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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.
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.
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 also included adolescent or advanced maternal age, low or unspecified socioeconomic status (SES), single marital status, smoking, prior pregnancy terminations, anaemia and gestational diabetes regardless of a history of depression. Outcomes of pregnancies were worse among women with major depression than without. The contribution of smoking was substantial to modest for small-for-gestational age newborn (<–2 SD below mean birth), low birth weight (<2500 g), preterm birth (<37 weeks) and admission to neonatal intensive care associated with major depression, whereas SES made only a minor contribution.
Physician-diagnosed major depression during pregnancy was found to be rare. The strongest risk factor was history of depression prior to pregnancy. Other associated factors were fear of childbirth, low SES, lack of social support and unhealthy reproductive behaviour such as smoking. Outcomes of pregnancies were worse among women with major depression than without. Smoking during pregnancy made a substantial to modest contribution to adverse outcomes associated with depression during pregnancy.
This paper reports secular trends in diabetes in pregnancy in Victoria, Australia and examines the effect of including or excluding women with pre-existing diabetes on gestational diabetes (GDM) prevalence estimates.
Population-based observational study.
All births in Victoria, Australia between 1999 and 2008
634 932 pregnancies resulting in a birth registered with the Victorian Perinatal Data Collection
Crude and age-standardised secular trends in pre-existing diabetes and GDM prevalence; secular GDM trends by maternal birthplace; effects on GDM prevalence of including and excluding pre-existing diabetes from the denominator.
Of the 634 932 pregnancies, 2954 (0.5%) occurred in women with pre-existing diabetes and 29 147 (4.6%) were complicated by GDM. Mean maternal age increased from 29.7 years in 1999 to 30.8 years in 2008. GDM prevalence increased in most maternal age groups. In 2008, age-standardised GDM prevalence was 31% higher than in 1999; secular increases were greater for Australian-born non-Indigenous (29% increase) than immigrant women (12.3% increase). The annual number of pregnancies in women with pre-existing diabetes almost doubled from 1999 to 2008 and prevalence increased from 0.4% to 0.6%. However, including or excluding pre-existing diabetes had little effect on GDM prevalence estimates.
Pre-existing diabetes and GDM prevalence increased in Victoria between 1999 and 2008 and rising maternal age does not fully explain these trends. These findings have important implications for preventive initiatives. Including or excluding small numbers of women with pre-existing diabetes resulted in minimal changes in GDM estimates. As pre-existing diabetes in young women increases, this methodological issue will likely become important.
To examine the effect of pre-existing atrial fibrillation (AF) and associated therapy on the risk of arterial thromboembolism (ATE) and death following pneumonia.
Population-based cohort study (1997–2012) of 88 315 patients with first-time hospitalisation with pneumonia in Northern Denmark.
Of the included patients (median age 73.4 years), 8880 (10.1%) had pre-existing AF. The risk of ATE within 30 days of admission was 5.2% in patients with AF and 3.6% in patients without AF. After adjustment for higher age and comorbidity, the adjusted HR (aHR) with AF was 1.06 (95% CI 0.96 to 1.18). Among patients with AF, reduced risk of ATE was observed in vitamin-K antagonist users compared with non-users (aHR 0.74 (95% CI 0.61 to 0.91)). Thirty-day mortality was 20.1% in patients with AF and 13.9% in patients without AF. Corresponding 1-year mortalities were 43.7% and 30.3%. The aHRs for 30-day and 1-year mortality with AF were 1.00 (95% CI 0.94 to 1.05) and 1.01 (95% CI 0.98 to 1.05). In patients with AF, reduced mortality risk was observed in users of vitamin-K antagonists (aHR 0.70 (95% CI 0.63 to 0.77)) and β-blockers (aHR 0.77 (95% CI 0.70 to 0.85). Increased mortality was found in digoxin users (aHR 1.16 (95% CI 1.06 to 1.28)).
Pre-existing AF is frequent in patients hospitalised with pneumonia and a marker of increased risk of ATE and death, explained by higher patient age and comorbidity. Prognosis is closely related to preadmission medical treatment for AF.
Metastasis from solid tumours is associated with significant morbidity and mortality, and is the leading cause of cancer-related deaths. Voltage-gated sodium channels (VGSCs) are drug targets for the treatment of epilepsy. VGSCs are also present in cancer cells, where they regulate metastatic cell behaviours, including cellular movement and invasion. Treating cancer cells with the VGSC-inhibiting anticonvulsant phenytoin reduces cellular invasion and migration. Together, these suggest that VGSCs may be useful targets for inhibiting metastasis. The purpose of this study is to test the hypothesis that use of VGSC-inhibiting drugs will reduce metastasis, and therefore increase survival time in patients with cancer.
A cohort study based on primary care data from the QResearch database will include patients with one of the three common tumours: breast, bowel and prostate. The primary outcome will be overall survival from the date of cancer diagnosis. Cox proportional hazards regression will be used to compare the survival of patients with cancer taking VGSC-inhibiting drugs (including anticonvulsants and class I antiarrhythmic agents) with patients with cancer not exposed to these drugs, adjusting for age and sex. Exposure to VGSC-inhibiting drugs will be defined as having at least one prescription for these drugs prior to cancer diagnosis. High and low exposure groups will be identified based on the length of use. A number of sensitivity and secondary analyses will be conducted.
The protocol has been independently peer-reviewed and approved by the QResearch Scientific Board. The project has also been approved by the University of York Ethical Review Process. The results will be presented at international conferences and published in an open access peer-reviewed journal, in accordance with the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) criteria.
Nodding syndrome (NS) is a poorly understood neurological disorder affecting thousands of children in Africa. In March 2012, we introduced a treatment intervention that aimed to provide symptomatic relief. This intervention included sodium valproate for seizures, management of behaviour and emotional difficulties, nutritional therapy and physical rehabilitation. We assessed the clinical and functional outcomes of this intervention after 12 months of implementation.
This was a cross-sectional study of a cohort of patients with NS receiving the specified intervention. We abstracted preintervention features from records and compared these with the current clinical status. We performed similar assessments on a cohort of patients with other convulsive epilepsies (OCE) and compared the outcomes of the two groups.
Participants were patients with WHO-defined NS and patients with OCE attending the same centres.
The primary outcome was the proportion of patients with seizure freedom (≥1 month without seizures). Secondary outcome measures included a reduction in seizure frequency, resolution of behaviour and emotional difficulties, and independence in basic self-care.
Patients with NS had had a longer duration of symptoms (median 5 (IQR 3, 6) years) compared with those with OCE (4 (IQR 2, 6) years), p<0.001. The intervention resulted in marked improvements in both groups; compared to the preintervention state, 121/484 (25%) patients with NS achieved seizure freedom and there was a >70% reduction in seizure frequency; behaviour and emotional difficulties resolved in 194/327 (59%) patients; 193/484 (40%) patients had enrolled in school including 17.7% who had earlier withdrawn due to severe seizures, and over 80% had achieved independence in basic self-care. These improvements were, however, less than that in patients with OCE of whom 243/476 (51.1%) patients were seizure free and in whom the seizure frequency had reduced by 86%.
Ugandan children with NS show substantial clinical and functional improvements with symptomatic treatments suggesting that NS is probably a reversible encephalopathy.
To assess the proportion of the adult obese population in Great Britain who would describe their weight using the terms 'obese' and 'very overweight' in 2007 and 2012, and identify factors associated with more accurate weight perceptions.
Analysis of weight perception data from two population-based surveys.
Population surveys conducted in Great Britain.
Survey respondents (N=657) whose self-reported weight and height placed them in the obese category: body mass index (BMI) ≥30.
Self-identification using the terms 'obese' and 'very overweight'.
The proportion of obese adults selecting the term 'obese' to describe their body size was very low in both women (13% in 2007 and 11% in 2012) and men (4% in 2007 and 7% in 2012) and did not change significantly. Recognition of a substantial degree of overweight (as indexed by endorsement of either of the terms 'obese' or 'very overweight') declined substantially in women, from 50% in 2007 to 34% in 2012. It was not significantly changed in men (27% in 2007 and 23% in 2012). Having a higher BMI, and being able to identify the BMI threshold for obesity were associated with self-identifying as obese or very overweight.
The majority of the adult obese population of Great Britain do not identify themselves as either 'obese' or even 'very overweight'. Public health initiatives to tackle obesity are likely to be hampered by this lack of recognition of weight status. It is important to understand whether moves to increase personal awareness of weight status in the obese population can facilitate beneficial behaviour change, and what role health professionals can play in increasing awareness of weight status in obese patients.
Laramée P, Brodtkorb T-H, Rahhali N, et al. The cost-effectiveness and public health benefit of nalmefene added to psychosocial support for the reduction of alcohol consumption in alcoholdependent patients with high/very high drinking risk levels: a Markov model. BMJ Open 2014;4:
Number of patients experiencing modelled harmful events at one year and five years per 100 000 patients for nalmefene plus psychosocial support, psychosocial support alone or patients in the continuous high drinking arm
Number of patients experiencing modelled harmful events at one year and five years per 100 000 patients for nalmefene plus psychosocial support, psychosocial support alone or patients in the continuous high drinking arm
Pain in rheumatoid arthritis (RA) is traditionally considered to be of inflammatory origin. Despite better control of inflammation, some patients still report pain as a significant concern, even when being in clinical remission. This suggests that RA may prompt central sensitisation—one aspect of chronic pain. In contrast, other patients report good treatment response, although imaging shows signs of inflammation, which could indicate a possible enhancement of descending pain inhibitory mechanisms.
When assessing disease activity in patients with central sensitisation, the commonly used disease activity scores (eg, DAS28-CRP (C reactive protein)) will yield constant high total scores due to high tender joint count and global health assessments, whereas MRI provides an isolated estimate of inflammation.
The objective of this study is, in patients with RA initiating anti-inflammatory treatment, to explore the prognostic value of a screening questionnaire for central sensitisation, hand inflammation assessed by conventional MRI, and the interaction between them regarding treatment outcome evaluated by clinical status (DAS28-CRP). For the purpose of further exploratory analyses, dynamic contrast-enhanced MRI (DCE-MRI) is performed.
The painDETECT Questionnaire (PDQ), originally developed to screen for a neuropathic pain component, is applied to indicate the presence of central sensitisation. Adults diagnosed with RA are included when either (A) initiating disease-modifying antirheumatic drug treatment, or (B) initiating or switching to biological therapy.
We anticipate that 100 patients will be enrolled, tested and reassessed after 4 months of treatment.
Clinical data, conventional MRI, DCE-MRI, blood samples and patient-reported outcomes.
This study aims at supporting rheumatologists to define strategies to reach optimal treatment outcomes in patients with RA based on chronic pain prognostics. The study has been approved by The Capital region of Denmark's Ethics Committee; identification number H-3-2013-049. The results will be published in international peer-reviewed journals.
Postoperative nausea and vomiting (PONV) are frequent but unwanted complications for patients following anaesthesia and cardiac surgery, affecting at least a third of patients, despite pharmacological treatment. The primary aim of the proposed research is to test the efficacy of PC6 acupoint stimulation versus placebo for reducing PONV in cardiac surgery patients. In conjunction with this we aim to develop an understanding of intervention fidelity and factors that support, or impede, the use of PC6 acupoint stimulation, a knowledge translation approach.
712 postcardiac surgery participants will be recruited to take part in a two-group, parallel, superiority, randomised controlled trial. Participants will be randomised to receive a wrist band on each wrist providing acupressure to PC six using acupoint stimulation or a placebo. Randomisation will be computer generated, use randomly varied block sizes, and be concealed prior to the enrolment of each patient. The wristbands will remain in place for 36 h. PONV will be evaluated by the assessment of both nausea and vomiting, use of rescue antiemetics, quality of recovery and cost. Patient satisfaction with PONV care will be measured and clinical staff interviewed about the clinical use, feasibility, acceptability and challenges of using acupressure wristbands for PONV.
Ethics approval will be sought from appropriate Human Research Ethics Committee/s before start of the study. A systematic review of the use of wrist acupressure for PC6 acupoint stimulation reported minor side effects only. Study progress will be reviewed by a Data Safety Monitoring Committee (DSMC) for nausea and vomiting outcomes at n=350. Dissemination of results will include conference presentations at national and international scientific meetings and publications in peer-reviewed journals. Study participants will receive a one-page lay-summary of results.
Australian New Zealand Clinical Trials Registry—ACTRN12614000589684.
This study compares the characteristics and performance of spine specialty hospitals versus other types of hospitals for inpatients with spinal diseases in South Korea. We also assessed the effect of the government's specialty hospital designation on hospital operating efficiency.
We used data of 823 hospitals including 17 spine specialty hospitals in Korea.
All spine disease-related inpatient claims nationwide (N=645 449) during 2010–2012.
No interventions were made.
Using a multilevel generalised estimating equation and multilevel modelling, this study compared inpatient charges, length of stay (LOS), readmission within 30 days of discharge and in-hospital death within 30 days of admission in spine specialty versus other types of hospitals.
Spine specialty hospitals had higher inpatient charges per day (27.4%) and a shorter LOS (23.5%), but per case charges were similar after adjusting for patient-level and hospital-level confounders. After government designation, spine specialty hospitals had 8.8% lower per case charges, which was derived by reduced per day charge (7.6%) and shorter LOS (1.0%). Rates of readmission also were lower in spine specialty hospitals (OR=0.796). Patient-level and hospital-level factors both played important roles in determining outcome measures.
Spine specialty hospitals had higher per day inpatient charges but a much shorter LOS than other types of hospitals due to their specialty volume and experience. In addition, their readmission rate was lower. Spine specialty hospitals also endeavoured to be more efficient after governmental 'specialty' designation.
To explore the prevalence and combined cardiovascular risk factors of prehypertension in southern China.
A retrospective study; the logistic regression model was used to find the risk factors of prehypertension.
The study was conducted in Shunde District, southern China, using the community-based health check-up information.
Participants aged ≥35 years with complete health check-up information data between January 2011 and December 2013 were enrolled and divided into hypertension, prehypertension and optimal blood pressure (BP) groups. Prehypertension was further divided into low-range (BP 120–129/80–84 mm Hg) and high-range (BP 130–139/85–89 mm Hg) subgroups.
The prevalence of prehypertension and the combined cardiovascular risk factors within the prehypertensive subgroups.
Of the 5362 initially reviewed cases (aged ≥35 years), 651 were excluded because of missing data. The proportions of optimal BP, prehypertension and hypertension were 39.1%, 38.6% and 22.3%, respectively. The average age, proportion of male sex, overweight, impaired fasting glucose (IFG), dyslipidaemia and hyperuricaemia were significantly higher in the prehypertension group than in the optimal BP group (all p <0.05). Compared with low-range prehypertension, the proportions of overweight, dyslipidaemia and IFG were higher in the high-range prehypertension group (all p<0.05). Multivariate logistic regression analysis showed that overweight (OR=2.84, 95% CI 1.55 to 5.20), male sex (OR=2.19, 95% CI 1.39 to 3.45), age (per 10 years, OR=1.21, 95% CI 1.02 to 1.44, p=0.03) and hyperuricaemia (OR=1.70, 95% CI 1.14 to 2.54) were independent risk factors of prehypertension.
Prehypertension is highly prevalent in southern China. Prehypertensive individuals presented with many other cardiovascular risk factors. There was heterogeneity of combined risk factors within the prehypertensive subgroups.
To estimate isotretinoin exposure in Dutch pregnant women despite the implemented pregnancy prevention programme (PPP) and second, to analyse the occurrence of adverse fetal or neonatal outcomes in these isotretinoin exposed pregnancies.
Population-based study.
The Netherlands.
A cohort of 203 962 pregnancies with onset between 1 January 1999 and 1 September 2007 consisting of 208 161 fetuses or neonates.
Isotretinoin exposure in the 30 days before or during pregnancy. Proportions of adverse fetal or neonatal outcomes, defined as intrauterine deaths ≥16 week of gestation and neonates with major congenital anomalies. ORs with 95% CIs adjusted for maternal age were calculated to estimate the risk of adverse fetal or neonatal outcome after maternal isotretinoin exposure.
51 pregnancies, 2.5 (95% CI 1.9 to 3.3) per 10 000 pregnancies, were exposed to isotretinoin despite the pregnancy prevention programme. Forty-five of these pregnancies, 2.2 (95% CI 1.6 to 2.9) per 10 000 pregnancies, were exposed to isotretinoin during pregnancy and six additional women became pregnant within 30 days after isotretinoin discontinuation. In 60% of isotretinoin exposed pregnancies, women started isotretinoin while already pregnant. In five out of the 51 isotretinoin exposed pregnancies (53 fetuses), 9.4% (95% CI 1.3% to 17.6%), had an adverse fetal or neonatal outcome. The OR for adverse fetal or neonatal outcomes after isotretinoin exposure in 30 days before or during pregnancy was 2.3 (95% CI 0.9 to 5.7) after adjustment for maternal age.
Although a PPP was already implemented in 1988, we showed that isotretinoin exposed pregnancies and adverse fetal and neonatal events potentially related to the exposure still occur. These findings from the Netherlands add to the evidence that there is no full compliance to the isotretinoin PPP in many Western countries. Given the limited success of iPLEDGE, the question is which further measures are able to improve compliance.
Postherpetic neuralgia (PHN) is one of the most common complications following herpes zoster. Clinical trials indicate that acupuncture could reduce pain and discomfort among patients with PHN. This protocol aims to describe how to accumulate the current evidence on the efficacy and safety of acupuncture for treating PHN.
This systematic review will electronically search multiple databases including the Cochrane Skin Group Trials Register, MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), the Chinese Biomedical Literature Database (CBM), the Chinese Medical Current Content (CMCC) and the China National Knowledge Infrastructure (CNKI), and will hand search a list of medical journals as a supplement. Any clinical randomised controlled trials related to acupuncture for treating PHN will be included. Outcomes will include pain intensity, global impression, quality of life, safety and costs. By screening the titles, abstracts and full texts, two reviewers will independently select studies, extract data, and assess study quality. Meta-analysis of randomised controlled trials will be conducted using Revman 5.1 software. The results will be presented as risk ratio for dichotomous data, and standardised or weighted mean difference for continuous data.
This systematic review does not need ethical approval because there are no data used in our study that are linked to individual patient data. Also, the findings will be disseminated through a peer-review publication or conference presentation.
PROSPERO registration number: CRD42014009555.
To explore whether daytime napping and sleep duration are linked to serum C reactive protein (CRP), a pro-inflammatory marker, in an older aged British population.
Cross-sectional study.
European Prospective Investigation into Cancer and Nutrition (EPIC)-Norfolk study.
A total of 5018 men and women aged 48–92 years reported their sleep habits and had serum CRP levels measured.
CRP was measured (mg/L) during 2006–2011 in fresh blood samples using high-sensitivity methods. Participants reported napping habits during 2002–2004, and reported sleep quantity during 2006–2007. Multivariable linear regression models were used to examine the association between napping and log-transformed CRP, and geometric mean CRP levels were calculated.
After adjustment for age and sex, those who reported napping had 10% higher CRP levels compared with those not napping. The association was attenuated but remained borderline significant (β=0.05 (95% CI 0.00 to 0.10)) after further adjustment for social class, education, marital status, body mass index, physical activity, smoking, alcohol intake, self-reported health, pre-existing diseases, systolic blood pressure, hypnotic drug use, depression and in women-only hormone replacement therapy use. The geometric means (95% CI) of CRP levels were 2.38 (2.29 to 2.47) mg/L and 2.26 (2.21 to 2.32) mg/L for those who reported napping and no napping, respectively. A U-shaped association was observed between time spent in bed at night and CRP levels, and nighttime sleep duration was not associated with serum CRP levels. The association between napping and CRP was stronger for older participants, and among extremes of time spent in bed at night.
Daytime napping was associated with increased CRP levels in an older aged British population. Further studies are needed to determine whether daytime napping is a cause for systemic inflammation, or if it is a symptom or consequence of underlying health problems.
To evaluate the associations between maternal age and obstetric and neonatal outcomes in primiparous women with emphasis on teenagers and older women.
A population-based cohort study.
The Swedish Medical Birth Register.
Primiparous women with singleton births from 1992 through 2010 (N=798 674) were divided into seven age groups: <17 years, 17–19 years and an additional five 5-year classes. The reference group consisted of the women aged 25–29 years.
Obstetric and neonatal outcome.
The teenager groups had significantly more vaginal births (adjusted OR (aOR) 2.04 (1.79 to 2.32) and 1.95 (1.88 to 2.02) for age <17 years and 17–19 years, respectively); fewer caesarean sections (aOR 0.57 (0.48 to 0.67) and 0.55 (0.53 to 0.58)), and instrumental vaginal births (aOR 0.43 (0.36 to 0.52) and 0.50 (0.48 to 0.53)) compared with the reference group. The opposite was found among older women reaching a fourfold increased OR for caesarean section. The teenagers showed no increased risk of adverse neonatal outcome but presented an increased risk of prematurity <32 weeks (aOR 1.66 (1.10 to 2.51) and 1.20 (1.04 to 1.38)). Women with advancing age (≥30 years) revealed significantly increased risk of prematurity, perineal lacerations, preeclampsia, abruption, placenta previa, postpartum haemorrhage and unfavourable neonatal outcomes compared with the reference group.
For clinicians counselling young women it is of importance to highlight the obstetrically positive consequences that fewer maternal complications and favourable neonatal outcomes are expected. The results imply that there is a need for individualising antenatal surveillance programmes and obstetric care based on age grouping in order to attempt to improve the outcomes in the age groups with less favourable obstetric and neonatal outcomes. Such changes in surveillance programmes and obstetric interventions need to be evaluated in further studies.
To determine the prevalence of the hepatitis B viral (HBV) infection and hepatitis B e antigen (HBeAg) positivity among pregnant women attending antenatal clinics in two referral hospitals in northern Uganda.
Cross-sectional observational study.
Two tertiary hospitals in a postconflict region in a low-income country.
Randomly selected 402 pregnant women attending routine antenatal care in two referral hospitals. Five women withdrew consent for personal reasons. Data were analysed for 397 participants.
Hepatitis B surface antigen (HBsAg) positivity.
Of 397 pregnant women aged 13–43 years, 96.2% were married or cohabiting. 47 (11.8%) tested positive for HBsAg; of these, 7 (14.9%) were HBeAg positive. The highest HBsAg positivity rate was seen in women aged 20 years or less (20%) compared with those aged above 20 years (8.7%), aOR=2.54 (95% CI 1.31 to 4.90). However, there was no statistically significant difference between women with positive HBsAg and those with negative tests results with respect to median values of liver enzymes, haemoglobin level, absolute neutrophil counts and white cell counts. HIV positivity, scarification and number of sexual partners were not predictive of HBV positivity.
One in eight pregnant women attending antenatal care in the two study hospitals has evidence of hepatitis B infection. A significant number of these mothers are HBeAg positive and may be at increased risk of transmitting hepatitis B infection to their unborn babies. We suggest that all pregnant women attending antenatal care be tested for HBV infection; exposed babies need to receive HBV vaccines at birth.
Electronic health record (EHR)-based alerts can facilitate transmission of test results to healthcare providers, helping ensure timely and appropriate follow-up. However, failure to follow-up on abnormal test results (missed test results) persists in EHR-enabled healthcare settings. We aimed to identify contextual factors associated with facility-level variation in missed test results within the Veterans Affairs (VA) health system.
Based on a previous survey, we categorised VA facilities according to primary care providers' (PCPs') perceptions of low (n=20) versus high (n=20) risk of missed test results. We interviewed facility representatives to collect data on several contextual factors derived from a sociotechnical conceptual model of safe and effective EHR use. We compared these factors between facilities categorised as low and high perceived risk, adjusting for structural characteristics.
Facilities with low perceived risk were significantly more likely to use specific strategies to prevent alerts from being lost to follow-up (p=0.0114). Qualitative analysis identified three high-risk scenarios for missed test results: alerts on tests ordered by trainees, alerts 'handed off' to another covering clinician (surrogate clinician), and alerts on patients not assigned in the EHR to a PCP. Test result management policies and procedures to address these high-risk situations varied considerably across facilities.
Our study identified several scenarios that pose a higher risk for missed test results in EHR-based healthcare systems. In addition to implementing provider-level strategies to prevent missed test results, healthcare organisations should consider implementing monitoring systems to track missed test results.
Stroke is a major health problem and transient ischaemic attack (TIA) is an important risk factor for stroke. Primary prevention of stroke and TIA will have the greatest impact on reducing the burden of these conditions. Evidence-based guidelines for stroke/TIA prevention identify individuals eligible for preventative interventions in primary care. This study will investigate: (1) the proportion of strokes/TIAs with prior missed opportunities for prevention in primary care; (2) the influence of patient characteristics on missed prevention opportunities and (3) how the proportion of missed prevention opportunities has changed over time.
A retrospective case review will identify first-ever stroke and patients with TIA between 2000 and 2013 using anonymised electronic medical records extracted from the health improvement network (THIN) database. Four categories of missed opportunities for stroke/TIA prevention will be sought: untreated high blood pressure in patients eligible for treatment (either blood pressure ≥160/100 or ≥140/90 mm Hg in patients at high cardiovascular disease (CVD) risk); patients with atrial fibrillation with high stroke risk and no anticoagulant therapy; no lipid modifying drug therapy prescribed in patients at high CVD risk or with familial hypercholesterolaemia. The proportion of patients with each missed opportunity and multiple missed opportunities will be calculated. Mixed effect logistic regression will model the relationship between demographic and patient characteristics and missed opportunities for care; practice will be included as a random effect.
THIN data collection was approved by the NHS South East Multi-centre Research Ethics Committee (MREC) in 2003. This study was approved by the independent scientific review committee in May 2013. Dissemination of findings has the potential to change practice, improve the quality of care provided to patients and ultimately reduce the incidence of strokes and TIAs. Findings will be published in a peer-reviewed journal and disseminated at national and international conferences.
Chronic obstructive pulmonary disease (COPD) represents an important public health challenge. Patients are confronted with limitations during activities of daily living (ADLs). Resident loved ones of patients with COPD may be uniquely positioned to witness these limitations. COPD may have an impact on not only the patients' life, but also on the lives of the resident loved ones. Furthermore, COPD exacerbation-related hospital admissions often occur in patients with COPD. However, whether and to what extent these admissions influence resident loved ones' burden and health status remains currently unknown. Therefore, the primary objectives of this study are to investigate the differences between patients with COPD and resident loved ones' perceptions of patients' health status and problematic ADLs and to study prospectively the effects of a COPD exacerbation on resident loved ones' perceptions of patients' health status and problematic ADLs.
An observational, longitudinal study will be performed in 192 patients with COPD and their 192 resident loved ones. Primary outcomes are daily functioning, ADL, disease-specific health status, generic health status and dyspnoea. These will be assessed during home visits at baseline and after 12 months. Additional home visits will be performed when a COPD exacerbation-related hospital admission occurs during the 12-month follow-up period.
This protocol was approved by the Medical Ethics Committee of the Catharina Hospital Eindhoven, the Netherlands (NL42721.060.12/M12-1280) and is registered in the Dutch Trial Register (NTR3941).
This nationwide cohort study investigated the association between proton pump inhibitor (PPI) usage and the risk of pneumonia in patients with non-traumatic intracranial haemorrhage (ICH).
Nationwide population-based cohort study.
Longitudinal Health Insurance Database 2010 (LHID2010) sampled from the Taiwan National Health Insurance Research Database.
4644 patients with non-traumatic ICH from 2010 to 2011 were identified. Patients aged <18 years and newly diagnosed with non-traumatic ICH complicated with pneumonia during the same admission period were excluded. A total of 2170 participants were eligible for the final analysis.
Patients using PPIs or not during the study period were tracked to identify the occurrence of any type of pneumonia.
The adjusted HR of the risk of pneumonia for ICH patients who used PPIs was 1.61 (95% CI 1.32 to 1.97, p<0.001). The risk of pneumonia was positively associated with the administration of PPIs. We observed a greater risk of pneumonia in patients who used PPIs than in those who did not. Moreover, we observed that the risk of pneumonia in patients who used PPIs was 2.60 and 2.04 (95% CI 2.01 to 3.38, p<0.001; 95% CI 1.34 to 3.10, p<0.001) greater than that in patients who did not use PPIs when the defined daily dose was <30 and 30–60, respectively.
The results of this study indicate that the use of PPIs in patients with non-traumatic ICH is associated with an increased risk of pneumonia, and the severity of this risk depends on the defined daily dose. Physicians should exercise caution when prescribing PPIs for patients with non-traumatic ICH.
The present study aimed to evaluate the frequency of warning signs in younger patients with stroke with a special regard to the 'FAST' scheme, a public stroke recognition instrument (face, arm, speech, timely).
Primary stroke care in participating centres of a multinational European prospective cross-sectional study (Stroke in Young Fabry Patients; sifap1). Forty-seven centres from 15 European countries participate in sifap1.
5023 acute patients with stroke (aged 18–55 years) patients (96.5% Caucasians) were enrolled in the study between April 2007 and January 2010.
sifap1 was originally designed to investigate the relation of juvenile stroke and Fabry disease. A secondary aim of sifap1 was to investigate stroke patterns in this specific group of patients. The present investigation is a secondary analysis addressing stroke presenting symptoms with a special regard to signs included in the FAST scheme.
4535 patients with transient ischaemic attack (TIA; n=1071), ischaemic stroke (n=3396) or other (n=68) were considered in the presented analysis. FAST symptoms could be traced in 76.5% of all cases. 35% of those with at least one FAST symptom had all three symptoms. At least one FAST symptom could be recognised in 69.1% of 18–24 years-old patients, in 74% of those aged 25–34 years, in 75.4% of those aged 35–44 years, and 77.8% in 45–55 years-old patients. With increasing stroke severity signs included in the FAST scheme were more prevalent (National Institute of Health Stroke Scale, NIHSS<5: 69%, NIHSS 6–15: 98.9%, NIHSS>15: 100%). Clustering clinical signs according to FAST lower percentages of strokes in the posterior circulation (65.2%) and in patients with TIA (62.3%) were identified.
FAST may be applied as a useful and rapid tool to identify stroke symptoms in young individuals aged 18–55 years. Especially in patients eligible for thrombolysis FAST might address the majority of individuals.
The study was registered in http://www.clinicaltrials.gov (No. NCT00414583).
The first- and second-trimester screening for trisomy 21 (T21) are reimbursed for all pregnant women in Belgium. Using a cut-off risk of 1:300 for T21, about 5% of all pregnant women are referred for definitive prenatal diagnosis using an invasive test, at a sensitivity of (only) 72.5%. The sensitivity and specificity of the non-invasive prenatal test (NIPT) are over 99% but come at a cost of 460 (£373) per test. The objective is to estimate the consequences of introducing NIPT for the detection of T21.
A cost-consequences analysis was performed presenting the impact on benefits, harms and costs. Context-specific real-world information was available to set up a model reflecting the current screening situation in Belgium. This model was used to construct the second and first line NIPT screening scenarios applying information from the literature on NIPT's test accuracy.
Introducing NIPT in the first or second line reduces harm by decreasing the number of procedure-related miscarriages after invasive testing. In contrast with NIPT in the second line, offering NIPT in the first line additionally will miss fewer cases of T21 due to less false-negative test results. The introduction of NIPT in the second line results in cost savings, which is not true for NIPT at the current price in the first line. If NIPT is offered to all pregnant women, the price should be lowered to about 150 to keep the screening cost per T21 diagnosis constant.
In Belgium, the introduction and reimbursement of NIPT as a second line triage test significantly reduces procedure-related miscarriages without increasing the short-term screening costs. Offering and reimbursing NIPT in the first line to all pregnant women is preferred in the long term, as it would, in addition, miss fewer cases of T21. However, taking into account the government's limited resources for universal reimbursement, the price of NIPT should first be lowered substantially before this can be realised.
Lithium is a mainstay of bipolar disorder treatment, however, there are still differences in opinion on the effects of lithium use on renal function. The aim of this analysis was to determine if there is an association between short-term exposure to various elevated lithium levels and estimated-glomerular filtration rate (eGFR) at ≤3 months, 6 months (±3 months) and 1 year (±3 months) follow-up.
Norfolk-wide (UK) lithium register and database.
699 patients from the Norfolk database.
eGFR change from baseline at ≤3 months, 6 months (±3 months) and 1 year (±3 months) after exposure to a lithium level within these ranges: 0.81–1.0 mmol/L (group 2), 1.01–1.2 mmol/L (group 3) and 1.21–2.0 mmol/L (group 4). The reference group was patients whose lithium levels never exceeded 0.8 mmol/L.
Compared to the reference group, groups 3 and 4 showed a significant decrease in eGFR in the first 3 months after exposure (p=0.047 and p=0.040). At 6 months (±3 months) postexposure group 4 still showed a decline in eGFR, however, this result was not significant (p=0.298).
These results show for the first time that a single incident of a lithium level >1.0 mmol/L is associated with a significant decrease in eGFR in the following 3 months when compared to patients whose lithium levels never exceeded 0.8 mmol/L. It is still not known whether the kidneys can recover this lost function and the impact that more than a single exposure to a level within these ranges can have on renal function. These results suggest that lithium level monitoring should be undertaken at least every 3 months, in line with current UK guidelines and not be reduced further until the impact of more than one exposure to these lithium levels has been fully established.
To assess the clinical evidence for bee venom acupuncture (BVA) for rheumatoid arthritis (RA).
Systematic review of randomised controlled trials (RCTs).
We searched 14 databases up to March 2014 without a language restriction.
Patients with RA.
BVA involved injecting purified, diluted BV into acupoints. We included trials on BVA used alone or in combination with a conventional therapy versus the conventional therapy alone.
Morning stiffness, pain and joint swelling
Erythrocyte sedimentation rate (ESR), C reactive protein (CRP), rheumatoid factor, the number of joints affected by RA and adverse effects likely related to RA.
A total of 304 potentially relevant studies were identified; only one RCT met our inclusion criteria. Compared with placebo, BVA may more effectively improve joint pain, swollen joint counts, tender joint counts, ESR and CRP but was not shown to improve morning stiffness.
There is low-quality evidence, based on one trial, that BVA can significantly reduce pain, morning stiffness, tender joint counts, swollen joint counts and improve the quality of life of patients with RA compared with placebo (normal saline injection) control. However, the number of trials, their quality and the total sample size were too low to draw firm conclusions.
Chromosome 22q11.2 deletion is the most commonly occurring known microdeletion syndrome. Deaths related to the syndrome have been reported, but the magnitude of death has not been quantified. This study evaluated the deletion's impact on survival and its clinical manifestations in a large cohort of Chilean patients.
Demographic and clinical data of individuals with 22q11 deletions diagnosed between 1998 and 2013 were collected from medical records and death certificates. Case fatality rate was calculated and compared with national vital statistics. OR with 95% CI analysis was used to assess the association between clinical manifestations and death.
Genetic services in tertiary care centres in Chile, following patients with 22q11.2 deletion.
Fatality rate and associated factors.
59 of 419 patients (14.1%) died during the study period at a median of 3.4 months (range 0 to 32 years of age). Factors associated with death included congenital heart disease (OR 5.27; 95% CI 2.06 to 13.99; p<0.0001), hypocalcaemia (OR 4.27; 95% CI 1.67 to 11.15; p<0.002) and airway malacia (OR 13.37; 95% CI 1.19 to 110.51; p<0.002). Patients with deletions and defects such as tetralogy of Fallot with or without pulmonary atraesia, truncus arteriosus or ventricular septal defect, had a 2.6-fold to 4.6-fold higher death rate compared with nationwide reports for the same types of defects.
In this cohort, we observed a death rate of 14.1%, implying that one in seven patients with 22q11 deletion died during the study period. Significant associations with cardiac defects, hypocalcaemia and airway malacia were observed. Furthermore, the death risk in patients with 22q11 deletion and cardiac defects exceeded the global figures observed in Chile for infants with structurally similar but apparently isolated anomalies. These observations indicate a need to identify patients who may require specific perioperative management to improve survival.
To explore physician satisfaction with an electronic medical records (EMR) system, to identify and explore the main limitations of the system and finally to submit recommendations to address these limitations.
A descriptive qualitative study that entailed three focus group interviews was performed among physicians using open-ended questions. The interviews were audiotaped, documented and transcribed verbatim. The themes were explored and analysed in different categories.
The study was conducted in primary healthcare centres (PHC) in Al Ain, United Arab Emirates (UAE).
A total of 23 physicians, all using the same EMR system, attended one of three focus groups held in PHC in Al Ain Medical District. Each focus group consisted of 7–9 physicians working in PHC as family medicine specialists, residents or general practitioners.
Physician satisfaction with the EMR system.
Key themes emerged and were categorised as physician-dependent, patient-related and system-related factors. In general, physicians were satisfied with the EMR system in spite of initial difficulties with implementation. Most participants identified that the long time required to do the documentation affected their practice and patient communication. Many physicians expressed satisfaction with the orders and results of laboratory and radiology functions and they emphasised that this was the strongest point in the EMR. They were also satisfied with the electronic prescription function, stating that it reduced errors and saved time.
Physicians are satisfied with the EMR and have a positive perception regarding the application of the system. Several themes emerged during this study that need to be considered to enhance the EMR system. Further studies need to be conducted among other healthcare practitioners and patients to explore their attitude and perception about the EMR.
Malignant pleural effusion can complicate most cancers. It causes breathlessness and requires hospitalisation for invasive pleural drainages. Malignant effusions often herald advanced cancers and limited prognosis. Minimising time spent in hospital is of high priority to patients and their families. Various treatment strategies exist for the management of malignant effusions, though there is no consensus governing the best choice. Talc pleurodesis is the conventional management but requires hospitalisation (and substantial healthcare resources), can cause significant side effects, and has a suboptimal success rate. Indwelling pleural catheters (IPCs) allow ambulatory fluid drainage without hospitalisation, and are increasingly employed for management of malignant effusions. Previous studies have only investigated the length of hospital care immediately related to IPC insertion. Whether IPC management reduces time spent in hospital in the patients' remaining lifespan is unknown. A strategy of malignant effusion management that reduces hospital admission days will allow patients to spend more time outside hospital, reduce costs and save healthcare resources.
The Australasian Malignant Pleural Effusion (AMPLE) trial is a multicentred, randomised trial designed to compare IPC with talc pleurodesis for the management of malignant pleural effusion. This study will randomise 146 adults with malignant pleural effusions (1:1) to IPC management or talc slurry pleurodesis. The primary end point is the total number of days spent in hospital (for any admissions) from treatment procedure to death or end of study follow-up. Secondary end points include hospital days specific to pleural effusion management, adverse events, self-reported symptom and quality-of-life scores.
The Sir Charles Gairdner Group Human Research Ethics Committee has approved the study as have the ethics boards of all the participating hospitals. The trial results will be published in peer-reviewed journals and presented at scientific conferences.
Australia New Zealand Clinical Trials Registry—ACTRN12611000567921; National Institutes of Health—NCT02045121.
To clarify and quantify the potential dose–response association between the intake of fruit and vegetables and risk of type 2 diabetes.
Meta-analysis and systematic review of prospective cohort studies.
Studies published before February 2014 identified through electronic searches using PubMed and Embase.
Prospective cohort studies with relative risks and 95% CIs for type 2 diabetes according to the intake of fruit, vegetables, or fruit and vegetables.
A total of 10 articles including 13 comparisons with 24 013 cases of type 2 diabetes and 434 342 participants were included in the meta-analysis. Evidence of curve linear associations was seen between fruit and green leafy vegetables consumption and risk of type 2 diabetes (p=0.059 and p=0.036 for non-linearity, respectively). The summary relative risk of type 2 diabetes for an increase of 1 serving fruit consumed/day was 0.93 (95% CI 0.88 to 0.99) without heterogeneity among studies (p=0.477, I2=0%). For vegetables, the combined relative risk of type 2 diabetes for an increase of 1 serving consumed/day was 0.90 (95% CI 0.80 to 1.01) with moderate heterogeneity among studies (p=0.002, I2=66.5%). For green leafy vegetables, the summary relative risk of type 2 diabetes for an increase of 0.2 serving consumed/day was 0.87 (95% CI 0.81 to 0.93) without heterogeneity among studies (p=0.496, I2=0%). The combined estimates showed no significant benefits of increasing the consumption of fruit and vegetables combined.
Higher fruit or green leafy vegetables intake is associated with a significantly reduced risk of type 2 diabetes.
Venous thromboembolism (VTE) continues to be a frequent medical emergency requiring rapid recognition so as to reach diagnosis and initiate anticoagulation therapy. The use of statins in addition to reducing the incidence of arterial thrombosis for decreasing the incidence and reoccurrence of VTE is reported. The aim of our study was to explore the association between statin usage and the incidence of new VTE at the population level during a 10-year follow-up.
Population-based historic cohort.
The Health 2000 Survey was based on a nationally representative sample.
8028 individuals aged 30 years or over in Finland.
The primary end point event was the first ever hospitalisation due to one of the following causes: pulmonary embolism (International Classification of Diseases-10 I26), cerebral venous non-pyogenic thrombosis (I63.6), or venous thrombosis (I80.9–189).
The preselected explanatory variables applied to the Poisson regression model were statin usage (no/yes) during follow-up (2000–2011) and several baseline data (age, sex; usage of blood glucose lowering drugs, vitamin K antagonists and antiplatelet agents). We observed 136 VTE events, the incidence of 1.72 (95% CI 1.44 to 2.04) per 1000 person-years. Current statin usage did not associate with the incidence of VTE according to the univariate model (rate ratio (RR) 0.93, 0.56 to 1.52), but when adjusted with baseline variables (age, sex, medications) the RR declined to 0.60 (0.36 to 1.00, p=0.04).
Statin use offers protection against first ever VTE events and appears as a primary prevention tool in patients without anticoagulation or antiplatelet medication.
To examine the associations between socioeconomic position (SEP) and multidomain self-reported and objectively-assessed sedentary time (ST).
General population households in England.
2289 adults aged 16–96 years who participated in the 2008 Health Survey for England.
Accelerometer-measured ST, and self-reported television time, non-television leisure-time sitting and occupational sitting/standing. We examined multivariable associations between household income, social class, education, area deprivation for each SEP indicator (including a 5-point composite SEP score computed by aggregating individual SEP indicators) and each ST indicator using generalised linear models.
Accelerometry-measured total ST and occupational sitting/standing were positively associated with SEP score and most of its constituent SEP indicators, while television time was negatively associated with SEP score and education level. Area-level deprivation was largely unrelated to ST. Those in the lowest composite SEP group spent 64 (95% CIs 52 to 76) and 72 (48 to 98), fewer minutes/day in total ST and occupational sitting/standing compared to those in the top SEP group, and an additional 48 (35–60) min/day watching television (p<0.001 for linear trend). Stratified analyses showed that these associations between composite SEP score and total ST were evident only among participants who were in employment.
Occupational sitting seems to drive the positive association between SEP and total ST. Lower SEP is linked to higher TV viewing times.
To assess whether electronic prescribing is a comprehensive health management tool that may contribute to rational drug use, particularly in polymedicated patients receiving 16 or more medications in the public healthcare system in the Barcelona Health Region (BHR).
16 months of retrospective study followed by 12 months of prospective monitoring.
Primary healthcare in BHR, Catalonia, Spain.
All insured patients, especially those who are polymedicated in six basic health areas (BHA). Polymedicated patients were those with a consumption of ≥16 drugs/month.
Monitoring demographic and consumption variables obtained from the records of prescriptions dispensed in pharmacies and charged to the public health system, as well as the resulting drug use indicators. Territorial variables related to implementation of electronic prescribing were also described and were obtained from the institutional data related to the deployment of the project.
Trend in drug use indicators (number of prescriptions per polymedicated user, total cost per polymedicated user and total cost per prescription) according to e-prescription implementation.
There was a significant upward trend in the number of polymedicated users, number of prescriptions and total cost (p<0.05), which seemed independent from the implementation of electronic prescribing when comparing the preimplementation and postimplementation period. Prescriptions per user and cost per user showed a decrease between the preimplementation and postimplementation period, being significant in two BHAs (p<0.05).
Results suggest that after the implementation of electronic prescribing, the rationality of prescribing in polymedicated patients improved. In addition, this study provides a very valuable approach for future impact assessment.
To explore healthcare professionals' views of antibiotic prescribing in long-term care facilities (LTCFs). To use the findings to recommend intervention strategies for antimicrobial stewardship in LTCFs.
Qualitative semistructured interviews were conducted. The data were analysed by thematic content analysis. After the interviews, the emerging findings were mapped to the theoretical domains framework (TDF), and the behaviour change wheel and behaviour change technique (BCT) taxonomy were used to recommend future intervention strategies.
Interviews were conducted with 37 healthcare professionals who work in LTCFs (10 general practitioners, 4 consultants, 14 nurses, 9 pharmacists) between December 2012 and March 2013.
Interviews were conducted in the greater Cork region.
The main domains from the TDF which emerged were: 'Knowledge', 'Environmental context and resources', 'Social influences', 'Beliefs about consequences', 'Memory, attention and decision making', with the findings identifying a need for 'Behavioural regulation'. Many participants believed that antibiotic prescribing was satisfactory at their LTCF, despite the lack of surveillance activities.
This study, using the TDF and BCT taxonomy, has found that antibiotic prescribing in LTCFs is influenced by many social and contextual factors. The challenges of the setting and patient population, the belief about consequences to the patient, and the lack of implementation of guidelines and knowledge regarding antibiotic prescribing patterns are significant challenges to address. On the basis of the study findings and the application of the TDF and BCT taxonomy, we suggest some practical intervention functions for antimicrobial stewardship in LTCFs.
Previous studies on the association between vitamin D binding protein (DBP) polymorphisms and the risk of type 2 diabetes mellitus (T2DM) have produced conflicting results. The purpose of this meta-analysis was to examine whether DBP polymorphisms are associated with the risk of T2DM.
Systematic review and meta-analysis.
All eligible studies were searched and acquired from the Cochrane, Pubmed, ISI, CNKI (Chinese) and Wanfang (Chinese) databases. ORs with corresponding 95% CIs were computed to estimate the association between DBP polymorphisms and T2DM. In addition, heterogeneity test, meta-regression and sensitivity analysis were also conducted.
Six studies, which included 1191 cases and 882 controls, met the inclusion criteria and were included in the meta-analysis. The results showed that no significant associations were found between codon 416 and codon 420 polymorphisms in the DBP and the risk of T2DM in the overall analyses. In stratified analysis, significant associations between the codon 420 polymorphism and T2DM were found in Asians (allele Lys vs Thr: OR (95% CI) 1.49 (1.19 to 1.85), genotype Lys/Thr versus Thr/Thr: OR (95% CI) 1.80 (1.36 to 2.38), and Lys/Thr+Lys/Lys versus Thr/Thr: OR (95% CI) 1.81 (1.37 to 2.39), respectively) but not in Caucasians. For the codon 416, the significant association with T2DM was also detected in Asians (genotype Glu/Asp+Glu/Glu vs Asp/Asp: OR (95% CI) 1.36 (1.04 to 1.78)) but not in Caucasians.
This meta-analysis demonstrated that the DBP polymorphism was moderately associated with increased susceptibility to T2DM in Asians, but a similar association was not found in Caucasians. It suggested that ethnicity might be the potential factor associated with heterogeneity.
