours were defined as performing intensive anaerobic training (IAT), and those who had performed more than one act of unprotected anal/vaginal intercourse in the preceding 6 months with a partner whose HIV status was unknown were defined as high risk.
MSM showed a stronger desire to become muscular than heterosexual men, were more likely to perform IAT, and used protein powders or anabolic steroids. They reported that improving their body shape and increasing their self-confidence were their main reasons for training, whereas heterosexual men indicated weight loss and health improvement as the main reasons for training. MSM engaged in riskier sexual behaviour than heterosexual men. Of all the high-risk men, 61.9% (N=70) performed IAT, while 38.1% (N=43) performed moderate anaerobic training (p<0.01). The association between IAT and sexual risk was stronger in MSM than in heterosexual men (p<0.01 vs p=0.05, respectively). The interaction between MSM and IAT in high-risk participants was multiplicative.
MSM practised more IAT than heterosexual men, and their interaction between IAT and sexual risk was multiplicative. The MSM community could benefit from a holistic approach to sexual health and its association with body image and IAT. The gym MSM culture demonstrates how internal dynamics and social norms are possible factors driving MSM to high-risk behaviour for HIV/STI.
The study was approved by the Wolfson Hospital Review Board, Holon, Israel (WOMC-0058-09).
To assess extent and determinants of past-month recognition of suspected adverse drug reactions (ADR) and past-year ADR reporting among healthcare professionals (HCPs) in Uganda.
Geographically diverse health facilities (public, private for-profit, private not-for-profit).
Of 2000 questionnaires distributed, 1345 were completed: return rate of 67%.
Per cent HCPs who suspected ADR in the past month; reported ADR in the past year.
Nurses were the majority (59%, 792/1345). Only half the respondents had heard about pharmacovigilance: 39% of nurses (295/763; 95% CI 35% to 42%), 70% otherwise (383/547; 95% CI 66% to 74%). One fifth (268/1289 or 21%; 95% CI 19% to 23%) had suspected an ADR in the previous 4 weeks, 111 of them were nurses; 15% (190/1296) had reported a suspected ADR in the past year, 103 of them were nurses. Past-month ADR suspicion was more likely by non-nurses (OR=1.7, 95% CI 1.16 to 2.40) and with medical research involvement (OR=1.5, 95% CI 1.05 to 2.15) but past-month receipt of patient ADR-complaint predominated (OR=19, 95% CI 14 to 28). Past-year ADR reporting was higher by hospital staff (OR=1.9, 95% CI 1.18 to 3.10), especially in medicine (OR=2.3, 95% CI 1.08 to 4.73); but lower from private for-profit health facilities (OR=0.5, 95% CI 0.28 to 0.77) and by older staff (OR=0.6, 95% CI 0.43 to 0.91); more likely by HCPs who had ever encountered a fatal ADR (OR=2.9, 95% CI 1.94 to 4.25), knew to whom to report (OR=1.7, 95% CI 1.18 to 2.46), or suggested how to improve ADR reporting (OR=1.6, 95% CI 1.04 to 2.49). Two attitudinal factors were important: diffidence and lethargy.
One in five HCPs suspected an ADR in the past-month and one in seven reported ADR in the previous year. Empowering patients could strengthen ADR detection and reporting in Africa.
To evaluate the association between white matter lesion (WML) volume, silent infarcts and restless legs syndrome (RLS) in a population-based study of elderly individuals.
Cross-sectional study.
Population-based Three-City study.
1035 individuals from the Dijon, France, centre of the Three-City study who had available information on volume of WMLs from MRIs and who answered questions about the prevalence of RLS.
Prevalence of RLS.
WML volume was measured using an automated tissue segmentation method. Logistic regression was used to evaluate adjusted associations between tertiles of WML volume and RLS and between silent infarcts and RLS. 218 individuals (21.1%) were determined to have RLS. Compared with those in the first tertile of WML volume, individuals in the second tertile (OR=1.09; 95% CI 0.75 to 1.60) or third tertile (OR=1.17; 95% CI 0.79 to 1.74) did not have an increased prevalence of RLS. We also did not observe associations between the volume of deep or periventricular WML and RLS; nor did we observe an association between silent brain infarcts and RLS (OR=0.74; 95% CI 0.40 to 1.39). These findings were not modified by age or gender.