To test for any temporal association of Nodding syndrome with wartime conflict, casualties and household displacement in Kitgum District, northern Uganda.
Data were obtained from publicly available information reported by the Ugandan Ministry of Health (MOH), the Armed Conflict Location & Event Data (ACLED) Project of the University of Sussex in the UK, peer-reviewed publications in professional journals and other sources.
Reports of Nodding syndrome began to appear in 1997, with the first recorded cases in Kitgum District in 1998. Cases rapidly increased annually beginning in 2001, with peaks in 2003–2005 and 2008, 5–6 years after peaks in the number of wartime conflicts and deaths. Additionally, peaks of Nodding syndrome cases followed peak influxes 5–7 years earlier of households into internal displacement camps.
Peaks of Nodding syndrome reported by the MOH are associated with, but temporally displaced from, peaks of wartime conflicts, deaths and household internment, where infectious disease was rampant and food insecurity rife.
Pseudomonas aeruginosa is a common nosocomial pathogen responsible for significant morbidity and mortality internationally. Patients may become colonised or infected with P. aeruginosa after exposure to contaminated sources within the hospital environment. The aim of this study was to determine whether whole-genome sequencing (WGS) can be used to determine the source in a cohort of burns patients at high risk of P. aeruginosa acquisition.
An observational prospective cohort study.
Burns care ward and critical care ward in the UK.
Patients with >7% total burns by surface area were recruited into the study.
All patients were screened for P. aeruginosa on admission and samples taken from their immediate environment, including water. Screening patients who subsequently developed a positive P. aeruginosa microbiology result were subject to enhanced environmental surveillance. All isolates of P. aeruginosa were genome sequenced. Sequence analysis looked at similarity and relatedness between isolates.
WGS for 141 P. aeruginosa isolates were obtained from patients, hospital water and the ward environment. Phylogenetic analysis revealed eight distinct clades, with a single clade representing the majority of environmental isolates in the burns unit. Isolates from three patients had identical genotypes compared with water isolates from the same room. There was clear clustering of water isolates by room and outlet, allowing the source of acquisitions to be unambiguously identified. Whole-genome shotgun sequencing of biofilm DNA extracted from a thermostatic mixer valve revealed this was the source of a P. aeruginosa subpopulation previously detected in water. In the remaining two cases there was no clear link to the hospital environment.
This study reveals that WGS can be used for source tracking of P. aeruginosa in a hospital setting, and that acquisitions can be traced to a specific source within a hospital ward.
Asthma is now one of the most common long-term conditions in the UK. It is therefore important to develop a comprehensive appreciation of the healthcare and societal costs in order to inform decisions on care provision and planning. We plan to build on our earlier estimates of national prevalence and costs from asthma by filling the data gaps previously identified in relation to healthcare and broadening the field of enquiry to include societal costs. This work will provide the first UK-wide estimates of the costs of asthma. In the context of asthma for the UK and its member countries (ie, England, Northern Ireland, Scotland and Wales), we seek to: (1) produce a detailed overview of estimates of incidence, prevalence and healthcare utilisation; (2) estimate health and societal costs; (3) identify any remaining information gaps and explore the feasibility of filling these and (4) provide insights into future research that has the potential to inform changes in policy leading to the provision of more cost-effective care.
Secondary analyses of data from national health surveys, primary care, prescribing, emergency care, hospital, mortality and administrative data sources will be undertaken to estimate prevalence, healthcare utilisation and outcomes from asthma. Data linkages and economic modelling will be undertaken in an attempt to populate data gaps and estimate costs. Separate prevalence and cost estimates will be calculated for each of the UK-member countries and these will then be aggregated to generate UK-wide estimates.
Approvals have been obtained from the NHS Scotland Information Services Division's Privacy Advisory Committee, the Secure Anonymised Information Linkage Collaboration Review System, the NHS South-East Scotland Research Ethics Service and The University of Edinburgh's Centre for Population Health Sciences Research Ethics Committee. We will produce a report for Asthma-UK, submit papers to peer-reviewed journals and construct an interactive map.
Evaluation of the performance of VIA (visual inspection with acetic acid) trained nurses to learn colposcopy and the Swede score method to detect cervical lesions by using stationary colposcope or a portable, hand-held colposcope; the Gynocular, as compared to doctors.
A crossover randomised clinical trial.
The Colposcopy Clinic of Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka, Bangladesh.
932 women attending the clinic as either screening naïve for VIA screening (404) or women referred as VIA positive (528) from other VIA screening centres in the Dhaka region.
VIA trained nurses were trained on-site in colposcopy and in the Swede score systematic colposcopy method. The Swede score grade cervical acetowhiteness, margins plus surface. vessel pattern, lesion size and iodine staining. The women were randomised to start the examination by either a stationary colposcope or the Gynocular. Swede scores were first obtained by a nurse and the same patient was equally evaluated by a doctor.
Agreement between nurses and doctors in Swede scores was evaluated using the weighted statistic for the Gynocular and standard colposcope. The ability to predict CIN 2+ (CIN 2, CIN 3 and invasive cervical cancer) using Swede scores was evaluated using receiver-operating characteristic curves.
The Swede scores obtained by nurses and doctors using the Gynocular and stationary colposcope showed high agreement with a statistic of 0.858 and 0.859, respectively, and no difference in detecting cervical lesions in biopsy. Biopsy detected CIN 2+ in 39 (4.2%) women.
Our study showed that VIA nurses can perform colposcopy. There was no significant differences compared to doctors in detecting cervical lesions by stationary colposcope or the Gynocular using the Swede score system. Swede scores obtained by nurses using the Gynocular could offer an accurate cervical diagnostic approach in low resource settings.
Guided by the UNICEF framework for childcare, this study examined the association of childcare practices (CCP) with infant and young children's growth (height-for-age Z-scores, HAZ), and investigated whether care practices are more important to growth in some sociodemographic subgroups of children.
Cross-sectional survey.
Urban and rural Ghana.
The study sample comprised 1187 dyads of mothers aged 15–49 years and their youngest child (aged 6–36 months).
The results showed that CCP was a significant predictor of HAZ, after controlling for covariates/confounders at child, maternal and household levels. Children with higher CCP scores had higher HAZ. A 1-unit increase in the CCP score was associated with a 0.17-unit increase in HAZ. Child's and mother's age, number of children under 5 years, place of residence, maternal weight and wealth index were also significantly associated with HAZ. Statistical interaction analyses revealed no subgroup differences in the CCP/HAZ relationship.
This study found a significant, positive association between CCP and child growth, after accounting for other important determinants of child growth at maternal and household levels. This calls for research into the effects on growth of various CCP components, with longitudinal cohort study designs that can disentangle causal relationships.
To assess the dietary total and complex carbohydrate (CHO) contents in type-2 diabetes mellitus (T2DM) participants in India.
We enrolled 796 participants in this cross-sectional, single-visit, multicentre, two-arm, single-country survey. Participants were enrolled from 10 specialty endocrinology/dialectology centres from five regions of India.
A total of 796 participants (Asian) were enrolled in this study (385, T2DM and 409, non-T2DM). Key inclusion criteria—male or female ≥18 years, diagnosed with T2DM ≥12 months (T2DM), and not on any diet plan (non-T2DM).
Primary outcome was to find out the percentage of total energy intake as simple and complex CHO from total CHO. Secondary outcomes were to find the differences in percentage of total energy intake as simple CHO, complex CHO, proteins and fats between T2DM and non-T2DM groups. The percentage of T2DM participants adhering to diet plan and showing glycaemic controls were also examined.
The mean (SD) of total calorie intake per day (Kcal) was 1547 (610, 95% CI 1486 to 1608) and 2132 (1892, 95% CI 1948 to 2316), respectively, for T2DM and non-T2DM groups. In the T2DM group (n=385), the mean (SD) percentage of total energy intake as total CHO, complex CHO and simple CHO was 64.1±8.3 (95% CI 63.3 to 64.9), 57.0±11.0 (95% CI 55.9 to 58.1) and 7.1±10.8 (95% CI 6.0 to 8.2), respectively. The mean (SD) percentage of complex CHO intake from total CHO was 89.5±15.3 (95% CI 88.0 to 91.1). The mean (SD) total protein/fat intake per day (g) was 57.1 (74.0)/37.2 (18.6) and 57.9 (27.2)/55.3 (98.2) in T2DM and non-T2DM groups, respectively.
Our study shows that CHO constitutes 64.1% of total energy from diet in T2DM participants, higher than that recommended in India. However, our findings need to be confirmed in a larger epidemiological survey.
NCT01450592 & Clinical Trial Registry of India: CTRI/2012/02/002398.
Coronary heart disease (CHD) is one of the leading causes of death in both men and women worldwide. Despite the common misconception that CHD is a 'man's disease', it is now well accepted that women endure worse clinical outcomes than men following CHD-related events. A number of studies have explored whether or not gender differences exist in patients presenting with CHD, and specifically whether women delay seeking help for cardiac conditions. UK and overseas studies on help-seeking for emergency cardiac events are contradictory, yet suggest that women often delay help-seeking. In addition, no studies have looked at presumed cardiac symptoms outside an emergency situation. Given the lack of understanding in this area, an explorative qualitative study on the gender differences in help-seeking for a non-emergency cardiac events is needed.
A purposive sample of 20–30 participants of different ethnic backgrounds and ages attending a rapid access chest pain clinic will be recruited to achieve saturation. Semistructured interviews focusing on help-seeking decision-making for apparent cardiac symptoms will be undertaken. Interview data will be analysed thematically using qualitative software (NVivo) to understand any similarities and differences between the way men and women construct help-seeking. Findings will also be used to inform the preliminary development of a cardiac help-seeking intentions questionnaire.
Ethical approvals were sought and granted. Namely, the University of Westminster (sponsor) and St Georges NHS Trust REC, and the Trust Research and Development Office granted approval to host the study on the Queen Mary's Roehampton site. The study is low risk, with interviews being conducted on hospital premises during working hours. Investigators will disseminate findings via presentations and publications. Participants will receive a written summary of the key findings.
Progression-free survival (PFS) is frequently used as an efficacy end point in oncology clinical trials. However, there is limited evidence to support a positive association between improvement in PFS and improvement in health-related quality of life (HRQoL). The association between PFS and HRQoL was evaluated in two randomised trials.
Data from two randomised controlled trials in patients with non-small cell lung cancer (NSCLC; LUX-Lung 1 and LUX-Lung 3) were used to investigate HRQoL in patients to determine whether tumour progression is accompanied by worsening HRQoL. HRQoL was assessed using the cancer-specific European Organization for Research and Treatment of Cancer (EORTC) core questionnaire QLQ-C30, the EuroQol EQ-5D overall utility and EuroQol EQ visual analogue scale. In both studies, progression was evaluated by independent review using RECIST criteria (primary end point) and also by investigator assessment. The relationship between tumour progression and HRQoL was evaluated using analysis of covariance and a longitudinal model.
Compliance with HRQoL questionnaire completion was high. In both studies, patients with progression consistently experienced numerically poorer HRQoL at the time of progression than patients without progression. Differences in mean scores were statistically significant (p<0.05) between patients with and without progression at week 4 in all analyses in LUX-Lung 1 and at multiple time points in LUX-Lung 3. Results from the longitudinal analysis showed that progression (by independent review and investigator assessment) appears to have consistent negative impact on all three HRQoL measures (all p<0.0001).
Tumour progression in patients with NSCLC was associated with statistically significant worsening in HRQoL. These findings confirm the value of PFS as a patient-relevant end point.
To evaluate the clinical utility of individualising dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) in an all-comers population, including ST-elevation myocardial infarction (STEMI) patients.
Tertiary care single centre registry.
1008 consecutive PCI patients with stent implantation, without exclusion criteria.
Peri-interventional individualisation of DAPT, guided by multiple electrode aggregometry (MEA), to overcome high on-treatment platelet reactivity (HPR) to ADP-induced (≥50 U) and arachidonic acid (AA)-induced aggregation (>35 U).
The primary efficacy end point was definite stent thrombosis (ST) at 30 days. The primary safety end point was thrombolysis in myocardial infarction (TIMI) major and minor bleeding. Secondary end points were probable ST, myocardial infarction, cardiovascular death and the combined end point: major cardiac adverse event (MACE).
53% of patients presented with acute coronary syndrome (9% STEMI, 44% non-ST-elevation). HPR to ADP after 600 mg clopidogrel loading occurred in 30% of patients (73±19 U vs 28±11 U; p<0.001) and was treated by prasugrel or ticagrelor (73%), or clopidogrel (27%) reloading (22±12 U; p<0.001). HPR to ADP after prasugrel loading occurred in 2% of patients (82±26 U vs 19±10 U; p<0.001) and was treated with ticagrelor (34±15 U; p=0.02). HPR to AA occurred in 9% of patients with a significant higher proportion in patients with HPR to ADP (22% vs 4%, p<0.001) and was treated with aspirin reloading. Definite ST occurred in 0.09% of patients (n=1); probable ST, myocardial infarction, cardiovascular death and MACE occurred in 0.19% (n=2), 0.09% (n=1) and 1.8% (n=18) of patients. TIMI major and minor bleeding did not differ between patients without HPR and individualised patients (2.6% for both).
Individualisation of DAPT with MEA minimises early thrombotic events in an all-comers PCI population to an unreported degree without increasing bleeding. A randomised multicentre trial utilising MEA seems warranted.
http://www.clinicaltrials.gov; NCT01515345.
To provide an overview of the demographic characteristics of patients with positive blood alcohol concentration (BAC) and to investigate the performance of brain CT scans in these patients.
Cross-sectional study.
2192 patients who had undergone a test for blood alcohol of 13 233 patients registered in the Trauma Registry System between 1 January 2009 and 31 December 2012. A BAC level of 50 mg/dL was defined as the cut-off value. Detailed information was retrieved from the patients with positive BAC (n=793) and was compared with information from those with a negative BAC (n=1399).
Glasgow Coma Scale (GCS) and Injury Severity Score (ISS) as well as the performance and findings of obtained brain CT scans.
Patients with positive BAC had a higher rate of face injury, but a lower GCS score, a lower rate of head and neck injury, a lower ISS and New Injury Severity Score. Alcohol use was associated with a shorter length of hospital stay (8.6 vs 11.4 days, p=0.000) in patients with an ISS of <16. Of 496 patients with positive BAC who underwent brain CT, 164 (33.1%) showed positive findings on CT scan. In contrast, of 891 patients with negative BAC who underwent brain CT, 389 (43.7%) had positive findings on CT scan. The lower percentage of positive CT scan findings in patients with positive BAC was particularly evident in patients with an ISS <16 (18.0% vs 28.8%, p=0.001).
Patients who consumed alcohol tended to have a low GCS score and injuries that were less severe. However, given the significantly low percentage of positive findings, brain CT might be overused in these patients with less severe injuries.
To explore the quality and safety of medicines in Canada.
A retrospective review of drug recalls and risk communication documents conveying issues relating to defective (ie, substandard and falsified) medicines.
The Health Canada website search for drug recalls and risk communication documents issued between 2005 and 2013.
Drug recalls and risk communication documents related to quality defect in medicinal products.
Relevant data about defective medicines reported in drug recalls and risk communication documents, including description of the defect, type of formulation, year of the recall and category of the recall or the document.
There were 653 defective medicines of which 649 were substandard. The number of defective medicines reported by Health Canada increased from 42 in 2005 to 143 in 2013. The two most frequently reported types of defects were stability (205 incidents) and contamination issues (139 incidents). Some of these defects were found to be more prominent and repetitive over other types within some manufacturers. Tablet formulation (251 incidents) was the formulation most frequently compromised. No significant differences were observed between the manufacturers and distributors in the number of substandard medicines reported under each defect type. There were only four falsified medicines reported over the 9-year period.
Substandard medicines are a problem in Canada and have resulted in an increasing number of recalled medicines. Most of the failures were related to stability issues, raising the need to investigate the root causes and for stringent preventative measures to be implemented by manufacturers.
To compare maternal and neonatal birth outcomes and morbidities associated with the intention to give birth in two freestanding midwifery units and two tertiary-level maternity units in New South Wales, Australia.
Prospective cohort study.
494 women who intended to give birth at freestanding midwifery units and 3157 women who intended to give birth at tertiary-level maternity units. Participants had low risk, singleton pregnancies and were at less than 28+0 weeks gestation at the time of booking.
Primary outcomes were mode of birth, Apgar score of less than 7 at 5 min and admission to the neonatal intensive care unit or special care nursery. Secondary outcomes were onset of labour, analgesia, blood loss, management of third stage of labour, perineal trauma, transfer, neonatal resuscitation, breastfeeding, gestational age at birth, birth weight, severe morbidity and mortality.
Women who planned to give birth at a freestanding midwifery unit were significantly more likely to have a spontaneous vaginal birth (AOR 1.57; 95% CI 1.20 to 2.06) and significantly less likely to have a caesarean section (AOR 0.65; 95% CI 0.48 to 0.88). There was no significant difference in the AOR of 5 min Apgar scores, however, babies from the freestanding midwifery unit group were significantly less likely to be admitted to neonatal intensive care or special care nursery (AOR 0.60; 95% CI 0.39 to 0.91). Analysis of secondary outcomes indicated that planning to give birth in a freestanding midwifery unit was associated with similar or reduced odds of intrapartum interventions and similar or improved odds of indicators of neonatal well-being.
The results of this study support the provision of care in freestanding midwifery units as an alternative to tertiary-level maternity units for women with low risk pregnancies at the time of booking.
The 1 year prevalence of depression in adolescents is about 2%. Treatment with antidepressant medication is not recommended for initial treatment in young people due to concerns over high side effects, poor efficacy and addictive potential. Evidence suggests that cognitive behaviour therapy (CBT) is an effective treatment for depression and is currently one of the main treatment options recommended in adolescents. Given the affinity young people have with information technology they may be treated effectively, more widely and earlier in their illness evolution using computer-administered CBT (CCBT). Currently little is known about the clinical and resource implications of implementing CCBT within the National Health Service for adolescents with low mood/depression. We aim to establish the feasibility of running a fully powered randomised controlled trial (RCT).
Adolescents aged 12–18 with low mood/depression, (scoring ≥20 on the Mood and Feelings Questionnaire (MFQ)), will be approached to participate. Consenting participants will be randomised to either a CCBT programme (Stressbusters) or accessing selected websites providing information about low mood/depression. The primary outcome measure will be the Beck Depression Inventory (BDI). Participants will also complete generic health measures (EQ5D-Y, HUI2) and resource use questionnaires to examine the feasibility of cost-effectiveness analysis. Questionnaires will be completed at baseline, 4 and 12-month follow-ups. Progress and risk will be monitored via the MFQ administered at each treatment session. The acceptability of a CCBT programme to adolescents; and the willingness of clinicians to recruit participants and of participants to be randomised, recruitment rates, attrition rates and questionnaire completion rates will be collected for feasibility analysis. We will estimate 'numbers needed' to plan a fully powered RCT of clinical and cost-effectiveness.
The current trial protocol received a favourable ethical opinion from Leeds (West) Research and Ethics Committee. (Reference: 10/H1307/137).
Bacterial carriage in the upper respiratory tract is usually asymptomatic but can lead to respiratory tract infection (RTI), meningitis and septicaemia. We aimed to provide a baseline measure of Streptococcus pneumoniae, Moraxella catarrhalis, Pseudomonas aeruginosa, Staphylococcus aureus, Haemophilus influenzae and Neisseria meningitidis carriage within the community. Self-swabbing and healthcare professional (HCP) swabbing were compared.
Cross-sectional study.
Individuals registered at 20 general practitioner practices within the Wessex Primary Care Research Network South West, UK.
10 448 individuals were invited to participate; 5394 within a self-swabbing group and 5054 within a HCP swabbing group. Self-swabbing invitees included 2405 individuals aged 0–4 years and 3349 individuals aged ≥5 years. HCP swabbing invitees included 1908 individuals aged 0–4 years and 3146 individuals aged ≥5 years.
1574 (15.1%) individuals participated, 1260 (23.4%, 95% CI 22.3% to 24.5%) undertaking self-swabbing and 314 (6.2%, 95% CI 5.5% to 6.9%) undertaking HCP-led swabbing. Participation was lower in young children and more deprived practice locations. Swab positivity rates were 34.8% (95% CI 32.2% to 37.4%) for self-taken nose swabs (NS), 19% (95% CI 16.8% to 21.2%) for self-taken whole mouth swabs (WMS), 25.2% (95% CI 20.4% to 30%) for nasopharyngeal swabs (NPS) and 33.4% (95% CI 28.2% to 38.6%) for HCP-taken WMS. Carriage rates of S. aureus were highest in NS (21.3%). S. pneumoniae carriage was highest in NS (11%) and NPS (7.4%). M. catarrhalis carriage was highest in HCP-taken WMS (28.8%). H. influenzae and P. aeruginosa carriage were similar between swab types. N. meningitidis was not detected in any swab. Age and recent RTI affected carriage of S. pneumoniae and H. influenzae. Participant costs were lower for self-swabbing (£41.21) versus HCP swabbing (£69.66).
Higher participation and lower costs of self-swabbing as well as sensitivity of self-swabbing favour this method for use in large population-based respiratory carriage studies.
Care farms, where all or part of the farm is used for therapeutic purposes, show much potential for improving the health and well-being of a range of disadvantaged groups. Studies to date have been qualitative or observational, with limited empirical evidence of the effectiveness of care farms in improving health and well-being. Understanding the underlying mechanisms that lead to improvements for different disadvantaged groups is a further gap in the evidence. Participants in this study are offenders serving community orders. Their low socioeconomic status and poor health outcomes relative to the general population exemplifies disadvantage.
This paper describes the protocol of a study to understand the impacts of care farms and to pilot the design and tools for a study to assess cost-effectiveness of care farms in improving the quality of life of offenders. As a pilot study, no power calculation has been conducted. However, 150 offenders serving community sentences on care farms and 150 on other probation locations (eg, litter picking, painting) will be recruited over a 1-year period. Changes in quality of life, measured by Clinical Outcome in Routine Evaluation–Outcome Measure, health and reconvictions of offenders at care farms compared to other probation locations will be analysed to inform the sample size calculation for the follow on study. The feasibility of recruitment, retention, collecting cost data and modelling cost-effectiveness will also be assessed. The study will use qualitative methods to explore the experiences of offenders attending care farms and perceptions of probation and care farm staff on the processes and impacts of the intervention.
Findings will be published and inform development of a natural experiment and will be disseminated to probation services, care farms and academics. University of Leeds Ethical Review Board approved: SoMREC/13/014. National Offender Management Service (NOMS) approved: 2013-257.
Many maternity providers recommend that women with diabetes in pregnancy express and store breast milk in late pregnancy so breast milk is available after birth, given (1) infants of these women are at increased risk of hypoglycaemia in the first 24 h of life; and (2) the delay in lactogenesis II compared with women without diabetes that increases their infant's risk of receiving infant formula. The Diabetes and Antenatal Milk Expressing (DAME) trial will establish whether advising women with diabetes in pregnancy (pre-existing or gestational) to express breast milk from 36 weeks gestation increases the proportion of infants who require admission to special or neonatal intensive care units (SCN/NICU) compared with infants of women receiving standard care. Secondary outcomes include birth gestation, breastfeeding outcomes and economic impact.
Women will be recruited from 34 weeks gestation to a multicentre, two arm, unblinded randomised controlled trial. The intervention starts at 36 weeks. Randomisation will be stratified by site, parity and diabetes type. Women allocated to the intervention will be taught expressing and encouraged to hand express twice daily for 10 min and keep an expressing diary. The sample size of 658 (329 per group) will detect a 10% difference in proportion of babies admitted to SCN/NICU (85% power, α 0.05). Data are collected at recruitment (structured questionnaire), after birth (abstracted from medical record blinded to group), and 2 and 12 weeks postpartum (telephone interview). Data analysis: the intervention group will be compared with the standard care group by intention to treat analysis, and the primary outcome compared using 2 and ORs.
Research ethics approval will be obtained from participating sites. Results will be published in peer-reviewed journals and presented to clinicians, policymakers and study participants.
Australian Controlled Trials Register ACTRN12611000217909.
Current surgical and ablative treatment options for prostate cancer have a relatively high incidence of side effects, which may diminish the quality of life. The side effects are a consequence of procedure-related damage of the blood vessels, bowel, urethra or neurovascular bundle. Ablation with irreversible electroporation (IRE) has shown to be effective in destroying tumour cells and harbours the advantage of sparing surrounding tissue and vital structures. The aim of the study is to evaluate the safety and efficacy and to acquire data on patient experience of minimally invasive, transperineally image-guided IRE for the focal ablation of prostate cancer.
In this multicentre pilot study, 16 patients with prostate cancer who are scheduled for a radical prostatectomy will undergo an IRE procedure, approximately 30 days prior to the radical prostatectomy. Data as adverse events, side effects, functional outcomes, pain and quality of life will be collected and patients will be controlled at 1 and 2 weeks post-IRE, 1 day preprostatectomy and postprostatectomy. Prior to the IRE procedure and the radical prostatectomy, all patients will undergo a multiparametric MRI and contrast-enhanced ultrasound of the prostate. The efficacy of ablation will be determined by whole mount histopathological examination, which will be correlated with the imaging of the ablation zone.
The protocol is approved by the ethics committee at the coordinating centre (Academic Medical Center (AMC) Amsterdam) and by the local Institutional Review Board at the participating centres. Data will be presented at international conferences and published in peer-reviewed journals.
This pilot study will determine the safety and efficacy of IRE in the prostate. It will show the radiological and histopathological effects of IRE ablations and it will provide data to construct an accurate treatment planning tool for IRE in prostate tissue.
Clinicaltrials.gov database: NCT01790451.
Emergency abdominal surgery outcomes represent an internationally important marker of healthcare quality and capacity. In this study, a novel approach to investigating global surgical outcomes is proposed, involving collaborative methodology using 'snapshot' clinical data collection over a 2-week period. The primary aim is to identify internationally relevant, modifiable surgical practices (in terms of modifiable process, equipment and clinical management) associated with best care for emergency abdominal surgery.
This is a multicentre, international, prospective cohort study. Any hospital in the world performing acute surgery can participate, and any patient undergoing emergency intraperitoneal surgery is eligible to enter the study. Centres will collect observational data on patients for a 14-day period during a 5-month window and required data points will be limited to ensure practicality for collaborators collecting data. The primary outcome measure is the 24 h perioperative mortality, with 30-day perioperative mortality as a secondary outcome measure. During registration, participants will undertake a survey of available resources and capacity based on the WHO Tool for Situational Analysis.
The study will not affect clinical care and has therefore been classified as an audit by the South East Scotland Research Ethics Service in Edinburgh, Scotland. Baseline outcome measurement in relation to emergency abdominal surgery has not yet been undertaken at an international level and will provide a useful indicator of surgical capacity and the modifiable factors that influence this. This novel methodological approach will facilitate delivery of a multicentre study at a global level, in addition to building international audit and research capacity.
The study has been registered with ClinicalTrials.gov (Identifier: NCT02179112).
To evaluate maternal and neonatal outcomes associated with operative vaginal deliveries (OVDs) performed by day and at night.
Prospective cohort study.
Urban maternity unit in Ireland with off-site consultant staff at night.
All nulliparous women requiring an OVD with a term singleton fetus in a cephalic presentation from February to November 2013.
Delivery outcomes were compared for women who delivered by day (08:00–19:59) or at night (20:00–07:59).
The main outcomes included postpartum haemorrhage (PPH), anal sphincter tear and neonatal unit admission. Procedural factors included operator grade, sequential use of instruments and caesarean section.
Of the 597 women who required an OVD, 296 (50%) delivered at night. Choice of instrument, place of delivery, sequential use of instruments and caesarean section did not differ significantly in relation to time of birth. Mid-grade operators performed less OVDs by day than at night, OR 0.60 (95% CI 0.43 to 0.83), and a consultant supervisor was more frequently present by day, OR 2.26 (95% CI 1.05 to 4.83). Shoulder dystocia occurred more commonly by day, OR 2.57 (95% CI 1.05 to 6.28). The incidence of PPH, anal sphincter tears, neonatal unit admission, fetal acidosis and neonatal trauma was similar by day and at night. The mean decision to delivery intervals were 12.0 and 12.6 min, respectively.
There was no evidence of an association between time of OVD and adverse perinatal outcomes despite off-site consultant obstetric support at night.
Procalcitonin (PCT) is activated during cardiopulmonary bypass (CPB) and may be a predictor of acute respiratory distress syndrome (ARDS). The objective of this study is to determine whether patients with different serum PCT concentrations exhibit different rates of developing moderate to severe ARDS.
This is a prospective, single centre, observational cohort study. All patients admitted to the cardiosurgery department for cardiac surgery with CPB were screened for study eligibility. All eligible patients received a CPB procedure. Blood samples were obtained to determine white cell counts as well as N-terminal pro-B-type natriuretic peptide, C reactive protein and PCT levels. Patients were assigned to the PCT elevated cohort or the control cohort based on serum PCT concentrations on the first postoperative day with a cut-off value of 7.0 ng/mL. Data, including baseline, perioperative and outcome data, were collected daily for 7 days. The primary end point was the incidence of moderate to severe ARDS, which was diagnosed according to the Berlin definition.
The study was approved by the Institutional Review Board of Fujian Provincial Hospital. Study findings are disseminated through peer-reviewed publications and conference presentations.
Chinese Clinical Trial Registry (ChiCTR-OCH-14005076).
To study stroke incidence among women over 32 years of age with a focus on subdividing by stroke type, to consolidate end points and associations with risk factors.
Prospective population study initiated in 1968–1969 with follow-ups in 1974, 1980, 1992 and 2001.
Gothenburg, Sweden.
A sample of 1462 women from five age strata examined in 1968–1969, representative of women in the general population.
Main types of first-ever stroke and fatal stroke during 1968–2001 identified and validated. Stroke incidence rates in different age strata. Association with baseline smoking, body mass index (BMI), waist–hip ratio, hypertension, serum lipids, physical inactivity, perceived mental stress and education. Associations with atrial fibrillation (AF), diabetes, baseline hypertension and myocardial infarction (MI). Blood pressure (BP) levels 1–3, corresponding to modern guidelines, in relation to stroke risk.
184 (12.6%) cases of first-ever stroke, 33 (18%) of them fatal. Validation reduced unspecified stroke diagnoses from 37% to 11%. Age-standardised incidence rate per 100 000 person-years was 448. A multivariate model showed a significant association between ischaemic stroke and high BMI: HR 1.07 (95% CI 1.02 to 1.12), smoking 1.78 (1.23 to 2.57) and low education 1.17 (1.01 to 1.35). Significant association was seen between haemorrhagic stroke and, besides age, physical inactivity 2.18 (1.04 to 4.58) and for total stroke also hypertension 1.45 (1.02 to 2.08). Survival analysis showed a significantly increased risk of stroke in participants with diabetes (p<0.001), AF (p<0.001) and hypertension (p=0.001), but not MI. Stroke risk increased with increasing BP levels but was already seen for diastolic pressure grade 1 and particularly when combined with systolic BP grade 1; 1.62 (1.17 to 2.25).
Hypertension, smoking, AF, diabetes and high BMI were associated with increased stroke risk. Low education was associated with stroke. Validation of National Patient Registry diagnoses to increase specified diagnoses improved data quality.
To compare the electromyographic activity of preterm newborns placed in the kangaroo position with the activity of newborns not placed in this position.
A cohort study.
A Kangaroo Unit sector and a Nursery sector in a secondary and tertiary care at a mother-child hospital in Recife, Brazil.
Preterm infants of gestational age 27–34 weeks (n=38) and term infants (n=39).
Surface electromyography was used to investigate muscle activity in the brachial biceps at rest. 3 groups were designed: (1) preterm newborns in the kangaroo position (PT-KAN), where the newborn remains in a vertical position, lying face down, with limbs flexed, dressed in light clothes, maintaining skin-to-skin contact with the adult's thorax. Her electromyographic activity was recorded at 0 h (immediately before starting this position), and then at 48 h after the beginning of the position (but newborns were kept in the kangaroo position for 8–12 h per day) and at term equivalent age (40±1 weeks); (2) preterm newborns not in the kangaroo position (PT-NKAN), in which measurements were made at 0 h and 48 h; and (3) term newborns (T), in which measurements were made at 24 h of chronological age.
The Root Mean Square (RMS) values showed significant differences among groups (F(5,108)=56.69; p<0.001). The multiple comparisons showed that RMS was greater at 48 h compared to 0 h in the preterm group in the kangaroo position, but not in the group not submitted in the kangaroo position. The RMS in the term equivalent aged group in the kangaroo position was also greater when compared with those in the term group.
The kangaroo position increases electromyographic activity in the brachial biceps of preterm newborns and those who have reached the age equivalent to term.
Although sickness absence often is a process over time, most studies have treated the phenomenon as a discrete event and focused more on its causes than its consequences. We aimed to examine whether various patterns of previous long-term sickness absence were associated with current low perceived social support at work.
This is a historical cohort study based on data from a population-based survey among Swedish employees (n=2581). The survey data were linked to official registries yielding data on sickness absence 1–7 years prior to the survey.
The main finding was that previous sickness absence was associated with current low perceived social support at work. The highest odds for low social support were found among those who had a stable high level of sickness absence. The two indicators of perceived social support employed were somewhat differently associated with previous sickness absence: Recency of absence showed to be of importance for general support at the workplace and the relationship with colleagues and superiors. Experiencing that one's immediate superior rarely or never regards one's view was, on the other hand, mainly related to having had a high level of sickness absence, irrespective of recency.
Our results indicate that recency and extent of previous sickness absence are related to perceived social support at work. Future research on the relationship between social support and sickness absence should use repeated measurements and acknowledge the possible bidirectional relationship.
The improvement in breast cancer survival rates, along with the expected overdiagnosis and overtreatment associated with breast cancer screening, requires a comprehensive assessment of its burden. Neurological complications can have a devastating impact on these patients; neuropathic pain and chemotherapy-induced peripheral neuropathy are among the most frequently reported. This project aims to understand the burden of neurological complications of breast cancer treatment in Northern Portugal, and their role as mediator of the impact of the treatment in different dimensions of the patients' quality of life.
A prospective cohort study was designed to include 500 patients with breast cancer, to be followed for 3 years. The patients were recruited at the Portuguese Oncology Institute of Porto and evaluations were planned at different stages: pretreatment, after surgery, after chemotherapy (whenever applicable) and at 1 and 3 years after enrolment. Patients diagnosed with neuropathic pain or chemotherapy-induced peripheral neuropathy (subcohorts), were also evaluated at the moment of confirmation of clinical diagnosis of the neurological complication and 6 months later. In each of the follow-up periods, a neurological examination has been performed by a neurologist. Data were collected on sociodemographic and clinical characteristics, quality of life, sleep quality, and anxiety and depression. Between January and December 2012, we recruited and conducted the baseline evaluation of 506 participants. The end of the follow-up period is scheduled for December 2015.
The study protocol was approved by the Ethics Committee of the Portuguese Oncology Institute of Porto and all patients provided written informed consent. All study procedures were developed in order to assure data protection and confidentiality. Results from this project will be disseminated in international peer-reviewed journals and presented in relevant conferences.
The National Clinical Guidelines for Stroke recommend 'routine follow-up of patients 6 months post discharge'. The Sentinel Stroke National Audit Programme sets a standard of 6 months postadmission follow-up, capturing data on process and outcomes. There appears to be no convincing model of stroke follow-up at 6 months, and despite evidence of unmet need in almost 50% of stroke survivors 1–5 years after their stroke, little work focuses on the first 12 months of recovery. By listening to the living experiences of stroke, the research aims to tailor the stroke care pathway to the needs of those affected.
A focus group of six stroke survivors and carers will be invited to identify appropriate interview questions about the value of follow-up at 6 months, ensuring that this study has its genesis in the participant experience. A pilot study of four stroke survivors will ascertain the feasibility of the method. Thirty stroke survivors from the follow-up clinic will be invited to take part in semistructured interviews. Raw data, in the form of digital recordings of the interviews, will be transcribed. Interview transcriptions will be checked by the participant for accuracy prior to analysis using NVivo software. Literal and reflective narrative analysis will be used to code transcribed text to examine shared themes and reflect on content.
Study documentation has been reviewed by the Coventry and Warwickshire Research Ethics Committee; the chief investigator met with the committee to scrutinise the study and justify its methodology. The committee has approved this study. A copy of the final report will be given to participants, the Stroke Association, the local Clinical Commissioning Group and participants' general practitioners. It is intended to disseminate the results locally by presentation to the Trust board, at academic conferences and by publication in a peer-reviewed scientific journal.
Overutilisation of antibiotics may contribute to the emergence of antimicrobial drug resistance, a growing international concern. This study aimed to analyse the performance of UK general practices with respect to antibiotic prescribing for respiratory tract infections (RTIs) among young and middle-aged adults.
Data are reported for 568 UK general practices contributing to the Clinical Practice Research Datalink.
Participants were adults aged 18–59 years. Consultations were identified for acute upper RTIs including colds, cough, otitis-media, rhino-sinusitis and sore throat.
For each consultation, we identified whether an antibiotic was prescribed. The proportion of RTI consultations with antibiotics prescribed was estimated.
There were 568 general practices analysed. The median general practice prescribed antibiotics at 54% of RTI consultations. At the highest prescribing 10% of practices, antibiotics were prescribed at 69% of RTI consultations. At the lowest prescribing 10% of practices, antibiotics were prescribed at 39% RTI consultations. The median practice prescribed antibiotics at 38% of consultations for 'colds and upper RTIs', 48% for 'cough and bronchitis', 60% for 'sore throat', 60% for 'otitis-media' and 91% for 'rhino-sinusitis'. The highest prescribing 10% of practices issued antibiotic prescriptions at 72% of consultations for 'colds', 67% for 'cough', 78% for 'sore throat', 90% for 'otitis-media' and 100% for 'rhino-sinusitis'.
Most UK general practices prescribe antibiotics to young and middle-aged adults with respiratory infections at rates that are considerably in excess of what is clinically justified. This will fuel antibiotic resistance.
To understand the impact of social organisation affiliation and farmers' agricultural production practices on farmer health. Organisations facilitate the acquisition and exchange of forms of social capital which can influence the adoption of practices with potential health impacts. In countries such as Ecuador, smallholder agriculture is practised by socially vulnerable populations. Agricultural production often involves the use of extremely hazardous pesticides, while practices that reduce the use of chemicals through integrated pest management (IPM) remain uncommon.
Longitudinal study (2007–2010).
12 Ecuadorian communities, previously part of a participatory action research study.
208 small-scale farmers. Inclusion criteria were: age between 18 and 65 years, literate and resident in the community for the previous 3 years.
The differential effects of the membership in social organisations (as an effect modifier), on the relationship between the implementation of IPM practices (main independent variable) and farmers' health, measured by neurocognitive performance scores (better higher value; dependent variable).
Among organisational participants, the coefficient of association between the implementation of IPM practices for the category good/very good (vs no use) and neurocognitive performance, when farmers were involved in organisations, was negative and moderate (β=–0.17, SE 0.21) though not significant (p>0.1); for the category little/moderate use, the coefficient was positive (β=0.34, SE 0.19) and significant. Among those who did not participate in organisations, both little/moderate use and good/very good use of IPM practices were associated with an increase in neurocognitive performance.
The effect of agricultural production practices on farmers' health, transmitted through organisations, can be differentiated. Organisations as structures of social capital seem to be functional in the social reproduction process of the communities studied. Results highlight the need to redirect the analysis of social capital to a more integrated study of social determination of health.
We compared the distribution by wealth of self-reported illness burden (estimated from validated scales, biomarker and reported symptoms) for angina, cataract, depression, diabetes and osteoarthritis, with the distribution of self-reported medical diagnosis and treatment. We aimed to determine if the greater illness burden borne by poorer participants was matched by appropriately higher levels of diagnosis and treatment.
The English Longitudinal Study of Ageing, a panel study of 12 765 participants aged 50 years and older in four waves from 2004 to 2011, selected using a stratified random sample of households in England. Distribution of illness burden, diagnosis and treatment by wealth was estimated using regression analysis.
The main outcome measures were ORs for the illness burden, diagnosis and treatment, respectively, adjusted for age, sex and wealth. We estimated the illness burden for angina with the Rose Angina scale, diabetes with fasting glycosylated haemoglobin, depression with the Centre for Epidemiologic Studies Depression Scale, osteoarthritis with self-reported pain and disability and cataract with self-reported poor vision. Medical diagnoses were self-reported for all conditions. Treatment was defined as β-blocker prescription for angina, surgery for osteoarthritis and cataract, and receipt of predefined effective interventions for diabetes and depression.
Compared with the wealthiest, the least wealthy participant had substantially higher odds for illness burden from any of the five conditions at all four time points, with ORs ranging from 4.2 (95% CI 2.6 to 6.8) for diabetes to 15.1 (11.4 to 20.0) for osteoarthritis. The ORs for diagnosis and treatment were smaller in all five conditions, and ranged from 0.9 (0.5 to 1.4) for diabetes treatment to 4.5 (3.3 to 6.0) for angina diagnosis.
The substantially higher illness burden in less wealthy participants was not matched by appropriately higher levels of diagnosis and treatment.
Insufficient skills in drug dose calculations increase the risk for medication errors. Even experienced nurses may struggle with such calculations. Learning flexibility and cost considerations make e-learning interesting as an alternative to classroom teaching. This study compared the learning outcome and risk of error after a course in drug dose calculations for nurses with the two methods.
In a randomised controlled open study, nurses from hospitals and primary healthcare were randomised to either e-learning or classroom teaching. Before and after a 2-day course, the nurses underwent a multiple choice test in drug dose calculations: 14 tasks with four alternative answers (score 0–14), and a statement regarding the certainty of each answer (score 0–3). High risk of error was being certain that incorrect answer was correct. The results are given as the mean (SD).
16 men and 167 women participated in the study, aged 42.0 (9.5) years with a working experience of 12.3 (9.5) years. The number of correct answers after e-learning was 11.6 (2.0) and after classroom teaching 11.9 (2.0) (p=0.18, NS); improvement were 0.5 (1.6) and 0.9 (2.2), respectively (p=0.07, NS). Classroom learning was significantly superior to e-learning among participants with a pretest score below 9. In support of e-learning was evaluation of specific value for the working situation. There was no difference in risk of error between groups after the course (p=0.77).
The study showed no differences in learning outcome or risk of error between e-learning and classroom teaching in drug dose calculations. The overall learning outcome was small. Weak precourse knowledge was associated with better outcome after classroom teaching.
Critical illness myopathy (CIM) and polyneuropathy (CIP) are common complications of critical illness that frequently occur together. Both cause so called intensive care unit (ICU)-acquired muscle weakness. This weakness of limb muscles increases morbidity and delay rehabilitation and recovery of walking ability. Although full recovery has been reported people with severe weakness may take months to improve walking. Focused physical rehabilitation of people with ICU-acquired muscle weakness is therefore of great importance. However, although physical rehabilitation is common, detailed knowledge about the pattern and the time course of recovery of walking function are not well understood. Therefore, the aim of the General Weakness Syndrome Therapy (GymNAST) study is to describe the time course of recovery of walking function and other activities of daily living in these patients.
We conduct a prospective cohort study of people with ICU-acquired muscle weakness with defined diagnosis of CIM or CIP. Based on our sample size calculation, approximately 150 patients will be recruited from the ICU of our hospital in Germany. Amount and content of physical rehabilitation, clinical tests for example, muscle strength and motor function and neuropsychological assessments will be used as independent variables. The primary outcomes will include recovery of walking function and mobility. Secondary outcomes will include global motor function, activities in daily life and participation.
The study is being carried out in agreement with the Declaration of Helsinki and conducted with the approval of the local medical Ethics Committee (Landesärztekammer Sachsen, Germany, reference number EK-BR-32/13-1) and with the understanding and written consent of each patient's guardian. The results of this study will be published in peer-reviewed journals and disseminated to the medical society and general public.
Innovative new drugs offer potential benefits to patients, healthcare systems, governments and the pharmaceutical industry. Recent data suggest annual numbers of new drugs launched in the UK have increased in recent years, and we sought to understand whether this represents increasing numbers of highly innovative drugs being made available or the introduction of increasing numbers of drugs with limited additional therapeutic value.
Retrospective observational study of new drug entries in the British National Formulary (BNF).
Number of new drugs launched in the UK each year (based on first appearance in the BNF) from 2001 to 2012, including new chemical entities and new biological drugs, categorised by degree of innovativeness according to published criteria that incorporate both clinical usefulness and the nature of the innovation.
Highly innovative, moderately innovative and slightly innovative drugs made up 26%, 18% and 56% of all newly launched drugs, respectively, for the study period (n=290). There was an upward trend in annual numbers of slightly innovative drugs from 2004 onwards (R2=0.44), which aligned closely with the recovery in total numbers of new drugs launched each year since that time. There were no discernible time trends in the highly or moderately innovative categories. New drugs for malignancy and skin disease were most likely to be characterised as highly innovative (44% and 57%, respectively).
Highly innovative new drugs comprise only around a quarter of all new drug launches in the UK. In contrast, drugs categorised as only slightly innovative comprised well over half of all new drugs and annual numbers in this category are increasing. Current policy initiatives that seek to increase the supply of innovative new drugs have long-lead times to impact, and will need careful assessment to ensure they deliver their aims without unintended consequences.
To examine the prevalence of atrial fibrillation (AF) and cardiac structural characteristics in Indigenous and non-Indigenous Australians.
Retrospective cross-sectional study linking clinical, echocardiography and administrative databases over a 10-year period.
A tertiary, university teaching hospital in Adelaide, Australia.
Indigenous and non-Indigenous Australians.
AF prevalence and echocardiographic characteristics.
Indigenous Australians with AF were significantly younger compared to non-Indigenous Australians (55±13 vs 75±13 years, p<0.001). As a result, racial differences in AF prevalence and left atrial diameter varied according to age. In those under 60 years of age, Indigenous Australians had a significantly greater AF prevalence (2.57 vs1.73%, p<0.001) and left atrial diameters (39±7 vs 37±7 mm, p<0.001) compared to non-Indigenous Australians. In those aged 60 years and above, however, non-Indigenous Australians had significantly greater AF prevalence (9.26 vs 4.61%, p<0.001) and left atrial diameters (39±7 vs 37±7 mm, p<0.001). Left ventricular ejection fractions were less in Indigenous Australians under 60 years of age (49±14 vs 55±11%, p<0.001) and not statistically different in those aged 60 years and above (47±11 vs 52±13, p=0.074) compared to non-Indigenous Australians. Despite their younger age, Indigenous Australians with AF had similar or greater rates of cardiovascular comorbidities than non-Indigenous Australians with AF.
Young Indigenous Australians have a significantly greater prevalence of AF than their non-Indigenous counterparts. In contrast, older non-Indigenous Australians have a greater prevalence of AF compared to their Indigenous counterparts. These observations may be mediated by age-based differences in comorbid cardiovascular conditions, left atrial diameter and left ventricular ejection fraction. Our findings suggest that AF is likely to be contributing to the greater burden of morbidity and mortality experienced by young Indigenous Australians. Further study is required to elucidate whether strategies to prevent and better manage AF in Indigenous Australians may reduce this burden.
In non-inferiority trials of radiotherapy in patients with early stage breast cancer, it is inevitable that some patients will cross over from the experimental arm to the standard arm prior to initiation of any treatment due to complexities in treatment planning or subject preference. Although the intention-to-treat (ITT) analysis is the preferred approach for superiority trials, its role in non-inferiority trials is still under debate. This has led to the use of alternative approaches such as the per-protocol (PP) analysis or the as-treated (AT) analysis, despite the inherent biases of such approaches.
Using simulations, we investigate the effect of 2%, 5% and 10% random and non-random crossovers prior to radiotherapy initiation on the ITT, PP, AT and the combination of ITT and PP analyses with respect to type I error in trials with time-to-event outcomes. We also evaluate bias and SE of the estimates from the ITT, PP and AT approaches.
The AT approach had the best performance in terms of type I error, but was anticonservative as non-random crossover increased. The ITT and PP approaches were anticonservative under all percentages of random and non-random crossover. Similarly, lowest bias was seen with the AT approach; however, bias increased as the percentage of non-random crossover increased. The ITT and PP had poor performance in terms of bias as crossovers increased.
If minimal crossovers were to occur, we have shown that the AT approach has the lowest type I error rates and smallest opportunity for bias. Results of trials with a high number of crossovers should be interpreted with caution, especially when crossover is non-random. Attempts to prevent crossovers should be maximised.
The scientific evidence base in support of salt reduction is strong but the data required to translate these insights into reduced population salt intake are mostly absent. The aim of this research project is to develop the evidence base required to formulate and implement a national salt reduction programme for India.
The research will comprise three components: a stakeholder analysis involving government, industry, consumers and civil society organisations; a population survey using an age-stratified and sex-stratified random samples drawn from urban (slum and non-slum) and rural areas of North and South India; and a systematic quantitative evaluation of the nutritional components of processed and restaurant foods. The stakeholder interviews will be analysed using qualitative methods to summarise the main themes and define the broad range of factors influencing the food environment in India. The population survey will estimate the mean daily salt consumption through the collection of 24 h urine samples with concurrent dietary surveys identifying the main sources of dietary sodium/salt. The survey of foods will record the nutritional composition of the chief elements of food supply. The findings from this research will be synthesised and proposals for a national salt reduction strategy for India will be developed in collaboration with key stakeholders.
This study has been approved by the Human Research Ethics Committees of the University of Sydney and the Centre for Chronic Disease Control in New Delhi, and also by the Indian Health Ministry's Screening Committee. The project began fieldwork in February 2014 and will report the main results in 2016. The findings will be targeted primarily at public health policymakers and advocates, but will be disseminated widely through other mechanisms including conference presentations and peer-reviewed publications, as well as to the participating communities.
Medical decision-making in oncology is a complicated process and to date there are few studies examining how patients with cancer make choices with respect to different features of their care. It is also unknown whether patient choices vary by geographical location and how location could account for observed rural and metropolitan cancer differences. This paper describes an ongoing study that aims to (1) examine patient and healthcare-related factors that influence choices of patients with cancer; (2) measure and quantify preferences of patients with cancer towards cancer care using a discrete choice experiment (DCE) and (3) explore preference heterogeneity between metropolitan and rural locations.
A DCE is being conducted to understand how patients with cancer choose between two clinical scenarios accounting for different patient and healthcare-related factors (and levels). Preliminary qualitative research was undertaken to guide the development of an appropriate DCE design including characteristics that are important and relevant to patients with cancer. A fractional factorial design using the D-efficiency criteria was used to estimate interactions among attributes. Multinomial logistic regression will be used for the primary DCE analysis and to control for sociodemographic and clinical characteristics.
The Barwon Health Human Research Ethics Committee approved the study. Findings from the study will be presented in national/international conferences and peer-reviewed journals. Our results will form the basis of a feasibility study to inform the development of a larger scale study into preferences of patients with cancer and their association with cancer outcomes.
The purpose of the study was to examine whether the insertion (I) and/or deletion (D) polymorphism of ACE confers susceptibility to primary pterygium in Sardinian patients in a case–control study.
Polymorphism genotyping was performed by nested PCR using genomic DNA extracted from the whole peripheral blood of participants with (n=251) and without (n=260) pterygium. DD, ID and II genotype frequencies were: 48%, 39% and 13%, respectively, for patients with pterygium, and 15%, 40% and 44%, respectively, for the control group. A statistically significant difference was found between the pterygium and control groups for the ACE I/D polymorphism (p<0.001). Moreover, a statistically significant difference was found between the DD and II groups (p<0.01; OR=10.49; 95% CI 6.18 to 17.79), DD+ID versus II group (p<0.01; OR=5.23; 95% CI 3.37 to 8.13) and DD versus ID groups (p<0.01; OR=3.21; 95% CI 2.04 to 5.04).
Statistical analysis showed that the DD genotype is associated with an increased risk of developing pterygium, and with a good chance that the D allele may play an important role in the development of disease.
Rapid urbanisation in Kenya has resulted in growth of slums in urban centres, characterised by poverty, inadequate social services and poor health outcomes. The government's initiatives to improve access to quality healthcare for mothers and children are largely limited to public health facilities, which are few and/or inaccessible in underserved areas such as the slums. The 'Partnership for Maternal, Newborn and Child Health' (PAMANECH) project is being implemented in two Nairobi slums, Viwandani and Korogocho, to assess the impact of strengthening public–private partnerships for the delivery of healthcare on the health of mothers, newborns and young children in two informal settlements in Kenya.
This is a quasi-experimental study; our approach is to support private as well as public health providers and the community to enhance access to and demand for quality healthcare services. Key activities include: infrastructural upgrade of selected Private Not-For-Profit health facilities operating in the two slums, building capacity for healthcare providers as well as the Health Management Teams in Nairobi, facilitating provision of supportive supervision by the local health authorities and forming networks of Community Health Volunteers (CHVs) to create demand for health services. To assess the impact of the intervention, the study is utilising multiple data sources using a combination of qualitative and quantitative methods. A baseline survey was conducted in 2013 and an end-line survey will be conducted at least 1 year after full implementation of the intervention. Systematic monitoring and documentation of the intervention is on-going to strengthen the case for causal inference.
Ethical approval for the study was obtained from the Kenya Medical Research Institute. Key messages from the results will be packaged and widely disseminated through workshops, conference presentations, reports, factsheets and academic publications to facilitate uptake by policymakers.
KEMRI- NON-SSC-PROTOCOL No. 393.
Intracranial arteriovenous malformations (AVMs) are associated with high morbidity and mortality. Modern microsurgery has improved the results of surgical treatment of AVMs; however, the treatment of AVMs, particularly eloquently located AVMs, still carries a high risk. Functional MRI (fMRI) has been reported to be used for the preoperative evaluation of AVMs in small case series. The purpose is to identify the utility and efficacy of fMRI-guided microsurgery of AVMs in a large randomised controlled trial.
The study is a prospective, randomised controlled clinical trial. This study will enrol a total of 600 eligible patients. These eligible patients will be randomised to the standard microsurgery group and the fMRI-guided microsurgery group in a 1:1 ratio. Patient baseline characteristics and AVM architecture and characteristics will be described. In the fMRI-guided group, fMRI mapping of an eloquent cortex in all AVMs will be identified. Surgical complications and outcomes at pretreatment, post-treatment, at discharge and at 1-month, 3-month and 6-month follow-up intervals will be analysed using the modified Rankin Scale (mRS). This trial will determine whether fMRI-guided microsurgery could improve outcomes in patients with AVMs and also identify the safety and efficacy of fMRI-guided microsurgery.
The study protocol and written informed consent were reviewed and approved by the Institutional Review Board of Beijing Tiantan Hospital Affiliated to Capital Medical University (ky2012-016-02). Study findings will be disseminated in the printed media.
ClinicalTrials.gov NCT01758211.
Recent publications have called for substantial improvements in the design, conduct, analysis and reporting of prediction models. Publication of study protocols, with prespecification of key aspects of the analysis plan, can help to improve transparency, increase quality and protect against increased type I error. Valid population-based risk algorithms are essential for population health planning and policy decision-making. The purpose of this study is to develop, evaluate and apply cardiovascular disease (CVD) risk algorithms for the population setting.
The Ontario sample of the Canadian Community Health Survey (2001, 2003, 2005; 77 251 respondents) will be used to assess risk factors focusing on health behaviours (physical activity, diet, smoking and alcohol use). Incident CVD outcomes will be assessed through linkage to administrative healthcare databases (619 886 person-years of follow-up until 31 December 2011). Sociodemographic factors (age, sex, immigrant status, education) and mediating factors such as presence of diabetes and hypertension will be included as predictors. Algorithms will be developed using competing risks survival analysis. The analysis plan adheres to published recommendations for the development of valid prediction models to limit the risk of overfitting and improve the quality of predictions. Key considerations are fully prespecifying the predictor variables; appropriate handling of missing data; use of flexible functions for continuous predictors; and avoiding data-driven variable selection procedures. The 2007 and 2009 surveys (approximately 50 000 respondents) will be used for validation. Calibration will be assessed overall and in predefined subgroups of importance to clinicians and policymakers.
This study has been approved by the Ottawa Health Science Network Research Ethics Board. The findings will be disseminated through professional and scientific conferences, and in peer-reviewed journals. The algorithm will be accessible electronically for population and individual uses.
ClinicalTrials.gov NCT02267447.
Major depression is a serious mental disorder that causes substantial distress and impairment in individuals and places an enormous burden on society. Although antidepressant treatment is the most common therapy provided in routine practice, there is little evidence to guide second-line therapy for patients who have failed to respond to antidepressants. The aim of this paper is to describe the study protocol for a randomised controlled trial that measures the clinical effectiveness of cognitive behavioural therapy (CBT) as an augmentation strategy to treat patients with non-psychotic major depression identified as suboptimal responders to usual depression care.
The current study is a 16-week assessor-blinded randomised, parallel-groups superiority trial with 12-month follow-up at an outpatient clinic as part of usual depression care. Patients aged 20–65 years with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) Major Depressive Disorder who have experienced at least one failed trial of antidepressants as part of usual depression care, will be randomly assigned to receive CBT plus treatment as usual, or treatment as usual alone. The primary outcome is the change in clinician-rated 17-item GRID-Hamilton Depression Rating Scale (GRID-HAMD) score at 16 weeks, and secondary outcomes include severity and change in scores of subjective depression symptoms, proportion of responders and remitters, safety and quality of life. The primary population will be the intention-to-treat patients.
All protocols and the informed consent form comply with the Ethics Guideline for Clinical Research (Japanese Ministry of Health, Labour and Welfare). Ethics review committees at the Keio University School of Medicine and the Sakuragaoka Memorial Hospital approved the study protocol. The results of the study will be disseminated at several research conferences and as published articles in peer-reviewed journals. The study will be implemented and reported in line with the CONSORT statement.
UMIN Clinical Trials Registry: UMIN000001218.
Hip fractures are a significant cause of morbidity and mortality and care of hip fracture patients places a heavy burden on healthcare systems due to prolonged recovery time. Measuring quality of care delivered to hip fracture patients is important to help target efforts to improve care for patients and efficiency of the health system. The purpose of this study is to synthesise the evidence surrounding quality of care indicators for patients who have sustained a hip fracture. Using a scoping review methodology, the research question that will be addressed is: "What patient, institutional, and system-level indicators are currently in use or proposed for measuring quality of care across the continuum for individuals following a hip fracture?".
We will employ the methodological frameworks used by Arksey and O'Malley and Levac et al. The synthesis will be limited to quality of care indicators for individuals who suffered low trauma hip fracture. All English peer-reviewed studies published from the year 2000-most recent will be included. Literature search strategies will be developed using medical subject headings and text words related to hip fracture quality indicators and the search will be peer-reviewed. Numerous electronic databases will be searched. Two reviewers will independently screen titles and abstracts for inclusion, followed by screening of the full text of potentially relevant articles to determine final inclusion. Abstracted data will include study characteristics and indicator definitions.
To improve quality of care for patients and create a more efficient healthcare system, mechanisms for the measurement of quality of care are required. The implementation of quality of care indicators enables stakeholders to target areas for improvement in service delivery. Knowledge translation activities will occur throughout the review with dissemination of the project goals and findings to local, national, and international stakeholders.
To understand how often 'breakthroughs,' that is, treatments that significantly improve health outcomes, can be developed.
We applied weighted adaptive kernel density estimation to construct the probability density function for observed treatment effects from five publicly funded cohorts and one privately funded group.
820 trials involving 1064 comparisons and enrolling 331 004 patients were conducted by five publicly funded cooperative groups. 40 cancer trials involving 50 comparisons and enrolling a total of 19 889 patients were conducted by GlaxoSmithKline.
We calculated that the probability of detecting treatment with large effects is 10% (5–25%), and that the probability of detecting treatment with very large treatment effects is 2% (0.3–10%). Researchers themselves judged that they discovered a new, breakthrough intervention in 16% of trials.
We propose these figures as the benchmarks against which future development of 'breakthrough' treatments should be measured.
Cholangiocarcinoma (CCA) is the most common malignancy in a Northeast Thai population. Smoking and alcohol drinking are associated with the production of free radical intermediates, which can cause several types of DNA lesions. Reduced repair of these DNA lesions would constitute an important risk factor for cancer development. We therefore examined whether polymorphisms in DNA base-excision repair (BER) genes, XRCC1 G399A and OGG1 C326G, were associated with CCA risk and whether they modified the effect of smoking and alcohol drinking in the Thai population.
A nested case–control study within the cohort study was conducted: 219 participants with primary CCA were each matched with two non-cancer controls from the same cohort on sex, age at recruitment and the presence/absence of Opisthorchis viverrini eggs in stools. Smoking and alcohol consumption were assessed on recruitment. Polymorphisms in BER genes were analysed using a PCR with high-resolution melting analysis. The associations were assessed using conditional logistic regression.
Our results suggest that, in the Thai population, polymorphisms in XRCC1 and OGG1 genes, particularly in combination, are associated with increased susceptibility to CCA, and that their role as modifiers of the effect of smoking and alcohol consumption influences the risk of CCA.
Better ways of reducing habitual smoking and alcohol consumption, targeted towards subgroups which are genetically susceptible, are recommended. CCA is a multifactorial disease, and a comprehensive approach is needed for its effective prevention. This approach would also have the additional advantage of reducing the onset of other cancers.
Our objective was to augment the limited evidence mainly from local, clinical studies of ethnic differences in gastrointestinal disorders. Our question was: are there ethnic variations in hospitalisation/death for lower gastrointestinal disorders in Scotland?
This retrospective-cohort linked 4.65 (of 4.9) million people in the 2001 census of Scotland (providing data on ethnicity, country of birth and indicators of socioeconomic deprivation) to 9 years of National Health Service hospitalisation and death records.
For appendicitis, we studied all ages; for irritable bowel syndrome, ulcerative colitis, Crohn's disease and diverticular disease, we included those ≥20 years. Using Poisson regression (robust variance) we calculated, by ethnic group and sex, first-hospitalisation/death age-adjusted rates per 100 000 person-years, and relative risks (RRs) with 95% CIs multiplied by 100, so the White Scottish reference population had an RR=100.
There were ethnic variations; for example, for irritable bowel syndrome, RRs (95% CIs) were comparatively high in Other White British women (128.4 (111.0 to 148.6)), and low in Pakistani women (75.1 (60.6 to 93.1)). For appendicitis, RRs were high in men in Other White British (145.2 (127.8 to 164.9)), and low in most non-White groups, for example, Pakistanis (73.8 (56.9 to 95.6)). For ulcerative colitis, RRs were high in Indian (169.8 (109.7 to 262.7)) and Pakistani (160.8 (104.2 to 248.2)) men. For Crohn's disease, the RR was high in Pakistani men (209.2 (149.6 to 292.6)). For diverticular disease, RRs were high in Irish men (176.0 (156.9 to 197.5)), and any Mixed background women (144.6 (107.4 to 194.8)), and low in most non-White groups, for example, Chinese men (47.1 (31.0 to 71.6) and women (46.0 (30.4 to 69.8)).
Appendicitis and diverticular disease were comparatively low in most non-White groups, while ulcerative colitis and Crohn's disease were mostly higher in South Asians. Describing and understanding such patterns may help clinical practice and research internationally.
Ginger-salt-indirect moxibustion is widely applied to treat urge urinary incontinence after stroke, which is a common complication in stroke survivors. Moxa cone moxibustion and moxa box moxibustion are the main techniques of ginger-salt-indirect moxibustion. Our previous study had shown that ginger-salt-indirect moxibustion using moxa cones was feasible and effective for urination disorders post-stroke. This pilot study aims to assess the feasibility of conducting research to evaluate the efficacy and safety of ginger-salt-indirect moxibustion for patients with post-stroke urge urinary incontinence.
This is a multicentre, prospective, single-blinded, pilot randomised controlled trial. 120 eligible patients will be randomly allocated to three groups. Treatment group A (n=40) will receive moxa cone moxibustion and routine care; treatment group B (n=40) will receive moxa box moxibustion and routine care; control group (n=40) will only receive routine care for stroke recovery. The entire moxibustion treatment will consist of a total of 28 sessions during the course of 4 weeks. The primary outcome measure will be the increase in mean volume per void assessed at week 4 from the first moxibustion session (baseline). Secondary outcome measures will include mean frequency of urination per day and quality of life assessments measured by completion of the Incontinence Quality of Life Questionnaire and Barthel Index. All outcome measures will be assessed at baseline and at 4 and 16 weeks from baseline. Adverse events in the three groups will be recorded to assess the safety of moxibustion.
Research ethics was approved by the Research Ethical Committee of Beijing Hospital of Traditional Chinese Medicine Affiliated to the Capital Medical University (ref: 2013BL-094). Written informed consent will be obtained from all participants. Study results will be published in peer reviewed journals.
Despite the fact that a considerable portion of hepatitis C virus (HCV) positive individuals are viraemic, the risk of transmitting HCV to others is context dependent. Prison is a particularly risky environment as HCV prevention tools are often unavailable. Using data from a cross-sectional study conducted in centres for HCV testing in southeastern France, we aimed to compare the patterns of risk factors in HCV-positive inmates with those in the general population.
26 centres for HIV/HCV testing in southeastern France (23 in the general population and 3 in prison).
HCV seropositivity measured with ELISA test.
A propensity score method to ensure that the general and inmate populations could be compared and a multimodel averaging to estimate the degree (strong, weak, none) of the association of a number of specific factors with HCV seropositivity in each group.
Among the 52 082 participants, HCV infection prevalence was 1.5% and 5.2% in the general (n=46 125) and inmate (n=5957) populations, respectively. In both populations, 'drug injection without snorting' and 'drug injection with snorting' were very strongly associated with HCV seropositivity. Among inmates, 'drug snorting alone' (OR (95% CI) 2.21 (1.39 to 3.52) was also a strong correlate while tattoos, piercings (OR (95% CI) 1.22 (0.92 to 1.61)) and the sharing of toiletry items (OR (95% CI) 1.44 (0.84 to 2.47)) were weak correlates.
The pattern of risk factors associated with HCV seropositivity is different between the general and prison populations, injection and snorting practices being more prevalent in the latter. Access to prevention measures in prisons is not only a public health issue but also a human right for inmates who deserve equity of care and prevention.
Symptomatic hip osteoarthritis (OA) is a disabling condition with up to a 25% cumulative lifetime risk. Total hip arthroplasty (THA) is effective in relieving patients' symptoms and improving function. It is, however, associated with substantial risk of complications, pain and major functional limitation before patients can return to full function. In contrast, hip arthroscopy (HA) is less invasive and can postpone THA. However, there is no evidence regarding the delay in the need for THA that patients would find acceptable to undergoing HA. Knowing patients' values and preferences (VP) on this expected delay is critical when making recommendations regarding the advisability of HA. Furthermore, little is known on the optimal amount of information regarding interventions and outcomes needed to present in order to optimally elicit patients' VP.
We will perform a multinational, structured interview-based survey of preference in delay time for THA among patients with non-advanced OA who failed to respond to conservative therapy. We will combine these interviews with a randomised trial addressing the optimal amount of information regarding the interventions and outcomes required to elicit preferences. Eligible patients will be randomly assigned (1 : 1) to either a short or a long format of health scenarios of THA and HA. We will determine each patient's VP using a trade-off and anticipated regret exercises. Our primary outcomes for the combined surveys will be: (1) the minimal delay time in the need for THA surgery that patients would find acceptable to undertaking HA, (2) patients' satisfaction with the amount of information provided in the health scenarios used to elicit their VPs.
The protocol has been approved by the Hamilton Integrated Research Ethics Board (HIREB13-506). We will disseminate our study findings through peer-reviewed publications and conference presentations, and make them available to guideline makers issuing recommendations addressing HA and THA.
Providing lifetime smoking prevalence data and gender-specific cigarette consumption data for use in epidemiological studies of tobacco-induced cancer in Norway. Characterising smoking patterns in birth cohorts is essential for evaluating the impact of tobacco control interventions and predicting smoking-related mortality.
Previously analysed annual surveys of smoking habits from 1954 to 1992, and individual lifetime smoking histories collected in 1965 from a sample of people born in 1893–1927, were supplemented with new annual surveys of smoking habits from 1993 to 2013. Age range 15–74 years.
Current smoking proportions in 5-year gender-and-birth cohorts of people born between 1890 and 1994.
The proportion of smokers increased in male cohorts until the 1950s, when the highest proportion of male smokers (76–78%) was observed among those born in 1915–1934. Among women, the peak (52%) occurred 20 years later, in women born in 1940–1949. After 1970 smoking has declined in all cohorts of men and women. In the 1890–1894 cohorts, male smoking prevalence was several times higher than female, but the gap declined until no gender difference was present among those born after 1950. Gender-specific per capita consumption was even more skewed, and men have consumed over 70% of all cigarettes since 1930. The incidence of lung cancer for men peaked at around 2000, with the highest incidence rate estimated at ca. 38%. The incidence of lung cancer for women is still increasing, and estimated incidence rate for 2011 was 25.2%.
In an epidemiological perspective, men have had a longer and more intense exposure to cigarettes than women. The gender-specific incidence of lung cancer reflects the gender difference in consumption over time.
To seek the experiences and perspectives of parents caring for children with dysphagia, with emphasis on their experiences of working within their child's multidisciplinary team (MDT).
This research was completed in community settings, within families' homes across the UK.
14 families self-selected to participate in the study. Criteria specified that participants must care for a child under the age of 18 and to decrease ambiguity the term 'diagnosis of dysphagia' was defined as the need for modified (thickened) fluids. Exclusion criteria: caring for an adult over the age of 18; diet and fluid modifications for reasons other than dysphagia (eg, for symptomatic treatment of gastro-oesophageal reflux disease. Participants were interviewed within their homes using a semistructured questionnaire and data was analysed using a descriptive phenomenological approach through use of thematic coding and constant comparison. Themes and relationships were inductively generated from the data.
Participants universally expressed a desire to be involved with their child's MDT; this study identified the following facilitators and barriers to collaboration: accessing services, professional knowledge and professional skillset. Participants described three means of responding to these barriers: reacting emotionally, seeking solutions and making decisions.
This study recorded in-depth reports of participants' experiences of working with healthcare providers. Despite government-driven efforts towards person-centred healthcare and social care, participants shared accounts of times when this has not occurred, describing a negative impact on the well-being and quality of life of their child and family.
To determine the detection rate (sensitivity) of the high-risk strategy recommended in the European Society of Cardiology (ESC) and National Institute for Health and Care Excellence (NICE/UK) and American College of Cardiology/American Heart Association (ACC/AHA) guidelines on cardiovascular disease (CVD) prevention. In particular, to evaluate the ability to ensure statin therapy to contemporary Europeans destined for a first myocardial infarction (MI).
393 consecutive statin-naïve, CVD-free patients without diabetes hospitalised for a first MI, 247 of whom were 40–75 years of age. We assumed they had undergone a health check the day before their MI and estimated the predicted risk.
Sensitivity of the risk-based eligibility for primary prevention with statins recommended by the guidelines.
All recommended risk scores rank-ordered patients similarly, but the sensitivity of the cut point above which statin therapy should be considered differed substantially. In younger patients (age 40–60), 62% of men and 13% of women qualified for statin therapy by ACC/AHA criteria, compared with only 2% of men and no women using the ESC criteria recommended for most non-Eastern European countries. In those 60–75 years of age, the ACC/AHA guidelines captured all men and 85% of women, compared with 12% and 2%, respectively, using the new ESC guideline. This guideline restricted the eligibility for primary prevention with statins substantially by reclassifying many European countries from 'high-risk' to 'low-risk', whereas the eligibility was expanded in the ACC/AHA and the new NICE/UK guidelines by lowering the decision threshold.
The 2012 ESC guidelines differ substantially from the 2013 ACC/AHA and 2014 NICE/UK guidelines in ability to secure statin therapy to those destined for a first MI. A great opportunity for primary prevention with statins remains unexploited in Europe.
To estimate the attributable and targeted avoidable deaths (ADs; TADs) of outdoor air pollution by ambient particulate matter (PM10), PM2.5 and O3 according to specific WHO methodology.
Health impact assessment.
City of Valladolid, Spain (around 300 000 residents).
Demographics; mortality; pollutant concentrations collected 1999–2008.
Attributable fractions; ADs and TADs per year for 1999–2008.
Higher TADs estimates (shown here) were obtained when assuming as 'target' concentrations WHO Air Quality Guidelines instead of Directive 2008/50/EC. ADs are considered relative to pollutant background levels. All-cause mortality associated to PM10 (all ages): 52 ADs (95% CI 39 to 64); 31 TADs (95% CI 24 to 39).All-cause mortality associated to PM10 (<5 years): 0 ADs (95% CI 0 to 1); 0 TADs (95% CI 0 to 1). All-cause mortality associated to PM2.5 (>30 years): 326 ADs (95% CI 217 to 422); 231 TADs (95% CI 153 to 301). Cardiopulmonary and lung cancer mortality associated to PM2.5 (>30 years):
Cardiopulmonary: 186 ADs (95% CI 74 to 280); 94 TADs (95% CI 36 to 148).
Lung cancer : 51 ADs (95% CI 21 to 73); 27 TADs (95% CI 10 to 41).All-cause, respiratory and cardiovascular mortality associated to O3 (all ages):
All-cause: 52ADs (95% CI 25 to 77) ; 31 TADs (95% CI 15 to 45).
Respiratory: 5ADs (95% CI –2 to 13) ; 3 TADs (95% CI –1 to 8).
Cardiovascular: 30 ADs (95% CI 8 to 51) ; 17 TADs (95% CI 5 to 30).
Negative estimates which should be read as zero were obtained when pollutant concentrations were below counterfactuals or assumed risk coefficients were below one.
Our estimates suggest a not negligible negative impact on mortality of outdoor air pollution. The implementation of WHO methodology provides critical information to distinguish an improvement range in air pollution control.
To describe the health-related quality of life (HRQOL) burden of cervical dystonia (CD) and report on the HRQOL and patient perception of treatment benefits of abobotulinumtoxinA (Dysport).
The safety and efficacy of a single injection of abobotulinumtoxinA for CD treatment were evaluated in a previously reported international, multicenter, double-blind, randomised trial. HRQOL measures were assessed in the trial and have not been previously reported.
Movement disorder clinics in the USA and Russia.
Patients had to have a diagnosis of CD with symptoms for at least 18 months, as well as a total Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) score of at least 30; a Severity domain score of at least 15; and a Disability domain score of at least 3. Key exclusion criteria included treatment with botulinum toxin type A (BoNT-A) or botulinum toxin type B (BoNT-B) within 16 weeks of enrolment.
Patients were randomised to receive either 500 U abobotulinumtoxinA (n=55) or placebo (n=61).
Efficacy assessments included TWSTRS total (primary end point) and subscale scores at weeks 0, 4, 8, 12; a pain visual analogue scale at weeks 0 and 4; and HRQOL assessed by the SF-36 Health Survey (SF-36; secondary end point) at weeks 0 and 8.
Patients with CD reported significantly greater impairment for all SF-36 domains relative to US norms. Patients treated with abobotulinumtoxinA reported significantly greater improvements in Physical Functioning, Role Physical, Bodily Pain, General Health and Role Emotional domains than placebo patients (p≤0.03 for all). The TWSTRS was significantly correlated with Physical Functioning, Role Physical and Bodily Pain scores, for those on active treatment.
CD has a marked impact on HRQOL. Treatment with a single abobotulinumtoxinA injection results in significant improvement in patients' HRQOL.
The trial is registered at ClinicalTrials.gov, numbers NCT00257660 and NCT00288509.
Railway workers performing maintenance work of trains and tracks could be at risk of developing noise-induced hearing loss, since they are exposed to noise levels of 75–90 dB(A) with peak exposures of 130–140 dB(C). The objective was to make a risk assessment by comparing the hearing thresholds among train and track maintenance workers with a reference group not exposed to noise and reference values from the ISO 1999.
A major Norwegian railway company.
1897 and 2730 male train and track maintenance workers, respectively, all exposed to noise, and 2872 male railway traffic controllers and office workers not exposed to noise.
The primary outcome was the hearing threshold (pure tone audiometry, frequencies from 0.5 to 8 kHz), and the secondary outcome was the prevalence of audiometric notches (Coles notch) of the most recent audiogram.
Train and track maintenance workers aged 45 years or older had a small mean hearing loss in the 3–6 kHz area of 3–5 dB. The hearing loss was less among workers younger than 45 years. Audiometric notches were slightly more prevalent among the noise exposed (59–64%) group compared with controls (49%) for all age groups. They may therefore be a sensitive measure in disclosing an early hearing loss at a group level.
Train and track maintenance workers aged 45 years or older, on average, have a slightly greater hearing loss and more audiometric notches compared with reference groups not exposed to noise. Younger (<45 years) workers have hearing thresholds comparable to the controls.
In spite of considerable attention, patients diagnosed with cancer continue to report poor experiences of care. The root causes of this remain unclear. This exploratory study aimed to investigate new ways of understanding the experience of patients with cancer, using a literary-based research approach.
Interviews were undertaken with four patients diagnosed with high-grade brain cancers at least 6 months from diagnosis and with people (n=5) identified by the patients as important in their care pathway. Interview transcripts were analysed by humanities academics as pieces of literature, where each patient's story was told from more than one person's perspective. The academics then came together in a facilitated workshop to agree major themes within the patient experiences. The themes were presented at a patient and carer event involving 70 participants to test the validity of the insights.
Insights into the key issues for patients with cancer could be grouped into six themes: accountability; identity; life context; time; language; rigour and emotion. Patients often held a different perspective to the traditionally held medical views of what constitutes good care. For example, patients did not see any conflict between a doctor having scientific rigour and portraying emotion.
One key feature of the approach was its comparative nature: patients often held different views from those traditionally held by physicians of what constitutes health and good outcomes. This revealed aspects that may be considered by healthcare professionals when designing improvements. Proposals for further testing are discussed, with a particular emphasis on the need for sensitivity to individual differences in experiences.
To use newly available self-assigned ethnicity information to investigate variation in breast cancer screening uptake for women from the 16 specific ethnic groups within the broad Asian, Black and White groups that previous studies report.
National cancer screening programme services within London.
655 516 female residents aged 50–69, invited for screening between March 2006 and December 2009. Ethnicity information was available for 475 478 (72.5%). White British women were the largest group (306 689, 46.8%), followed by Indian (34 687, 5.3%), White Other (30 053, 4.6%), Black Caribbean (25 607, 3.9%), White Irish (17 271, 2.6%), Black African (17 071, 2.6%) and Asian Other (10 579, 1.6%).
Uptake for women in different ethnic groups aged 50–52 for a first call invitation to the programme, and for women aged 50–69 for a routine recall invitation after a previous mammography. Uptake is reported (1) for London overall, adjusted using logistic regression, for age at invitation, socioeconomic deprivation and geographical screening area, and (2) for individual areas, adjusted for age and deprivation.
White British women attended their first call (67%) and routine recall (78%) invitations most often. Indian women were more likely to attend their first (61%) or routine recall (74%) than Bangladeshi women (43% and 61%, respectively), and Black Caribbean women were more likely than Black African women to attend first call (63% vs 49%, respectively) and routine recall (74% vs 64%, respectively). There was less variation between ethnic groups in some screening areas.
Breast cancer screening uptake in London varies by specific ethnic group for first and subsequent invitations, with White British women being more likely to attend. The variation in the uptake for women from the same ethnic groups in different geographical areas suggests that collaboration about the successful engagement of services with different communities could improve uptake for all women.
Little is known about the barriers, facilitators and interventions that impact on systematic review uptake. The objective of this study was to identify how uptake of systematic reviews can be improved.
Studies were included if they addressed interventions enhancing the uptake of systematic reviews. Reports in any language were included. All decisionmakers were eligible. Studies could be randomised trials, cluster-randomised trials, controlled-clinical trials and before-and-after studies.
We searched 19 databases including PubMed, EMBASE and The Cochrane Library, covering the full range of publication years from inception to December 2010. Two reviewers independently extracted data and assessed quality according to the Effective Practice and Organisation of Care criteria.
10 studies from 11 countries, containing 12 interventions met our criteria. Settings included a hospital, a government department and a medical school. Doctors, nurses, mid-wives, patients and programme managers were targeted. Six of the studies were geared to improving knowledge and attitudes while four targeted clinical practice.
Three studies of low-to-moderate risk of bias, identified interventions that showed a statistically significant improvement: educational visits, short summaries of systematic reviews and targeted messaging. Promising interventions include e-learning, computer-based learning, inactive workshops, use of knowledge brokers and an e-registry of reviews. Juxtaposing barriers and facilitators alongside the identified interventions, it was clear that the three effective approaches addressed a wide range of barriers and facilitators.
A limited number of studies were found for inclusion. However, the extensive literature search is one of the strengths of this review.
Targeted messaging, educational visits and summaries are recommended to enhance systematic review uptake. Identified promising approaches need to be developed further. New strategies are required to encompass neglected barriers and facilitators. This review addressed effectiveness and also appropriateness of knowledge uptake strategies.
Diabetes is a major public health concern worldwide, particularly in low-income and middle-income countries (LMICs). Limited data exist on the status of access to diabetes medicines in LMICs. We assessed the utilisation and affordability of diabetes medicines in Iran as a middle-income country.
We used a retrospective time-series design (2000–2012) and assessed national diabetes medicines' utilisation using pharmaceuticals wholesale data.
We calculated defined daily dose consumptions per population days (DDDs/1000 inhabitants/day; DIDs) indicator. Findings were benchmarked with data from Organization for Economic Co-operation and Development (OECD) countries. We also employed Drug Utilization-90% (DU-90) method to compare DU-90s with the Essential Medicines List published by the WHO. We measured affordability using number of minimum daily wage required to purchase a treatment course for 1 month.
Diabetes medicines' consumption increased from 4.47 to 33.54 DIDs. The benchmarking showed that medicines' utilisation in Iran in 2011 was only 54% of the median DIDs of 22 OECD countries. Oral hypoglycaemic agents consisted over 80% of use throughout the study period. Regular and isophane insulin (NPH), glibenclamide, metformin and gliclazide were the DU-90 drugs in 2012. Metformin, glibenclamide and regular/NPH insulin combination therapy were affordable throughout the study period (~0.4, ~0.1, ~0.3 of minimum daily wage, respectively). While the affordability of novel insulin preparations improved over time, they were still unaffordable in 2012.
The utilisation of diabetes medicines was relatively low, perhaps due to underdiagnosis and inadequate management of patients with diabetes. This had occurred despite affordability of essential diabetes medicines in Iran. Appropriate policies are required to address the underutilisation of diabetes medicines in Iran.
To explore Foundation trainees' and trainers' understandings and experiences of supervised learning events (SLEs), compared with workplace-based assessments (WPBAs), and their suggestions for developing SLEs.
A narrative interview study based on 55 individual and 19 group interviews.
UK-wide study across three sites in England, Scotland and Wales.
Using maximum-variation sampling, 70 Foundation trainees and 40 trainers were recruited, shared their understandings and experiences of SLEs/WPBAs and made recommendations for future practice.
Data were analysed using thematic and discourse analysis and narrative analysis of one exemplar personal incident narrative.
While participants volunteered understandings of SLEs as learning and assessment, they typically volunteered understandings of WPBAs as assessment. Trainers seemed more likely to describe SLEs as assessment and a 'safety net' to protect patients than trainees. We identified 333 personal incident narratives in our data (221 SLEs; 72 WPBAs). There was perceived variability in the conduct of SLEs/WPBAs in terms of their initiation, tools used, feedback and finalisation. Numerous factors at individual, interpersonal, cultural and technological levels were thought to facilitate/hinder learning. SLE narratives were more likely to be evaluated positively than WPBA narratives overall and by trainees specifically. Participants made sense of their experiences, emotions, identities and relationships through their narratives. They provided numerous suggestions for improving SLEs at individual, interpersonal, cultural and technological levels.
Our findings provide tentative support for the shift to formative learning with the introduction of SLEs, albeit raising concerns around trainees' and trainers' understandings about SLEs. We identify five key educational recommendations from our study. Additional research is now needed to explore further the complexities around SLEs within workplace learning.
To evaluate evidence from published randomised controlled trials (RCTs) for the use of task-shifting strategies for cardiovascular disease (CVD) risk reduction in low-income and middle-income countries (LMICs).
Systematic review of RCTs that utilised a task-shifting strategy in the management of CVD in LMICs.
We searched the following databases for relevant RCTs: PubMed from the 1940s, EMBASE from 1974, Global Health from 1910, Ovid Health Star from 1966, Web of Knowledge from 1900, Scopus from 1823, CINAHL from 1937 and RCTs from ClinicalTrials.gov.
We focused on RCTs published in English, but without publication year. We included RCTs in which the intervention used task shifting (non-physician healthcare workers involved in prescribing of medications, treatment and/or medical testing) and non-physician healthcare providers in the management of CV risk factors and diseases (hypertension, diabetes, hyperlipidaemia, stroke, coronary artery disease or heart failure), as well as RCTs that were conducted in LMICs. We excluded studies that are not RCTs.
Of the 2771 articles identified, only three met the predefined criteria. All three trials were conducted in practice-based settings among patients with hypertension (2 studies) and diabetes (1 study), with one study also incorporating home visits. The duration of the studies ranged from 3 to 12 months, and the task-shifting strategies included provision of medication prescriptions by nurses, community health workers and pharmacists and telephone follow-up posthospital discharge. Both hypertension studies reported a significant mean blood pressure reduction (2/1 mm Hg and 30/15 mm Hg), and the diabetes trial reported a reduction in the glycated haemoglobin levels of 1.87%.
There is a dearth of evidence on the implementation of task-shifting strategies to reduce the burden of CVD in LMICs. Effective task-shifting interventions targeted at reducing the global CVD epidemic in LMICs are urgently needed.
To explore the perceived consequences of knee symptoms on the lives of people aged 35–65 years who had diagnosed osteoarthritis (OA) or OA-like symptoms.
A qualitative study with six focus groups and 10 one-on-one interviews. Constructivist grounded theory guided data collection and analysis. Data were analysed using the constant comparative method.
Toronto, Canada.
51 participants (median age 49; 61% female) who self-reported knee OA or reported knee pain, aching or stiffness on most days of the past month participated in the study.
The core finding, disruption and change, illustrates the range of perceived consequences of knee symptoms in peoples' lives. Participants described the consequences of symptoms on their physical activity (giving up high-level activities or changing how or how much they performed activities), social life (leisure, family and work) and emotional life. Knee symptoms also altered the way participants thought about their bodies and themselves. They reported that they had a new awareness of their knee and that they no longer trusted their knee. They also conveyed that their sense of self was altered.
This study illuminates the significant and varied consequences that mild to moderate knee symptoms have on the lives of adults age 35–65 years. Findings highlight the need for clinicians to tailor advice and support to the individual's needs considering their symptoms, the consequences of symptoms on their lives and their personal context.
To investigate use of dual tests for Chlamydia trachomatis and Neisseria gonorrhoeae on samples collected through the National Chlamydia Screening Programme (NCSP) in England.
During May–July 2013, we delivered an online survey to commissioners of sexual health services in the 152 upper-tier English Local Authorities (LAs) who were responsible for commissioning chlamydia screening in people aged 15–24 years.
(1) The proportion of English LAs using dual tests on samples collected by the NCSP; (2) The estimated number of gonorrhoea tests and false positives from samples collected by the NCSP, calculated using national surveillance data on the number of chlamydia tests performed, assuming the gonorrhoea prevalence to range between 0.1% and 1%, and test sensitivity and specificity of 99.5%.
64% (98/152) of LAs responded to this national survey; over half (53% (52/98)) reported currently using dual tests in community settings. There was no significant difference between LAs using and not using dual tests by chlamydia positivity, chlamydia diagnosis rate or population screening coverage. Although positive gonorrhoea results were confirmed with supplementary tests in 93% (38/41) of LAs, this occurred after patients were notified about the initial positive result in 63% (26/41). Approximately 450–4500 confirmed gonorrhoea diagnoses and 2300 false-positive screens might occur through use of dual tests on NCSP samples each year. Under reasonable assumptions, the positive predictive value of the screening test is 17–67%.
Over half of English LAs already commission dual tests for samples collected by the NCSP. Gonorrhoea screening has been introduced alongside chlamydia screening in many low prevalence settings without a national evidence review or change of policy. We question the public health benefit here, and suggest that robust testing algorithms and clinical management pathways, together with rigorous evaluation, be implemented wherever dual tests are deployed.
A substantial proportion of low birth weight is attributable to the mother's cultural and socioeconomic circumstances. Early childhood programmes have been widely developed to improve child outcomes. In the UK, the Health in Pregnancy (HiP) grant, a universal conditional cash transfer of £190, was introduced for women reaching the 25th week of pregnancy with a due date on/or after 6 April 2009 and subsequently withdrawn for women reaching the 25th week of pregnancy on/or after 1 January 2011. The current study focuses on the evaluation of the effectiveness and cost-effectiveness of the HiP grant.
The population under study will be all singleton births in Scotland over the periods of January 2004 to March 2009 (preintervention), April 2009 to April 2011 (intervention) and May 2011 to December 2013 (postintervention). Data will be extracted from the Scottish maternity and neonatal database. The analysis period 2004–2013 should yield over 585 000 births. The primary outcome will be birth weight among singleton births. Other secondary outcomes will include gestation at booking, booking before 25 weeks; measures of size and stage; gestational age at delivery; weight-for-dates, term at birth; birth outcomes and maternal smoking. The main statistical method we will use is interrupted time series. Outcomes will be measured on individual births nested within mothers, with mothers themselves clustered within data zones. Multilevel regression models will be used to determine whether the outcomes changed during the period in which the HiP grants was in effect. Subgroup analyses will be conducted for those groups most likely to benefit from the payments.
Approval for data collection, storage and release for research purpose has been given (6 May 2014, PAC38A/13) by the Privacy Advisory Committee. The results of this study will be disseminated through peer-reviewed publications in journals, national and international conferences.
To explore the possible discomfort perceived by children participating in 7 T MRI research, and the age range in which children are most likely to tolerate it well.
A cross-sectional survey using age-appropriate questionnaires containing six measures of subjective discomfort (general discomfort, dizziness, noisiness, claustrophobia and feeling of cold or warm).
For children, 3 T clinical scanner in a tertiary referral teaching hospital; for adults, 3 and 7 T scanner in a university research building.
Non-sedated children and young people under 18 years of age who underwent 3 T clinical MRI for brain or musculoskeletal scans and adult volunteers attending 7 T with or without 3 T for brain scans.
83% (89/107) of involved individuals returned questionnaires. The most common discomfort among 31 children receiving 3 T MRI was noisiness (39%), followed by cold (19%), general discomfort (16%), dizziness (13%) and claustrophobia (10%). The noise was reported more frequently in children younger than 12 years than those older (p=0.021). The most common discomfort for 58 adults receiving 7 T MRI was noisiness (43%). In adults, there was a higher frequency of general discomfort during 7 than 3 T scans (p=0.031). More than 85% of adult respondents thought children aged 12–17 years would tolerate 7 T scans well, but only 35% and 15% thought children aged 10–11 and 8–9 years, respectively, would.
Noisiness was the most common discomfort across all ages in 3 and 7 T scanners. Although general discomfort was more common during 7 than 3 T scans in adults, most adults thought children aged 12 years or more would tolerate 7 T MRI well. Cautious enrolment of children in 7 T MRI study is warranted, but until there is more evidence of how well those aged 12 years or more tolerate 7 T MRI, we would caution against enrolling younger children.
Adverse work-related exposures have been linked with decreased physical and mental functioning in later life, however, whether childhood factors explain the associations between work exposures and functioning is unknown. Our aim was to investigate if job demand and control in mid-life were related to self-reported physical and mental functioning in early old age and whether childhood factors explained these associations.
Prospective cohort study.
England, Scotland and Wales.
Data come from the UK Medical Research Council National Survey of Health and Development, a cohort with follow-up since birth in 1946. 1485 occupationally active study members had data available on job demand and control in mid-life and on physical and mental functioning assessed using the Short Form-36 questionnaire at 60–64 years.
Those with higher job control in mid-life had better physical functioning than those who reported lower job control (β 0.51, 95% CI 0.02 to 1.01, p=0.04 adjusted for adult confounders). Those with higher job demand in mid-life had poorer mental functioning (β –0.82, 95% CI –1.14 to –0.51, p<0.001). Associations between job control and mental functioning were similar but less pronounced. Adjustment for childhood factors (father's and mother's educational attainment, parents' interest in school at age 7 and cognitive ability at age 8) partially explained the association between job control and physical functioning, but did not explain the association between job demand and mental functioning.
Job demand and control in mid-life are differentially associated with mental and physical functioning in early old age and some of these associations may be partially explained by childhood factors.
To explore HIV virological failure and drug resistance among injecting drug users (IDUs) receiving first-line antiretroviral treatment (ART) in China.
A series of cross-sectional surveys from 2003 to 2012 from the Chinese National HIV Drug Resistance (HIVDR) Surveillance and Monitoring Network.
Data were analysed by the Chinese National (HIVDR) Surveillance and Monitoring Network from 2003 to 2012. Demographic, ART and laboratory data (CD4+ cell count, viral load and drug resistance) were included. Factors associated with virological failure were identified by logistic regression analysis.
929 of the 8556 individuals in the Chinese HIVDR database were IDUs receiving first-line ART. For these 929 IDUs, the median duration of treatment was 14 months (IQR 6.0–17.8). 193 of the 929 IDUs (20.8%) experienced virological failure (HIV viral load ≥1000 copies/mL). The prevalence of HIVDR among patients with virological failure was 38.9% (68/175). The proportion of patients with drug resistance to non-nucleoside reverse transcriptase inhibitor (NNRTIs), nucleoside reverse transcriptase inhibitor (NRTIs) and protease inhibitors (PIs) was 52.9%, 76.5% and 4.4%, respectively. Factors independently associated with virological failure include: ethnic minorities, junior high school education or less, farmers, self-reported missing doses in the past month, CD4 cell count at survey from 200 to 349 cells/mm3 or from 0 to 199 cells/mm3, and residence of Guangxi and Yunnan provinces.
The proportion of virological failure was high among IDUs receiving first-line ART in China. However, better treatment outcomes were observed in Guangxi and Yunnan, which indicates the importance of ART education and adherence to intervention, especially for patients who are farmers, minorities or have a poor educational background.