Higher volume of WML and the presence of silent infarcts were not associated with an increased prevalence of RLS in this population-based cohort of elderly individuals.
To examine risk of suicide among individuals with hospitalised chronic obstructive pulmonary disease (COPD) and to profile differences according to sex, age, psychiatric history, and recency and frequency of COPD hospitalisations.
Nested case–control study.
Data were retrieved from Danish national registries.
All suicide cases aged 40–95 years deceased between 1981 and 2006 in Denmark (n=19 869) and up to 20 live population controls per case matched on sex and date of birth (n=321 867 controls).
The relative risk of suicide associated with COPD was computed using conditional logistic regression and adjusted for effects of psychiatric history and important sociodemographic factors.
In our study population, 3% of suicide cases had been hospitalised for COPD compared with 1% of matched population controls. Thus, a hospitalised COPD was associated with a significantly increased risk for suicide (OR 2.6; 95% CI 2.3 to 2.8). The increased risk remained significant after adjustment for psychiatric history and sociodemographic variables (OR 2.0; 95% CI 1.8 to 2.2), and increased progressively with frequency and recency of COPD hospitalisation. At the same time, suicide risk associated with COPD differed significantly by sex, age and psychiatric status. The relative risk was more pronounced in women, in individuals older than 60 years and in persons with no history of psychiatric illness.
COPD confers an important risk factor for suicide completion. Risk assessment and prevention efforts should take patients' sex, age and psychiatric history into consideration.
Childhood asthma is a complex condition where many environmental factors are implicated in causation. The aim of this study was to complete a systematic review of the literature describing associations between environmental exposures and the development of asthma in young children.
A systematic review of the literature up to November 2013 was conducted using key words agreed by the research team. Abstracts were screened and potentially eligible papers reviewed. Papers describing associations between exposures and exacerbation of pre-existing asthma were not included. Papers were placed into the following predefined categories: secondhand smoke (SHS), inhaled chemicals, damp housing/mould, inhaled allergens, air pollution, domestic combustion, dietary exposures, respiratory virus infection and medications.
Children aged up to 9 years.
Diagnosed asthma and wheeze.
14 691 abstracts were identified, 207 papers reviewed and 135 included in the present review of which 15 were systematic reviews, 6 were meta-analyses and 14 were intervention studies. There was consistent evidence linking exposures to SHS, inhaled chemicals, mould, ambient air pollutants, some deficiencies in maternal diet and respiratory viruses to an increased risk for asthma (OR typically increased by 1.5–2.0). There was less consistent evidence linking exposures to pets, breast feeding and infant dietary exposures to asthma risk, and although there were consistent associations between exposures to antibiotics and paracetamol in early life, these associations might reflect reverse causation. There was good evidence that exposures to house dust mites (in isolation) was not associated with asthma risk. Evidence from observational and intervention studies suggest that interactions between exposures were important to asthma causation, where the effect size was typically 1.5–3.0.
There are many publications reporting associations between environmental exposures and modest changes in risk for asthma in young children, and this review highlights the complex interactions between exposures that further increase risk.
Newborn bloodspot screening (NBS) involves testing a small sample of blood taken from the heel of the newborn for a number of serious and life-limiting conditions. In Canada, newborn screening programmes fall under provincial and territorial jurisdiction with no federal coordination. To date, we know very little about the underlying beliefs around different consent practices or how terminology is interpreted by different individuals. Differences in attitudes may have important healthcare consequences. This study will provide empirical data comparing stakeholder opinions on their understanding of consent-related terminology, the perceived applicability of different consent approaches to newborn screening, and the requirements of these different approaches.
Parents, healthcare professionals and policymakers will be recruited in the provinces of Ontario and Newfoundland and Labrador. Parents will be identified through records held by each provincial screening programme. Healthcare professionals will be purposively sampled on the basis of engagement with newborn screening. Within each province we will identify policymakers who have policy analysis or advisory responsibilities relating to NBS. Data collection will be by qualitative interviews. We will conduct 20 interviews with parents of young children, 10 interviews with key healthcare professionals across the range of appropriate specialties and 10 with policymakers at each site (40 per site, total, N=80). The examination of the transcripts will follow a thematic analysis approach. Recruitment started in June 2014 and is expected to be complete by June 2015.