The 2010 healthcare reform in England introduced primary care-led commissioning in the National Health Service (NHS) by establishing clinical commissioning groups (CCGs). A key factor for the success of the reform is the provision of excellent commissioning support services to CCGs. The Government's aim is to create a vibrant market of competing providers of such services (from both for-profit and not-for-profit sectors). Until this market develops, however, commissioning support units (CSUs) have been created from which CCGs are buying commissioning support functions. This study explored the attitudes of CCGs towards outsourcing commissioning support functions during the initial stage of the reform.
The research took place between September 2011 and June 2012. We used a case study research design in eight CCGs, conducting in-depth interviews, observation of meetings and analysis of policy documents.
We conducted 96 interviews and observed 146 meetings (a total of approximately 439 h).
Many CCGs were reluctant to outsource core commissioning support functions (such as contracting) for fear of losing local knowledge and trusted relationships. Others were disappointed by the absence of choice and saw CSUs as monopolies and a recreation of the abolished PCTs. Many expressed doubts about the expectation that outsourcing of commissioning support functions will result in lower administrative costs.
Given the nature of healthcare commissioning, outsourcing vital commissioning support functions may not be the preferred option of CCGs. Considerations of high transaction costs, and the risk of fragmentation of services and loss of trusted relationships involved in short-term contracting, may lead most CCGs to decide to form long-term partnerships with commissioning support suppliers in the future. This option, however, limits competition by creating 'network closure' and calls into question the Government's intention to create a vibrant market of commissioning support provision.
Since the response of spouses has been proven to be an important reinforcement of pain behaviour and disability it has been addressed in research and therapy. Fordyce suggested pain behaviour and well behaviour be considered in explaining suffering in chronic pain patients. Among existing instruments concerning spouse's responses the aspect of well behaviour has not been examined so far. The SRI (Spouse Response Inventory) tries to consider pain behaviour and well behaviour and appears to be acceptable because of its brevity and close proximity to daily language. The aim of the study is the translation into German, followed by evaluation and validation, of the SRI on a German sample of patients with chronic pain.
The study is comprehensively designed: initially, the focus will lie on the translation of the instrument following the guidelines for cross-cultural translation and adaptation and evaluation of the German version according to the source study. Subsequently, a validation referring to predictive, incremental and construct validation will be conducted using instruments based on similar or close but different constructs. Evaluation of the resulting SRI-G (SRI-German) will be conducted on a sample of at least 30 patients with chronic pain attending a comprehensive pain centre. For validation at least 120 patients with chronic headache, back pain, cancer related pain and somatoform pain disorder shall be included, for a total of 480 patients. Separate analyses according to specific pain diagnoses will be performed to ensure psychometric property, interpretability and control of diagnosis of specific limitations. Analyses will include comprehensive investigation of psychometric property of the scale by hierarchical regression analyses, correlation analyses, multivariate analysis of variance and exploratory factor analyses (SPSS).
The study protocol was approved by the Ethics Committee of the University of Dresden (EK 335 122008) based on the Helsinki declaration.
To assess the implementation and first results of a term perinatal internal audit by a standardised method.
Population-based cohort study.
All 90 Dutch hospitals with obstetric/paediatric departments linked to community practices of midwives, general practitioners in their attachment areas, organised in perinatal cooperation groups (PCG).
The population consisted of 943 registered term perinatal deaths occurring in 2010–2012 with detailed information, including 707 cases with completed audit results.
Participation in the audit, perinatal death classification, identification of substandard factors (SSF), SSF in relation to death, conclusive recommendations for quality improvement in perinatal care and antepartum risk selection at the start of labour.
After the introduction of the perinatal audit in 2010, all PCGs participated. They organised 645 audit sessions, with an average of 31 healthcare professionals per session. Of all 1102 term perinatal deaths (2.3/1000) data were registered for 86% (943) and standardised anonymised audit results for 64% (707). In 53% of the cases at least one SSF was identified. Non-compliance to guidelines (35%) and deviation from usual professional care (41%) were the most frequent SSF. There was a (very) probable relation between the SSF and perinatal death for 8% of all cases. This declined over the years: from 10% (n=23) in 2010 to 5% (n=10) in 2012 (p=0.060). Simultaneously term perinatal mortality decreased from 2.3 to 2.0/1000 births (p<0.00001). Possibilities for improvement were identified in the organisation of care (35%), guidelines or usual care (19%) and in documentation (15%). More pregnancies were antepartum selected as high risk, 70% in 2010 and 84% in 2012 (p=0.0001).
The perinatal audit is implemented nationwide in all obstetrical units in the Netherlands in a short time period. It is possible that the audit contributed to the decrease in term perinatal mortality.
Patient-centredness has become an important aspect of health service delivery; however, there are a limited number of studies that focus on this concept in the domain of hearing healthcare. The objective of this study was to examine and compare audiologists' preferences for patient-centredness in Portugal, India and Iran.
The study used a cross-sectional survey design with audiologists recruited from three different countries.
A total of 191 fully-completed responses were included in the analysis (55 from Portugal, 78 from India and 58 from Iran).
The Patient–Practitioner Orientation Scale (PPOS).
PPOS mean scores suggest that audiologists have a preference for patient-centredness (ie, mean of 3.6 in a 5-point scale). However, marked differences were observed between specific PPOS items suggesting these preferences vary across clinical situations. A significant level of difference (p<0.001) was found between audiologists' preferences for patient-centredness in three countries. Audiologists in Portugal had a greater preference for patient-centredness when compared to audiologists in India and Iran, although no significant differences were found in terms of age and duration of experience among these sample populations.
There are differences and similarities in audiologists' preferences for patient-centredness among countries. These findings may have implications for the training of professionals and also for clinical practice in terms of optimising hearing healthcare across countries.
The objective of this study was to explore the association between sexual violence and neonatal outcomes.
National cohort study.
Women were recruited to the Norwegian Mother and Child Cohort Study (MoBa) while attending routine ultrasound examinations from 1999 to 2008.
A total of 76 870 pregnant women.
Sexual violence and maternal characteristics were self-reported in postal questionnaires during pregnancy. Neonatal outcomes were retrieved from the Medical Birth Registry of Norway (MBRN). Risk estimations were performed with linear and logistic regression analysis. Outcome measures: gestational age at birth, birth weight, preterm birth (PTB), low birth weight (LBW) and small for gestational age (SGA).
Of 76 870 women, 18.4% reported a history of sexual violence. A total of 4.7% delivered prematurely, 2.7% had children with a birth weight <2500 g and 8.1% children were small for their gestational age. Women reporting moderate or severe sexual violence (rape) had a significantly reduced gestational length (2 days) when the birth was provider-initiated in an analysis adjusted for age, parity, education, smoking, body mass index and mental distress. Those exposed to severe sexual violence had a significantly reduced gestational length of 0.51 days with a spontaneous start of birth. Crude estimates showed that severe sexual violence was associated with PTB, LBW and SGA. When controlling for the aforementioned sociodemographic and behavioural factors, the association was no longer significant.
Sexual violence was not associated with adverse neonatal outcomes. Moderate and severe violence had a small but significant effect on gestational age; however, the clinical influence of this finding is most likely limited. Women exposed to sexual violence in this study reported more of the sociodemographic and behavioural factors associated with PTB, LBW and SGA compared with non-abused women.
Pulmonary hypertension (PH) is a devastating, progressive disease with increasingly debilitating symptoms and usually shortened overall life expectancy due to a narrowing of the pulmonary vasculature and consecutive right heart failure. Little is known about PH in Africa, but limited reports suggest that PH is more prevalent in Africa compared with developed countries due to the high prevalence of risk factors in the region.
A multinational multicentre registry-type cohort study was established and tailored to resource-constraint settings to describe disease presentation, disease severity and aetiologies of PH, comorbidities, diagnostic and therapeutic management, and the natural course of PH in Africa. PH will be diagnosed by specialist cardiologists using echocardiography (right ventricular systolic pressure >35 mm Hg, absence of pulmonary stenosis and acute right heart failure), usually accompanied by shortness of breath, fatigue, peripheral oedema and other cardiovascular symptoms, ECG and chest X-ray changes in keeping with PH as per guidelines (European Society of Cardiology and European Respiratory Society (ESC/ERS) guidelines). Additional investigations such as a CT scan, a ventilation/perfusion scan or right heart catheterisation will be performed at the discretion of the treating physician. Functional tests include a 6 min walk test and the Karnofsky Performance Score. The WHO classification system for PH will be applied to describe the different aetiologies of PH. Several substudies have been implemented within the registry to investigate specific types of PH and their outcome at up to 24 months. Data will be analysed by an independent institution following a data analyse plan.
All local ethics committees of the participating centres approved the protocol. The data will be disseminated through peer-reviewed journals at national and international conferences and public events at local care providers.
To estimate the heritability of child behaviour problems and investigate the association between maternal pre-pregnancy overweight and child behaviour problems in a genetically sensitive design.
Observational cross-sectional study.
The Twins and Multiple Births Association Heritability Study (TAMBAHS) is an online UK-wide volunteer-based study investigating the development of twins from birth until 5 years of age.
A total of 443 (16% of the initial registered members) mothers answered questions on pre-pregnancy weight and their twins' internalising and externalising problems using the Child Behavior Checklist and correcting for important covariates including gestational age, twins' birth weight, age and sex, mother's educational level and smoking (before, during and after pregnancy).
The heritability of behaviour problems and their association with maternal pre-pregnancy weight.
The genetic analysis suggested that genetic and common environmental factors account for most of the variation in externalising disorders (an ACE model was the most parsimonious with genetic factors (A) explaining 46% (95% CI 33% to 60%) of the variance, common environment (C) explaining 42% (95% CI 27% to 54%) and non-shared environmental factors (E) explaining 13% (95% CI 10% to 16%) of the variance. For internalising problems, a CE model was the most parsimonious model with the common environment explaining 51% (95% CI 44% to 58%) of the variance and non-shared environment explaining 49% (95% CI 42% to 56%) of the variance. Moreover, the regression analysis results suggested that children of overweight mothers showed a trend (OR=1.10, 95% CI 0.58% to 2.06) towards being more aggressive and exhibit externalising behaviours compared to children of normal weight mothers.
Maternal pre-pregnancy weight may play a role in children's aggressive behaviour.
Recent systematic reviews have highlighted the dearth of evidence on the effectiveness of regeneration on health and health inequalities. 'Communities First' is an area-wide regeneration scheme to improve the lives of people living in the most deprived areas in Wales (UK). This study will evaluate the impact of Communities First on residents' mental health and social cohesion.
A prospective controlled quasi-experimental study of the association between residence in Communities First regeneration areas in Caerphilly county borough and change in mental health and social cohesion. The study population is the 4226 residents aged 18–74 years who responded to the Caerphilly Health and Social Needs Study in 2001 (before delivery) and 2008 (after delivery of Communities First). Data on the location, type and cost of Communities First interventions will be extracted from records collected by Caerphilly county borough council. The primary outcome is the change in mental health between 2001 and 2008. Secondary outcomes are changes: in common mental disorder case status (using survey and general practice data), social cohesion and mental health inequalities. Multilevel models will examine change in mental health and social cohesion between Communities First and control areas, adjusting for individual and household level confounding factors. Further models will examine the effects of (1) different types of intervention, (2) contamination across areas, (3) length of residence in a Communities First area, and (4) population migration. We will carry out a cost-consequences analysis to summarise the outcomes generated for participants, as well as service utilisation and utility gains.
This study has had approval from the Information Governance Review Panel at Swansea University (Ref: 0266 CF). Findings will be disseminated through peer-review publications, international conferences, policy and practice partners in local and national government, and updates on our study website (http://medicine.cardiff.ac.uk/clinical-study/communities-first-regeneration-programme/).
This study sought to examine the level of health-related knowledge and its predictors among vocational college students in China.
A cross-sectional study.
A survey was performed to collect data on heath-related knowledge and potential risk factors among 708 students in four higher vocational colleges at Nanyang, Henan, China. Linear regression models were conducted to identify the predictors of the level of health-related knowledge.
The level of health-related knowledge among Chinese vocational college students is extremely low (only 1.4% students have an adequate level of health-related knowledge). According to the multivariate analysis, major, year of class, place of origin and a mother's education level are significantly associated with health-related knowledge in Chinese vocational college students.
Health education and health promotion efforts are encouraged to improve the level of health-related knowledge in this population. Attention and efforts to improve health-related knowledge of Chinese vocational college students who come from rural areas, whose mothers have a lower level of education, who are in non-medicine majors and during the first few years of vocational college is warranted.
To examine the weekly working hours of Norwegian hospital doctors from 1994 to 2012 with special emphasis on the quality of postgraduate training and work–home balance, and in relation to the requirements of the European Working Time Directive (EWTD).
Panel study based on postal questionnaires.
Unbalanced cohort of 1300–1600 doctors in 1994, 1995, 1996, 1997, 2000, 2002, 2004, 2006, 2008, 2010 and 2012.
Self-reported total weekly working hours and whether 45 weekly working hours are too short, sufficient, or too long to meet the quality requirements of obligatory postgraduate training for junior doctors.
From 1994 to 2012, the number of weekly working hours was stable for senior (46–47 h) and junior (45–46 h) hospital doctors. In 2012, significantly more senior (27–35%) than junior (11–20%) doctors reported suboptimal work–home balance, defined as working more than 48 h a week. The majority perceived the present situation with an average of 45 h per week for juniors as sufficient for obligatory postgraduate specialist training, but doctors of higher age (OR 1.04, 95% CI 1.01 to 1.08), senior doctors (1.07, 1.04 to 1.11) and doctors working in surgical specialties (OR 1 vs laboratory medicine 0.03, 0.01 to 0.25, internal medicine 0.31, 0.17 to 0.58, psychiatry 0.12, 0.04 to 0.36, paediatrics 0.36, 0.12 to 1.07, anaesthesiology 0.08, 0.02 to 0.39, gynaecology 0.07, 0.01 to 0.56 and others 0.39, 0.04 to 3.56) were more likely to want the work-week to be longer.
The weekly working hours of Norwegian hospital doctors were always below the EWTD requirements. A significant growth of hospital doctor density over the past two decades, national regulations and cultural values might be important factors. Specialty differences in perception of sufficient training time may call for more flexibility in working time regulations.
Evidence of patients' experiences is fundamental to creating effective health policy and service responses, yet is missing from our knowledge of adverse events. This protocol describes explorative research redressing this significant deficit; investigating the experiences of a large cohort of recently hospitalised patients aged 45 years and above in hospitals in New South Wales (NSW), Australia.
The 45 and Up Study is a cohort of 265 000 adults aged 45 years and above in NSW. Patients who were hospitalised between 1 January and 30 June 2014 will be identified from this cohort using data linkage and a random sample of 20 000 invited to participate. A cross-sectional survey (including qualitative and quantitative components) will capture patients' experiences in hospital and specifically of adverse events. Approximately 25% of respondents are likely to report experiencing an adverse event. Quantitative components will capture the nature and type of events as well as common features of patients' experiences. Qualitative data provide contextual knowledge of their condition and care and the impact of the event on individuals. Respondents who do not report an adverse event will report their experience in hospital and be the control group. Statistical and thematic analysis will be used to present a patient perspective of their experiences in hospital; the characteristics of patients experiencing an adverse event; experiences of information sharing after an event (open disclosure) and the other avenues of redress pursued. Interviews with key policymakers and a document analysis will be used to create a map of the current practice.
Dissemination via a one-day workshop, peer-reviewed publications and conference presentations will enable effective clinical responses and service provision and policy responses to adverse events to be developed.
Antipsychotic treatment in early-onset schizophrenia (EOS) lacks a rich evidence base, and efforts to rank different drugs concerning their efficacy have not proven any particular drug superior. In contrast to the literature regarding adult-onset schizophrenia (AOS), comparative effectiveness studies in children and adolescents are limited in number and size, and only a few meta-analyses based on conventional methodologies have been conducted.
We will conduct a network meta-analysis of all randomised controlled trials (RCTs) that evaluate antipsychotic therapies for EOS to determine which compounds are efficacious, and to determine the relative efficacy and safety of these treatments when compared in a network meta-analysis.
Unlike a contrast-based (standard) meta-analysis approach, an arm-based network meta-analysis enables statistical inference from combining both direct and indirect comparisons within an empirical Bayes framework. We will acquire eligible studies through a systematic search of MEDLINE, the Cochrane Central Registry of Controlled Trials, Clinicaltrials.gov and Centre for Reviews and Dissemination databases. Eligible studies should randomly allocate children and adolescents presenting with schizophrenia or a related non-affective psychotic condition to an intervention group or to a control group. Two reviewers will—independently and in duplicate—screen titles and abstracts, complete full text reviews to determine eligibility, and subsequently perform data abstraction and assess risk of bias of eligible trials. We will conduct meta-analyses to establish the effect of all reported therapies on patient-relevant efficacy and safety outcomes when possible.
No formal ethical procedures regarding informed consent are required as no primary data collection is undertaken. The review will help facilitate evidence-based management, identify key areas for future research, and provide a framework for conducting large systematic reviews combining direct and indirect comparisons. The study will be disseminated by peer-reviewed publication and conference presentation.
This study seeks to determine not only the reliability of parental touch in detecting fever as compared to rectal thermometry in under-five children, but also the sociodemographic factors that may predict its reliability.
The study was carried out in the Emergency Paediatric Unit of a tertiary hospital in North Central Nigeria.
409 children aged less than 5 years with a history of fever in the 48 h prior to presentation and their mothers were recruited consecutively. All the children recruited completed the study. Children with clinical parameters suggestive of shock, and those who were too ill, were excluded from the study.
The primary outcome was the proportion of mothers who could accurately predict if their child was febrile or not (defined by rectal temperature) using tactile assessment only. Secondary outcomes were the validity and accuracy of touch in detecting fever and factors related to its accuracy.
About 85% of the children were febrile using rectal thermometry. The sensitivity, specificity, positive predictive and negative predictive values for touch as a screening tool were 63%, 54%, 88.3% and 21%, respectively. High maternal socioeconomic status and low maternal age influenced positively the accuracy of touch in correctly determining the presence or absence of fever.
This study has shown that tactile assessment of temperature is not reliable and that absence of fever in a previously febrile child should be confirmed by objective methods of temperature measurement.
Low levels of health-enhancing physical activity require novel approaches that have the potential to reach broad populations. Web-based interventions are a popular approach for behaviour change given their wide reach and accessibility. However, challenges with participant engagement and retention reduce the long-term maintenance of behaviour change. Web 2.0 features present a new and innovative online environment supporting greater interactivity, with the potential to increase engagement and retention. In order to understand the applicability of these innovative interventions for the broader population, 'real-world' interventions implemented under 'everyday conditions' are required. The aim of this study is to investigate the difference in physical activity behaviour between individuals using a traditional Web 1.0 website with those using a novel Web 2.0 website.
In this study we will aim to recruit 2894 participants. Participants will be recruited from individuals who register with a pre-existing health promotion website that currently provides Web 1.0 features (http://www.10000steps.org.au). Eligible participants who provide informed consent will be randomly assigned to one of the two trial conditions: the pre-existing 10 000 Steps website (with Web 1.0 features) or the newly developed WALK 2.0 website (with Web 2.0 features). Primary and secondary outcome measures will be assessed by self-report at baseline, 3 months and 12 months, and include: physical activity behaviour, height and weight, Internet self-efficacy, website usability, website usage and quality of life.
This study has received ethics approval from the University of Western Sydney Human Research Ethics Committee (Reference Number H8767) and has been funded by the National Health and Medical Research Council (Reference Number 589903). Study findings will be disseminated widely through peer-reviewed publications, academic conferences and local community-based presentations.
Australian New Zealand Clinical Trials Registry Number: ACTRN12611000253909, WHO Universal Trial Number: U111-1119-1755
We aimed to investigate suitable conditions of 8-hydroxy-2'-deoxyguanosine (8-OHdG) and micronucleus (MN) as genotoxic biomarkers at different levels of occupational chromate exposure.
A cross-sectional study was used.
84 workers who were exposed to chromate for at least 1 year were chosen as the chromate exposed group, while 30 non-exposed individuals were used as controls.
Environmental and biological exposure to chromate was respectively assessed by measuring the concentration of chromate in the air (CrA) and blood (CrB) by inductively coupled plasma mass spectrometer (ICP-MS) in all participants. MN indicators, including micronucleus cell count (MNCC), micro-nucleus count (MNC), nuclear bridge (NPB) and nuclear bud (NBUD) were calculated by the cytokinesis-block micronucleus test (CBMN), while the urinary 8-OHdG was measured by the ELISA method and normalised by the concentration of Cre.
Compared with the control group, the levels of CrA, CrB, MNCC, MNC and 8-OHdG in the chromate-exposed group were all significantly higher (p<0.05). There were positive correlations between log(8-OHdG) and LnMNCC or LnMNC (r=0.377 and 0.362). The levels of LnMNCC, LnMNC and log (8-OHdG) all have parabola correlations with the concentration of CrB. However, there was a significantly positive correlation between log (8-OHdG) and CrB when the CrB level was below 10.50 µg/L (r=0.355), while a positive correlation was also found between LnMNCC or LnMNC and CrB when the CrB level was lower than 9.10 µg/L (r=0.365 and 0.269, respectively).
MN and 8-OHdG can be used as genotoxic biomarkers in the chromate-exposed group, but it is only when CrB levels are lower than 9.10 and 10.50 µg/L, respectively, that they can accurately reflect the degree of genetic damage.
This study is a European multicentre, randomised, double-blind, placebo-controlled trial investigating the efficacy and safety of nilvadipine as a disease course modifying treatment for mild-to-moderate Alzheimer's disease (AD) in a phase III study that will run for a period of 82 weeks with a treatment period of 78 weeks.
Adult patients, males and females over 50 years with mild-to-moderate AD as defined by the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's disease and Related Disorders Association (NINCDS-ADRDA) criteria, will be included in the study. It aims to recruit a total of 500 patients with AD; 250 in the nilvadipine group and 250 in the placebo group. Participants will be randomised to receive nilvadipine, an 8 mg overencapsulated, sustained release capsule, or a matching overencapsulated placebo (sugar pill) for a period of 78 weeks of treatment. The primary efficacy outcome measure in this study is the change in cognitive function as assessed by the Alzheimer's disease Assessment Scale (ADAS-Cog 12) from baseline to the end of treatment duration (78 weeks). There are two key secondary outcome measures, the Clinical Dementia Rating Scale Sum of Boxes (CDR-sb) and the Disability Assessment for Dementia (DAD). If a statistically significant effect is seen in the primary outcome, CDR-sb will be considered to be a coprimary end point and only the DAD will contribute to the secondary outcome analysis.
The study and all subsequent amendments have received ethical approval within each participating country according to national regulations. Each participant will provide written consent to participate in the study. All participants will remain anonymised throughout and the results of the study will be published in an international peer-reviewed journal.
EUDRACT Reference Number: 2012-002764-27.
To understand patients' preferences for physician behaviours during end-of-life communication.
We used interpretive description methods to analyse data from semistructured, one-on-one interviews with patients admitted to general medical wards at three Canadian tertiary care hospitals. Study recruitment took place from October 2012 to August 2013. We used a purposive, maximum variation sampling approach to recruit hospitalised patients aged ≥55 years with a high risk of mortality within 6–12 months, and with different combinations of the following demographic variables: race (Caucasian vs non-Caucasian), gender and diagnosis (cancer vs non-cancer).
A total of 16 participants were recruited, most of whom (69%) were women and 70% had a non-cancer diagnosis. Two major concepts regarding helpful physician behaviour during end-of-life conversations emerged: (1) 'knowing me', which reflects the importance of acknowledging the influence of family roles and life history on values and priorities expressed during end-of-life communication, and (2) 'conditional candour', which describes a process of information exchange that includes an assessment of patients' readiness, being invited to the conversation, and sensitive delivery of information.
Our findings suggest that patients prefer a nuanced approach to truth telling when having end-of-life discussions with their physician. This may have important implications for clinical practice and end-of-life communication training initiatives.
Dehydroepiandrosterone (DHEA) has been proposed to improve pregnancy rates in women with diminished ovarian reserve undergoing in vitro fertilisation (IVF) treatment. However, evidence regarding its efficacy is supported by a limited number of randomised controlled trials (RCTs). This double-blinded RCT aims to measure the effect of DHEA supplementation prior to and during controlled ovarian hyperstimulation on ovarian response prior to IVF treatment in women predicted to have poor ovarian reserve.
Sixty women with ovarian antral follicle count ≤10 and serum anti-Mullerian hormone ≤5 pmol/L undergoing IVF/intracytoplasmic sperm injection (ICSI) treatment at the Nurture fertility clinic, Nottingham will be recruited. They will be randomised to either receive DHEA capsule 75 mg/day or placebo for at least 12 weeks before egg collection. All participants will undergo standard long down regulation protocol using human menopausal gonadotropin 300 IU/day. Serum samples and follicular fluids at the time of egg collection will be collected for hormonal immunoassays. For ICSI participants, cumulus cells stripped from oocyte will be collected for cumulus gene expression analyses regarding oocyte competence. Microdrops of oocyte culture media before the time of ICSI will be assessed for glucose, pyruvate and lactate utilisation. Embryo transfer will be performed on day 2, 3 or 5 based on the number and quality of the embryos available. Pregnancy will be defined as urine pregnancy test positive (biochemical pregnancy) and 6–8 weeks ultrasound scan with fetal heart beat (clinical pregnancy) and live birth. It is planned to perform the molecular and nutritional fingerprint analyses in batches after finishing the clinical phase of the study.
The approval of the study was granted by the NHS Research Ethics Committee (Ref number NRES 12/EM/0002), the Medicines and Healthcare products Regulatory Agency (MHRA), and the Nottingham University Hospitals Trust Research and Development department. All participants shall provide written informed consent before being randomised into allocated treatment groups.
Protocol V.2.0; EudraCT number: 2011-002425-21; http://www.clinicaltrials.gov; NCT01572025; CTA reference: 03057/0053/001-0002
Nursing home residents often have a high number of comorbidities resulting in polypharmacy. Inappropriate prescribing is therefore likely to occur, which in turn is expected to worsen cognitive impairment, to increase the fall risk and to decrease residents' quality of life. The objective of the 'Discontinuing Inappropriate Medication in Nursing Home Residents' (DIM-NHR) study is to examine the efficacy and cost-effectiveness of the Multidisciplinary Multistep Medication Review (3MR) that is aimed at optimising prescribing and discontinuing inappropriate medication.
A cluster randomised controlled trial will be conducted. Elderly care physicians and their wards (clusters) will be randomised. Data will be collected at baseline and 4 months after the 3MR has taken place. Six hundred nursing home residents will be recruited of whom more than half are expected to suffer from dementia. The 3MR will be based on consensus criteria and the relevant literature and will be performed by the patient's elderly care physician in collaboration with a pharmacist.
Primary outcomes—the difference in proportion of residents who successfully discontinued inappropriate medication between the intervention and control group at follow-up. Secondary outcomes—undertreatment, exposure to anticholinergic and sedative medicines, neuropsychiatric symptoms, cognitive function, falls, hospital admission, quality of life and cost-effectiveness.
Participant burden will be kept at a minimum. The elderly care physician will remain free to adjust medication when symptoms relapse or adverse events occur, rendering serious adverse events highly unlikely. Study findings will be published in peer-reviewed journals and a 3MR toolkit will be developed.
This study has been registered at http://www.ClinicalTrials.gov (trial registration number: NCT01876095)
We sought to determine whether the use of Pentax-AWS Airwayscope (AWS) applied less force on oral structures during intubation attempts than a conventional direct laryngoscope (DL).
Prospective cross-over study.
A total of 37 physicians (9 transitional-year residents, 20 emergency medicine residents and 8 emergency physicians) were enrolled.
We used four simulation scenarios according to the difficulty of intubation and devices and used a high-fidelity simulator to quantify the forces applied on the oral structures.
Primary outcomes were the maximum force applied on the maxillary incisors and tongue. Other outcomes of interest were time to intubation and glottic view during intubation attempts.
The maximum force applied on the maxillary incisors in the normal airway scenario was higher with the use of AWS than that with DL (107 newton (N) vs 77 N, p=0.02). By contrast, the force in the difficult airway scenario was significantly lower with the use of AWS than that of the DL (89 N vs 183 N, p<0.01). Likewise, the force applied on the tongue was significantly lower with the use of AWS than the use of DL in both airway scenarios (11 N vs 27 N, p<0.001 in the normal airway scenario; 12 N vs 40 N, p<0.01 in the difficult airway scenario).
The use of AWS during intubation attempts was associated with decreased forces applied to oral structures in the simulated difficult airway scenario.
Recently, the European Medicines Agency reported that strontium ranelate increases myocardial infarction risk in postmenopausal women, 8.5 years after it was registered for use in osteoporosis. Unreported serious adverse events in clinical trials for other pharmaceuticals have been described in recent years. We assessed reporting of adverse events and fracture efficacy of strontium.
We compared data on adverse effects (myocardial infarction, venous thromboembolism and pulmonary embolism) and fracture efficacy of strontium in publicly available regulatory documents with data in publications retrieved from searching PubMed.
We identified 5 regulatory documents and 9 primary publications of 7 randomised, placebo-controlled trials of strontium that reported relevant data. We identified several areas of concern in these reports: the increased risk of myocardial infarction with strontium was not identified in a pivotal phase 3 clinical trial despite specific regulatory review of cardiovascular events; data on myocardial infarction were not included in any primary publication; increased risks of venous thromboembolism and pulmonary embolism with strontium were not reported in either of the phase 3 clinical trials; data on venous thromboembolism were reported in only 5 of 9 primary publications, data on pulmonary embolism in only 2 of 9 primary publications, and either was discussed in <50% of subsequent review articles. There were differences in participant numbers, fracture cases and venous thromboembolism cases between regulatory documents and primary publications. Based on all available data from primary publications and regulatory documents, the number of fractures prevented by strontium use is similar to the number of extra cases of venous thromboembolism, pulmonary embolism and myocardial infarction caused by strontium use.
The risks of strontium use are similar to the benefits. Full disclosure of the clinical trial data and regulatory documents would allow clinicians and their patients to decide whether use of the drug is worthwhile.
Sri Lanka has one of the highest suicide and self-harm rates in the world and although alcohol has been found to be a risk factor for self-harm in Sri Lanka, we know little about the connection between the two. This paper comprises a protocol for a qualitative study investigating alcohol's role in self-harm in rural Sri Lanka at three levels: the individual, community and policy level. The analysis will bring new understanding of the link between alcohol and self-harm in Sri Lanka, drawing on structural, cultural and social concepts. It will equip researchers, health systems and policy makers with vital information for developing strategies to address alcohol-related problems as they relate to self-harm.
To capture the complexity of the link between alcohol and self-harm in the Anuradhapura district in the North Central Province in Sri Lanka, qualitative methods will be utilised. Specifically, the data will consist of serial narrative life-story interviews with up to 20 individuals who have non-fatally self-harmed and where alcohol directly or indirectly was involved in the incidence as well as with their significant others; observations in communities and families; six focus group discussions with community members; and key-informant interviews with 15–25 stakeholders who have a stake in alcohol distribution, marketing, policies, prevention and treatment as they relate to self-harm.
The study has received ethical approval from the Ethical Review Committee of the Faculty of Medicine and Allied Sciences, Rajarata University of Sri Lanka. A sensitive data collection technique will be used and ethical issues will be considered throughout the study.
The results will be disseminated in scientific peer-reviewed articles in collaboration with Sri Lankan and other international research partners.
To investigate whether associations of smoking with depression and anxiety are likely to be causal, using a Mendelian randomisation approach.
Mendelian randomisation meta-analyses using a genetic variant (rs16969968/rs1051730) as a proxy for smoking heaviness, and observational meta-analyses of the associations of smoking status and smoking heaviness with depression, anxiety and psychological distress.
Current, former and never smokers of European ancestry aged ≥16 years from 25 studies in the Consortium for Causal Analysis Research in Tobacco and Alcohol (CARTA).
Binary definitions of depression, anxiety and psychological distress assessed by clinical interview, symptom scales or self-reported recall of clinician diagnosis.
The analytic sample included up to 58 176 never smokers, 37 428 former smokers and 32 028 current smokers (total N=127 632). In observational analyses, current smokers had 1.85 times greater odds of depression (95% CI 1.65 to 2.07), 1.71 times greater odds of anxiety (95% CI 1.54 to 1.90) and 1.69 times greater odds of psychological distress (95% CI 1.56 to 1.83) than never smokers. Former smokers also had greater odds of depression, anxiety and psychological distress than never smokers. There was evidence for positive associations of smoking heaviness with depression, anxiety and psychological distress (ORs per cigarette per day: 1.03 (95% CI 1.02 to 1.04), 1.03 (95% CI 1.02 to 1.04) and 1.02 (95% CI 1.02 to 1.03) respectively). In Mendelian randomisation analyses, there was no strong evidence that the minor allele of rs16969968/rs1051730 was associated with depression (OR=1.00, 95% CI 0.95 to 1.05), anxiety (OR=1.02, 95% CI 0.97 to 1.07) or psychological distress (OR=1.02, 95% CI 0.98 to 1.06) in current smokers. Results were similar for former smokers.
Findings from Mendelian randomisation analyses do not support a causal role of smoking heaviness in the development of depression and anxiety.
Cardiac autonomic neuropathy (CAN) and elevated nocturnal blood pressure are independent risk factors for cardiovascular disease in patients with diabetes. Previously, associations between CAN, non-dipping of nocturnal blood pressure and coronary artery calcification have been demonstrated. The present protocol describes a trial to test the efficacy of bedtime dosing of the ACE inhibitor enalapril on night time blood pressure and left ventricular mass in patients with type 1 diabetes.
In a randomised, double-blind, two-way cross-over study, 24 normoalbuminuric patients with type 1 diabetes with CAN will be treated for 12 weeks with either morning or bedtime dosing of 20 mg enalapril, followed by 12 weeks of switched treatment regimen. During each treatment period, two 24 h ambulatory blood pressure measurements will be performed and after each treatment period left ventricular mass will be determined by multisliced CT. Primary end points will be reduction in blood pressure and reduction in left ventricular mass.
The study has been approved by the Danish Medicines Agency, the Scientific-Ethical Committee of the Capital Region of Denmark and the Danish Data Protection Agency. An external monitoring committee (the Good Clinical Practice Unit at Copenhagen University Hospital) will oversee the study. The results of the study will be presented at national and international scientific meetings and publications will be submitted to peer-reviewed journals.
EudraCT (2012- 002136-90).
Although pain is a significant symptom in chronic fatigue syndrome (CFS), pain is poorly understood in adolescents with CFS. The aim of this study was to explore pain distribution and prevalence, pain intensity and its functional interference in everyday life, as well as pressure pain thresholds (PPT) in adolescents with CFS and compare this with a control group of healthy adolescents (HC).
This is a case–control, cross-sectional study on pain including 120 adolescents with CFS and 39 HCs, aged 12–18 years. We measured pain frequency, pain severity and pain interference using self-reporting questionnaires. PPT was measured using pressure algometry. Data were collected from March 2010 until October 2012 as part of the Norwegian Study of Chronic Fatigue Syndrome in Adolescents: Pathophysiology and Intervention Trial.
Adolescents with CFS had significantly lower PPTs compared with HCs (p<0.001). The Pain Severity Score and the Pain Interference Score were significantly higher in adolescents with CFS compared with HCs (p<0.001). Almost all adolescents with CFS experienced headache, abdominal pain and/or pain in muscles and joints. Moreover, in all sites, the pain intensity levels were significantly higher than in HCs (p<0.001).
We found a higher prevalence of severe pain among adolescents with CFS and lowered pain thresholds compared with HCs. The mechanisms, however, are still obscure. Large longitudinal population surveys are warranted measuring pain thresholds prior to the onset of CFS.
Clinical Trials, NCT01040429; The Norwegian Study of Chronic Fatigue Syndrome in Adolescents: Pathophysiology and Intervention Trial (NorCAPITAL) http://www.clinicaltrials.gov.
Many young people do not practise enough physical activity (PA) to benefit their health. The three-cohort study aimed to investigate the prevalence of PA and understand the trends between 2002 and 2010, using a representative sample of Portuguese adolescents.
The participants were 8483 adolescents (4067 boys, 4416 girls) who participated in the Health Behaviour in School-aged Children Portuguese survey in 2002, 2006 and 2010.
A questionnaire was used to collect data of PA. Analyses were run separately for boys and girls.
Boys aged 15–17 reported practising 3.5±1.9 times a week in 2002, 3.9±1.9 times a week in 2006 and 3.8±1.9 times a week in 2010, with a significant increase from 2002 to 2006/2010 (p<0.05). PA practice during the past 7 days decreased from 4.2±2.1 to 3.9+1.9 between 2002 and 2006 (p<0.001) and also decreased from 4.4±2.1 to 3.8±1.9 between 2006 and 2010 (p<0.001). Among girls, PA practices during the past 7 days declined significantly from 3.5±1.9 to 2.7±1.7 between 2002 and 2006 (p<0.001), and from 3.3±1.9 to 2.9±1.7 between 2006 and 2010 (p<0.001).
The study points to age as a factor related to diminished PA participation. The study also revealed that the prevalence of PA has decreased over the years for the same age groups.
Optimal ventilator management for patients with acute respiratory distress syndrome (ARDS) remains uncertain. Lower tidal volume ventilation appears to be beneficial, but optimal management of positive end-expiratory pressure (PEEP) remains unclear. The Esophageal Pressure-Guided Ventilation 2 Trial (EPVent2) aims to examine the impact of mechanical ventilation directed at maintaining a positive transpulmonary pressure (PTP) in patients with moderate-to-severe ARDS.
EPVent2 is a multicentre, prospective, randomised, phase II clinical trial testing the hypothesis that the use of a PTP-guided ventilation strategy will lead to improvement in composite outcomes of mortality and time off the ventilator at 28 days as compared with a high-PEEP control. This study will enrol 200 study participants from 11 hospitals across North America. The trial will utilise a primary composite end point that incorporates death and days off the ventilator at 28 days to test the primary hypothesis that adjusting ventilator pressure to achieve positive PTP values will result in improved mortality and ventilator-free days.
Safety oversight will be under the direction of an independent Data and Safety Monitoring Board (DSMB). Approval of the protocol was obtained from the DSMB prior to enrolling the first study participant. Approvals of the protocol as well as informed consent documents were also obtained from the Institutional Review Board of each participating institution prior to enrolling study participants at each respective site. The findings of this investigation, as well as associated ancillary studies, will be disseminated in the form of oral and abstract presentations at major national and international medical specialty meetings. The primary objective and other significant findings will also be presented in manuscript form. All final, published manuscripts resulting from this protocol will be submitted to PubMed Central in accordance with the National Institute of Health Public Access Policy.
ClinicalTrials.gov under number NCT01681225.
To evaluate the reference values for short-term heart rate variability (HRV), estimate the performance of cardiovascular autonomic neuropathy (CAN) diagnostic tests in the absence of a gold standard, and assess CAN prevalence in our dataset.
Community and hospital health centre.
Of 2092 subjects available for data analysis, 371 healthy subjects were selected so the reference values for the short-term HRV test could be evaluated. An external dataset contained 88 subjects who completed both the short-term HRV test and Ewing's test.
Collection of information on clinical outcome.
Cardiovascular autonomic function evaluated by using the short-term HRV test and/or Ewing's test.
Cut-off points of 356.13, 55.45 and 36.64 ms2 were set for total power, low frequency and high frequency (HF), respectively. The diagnostic test for CAN based on the mentioned reference value was created. The HRV test had a high sensitivity (80.01–85.09%) and specificity (82.30–85.20%) for CAN. In addition, the non-inferiority test rejected the null hypothesis that the performance of the HRV test was inferior to that of Ewing's test (p<0.05). The estimated CAN prevalence was 14.92% and 29.17% in the total sample and patients with diabetes, respectively.
Our findings provided reference values for short-term HRV, which were used for the CAN diagnostic test with high sensitivity and specificity. The estimated CAN prevalence was high in the Chinese population.
Gliomas are among the biggest challenges in neurological and oncology rehabilitation and optimising treatment is of major clinical importance in this population. Although inpatient rehabilitation among glioma patients' results in improved functional measures, rehabilitation efforts are still not emphasised in this patient group and the literature lacks studies investigating the impact of outpatient rehabilitation.
This protocol describes a randomised 6-week parallel group rehabilitation study investigating an outpatient interdisciplinary rehabilitation programme. The intervention consists of 6 weeks intensive physiotherapy as groups exercise in conjunction with 0–6 weeks of individual occupational therapy if a need is present. The aim of this study is to describe the design of the upcoming randomised control trial (RCT). The results of the RCT will add to the growing body of literature investigating the potential role of exercise as a supportive therapeutic intervention for a patient with cancer.
The project is approved by the Regional Scientific Ethical Committees for Southern Denmark under Project-ID: (S-20140108) and by the Danish Data Protection Agency (J. no.2008-58-0035). Dissemination will occur through presentation and findings will be published in peer-reviewed journals. The key strength of this study is its randomised design and it is the first study to investigate a standardised outpatient interdisciplinary rehabilitation programme among patients with glioma. A potential limitation is the uncertainty and risk of side effects to the concomitant treatment, which enhances the risk of dropout.
ClinicalTrials.gov Identifier NCT02221986.
The validity of systematic reviews and meta-analysis depends on methodological quality and unbiased dissemination of trials. Our objective is to evaluate the association of estimates of treatment effects with different bias-related study characteristics in meta-analyses of interventions used for treating pain in osteoarthritis (OA). From the findings, we hope to consolidate guidance on interpreting OA trials in systematic reviews based on empirical evidence from Cochrane reviews.
Only systematic reviews that compare experimental interventions with sham, placebo or no intervention control will be considered eligible. Bias will be assessed with the risk of bias tool, used according to the Cochrane Collaboration's recommendations. Furthermore, center status, trial size and funding will be assessed. The primary outcome (pain) will be abstracted from the first appearing forest plot for overall pain in the Cochrane review. Treatment effect sizes will be expressed as standardised mean differences (SMDs), where the difference in mean values available from the forest plots is divided by the pooled SD. To empirically assess the risk of bias in treatment benefits, we will perform stratified analyses of the trials from the included meta-analyses and assess the interaction between trial characteristics and treatment effect. A relevant study-level covariate is defined as one that decreases the between-study variance (2, estimated as Tau-squared) as a consequence of inclusion in the mixed effects statistical model.
Meta-analyses and randomised controlled trials provide the most reliable basis for treatment of patients with OA, but the actual impact of bias is unclear. This study will systematically examine the methodological quality in OA Cochrane reviews and explore the effect estimates behind possible bias. Since our study does not collect primary data, no formal ethical assessment and informed consent are required.
Despite the burden of venous thromboembolism (VTE) among surgical patients on health systems in Australia, data on VTE incidence and its variation within Australia are lacking. We aim to explore VTE and subsequent mortality rates, trends and variations across Australian acute public hospitals.
A large retrospective cohort study using all elective surgical patients in 82 acute public hospitals during 2002–2009 in New South Wales, Australia.
Patients underwent elective surgery within 2 days of admission, aged between 18 and 90 years, and who were not transferred to another acute care facility; 4 362 624 patients were included.
VTE incidents were identified by secondary diagnostic codes. Poisson mixed models were used to derive adjusted incidence rates and rate ratios (IRR).
2/1000 patients developed postoperative VTE. VTE increased by 30% (IRR=1.30, CI 1.19 to 1.42) over the study period. Differences in the VTE rates, trends between hospital peer groups and between hospitals with the highest and those with the lowest rates were significant (between-hospital variation). Smaller hospitals, accommodated in two peer groups, had the lowest overall VTE rates (IRR=0.56:0.33 to 0.95; IRR=0.37:0.23 to 0.61) and exhibited a greater increase (64% and 237% vs 19%) overtime and greater between-hospital variations compared to larger hospitals (IRR=8.64:6.23 to 11.98; IRR=8.92:5.49 to 14.49 vs IRR=3.70:3.32 to 4.12). Mortality among patients with postoperative VTE was 8% and remained stable overtime. No differences in post-VTE death rates and trends were seen between hospital groups; however, larger hospitals exhibited less between-hospital variations (IRR=1.78:1.30 to 2.44) compared to small hospitals (IRR>23). Hospitals performed differently in prevention versus treatment of postoperative VTE.
VTE incidence is increasing and there is large variation between-hospital and within-hospital peer groups suggesting a varied compliance with VTE preventative strategies and the potential for targeted interventions and quality improvement opportunities.
We examined the association between socioeconomic position (SEP) and oral health, and the associations of economic difficulties in childhood and workplace-related factors on these parameters.
Cross-sectional study.
A total of 3201 workers aged 25–50 years, living in and around Tokyo, Japan, from the J-SHINE (Japanese study of Stratification, Health, Income, and Neighborhood) study. The response rate was 31.6%.
Self-rated oral health (SROH)—A logistic regression model was used to estimate ORs for the association between poor SROH and each indicator of SEP (annual household income, wealth, educational attainment, occupation and economic situation in childhood). Multiple imputation was used to address missing values.
Each indicator of SEP, including childhood SEP, was significantly inversely associated with SROH, and all of the workplace-related factors (social support in the workplace, job stress, working hours and type of employment) were also significantly associated with SROH. Compared with professionals, blue-collar workers had a significantly higher OR of poor SROH and the association was substantially explained by the workplace-related factors; ORs ranged from 1.44 in the age-adjusted and sex-adjusted model to 1.18 in the multivariate model. Poverty during childhood at age 5 and at age 15 was associated with poorer SROH, and these two factors seemed to be independently associated with SROH.
We found oral health disparity across SEP among workers in Japan. Approximately 60% of the association between occupation and SROH was explained by job-related factors. Economic difficulties during childhood appear to affect SROH in adulthood separately from sex, age and the current workplace-related factors.
The purpose of this study is to compare communication patterns in calls subjected to a malpractice claim with matched controls.
In many countries, telephone advice nursing is patients' first contact with healthcare. Telenurses' assessment of callers' symptoms and needs are based on verbal communication only, and problems with over-triage and under-triage have been reported.
A total sample of all reported medical errors (n=33) during the period 2003–2010 within Swedish Healthcare Direct was retrieved. Corresponding calls were thereafter identified and collected as sound files from the manager in charge at the respective call centres. For technical reasons, calls from four of the cases were not possible to retrieve. For the present study, matched control calls (n=26) based on the patient's age, gender and main symptom presented by the caller were collected.
Male patients were in majority (n=16), and the most common reasons for calling were abdominal pain (n=10) and chest pain (n=5). There were statistically significant differences between the communication in the cases and controls: telenurses used fewer open-ended medical questions (p<0.001) in the cases compared to the control calls; callers provided telenurses with more medical information in the control calls compared to the cases (p=0.001); and telenurses used more facilitation and patient activation activities in the control calls (p=0.034), such as back-channel response (p=0.001), compared to the cases.
The present study shows that telenurses in malpractice claimed calls used more closed-ended questioning compared to those in control calls, who used more open-ended questioning and back-channel response, which provided them with richer medical descriptions and more information from the caller. Hence, these communicative techniques are important in addition to solid medical and nursing competence and sound decision aid systems.
To synthesise the evidence on implementing family involvement in the treatment of patients with psychosis with a focus on barriers, problems and facilitating factors.