This study received ethics approval from the Ottawa Health Science Network Research Ethics Board, the Children's Hospital of Eastern Ontario Research Ethics Board (both Ontario), and the Health Research Ethics Authority (Newfoundland and Labrador).
These will be reported in peer-reviewed publications and conference presentations. The results will have specific application to the development of parent education materials for newborn screening.
Tobacco smoking claims 700 000 lives every year in Europe and the cost of tobacco smoking in the EU is estimated between 98 and 130 billion annually; direct medical care costs and indirect costs such as workday losses each represent half of this amount. Policymakers all across Europe are in need of bespoke information on the economic and wider returns of investing in evidence-based tobacco control, including smoking cessation agendas. EQUIPT is designed to test the transferability of one such economic evidence base—the English Tobacco Return on Investment (ROI) tool—to other EU member states.
EQUIPT is a multicentre, interdisciplinary comparative effectiveness research study in public health. The Tobacco ROI tool already developed in England by the National Institute for Health and Care Excellence (NICE) will be adapted to meet the needs of European decision-makers, following transferability criteria. Stakeholders' needs and intention to use ROI tools in sample countries (Germany, Hungary, Spain and the Netherlands) will be analysed through interviews and surveys and complemented by secondary analysis of the contextual and other factors. Informed by this contextual analysis, the next phase will develop country-specific ROI tools in sample countries using a mix of economic modelling and Visual Basic programming. The results from the country-specific ROI models will then be compared to derive policy proposals that are transferable to other EU states, from which a centralised web tool will be developed. This will then be made available to stakeholders to cater for different decision-making contexts across Europe.
The Brunel University Ethics Committee and relevant authorities in each of the participating countries approved the protocol. EQUIPT has a dedicated work package on dissemination, focusing on stakeholders' communication needs. Results will be disseminated via peer-reviewed publications, e-learning resources and policy briefs.
Although there is evidence that socioeconomic conditions in adulthood are associated with worse self-rated health, the putative effect of early adverse life circumstances on adult self-rated health is not consistent. Besides, little is known on this subject in the context of middle-income countries. We aimed to investigate the association between indicators of socioeconomic position in early life and self-rated health in adulthood, taking into account the influence of current socioeconomic position.
3339 civil servants (44.5% male) working at a public university in Rio de Janeiro, Brazil, participants of the Pró-Saúde cohort study.
Through a lifecourse approach, we evaluated if seven indicators of participants' socioeconomic position earlier in life were associated with worse self-rated health in adulthood. Ordinal logistic regression analysis with a proportional odds model was used.
After adjusting for socioeconomic position in adulthood (education and income), the indicators of early socioeconomic position associated with poor self-rated health were as follows: not eating at home due to lack of money at the age of 12 (OR=1.29 95% CI 1.06 to 1.57) and having lived in a small city or rural area at the age of 12 (OR=1.51 95% CI 1.21 to 1.89).
Self-rated health was associated with two indicators of remarkable experiences of poverty in early life, even when socioeconomic conditions improved throughout life. Our findings have shown a long-term impact of extreme socioeconomic hardship during childhood and/or adolescence on the development of social inequalities in health. In terms of implications for public health, our work emphasises that health policies, usually focused on adult lifestyle interventions, should be complemented by initiatives aimed at reducing socioeconomic inequalities during the earliest stages of development, such as childhood and adolescence.
To explore health-seeking behaviour and experiences of undocumented migrants (UMs) in general practice in relation to mental health problems.
Qualitative study using semistructured interviews and thematic analysis.
15 UMs in the Netherlands, varying in age, gender, country of origin and education; inclusion until theoretical saturation was reached.
4 cities in the Netherlands.
UMs consider mental health problems to be directly related to their precarious living conditions. For support, they refer to friends and religion first, the general practitioner (GP) is their last resort. Barriers for seeking help include taboo on mental health problems, lack of knowledge of and trust in GPs competencies regarding mental health and general barriers in accessing healthcare as an UM (lack of knowledge of the right to access healthcare, fear of prosecution, financial constraints and practical difficulties). Once access has been gained, satisfaction with care is high. This is primarily due to the attitude of the GPs and the effectiveness of the treatment. Reasons for dissatisfaction with GP care are an experienced lack of time, lack of personal attention and absence of physical examination. Expectations of the GP vary, medication for mental health problems is not necessarily seen as a good practice.
UMs often see their precarious living conditions as an important determinant of their mental health; they do not easily seek help for mental health problems and various barriers hamper access to healthcare for them. Rather than for medication, UMs are looking for encouragement and support from their GP. We recommend that barriers experienced in seeking professional care are tackled at an institutional level as well as at the level of GP.
The development and application of an integral descriptive model for monitoring and evaluation of patient flows and adverse outcomes of childbirth related to distinct categories of professional organisational contexts.
After categorisation of the individual professional contexts in which deliveries take place, the resulting framework has been superimposed on the 2002–2010 database of the Netherlands Perinatal Registry.
All Dutch hospitals and almost all first-line midwife practices recorded 1 469 955 (post-)term births from which only the patients with a spontaneous onset of labour (n=1 120 508) were included in a study on the quality of obstetric care outside office hours.
For the performance of professional organisational contexts the difference in relative incidence of perinatal death or Apgar score <7 between the related patient groups and the reference patient groups has been used. These differences have been expressed as risk ratio (RR) with a 95% CI.
Only the group of patients who started labour spontaneously under the supervision of the first-line midwife shows a proportional distribution over the parts of the day. In all other groups the distribution of patients is disproportional. The perinatal mortality rate declines by about 30% in the successive periods. This decline concerns mainly those patients who gave birth outside office hours.
The complexity and the dynamics of the obstetric care system make it virtually impossible to demonstrate fixed patterns in the relationships between the separate contextual factors and the (adverse) outcomes of births. To generate useful knowledge, it is necessary to evaluate changes in the obstetric care system periodically and systematically. Thus, the longitudinal application of the model demonstrated that the differences in perinatal mortality rate between the parts of the day have disappeared in recent years.
Worldwide, an estimated 125 million girls and women live with female genital mutilation/cutting (FGM/C). We aimed to systematically review the evidence for physical health risks associated with FGM/C.
We searched 15 databases to identify studies (up to January 2012). Selection criteria were empirical studies reporting physical health outcomes from FGM/C, affecting females with any type of FGM/C, irrespective of ethnicity, nationality and age. Two review authors independently screened titles and abstracts, applied eligibility criteria, assessed methodological study quality and extracted full-text data. To derive overall risk estimates, we combined data from included studies using the Mantel-Haenszel method for unadjusted dichotomous data and the generic inverse-variance method for adjusted data. Outcomes that were sufficiently similar across studies and reasonably resistant to biases were aggregated in meta-analyses. We applied the instrument Grading of Recommendations Assessment, Development and Evaluation to assess the extent to which we have confidence in the effect estimates.
Our search returned 5109 results, of which 185 studies (3.17 million women) satisfied the inclusion criteria. The risks of systematic and random errors were variable and we focused on key outcomes from the 57 studies with the best available evidence. The most common immediate complications were excessive bleeding, urine retention and genital tissue swelling. The most valid and statistically significant associations for the physical health sequelae of FGM/C were seen on urinary tract infections (unadjusted RR=3.01), bacterial vaginosis (adjusted OR (AOR)=1.68), dyspareunia (RR=1.53), prolonged labour (AOR=1.49), caesarean section (AOR=1.60), and difficult delivery (AOR=1.88).
While the precise estimation of the frequency and risk of immediate, gynaecological, sexual and obstetric complications is not possible, the results weigh against the continuation of FGM/C and support the diagnosis and management of girls and women suffering the physical risks of FGM/C.
This study is registered with PROSPERO, number CRD42012003321.
To assess the reproducibility of an educational intervention EdAl-2 (
Reproduction of a cluster randomised controlled trial.
Two semi-rural town-group primary-school clusters were randomly assigned to the intervention or control group.
Pupils (n=690) of whom 320 constituted the intervention group (1 cluster) and 370 constituted the control group (1 cluster). Ethnicity was 78% Western European. The mean age (±SD) was 8.04±0.6 years (47.7% females) at baseline. Inclusion criteria for clusters were towns from the southern part of Catalonia having a minimum of 500 children aged 7–8 year; complete data for participants, including name, gender, date and place of birth, and written informed consent from parents or guardians.
The intervention focused on eight lifestyle topics covered in 12 activities (1 h/activity/session) implemented by health promoting agents in the primary school over three academic years.