Systematic review of studies evaluating the involvement of families in tripartite communication between health professionals, 'families' (or other unpaid carers) and adult patients, in a single-family context. A theoretical thematic analysis approach and thematic synthesis were used.
A systematic electronic search was carried out in seven databases, using database-specific search strategies and controlled vocabulary. A secondary manual search of grey literature was performed as well as using forwards and backwards snowballing techniques.
A total of 43 studies were included. The majority featured qualitative data (n=42), focused solely on staff perspectives (n=32) and were carried out in the UK (n=23). Facilitating the training and ongoing supervision needs of staff are necessary but not sufficient conditions for a consistent involvement of families. Organisational cultures and paradigms can work to limit family involvement, and effective implementation appears to operate via a whole team coordinated effort at every level of the organisation, supported by strong leadership. Reservations about family involvement regarding power relations, fear of negative outcomes and the need for an exclusive patient–professional relationship may be explored and addressed through mutually trusting relationships.
Implementing family involvement carries additional challenges beyond those generally associated with translating research to practice. Implementation may require a cultural and organisational shift towards working with families. Family work can only be implemented if this is considered a shared goal of all members of a clinical team and/or mental health service, including the leaders of the organisation. This may imply a change in the ethos and practices of clinical teams, as well as the establishment of working routines that facilitate family involvement approaches.
Postnatal mental health problems, which are an international public health priority, are a suitable target for preventive approaches. The financial burden of these disorders is borne across sectors in society, including health, early childhood, education, justice and the workforce. This paper describes the planned economic evaluation of What Were We Thinking, a psychoeducational intervention for the prevention of postnatal mental health problems in first-time mothers.
The evaluation will be conducted alongside a cluster-randomised controlled trial of its clinical effectiveness. Cost-effectiveness and costs-utility analyses will be conducted, resulting in estimates of cost per percentage point reduction in combined 30-day prevalence of depression, anxiety and adjustment disorders and cost per quality-adjusted life year gained. Uncertainty surrounding these estimates will be addressed using non-parametric bootstrapping and represented using cost-effectiveness acceptability curves. Additional cost analyses relevant for implementation will also be conducted. Modelling will be employed to estimate longer term cost-effectiveness if the intervention is found to be clinically effective during the period of the trial.
Approval to conduct the study was granted by the Southern Health (now Monash Health) Human Research Ethics Committee (24 April 2013; 11388B). The study was registered with the Monash University Human Research Ethics Committee (30 April 2013; CF12/1022-2012000474). The Education and Policy Research Committee, Victorian Government Department of Education and Early Childhood Development approved the study (22 March 2012; 2012_001472). Use of the EuroQol was registered with the EuroQol Group; 16 August 2012.
The trial was registered with the Australian New Zealand Clinical Trials Registry on 7 May 2012 (registration number ACTRN12613000506796).
Coronary artery bypass grafting (CABG) and percutaneous coronary interventions (PCI) are procedures commonly performed on patients with significant obstructive coronary artery disease to relieve symptoms of ischaemia, improve survival or both. Although the efficacy of both procedures at the individual level has been established, the impact of advances in coronary artery revascularisation procedures (CARP) on long-term outcomes and cost-effectiveness at the population level are yet to be assessed. Our aim is to evaluate a minimum of 6-year outcomes and costs for the total population of patients who had CARP in Western Australia (WA) in 2000–2005.
This retrospective population cohort study will link clinical and administrative health data for a previously defined cohort including all patients in WA who had a CARP in the period 2000–2005. The cohort consists of 19 014 patients who had 21 175 procedures (15 429 PCI and 5746 CABG). We are now collecting a minimum of 6 years follow-up of morbidity and mortality data for the cohort using the WA Data Linkage System, clinical registries and hospital records, with 12 years follow-up for cases in the year 2000. Comparison of long-term outcomes for different CARP will be reported (PCI vs CABG; bare metal stents vs drug-eluting stents vs CABG). Cost-effectiveness analysis of CARP from the perspective of the healthcare sector will be performed using individual level cost data and average costs from Australian Refined Diagnosis Related Groups.
This study has received ethics approval from the University of Western Australia, the Western Australian Department of Health and all participating hospitals. Being a large population cohort study, approval included a waiver of informed consent. All findings will be presented at local, national and international healthcare/academic conferences and published in peer-reviewed journals.
Current techniques for monitoring patients for apnoea suffer from significant limitations. These include insufficient availability to meet diagnostic needs, cost, accuracy of results in the presence of artefacts and difficulty of use in unsupervised conditions.
We created and clinically tested a novel miniature medical device that targets overcoming these limitations.
We studied 20 healthy control participants and 10 patients who had been referred for sleep apnoea diagnosis. The performances of the new system and also of the Food and Drug Administration (FDA) approved SOMNO clinical system, conventionally used for sleep apnoea diagnosis were evaluated under the same conditions. Both systems were tested during a normal night of sleep in controls and patients. Their performances were quantified in terms of detection of apnoea and hypopnoea in individual 10 s epochs, which were compared with scoring of signals by a blinded clinician.
For spontaneous apnoeas during natural sleep and considering the clinician scorer as the gold standard, the new wearable apnoea detection device had 88.6% sensitivity and 99.6% specificity. In comparison the SOMNO system had 14.3% sensitivity and 99.3% specificity. The novel device had been specifically designed to detect apnoea, but if apnoea and hypopnoea during sleep were both considered in the assessment, the sensitivity and specificity were 77.1% and 99.7%, respectively, versus 54% and 98.5%, respectively, for the SOMNO.
The performance of the novel device compares very well to the scoring by an experienced clinician even in the presence of breathing artefacts, in this small pilot study. This can potentially make it a real solution for apnoea home monitoring.
The purpose of this study was to determine the relationship between serum -glutamyltranspeptidase (GGT) and brachial-ankle pulse wave velocity (baPWV) as an indicator for atherosclerosis in Japanese men and women after adjusting for fatty liver.
A cross-sectional study.
A health check-up centre in Japan.
912 Japanese men and women aged 24–84 years recruited from people who received a medical health check-up programme with a standardised questionnaire and an automatic waveform analyser to measure baPWV.
We measured serum GGT concentrations and baPWV. Fatty liver was diagnosed by standardised criteria using abdominal ultrasonography. The postmenopausal state was defined as beginning 1 year after the cessation of menses.
In women, log2 GGT was positively associated with baPWV (β=0.11, 95% CI 0.02 to 0.19, p<0.05), independent of age, body mass index, systolic blood pressure, fasting plasma glucose, triglycerides, estimated glomerular filtration rate, fatty liver, menopausal state and parameters of lifestyles. However, in men, the positive association of log2 GGT with baPWV was not significant (β=–0.04, 95% CI –0.10 to 0.03, p=0.28) in multivariable linear regression analyses.
The serum GGT level was associated with baPWV, independently of covariates including fatty liver or menopausal state just in women, but not in men.
Study associations between three measures of alcohol consumption (recent, typical/habitual, binging), semen quality and serum reproductive hormones.
Cross-sectional population based study.
1221 young Danish men, aged 18–28 years were recruited when they attended a compulsory medical examination to determine their fitness for military service from 2008 to 2012. Total alcohol consumption: (1) in the week preceding (habitual/typical) the visit (recent alcohol intake), (2) in a typical week and (3) frequency of 'binge drinking' (consuming more than 5 units/day)) in the past 30 days was estimated.
Semen quality (volume, sperm concentration, total sperm count, and percentages of motile and morphologically normal spermatozoa) and serum concentration of reproductive hormones (follicle-stimulating hormone, luteinising hormone, testosterone, sex hormone binding globulin, oestradiol, free testosterone and inhibin B).
Sperm concentration, total sperm count and percentage of spermatozoa with normal morphology were negatively associated with increasing habitual alcohol intake. This association was observed in men reporting at least 5 units in a typical week but was most pronounced for men with a typical intake of more than 25 units/week. Men with a typical weekly intake above 40 units had a 33% (95% CI 11% to 59%) reduction in sperm concentration compared to men with an intake of 1–5 units/week. A significant increase in serum free testosterone with increasing alcohol consumption the week preceding the visit was found. Binging was not independently associated with semen quality.
Our study suggests that even modest habitual alcohol consumption of more than 5 units per week had adverse effects on semen quality although most pronounced associations were seen in men who consumed more than 25 units per week. Alcohol consumption was also linked to changes in testosterone and SHBG levels. Young men should be advised to avoid habitual alcohol intake.
Strategies to reduce hospital admissions for mental health service users have received vast amounts of attention, yet the transfer of care from hospital to the community has been ignored. The discharge process is complex, messy, disjointed and inefficient, relying on cross-agency and organisational working. Focusing on one acute mental health admission ward, we will investigate whether the discharge process for people with severe mental health problems can be enhanced through the creation, implementation and utilisation of a knowledge sharing proforma that is used on their admission to the ward.
The project uses qualitative interviews to understand the complex processes associated with being admitted and discharged from inpatient mental health wards. Practitioners will be asked to identify and map the relevant stakeholders involved in admission and discharge, and discuss any problems with the process. The study team will work with clinicians to develop a knowledge collection proforma, which will be piloted for 2 months. Qualitative interviews will be carried out to collect reflections on the experiences of using the tool, with data used for further refinement of the intervention. Baseline and repeat quantitative measures will be taken to illustrate any changes to length of stay and readmission rates achieved as a result of the study.
A key issue is that participants are able to comment frankly on something that is a core part of their work, without fear or reprise. It is equally important that all participants are offered the opportunity to develop and coproduce the knowledge collection proforma, in order that the intervention produced is fit for purpose and usable in the real world, away from a research environment. The study has received ethical approval from Nottingham University Business School ethics committee, and has all appropriate National Health Service research governance clearances.
To determine the prevalence, nature and predictors of prescribing errors (PEs) in three mental health hospitals.
Inpatient units in three National Health Service (NHS) mental health hospitals in the North West of England.
Trained clinical pharmacists prospectively recorded the number of PEs in newly written or omitted prescription items screened during their routine work on 10 data collection days. A multidisciplinary panel reviewed PE data using established methods to confirm (1) the presence of a PE, (2) the type of PE and (3) whether errors were clinically relevant and likely to cause harm.
Frequency, nature and predictors of PEs.
Of 4427 screened prescription items, 281 were found to have one or more PEs (error rate 6.3% (95% CI 5.6 to 7.1%)). Multivariate analysis revealed that specialty trainees (OR 1.23 (1.01 to 1.51)) and staff grade psychiatrists (OR 1.50 (1.05 to 2.13)) were more likely to make PEs when compared to foundation year (FY) one doctors, and that specialty trainees and consultant psychiatrists were twice as likely to make clinically relevant PEs (OR 2.61 (2.11 to 3.22) and 2.03 (1.66 to 2.50), respectively) compared to FY one staff. Prescription items screened during the prescription chart rewrite (OR 0.52 (0.33 to 0.82)) or at discharge (OR 0.87 (0.79 to 0.97)) were less likely to be associated with PEs than items assessed during inpatient stay, although they were more likely to be associated with clinically relevant PEs (OR 2.27 (1.72 to 2.99) and 4.23 (3.68 to 4.87), respectively). Prescription items screened at hospital admission were five times more likely (OR 5.39 (2.72 to 10.69)) to be associated with clinically relevant errors than those screened during patient stay.
PEs may be more common in mental health hospitals than previously reported and important targets to minimise these errors have been identified.
To assess the effect of physician preference for a particular tumour necrosis factor α (TNF) antagonist on the risk of treatment discontinuation in rheumatoid arthritis.
Population-based cohort study.
British Columbia administrative health data (inpatients, outpatients and pharmacy).
2742 British Columbia residents who initiated a first course of a TNF antagonist between 2001 and December 2008, had been diagnosed with rheumatoid arthritis, and were treated by 1 of 58 medium-volume to high-volume prescribers.
A level of physician preference for the drug (higher or lower) was assigned based on preceding prescribing records of the care-providing physician. Higher preference was defined as at least 60% of TNF antagonist courses initiated in the preceding year. Sensitivity analysis was conducted with different thresholds for higher preference.
Drug discontinuation was defined as a drug-free interval of 180 days or switching to another TNF antagonist, anakinra, rituximab or abatacept. The risk of discontinuation was compared between different levels of physician preference using survival analysis.
Higher preference for the prescribed TNF antagonist was associated with improved persistence with the drug (4.28 years (95% CI 3.70 to 4.90) vs 3.27 (2.84 to 3.84), with log rank test p value of 0.017). The adjusted HR for discontinuation was significantly lower in courses of drugs with higher preference (0.85 (0.76 to 0.96)). The results were robust in a sensitivity analysis.
Higher physician preference was associated with decreased risk of discontinuing TNF antagonists in patients with rheumatoid arthritis. This finding suggests that physicians who strongly prefer a specific treatment help their patients to stay on treatment for a longer duration. Similar research on other treatments is warranted.
Nurses are generally present, and often influential, in supporting patient and family acceptance of medical futility and in assisting doctors in negotiating referral to palliative care. Yet the specificities of the nursing role and how nurses may contribute to timely and effective referrals is not well understood. This study aimed to systematically explore hospital-based nurses' accounts of the transition to palliative care, and the potential role of nurses in facilitating more effective palliative care transitions.
Qualitative study using semistructured interviews.
Two health services with public as well as private clinical environments in a major metropolitan area of Australia.
Hospital-based nurses (n=20) who regularly work with patients at the point of referral and in managing transitions to palliative care.
Four significant themes emerged from thematic analysis. These include: (1) professional dynamics and the roles played by nurses in initiating the transition to palliative care; (2) the value of nurses' informal interactions in timely and effective transitions; (3) the emerging challenge of managing task-oriented nursing versus intense emotional nursing work at the point of medical futility and (4) the emotional burden experienced by nurses within this clinical context. Nurses self-reported occupying critical albeit complex roles in the management of medical futility and the transition to palliative care. They reported experiencing significant emotional burden in balancing interpersonal and interprofessional relationships during this time.
The results suggest that nurses may be utilised in a more formalised and systematic fashion in the context of managing medical futility and the need to topicalise the transition, with the focus shifted away from medical referrals towards more team-based and patient-centred timely transitions. Further research focused on the experiences of doctors, allied health professionals, patients and families is required to provide a broader interdisciplinary understanding of futility and contributions to the negotiation of palliative care.
We previously demonstrated that a calcium channel blocker, azelnidipine, improves left ventricular relaxation in patients with hypertension and diastolic dysfunction in a multicentre, Clinical impact of Azelnidipine on Left VentricuLar diastolic function and OutComes in patients with hypertension (CALVLOC) trial. The objectives of the present subanalysis were to investigate the differences in diastolic function in hypertensive patients with and without diabetes, and the efficacy of azelnidipine on diastolic function among them.
Subanalysis of a prospective single-arm multicentre study.
228 hypertensive patients with normal ejection fraction and impaired left ventricular relaxation (septal e' velocity <8 cm/s on echocardiography) enrolled for CALVLOC trial. They were divided into two groups based on presence or absence of diabetes.
Administration of 16 mg of azelnidipine for 8 months (range 6–10 months).
Septal e' velocity before and at the end of the study.
Whereas patients with diabetes (n=53, 23.2%) had lower systolic blood pressure (BP) than patients without diabetes (155±17 vs 161±16 mm Hg, p=0.03), they had lower e' velocity (5.7±1.5 vs 6.1±1.4 cm/s, p=0.04) at baseline. Azelnidipine decreased BP and heart rate, and increased e' velocity similarly in patients with diabetes (5.7±1.5 to 6.3±1.5 cm/s, p=0.0003) and without diabetes (6.1±1.4 to 6.9±1.4 cm/s, p<0.0001). Increase in e' velocity was not influenced by presence of diabetes, and patients with diabetes still had lower e' velocity after treatment (p=0.006). There was a significant correlation between increase in e' velocity and decrease in systolic BP (R=0.25, p=0.0001), which was not influenced by diabetes.
Comorbid diabetes could impair left ventricular relaxation independently in patients with hypertension, which might not be improved solely by BP lowering.
Over 16 000 mastectomies are performed in England and Wales annually. Acute postoperative pain and nausea are common. The most frequently occurring long-term complications are chronic pain (up to 50%) and reduced shoulder function (reported at 35%). Regional techniques that improve acute postoperative pain relief may reduce the incidence of these complications. This study assesses the effectiveness of a 24-hour continuous local anaesthetic in the subpectoral plane in improving postoperative pain and quality of life in patients undergoing mastectomy.
This is a randomised, double blind, placebo-controlled, two-centre, parallel group trial in women undergoing mastectomy with or without axillary involvement. One hundred and sixty participants will be randomised in a 1:1 ratio to receive either 0.25% levobupivacaine or 0.9% saline by subpectoral infusion postoperatively for 24 h. All participants will be provided with an intravenous morphine patient-controlled analgesia (PCA) system. Participants will be followed-up for 24 h in hospital and at approximately 14 days and 6 months postoperatively. Joint primary outcome measures are total morphine consumption and total pain score (captured via patient-recorded visual analogue scale (VAS) 4 hourly) during the first 24 h postoperatively. Primary statistical analysis of total pain is based on the area under the curve of pain versus time graph. Secondary outcomes include PCA attempts in first 24 h; VAS pain scores and shoulder function by goniometry at 24 h, 14 days (approximately) and 6 months; Verbal Rating Scale pain scores in first 24 h; Brief Pain Inventory and Oxford Shoulder Score at 6 months; duration of hospital stay; incidence of postoperative nausea and vomiting; cost-effectiveness.
The study is approved by the South West England Research Ethics Committee (12/SW/0149).
will be published in a peer-reviewed journal and presented at local, national and international scientific meetings.
ISRCTN46621916. EudraCT 2011-005775-16.
The Cochrane risk of bias tool is a prominent instrument used to evaluate potential biases in clinical trials. In three updates of our Cochrane review on neuraminidase inhibitors, we assessed risk of bias on the same trials using different levels of detail: the trials in journal publications, in core reports, and in full clinical study reports. Here we analyse whether progressively greater amounts of information and detail in full clinical study reports (including trial protocols, statistical analysis plans, certificates of analyses, individual participant data listings and randomisation lists) affected our risk of bias assessments.
We used the Cochrane risk of bias tool to assess and compare risk of bias in 14 oseltamivir trials (reported in 10 clinical study reports) obtained from the European Medicines Agency (EMA) and the manufacturer, Roche. With more detailed information, reported in clinical study reports, no previous assessment of 'high' risk of bias was reclassified as 'low' or 'unclear' in the main analysis, and over half (55%, 34/62) of the previous assessments of 'low' risk of bias were reclassified as 'high'. Most assessments of 'unclear' risk of bias (67%, or 28/42) were reclassified as 'high' risk of bias when our judgements were based on full clinical study reports. The limits of our study were our relative inexperience in dealing with large information sets, sometimes subjective bias judgements and focus on industry trials. Comparison with journal publications was not possible because of the low number of trials published.
We found that as information increased in the document, this increased our assessment of bias. This may mean that risk of bias has been insufficiently assessed in Cochrane reviews based on journal publications.
To determine whether the prevalence of chronic kidney disease (CKD) in England has changed over time.
Cross-sectional analysis of nationally representative Health Survey for England (HSE) random samples.
England 2003 and 2009/2010.
13 896 adults aged 16+ participating in HSE, adjusted for sampling and non-response, 2009/2010 surveys combined.
Change in prevalence of estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 (as proxy for stage 3–5 CKD), from 2003 to 2009/2010 based on a single serum creatinine measure using an isotope dilution mass spectrometry traceable enzymatic assay in a single laboratory; eGFR derived using Modified Diet in Renal Disease (MDRD) and Chronic Kidney Disease Epidemiology Collaboration (CKDEPI) eGFR formulae.
Multivariate logistic regression modelling to adjust time changes for sociodemographic and clinical factors (body mass index, hypertension, diabetes, lipids). A correction factor was applied to the 2003 HSE serum creatinine to account for a storage effect.
National prevalence of low eGFR (<60) decreased within each age and gender group for both formulae except in men aged 65–74. Prevalence of obesity and diabetes increased in this period, while there was a decrease in hypertension. Adjustment for demographic and clinical factors led to a significant decrease in CKD between the surveyed periods. The fully adjusted OR for eGFR <60 mL/min/1.73 m2 was 0.75 (0.61 to 0.92) comparing 2009/2010 with 2003 using the MDRD equation, and was similar using the CKDEPI equation 0.73 (0.57 to 0.93).
The prevalence of a low eGFR indicative of CKD in England appeared to decrease over this 7-year period, despite the rising prevalence of obesity and diabetes, two key causes of CKD. Hypertension prevalence declined and blood pressure control improved but this did not appear to explain the fall. Periodic assessment of eGFR and albuminuria in future HSEs is needed to evaluate trends in CKD.
National guidelines recommend 'early' coronary angiography within 96 h of presentation for patients with non-ST elevation acute coronary syndromes (NSTE-ACS). Most patients with NSTE-ACS present to their district general hospital (DGH), and await transfer to the regional cardiac centre for angiography. This care model has inherent time delays, and delivery of timely angiography is problematic. The objective of this study was to assess a novel clinical care pathway for the management of NSTE-ACS, known locally as the Heart Attack Centre-Extension or HAC-X, designed to rapidly identify patients with NSTE-ACS while in DGH emergency departments (ED) and facilitate transfer to the regional interventional centre for 'early' coronary angiography.
This was an observational study of 702 patients divided into two groups; 391 patients treated before the instigation of the HAC-X pathway (Pre-HAC-X), and 311 patients treated via the novel pathway (Post-HAC-X). Our primary study end point was time from ED admission to coronary angiography. We also assessed the length of hospital stay.
Median time from ED admission to coronary angiography was 7.2 (IQR 5.1–10.2) days pre-HAC-X compared to 1.0 (IQR 0.7–2.0) day post-HAC-X (p<0.001). Median length of hospital stay was 3.0 (IQR 2.0–6.0) days post-HAC-X v 9.0 (IQR 6.0–14.0) days pre-HAC-X (p<0.0005). This equates to a reduction of six hospital bed days per NSTE-ACS admission.
The introduction of this novel care pathway was associated with significant reductions in time to angiography and in total hospital bed occupancy for patients with NSTE-ACS.
We hypothesise that there is an association between an elevated pulmonary artery/aorta (PA/A) and World Trade Center-Lung Injury (WTC-LI). We assessed if serum vascular disease biomarkers were predictive of an elevated PA/A.
Retrospective case-cohort analysis of thoracic CT scans of WTC-exposed firefighters who were symptomatic between 9/12/2001 and 3/10/2008. Quantification of vascular-associated biomarkers from serum collected within 200 days of exposure.
Urban tertiary care centre and occupational healthcare centre.
Male never-smoking firefighters with accurate pre-9/11 forced expiratory volume in 1 s (FEV1) ≥75%, serum sampled ≤200 days of exposure was the baseline cohort (n=801). A subcohort (n=97) with available CT scans and serum biomarkers was identified. WTC-LI was defined as FEV1≤77% at the subspecialty pulmonary evaluation (n=34) and compared with controls (n=63) to determine the associated PA/A ratio. The subcohort was restratified based on PA/A≥0.92 (n=38) and PA/A<0.92(n=59) to determine serum vascular biomarkers that were predictive of this vasculopathy.
The primary outcome of this study was to identify a PA/A ratio in a cohort of individuals exposed to WTC dust that was associated with WTC-LI. The secondary outcome was to identify serum biomarkers predictive of the PA/A ratio using logistic regression.
PA/A≥0.92 was associated with WTC-LI, OR of 4.02 (95% CI 1.21 to 13.41; p=0.023) when adjusted for exposure, body mass index and age at CT. Elevated macrophage derived chemokine and soluble endothelial selectin were predictive of PA/A≥0.92, (OR, 95% CI 2.08, 1.05 to 4.11, p=0.036; 1.33, 1.06 to 1.68, p=0.016, respectively), while the increased total plasminogen activator inhibitor 1 was predictive of not having PA/A≥0.92 (OR 0.88, 0.79 to 0.98; p=0.024).
Elevated PA/A was associated with WTC-LI. Development of an elevated PA/A was predicted by biomarkers of vascular disease found in serum drawn within 6 months of WTC exposure. Increased PA/A is a potentially useful non-invasive biomarker of WTC-LI and warrants further study.
Acute pain is common during the endotracheal extubation period, and is related to complications and adverse outcomes. Patients with delayed extubation after craniotomy are vulnerable to pain and complications of extubation. However, pain control during extubation is still inadequate. Remifentanil, a new opioid with rapid onset and short duration of action, provides adequate analgesia during procedures with minimal effect of respiratory depression.
The study is a prospective, randomised, double-blinded, controlled parallel-group design. Patients with delayed extubation after intracranial surgery are screened daily. Adult patients ready for extubation are enrolled and assigned randomly to one of the two treatment study groups, labelled as the 'Remi group' or 'Saline group'. Patients in the Remi group receive an intravenous bolus dose of remifentanil 0.5 μg/kg over 60 s followed by a continuous infusion 0.05 μg/kg/min for 20 min. Patients in the Saline group receive an intravenous infusion of 0.9% sodium chloride at a volume and rate equal to that of remifentanil. Pain intensity is measured by the visual analogue scale (VAS) pain score. Adverse events during drug infusion are documented and reported. Patients will be followed up until hospital discharge, death or 60 days after the trial intervention on a first come, first served basis. Details of the incidence of reintubation and reoperation within 72 h after extubation, length of stay in the intensive care unit and hospital and mortality are collected. The primary end point is the incidence of severe pain (defined as a VAS pain score more than 5 cm) during the periextubation period (defined as the period of time from immediately before extubation to 20 min after extubation).
The study was approved by the Institutional Review Board (IRB) of the Beijing Tiantan Hospital, Capital Medical University. The study findings will be disseminated through peer-reviewed publications and conference presentations.
ClinicalTrials (NCT): ChiCTR-PRC-13003879.
To identify characteristics of consultations that do not conform to the traditionally understood communication 'dyad', in order to highlight implications for medical education and develop a reflective 'toolkit' for use by medical practitioners and educators in the analysis of consultations.
A series of interdisciplinary research workshops spanning 12 months explored the social impact of globalisation and computerisation on the clinical consultation, focusing specifically on contemporary challenges to the clinician–patient dyad. Researchers presented detailed case studies of consultations, taken from their recent research projects. Drawing on concepts from applied sociolinguistics, further analysis of selected case studies prompted the identification of key emergent themes.
University departments in the UK and Switzerland.
Six researchers with backgrounds in medicine, applied linguistics, sociolinguistics and medical education. One workshop was also attended by PhD students conducting research on healthcare interactions.
The contemporary consultation is characterised by a multiplicity of voices. Incorporation of additional voices in the consultation creates new forms of order (and disorder) in the interaction. The roles 'clinician' and 'patient' are blurred as they become increasingly distributed between different participants. These new consultation arrangements make new demands on clinicians, which lie beyond the scope of most educational programmes for clinical communication.
The consultation is changing. Traditional consultation models that assume a 'dyadic' consultation do not adequately incorporate the realities of many contemporary consultations. A paradox emerges between the need to manage consultations in a 'super-diverse' multilingual society, while also attending to increasing requirements for standardised protocol-driven approaches to care prompted by computer use. The tension between standardisation and flexibility requires addressing in educational contexts. Drawing on concepts from applied sociolinguistics and the findings of these research observations, the authors offer a reflective 'toolkit' of questions to ask of the consultation in the context of enquiry-based learning.
When participants drop out of randomised clinical trials, as frequently happens, the intention-to-treat (ITT) principle does not apply, potentially leading to attrition bias. Data lost from patient dropout/lack of follow-up are statistically addressed by imputing, a procedure prone to bias. Deviations from the original definition of ITT are referred to as modified intention-to-treat (mITT). As yet, the impact of the potential bias associated with mITT has not been assessed. Our objective is to investigate potential bias and disadvantages of performing mITT and evaluate possible concerns when executing different mITT approaches in meta-analyses.
Using meta-epidemiology on randomised trials considered less prone to bias (ie, good internal validity) and assessing biological or targeted agents in patients with rheumatoid arthritis, we will meta-analyse data from 10 biological and targeted drugs based on collections of trials that would correspond to 10 individual meta-analyses.
This study will enhance transparency for evaluating mITT treatment effects described in meta-analyses. The intended audience will include healthcare researchers, policymakers and clinicians. Results of the study will be disseminated by peer-review publication.
In PROSPERO CRD42013006702, 11. December 2013.
The underutilisation of venous thromboembolism (VTE) prophylaxis is still a problem in the UK despite the emergence of national guidelines and incentives to increase the number of patients undergoing VTE risk assessments. Our objective was to examine the reasons doctors gave for not prescribing enoxaparin when recommended by an electronic VTE risk assessment alert.
We used a qualitative research design to conduct a thematic analysis of free text entered into an electronic prescribing system.
The study took place in a large University teaching hospital, which has a locally developed electronic prescribing system known as PICS (Prescribing, Information and Communication System).
We extracted prescription data from all inpatient admissions over a 7-month period in 2012 using the audit database of PICS.
The completion of the VTE risk assessment form introduced into the hospital-wide electronic prescribing and health records system is mandatory. Where doctors do not prescribe VTE prophylaxis when recommended, they are asked to provide a reason for this decision. The free-text field was introduced in May 2012.
Free-text reasons for not prescribing enoxaparin when recommended were thematically coded.
A total of 1136 free-text responses from 259 doctors were collected in the time period and 1206 separate reasons were analysed and coded. 389 reasons (32.3%) for not prescribing enoxaparin were coded as being due to 'clinical judgment'; in 288 (23.9%) of the responses, doctors were going to reassess the patient or prescribe enoxaparin; and in 245 responses (20.3%), the system was seen to have produced an inappropriate alert.
In order to increase specificity of warnings and avoid users developing alert fatigue, it is essential that an evaluation of user responses and/or end user feedback as to the appropriateness and timing of alerts is obtained.
To systematically investigate the prevalence of pain, factors related with pain and pain management interventions in patients with chronic obstructive pulmonary disease (COPD).
Systematic review and meta-analysis.
PubMed (MEDLINE), EMBASE, CINAHL and PsychINFO from 1966 to December 2013. Studies were included if they presented clinical data on pain or symptom burden in patients with COPD, or pain as a domain of quality of life (QoL). All types of study designs were included.
Of the 1571 articles that were identified, 39 met the inclusion criteria and were included in this review. Fourteen studies focused on pain and symptom burden (including pain) in patients with COPD and 25 studies focused on QoL using a questionnaire that included a separate pain domain. Reported pain prevalence in high-quality studies ranged from 32 to 60%. Included studies report that pain is more prevalent in patients with COPD compared to participants from the general population. Comorbidity, nutritional status, QoL and several symptoms were related to pain. None of the included studies reported a significant relationship between lung function and pain prevalence or severity. However, studies investigating pain in patients with moderate COPD reported higher pain prevalence compared to studies in patients with severe of very severe COPD.
Although literature on this topic is limited and shows substantial heterogeneity, pain seems to be a significant problem in patients with COPD and is related to several other symptoms, comorbidity and QoL. Data synthesis suggests that pain is more prevalent in patients with moderate COPD compared to patients with severe or very severe COPD. Further research is needed and should focus on determining a more accurate pain prevalence, investigating the relationship between pain prevalence, disease severity and comorbidity and explore implementation and efficacy of pain management interventions in patients with COPD.
Injuries, trauma and non-communicable diseases are responsible for a rising proportion of death and disability in low-income and middle-income countries. Delivering effective emergency and urgent healthcare for these and other conditions in resource-limited settings is challenging. In this study, we sought to examine and characterise emergency and urgent care capacity in a resource-limited setting.
We conducted an assessment within all 30 primary and secondary hospitals and within a stratified random sampling of 30 dispensaries and health centres in western Kenya. The key informants were the most senior facility healthcare provider and manager available. Emergency physician researchers utilised a semistructured assessment tool, and data were analysed using descriptive statistics and thematic coding.
No lower level facilities and 30% of higher level facilities reported having a defined, organised approach to trauma. 43% of higher level facilities had access to an anaesthetist. The majority of lower level facilities had suture and wound care supplies and gloves but typically lacked other basic trauma supplies. For cardiac care, 50% of higher level facilities had morphine, but a minority had functioning ECG, sublingual nitroglycerine or a defibrillator. Only 20% of lower level facilities had glucometers, and only 33% of higher level facilities could care for diabetic emergencies. No facilities had sepsis clinical guidelines.
Large gaps in essential emergency care capabilities were identified at all facility levels in western Kenya. There are great opportunities for a universally deployed basic emergency care package, an advanced emergency care package and facility designation scheme, and a reliable prehospital care transportation and communications system in resource-limited settings.
Physical activity levels of Australia's ageing population are declining and coincidentally rates of overweight and obesity are increasing. Adequate levels of physical activity and a healthy diet are recognised as important lifestyle factors for the maintenance of a healthy weight and prevention of chronic diseases. Retirement village (RV) residents rarely engage in physical activity and nutrition programmes offered, with poor attendance and low use of existing facilities such as on-site fitness centres and classes and nutrition seminars. The RV provides a unique setting to access and engage with this older target group, to test the effectiveness of strategies to increase levels of physical activity, improve nutrition and maintain a healthy weight.
This cluster-randomised controlled trial will evaluate a physical activity, nutrition and healthy weight management intervention for insufficiently active ('not achieving 150 min of moderate-intensity physical activity per week') adults aged 60–75 residing in RV's. A total of 400 participants will be recruited from 20 randomly selected RV's in Perth, Western Australia. Villages will be assigned to either the intervention group (n=10) or the control group (n=10) each containing 200 participants. The Retirement Village Physical Activity and Nutrition for Seniors (RVPANS) programme is a home-based physical activity and nutrition programme that includes educational resources, along with facilitators who will motivate and guide the participants during the 6-month intervention. Descriptive statistics and mixed regression models will be performed to assess the intervention effects. This trial will evaluate an intervention for the modification of health risk factors in the RV setting. Such research conducted in RV's has been limited.
Curtin University Human Research Ethics Committee (approval number: HR128/2012). Dissemination of the study results will occur through publications, reports, conference presentations and community seminars.
Australia and New Zealand Clinical Trial Registry (ACTRN12612001168842)
Chronic obstructive lung disease is not only a major cause of morbidity and mortality, but is also the major reason for intensive care unit (ICU) admission. Cardiac function is often impaired in this disease, but its association with clinical outcome has not been fully established.
This is a prospective observational study conducted in a 47-bed mixed ICU of a tertiary academic teaching hospital. The study will be performed from January 2014 to December 2015. All patients meeting the diagnostic criteria of acute exacerbation of chronic obstructive pulmonary disease and admitted to the ICU are potentially eligible for the present study. The relevant demographics and laboratory measurements have been obtained. Transthoracic echocardiography was performed immediately after ICU admission by experienced intensivists. The Cox proportional hazard regression model has been fitted by using a stepwise forward selection and backward elimination technique. If linear assumption is not satisfied, the linear spline function will be used.
The study protocol was approved by the ethics committee of Jinhua municipal central hospital. The results will be published in a peer-reviewed journal and shared with the worldwide medical community.
The study protocol is registered at ClinicalTrials.gov (NCT02099279).
Cognitive–behavioural therapy (CBT) is an effective treatment for body dysmorphic disorder (BDD). However, most sufferers do not have access to this treatment. One way to increase access to CBT is to administer treatment remotely via the Internet. This study piloted a novel therapist-supported, Internet-based CBT program for BDD (BDD-NET).
Uncontrolled clinical trial.
Patients (N=23) were recruited through self-referral and assessed face to face at a clinic specialising in obsessive–compulsive and related disorders. Suitable patients were offered secure access to BDD-NET.
BDD-NET is a 12-week treatment program based on current psychological models of BDD that includes psychoeducation, functional analysis, cognitive restructuring, exposure and response prevention, and relapse prevention modules. A dedicated therapist provides active guidance and feedback throughout the entire process.
The clinician-administered Yale-Brown Obsessive Compulsive Scale for BDD (BDD-YBOCS). Symptom severity was assessed pretreatment, post-treatment and at the 3-month follow-up.
BDD-NET was deemed highly acceptable by patients and led to significant improvements on the BDD-YBOCS (p=<0.001) with a large within-group effect size (Cohen's d=2.01, 95% CI 1.05 to 2.97). At post-treatment, 82% of the patients were classified as responders (defined as≥30% improvement on the BDD-YBOCS). These gains were maintained at the 3-month follow-up. Secondary outcome measures of depression, global functioning and quality of life also showed significant improvements with moderate to large effect sizes. On average, therapists spent 10 min per patient per week providing support.
The results suggest that BDD-NET has the potential to greatly increase access to CBT, at least for low-risk individuals with moderately severe BDD symptoms and reasonably good insight. A randomised controlled trial of BDD-NET is warranted.
Clinicaltrials.gov registration ID NCT01850433.
To develop, pilot and refine a decision aid (ahead of a randomised trial evaluation) for women around age 50 facing their initial decision about whether to undergo mammography screening.
Two-stage mixed-method pilot study including qualitative interviews (n=15) and a randomised comparison using a quantitative survey (n=34).
New South Wales, Australia.
Women aged 43–59 years with no personal history of breast cancer.
The decision aid provides evidence-based information about important outcomes of mammography screening over 20 years (breast cancer mortality reduction, overdetection and false positives) compared with no screening. The information is presented in a short booklet for women, combining text and visual formats. A control version produced for the purposes of comparison omits the overdetection-related content.
Comprehension of key decision aid content and acceptability of the materials.
Most women considered the decision aid clear and helpful and would recommend it to others. Nonetheless, the piloting process raised important issues that we tried to address in iterative revisions. Some participants found it hard to understand overdetection and why it is of concern, while there was often confusion about the distinction between overdetection and false positives. In a screening context, encountering balanced information rather than persuasion appears to be contrary to people's expectations, but women appreciated the opportunity to become better informed.
The concept of overdetection is complex and new to the public. This study highlights some key challenges for communicating about this issue. It is important to clarify that overdetection differs from false positives in terms of its more serious consequences (overtreatment and associated harms). Screening decision aids also must clearly explain their purpose of facilitating informed choice. A staged approach to development and piloting of decision aids is recommended to further improve understanding of overdetection and support informed decision-making about screening.
To test the impact of feedback on the proposed management of standardised patients presenting with behavioural change with a diagnosis of dementia in Australian primary care.
A video vignette study was performed with Australian general practitioners (GPs) in 2013. Participants viewed six pairs of matched videos depicting people presenting changed behaviour in the context of a dementia diagnosis in two phases. In both phases GPs indicated their diagnosis and management. After phase 1, GPs were offered feedback on management strategies for the patients depicted. Analyses focused on identification of change in management between the two phases of the study. Factors impacting on the intention to coordinate care for such patients were tested in a questionnaire based on the Theory of Planned Behaviour.
Forty-five GPs completed the study. There was significant improvement in the proposed management of three of the six scenarios after the intervention. Older GPs were more likely to refer appropriately (OR=1.11 (1.01 to 1.23), p=0.04.). Overall referral to support agencies was more likely after the intervention (OR=2.52 (1.53 to 4.14), p<0.001). Older GPs were less likely to intend to coordinate care for such patients (OR=0.89 (0.81 to 0.98) p=0.02). Participants who felt confident about their ability to coordinate care were more likely to do so (OR=3.79 (1.08 to 13.32) p=0.04).
The intervention described in this study promoted multidisciplinary management of patients with behavioural problems with a diagnosis of dementia. Increasing practitioner confidence in their ability to coordinate care may increase the proportion of GPs who will respond to patients and carers in this context. Older GPs may benefit in particular.
To assess the cost-effectiveness of a multifaceted quality improvement programme focused on reducing central line-associated bloodstream infections in intensive care units.
Cost-effectiveness analysis using a decision tree model to compare programme to non-programme intensive care units.
Adult patients in the intensive care unit.
Economic costs of the programme and of central line-associated bloodstream infections were estimated from the perspective of the hospital and presented in 2013 US dollars.
Central line-associated bloodstream infections prevented, deaths averted due to central line-associated bloodstream infections prevented, and incremental cost-effectiveness ratios. Probabilistic sensitivity analysis was performed.
Compared with current practice, the programme is strongly dominant and reduces bloodstream infections and deaths at no additional cost. The probabilistic sensitivity analysis showed that there was an almost 80% probability that the programme reduces bloodstream infections and the infections' economic costs to hospitals. The opportunity cost of a bloodstream infection to a hospital was the most important model parameter in these analyses.
This multifaceted quality improvement programme, as it is currently implemented by hospitals on an increasingly large scale in the USA, likely reduces the economic costs of central line-associated bloodstream infections for US hospitals. Awareness among hospitals about the programme's benefits should enhance implementation. The programme's implementation has the potential to substantially reduce morbidity, mortality and economic costs associated with central line-associated bloodstream infections.
Several studies suggest that overall and central-obesity are associated with increased breast cancer (BC) risk in postmenopausal-women. However, there are no studies investigating changes of central obesity and BC. We report on the association of BC risk with self-reported skirt size (SS; waist-circumference proxy) changes between 20s and postmenopausal-age.
Prospective cohort-study.
UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) involving the nine trial centres in England.
Postmenopausal-women aged >50 with no known history of BC prior to or on the day of completion of the study-entry questionnaire.
At recruitment and at study entry, women were asked to complete a questionnaire. Women were followed-up via 'flagging' at the NHS Information Centre in England and the Hospital Episode Statistics.
Time to initial BC diagnosis.
Between 2 January 2005 and 1 July 2010, 92 834 UKCTOCS participants (median age 64.0) completed the study-entry questionnaire. During median follow-up of 3.19 years (25th–75th centile: 2.46–3.78), 1090 women developed BC. Model adjusted analysis for potential confounders showed body mass index (BMI) at recruitment to UKCTOCS (HR for a 5 unit change=1.076, 95% CI 1.012 to 1.136), current SS at study entry (HR=1.051; 95% CI 1.014 to 1.089) and change in SS per 10 years (CSS) (HR=1.330; 95% CI 1.121 to 1.579) were associated with increased BC risk but not SS at 25 (HR=1.006; 95% CI 0.958 to 1.056). CSS was the most predictive singe adiposity measure and further analysis including both CSS and BMI in the model revealed CSS remained significant (HR=1.266; 95% CI 1.041 to 1.538) but not BMI (HR=1.037; 95% CI 0.970 to 1.109).
CSS is associated with BC risk independent of BMI. A unit increase in UK SS (eg, 12–14) every 10-years between 25 and postmenopausal-age is associated with postmenopausal BC risk by 33%. Validation of these results could provide women with a simple and easy to understand message.
The study aims are twofold. First, to investigate the suitability of hand hygiene as an indicator of accreditation outcomes and, second, to test the hypothesis that hospitals with better accreditation outcomes achieve higher hand hygiene compliance rates.
A retrospective, longitudinal, multisite comparative survey.
Acute public hospitals in New South Wales, Australia.
96 acute hospitals with accreditation survey results from two surveys during 2009–2012 and submitted data for more than four hand hygiene audits between 2010 and 2013.
Our primary outcome comprised observational hand hygiene compliance data from eight audits during 2010–2013. The explanatory variables in our multilevel regression model included: accreditation outcomes and scores for the infection control standard; timing of the surveys; and hospital size and activity.
Average hand hygiene compliance rates increased from 67.7% to 80.3% during the study period (2010–2013), with 46.7% of hospitals achieving target compliance rates of 70% in audit 1, versus 92.3% in audit 8. Average hand hygiene rates at small hospitals were 7.8 percentage points (pp) higher than those at the largest hospitals (p<0.05). The association between hand hygiene rates, accreditation outcomes and infection control scores is less clear.
Our results indicate that accreditation outcomes and hand hygiene audit data are measuring different parts of the quality and safety spectrum. Understanding what is being measured when selecting indicators to assess the impact of accreditation is critical as focusing on accreditation results would discount successful hand hygiene implementation by smaller hospitals. Conversely, relying on hand hygiene results would discount the infection control related research and leadership investment by larger hospitals. Our hypothesis appears to be confounded by an accreditation programme that makes it more difficult for smaller hospitals to achieve high infection control scores.
Postnatal common mental disorders among women are an important public health problem internationally. Interventions to prevent postnatal depression have had limited success. What Were We Thinking (WWWT) is a structured, gender-informed, psychoeducational group programme for parents and their first infant that addresses two modifiable risks to postnatal mental health. This paper describes the protocol for a cluster randomised controlled trial to test the clinical effectiveness and cost-effectiveness of WWWT when implemented in usual primary care.
48 maternal and child health (MCH) centres from six diverse Local Government Areas, in Victoria, Australia are randomly allocated to the intervention group (usual care plus WWWT) or the control group (usual care). The required sample size is 184 women in each group. English-speaking primiparous women receiving postpartum healthcare in participating MCH centres complete two computer-assisted telephone interviews: baseline at 4 weeks and outcome at 6 months postpartum. Women attending intervention MCH centres are invited to attend WWWT in addition to usual care. The primary outcome is meeting Diagnostic and Statistical Manual-IV (DSM-IV) diagnostic criteria for major depressive episode; generalised anxiety disorder; panic disorder with or without agoraphobia, agoraphobia with or without panic, social phobia, adult separation anxiety or adjustment disorder with depressed mood, anxiety or mixed depressed mood and anxiety within the past 30 days at 6 months postpartum. Secondary outcomes are self-rated general and emotional health, infant sleep problems, method of infant feeding, quality of mother–infant relationship and intimate partner relationship, and healthcare costs and outcomes.
Approval to conduct the study has been granted. A comprehensive dissemination plan has been devised.
Australian New Zealand Clinical Trials Registry ACTRN12613000506796.
The use of alcohol and drugs is prevalent among adolescents, but too little is known about the association between debut of alcohol and drug use, problematic use and concurrent mental health. The aim of the study was to investigate the cross-sectional association between debut of any alcohol or drug use and alcohol-related and drug-related problems and mental health. We also wanted to examine potential interactions between gender and age, and alcohol-related and drug-related variables.
Cross-sectional study.
Population-based sample of Norwegian adolescents.
Data stem from the large population-based ung@hordaland study (N=9203), where all adolescents aged 17–19 years living in Hordaland county (Norway) were invited to participate. The main independent variables were debut of alcohol and drug use, alcohol consumption and the presence of alcohol and drug problems as measured by CRAFFT.
The dependent variables were self-reported symptoms of anxiety, depression, inattention and hyperactivity. Statistical analyses included logistic regression models.
Debut of alcohol and drug use were associated with symptoms of depression, inattention and hyperactivity (crude ORs 1.69–2.38, p<0.001), while only debut of drug use was associated with increased symptoms of anxiety (OR=1.33, CI 95% 1.05 to 1.68, p=0.017). Alcohol-related and drug-related problems as measured by CRAFFT were associated with all mental health problems (crude ORs 1.68–3.24, p<0.001). There was little evidence of any substantial age or gender confounding on the estimated associations between alcohol-related and drug-related measures and mental health problems.
Early debut of alcohol and drug use and drug problems is consistently associated with more symptoms of mental health problems, indicating that these factors are an important general indicator of mental health in adolescence.
HIV prevention efforts, particularly among men who have sex with men (MSM), have not achieved maximum effectiveness. A survey of MSM in Ottawa, Canada was completed to ascertain whether there were differences in how the perceived HIV status of participants and their partners influenced sexual practices.
Self-directed surveys were administered to a convenience sample of 721 MSM in Ottawa, Canada from November 2011 through May 2012. Data collection occurred at 14 sites. The survey identified whether participants identified as HIV positive, negative or unsure of their HIV status.
The findings indicated variation between HIV-negative MSM and those who are unsure of their HIV status. Men who were unsure of their HIV status were less likely to report that they asked sexual partners or have had their partners ask about HIV status.
The results of this study indicate that some MSM may base decisions about HIV prevention on discussion about HIV status with their partners, rather than condom use. These practices may increase, rather than decrease, HIV transmission. Survey findings and extant literature demonstrate a need to inform MSM about the limitations of serosorting as a prevention strategy, and to provide facilitated access to sexually transmitted infection testing and treatment to further reduce onward HIV transmission.
This study was designed to assess the knowledge acquired by very young children (<6 years) trained by their own teachers at nursery school. This comparative study assessed the effect of training before the age of 6 years compared with a group of age-matched untrained children.
Some schoolteachers were trained by emergency medical teams to perform basic first aid.
Eighteen classes comprising 315 pupils were randomly selected: nine classes of trained pupils (cohort C1) and nine classes of untrained pupils (cohort C2).
The test involved observing and describing three pictures and using the phone to call the medical emergency centre. Assessment of each child was based on nine criteria, and was performed by the teacher 2 months after completion of first aid training.
This study concerned 285 pupils: 140 trained and 145 untrained. The majority of trained pupils gave the expected answers for all criteria and reacted appropriately by assessing the situation and alerting emergency services (55.7–89.3% according to the questions). Comparison of the two groups revealed a significantly greater ability of trained pupils to describe an emergency situation (p<0.005) and raise the alert (p<0.0001).
This study shows the ability of very young children to assimilate basic skills as taught by their own schoolteachers.
Major behavioural risk factors are known to adversely affect health outcomes and be strongly associated with mental illness. However, little is known about the association of these risk factors with mental well-being in the general population. We sought to examine behavioural correlates of high and low mental well-being in the Health Survey for England.
Participants were 13 983 adults, aged 16 years and older (56% females), with valid responses for the combined 2010 and 2011 surveys. Mental well-being was assessed using the Warwick-Edinburgh Mental Well-being Scale (WEMWBS). ORs of low and high mental well-being, compared to the middle-range category, were estimated for body mass index (BMI), smoking, drinking habits, and fruit and vegetable intake.
ORs for low mental well-being were increased in obese individuals (up to 1.72, 95% CI 1.26 to 2.36 in BMI 40+ kg/m2). They increased in a linear fashion with increasing smoking (up to 1.98, 95% CI 1.55 to 2.53, >20 cigarettes/day) and with decreasing fruit and vegetable intake (up to 1.53, 95% CI 1.24 to 1.90, <1 portion/day); whereas ORs were reduced for sensible alcohol intake (0.78, 95% CI 0.66 to 0.91, ≤4 units/day in men, ≤3 units/day in women). ORs for high mental well-being were not correlated with categories of BMI or alcohol intake. ORs were reduced among ex-smokers (0.81, 95% CI 0.71 to 0.92), as well as with lower fruit and vegetable intake (up to 0.79, 95% CI 0.68 to 0.92, 1 to <3 portions/day).
Along with smoking, fruit and vegetable consumption was the health-related behaviour most consistently associated with mental well-being in both sexes. Alcohol intake and obesity were associated with low, but not high mental well-being.
The chronic care model is an increasingly used approach to improve the quality of care through system changes in care delivery. While theoretically these system changes are expected to increase productive patient–professional interaction empirical evidence is lacking. This study aims to identify the influence of quality of care on productive patient–professional interaction.
Longitudinal study in 18 Dutch regions.
Questionnaires were sent to all 5076 patients participating in 18 Disease Management Programmes (DMPs) in 2010 (2676 (53%) respondents). One year later (T1), 4693 patients still participating in the DMPs received a questionnaire (2191 (47%) respondents) and 2 years later (in 2012; T2) 1722 patients responded (out of 4350; 40% response).
Patients' perceptions of the productivity of interactions (measured as relational coordination/coproduction of care) with professionals. Patients were asked about communication dimensions (frequent, accurate, and problem-solving communication) and relationship dimensions (shared goals and mutual respect).
After controlling for background characteristics these results clearly show that quality of chronic care (T0), first-year changes in quality of chronic care (T1—T0) and second-year changes in quality of chronic care (T2—T1) predicted productive interactions between patients and professionals at T2 (all at p≤0.001). Furthermore, we found a negative relationship between lower educational level and productive interactions between patients and professionals 2 years later.
We can conclude that successfully dealing with the consequences of chronic illnesses requires proactive patients who are able to make productive decisions together with their healthcare providers. Since patients and professionals share responsibility for management of the chronic illness, they must also share control of interactions and decisions. The importance of patient-centeredness is growing and this study reports a first example of how quality of chronic care stimulates productive interactions between patients and professionals.
To synthesise contributing factors leading to medicine-related problems (MRPs) in adult patients with cardiovascular diseases and/or diabetes mellitus from their perspectives.
A systematic literature review of qualitative studies regarding the contributory factors leading to MRPs, medication errors and non-adherence, followed by a thematic synthesis of the studies.
We screened Pubmed, EMBASE, ISI Web of Knowledge, PsycInfo, International Pharmaceutical Abstract and PsycExtra for qualitative studies (interviews, focus groups and questionnaires of a qualitative nature).
Thematic synthesis was achieved by coding and developing themes from the findings of qualitative studies.
The synthesis yielded 21 studies that satisfied the inclusion and exclusion criteria. Three themes emerged that involved contributing factors to MRPs: patient-related factors including socioeconomic factors (beliefs, feeling victimised, history of the condition, lack of finance, lack of motivation and low self-esteem) and lifestyle factors (diet, lack of exercise/time to see the doctor, obesity, smoking and stress), medicine-related factors (belief in natural remedies, fear of medicine, lack of belief in medicines, lack of knowledge, non-adherence and polypharmacy) and condition-related factors (lack of knowledge/understanding, fear of condition and its complications, and lack of control).
MRPs represent a major health threat, especially among adult patients with cardiovascular diseases and/or diabetes mellitus. The patients' perspectives uncovered hidden factors that could cause and/or contribute to MRPs in these groups of patients.
To document overall, racial, ethnic and intent-specific spatiotemporal trends of firearm-related fatality rates (FRF rates) in the USA.
Cross-sectional study per year from 2000 to 2010.
Aggregate count of all people in the USA from 2000 to 2010.
Data from the Web-based Injury Statistics Query and Reporting System from 2000 to 2010 was used to determine annual FRF rates per 100 000 and by states, race, ethnicity and intent.
The average national 11-year FRF rate was 10.21/100 000, from 3.02 in Hawaii to 18.62 in Louisiana: 60% of states had higher than national rates and 41 states showed no temporal change. The average national FRF rates among African-Americans and Caucasians were 18.51 and 9.05/100 000 and among Hispanics and non-Hispanics were 7.13 and 10.13/100 000; Hispanics had a decreasing change of –0.18, p trend<0.0001. In states with increasing trends (Florida and Massachusetts), Caucasians and non-Hispanics drove the rise; while in states with decreasing trends (California, North Carolina, Arizona, Nevada, New York, Illinois, Maryland), Hispanics and African-Americans drove the fall. The average national FRF rates due to homicides (4.1/100 000) and suicides (5.8/100 000) remained constant, but varied between states.
Endemic national FRF rates mask a wide variation in time trends between states. FRF rates were twice as high in African-Americans than Caucasians but decreased among Hispanics. Efforts to identify state-specific best practices can contribute to changes in national FRF rates that remain high.
Sleep disordered breathing in the paediatric population can manifest as an array of different systemic symptoms; among them is a distinct malocclusion and craniofacial phenotype. Emerging research suggests that the treatment of this malocclusion and/or craniofacial phenotype through orthodontic intervention may help with the symptoms of these patients. Selecting the patients who would benefit from orthodontic treatment can be a difficult task for the physician with minimal dental training. Therefore the aim of this study is to develop a simple index to be used by medical professionals to identify those paediatric patients with orthodontic treatment needs who may benefit their obstructive sleep apnoea (OSA) symptoms.
The methodology in this project has been devised through the WHO's recommendations on developing an index, with modifications based on the specific needs of this study. Based on the available literature, a draft index will be produced and subjected to multiple iterative revisions based on the feedback from: the Index Development Group, a group of multidisciplinary and internationally acclaimed experts in the field; the External Review Group, a group of potential end users and interested parties and the Steering Committee. Once the index has been formalised, it will be subjected to a pair of reliability tests using physicians and orthodontists scored 2 weeks apart. Subsequently, the index will be validated using dichotomous responses from orthodontists on whether they would treat a patient for OSA symptoms, and comparing the responses to the score of the index on the same patient.
The index will be translated into French and will be presented in orthodontic and medical conferences, workshops, seminars, round table discussions, and free copies for download will be made available on the website of the University of Alberta Interdisciplinary Airway Research Clinic (iarc.ualberta.ca). Furthermore, the index will be published in a peer-reviewed medical journal to further increase the exposure of the index.
Although cardiovascular disease is typically associated with middle or old age, the atherosclerotic process often initiates early in childhood. The process of atherosclerosis appears to be occurring at an increasing rate, even in pre-adolescents, and has been linked to the childhood obesity epidemic. This study will investigate the relationships between obesity, lifestyle behaviours and cardiometabolic health in pre-pubescent children aged 8–10 years, and investigates whether there are differences in the correlates of cardiometabolic health between Māori and Caucasian children. Details of the methodological aspects of recruitment, inclusion/exclusion criteria, assessments, statistical analyses, dissemination of findings and anticipated impact are described.
Phase 1: a cross-sectional study design will be used to investigate relationships between obesity, lifestyle behaviours (nutrition, physical activity/fitness, sleep behaviour, psychosocial influences) and cardiometabolic health in a sample of 400 pre-pubescent (8–10 years old) children. Phase 2: in a subgroup (50 Caucasian, 50 Māori children), additional measurements of cardiometabolic health and lifestyle behaviours will be obtained to provide objective and detailed data. General linear models and logistic regression will be used to investigate the strongest correlate of (1) fatness; (2) physical activity; (3) nutritional behaviours and (4) cardiometabolic health.
Ethical approval will be obtained from the New Zealand Health and Disabilities Ethics Committee. The findings from this study will elucidate targets for decreasing obesity and improving cardiometabolic health among preadolescent children in New Zealand. The aim is to ensure an immediate impact by disseminating these findings in an applicable manner via popular media and traditional academic forums. Most importantly, results from the study will be disseminated to participating schools and relevant Māori health entities.
Secondary prevention drugs for cardiac disease have been demonstrated by clinical trials to be effective in reducing future cardiovascular and mortality events (WAMACH is the Western Australian Medication Adherence and Costs in Heart disease study). Hence, most countries have adopted health policies and guidelines for the use of these drugs, and included them in government subsidised drug lists to encourage their use. However, suboptimal prescribing and non-adherence to these drugs remains a universal problem. Our study will investigate trends in dispensing patterns of drugs for secondary prevention of cardiovascular events and will also identify factors influencing these patterns. It will also assess the clinical and economic consequences of non-adherence and the cost-effectiveness of using these drugs.
This population-based cohort study will use longitudinal data on almost 40 000 people aged 65 years or older who were hospitalised in Western Australia between 2003 and 2008 for coronary heart disease, heart failure or atrial fibrillation. Linking of several State and Federal government administrative data sets will provide person-based information on drugs dispensed precardiac and postcardiac event, reasons for hospital admission, emergency department visits, mortality and medical visits. Dispensed drug trends will be described, drug adherence measured and their association with future all-cause/cardiovascular events will be estimated. The cost-effectiveness of these long-term therapies for cardiac disease and the impact of adherence will be evaluated.
Human Research Ethics Committee (HREC) approvals have been obtained from the Department of Health (Western Australian #2011/62 and Federal) and the University of Western Australia (RA/4/1/1130), in addition to HREC approvals from all participating hospitals. Findings will be published in peer-reviewed medical journals and presented at local, national and international conferences. Results will also be disseminated to consumer groups.
To examine the association between obese-years and the risk of cardiovascular disease (CVD).
Prospective cohort study.
Boston, USA.
5036 participants of the Framingham Heart Study were examined.
Obese-years was calculated by multiplying for each participant the number of body mass index (BMI) units above 29 kg/m2 by the number of years lived at that BMI during approximately 50 years of follow-up. The association between obese-years and CVD was analysed using time-dependent Cox regression adjusted for potential confounders and compared with other models using the Akaike information criterion (AIC). The lowest AIC indicated better fit.
The median cumulative obese-years was 24 (range 2–556 obese-years). During 138 918 person-years of follow-up, 2753 (55%) participants were diagnosed with CVD. The incidence rates and adjusted HR (AHR) for CVD increased with an increase in the number of obese-years. AHR for the categories 1–24.9, 25–49.9, 50–74.9 and ≥75 obese-years were, respectively, 1.31 (95% CI 1.15 to 1.48), 1.37 (95% CI 1.14 to 1.65), 1.62 (95% CI 1.32 to 1.99) and 1.80 (95% CI 1.54 to 2.10) compared with those who were never obese (ie, had zero obese-years). The effect of obese-years was stronger in males than females. For every 10 unit increase in obese-years, the AHR of CVD increased by 6% (95% CI 4% to 8%) for males and 3% (95% CI 2% to 4%) for females. The AIC was lowest for the model containing obese-years compared with models containing either the level of BMI or the duration of obesity alone.
This study demonstrates that obese-years metric conceptually captures the cumulative damage of obesity on body systems, and is found to provide slightly more precise estimation of the risk of CVD than the level or duration of obesity alone.
Postoperative delirium is one of the most common complications of major surgery, affecting 10–70% of surgical patients 60 years and older. Delirium is an acute change in cognition that manifests as poor attention and illogical thinking and is associated with longer intensive care unit (ICU) and hospital stay, long-lasting cognitive deterioration and increased mortality. Ketamine has been used as an anaesthetic drug for over 50 years and has an established safety record. Recent research suggests that, in addition to preventing acute postoperative pain, a subanaesthetic dose of intraoperative ketamine could decrease the incidence of postoperative delirium as well as other neurological and psychiatric outcomes. However, these proposed benefits of ketamine have not been tested in a large clinical trial.
The Prevention of Delirium and Complications Associated with Surgical Treatments (PODCAST) study is an international, multicentre, randomised controlled trial. 600 cardiac and major non-cardiac surgery patients will be randomised to receive ketamine (0.5 or 1 mg/kg) or placebo following anaesthetic induction and prior to surgical incision. For the primary outcome, blinded observers will assess delirium on the day of surgery (postoperative day 0) and twice daily from postoperative days 1–3 using the Confusion Assessment Method or the Confusion Assessment Method for the ICU. For the secondary outcomes, blinded observers will estimate pain using the Behavioral Pain Scale or the Behavioral Pain Scale for Non-Intubated Patients and patient self-report.
The PODCAST trial has been approved by the ethics boards of five participating institutions; approval is ongoing at other sites. Recruitment began in February 2014 and will continue until the end of 2016. Dissemination plans include presentations at scientific conferences, scientific publications, stakeholder engagement and popular media.
The study is registered at clinicaltrials.gov, NCT01690988 (last updated March 2014). The PODCAST trial is being conducted under the auspices of the Neurological Outcomes Network for Surgery (NEURONS).
NCT01690988 (last updated December 2013).
In England, in 2006, new dental contracts devolved commissioning of dental services locally to Primary Care Trusts to meet the needs of their local population. The new national General Dental Services contracts (nGDS) were based on payment for Units of Dental Activity (UDAs) awarded in three treatment bands based on complexity of care. Recently, contract currency in UK dentistry is evolving from UDAs based on volume and case complexity towards 'blended contracts' that include incentives linked with key performance indicators such as quality and improved health outcome. Overall, evidence of the effectiveness of incentive-driven contracting of health providers is still emerging. The INCENTIVE Study aims to evaluate a blended contract model (incentive-driven) compared to traditional nGDS contracts on dental service delivery in practices in West Yorkshire, England.
The INCENTIVE model uses a mixed methods approach to comprehensively evaluate a new incentive-driven model of NHS dental service delivery. The study includes 6 dental surgeries located across three newly commissioned dental practices (blended contract) and three existing traditional practices (nGDS contracts). The newly commissioned practices have been matched to traditional practices by deprivation index, age profile, ethnicity, size of practice and taking on new patients. The study consists of three interlinked work packages: a qualitative study to explore stakeholder perspectives of the new service delivery model; an effectiveness study to assess the INCENTIVE model in reducing the risk of and amount of dental disease and enhance oral health-related quality of life in patients; and an economic study to assess cost-effectiveness of the INCENTIVE model in relation to clinical status and oral health-related quality of life.
The study has been approved by NRES Committee London, Bromley. The results of this study will be disseminated at national and international conferences and in international journals.
Australian Aboriginal people have at least eight times the incidence of end-stage kidney disease, requiring dialysis, as the non-Aboriginal population. Provision of health services to rural Aboriginal people with renal disease is challenging due to barriers to access and cultural differences. We aimed to describe the experiences of Aboriginal people receiving haemodialysis in rural Australia, to inform strategies for improving renal services.
A qualitative design incorporating: Indigenist research methodology and Community Based Participatory Research principles. In-depth interviews used a 'yarning' and storytelling approach. Thematic analysis was undertaken and verified by an Aboriginal Community Reference Group.
A health district in rural New South Wales, Australia.
Snowball sampling recruited 18 Aboriginal haemodialysis recipients.
Six themes emerged which described the patient journey: 'The biggest shock of me life,' expressed the shock of diagnosis and starting the dialysis; 'Beats the alternative but it messes up your life,' explained how positive attitudes to treatment develop; 'Family is everything', described the motivation and support to continue dialysis; 'If I had one of them nurses at home to help me', depicted acute hospital settings as culturally unsafe; 'Don't use them big jawbreakers', urged service providers to use simple language and cultural awareness; 'Stop 'em following us onto the machine', emphasised the desire for education for the younger generations about preventing kidney disease. An Aboriginal interpretation of this experience, linked to the analysis, was depicted in the form of an Aboriginal painting.
Family enables Aboriginal people to endure haemodialysis. Patients believe that priorities for improving services include family-centred and culturally accommodating healthcare systems; and improving access to early screening of kidney disease. Inclusion of Aboriginal patients in cultural education for renal staff is recommended. Providing opportunities for patients to educate young Aboriginal people about kidney disease prevention may be highly effective and empowering.
Although B-type natriuretic peptide (BNP) and highly sensitive cardiac troponin T (cTnT) are useful for the evaluation of clinical features in various cardiovascular diseases, there are comparatively few data regarding the utility of these parameters in patients with hypertrophic obstructive cardiomyopathy (HOCM). The goal of this study was to assess the association between BNP, cTnT and clinical parameters in patients with HOCM.
Cross-sectional survey
The relationship between BNP, cTnT and clinical end points and echocardiographic data was investigated.
This study included 102 consecutive outpatients with HOCM who were clinically stable.
BNP was significantly associated with both maximum left ventricular (LV) wall thickness (r=0.28; p=0.003), and septal peak early transmitral filling velocity/peak early diastolic mitral annulus velocity (r=0.51; p=0.0001). No statistically significant associations were seen between cTnT and any echocardiographic parameters, but the presence of atrial fibrillation (AF) was associated with a high level of cTnT (p=0.01).
BNP is useful for monitoring clinical parameters and as a reflection of both LV systolic/diastolic function and increased LV pressure in patients with HOCM. A high level of serum cTnT is associated with the presence of AF.
Breast cancer is the most prevalent cancer among women. In Germany, women are invited to a population-based mammography screening programme for the first time at the age of 50. Since it is still discussed whether the benefits of mammography screening outweigh its harms, the concept of informed choice has gained importance. The objective of this cross-sectional study is to assess the proportion of informed choices in the mammography screening programme. A special focus is on the examination of the impact of Turkish migration background and educational level on informed choices.
The proportion of informed choices is evaluated in a cross-sectional study with 3-month follow-up for behavioural implementation of the screening intention. A randomly selected sample of 17 000 women aged 50 years living in Westphalia-Lippe, a region in the Federal State of North-Rhine Westphalia, is invited to participate in this study. To reach adequate numbers of Turkish women, all possibly Turkish women in the sample are identified through a name algorithm and contacted. The sample is drawn from women registered in the study area for which the registration offices consented to supply data for the study (88% of all towns/cities in the study region). Women identified through the Turkish name algorithm received all materials in German and Turkish. The primary outcome is informed choice. Data are collected on informed choice components (knowledge, attitude, decision/implementation) as well as on its possible determinants (eg, health behaviour, perceived behavioural control, subjective norms, invitation status, migration background and other demographic variables). Data are collected before the screening appointment and at 3 months follow-up.
The study was approved by the ethical committee of the Medical Faculty of Muenster University. Results will be published in a relevant scientific journal and communicated to respondents and relevant institutions.
While overall survival for most common cancers in Australia is improving, the rural–urban differential has been widening, with significant excess deaths due to lung, colorectal, breast and prostate cancer in regional Australia. Internationally a major focus on understanding variations in cancer outcomes has been later presentation to healthcare and later diagnosis. Approaches to reducing time to diagnosis of symptomatic cancer include public symptom awareness campaigns and interventions in primary care to improve early cancer detection. This paper reports the protocol of a factorial cluster-randomised trial of community and general practice (GP) level interventions to reduce the time to diagnosis of cancer in rural Western Australia (WA).
The community intervention is a symptom awareness campaign tailored for rural Australians delivered through a community engagement model. The GP intervention includes a resource card with symptom risk assessment charts and local referral pathways implemented through multiple academic detailing visits and case studies. Participants are eligible if recently diagnosed with breast, colorectal, lung or prostate cancer who reside in specific regions of rural WA with a planned sample size of 1350. The primary outcome is the Total Diagnostic Interval, defined as the duration from first symptom (or date of cancer screening test) to cancer diagnosis. Secondary outcomes include cancer stage, healthcare utilisation, disease-free status, survival at 2 and 5 years and cost-effectiveness.
Ethics approval has been granted by the University of Western Australia and from all relevant hospital recruitment sites in WA.
Results of this trial will be reported in peer-reviewed publications and in conference presentations.
Australian New Zealand Clinical Trials Registry (ANZCTR). ACTRN12610000872033.
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'...patients treated in CAM practices suffer more often from severe and chronic illnesses.
Develop predictive models using an administrative healthcare database that provide information for Patient-Centred Medical Homes to proactively identify patients at risk of hospitalisation for conditions that may be impacted through improved patient care.
Retrospective healthcare utilisation analysis with multivariate logistic regression models.
A population-based longitudinal database of residents served by the Emilia-Romagna, Italy, health service in the years 2004–2012 including demographic information and utilisation of health services by 3 726 380 people aged ≥18 years.
Models designed to predict risk of hospitalisation or death in 2012 for problems that are potentially avoidable were developed and evaluated using the area under the receiver operating curve C-statistic, in terms of their sensitivity, specificity and positive predictive value, and for calibration to assess performance across levels of predicted risk.
Among the 3 726 380 adult residents of Emilia-Romagna at the end of 2011, 449 163 (12.1%) were hospitalised in 2012; 4.2% were hospitalised for the selected conditions or died in 2012 (3.6% hospitalised, 1.3% died). The C-statistic for predicting 2012 outcomes was 0.856. The model was well calibrated across categories of predicted risk. For those patients in the highest predicted risk decile group, the average predicted risk was 23.9% and the actual prevalence of hospitalisation or death was 24.2%.
We have developed a population-based model using a longitudinal administrative database that identifies the risk of hospitalisation for residents of the Emilia-Romagna region with a level of performance as high as, or higher than, similar models. The results of this model, along with profiles of patients identified as high risk are being provided to the physicians and other healthcare professionals associated with the Patient Centred Medical Homes to aid in planning for care management and interventions that may reduce their patients' likelihood of a preventable, high-cost hospitalisation.
Dipeptidyl peptidase-4 (DPP-4) inhibitors including alogliptin are categorised as a newer class of oral hypoglycaemic, antidiabetic drugs to suppress the degradation of incretin hormones ((glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP)) by DPP-4. We have scheduled a large-scale, multicentre, prospective, observational study (Japan-Based clinical ReseArch Network for Diabetes Registry: J-BRAND Registry) to construct an extensive database over a long-term clinical course in patients with type 2 diabetes receiving oral hypoglycaemic agents (OHAs) and to evaluate the safety and efficacy of alogliptin in Japanese population.
20 000 patients with type 2 diabetes will be registered into two groups of 10 000 each: group A patients will be treated with alogliptin, while group B patients will be treated with non-DPP-4 inhibitor OHA(s). Approximately 300 institutions nationwide will enrol and assign eligible patients equally to either group. Each patient's data will be collected every 6 months for a 3-year period, during which time treatment with OHA(s) may be changed or discontinued, as per package insert for each OHA. Primary end points are safety variables to be compared between the two groups and their subgroups, with respect to hypoglycaemia, pancreatitis, skin disorders, infections and cancer. Secondary end points are efficacy variables including from-baseline changes of A1c, fasting glucose, fasting insulin and urinary albumin, which will be compared between groups/subgroups. New onset and progression of microangiopathy will also be evaluated against OHA(s). Overall, the J-BRAND Registry will evaluate the safety and efficacy of antidiabetic OHA(s) including alogliptin, based on a large-scale database.
This study will be conducted with the highest respect for individual participants according to this protocol, the Declaration of Helsinki, the Ethical Guidelines for Clinical Research (Japan Ministry of Health, Labour and Welfare, 2008) and relevant laws/regulations. The present study will construct a valuable database of patients with type 2 diabetes treated with OHA(s) including alogliptin.
To determine if the metabolic cost of the incremental shuttle-walking test protocol is the same as treadmill walking or predicted values of walking-speed equations.
Primary care (community-based cardiac rehabilitation).
Eight Caucasian cardiac rehabilitation patients (7 males) with a mean age of 67±5.2 years.
Oxygen consumption, metabolic power and energy cost of walking during treadmill and shuttle walking performed in a balanced order with 1 week between trials.
Average overall energy cost per metre was higher during treadmill walking (3.22±0.55 J kg/m) than during shuttle walking (3.00±0.41 J kg/m). There were significant post hoc effects at 0.67 m/s (p<0.004) and 0.84 m/s (p<0.001), where the energy cost of treadmill walking was significantly higher than that of shuttle walking. This pattern was reversed at walking speeds 1.52 m/s (p<0.042) and 1.69 m/s (p<0.007) where shuttle walking had a greater energy cost per metre than treadmill walking. At all walking speeds, the energy cost of shuttle walking was higher than that predicted using the American College of Sports Medicine walking equations.
The energetic demands of shuttle walking were fundamentally different from those of treadmill walking and should not be directly compared. We warn against estimating the metabolic cost of the incremental shuttle-walking test using the current walking-speed equations.
To explore pupils' and teachers' experiences of physical education (PE).
A qualitative investigation employing semistructured interviews. Self Determination Theory was used as a guiding theory and Template Analysis was used to analyse the data.
A secondary school in the North East of England.
14 pupils (aged 13 and 14, boys and girls) with a range of self-perceived competencies regarding PE and four PE teachers of the pupils (3 male, 1 female).
(1) Attitudes and perceptions of PE pupils regarding their experiences of compulsory school PE lessons. (2) PE teachers' experiences of teaching PE.
Key results from pupils and teachers suggest pupils enjoy participation in PE when they feel competent, in control and supported by others. Feeling competent depended on (1) the activity within PE and (2) the pupils perceived physical capabilities/aptitude. Feeling in control related to (1) having a choice of activities, (2) being able to set exertion levels and (3) control over clothes worn while taking part. Relationships within pupil groups and between pupils and teachers were perceived as important. Teachers could positively influence their pupils' enjoyment by understanding and supporting their personal goals, as opposed to dictating and controlling what they did and for how long, and by promoting a non-threatening atmosphere between pupils.
Rising obesity levels and concerns over the fitness of children and young people has returned the focus of PE to its potential as a vehicle for promoting health. This study suggests schools and PE teachers in particular can positively influence the PE experience of both boys and girls by providing more choice of activities and letting pupils make their own decisions based on their personal needs.
The purpose of the study was to investigate the incidence of HIV and syphilis and their related factors, as well as to examine the predictors associated with seroconversion among migrant men who have sex with men (MSM) in Beijing, China.
Prospective cohort study.
Beijing, China.
511 HIV-negative migrant MSM.
Sociodemographic and behavioural information of participants, HIV and syphilis incidence rates, and factors associated with HIV/syphilis seroconversion and cohort retention.
Of the 511 participants, 60.3% (308) and 52.4% (273) were retained at the 4- and 8-month follow-up visits, respectively. The HIV and syphilis incidence rates were 7.83 (95% CI 4.48 to 12.72) and 11.11 (95% CI 6.47 to 17.80) per 100 person-years, respectively. HIV seroconversion was significantly associated with 'had first anal intercourse at age 15 or younger' (adjusted HR (aHR) 9.20, 95% CI 1.94 to 43.56) and 'ever had group sex' (aHR 4.30, 95% CI 1.40 to 13.18). Bisexual orientation (aHR 5.09, 95% CI 1.02 to 25.57) was significantly associated with syphilis seroconversion. Predictors associated with both 4- and 8-month retention rates included age ≥25 years old and living in Beijing for more than 1 year.
The high incidence of HIV and syphilis among migrant MSM is a cause for concern. A comprehensive strategy should be implemented to maintain a higher retention rate among migrant MSM.
To determine whether nalmefene combined with psychosocial support is cost-effective compared with psychosocial support alone for reducing alcohol consumption in alcohol-dependent patients with high/very high drinking risk levels (DRLs) as defined by the WHO, and to evaluate the public health benefit of reducing harmful alcohol-attributable diseases, injuries and deaths.
Decision modelling using Markov chains compared costs and effects over 5 years.
The analysis was from the perspective of the National Health Service (NHS) in England and Wales.
The model considered the licensed population for nalmefene, specifically adults with both alcohol dependence and high/very high DRLs, who do not require immediate detoxification and who continue to have high/very high DRLs after initial assessment.
We modelled treatment effect using data from three clinical trials for nalmefene (ESENSE 1 (NCT00811720), ESENSE 2 (NCT00812461) and SENSE (NCT00811941)). Baseline characteristics of the model population, treatment resource utilisation and utilities were from these trials. We estimated the number of alcohol-attributable events occurring at different levels of alcohol consumption based on published epidemiological risk-relation studies. Health-related costs were from UK sources.
We measured incremental cost per quality-adjusted life year (QALY) gained and number of alcohol-attributable harmful events avoided.
Nalmefene in combination with psychosocial support had an incremental cost-effectiveness ratio (ICER) of £5204 per QALY gained, and was therefore cost-effective at the £20 000 per QALY gained decision threshold. Sensitivity analyses showed that the conclusion was robust. Nalmefene plus psychosocial support led to the avoidance of 7179 alcohol-attributable diseases/injuries and 309 deaths per 100 000 patients compared to psychosocial support alone over the course of 5 years.
Nalmefene can be seen as a cost-effective treatment for alcohol dependence, with substantial public health benefits.
This cost-effectiveness analysis was developed based on data from three randomised clinical trials: ESENSE 1 (NCT00811720), ESENSE 2 (NCT00812461) and SENSE (NCT00811941).
Statins are commonly prescribed cholesterol-lowering drugs. Preclinical studies suggest that statins may possess cancer preventive properties. The primary objective of this meta-analysis was to determine the association between statin use and risk of liver cancer.
A comprehensive literature search of PubMed, BIOSIS Previews, Web of Science, EMBASE, EBSCO and Cochrane Library was conducted through March 2014. The effect estimate was reported as pooled relative risk (RR) with 95% CIs, using the random-effects model.
A total of 12 studies (1 individual patient data analysis of 22 randomised controlled trials, 5 cohorts and 6 case–controls) were qualified for this meta-analysis, involving 5 640 313 participants including 35 756 liver cancer cases. Our results indicated a significant risk reduction of liver cancer among all statin users (RR=0.58, 95% CIs 0.51 to 0.67). The difference of the study designs can partly explain the significant heterogeneity found in the overall analysis (I2=65%, p=0.0006). No evidence of publication bias was observed in this meta-analysis. Similar risk reductions were found in the subgroups analysis of Western and Asian countries, lipophilic and hydrophilia statins. There was a trend towards more risk reductions in subgroups with higher baseline risk, inadequate adjustment and higher cumulative dosage of statin use.
This meta-analysis suggests that statin is associated with a significant risk reduction of liver cancer when taken daily for cardiovascular event prevention. However, this preventive effect might be overestimated due to the exposure period, the indication and contraindication of statins and other confounders. Statins might be considered as an adjuvant in the treatment of liver cancer.
The HIV epidemic in Latin America is concentrated among men who have sex with men (MSM) and transgender women (TGW) with transmission predominately occurring during unprotected anal intercourse. This mode of transmission is also responsible for other sexually transmitted infections (STIs) such as herpes simplex, chlamydia and gonorrhoea, human papillomavirus (HPV)/genital warts and syphilis. Studies assessing the prevalence of HIV and HPV among MSM have not addressed the role of genital warts and HPV-related diseases in the acquisition of HIV infection. Community-based testing programmes are a potentially important way to remove barriers including stigma for individuals to learn about their STI status.
The prospective cohort study will recruit 600 MSM/TGW at a community centre in Lima, Peru, named Epicentro. Half of the participants will have a history of or have current anogenital warts (AGW), and the other half will have no history of AGW. We will measure the prevalence and acquisition of STIs including syphilis, HPV, chlamydia and gonorrhoea and the HIV-incidence in the two groups. To the best of our knowledge, it will be the first study that specifically examines the impact of genital warts on incident HIV infection. This study will help to understand the relationship between AGW and HIV infection among MSM/TGW in Peru. Furthermore, it may facilitate the development of preventive intervention strategies to reduce the prevalence of AGW and prevent incident HIV infection. HPV-related manifestations may be a good proxy for HIV risk.
This study was approved by institutional review boards at the University of California, Los Angeles (UCLA) in the USA and Impacta in Peru. Study findings will be shared with the Peruvian Ministry of Health as well as other international and national public health organisations. Study results will be translated into Spanish for participants.
The Clinicaltrials.gov registration number is NCT01387412
To investigate the length of time taken to open UK research sites in multicentre clinical trials and to identify reasons for any delays.
A case study, recording key milestone dates from the time a site receives ethical approval through to opening to recruitment. Delay reasons were prospectively logged by trial staff at a minimum of fortnightly periods using a coding system.
SANADII, a phase IV pragmatic trial, managed by the Clinical Trials Research Centre, Liverpool. The trial seeks to work with over 100 National Health Service (NHS) sites to meet its recruitment target of 1510 patients.
The primary outcome was time from Multicentre Regional Ethics Committee (MREC) approval to site opening using survival analysis. Where sites took over a specified time to reach milestones (>3 months from MREC to Site Specific Information (SSI) submission, >30 days from SSI validation to local R&D approval, or >30 days from local Research and Development (R&D) approval to opening to recruitment), the longest continuous delay during that milestone was identified.
The median opening time for participating sites was 9.7 months (IQR 6.2 to Not Reached). SSI submission took 7 months (IQR 4.1–12.3) from ethics approval, R&D approval took 16 days (IQR 5.0–32.0) from SSI validation and site opening took 15 days (IQR 8.5–40.0) following R&D approval. The longest delays before SSI submission resulted from negotiating excess treatment costs, finalising logistics, collecting CVs and ongoing participation discussions.
While recently imposed targets are reducing the time taken for R&D departments to approve valid applications, the time taken to open UK research sites remains excessive and must be reduced. At present significant public funds are being used inefficiently in order to navigate NHS systems, challenging the resolve of trial teams and the competitiveness of the UK.
Genotoxic biomarkers have been studied largely in adult population, but few studies so far have investigated them in children exposed to air pollution. Children are a high-risk group as regards the health effects of air pollution and some studies suggest that early exposure during childhood can play an important role in the development of chronic diseases in adulthood. The objective of the project is to evaluate the associations between the concentration of urban air pollutants and biomarkers of early biological effect in children, and to propose a model for estimating the global risk of early biological effects due to air pollutants and other factors in children.
Two biomarkers of early biological effects, DNA damage by the comet assay and the micronuclei (MN) test, will be investigated in oral mucosa cells of 6–8-year-old children. Concurrently, some toxic airborne pollutants (polycyclic aromatic hydrocarbon (PAH) and nitro-PAH) and in vitro air mutagenicity and toxicity in ultra-fine air particulates (PM0.5) will be evaluated. Furthermore, demographic and socioeconomic variables, other sources of exposures to air pollutants and lifestyle variables will be assessed by a structured questionnaire. The associations between sociodemographic, environmental and other exposure variables and biomarkers of early biological effect using univariate and multivariate models will be analysed. A tentative model for calculating the global absolute risk of having early biological effects caused by air pollution and other variables will be proposed.
The project has been approved by the Ethics Committees of the local Health Authorities. The results will be communicated to local Public Health Agencies, for supporting educational programmes and health policy strategies. LIFE+2012 Environment Policy and Governance. LIFE12 ENV/IT/000614.
An integrated approach to the mental healthcare of older people is advocated across health, aged care and social care sectors. It is not clear, however, how the management of integrated servicing should occur, although interorganisational relations theory suggests a reflective network approach using evaluation feedback. This research will test a network management approach to help regional primary healthcare organisations improve mental health service integration.
This mixed methods case study in rural South Australia will test facilitated reflection within a network of health and social care services to determine if this leads to improved integration. Engagement of services will occur through a governance group and a series of three 1-day service stakeholder workshops. Facilitated reflection and evaluation feedback will use information from a review of health sector and local operational policies, a network survey about current service links, gaps and enablers and interviews with older people and their carers about their help seeking journeys. Quantitative and qualitative analysis will describe the policy enablers and explore the current and ideal links between services. The facilitated reflection will be developed to maximise engagement of senior management in the governance group and the service staff at the operational level in the workshops. Benefit will be assessed through indicators of improved service coordination, collective ownership of service problems, strengthened partnerships, agreed local protocols and the use of feedback for accountability.
Ethics approval will deal with the sensitivities of organisational network research where data anonymity is not preserved. The benefit will be the tested utility of a facilitated reflective process for a network of health and social care services to manage linked primary mental healthcare for older people in a rural region. Dissemination will make use of the sectoral networks of the governance group.
To assess the effectiveness of conservative treatment for adhesive small bowel obstruction (ASBO) in children.
Systematic review of studies involved children with ASBO who received initial conservative/non-operative treatment.
The search was performed in April 2013 using PubMed (see online supplementary file 1), current contents, and the Cochrane database.
Children with ASBO.
Conservative treatment included nasogastric decompression, parenteral fluids and correction of electrolyte and fluid imbalance.
Treatment success.
Length of hospital stay and the time to first feeding after hospital admission.
7 studies (six retrospective, one prospective), involving 8–109 patients (age: 1 month to 16 years) treated conservatively, were included in the review. The nature of conservative treatment was generally consistent between studies (nasogastric decompression, parenteral fluids and correction of electrolyte and fluid imbalance), although patients in one study also received Gastrografin. The rate of conservative treatment success ranged from 16% to 75% among the five studies, but one trial showed 0% successful rate. The hospital length of stay ranged from 3 to 6.5 days for conservative treatment (vs 10.2–13 days for operative treatment). The time to first feeding ranged from 31 to 84 h for conservative treatment.
In conclusion, in the majority of cases, conservative treatment is an effective means of managing ASBO in children.
Safe midwifery staffing levels on delivery suites is a priority area for any maternity service. Escalation policies are tools that provide an operational response to emergency pressures. The aim of this study was to assess the feasibility of using a scoring system to contemporaneously assess the required staffing level based on demand and use this to determine delivery suite escalation level and utilise the information generated regarding clinical activity (Demand) and staffing levels (Capacity) to generate unit-specific calculation for the actual number of midwifery staff required.
A maternity unit of a university-affiliated tertiary referral hospital.
Over a 12-month period, specifically designed scoring sheets were completed by delivery suite shift co-ordinators four times a day (04:00, 10:00, 16:00 and 22:00). Based on the dependency score (Demand) and the number of midwifery staff available (Capacity), an escalation level was determined for each shift. The 80th centile of the demand was used to determine optimal capacity.
A total of 1160 scoring sheets were completed. Average staff number throughout the year on any shift was 7 (range 3–11). Average dependency score was 7 (range 1–14). The 80th centile for demand was calculated to be 11.
This study stresses the importance and usefulness of a simple tool that can be used to determine the level of escalation on delivery suite based on an objective scoring system and can also be used to determine the appropriate staffing on delivery suite.
To assess variation in access to and use of community rehabilitation services for patients with a hip fracture, and whether this affects length of stay in hospital.
Cross-sectional study using administrative patient-level data from Hospital Episode Statistics (HES) and organisational survey data.
A regional health economy in South West England served by four acute National Health Service (NHS) hospital trusts and six former Primary Care Trusts (PCTs).
1230 hip fracture patients treated in an acute hospital between 1 April 2011 and 29 February 2012.
Information about access to community rehabilitation services for each acute hospital and PCT, reported by organisational survey. Rates of patients transferred from acute hospital to community rehabilitation hospitals (CRH) across eight groups with varying access; determined by acute hospital and PCT. Median lengths of stay in the acute hospital, and in the acute hospital plus CRH combined. Associations between the rate of transfer to a CRH and median lengths of stay assessed using Spearman's rank correlation coefficient (rs).
Access to community rehabilitation services varied, including the number of CRH inpatient beds, formal access criteria and waiting times. In one PCT, no home-based rehabilitation service was available. The percentage of patients transferred to a CRH ranged from 2.1% to 54.7%. A higher transfer rate was associated with a shorter median length of stay in the acute hospital (rs=–0.8; p=0.01), but a longer median combined length of stay in the acute hospital and CRH (rs=+0.7; p=0.04).
Within one geographical area, there was wide variation in availability and use of community rehabilitation services for patients discharged from an acute hospital following a hip fracture. Reliance on transfers to community rehabilitation hospitals was associated with a longer length of stay in the NHS.
Little is known about the potential health effects of eating organic food either in the general population or during pregnancy. The aim of this study was to examine associations between organic food consumption during pregnancy and the risk of pre-eclampsia among nulliparous Norwegian women.
Prospective cohort study.
Norway, years 2002–2008.
28 192 pregnant women (nulliparous, answered food frequency questionnaire and general health questionnaire in mid-pregnancy and no missing information on height, body weight or gestational weight gain).
Relative risk was estimated as ORs by performing binary logistic regression with pre-eclampsia as the outcome and organic food consumption as the exposure.
The prevalence of pre-eclampsia in the study sample was 5.3% (n=1491). Women who reported to have eaten organic vegetables 'often' or 'mostly' (n=2493, 8.8%) had lower risk of pre-eclampsia than those who reported 'never/rarely' or 'sometimes' (crude OR=0.76, 95% CI 0.61 to 0.96; adjusted OR=0.79, 95% CI 0.62 to 0.99). The lower risk associated with high organic vegetable consumption was evident also when adjusting for overall dietary quality, assessed as scores on a healthy food pattern derived by principal component analysis. No associations with pre-eclampsia were found for high intake of organic fruit, cereals, eggs or milk, or a combined index reflecting organic consumption.
These results show that choosing organically grown vegetables during pregnancy was associated with reduced risk of pre-eclampsia. Possible explanations for an association between pre-eclampsia and use of organic vegetables could be that organic vegetables may change the exposure to pesticides, secondary plant metabolites and/or influence the composition of the gut microbiota.
Neurogenic bladder is one of the most common complications following spinal cord injury (SCI). In China, acupuncture therapy is a common treatment for neurogenic bladder due to SCI, but its effects and safety remain uncertain. A protocol is described for a systematic review to investigate the beneficial effects and safety of acupuncture for neurogenic bladder due to SCI.
Eight databases will be searched from their inception: the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, Embase, the China National Knowledge Infrastructure (CNKI), the VIP database, the Wanfang database, the China Doctoral Dissertations Full-text Database (CDFD) and the China Master's Theses Full-text Database (CMFD). Any clinical randomised controlled trials (RCTs) and the first period of randomised cross-over studies related to acupuncture for neurogenic bladder due to SCI will be included. Outcomes will include change in urinary symptoms, urodynamic tests, clinical assessment and quality of life (QoL). The incidence of adverse events will be assessed as the safety outcome. Study selection, data extraction and quality assessment will be performed independently by two reviewers. Assessment of risk of bias, data synthesis and subgroup analysis will be carried out using Review Manager software.
Ethics approval is not required as this is a protocol for a systematic review. The findings of this systematic review will be disseminated via peer-reviewed publications and conference presentations.
To investigate the association between birth weight and blood pressure (BP) and to determine the effect of body size change from birth to adulthood on BP.
A cross-sectional design to collect retrospective data.
1253 female nurses aged 35–65 years in Hong Kong.
Birth weight, height, weight, BP, waist circumference, demographics and lifestyle factors were collected by a self-administered questionnaire through mail survey. These self-reported variables have been validated in a pilot study. The conditional relative weight (CRW), which was calculated as a residual of current weight regressed on birth weight, was used to express higher or lower relative weight gain from birth to adulthood.
No significant linear association between overall range of birth weight and BP was found. The curve estimation showed a significant quadratic curvilinear association ('J' shape). In the piecewise-linear analysis, a significant inverse association between birth weight z-scores and BP was observed in the birth weight ≤3.1 kg group (systolic BP (SBP): coefficient B=–1.73, 95% CI –3.17 to –0.30; diastolic BP (DBP): B=–1.12, 95% CI –2.19 to –0.06). A positive but non-significant association occurred in the birth weight >3.1 kg group. Participants who belonged to the lowest 10% birth weight category but at the current top 10% BMI group had higher BP than participants in other BMI groups. The CRW z-score was positively associated with BP (coefficient B: 4.18 for SBP and 2.87 for DBP).
Unlike most previous studies, we found a 'J' shape association rather than a linear association between birth weight and BP. Women with large percentile crossing of body size from birth to adulthood were more likely to have elevated BP. A higher weight gain from birth to adulthood than expected led to higher BP.
Obesity and overweight are becoming progressively more prevalent worldwide and are independently associated with a significant increase in the risk of cardiovascular diseases. Systemic arterial hypertension is frequently found in association with obesity and contributes significantly to increased cardiovascular risk. We hypothesise that Roux-en-Y gastric bypass (RYGB) surgery, a procedure that effectively reduces body weight, can also positively impact blood pressure control in obese and hypertensive individuals.
A unicentric, randomised, controlled, unblinded clinical trial. Sixty obese (body mass index between 30 and 39.9) and moderately well controlled hypertensive patients, in use of at least two antihypertensive medications at maximum doses or more than two in moderate doses, will be randomly allocated, using an online, electronic and concealed method, to receive either RYGB plus optimised clinical treatment (OCT) or OCT alone. The primary end point is the reduction of antihypertensive medication at 1 and 2 years of follow-up. Data analysis will primarily be conducted on an intention-to-treat basis.
The study was approved by the local institutional review board that works in total compliance with the latest version of the Helsinki Declaration, the Good Clinical Practices (GCP), the 'America's Document' and the national regulatory laws. Before the beginning of any study-related activities, each study participant is asked to provide a signed informed consent.