The primary outcome was obesity (OB) prevalence and the secondary outcomes were body mass index (BMI) collected every year and dietary habits and lifestyles collected by questionnaires filled in by parents at baseline and end-of-study.
At 22 months, the OB prevalence and BMI values were similar in intervention and control groups. Relative to children in control schools, the percentage of boys in the intervention group who performed ≥4 after-school PA h/week was 15% higher (p=0.027), whereas the percentage of girls in both groups remained similar. Also, 16.6% more boys in the intervention group watched ≤2 television (TV) h/day (p=0.009), compared to controls; and no changes were observed in girls in both groups.
Our school-based intervention is feasible and reproducible by increasing after-school PA (to ≥4 h/week) in boys. Despite this improvement, there was no change in BMI and prevalence of OB.
Clinical Trials NCT01362023.
To explore the acceptability of pre-exposure prophylaxis (PrEP) among gay, bisexual and men who have sex with men (MSM) and migrant African communities in Scotland, UK.
Consecutive mixed qualitative methods consisting of focus groups (FGs) and in-depth interviews (IDIs) explored PrEP acceptability. Data were digitally recorded, transcribed and analysed thematically to identify anticipated and emerging themes.
Participants were recruited through community sexual health and outreach support services, and from non-sexual health settings across Scotland.
Inclusion criteria included identification as either MSM and/or from migrant African communities; 18 years and older; living in Scotland at the time of participation. 7 FGs were conducted (n=33): 5 with MSM (n=22) and 2 mixed-sex groups with African participants (n=11, women=8), aged 18–75 years. 34 IDIs were conducted with MSM (n=20) and African participants (n=14, women=10), aged 19–60 years. The sample included participants who were HIV-positive and HIV-negative or untested (HIV-positive FG participants, n=22; HIV-positive IDI participants, n=17).
Understandings of PrEP effectiveness and concerns about maintaining regular adherence were identified as barriers to potential PrEP uptake and use. Low perception of HIV risk due to existing risk management strategies meant few participants saw themselves as PrEP candidates. Participants identified risk of other sexually transmitted infections and pregnancy as a concern which PrEP did not address for either themselves or their sexual partners. PrEP emerged as a contentious issue because of the potentially negative implications it had for HIV prevention. Many participants viewed PrEP as problematic because they perceived that others would stop using condoms if PrEP was to become available.
PrEP implementation needs to identify appropriate communication methods in the context of diverse HIV literacy; address risk-reduction concerns and; demonstrate how PrEP can be part of a safe and comprehensive risk management strategy.
Chronic neuropathic pain is associated with reduced health-related quality of life and substantial socioeconomic costs. Current research addressing management of chronic neuropathic pain is limited. No review has evaluated all interventional studies for chronic neuropathic pain, which limits attempts to make inferences regarding the relative effectiveness of treatments.
We will conduct a systematic review of all randomised controlled trials evaluating therapies for chronic neuropathic pain. We will identify eligible trials, in any language, by a systematic search of CINAHL, EMBASE, MEDLINE, AMED, HealthSTAR, DARE, PsychINFO and the Cochrane Central Registry of Controlled Trials. Eligible trials will be: (1) enrol patients presenting with chronic neuropathic pain, and (2) randomise patients to alternative interventions (pharmacological or non-pharmacological) or an intervention and a control arm. Pairs of reviewers will, independently and in duplicate, screen titles and abstracts of identified citations, review the full texts of potentially eligible trials and extract information from eligible trials. We will use a modified Cochrane instrument to evaluate risk of bias of eligible studies, recommendations from the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) to inform the outcomes we will collect, and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system to evaluate our confidence in treatment effects. When possible, we will conduct: (1) in direct comparisons, a random-effects meta-analysis to establish the effect of reported therapies on patient-important outcomes; and (2) a multiple treatment comparison meta-analysis within a Bayesian framework to assess the relative effects of treatments. We will define a priori hypotheses to explain heterogeneity between studies, and conduct meta-regression and subgroup analyses consistent with the current best practices.
We do not require ethics approval for our proposed review. We will disseminate our findings through peer-reviewed publications and conference presentations.
Elevation of C reactive protein (CRP) is one of the major acute-phase responses following ischaemic or haemorrhagic stroke. This study aims to investigate the associations between platelet indices, neutrophil-to-lymphocyte ratio (NLR) and erythrocyte sedimentation rate (ESR) compared with CRP in patients with cerebral infarction.