This systematic review aims to assess the effectiveness and safety of acupuncture for discomfort in patients during gastroscopy.
Randomised controlled trials will be searched electronically in several databases including OVID MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), Chinese Biomedical Literature Database (CBM), Chinese Medical Current Content (CMCC), Chinese Scientific Journal Database (VIP database), Wan-Fang Database and China National Knowledge Infrastructure (CNKI) from their respective founding dates to 30 April 2014. We will also try to find the literature by manually searching conference abstracts and reference lists. The study selection, extraction of data and assessment of study quality will be conducted independently by two researchers. Meta-analysis will be performed using RevMan V.5.2 statistical software. Data will be combined with either the fixed or random effect model based on a heterogeneity test. The results will be presented as a risk ratio for dichotomous data and standardised mean difference for continuous data.
This systematic review will evaluate the current evidence of acupuncture therapy for discomfort in patients during gastroscopy. The findings will be disseminated through peer-reviewed publication or conference presentations.
To investigate the effect of providing patients online access to their electronic health record (EHR) and linked transactional services on the provision, quality and safety of healthcare. The objectives are also to identify and understand: barriers and facilitators for providing online access to their records and services for primary care workers; and their association with organisational/IT system issues.
Primary care.
A total of 143 studies were included. 17 were experimental in design and subject to risk of bias assessment, which is reported in a separate paper. Detailed inclusion and exclusion criteria have also been published elsewhere in the protocol.
Our primary outcome measure was change in quality or safety as a result of implementation or utilisation of online records/transactional services.
No studies reported changes in health outcomes; though eight detected medication errors and seven reported improved uptake of preventative care. Professional concerns over privacy were reported in 14 studies. 18 studies reported concern over potential increased workload; with some showing an increase workload in email or online messaging; telephone contact remaining unchanged, and face-to face contact staying the same or falling. Owing to heterogeneity in reporting overall workload change was hard to predict. 10 studies reported how online access offered convenience, primarily for more advantaged patients, who were largely highly satisfied with the process when clinician responses were prompt.
Patient online access and services offer increased convenience and satisfaction. However, professionals were concerned about impact on workload and risk to privacy. Studies correcting medication errors may improve patient safety. There may need to be a redesign of the business process to engage health professionals in online access and of the EHR to make it friendlier and provide equity of access to a wider group of patients.
To determine the incremental value of ambulatory blood pressure (BP) in predicting cardiovascular risk when the Framingham Risk Score (FRS) is known.
We included 780 men without cardiovascular disease from the Uppsala Longitudinal Study of Adult Men, all aged approximately 70 years at baseline. We first screened ambulatory systolic BP (ASBP) parameters for their incremental value by adding them to a model with 10-year FRS. For the best ASBP parameter we estimated HRs and changes in discrimination, calibration and reclassification. We also estimated the difference in the number of men started on treatment and in the number of men protected against a cardiovascular event.
Mean daytime ASBP had the highest incremental value; adding other parameters did not yield further improvements. While ASBP was an independent risk factor for cardiovascular disease, addition to FRS led to only small increases to the overall model fit, discrimination (a 1% increase in the area under the receiver operating characteristic (ROC) curve), calibration and reclassification. We estimated that for every 10 000 men screened with ASBP, 141 fewer would start a new BP-lowering treatment (95% CI 62 to 220 less treated), but this would result in 7 fewer cardiovascular events prevented over the subsequent 10 years (95% CI 21 fewer events prevented to 7 more events prevented).
In addition to a standard cardiovascular risk assessment it is not clear that ambulatory BP measurement provides further incremental value. The clinical role of ambulatory BP requires ongoing careful consideration.
To review the empirical literature to identify the activities, time spent and engagement of hospital managers in quality of care.
A systematic review of the literature.
A search was carried out on the databases MEDLINE, PSYCHINFO, EMBASE, HMIC. The search strategy covered three facets: management, quality of care and the hospital setting comprising medical subject headings and key terms. Reviewers screened 15 447 titles/abstracts and 423 full texts were checked against inclusion criteria. Data extraction and quality assessment were performed on 19 included articles.
The majority of studies were set in the USA and investigated Board/senior level management. The most common research designs were interviews and surveys on the perceptions of managerial quality and safety practices. Managerial activities comprised strategy, culture and data-centred activities, such as driving improvement culture and promotion of quality, strategy/goal setting and providing feedback. Significant positive associations with quality included compensation attached to quality, using quality improvement measures and having a Board quality committee. However, there is an inconsistency and inadequate employment of these conditions and actions across the sample hospitals.
There is some evidence that managers' time spent and work can influence quality and safety clinical outcomes, processes and performance. However, there is a dearth of empirical studies, further weakened by a lack of objective outcome measures and little examination of actual actions undertaken. We present a model to summarise the conditions and activities that affect quality performance.
To examine the association between self-reported eating rate and metabolic syndrome.
Cross-sectional study.
Annual health checkup at a health check service centre in Japan.
A total of 56 865 participants (41 820 male and 15 045 female) who attended a health checkup in 2011 and reported no history of coronary heart disease or stroke.
Metabolic syndrome was defined by the joint of interim statement of the International Diabetes Federation and the American Heart Association/National Heart, Lung, and Blood Institute.
In multiple logistic regression models, eating rate was significantly and positively associated with metabolic syndrome. The multivariable-adjusted ORs (95% CI) for slow, normal and fast were 0.70 (0.62 to 0.79), 1.00 (reference) and 1.61 (1.53 to 1.70), respectively, in men (p for trend <0.001), and 0.74 (0.60 to 0.91), 1.00 (reference) and 1.27 (1.13 to 1.43), respectively, in women (p for trend <0.001). Of metabolic syndrome components, abdominal obesity showed the strongest association with eating rate. The associations of eating rate and metabolic syndrome and its components were largely attenuated after further adjustment for body mass index; however, the association of slow eating with lower odds of high blood pressure (men and women) and hyperglycaemia (men) and that of fast eating with higher odds of lipid abnormality (men) remained statistically significant.
Results suggest that eating rate is associated with the presence of metabolic syndrome and that this association is largely accounted for by the difference in body mass according to eating rate.
Hypokalaemia is frequently encountered in the daily clinical practices of a paediatric cardiac intensive care unit (PCICU). It is a strong independent predictor of mortality in patients with heart failure. Thus, prompt potassium replacement therapy holds pivotal importance in therapy for hypokalaemia. Although intravenous potassium replacement (IVPR) in hypokalaemia is the preferred route in most intensive care settings, it is associated with known safety risks and can lead to arrhythmias, cardiac arrest and death if inappropriately administered. Enteral potassium replacement (EPR), with its superior safety profile, may be a better alternative to IVPR.
Primary outcome To compare the efficacy EPR and IVPR for treatment of hypokalaemia. Secondary outcome measures include a comparison of adverse effects (hyperkalaemia, diarrhoea, gastrointestinal bleeds, nausea and vomiting) after EPR and IVPR and a comparison of the number of dose/s required to achieve resolution of hypokalaemia for each episode of hypokalaemia.
The Enteral Versus Intravenous Potassium Supplementation trial is designed as a randomised, controlled, non-blinded trial with two arms. Intervention arms will be block randomised on alternate weeks for IVPR and EPR. Recruited patients will receive treatment accordingly. For analysis, the percentage change in serum potassium levels in mEq/L after each event of potassium replacement in both arms will be used as an end point to compare the efficacy EPR and IVPR for treatment of hypokalaemia.
The study will be conducted at the PCICU at the Aga Khan University Hospital, Karachi.
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.
This trial is registered at Clinical Trials.Gov. Registration number: NCT02015962.
To describe the prevalence of expected work limitations (EWL) prior to future retirement age in osteoarthritis consulters, and the associated health, sociodemographic and workplace factors.
Population-based prospective cohort study.
General practices in Staffordshire, England.
297 working adults aged 50–65, who had consulted primary care for osteoarthritis.
EWL was defined using a single question, "Do you think joint pain will limit your ability to work before you reach 69 years old?"
51 (17.2%) indicated that joint pain would not limit their ability to work until 69, 79 (26.6%) indicated EWL and 167 (56.2%) did not know if joint pain would limit work before 69. In bivariate analysis, physical function (OR 0.93; 95% CI 0.91 to 0.96), depression (4.51; 1.81 to 11.3), cognitive symptom (3.84; 1.81 to 8.18), current smoker (2.75; 1.02 to 7.38), age (0.69; 0.58 to 0.82), physically demanding job (3.18; 1.50 to 6.72), no opportunities to retrain (3.01; 1.29 to 7.05) and work dissatisfaction (3.69; 1.43 to 9.49) were associated with EWL. The final multivariate model included physical function and age.
Only one in five osteoarthritis consulters expected that joint pain would not limit their work participation before 69 years of age. Given the expectation for people to work until they are older, the results highlight the increasing need for clinicians to include work participation in their consultation and implement strategies to address work loss/limitation. Targeting pain-related functional limitation and effective communication with employers to manage workplace issues could reduce EWL.
Post-thrombotic syndrome (PTS) is a serious complication of deep vein thrombosis (DVT) of the leg that affects 20–50% of patients. Once a patient experiences PTS there is no treatment that effectively reduces the debilitating complaints. Two randomised controlled trials showed that elastic compression stocking (ECS) therapy after DVT for 24 months can reduce the incidence of PTS by 50%. However, it is unclear whether all patients benefit to the same extent from ECS therapy or what the optimal duration of therapy for individual patients should be. ECS therapy is costly, inconvenient, demanding and sometimes even debilitating. Tailoring therapy to individual needs could save substantial costs. The objective of the IDEAL DVT study, therefore, is to evaluate whether tailoring the duration of ECS therapy on signs and symptoms of the individual patient is a safe and effective method to prevent PTS, compared with standard ECS therapy.
A multicentre, single-blinded, allocation concealed, randomised, non-inferiority trial. A total of 864 consecutive patients with acute objectively documented proximal DVT of the leg are randomised to either standard duration of 24 months or tailored duration of ECS therapy following an initial therapeutic period of 6 months. Signs and symptoms of PTS are recorded at regular clinic visits. Furthermore, quality of life, costs, patient preferences and compliance are measured. The primary outcome is the proportion of patients with PTS at 24 months.
Based on current knowledge the standard application of ECS therapy is questioned. The IDEAL DVT study will address the central questions that remain unanswered: Which individual patients benefit from ECS therapy and what is the optimal individual treatment duration? Primary ethics approval was received from the Maastricht University Medical Centre.
Results of the study will be disseminated via peer-reviewed publications and presentations at scientific conferences.
NCT01429714 and NTR 2597.
Suicide is an important public health problem and one of the most common causes of death throughout the world. Suicidal behaviour is complex, and its causes are multifactorial. Case–control studies have reported an association between an alteration of the serotonin system and suicidal behaviour. Recently, it has been suggested that the 5-HTRC2 serotonin receptor gene is involved in the pathogenesis of suicidal behaviour.
To evaluate the role of the 5-HTR2C gene in suicidal behaviour, we will perform a systematic review and a meta-analysis of worldwide reports that have investigated the association between the serotonin system and suicidal behaviour. This analysis will be reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) criteria. Studies deemed fit for inclusion in the systematic review will be scored for methodological quality using the Newcastle-Ottawa Assessment Scale (NOS). The inclusion criteria will be to present independent data, to be case–control studies and to be published in journal peer reviews. To generate more accurate analyses, we will grade the reports using the GRADES scale procedures.
This study will describe the association between the HTR2C gene and suicidal behaviour. The results will be reported in a peer-reviewed publication and in scientific presentations in Mexico and throughout the world.
During the last decade, coal-based sponge iron plants, a highly polluted industry, have grown rapidly in Barjora, India. Understanding their workers' perception of health is essential in people-centered healthcare. The aim of the study was to assess their health-related quality-of-life (HRQoL), and to determine factors that independently predict their HRQoL.
Cross-sectional study.
Coal-based sponge iron plants in Barjora, India.
258 coal-based sponge iron plant workers.
HRQoL was measured using the EuroQol-5D-5L.
The response rate was 100%. Participants with problems in mobility, self-care, usual activities, pain/discomfort and anxiety/depression were 23.3%, 5.1%, 10.9%, 39.5% and 45.5%, respectively. 36.8% of participants reported health state 11111 (no problem in any EQ-5D dimension). The mean visual analogue scale (EQ-VAS) was 69.8 (18.5 SD). The odds of mobility problems decreased with age (OR 0.95, 95% CI 0.91 to 0.99, p=0.016), were lower in participants with presence/history of any respiratory disease (0.27, 0.13 to 0.55, p<0.001), scheduled caste/scheduled tribe/other backward class workers (0.44, 0.22 to 0.89, p=0.021), manual workers (0.40, 0.16 to 0.99, p=0.047) and non-smokers (2.63, 1.27 to 5.46, p=0.009). The odds of pain/discomfort and anxiety/depression were lower in participants with any respiratory disease (0.44, 0.24 to 0.79, p=0.006; and 0.52, 0.29 to 0.92, p=0.026, respectively). The EQ-VAS was worse in manual participants (coefficient –6.91, 95% CI –12.40 to –1.41, p=0.014), with any respiratory disease (–8.13, –13.12 to –3.13, p=0.002), alcohol drinkers (–4.81, –9.47 to –0.15, p=0.043), literates (7.70, 0.97 to 14.43, p=0.025) and Hindus (13.41, 2.62 to 24.20, p=0.015).
Many coal-based sponge iron plant workers in Barjora have problems in their HRQoL, and the predictors of different aspects of HRQoL were identified. The study findings could be taken into consideration in future interventional studies aimed at improving the HRQoL of these workers.
To investigate predictors of healthcare professionals' (HCPs) attitudes towards family involvement in safety-relevant behaviours.
A cross-sectional fractional factorial survey that assessed HCPs' attitudes towards family involvement in two error scenarios relating to hand hygiene and medication safety. Each survey comprised two randomised vignettes that described the potential error, how the family member communicated with the HCP about the error and how the HCP responded to the family member's question.
5 teaching hospitals in London, the Midlands and York. HCPs were approached on a range of medical and surgical wards.
160 HCPs (73 doctors; 87 nurses) aged between 21 and 65 years (mean 37) 102 were female.
HCP approval of family member's behaviour; HCP reaction to the family member; anticipated effects on the family member–HCP relationship; HCP support for being questioned about hand hygiene/medication; affective rating responses.
HCPs supported family member's intervening (88%) but only 41% agreed this would have positive effects on the family member/HCP relationship. Across vignettes and error scenarios the strongest predictors of attitudes were how the HCP (in the scenario) responded to the family member and whether an error actually occurred. Doctors (vs nurses) provided systematically more positive affective ratings to the vignettes.
Important predictors of HCPs' attitudes towards family members' involvement in patient safety have been highlighted. In particular, a discouraging response from HCP's decreased support for family members being involved and had strong perceived negative effects on the family member/HCP relationship.
To examine risk factors for Clostridium difficile infection (CDI) morbidity and mortality in Japan.
Multimethod investigation including a case–control study and cohort study.
47 participating facilities of the National Hospital Organization (NHO).
1026 patients with CDI and 878 patients in the control group over the age of 18 years admitted to the subject NHO facilities from November 2010 to October 2011.
In a case–control study, we identify risk factors for CDI development. Next, in a cohort study, we identify risk factors for all-cause mortality within 30 days following CDI onset.
A total of 1026 cases of CDI meeting the definitions of this investigation were identified, encompassing 878 patients at 42 of the 47 subject facilities. In the case–control study, we identified, compared with no antibiotics use, use of first-generation and second-generation cephem antibiotics (OR 1.44; 95% CI 1.10 to 1.87), use of third-generation and fourth-generation cephem antibiotics (OR 1.86; 95% CI 1.48 to 2.33) and use of carbapenem antibiotics (OR 1.87; 95% CI 1.44 to 2.42) the risk factors for CDI development. However, use of penicillin was not identified as a risk factor. In the cohort study, sufficient data for analysis was available for 924 CDI cases; 102 of them (11.0%) resulted in death within 30 days of CDI onset. Compared with no anti-CDI drug use, use of vancomycin was associated with reduced risk of mortality (OR 0.43; 95% CI 0.25 to 0.75) whereas metronidazole was not.
The findings mirror those of previous studies from Europe and North America, identifying the administration of broad-spectrum antibiotics as a risk factor for CDI development. The use of vancomycin is associated with a decreased risk of mortality.
Currently identification, and therefore, management of patients at risk of osteoporotic fracture in the UK is suboptimal. As the majority of patients who fracture have fallen, it follows that people who fall can usefully be targeted in any programme that aims to reduce osteoporotic fracture. Targeting vulnerable patients who are likely to benefit from intervention may help shift the management of fracture prevention into primary care, away from emergency departments. Paramedics who attend to patients who have fallen may be well placed to assess future fracture risk, using the Fracture Risk Assessment Tool (FRAX) and communicate that information directly to general practitioners (GPs).
This feasibility study takes the form of a pragmatic, randomised controlled trial aimed at exploring and refining issues of study design, recruitment, retention, sample size and acceptability preceding a large-scale study with fracture as the end point. Patients (aged >50) who fall, call an ambulance, are attended by a study paramedic and give verbal consent will be asked FRAX and fall questions. Patients who subsequently formally consent to participation will be randomised to control (usual care) or intervention groups. Intervention will constitute transmission of calculated future fracture risk to the patients' GP with suitable, evidence-based recommendations for investigation or treatment. 3 months after the index fall, data (proportion of patients in each group undergoing investigation or starting new treatment, quality of life and health economic) will be collected and analysed using descriptive statistics. A nested qualitative study will explore issues of acceptability and study design with patients, paramedics and GPs.
This protocol was approved by NRES Committee South Central Oxford C in October 2012. Research Ethics Committee ref.12/SC/0604. The study findings will be disseminated through peer-reviewed journals, conference presentations and local public events. A publication plan and authorship criteria have been preagreed.
To investigate the nature and potential implications of under-reporting of morbidity information in administrative hospital data.
Retrospective analysis of linked self-report and administrative hospital data for 32 832 participants in the large-scale cohort study (45 and Up Study), who joined the study from 2006 to 2009 and who were admitted to 313 hospitals in New South Wales, Australia, for at least an overnight stay, up to a year prior to study entry.
Agreement between self-report and recording of six morbidities in administrative hospital data, and between-hospital variation and predictors of positive agreement between the two data sources.
Agreement between data sources was good for diabetes (=0.79); moderate for smoking (=0.59); fair for heart disease, stroke and hypertension (=0.40, =0.30 and =0.24, respectively); and poor for obesity (=0.09), indicating that a large number of individuals with self-reported morbidities did not have a corresponding diagnosis coded in their hospital records. Significant between-hospital variation was found (ranging from 8% of unexplained variation for diabetes to 22% for heart disease), with higher agreement in public and large hospitals, and hospitals with greater depth of coding.
The recording of six common health conditions in administrative hospital data is highly variable, and for some conditions, very poor. To support more valid performance comparisons, it is important to stratify or control for factors that predict the completeness of recording, including hospital depth of coding and hospital type (public/private), and to increase efforts to standardise recording across hospitals. Studies using these conditions for risk adjustment should also be cautious of their use in smaller hospitals.
Despite therapeutic advances, many people with type 1 diabetes are still unable to achieve optimal glycaemic control, limited by the occurrence of hypoglycaemia. The objective of the present study is to determine the effectiveness of day and night home closed-loop over the medium term compared with sensor-augmented pump therapy in adults with type 1 diabetes and suboptimal glycaemic control.
The study will adopt an open label, three-centre, multinational, randomised, two-period crossover study design comparing automated closed-loop glucose control with sensor augmented insulin pump therapy. The study will aim for 30 completed participants. Eligible participants will be adults (≥18 years) with type 1 diabetes treated with insulin pump therapy and suboptimal glycaemic control (glycated haemoglobin (HbA1c) ≥7.5% (58 mmol/mmol) and ≤10% (86 mmol/mmol)). Following a 4-week optimisation period, participants will undergo a 3-month use of automated closed-loop insulin delivery and sensor-augmented pump therapy, with a 4–6 week washout period in between. The order of the interventions will be random. All analysis will be conducted on an intention to treat basis. The primary outcome is the time spent in the target glucose range from 3.9 to 10.0 mmol/L based on continuous glucose monitoring levels during the 3 months free living phase. Secondary outcomes include HbA1c changes; mean glucose and time spent above and below target glucose levels. Further, participants will be invited at baseline, midpoint and study end to participate in semistructured interviews and complete questionnaires to explore usability and acceptance of the technology, impact on quality of life and fear of hypoglycaemia.
Ethical approval has been obtained at all sites. Before screening, all participants will be provided with oral and written information about the trial. The study will be disseminated by peer-review publications and conference presentations.
NCT01961622 (ClinicalTrials.gov).
People with type 1 diabetes (T1DM) require insulin therapy to sustain life, and need optimal glycaemic control to prevent diabetic ketoacidosis and serious long-term complications. Insulin is generally administered using multiple daily injections but can also be delivered using an infusion pump (continuous subcutaneous insulin infusion), a more costly option with benefits for some patients. The UK National Institute for Health and Care Excellence (NICE) recommend the use of pumps for patients with the greatest need, citing insufficient evidence to approve extension to a wider population. Far fewer UK adults use pumps than in comparable countries. Previous trials of pump therapy have been small and of short duration and failed to control for training in insulin adjustment. This paper describes the protocol for a large randomised controlled trial comparing pump therapy with multiple daily injections, where both groups are provided with high-quality structured education.
A multicentre, parallel group, cluster randomised controlled trial among 280 adults with T1DM. All participants attended the week-long dose adjustment for normal eating (DAFNE) structured education course, and receive either multiple daily injections or pump therapy for 2 years. The trial incorporates a detailed mixed-methods psychosocial evaluation and cost-effectiveness analysis. The primary outcome will be the change in glycosylated haemoglobin (HbA1c) at 24 months in those participants whose baseline HbA1c is at or above 7.5% (58 mmol/mol). The key secondary outcome will be the proportion of participants reaching the NICE target of an HbA1c of 7.5% (58 mmol/mol) or less at 24 months.
The protocol was approved by the Research Ethics Committee North West, Liverpool East and received Medicines and Healthcare products Regulatory Agency (MHRA) clinical trials authorisation. Each participating centre gave National Health Service R&D approval. We shall disseminate study findings to study participants and through peer reviewed publications and conference presentations, including lay user groups.
This study aimed to assess the efficacy and safety of an integrative complementary and alternative medicine (CAM) approach in the management of lumbar herniated disc (LHD) with sciatic pain and investigate pain relapse, use of medical care and surgery rates in patients who actively chose non-surgical CAM treatment for LHD.
This prospective observational study was undertaken at a Korean medicine hospital outpatient setting in Korea.
A total of 128 consecutive patients with LHD with a numeric rating scale for leg pain of ≥5 completed 6 months of CAM treatment after recruitment from November 2006, and 73/128 participants (57%) attended follow-up 3 years later.
6 months of CAM treatment (herbal medicine, acupuncture, bee venom pharmacopuncture, and Chuna manipulation).
Visual analogue scale (VAS) for low back and leg pain, Oswestry Disability Index (ODI), and Short Form (SF)-36 Health Survey.
Neurological impairment (muscular weakness, sensory loss, Straight Leg Raise test), MRIs, recurrence of low back pain and/or radiating pain, and use of medical care.
92 patients could be assessed for surgical state, of whom 4 replied that they had received surgery. 73 patients attended the 3-year follow-up. The baseline VAS of back pain (4.37±2.70) decreased after treatment (0.90±1.01; p<0.001) and was maintained at 3 years (1.12±1.64; p=0.19). The baseline VAS of leg pain (7.57±1.40) also decreased on treatment (0.82±1.18; p<0.001) and was sustained at 3 years (0.99±1.58; p=0.34). ODI scores declined from 40.74±16.15 to 9.84±9.67 (p<0.001), then decreased further to 6.30±7.19 (p<0.01). SF-36 scores increased from 34.96±13.30 to 69.20±14.96 (p<0.001), reaching 76.19±14.45 (p<0.001) at 3 years. 37 patients reported recurrence of pain and most chose CAM treatment for management of relapse symptoms.
Although the absence of a control group prevents validation of effectiveness, many patients showed favourable long-term outcomes.
ClinicalTrials.gov Identifier: NCT01989403.
To evaluate the effectiveness of a computerised self-adjusting anticoagulant algorithm to predict appropriate warfarin dosing and to assess its use in clinical practice.
A 3-year audit of anticoagulant control in patients managed by doctors and pharmacists using computer decision support and an evaluation of the impact of dose adjustments made by the users.
3660 patients on oral anticoagulants; one-third of patients managed by doctors and two-thirds by pharmacists.
Anticoagulant supervision in primary care and pharmacies at 60 sites in New Zealand.
The time in the therapeutic range (TTR), the outcome of adherence to the computer dosing algorithm, the percentage of time the clinicians over-ride the algorithm and the impact of their intervention on anticoagulant control.
A TTR of 72.9% was achieved for all patients. The TTR was significantly better in patients managed by pharmacists than doctors (75.1% versus 67.4%, p<0.0001). The computer algorithm provides appropriate dose recommendations for INR results from 1.5 to 4. Users administered a dose that differed from the computer recommendation 23.3% of the time. The doctors adjusted the dose more frequently (28.2% versus 21.1% of tests) and made larger dose changes than the pharmacists.
The clinicians predominantly change the dose when the INR is below the therapeutic range. The changes are not necessary to correct for inaccuracies in the algorithm. The most likely explanation is the clinician's belief that their own dose adjustment would achieve better control; however, in practice, their changes tend to underdose patients. The doctors achieved poorer control than the pharmacists; this is in part due to the action of the doctors over-riding the algorithm. Our results imply that clinicians could achieve better anticoagulant control if they more closely followed the computer algorithm.
The role of infection in rheumatoid arthritis (RA) has not been determined. We aimed to document the infectious burden and some aspects of antibacterial immunity in a large and prospective cohort study of RA patients in the early and late stages of the disease and in their relatives predisposed to RA.
Clinical and laboratory examination of all individuals enrolled in the study was performed in the Republican Clinical Hospital, Kazan, Russia.
376 patients with RA, 251 healthy first-degree relatives and 227 healthy controls without a family history of autoimmune disease (all females) were examined twice annually over more than 10 years.
The following parameters were investigated: type, duration and frequency of infections, bacterial colonisation and serum levels of IgG to bacteria, serum levels of total Ig, plasma cytokine levels, granulocyte reactive oxygen species production, lysozyme activity and phagocytosis.
There were no significant differences in infection rate between healthy controls (median 14 days/year) and RA patients (13). However, infection rates were higher (p<0.001) in healthy relatives (53) and early stage patients (62), which groups also showed heavy bacterial skin colonisation. In contrast, late stage patients had fewer infection days (12; p<0.001) than healthy controls, although bacterial colonisation was still heavy. Phagocyte function and antibacterial antibody generation, together with compensatory cytokine production, were observed to be subnormal in the healthy relatives as well as in RA patients.
We observed a marked increase in overall infections at the time of RA onset, and signs of a defective antibacterial defence mechanism, contrasting with fewer infections in the late RA stage. It can be speculated that frequent early infections initiate a compensatory immune hyper-reactivity which reduces the infection load while stimulating the development of RA in predisposed individuals.
To determine the prevalence and risk factors of allergic rhinitis among bakers in Douala.
A cross-sectional study; the logistic regression model was use to find the risk factors of allergic rhinitis.
The study was conducted in 42 bakeries randomly selected among a total of 151 bakeries in the city of Douala.
All bakers who consented to participate in the study between 1 May and 31 July 2013.
Allergic rhinitis was the outcome of interest. It was defined as the presence of the following symptoms: itchy nose, rhinorrhea, nasal obstruction and sneezing.
During the study period, a total of 273 bakers were invited and 229 finally agreed to participate in this study. Males were the most represented gender with 222 (96.9%) participants. The mean age of the participants was 36.29±8.9 years. Smoking was found in 55 participants (24.5%). The symptoms of allergic rhinitis were observed in 24.5% of participants. Work related nasal symptoms were present in 15% of participants. Sensitisation to wheat flour and α-amylase was found in 16.6% and 8.3% of participants, respectively. The Prick test was positive for mites in 12.2% of participants. After multivariate analysis, sensitisation to flour (OR 3.95, 95% CI 1.85 to 8.47) and storage mites (OR 3.44, 95% CI 1.45 to 8.18) were the factors independently associated with symptoms of allergic rhinitis.
Allergic rhinitis is frequent among bakers in Cameroon. Implementation of preventive measures against inhalation of airborne allergens in bakeries and clinical monitoring of bakers sensitised to wheat flour and mites could help to reduce the prevalence of allergic rhinitis among bakers.
To assess the construct validity of the HIV Disability Questionnaire (HDQ), a self-administered questionnaire that describes the presence, severity and episodic nature of disability experienced by people living with HIV.
We conducted a confirmatory factor analysis. We hypothesised that domains in the HDQ characterised six dimensions of disability, each represented by HDQ items: physical symptoms and impairments (20 items); cognitive symptoms and impairments (3 items); mental and emotional health symptoms and impairments (11 items); uncertainty (14 items); difficulties with day-to-day activities (9 items) and challenges to social inclusion (12 items). We developed a measurement model to test these hypotheses. We used maximum likelihood methods of estimation to determine model fit. We considered a threshold for the Root Mean Square Error of Approximation (RMSEA) of <0.05 as an indication of overall goodness of model fit. We considered variables with factor loadings of >0.30 as representing a given domain of disability.
We recruited adults with HIV from hospital clinics, AIDS service organisations and a specialty hospital in Ontario.
Of the 361 adults with HIV who completed the HDQ, 80% were men, 36% were 50 or older and 77% reported living with at least two concurrent health conditions in addition to HIV.
We administered the HDQ followed by a demographic questionnaire.
The model achieved good overall fit as indicated by a RMSEA of 0.030 (90% CI 0.028 to 0.033). All HDQ items represented our hypothesised dimensions of disability (factor loadings >0.30). Factor loadings ranged from 0.34 to 0.90. Domains of disability correlated with each other ranging from r=0.47 (between difficulties with day-to-day activities and uncertainty) to r=0.88 (between mental-emotional health challenges and challenges to social inclusion).
The six domain structure of the HDQ demonstrated construct validity when administered to adults living with HIV.
Amyotrophic lateral sclerosis (ALS) is the most common motor neurone disease. It occurs in two forms: (1) familial cases, for which several genes have been identified and (2) sporadic cases, for which various hypotheses have been formulated. Notably, the β-N-methylamino-L-alanine (L-BMAA) toxin has been postulated to be involved in the occurrence of sporadic ALS. The objective of the French BMAALS programme is to study the putative link between L-BMAA and ALS.
The programme covers the period from 1 January 2003 to 31 December 2011. Using multiple sources of ascertainment, all the incident ALS cases diagnosed during this period in the area under study (10 counties spread over three French regions) were collected. First, the standardised incidence ratio will be calculated for each municipality under concern. Then, by applying spatial clustering techniques, overincidence and underincidence zones of ALS will be sought. A case–control study, in the subpopulation living in the identified areas, will gather information about patients' occupations, leisure activities and lifestyle habits in order to assess potential risk factors to which they are or have been exposed. Specimens of drinking water, food and biological material (brain tissue) will be examined to assess the presence of L-BMAA in the environment and tissues of ALS cases and controls.
The study has been reviewed and approved by the French ethical committee of the CPP SOOM IV (Comité de Protection des Personnes Sud-Ouest & Outre-Mer IV). The results will be published in peer-reviewed journals and presented at national and international conferences.
High levels of oxidative stress can have considerable impact on the outcomes of in vitro fertilisation (IVF). Recent studies have reported that melatonin, a neurohormone secreted from the pineal gland in response to darkness, has significant antioxidative capabilities which may protect against the oxidative stress of infertility treatment on gametes and embryos. Early studies of oral melatonin (3–4 mg/day) in IVF have suggested favourable outcomes. However, most trials were poorly designed and none have addressed the optimum dose of melatonin. We present a proposal for a pilot double-blind randomised placebo-controlled dose–response trial aimed to determine whether oral melatonin supplementation during ovarian stimulation can improve the outcomes of assisted reproductive technology.
We will recruit 160 infertile women into one of four groups: placebo (n=40); melatonin 2 mg twice per day (n=40); melatonin 4 mg twice per day (n=40) and melatonin 8 mg twice per day (n=40). The primary outcome will be clinical pregnancy rate. Secondary clinical outcomes include oocyte number/quality, embryo number/quality and fertilisation rate. We will also measure serum melatonin and the oxidative stress marker, 8-hydroxy-2'-deoxyguanosine at baseline and after treatment and levels of these in follicular fluid at egg pick-up. We will investigate follicular blood flow with Doppler ultrasound, patient sleepiness scores and pregnancy complications, comparing outcomes between groups. This protocol has been designed in accordance with the SPIRIT 2013 Guidelines.
Ethical approval has been obtained from Monash Health HREC (Ref: 13402B), Monash University HREC (Ref: CF14/523-2014000181) and Monash Surgical Private Hospital HREC (Ref: 14107). Data analysis, interpretation and conclusions will be presented at national and international conferences and published in peer-reviewed journals.
To investigate the impact of a higher publishing probability for statistically significant positive outcomes on the false-positive rate in meta-analysis.
Meta-analyses of different sizes (N=10, N=20, N=50 and N=100), levels of heterogeneity and levels of publication bias were simulated.
The type I error rate for the test of the mean effect size (ie, the rate at which the meta-analyses showed that the mean effect differed from 0 when it in fact equalled 0) was estimated. Additionally, the power and type I error rate of publication bias detection methods based on the funnel plot were estimated.
In the presence of a publication bias characterised by a higher probability of including statistically significant positive results, the meta-analyses frequently concluded that the mean effect size differed from zero when it actually equalled zero. The magnitude of the effect of publication bias increased with an increasing number of studies and between-study variability. A higher probability of including statistically significant positive outcomes introduced little asymmetry to the funnel plot. A publication bias of a sufficient magnitude to frequently overturn the meta-analytic conclusions was difficult to detect by publication bias tests based on the funnel plot. When statistically significant positive results were four times more likely to be included than other outcomes and a large between-study variability was present, more than 90% of the meta-analyses of 50 and 100 studies wrongly showed that the mean effect size differed from zero. In the same scenario, publication bias tests based on the funnel plot detected the bias at rates not exceeding 15%.
This study adds to the evidence that publication bias is a major threat to the validity of medical research and supports the usefulness of efforts to limit publication bias.
Cigarette smoking continues to be the leading cause of preventable death and is the main risk factor of major diseases such as chronic obstructive pulmonary disease (COPD). The best treatment to help smokers quit is a combination of behavioural support with pharmacotherapy. Varenicline is the newest drug on the market and has been shown to be effective in the general smoking population and in smokers with COPD. The safety profile of varenicline was initially established using standard approaches to pharmacovigilance, but postmarketing reports have raised concerns about a possible association between the use of varenicline and cardiovascular and neuropsychiatric events. Although recent studies have not confirmed such an association, further research is needed given the large number of smokers who are being prescribed varenicline, including important subgroups such as smokers with COPD who may be particularly vulnerable to side effects of drugs. The aim of this study is to assess the cardiovascular and neuropsychiatric safety of varenicline using data from the QResearch general practice (GP) database.
We will conduct a retrospective cohort study in the QResearch GP database. Patients will be categorised into three exposure groups: prescription of (1) varenicline, (2) bupropion or (3) nicotine replacement therapy (NRT Rx; =reference group). We will separately consider major incident neuropsychiatric and cardiovascular outcomes that occur during 6 months of follow-up using Cox proportional hazards models, adjusted for confounders. Furthermore, propensity score analysis will be used as an analytical approach to account for potential confounding by indication.
This work involves analysis of anonymised, routinely collected data. The protocol has been independently peer-reviewed by the QResearch Scientific Board and meets the requirements of the Trent research ethics committee. We plan to disseminate the results from this study via articles in international peer-reviewed journals and presentations at relevant national and international health conferences.
To investigate the discrepancy between patient-reported symptoms and measured clinical findings and influencing factors in dry eye (DE).
A population-based, cross-sectional study was performed in July–August 2007 in northeast China. The study was performed on populations originating from two rural districts that are respectively located approximately 377 and 177 km from our hospital.
2600 eligible residents from 1300 households were identified; valid responses were obtained from 2262 residents (mean age 48 (range 12–88) years; 926 men and 1336 women; response rate 87%).
Patient-reported symptoms of DE, tear film break up time (BUT) and Schirmer scores (Schirmer II).
Subjects with normal BUT and Schirmer scores without any DE symptoms were defined as the control group. Those with abnormal BUT and Schirmer scores and symptoms of DE were defined as the DE group. Subjects with disparities between the occurrence of DE symptoms and measured clinical findings were regarded as the discrepancy. Out of 2262 subjects, the discrepant group contained 960 subjects (42.44%) with significant difference (2=4.027, p=0.045<0.05). Factors that influenced the subjective reporting of DE symptoms included gender, smoking status, environment and age. Schirmer II test and tear film BUT values were remarkably different among control, DE and discrepant groups.
Development of DE can be related to many factors. It is of great importance to put forward the preclinical phase concept (patients who are symptomatic for DE and yet show no aqueous deficiency or evaporative signs) and to screen outpatients with DE-inducing features. Future interventions should focus on patients demonstrating a discrepancy between self-reported symptomology and measured clinical findings.
Powered paragliding (PPG) and paragliding are two totally different sports, mainly because of the use of an engine in powered paragliding. As a consequence, the pattern of injuries caused by each of these two sports may be different.
To test this hypothesis, we analysed 384 incident reports gathered by the US Powered Paragliding Association from 1995 to 2012. The majority of the incidents occurred in the USA, while 26 incidents occurred elsewhere: Canada (8), Mexico (5), Panama (1), China (1), Japan (1), Malaysia (1), Indonesia (Java) (1), Europe (8): of which Spain (1), Belgium (1), UK (3), Italy (1), Romania (1), unknown (1).
To identify the most affected body area and the most common type of injury sustained in PPG, and to highlight any differences from paragliding.
The most affected body areas in PPG were the upper limbs (44.5%), followed by the lower limbs (32%), the back (9.8%), the head (7%), the pelvis (3.1), the chest (2.7%) and the abdomen (0.7%) (p<0.001). The engine caused 43 accidents (11.2%) in our study and was responsible for the majority of injuries to the upper limbs. The number of fatal accidents in PPG is not lower than in paragliding and hang-gliding.
To help prevent the specific injuries of PPG, the most appropriate equipment should be identified. The results of this study also suggest that, in the future, this sport should be analysed separately from paragliding.
To validate the performance of a set of risk prediction algorithms developed using the QResearch database, in an independent sample from general practices contributing to the Clinical Research Data Link (CPRD).
Prospective open cohort study using practices contributing to the CPRD database and practices contributing to the QResearch database.
The CPRD validation cohort consisted of 3.3 million patients, aged 25–99 years registered at 357 general practices between 1 Jan 1998 and 31 July 2012. The validation statistics for QResearch were obtained from the original published papers which used a one-third sample of practices separate to those used to derive the score. A cohort from QResearch was used to compare incidence rates and baseline characteristics and consisted of 6.8 million patients from 753 practices registered between 1 Jan 1998 and until 31 July 2013.
Incident events relating to seven different risk prediction scores: QRISK2 (cardiovascular disease); QStroke (ischaemic stroke); QDiabetes (type 2 diabetes); QFracture (osteoporotic fracture and hip fracture); QKidney (moderate and severe kidney failure); QThrombosis (venous thromboembolism); QBleed (intracranial bleed and upper gastrointestinal haemorrhage). Measures of discrimination and calibration were calculated.
Overall, the baseline characteristics of the CPRD and QResearch cohorts were similar though QResearch had higher recording levels for ethnicity and family history. The validation statistics for each of the risk prediction scores were very similar in the CPRD cohort compared with the published results from QResearch validation cohorts. For example, in women, the QDiabetes algorithm explained 50% of the variation within CPRD compared with 51% on QResearch and the receiver operator curve value was 0.85 on both databases. The scores were well calibrated in CPRD.
Each of the algorithms performed practically as well in the external independent CPRD validation cohorts as they had in the original published QResearch validation cohorts.
To assess HIV and sexually transmitted infection (STI) prevalence and associated risk factors in men who have sex with men (MSM) in two cities in mainland Tanzania.
We conducted respondent-driven sampling of 300 MSM in Dar es Salaam and Tanga.
In Dar es Salaam, 172 (86%) men (median age 23, IQR 21–28) consented to HIV/STI testing, and 30.2% were HIV seropositive. Only five reported a previous positive HIV test: >90% were new HIV detections. 2.5% were syphilis-exposed and none hepatitis B positive, but 21.4% had a curable STI. Over 90% of the gonorrhoea and chlamydia was rectal. In Tanga, 11.1% of MSM were HIV seropositive, 8% hepatitis B positive and 0% were syphilis-exposed, with 4.4% having a curable STI. Predictors of HIV infection were number of MSM known, city, identifying as gay and having first sex with a man. Predictors for STIs were recent unprotected receptive anal intercourse, and number of MSM seen in the last month. 30% of the sample reported that they sold sex. There was no significant association between HIV and STI infection.
HIV and STI rates were substantially lower in MSM in a provincial city than in a large metropolis and rates appear to depend on larger numbers of MSM known. Most HIV detected were new cases, and there was a high burden of asymptomatic curable rectal STIs (>1 in 5 MSM). Owing to stigma, MSM may not report homosexuality and thus not have rectal STIs treated. High need for tailored HIV testing and STI screening and treatment of MSM in Tanzania is apparent.
To compare healthcare costs and mortality rates of Dutch patients with a conventional (CON) general practitioner (GP) and patients with a GP who has additionally completed training in complementary and alternative medicine (CAM).
Comparative economic evaluation.
Database from the Dutch insurance company Agis.
1 521 773 patients (98.8%) from a CON practice and 18 862 patients (1.2%) from a CAM practice.
Annual information on five types of healthcare costs for the years 2006–2011: care by GP, hospital care, pharmaceutical care, paramedic care and care covered by supplementary insurance. Healthcare costs in the last year of life. Mortality rates.
The mean annual compulsory and supplementary healthcare costs of CON patients are respectively 1821 (95% CI 1813 to 1828) and 75.3 (95% CI 75.1 to 75.5). Compulsory healthcare costs of CAM patients are 225 (95% CI 169 to 281; p<0.001; 12.4%) lower and result mainly from lower hospital care costs (165; 95% CI 118 to 212; p<0.001) and lower pharmaceutical care costs (58; 95% CI 41 to 75; p<0.001), especially in the age categories 25–49 and 50–74 years. The costs in the last year of life of patients with CAM, GPs are 1161 (95% CI –138 to 2461; p<0.1) lower. This difference is entirely due to lower hospital costs (1250; 95% CI 19 to 2481; p<0.05). The mean annual supplementary costs of CAM patients are 33 (95% CI 30 to 37; p<0.001; 44%) higher. CAM patients do not have lower or higher mortality rates than CON patients.
Dutch patients whose GP additionally completed training in CAM on average have 192 (10.1%) lower annual total compulsory and supplementary healthcare costs and do not live longer or shorter than CON patients.
Developmental disorders, including intellectual disability and autism spectrum disorders, may limit an individual's capacity to conduct daily activities. The emotional and economic burden on families caring for an individual with a developmental disorder is substantial, and quality of life may be limited by a lack of services. Therefore, finding effective treatments to help this population should be a priority. Recent work has shown parent skills training interventions improve developmental, behavioural and family outcomes. The purpose of this review protocol is to extend previous findings by systematically analysing randomised controlled trials of parent skills training programmes for parents of children with developmental disorders including intellectual disabilities and autism spectrum disorders and use meta-analytic techniques to identify programme components reliably associated with successful outcomes of parent skills training programmes.
We will include all studies conducted using randomised control trials designs that compare a group of parents receiving a parent skills training programme to a group of parents in a no-treatment control, waitlist control or treatment as usual comparison group. To locate studies, we will conduct an extensive electronic database search and then use snowball methods, with no limits to publication year or language. We will present a narrative synthesis including visual displays of study effects on child and parental outcomes and conduct a quantitative synthesis of the effects of parent skills training programmes using meta-analytic techniques.
No ethical issues are foreseen and ethical approval is not required given this is a protocol for a systematic review. The findings of this study will be disseminated through peer-reviewed publications and international conference presentations. Updates of the review will be conducted, as necessary, to inform and guide practice.
To assess prevalence, determinants and impact of unawareness about the health consequences of tobacco use among school personnel in Africa.
Cross-sectional surveys.
Twenty-nine African countries.
Representative samples of school personnel from 29 African countries (n=17 929), using data from the 2006–2011 Global School Personnel Surveys.
We assessed if school personnel were aware of the following five facts about tobacco use: (1) tobacco use is addictive; (2) secondhand smoke exposure is harmful; (3) smoking causes lung cancer; (4) smoking causes heart disease and (5) smoking does not cause malaria. Using multivariate logistic regression, we measured the impact of unawareness of the health consequences of tobacco use on behaviour and attitudes towards tobacco control.
A median of 62.6% of school personnel were unaware of at least one health consequence of tobacco use. School personnel in countries with mandatory cigarette health warning labels had lower odds of being unaware of any health consequence of tobacco use than countries where health warning labels were not mandatory (adjusted OR [aOR]=0.51; 95% CI 0.37 to 0.71). A significant dose–response relationship was seen between being ignorant of 1; 2; or ≥3 tobacco use health consequences respectively (compared with not being ignorant of any), and the odds of the following outcomes: non-support of bans on tobacco industry sponsorship of school or extracurricular activities (aOR=1.47; 1.91; and 2.98); non-support of bans on all tobacco advertisements (aOR=1.24; 1.78; and 2.68) and non-support of policies prohibiting tobacco use by school personnel on campus (aOR=1.79; 4.45; and 4.56).
Unawareness of the health consequences of tobacco use was associated with poor support for tobacco control policies. Intensified efforts are needed in African countries to warn about the dangers of tobacco use.
This study seeks to analyse the prevalence and correlates of electronic cigarette (e-cigarette) use, purchase location and satisfaction with its use in a sample of the general population of the city of Barcelona, Spain.
We used participants from a longitudinal study of a representative sample of the adult (≥16 years old) population of Barcelona (336 men and 400 women). The field work was conducted between May 2013 and February 2014. We computed the prevalence, adjusted odds ratios (ORs) and their corresponding 95% confidence interval (CI).
The prevalence of ever e-cigarette use was 6.5% (95% CI 4.7% to 8.3%): 1.6% current use, 2.2% past use and 2.7% only e-cigarette experimentation. 75% (95% CI 62.8% to 87.3%) of ever e-cigarette users were current cigarette smokers at the moment of the interview. E-cigarette use was more likely among current smokers (OR=54.57; 95% CI 7.33 to 406.38) and highly dependent cigarette smokers (OR=3.96; 95% CI 1.60 to 9.82). 62.5% of the ever users charged their e-cigarettes with nicotine with 70% of them obtaining the liquids with nicotine in a specialised shop. 39.6% of ever e-cigarette users were not satisfied with their use, a similar percentage of not satisfied expressing the smokers (38.9%) and there were no statistically significant differences in the satisfaction between the users of e-cigarettes with and without nicotine.
E-cigarette use is strongly associated with current smoking (dual use) and most users continue to be addicted to nicotine. Six out of 10 e-cigarette users preferred devices that deliver nicotine. The satisfaction with e-cigarette use is very low.
Hsia RY, Akosa Antwi Y, Nath JP. Variation in charges for 10 common blood tests in California hospitals: a cross-sectional analysis. BMJ Open 2014;4:
To assess the evidence for the claim probiotics can correct dysbiosis of the normal microbiota resulting from disease or disruptive events.
Systematic review of published clinical trials of patients receiving a probiotic intervention for the prevention or treatment of various diseases.
Sources searched (1985–2013): PubMed, EMBASE, Cochrane Database of Systematic Reviews, CINAHL, AMED and ISI Web of Science. Three on-line clinical trial registries were searched: Cochrane Central Register of Controlled trials, MetaRegister of Controlled Trials and National Institutes of Health.
Included studies were randomised clinical trials of probiotic interventions having microbiological assays. Studies were evaluated following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines for specific probiotic strains. A standard data extraction form was used to collect the raw data.
The primary outcome is the degree of microbiota correction by specific probiotic strains. Secondary outcome was the association between the degree of dysbiosis correction and clinical efficacy.
The review of the literature found three distinct study designs: model A (restoration) assayed patients enrolled with a healthy, undisturbed microbiota and then assayed postdisruptive event and probiotic therapy; model B (alteration) assayed patients with pre-existing disrupted microbiota and then postprobiotic therapy; model C (no dysbiosis) assayed volunteers with no disruptive event prebiotic and postprobiotic. From a total of 63 trials, 83% of the probiotic products using model A restored the microbiota, 56% using model B improved the microbiota and only 21% using model C had any effect on microbiota. Clinical efficacy was more commonly associated with strains capable of restoration of the normal microbiota.
The ability to assess the degree of dysbiosis improvement is dependent on the enrolled population and the timing of microbiological assays. The functional claim for correcting dysbiosis is poorly supported for most probiotic strains and requires further research.
To detect Mycoplasma genitalium in urine samples of infertile men and men without any signs of infection in order to investigate whether M. genitalium and other genital mycoplasmas (Mycoplasma hominis and Ureaplasma spp) are found more often in urine samples of infertile men than in asymptomatic controls and to determine resistance to macrolides.
The study included first void urine samples taken from 145 infertile men and 49 men with no symptoms of urethritis. M. genitalium, Chlamydia trachomatis and Neisseria gonorrhoeae were detected by commercial PCR. Trichomonas vaginalis was detected by microscopy and culture. M. hominis and Ureaplasma spp were detected by culture. M. genitalium was detected by in-house conventional and real-time PCR.
Two M. genitalium positive samples were found among samples obtained from infertile men. All asymptomatic men were M. genitalium negative. Macrolide resistance was not found in either of the two positive samples.
In comparison with reported data, an unusually low prevalence of M. genitalium was found in infertile men. The reasons for this unexpected result are not known; possibly, local demographic and social characteristics of the population influenced the result. Further studies to investigate M. genitalium in infertile and other groups of patients are needed.
Plasmodium knowlesi has long been present in Malaysia, and is now an emerging cause of zoonotic human malaria. Cases have been confirmed throughout South-East Asia where the ranges of its natural macaque hosts and Anopheles leucosphyrus group vectors overlap. The majority of cases are from Eastern Malaysia, with increasing total public health notifications despite a concurrent reduction in Plasmodium falciparum and P. vivax malaria. The public health implications are concerning given P. knowlesi has the highest risk of severe and fatal disease of all Plasmodium spp in Malaysia. Current patterns of risk and disease vary based on vector type and competence, with individual exposure risks related to forest and forest-edge activities still poorly defined. Clustering of cases has not yet been systematically evaluated despite reports of peri-domestic transmission and known vector competence for human-to-human transmission.
A population-based case–control study will be conducted over a 2-year period at two adjacent districts in north-west Sabah, Malaysia. Confirmed malaria cases presenting to the district hospital sites meeting relevant inclusion criteria will be requested to enrol. Three community controls matched to the same village as the case will be selected randomly. Study procedures will include blood sampling and administration of household and individual questionnaires to evaluate potential exposure risks associated with acquisition of P. knowlesi malaria. Secondary outcomes will include differences in exposure variables between P. knowlesi and other Plasmodium spp, risk of severe P. knowlesi malaria, and evaluation of P. knowlesi case clustering. Primary analysis will be per protocol, with adjusted ORs for exposure risks between cases and controls calculated using conditional multiple logistic regression models.
This study has been approved by the human research ethics committees of Malaysia, the Menzies School of Health Research, Australia, and the London School of Hygiene and Tropical Medicine, UK.
To examine the handling system for patient complaints and to identify existing barriers that are associated with effective management of patient complaints in China.
Key stakeholders of the handling system for patient complaints at the national, Shanghai municipal and hospital levels in China.
35 key informants including policymakers, hospital managers, healthcare providers, users and other stakeholders in Shanghai.
Semistructured interviews were conducted to understand the process of handling patient complaints and factors affecting the process and outcomes of patient complaint management.
The Chinese handling system for patient complaints was established in the past decade. Hospitals shoulder the most responsibility of patient complaint handling. Barriers to effective management of patient complaints included service users' low awareness of the systems in the initial stage of the process; poor capacity and skills of healthcare providers, incompetence and powerlessness of complaint handlers and non-transparent exchange of information during the process of complaint handling; conflicts between relevant actors and regulations and unjustifiable complaints by patients during solution settlements; and weak enforcement of regulations, deficient information for managing patient complaints and unwillingness of the hospitals to effectively handle complaints in the postcomplaint stage.
Barriers to the effective management of patient complaints vary at the different stages of complaint handling and perspectives on these barriers differ between the service users and providers. Information, procedure design, human resources, system arrangement, unified legal system and regulations and factors shaping the social context all play important roles in effective patient complaint management.
Among surgical oncology patients, incisional surgical site infection is associated with substantially increased morbidity, mortality and healthcare costs. Moreover, while adults undergoing pancreaticoduodenectomy with preoperative placement of an intrabiliary stent have a high risk of this type of infection, and wound protectors may significantly reduce its risk, no relevant studies of wound protectors yet exist involving this patient population. This study will evaluate the efficacy of a dual-ring wound protector for prevention of incisional surgical site infection among adults undergoing pancreaticoduodenectomy with preoperatively-placed intrabiliary stents.
This study will be a parallel, dual-arm, randomised controlled trial that will utilise a more explanatory than pragmatic attitude. All adults (≥18 years) undergoing a pancreaticoduodenectomy at the Foothills Medical Centre in Calgary, Alberta, Canada with preoperative placement of an intrabiliary stent will be considered eligible. Exclusion criteria will include patient age <18 years and those receiving long-term glucocorticoids. The trial will employ block randomisation to allocate patients to a commercial dual-ring wound protector (the Alexis Wound Protector) or no wound protector and the current standard of care. The main outcome measure will be the rate of surgical site infection as defined by the Centers for Disease Control and Prevention criteria within 30 days of the index operation date as determined by a research assistant blinded to treatment allocation. Outcomes will be analysed by a statistician blinded to allocation status by calculating risk ratios and 95% CIs and compared using Fisher's exact test.
This will be the first randomised trial to evaluate the efficacy of a dual-ring wound protector for prevention of incisional surgical site infection among patients undergoing pancreaticoduodenectomy. Results of this study are expected to be available in 2016/2017 and will be disseminated using an integrated and end-of-grant knowledge translation strategy.
ClinicalTrials.gov identifier NCT01836237.
Community-acquired pneumonia is associated with a significant long-term mortality after initial recovery. It has been acknowledged that additional research is urgently needed to examine the contributors to this long-term mortality. The objective of the present study was to assess whether diabetes or newly discovered hyperglycaemia during pneumonia affects long-term mortality.
A prospective, observational cohort study.
A single secondary centre in eastern Finland.
153 consecutive hospitalised patients who survived at least 30 days after mild-to-moderate community-acquired pneumonia.
Plasma glucose levels were recorded seven times during the first day on the ward. Several possible confounders were also recorded. The surveillance status and causes of death were recorded after median of 5 years and 11 months.
In multivariate Cox regression analysis, a previous diagnosis of diabetes among the whole population (adjusted HR 2.84 (1.35–5.99)) and new postprandial hyperglycaemia among the non-diabetic population (adjusted HR 2.56 (1.04–6.32)) showed independent associations with late mortality. New fasting hyperglycaemia was not an independent predictor. The mortality rates at the end of follow-up were 54%, 37% and 10% among patients with diabetes, patients without diabetes with new postprandial hyperglycaemia and patients without diabetes without postprandial hyperglycaemia, respectively (p<0.001). The underlying causes of death roughly mirrored those in the Finnish general population with a slight excess in mortality due to chronic respiratory diseases. Pneumonia was the immediate cause of death in just 8% of all late deaths.
A previous diagnosis of diabetes and newly discovered postprandial hyperglycaemia increase the risk of death for several years after community-acquired pneumonia. As the knowledge about patient subgroups with an increased late mortality risk is gradually gathering, more studies are needed to evaluate the possible postpneumonia interventions to reduce late mortality.
A significant proportion of patients with primary Sjögren's syndrome (PSS) is functionally impaired and experience difficulties participating in various aspects of everyday life. There is currently no evidence of efficacy for non-pharmacological interventions aimed specifically at supporting the patients with PSS to improve their participation and ability to perform daily activities. This paper describes a research protocol for a mixed-methods study to develop an intervention to improve these outcomes. The protocol follows the Medical Research Council framework for complex interventions.
We will use group concept mapping with the patients, adults who live with them and healthcare professionals to identify factors which prevent people with PSS from participating in daily life and performing daily activities. The factors will be prioritised by participants for importance and feasibility and will inform an intervention to be delivered within a National Health Service (NHS) setting. Evidence-based intervention techniques will be identified for the prioritised factors and combined into a deliverable intervention package. Key stakeholders will comment on the intervention content and mode of delivery through focus groups, and the data will be used to refine the intervention. The acceptability and feasibility of the refined intervention will be evaluated in a future study.
The study has been approved by an NHS Research Ethics Committee, REC Reference: 13/NI/0190. The findings of this study will be disseminated in peer-reviewed journals and through presentation at national and international conferences.
UKCRN Study ID: 15939.
To confirm the accuracy of a diagnostic questionnaire for carpal tunnel syndrome (CTS) when presented via a public website rather than on paper.
Prospective comparison of the probability of CTS as assessed by the web-based questionnaire at http://www.carpal-tunnel.net with the results of nerve conduction studies.
Subregional neurophysiology laboratory serving a population of 700 000 in East Kent, UK.
2821 individuals who were able to complete an online diagnostic questionnaire out of 4899 referred for initial diagnostic testing for new presentations with suspected CTS from April 2011 to March 2013. No exclusions were made on grounds of age, gender or coincident pathology.
Main outcome measure—nerve conduction results confirming CTS. The severity of median nerve impairment demonstrated was also assessed using a validated neurophysiological scale.
The web-based questionnaire accurately estimates the probability of CTS being confirmed on nerve conduction studies. Using a website diagnostic score of ≥40% as an example cut-off value the questionnaire achieves 78% sensitivity and 68% specificity in predicting the finding of evidence of CTS on nerve conduction studies. The web-based version of the diagnostic questionnaire was as accurate as the original paper version with an area under the receiver operating characteristic curve of 0.79. There was also a significant correlation between the diagnostic score given by the website and the severity of CTS with higher scores being associated with greater nerve dysfunction (r=0.3, p<0.00001).
Completion of the symptom questionnaire on the website by patients at home provides a prediction of the likelihood of CTS which is sufficiently accurate to be used in initial planning of investigation and treatment.
To evaluate the effects of Quality and Outcomes Framework (QOF) incentivised case finding for depression on diagnosis and treatment in targeted and non-targeted long-term conditions.
Interrupted time series analysis.
General practices in Leeds, UK.
65 (58%) of 112 general practices shared data on 37 229 patients with diabetes and coronary heart disease targeted by case finding incentives, and 101 008 patients with four other long-term conditions not targeted (hypertension, epilepsy, chronic obstructive pulmonary disease and asthma).
Incentivised case finding for depression using two standard screening questions.
Clinical codes indicating new depression-related diagnoses and new prescriptions of antidepressants. We extracted routinely recorded data from February 2002 through April 2012. The number of new diagnoses and prescriptions for those on registers was modelled with a binomial regression, which provided the strength of associations between time periods and their rates.
New diagnoses of depression increased from 21 to 94/100 000 per month in targeted patients between the periods 2002–2004 and 2007–2011 (OR 2.09; 1.92 to 2.27). The rate increased from 27 to 77/100 000 per month in non-targeted patients (OR 1.53; 1.46 to 1.62). The slopes in prescribing for both groups flattened to zero immediately after QOF was introduced but before incentivised case finding (p<0.01 for both). Antidepressant prescribing in targeted patients returned to the pre-QOF secular upward trend (Wald test for equivalence of slope, z=0.73, p=0.47); the slope was less steep for non-targeted patients (z=–4.14, p<0.01).
Incentivised case finding increased new depression-related diagnoses. The establishment of QOF disrupted rising trends in new prescriptions of antidepressants, which resumed following the introduction of incentivised case finding. Prescribing trends are of concern given that they may include people with mild-to-moderate depression unlikely to respond to such treatment.
To investigate what impact individuals' position in a labour market core–periphery structure may have on their risk of disability pension (DP) in general and specifically on their risk of DP based on mental or musculoskeletal diagnoses.
The study comprised 45 567 individuals who had been interviewed for the annual Swedish Surveys of Living Conditions (1992–2007). The medical DP diagnoses were obtained from the Swedish Social Insurance Agency (1993–2011). The assumed predictors were studied in relation to DP by Cox's proportional hazards regression. The analyses were stratified on sex and age, controlling for social background and self-reported long-standing illness at baseline.
All three indicators underlying the categorisation of the core–periphery structure: employment income, work hours and unemployment, increased the risk of DP in all strata. The risk of DP tended to increase gradually the more peripheral the labour market position was. The risk estimates for DP in general and for DP based on mental diagnoses were particularly high among men aged 20–39 years.
The core–periphery position of individuals, representing their labour market attachment, was found to be a predictor of future DP. The association was most evident among individuals below 40 years of age with regard to DP based on mental diagnoses. This highlights the need for preventative measures that increase the participation of young people in working life.
Examining the associations between health and lifestyle factors recorded in the participants' early teens and development of suicidal thoughts recorded 4 years later.
Population-based prospective cohort study.
All students in the two relevant year classes in Nord-Trøndelag County were invited, 80% attended both waves of data collection.
2399 secondary school students who participated in the Young-HUNT1 study in 1995–1997 (13–15 years old) were included in a follow-up study 4 years later (17–19 years old).
Suicidal thoughts reported at age 17–19 years.
408 (17%, 95% CI 15.5% to 18.5%) of the adolescents reported suicidal thoughts at follow-up, 158 (14.2%, CI 13.6% to 16.4%) boys and 250 (19.5%, CI 18.8% to 22.0%) girls. Baseline anxiety and depressive symptoms (adjusted OR (aOR) 1.9, CI 1.4 to 2.6), conduct problems (aOR 1.8, CI 1.3 to 2.6), overweight (aOR 1.9 CI 1.4 to 2.4), and muscular pain and tension (aOR 1.8, CI 1.4 to 2.4), were all associated with reporting suicidal thoughts at follow-up.
One in six young adults experienced suicidal thoughts, girls predominating. Suicidal thoughts were most strongly associated with symptoms of anxiety/depression, conduct problems, pain/tension and overweight reported when participants were 13–15 years old. Specific preventive efforts in these groups might be indicated. Future research should investigate whether similar associations are seen with suicide/suicidal attempts as endpoints.
The aim of this protocol is to provide the methods used to assess the effectiveness and safety of acupuncture for the treatment of patients with Alzheimer's disease.
We will search the following electronic databases: The Cochrane Library, PubMed, Medline, Embase, PsycINFO, Chinese Biomedical Literature Database, Chinese Medical Current Contents and China National Knowledge Infrastructure without restriction of language and publication status. Other sources such as Chinese acupuncture journals and the reference list of selected studies will also be searched. After screening the studies, a meta-analysis of randomised controlled trials will be conducted, if possible. Results expressed as risk ratios for dichotomous data and standardised or weighted mean differences for continuous data, will be used for data synthesis.
The protocol of this systematic review will be disseminated in a peer-reviewed journal and presented at a relevant conference.
To assess the benefits and harms of targeting intensive versus conventional glycaemic control in patients with type 1 diabetes mellitus.
A systematic review with meta-analyses and trial sequential analyses of randomised clinical trials.
The Cochrane Library, MEDLINE, EMBASE, Science Citation Index Expanded and LILACS to January 2013.
Randomised clinical trials that prespecified different targets of glycaemic control in participants at any age with type 1 diabetes mellitus were included.
Two authors independently assessed studies for inclusion and extracted data.
18 randomised clinical trials included 2254 participants with type 1 diabetes mellitus. All trials had high risk of bias. There was no statistically significant effect of targeting intensive glycaemic control on all-cause mortality (risk ratio 1.16, 95% CI 0.65 to 2.08) or cardiovascular mortality (0.49, 0.19 to 1.24). Targeting intensive glycaemic control reduced the relative risks for the composite macrovascular outcome (0.63, 0.41 to 0.96; p=0.03), and nephropathy (0.37, 0.27 to 0.50; p<0.00001. The effect estimates of retinopathy, ketoacidosis and retinal photocoagulation were not consistently statistically significant between random and fixed effects models. The risk of severe hypoglycaemia was significantly increased with intensive glycaemic targets (1.40, 1.01 to 1.94). Trial sequential analyses showed that the amount of data needed to demonstrate a relative risk reduction of 10% were, in general, inadequate.
There was no significant effect towards improved all-cause mortality when targeting intensive glycaemic control compared with conventional glycaemic control. However, there may be beneficial effects of targeting intensive glycaemic control on the composite macrovascular outcome and on nephropathy, and detrimental effects on severe hypoglycaemia. Notably, the data for retinopathy and ketoacidosis were inconsistent. There was a severe lack of reporting on patient relevant outcomes, and all trials had poor bias control.
To compare the benefits and harms of third-wave cognitive therapy versus mentalisation-based therapy in a small sample of depressed participants.
The trial was conducted at an outpatient psychiatric clinic for non-psychotic patients in Roskilde, Denmark.
44 consecutive adult participants diagnosed with major depressive disorder.
18 weeks of third-wave cognitive therapy (n=22) versus 18 weeks of mentalisation-based treatment (n=22).
The primary outcome was the Hamilton Rating Scale for Depression (HDRS) at end of treatment (18 weeks). Secondary outcomes were: remission (HDRS <8), Beck's Depression Inventory, Symptom Checklist 90 Revised and The WHO-Five Well-being Index 1999.
The trial inclusion lasted for about 2 years as planned but only 44 out of the planned 84 participants were randomised. Two mentalisation-based participants were lost to follow-up. The unadjusted analysis showed that third-wave participants compared with mentalisation-based participants did not differ significantly regarding the 18 weeks HDRS score (12.9 vs 17.0; mean difference –4.14; 95% CI –8.30 to 0.03; p=0.051). In the analysis adjusted for baseline HDRS score, the difference was favouring third-wave cognitive therapy (p=0.039). At 18 weeks, five of the third-wave participants (22.7%) were in remission versus none of the mentalisation-based participants (p=0.049). We recorded no suicide attempts or suicides during the intervention period in any of the 44 participants. No significant differences were found between the two intervention groups on the remaining secondary outcomes.
Third-wave cognitive therapy may be more effective than mentalisation-based therapy for depressive symptoms measured on the HDRS. However, more randomised clinical trials are needed to assess the effects of third-wave cognitive therapy and mentalisation-based treatment for depression.
Registered with Clinical Trials government identifier: NCT01070134.
Suicide is a major global health problem imposing a considerable burden on populations in terms of disability-adjusted life years. There has been an increasing trend in fatal and attempted suicide in Iran over the past few decades. The aim of the current study was to assess overall, gender and social inequalities across Iran's provinces during 2006–2010.
Ecological study.
The data on distribution of population at the provinces were obtained from the Statistical Centre of Iran. The data on the annual number of deaths caused by suicide in each province were gathered from the Iranian Forensic Medicine Organization.
Suicide mortality rate per 100 000 population was calculated. Human Development Index was used as the provinces' social rank. Gini coefficient, rate ratio and Kunst and Mackenbach relative index of inequality were used to assess overall, gender and social inequalities, respectively. Annual percentage change was calculated using Joinpoint regression.
Suicide mortality has slightly increased in Iran during 2006–2010. There was a substantial and constant overall inequality across the country over the study period. Male-to-female rate ratio was 2.34 (95% CI 1.45 to 3.79) over the same period. There were social inequalities in suicide mortality in favour of people in better-off provinces. In addition, there was an increasing trend in these social disparities over time, although it was not statistically significant.
We found substantial overall, gender and social disparities in the distribution of suicide mortality across the provinces in Iran. The findings showed that men in the provinces with low socioeconomic status are at higher risk of suicide mortality. Further analyses are needed to explain these disparities.
Empirical studies of the association between neighbourhood food environments and individual obesity risk have found mixed results. One possible cause of these mixed findings is the variation in neighbourhood geographic scale used. The purpose of this paper was to examine how various neighbourhood geographic scales affected the estimated relationship between food environments and obesity risk.
Cross-sectional secondary data analysis.
Salt Lake County, Utah, USA.
403 305 Salt Lake County adults 25–64 in the Utah driver license database between 1995 and 2008.
Utah driver license data were geo-linked to 2000 US Census data and Dun & Bradstreet business data. Food outlets were classified into the categories of large grocery stores, convenience stores, limited-service restaurants and full-service restaurants, and measured at four neighbourhood geographic scales: Census block group, Census tract, ZIP code and a 1 km buffer around the resident's house. These measures were regressed on individual obesity status using multilevel random intercept regressions.
Food environment was important for obesity but the scale of the relevant neighbourhood differs for different type of outlets: large grocery stores were not significant at all four geographic scales, limited-service restaurants at the medium-to-large scale (Census tract or larger) and convenience stores and full-service restaurants at the smallest scale (Census tract or smaller).
The choice of neighbourhood geographic scale can affect the estimated significance of the association between neighbourhood food environments and individual obesity risk. However, variations in geographic scale alone do not explain the mixed findings in the literature. If researchers are constrained to use one geographic scale with multiple categories of food outlets, using Census tract or 1 km buffer as the neighbourhood geographic unit is likely to allow researchers to detect most significant relationships.
Demographic and presentation profile of patients using an innovative mobile outreach clinic compared with mainstream practice.
Retrospective cohort study.
Primary care mobile street health clinic and mainstream practice in Western Australia.
2587 street health and 4583 mainstream patients.
Prevalence and patterns of chronic diseases in anatomical domains across the entire age spectrum of patients and disease severity burden using Cumulative Illness Rating Scale (CIRS).
Multimorbidity (2+ CIRS domains) prevalence was significantly higher in the street health cohort (46.3%, 1199/2587) than age–sex-adjusted mainstream estimate (43.1%, 2000/4583), p=0.011. Multimorbidity prevalence was significantly higher in street health patients <45 years (37.7%, 615/1649) compared with age–sex-adjusted mainstream patients (33%, 977/2961), p=0.003 but significantly lower if 65+ years (62%, 114/184 vs 90.7%, 322/355, p<0.001). Controlling for age and gender, the mean CIRS Severity Index score for street health (M=1.4, SD=0.91) was significantly higher than for mainstream patients (M=1.1, SD=0.80), p<0.001. Furthermore, 44.2% (530/1199) of street health patients had at least one level 3 or 4 score across domains compared with 18.3% (420/2294) for mainstream patients, p<0.001. Street health population comprised 29.6% (766/2587) Aboriginal patients with 50.4% (386/766) having multimorbidity compared with 44.6% (813/1821) for non-Aboriginals, p=0.007. There were no comprehensive data on Indigenous status in the mainstream cohort available for comparison. Musculoskeletal, respiratory and psychiatric domains were most commonly affected with multimorbidity significantly associated with male gender, increasing age and Indigenous status.
Age–sex-adjusted multimorbidity prevalence and disease severity is higher in the street health cohort. Earlier onset (23–34 years) multimorbidity is found in the street health cohort but prevalence is lower in 65+ years than in mainstream patients. Multimorbidity prevalence is higher for Aboriginal patients of all ages.
We aimed to quantify the short-term effect of non-steroidal anti-inflammatory drugs (NSAIDs), aspirin and paracetamol analgesia dose prescribing on estimated glomerular filtration rate (eGFR) decline in the general practice population.
A population-based longitudinal clinical data linkage cohort study.
Two large general practices in North Staffordshire, UK.
Patients aged 40 years and over with ≥2 eGFR measurements spaced ≥90 days apart between 1 January 2009 and 31 December 2010 were selected.
Using WHO Defined Daily Dose standardised cumulative analgesia prescribing, patients were categorised into non-user, normal and high-dose groups.
The primary outcome was defined as a >5 mL/min/1.73 m2/year eGFR decrease between the first and last eGFR. Logistic regression analyses were used to estimate risk, adjusting for sociodemographics, comorbidity, baseline chronic kidney disease (CKD) status, renin-angiotensin-system inhibitors and other analgesia prescribing.
There were 4145 patients (mean age 66 years, 55% female) with an analgesia prescribing prevalence of 17.2% for NSAIDs, 39% for aspirin and 22% for paracetamol and stage 3–5 CKD prevalence was 16.1% (n=667). Normal or high-dose NSAID and paracetamol prescribing was not significantly associated with eGFR decline. High-dose aspirin prescribing was associated with a reduced risk of eGFR decline in patients with a baseline (first) eGFR ≥60 mL/min/1.73 m2; OR=0.52 (95% CI 0.35 to 0.77).
NSAID, aspirin and paracetamol prescribing over 2 years did not significantly affect eGFR decline with a reduced risk of eGFR decline in high-dose aspirin users with well-preserved renal function. However, the long-term effects of analgesia use on eGFR decline remain to be determined.
A passport-sized booklet, designed by patients for patients to record details about their medicines, has been developed as part of a wider project focusing on improving prescribing in the elderly ('ImPE'). We undertook an evaluation of 'My Medication Passport' to gain an understanding of its value to patients and how it may be used in communications about medicines.
The Passport was launched in secondary care with the initial users being older people discharged home after an admission to one of the four North West London participating Trusts. The uptake subsequently spread to other (community) locations and other age groups.
We recruited more than 200 patients from a cohort who had been given a passport as part of the improvement projects at one of four sites. Of them, 63% (133) completed the structured telephone questionnaire including 27% for whom English was not their first language. Approximately half of the respondents were male and 40% were over 70 years of age.
More than half of the respondents had found their medication passport useful or helpful in some way; 42% through sharing details from it with others (most frequently family, carer or doctor) or using it as a platform for conversations with healthcare professionals. One-third of those questioned carried the passport with them at all times.
My Medication Passport has been positively evaluated; we have a better understanding of how it is used by patients, what they are recording and how it can be an aid to dialogue about medicines with family, carers and healthcare professionals. Further development and spread is underway including an App for smartphones that will be subject to wider evaluation to include feedback from clinicians.
To examine the relationship between socioeconomic status (SES) and type 2 diabetes using the Korea National Health and Nutrition Examination Survey (KNHANES) 2010–2012.
A pooled sample cross-sectional study.
A nationally representative population survey data.
A total of 14 330 individuals who participated in the KNHANES 2010–2012 were included in our analysis.
Prevalence of type 2 diabetes.
The relationship between SES and type 2 diabetes was assessed using logistic regression after adjusting for covariates including age, gender, marital status, region, body mass index, physical activity, smoking and high-risk drinking behaviour. After adjustment for covariates, our results indicated that individuals with the lowest income were more likely to have type 2 diabetes than those with the highest income (OR 1.35; 95% CI 1.08 to 1.72). In addition, lower educational attainment was an independent factor for a higher prevalence of type 2 diabetes in Korea.
These findings suggest the need for developing a health policy to ameliorate socioeconomic inequalities, in particular income and education-related disparities in type 2 diabetes, along with risk factors at the individual level. In addition, future investigations of type 2 diabetes among Koreans should pay more attention to the social determinants of diabetes in order to understand the various causes of the condition.
To explore stakeholders' perceptions of decision aids designed to support the informed consent decision-making process for randomised controlled trials.
Qualitative semistructured interviews. Participants were provided with prototype trial decision aids in advance to stimulate discussion. Interviews were analysed using an established interpretive approach.
23 stakeholders: Trial Managers (n=5); Research Nurses (n=5); Ethics Committee Chairs (n=5); patients (n=4) and Clinical Principal Investigators (n=4).
Embedded within two ongoing randomised controlled trials. All interviews conducted with UK-based participants.
Certain key aspects (eg, values clarification exercises, presentation of probabilities, experiences of others and balance of options) in the prototype decision aids were perceived by all stakeholders as having a significant advantage (over existing patient information leaflets) in terms of supporting well informed appropriate decisions. However, there were some important differences between the stakeholder groups on specific content (eg, language used in the section on positive and negative features of taking part in a trial and the overall length of the trial decision aids). Generally the stakeholders believed trial decision aids have the potential to better engage potential participants in the decision-making process and allow them to make more personally relevant decisions about their participation.
Compared to existing patient information leaflets, stakeholders perceived decision aids for trial participation to have the potential to promote a more 'informed' decision-making process. Further efforts to develop, refine and formally evaluate trial decision aids should be explored.
To assess the prevalence and risk factors of gestational diabetes mellitus (GDM) in a population known to have a high prevalence of abnormal glucose metabolism.
A household random population-based cross-sectional study of 13 627 women in the childbearing age, who were subjected to fasting plasma glucose if they were not known to have been diagnosed before with any type of diabetes. GDM cases were diagnosed using the International Association of Diabetes and Pregnancy Study Group (IAPSG) criteria.
The overall GDM prevalence was 36.6%, categorised into 32.4% new cases and 4.2% known cases. Another 3.6% had preconception type 1 or 2 diabetes. GDM cases were older and had a significantly higher body mass index, in addition to a higher rate of macrocosmic baby and history of GDM. Monthly income, educational level, living in urban areas and smoking were not found to be significantly different between normal and GDM cases. The most important and significant risk factors for GDM were history of GDM, macrosomic baby, obesity and age >30 years. However, hypertension, low high-density lipoprotein, family history of diabetes and increased triglycerides did not show any significant effect on GDM prevalence in this cohort.
This society is facing a real burden of abnormal glucose metabolism during pregnancy, where almost half of the pregnant women are subjected to maternal and neonatal complications. Early screening of pregnant women, especially those at a high risk for GDM, is mandatory to identify and manage those cases.
Malaria due to Plasmodium knowlesi is reported throughout South-East Asia, and is the commonest cause of it in Malaysia. P. knowlesi replicates every 24 h and can cause severe disease and death. Current 2010 WHO Malaria Treatment Guidelines have no recommendations for the optimal treatment of non-severe knowlesi malaria. Artemisinin-combination therapies (ACT) and chloroquine have each been successfully used to treat knowlesi malaria; however, the rapidity of parasite clearance has not been prospectively compared. Malaysia's national policy for malaria pre-elimination involves mandatory hospital admission for confirmed malaria cases with discharge only after two negative blood films; use of a more rapidly acting antimalarial agent would have health cost benefits. P. knowlesi is commonly microscopically misreported as P. malariae, P. falciparum or P. vivax, with a high proportion of the latter two species being chloroquine-resistant in Malaysia. A unified ACT-treatment protocol would provide effective blood stage malaria treatment for all Plasmodium species.
ACT KNOW, the first randomised controlled trial ever performed in knowlesi malaria, is a two-arm open-label trial with enrolments over a 2-year period at three district sites in Sabah, powered to show a difference in proportion of patients negative for malaria by microscopy at 24 h between treatment arms (clinicaltrials.gov #NCT01708876). Enrolments started in December 2012, with completion expected by September 2014. A total sample size of 228 is required to give 90% power (α 0.05) to determine the primary end point using intention-to-treat analysis. Secondary end points include parasite clearance time, rates of recurrent infection/treatment failure to day 42, gametocyte carriage throughout follow-up and rates of anaemia at day 28, as determined by survival analysis.
This study has been approved by relevant institutional ethics committees in Malaysia and Australia. Results will be disseminated to inform knowlesi malaria treatment policy in this region through peer-reviewed publications and academic presentations.
To propose a feasible suggestion to reduce the high prevalence of anaemia in middle-aged and elderly women by investigating risk factors, particularly nutritional factors, and analysing the effect on anaemia in three different rural areas of China.
A case–control study.
Three counties of China.
Women aged 50–75 years in the three counties.
Adjusted OR (95% CI) of anaemia associated with diet, lifestyle and blood biochemical indices.
Compared with controls, women with anaemia had lower body mass index (22.1 (3.2) kg/m2 vs 23.2 (3.5) kg/m2; p<0.001), a higher experience of shortage of food (45.0% vs 36.5%; p<0.001), less soy food intake (0.5 (0.3, 26.7) g/day vs 5.6 (0.4, 27.8) g/day; p<0.048), lower serum iron (13.4 (5.4) μmol/L vs 16.4 (5.7) μmol/L; p<0.001), lower ferritin (109.6 (85.6) ng/mL vs 131.0 (92.0) ng/mL; p<0.001), lower transferrin saturation levels (22.5 (9.5)% vs 26.8 (9.6)%; p<0.001) and higher levels of free erythrocyte protoporphyrin (42.4 (21.2) μg/dL vs 39.6 (17.8) μg/dL; p<0.001). Anaemia was significantly associated with BMI(OR=0.90, 95% CI (0.87 to 0.92)), food shortage experience (OR=1.39, 95% CI (1.15 to 1.69)), total protein (OR=0.66, 95%CI (0.54 to 0.80)), Albumin (OR=0.72, 95%CI (0.59 to 0.87)) in univariate analysis. Multivariate analysis showed that body mass index, experience of food shortage, total protein and albumin were independently related to anaemia.
Among middle-aged and elderly women in rural China, the nutrition status of anaemic cases is far below that of controls. Lower body mass index and a greater experience of food shortage are closely related to anaemia. Improving the blood protein status by consuming protein-sufficient foods such as soy food is a feasible approach for elderly anaemic women. Further research is needed on the effect of chronic inflammation and infectious disease on anaemia in elderly women in rural China.
To examine the process of case finding for depression in people with diabetes and coronary heart disease within the context of a pay-for-performance scheme.
Ethnographic study drawing on observations of practice routines and consultations, debriefing interviews with staff and patients and review of patient records.
General practices in Leeds, UK.
12 purposively sampled practices with a total of 119 staff; 63 consultation observations and 57 patient interviews.
Audio recorded consultations and interviews with patients and healthcare professionals along with observation field notes were thematically analysed. We assessed outcomes of case finding from patient records.
Case finding exacerbated the discordance between patient and professional agendas, the latter already dominated by the tightly structured and time-limited nature of chronic illness reviews. Professional beliefs and abilities affected how case finding was undertaken; there was uncertainty about how to ask the questions, particularly among nursing staff. Professionals were often wary of opening an emotional 'can of worms'. Subsequently, patient responses potentially suggesting emotional problems could be prematurely shut down by professionals. Patients did not understand why they were asked questions about depression. This sometimes led to defensive or even defiant answers to case finding. Follow-up of patients highlighted inconsistent systems and lines of communication for dealing with positive results on case finding.
Case finding does not fit naturally within consultations; both professional and patient reactions somewhat subverted the process recommended by national guidance. Quality improvement strategies will need to take account of our results in two ways. First, despite their apparent simplicity, the case finding questions are not consultation-friendly and acceptable alternative ways to raise the issue of depression need to be supported. Second, case finding needs to operate within structured pathways which can be accommodated within available systems and resources.
Increasing numbers of older people are living with multiple long-term health conditions but global healthcare systems and clinical guidelines have traditionally focused on the management of single conditions. Having two or more long-term conditions, or 'multimorbidity', is associated with a range of adverse consequences and poor outcomes and could put patients at increased risk of safety failures. Traditionally, most research into patient safety failures has explored hospital or inpatient settings. Much less is known about patient safety failures in primary care. Our core aims are to understand the mechanisms by which multimorbidity leads to safety failures, to explore the different ways in which patients and services respond (or fail to respond), and to identify opportunities for intervention.
We plan to undertake an applied ethnographic study of patients with multimorbidity. Patients' interactions and environments, relevant to their healthcare, will be studied through observations, diary methods and semistructured interviews. A framework, based on previous studies, will be used to organise the collection and analysis of field notes, observations and other qualitative data. This framework includes the domains: access breakdowns, communication breakdowns, continuity of care errors, relationship breakdowns and technical errors.
Ethical approval was received from the National Health Service Research Ethics Committee for Wales. An individual case study approach is likely to be most fruitful for exploring the mechanisms by which multimorbidity leads to safety failures. A longitudinal and multiperspective approach will allow for the constant comparison of patient, carer and healthcare worker expectations and experiences related to the provision, integration and management of complex care. This data will be used to explore ways of engaging patients and carers more in their own care using shared decision-making, patient empowerment or other relevant models.
The International Consensus Diagnostic Criteria (ICDC) designed to diagnosis autoimmune pancreatitis (AIP) has been proposed recently. The diagnostic performance of ICDC has not been previously evaluated in diffuse-type and focal-type AIP, respectively, in comparison with the revised HISORt and Asian criteria in Taiwan.
Prospective, consecutive patient cohort.
Largest tertiary referred centre hospital managing pancreatic disease in Taiwan.
188 patients with AIP and 130 with tissue proofed pancreatic adenocarcinoma were consecutively recruited.
The ICDC, as well as revised HISORt and Asian criteria, was applied for each participant. Each diagnostic criterion of ICDC was validated with special reference to levels 1 and 2 in diffuse-type and focal-type AIP.
Sensitivity, specificity and accuracy. Each diagnostic criterion of ICDC was validated with special reference to levels 1 and 2 in AIP and focal-type AIP.
The sensitivity, specificity and accuracy of ICDC for all AIP were the best: 89.4%, 100% and 93.7%, respectively, in these three criteria. The sensitivity, specificity and accuracy of ICDC for focal-type AIP (84.9%, 100% and 93.8%) were also the best among these three criteria. The area under the curve of receiver-operator characteristic of ICDC was 0.95 (95% CI 0.92 to 0.97) in all AIP and 0.93 (95% CI 0.88 to 0.97) in focal-type AIP.
The sensitivity, specificity and accuracy of ICDC are higher than the revised HISORt and Asian criteria. The sensitivity, specificity and accuracy of each criterion are higher in diffuse-type AIP compared with focal-type AIP. Under the same specificity, the sensitivity and accuracy of ICDC are higher than other diagnostic criteria in focal-type AIP. ICDC has better diagnostic performance compared with previously proposed diagnostic criteria in diffuse-type and focal-type AIP.
There is limited evidence to guide the preparation of patients for radiotherapy. This paper describes the protocol for an evaluation of a radiation therapist led education intervention delivered to patients with breast cancer in order to reduce psychological distress.
A multiple-baseline study is being used. Usual care data is being collected prior to the start of the intervention at each of three sites. The intervention is delivered by radiation therapists consulting with patients prior to their treatment planning and on the first day of treatment. The intervention focuses on providing sensory and procedural information to patients and reducing pretreatment anxiety. Recruitment is occurring in three states in Australia. Eligible participants are patients who have been referred for radiotherapy to treat breast cancer. 200 patients will be recruited during a usual care phase and, thereafter, 200 patients in the intervention phase. Measures will be collected on four occasions—after meeting with their radiation oncologist, prior to treatment planning, on the first day of treatment and after treatment completion. The primary hypothesis is that patients who receive the radiotherapy preparatory intervention will report a significantly greater decrease in psychological distress from baseline to prior to radiotherapy treatment planning in comparison with the usual care group. Secondary outcome measures include concerns about radiotherapy, patient knowledge of radiotherapy, patient preparedness and quality of life. Patient health system usage and costs will also be measured. Multilevel mixed effects regression models will be applied to test for intervention effects.
Ethics approval has been gained from Curtin University and the three recruiting sites.
Results will be reported in international peer reviewed journals.
Australian and New Zealand Clinical Trials Registration: ACTRN12611001000998.
The impact of the national salt reduction programme in the UK on social inequalities is unknown. We examined spatial and socioeconomic variations in salt intake in the 2008–2011 British National Diet and Nutrition Survey (NDNS) and compared them with those before the programme in 2000–2001.
Cross-sectional survey in Great Britain.
1027 Caucasian males and females, aged 19–64 years.
Participants' dietary sodium intake measured with a 4-day food diary. Bayesian geo-additive models used to assess spatial and socioeconomic patterns of sodium intake accounting for sociodemographic, anthropometric and behavioural confounders.
Dietary sodium intake varied significantly across socioeconomic groups, even when adjusting for geographical variations. There was higher dietary sodium intake in people with the lowest educational attainment (coefficient: 0.252 (90% credible intervals 0.003, 0.486)) and in low levels of occupation (coefficient: 0.109 (–0.069, 0.288)). Those with no qualification had, on average, a 5.7% (0.1%, 11.1%) higher dietary sodium intake than the reference group. Compared to 2000-2001 the gradient of dietary sodium intake from south to north was attenuated after adjustments for confounders. Estimated dietary sodium consumption from food sources (not accounting for discretionary sources) was reduced by 366 mg of sodium (~0.9 g of salt) per day during the 10-year period, likely the effect of national salt reduction initiatives.
Social inequalities in salt intake have not seen a reduction following the national salt reduction programme and still explain more than 5% of salt intake between more and less affluent groups. Understanding the socioeconomic pattern of salt intake is crucial to reduce inequalities. Efforts are needed to minimise the gap between socioeconomic groups for an equitable delivery of cardiovascular prevention.
To test for early evidence whether, following the standardisation of tobacco packaging, smokers in Australia were—as predicted by the tobacco industry—less likely to purchase from small mixed business retailers, more likely to purchase cheap brands imported from Asia and more likely to use illicit tobacco.
Serial cross-sectional population telephone surveys in November 2011 (a year prior to implementation), 2012 (during roll-out) and 2013 (a year after implementation).
Smokers aged 18 years and over identified in an annual population survey in the Australian state of Victoria (2011: n=754; 2012: n=590; 2013: n=601).
Changes between 2011 and 2013 in: proportions of current smokers who purchased their last cigarette from discount outlets such as supermarkets compared with small mixed business retail outlets; prevalence of regular use of low-cost brands imported from Asia and use of unbranded tobacco.
The proportion of smokers purchasing from supermarkets did not increase between 2011 (65.4%) and 2013 (65.7%; p=0.98), and the percentage purchasing from small mixed business outlets did not decline (2011: 9.2%; 2012: 11.2%; p=0.32). The prevalence of low-cost Asian brands was low and did not increase between 2011 (1.1%) and 2013 (0.9%; p=0.98). The proportion reporting current use of unbranded illicit tobacco was 2.3% in 2011 and 1.9% in 2013 (p=0.46). In 2013, 2.6% of cigarette smokers reported having purchased one or more packets of cigarettes in non-compliant packaging in the past 3 months; 1.7% had purchased one or more packets from an informal seller in the past year.
One year after implementation, this study found no evidence of the major unintended consequences concerning loss of smoker patrons from small retail outlets, flooding of the market by cheap Asian brands and use of illicit tobacco predicted by opponents of plain packaging in Australia.
To determine the variation in charges for 10 common blood tests across California hospitals in 2011, and to analyse the hospital and market-level factors that may explain any observed variation.
We conducted a cross-sectional analysis of the degree of charge variation between hospitals for 10 common blood tests using charge data reported by all non-federal California hospitals to the California Office of Statewide Health Planning and Development in 2011.
Charges for 10 common blood tests at California hospitals during 2011.
We found that charges for blood tests varied significantly between California hospitals. For example, charges for a lipid panel ranged from US$10 to US$10 169, a thousand-fold difference. Although government hospitals and teaching hospitals were found to charge significantly less than their counterparts for many blood tests, few other hospital characteristics and no market-level predictors significantly predicted charges for blood tests. Our models explained, at most, 21% of the variation between hospitals in charges for the blood test in question.
These findings demonstrate the seemingly arbitrary nature of the charge setting process, making it difficult for patients to act as true consumers in this era of 'consumer-directed healthcare.'
The risk of fetal death increases steeply after 42 gestational weeks. Since 2009, Denmark has had a more proactive policy including prevention of prolonged pregnancy, and early intervention in women with diabetes, preeclampsia, high body mass index and of a higher age group. The aim of this study was to describe the development in fetal deaths with this more proactive birth induction practice, and to identify and quantify contributing factors for this development.
National cohort study.
Delivering women in Denmark, 1 January 2000 to 31 December 2012.
Stillbirths per 1000 women at risk (prospective risk of stillbirth) and per 1000 newborn from 37 and 40 gestational weeks, respectively, through the study period.
During the study period, 829 165 children were live born and 3770 (0.45%) stillborn. Induction of labour increased from 12.4% in year 2000 to 25.1% in 2012 (p<0.001), and the percentage of children born at or after 42 weeks decreased from 8.0% to 1.5% (p<0.001). Through the same period, the prospective risk of stillbirth after 37 weeks fell from 0.70 to 0.41/1000 ongoing pregnancies (p<0.001), and from 2.4 to 1.4/1000 newborn (p<0.001). The regression analysis confirmed the inverse association between year of birth and risk of stillbirth. The lowest risk was observed in the years 2011–2012 as compared with years 2000–2002 with a fully adjusted HR of 0.69 (95% CI 0.57 to 0.83). The general earlier induction, the focused earlier induction of women with body mass index >30, twins, and of women above 40 years and a halving of smoking pregnant women were all independent contributing factors for the decrease.
A gradually more proactive and differential earlier labour induction practice is likely to have mainly been responsible for the substantial reduction in stillbirths in Denmark.
The objective of this systematic review is to investigate the effectiveness, efficacy and safety of multiple concomitant lifestyle modification therapies for patients with hypertension or prehypertension.
Electronic searches will be performed in the Cochrane Library, OVID, EMBASE, etc, along with manual searches in the reference lists of relevant papers found during electronic search. We will identify eligible randomised controlled trials utilising multiple lifestyle modifications to lower blood pressure. The control could be drug therapy, single lifestyle change or no intervention. Changes in systolic blood pressure and diastolic blood pressure constitute primary end points, and secondary end points include the number of patients meeting the office target blood pressure, the number of patients reporting microvascular or macrovascular complications, etc. We will extract descriptive, methodological and efficacy data from identified randomised controlled trials (RCTs). We will calculate the relative risk for proportion of patients with a normal blood pressure in the experimental group. Dichotomous data will be analysed using risk difference and continuous data using weighted mean differences, both with 95% CI. We will use the 2 test and the I2 statistic to assess heterogeneity. We will use the fixed effects model to compute the efficacy unless there is evidence of heterogeneity. If heterogeneity of effect size persists with respect to blood pressure change, further metaregression will be performed within groups. We will examine the potential for publication bias by using a funnel plot.
We will synthesise results from RCTs which provide more precise and accurate information on th