The clinical data of patients with cerebral infarction were analysed retrospectively.
We analysed, unduplicated, 516 patients with cerebral infarction (mean age 66.2±12.7, male/female=291/225).
Mean platelet volume (MPV), MPV to platelet count, NLR and ESR were compared with CRP in patients with cerebral infarction in a single institute through Spearman correlation test.
There were significant correlations between CRP and MPV (=0.088, p=0.045), NLR (=0.4, p<0.001) and ESR (=0.468, p<0.001) in patients with cerebral infarction. In the male group, NLR (=0.398, p<0.001) and ESR (=0.502, p<0.001) showed significant correlations with CRP. In the female group, CRP showed significant correlations with MPV (=0.17, p=0.011), NLR (=0.392, p<0.001) and ESR (=0.475, p<0.001).
MPV, NLR and ESR showed significant correlation with CRP in patients with cerebral infarction. MPV and NLR are cost-effective and simple parameters that can be attainable by using an automatic haematology analyser. Further well-designed and large-scale prospective studies are warranted to evaluate platelet indices or NLR for monitoring patients with cerebral infarction.
Self-reported anal intercourse by female sex workers (FSWs) documented in recent studies from India range between 11.9% and 22%. However, comparable data on anal intercourse and condom use from male clients of FSWs is lacking. Using data from a bio-behavioural survey (2009–2010), we examined prevalence of anal intercourse, male clients' self-reported inconsistent condom use during anal intercourse with FSWs, and correlates of this behaviour in India's high HIV prevalence southern states (Andhra Pradesh, Maharashtra and Tamil Nadu combined).
Using two-stage time location cluster sampling, we recruited 4803 clients of FSWs, ages 18–60 years, who had purchased sex from an FSW in the past month. After obtaining informed consent, respondents were interviewed and tested for HIV and sexually transmitted infections (syphilis, gonorrhoea and chlamydia). Logistic regression analysis was used to identify the factors associated with inconsistent condom use during anal intercourse (in the past 6 months) with FSWs.
Overall, 12.3% clients reported anal intercourse in the past 6 months, of whom 48.4% used condoms inconsistently. Clients of FSWs who were ages 26 years or older (AOR 2.68, p=0.032); employed as manual labourers (AOR 2.43, p=0.013); consumed alcohol (AOR 2.63, p=0.001); reported five or more sex acts with FSWs in the past month (AOR 2.53, p=0.031); and perceived themselves to be at higher risk for HIV (AOR 4.82, p=0.001) were more likely to inconsistently use condoms during anal intercourse.
The results suggest that sex workers and their clients commonly practice anal intercourse, but a relatively high proportion of clients do not consistently use condoms, leading to a greater risk of acquiring HIV and its further transmission to other male and female sexual partners. Given the multidirectional risk, safer sex communication on heterosexual anal intercourse must be incorporated into HIV prevention programmes.
Pancreatic ductal adenocarcinoma (PDAC) and biliary tract cancers (BTC) are often diagnosed late and at an advanced stage. Population-based screening programmes do not exist and diagnosis is primarily dependent on symptom recognition. Recently symptom-based cancer decision support tools (CDSTs) have been introduced into primary care practices throughout the UK to support general practitioners (GPs) in identifying patients with suspected PDAC. However, future refinement of these tools to improve their diagnostic accuracy is likely to be necessary.
The Health Improvement Network (THIN) is a primary care database, which includes more than 11 million electronic patient records, from 562 GP practices in the UK.
All patients with a diagnosis of PDAC or BTC between 2000 and 2010 were included in the study along with six matched controls; 2773 patients with PDAC, 848 patients with BTC and 15 395 controls.
The primary aim of this study was to determine the early symptom profiles of PDAC and BTC. Secondary aims included comparing early symptom trends between BTC and PDAC, defining symptom onset in PDAC and evaluating trends in routine blood tests nearest to the time of diagnosis.
In the year prior to diagnosis, patients with PDAC visited their GP on a median of 18 (IQR 11–27) occasions. PDAC was associated with 11 alarm symptoms and BTC with 8. Back pain (OR 1.33 (95% CI 1.18 to 1.49) p<0.001), lethargy (1.42 (95% CI 1.25 to 1.62) p<0.001) and new onset diabetes (OR 2.46 (95% CI 2.16 to 2.80)) were identified as unique features of PDAC.
PDAC and BTC are associated with numerous early alarm symptoms. CDSTs are therefore likely to be useful in identifying these tumours at an early stage. Inclusion of unique symptoms, symptoms with an early onset and routinely performed blood tests is likely to further improve the sensitivity of these tools.
To identify metabolic markers that can classify patients with osteoarthritis (OA) into subgroups.
A case-only study design was utilised.
Patients were recruited from those who underwent total knee or hip replacement surgery due to primary OA between November 2011 and December 2013 in St. Clare's Mercy Hospital and Health Science Centre General Hospital in St. John's, capital of Newfoundland and Labrador (NL), Canada. 38 men and 42 women were included in the study. The mean age was 65.2±8.7 years.
Synovial fluid samples were collected at the time of their joint surgeries. Metabolic profiling was performed on the synovial fluid samples by the targeted metabolomics approach, and various analytic methods were utilised to identify metabolic markers for classifying subgroups of patients with OA. Potential confounders such as age, sex, body mass index (BMI) and comorbidities were considered in the analysis.
Two distinct patient groups, A and B, were clearly identified in the 80 patients with OA. Patients in group A had a significantly higher concentration on 37 of 39 acylcarnitines, but the free carnitine was significantly lower in their synovial fluids than in those of patients in group B. The latter group was further subdivided into two subgroups, that is, B1 and B2. The corresponding metabolites that contributed to the grouping were 86 metabolites including 75 glycerophospholipids (6 lysophosphatidylcholines, 69 phosphatidylcholines), 9 sphingolipids, 1 biogenic amine and 1 acylcarnitine. The grouping was not associated with any known confounders including age, sex, BMI and comorbidities. The possible biological processes involved in these clusters are carnitine, lipid and collagen metabolism, respectively.
The study demonstrated that OA consists of metabolically distinct subgroups. Identification of these distinct subgroups will help to unravel the pathogenesis and develop targeted therapies for OA.
Falling in older age is a serious and costly problem. At least one in three older people fall annually. Although exercise is recognised as an effective fall prevention intervention, low numbers of older people engage in suitable programmes. Health and exercise professionals play a crucial role in addressing fall risk in older adults. This trial aims to evaluate the effect of participation in a fall prevention educational programme, compared with a wait-list control group, on health and exercise professionals' knowledge about fall prevention and the effect on fall prevention exercise prescription behaviour and confidence to prescribe the exercises to older people.
A randomised controlled trial involving 220 consenting health and exercise professionals will be conducted. Participants will be individually randomised to an intervention group (n=110) to receive an educational workshop plus access to internet-based support resources, or a wait-list control group (n=110). The two primary outcomes, measured 3 months after randomisation, are: (1) knowledge about fall prevention and (2) self-perceived change in fall prevention exercise prescription behaviour. Secondary outcomes include: (1) participants' confidence to prescribe fall prevention exercises; (2) the proportion of people aged 60+ years seen by trial participants in the past month who were prescribed fall prevention exercise; and (3) the proportion of fall prevention exercises prescribed by participants to older people in the past month that comply with evidence-based guidelines. Outcomes will be measured with a self-report questionnaire designed specifically for the trial.
The trial protocol was approved by the Human Research Ethics Committee, The University of Sydney, Australia. Trial results will be disseminated via peer reviewed journals, presentations at international conferences and participants' newsletters.
Trial protocol was registered with the Australian and New Zealand Clinical Trials Registry (Number ACTRN12614000224628) on 3 March 2014.
To investigate why first-generation Chinese immigrants with diabetes have difficulty obtaining, processing and understanding diabetes related information despite the existence of translated materials and translators.
This qualitative study employed purposive sampling. Six focus groups and two individual interviews were conducted. Each group discussion lasted approximately 90 min and was guided by semistructured and open-ended questions.
Data were collected in two community health centres and one elderly retirement village in Los Angeles, California.
29 Chinese immigrants aged ≥45 years and diagnosed with type 2 diabetes for at least 1 year.
Eight key themes were found to potentially affect Chinese immigrants' capacity to obtain, communicate, process and understand diabetes related health information and consequently alter their decision making in self-care. Among the themes, three major categories emerged: cultural factors, structural barriers, and personal barriers.
Findings highlight the importance of cultural sensitivity when working with first-generation Chinese immigrants with diabetes. Implications for health professionals, local community centres and other potential service providers are discussed.
Several studies have found a U-shaped association between body mass index (BMI) and mortality in the general population. In similar studies among people with diabetes, the shape of the association is inconsistent. We investigated the relationship of BMI and waist circumference with mortality among people with diabetes.
The Third National Health and Nutrition Examination Survey (NHANES III) and the 1999–2004 NHANES Mortality Studies were designed to be representative of the US general population. Baseline data were collected in 1988–2004.
2607 adults ≥20 years of age with diabetes.
Participants were followed through 31 December 2006 for mortality (n=668 deaths).
Compared with people with a BMI 18.5–24.9 kg/m2, the HRs (95% CI) of mortality were 0.85 (0.60 to 1.21) for 25–29.9 kg/m2, 0.87 (0.57 to 1.33) for 30–34.9 kg/m2 and 1.05 (0.72 to 1.53) for ≥35 kg/m2 after adjustment for age, sex, race-ethnicity, smoking status, education, income and diabetes duration. Compared with people in the lowest sex-specific quartile of waist circumference, the adjusted HRs (95% CI) of mortality were 1.03 (0.77 to 1.37) for the second quartile, 1.02 (0.73 to 1.42) for the third quartile and 1.12 (0.77 to 1.61) for the highest quartile of waist circumference. When modelled as a restricted quadratic spline with knots at the 10th, 50th and 90th centiles, BMI and waist circumference were not associated with mortality. Several sensitivity analyses were conducted and most found no significant association between measures of adiposity and mortality, but there were significant results suggesting a U-shaped association among people in the highest tertile of glycated haemoglobin (≥7.1%), and there was an inverse association between BMI and mortality among people 20–44 years of age.
In a nationally representative sample of the non-institutionalised US population with diabetes, BMI and waist circumference were not associated with risk of mortality.
People are increasingly mobile for numerous reasons, including healthcare. Patient mobility has vast implications for individuals, communities and whole populations and yet, to date, research on patient mobility has been quite limited. Only a small body of evidence exists on patient mobility between low-income and middle-income countries, instead having focused primarily on cross-border movement between high-income and low-income countries. In this paper, we present a protocol for examining this under-studied phenomenon.
We propose to examine patient mobility between low-income and middle-income countries using a realist synthesis approach. Specifically, we aim to document why patients from low-income and middle-income countries cross international borders for healthcare, by identifying the mechanisms through which patients decide to cross-borders, and the contextual characteristics of domestic health markets that influence this choice. An underlying theory was established, based on the lead author's experience and a brief literature review, which will provide the basis to analyse search results in a subsequent paper. Search results will be obtained from databases (Ovid Medline, EMBASE, Scopus, EconLit, Web of Science) and the grey literature. An expert committee will be enlisted, prior to screening results, to review search results to ensure comprehensiveness. Based on this preliminary theory, we propose that, in some low-income and middle-income country markets, the interaction between demand-side and supply-side determinants results in market imperfections that, in turn, lead to patient movement across borders.
The study does not involve primary research and, therefore, does not require formal ethical approval; we do, however, follow the relevant standards of utility, usefulness, feasibility, propriety, accuracy and accountability. The standards of realist and meta-narrative evidence synthesis (RAMESES) will be adhered to in reporting the findings of the review. Once completed, the findings of the resulting manuscript will be published in a peer-reviewed journal.
This protocol has been registered with PROSPERO, registration number CRD42014014391.
To identify risk factors for and the consequences (several adverse perinatal outcomes) of physician-diagnosed major depression during pregnancy treated in specialised healthcare.
A population-based cross-sectional study.
Data were gathered from Finnish health registers for 1996–2010.
All singleton births (n=511 938) for 2002–2010 in Finland.
Prevalence, risk factors and consequences of major depression during pregnancy.
Among 511 938 women, 0.8% experienced major depression during pregnancy, of which 46.9% had a history of depression prior to pregnancy. After history of depression, the second strongest associated factor for major depression was fear of childbirth, with a 2.6-fold (adjusted OR (aOR=2.63, 95% CI 2.39 to 2.89) increased prevalence. The risk profile of major depression als