title: Public reporting improves antibiotic prescribing for upper respiratory tract infections in primary care: a matched-pair cluster-randomized trial in China An equity analysis of performance-based financing in Rwanda: are services reaching the poorest women? Strengthening malaria service delivery through supportive supervision and community mobilization in an endemic Indian setting: an evaluation of nested delivery models Decreasing Inappropriate Use of Antibiotics in Primary Care in Four Countries in South America—Cluster Randomized Controlled Trial Implementation of national guidelines, incorporated within structured diabetes and hypertension records at primary level care in Cape Town, South Africa: a randomised controlled trial Improving general practitioners’ interviewing skills in managing patients with depression and anxiety: a randomized controlled clinical trial The Effect of a Continuous Quality Improvement Intervention on Retention-In-Care at 6 Months Postpartum in a PMTCT Program in Northern Nigeria: Results of a Cluster Randomized Controlled Study The impact of training informal health care providers in India: A randomized controlled trial Effects of quality improvement in health facilities and community mobilization through women’s groups on maternal, neonatal and perinatal mortality in three districts of Malawi: MaiKhanda, a cluster randomized controlled effectiveness trial Improving feeding and growth of HIV-positive children through nutrition training of frontline health workers in Tanga, Tanzania An educational intervention to promote appropriate complementary feeding practices and physical growth in infants and young children in rural Haryana, India. The Impact of a Pay-for-Performance Scheme on Prescription Quality in Rural China: An Impact Evaluation eRegQual—an electronic health registry with interactive checklists and clinical decision support for improving quality of antenatal care: study protocol for a cluster randomized trial Newborn Infection Control and Care Initiative for health facilities to accelerate reduction of newborn mortality (NICCI): study protocol for a randomized controlled trial A combined community- and facility-based approach to improve pregnancy outcomes in low-resource settings: a Global Network cluster randomized trial Improving pneumonia case-management in Benin: a randomized trial of a multi-faceted intervention to support health worker adherence to Integrated Management of Childhood Illness guidelines The Impact of an Intervention to Improve Malaria Care in Public Health Centers on Health Indicators of Children in Tororo, Uganda (PRIME): A Cluster-Randomized Trial Effect of implementation of Integrated Management of Neonatal and Childhood Illness (IMNCI) programme on neonatal and infant mortality: cluster randomised controlled trial Simulated patient encounters to improve adolescent retention in HIV care in Kenya: study protocol of a stepped-wedge randomized controlled trial Evaluating a streamlined clinical tool and educational outreach intervention for health care workers in Malawi: the PALM PLUS case study The science of improvement. Improving access to services and interactions with clients in Guatemala: the value of distance learning Effects and cost-effectiveness of a guideline-oriented primary healthcare hypertension management program in Beijing, China: results from a 1-year controlled trial Implementing knowledge into practice for improved neonatal survival; a cluster-randomised, community-based trial in Quang Ninh province, Vietnam Training in Complementary Feeding Counselling of Healthcare Workers and Its Influence on Maternal Behaviours and Child Growth: A Cluster-randomized Controlled Trial in Lahore, Pakistan Improving community case management of diarrhoea and pneumonia in district Badin, Pakistan through a cluster randomised study—the NIGRAAN trial protocol Informal Health Provider and Practical Approach to Lung Health interventions to improve the detection of chronic airways disease and tuberculosis at primary care level in Malawi: study protocol for a randomised controlled trial Impact of performance-based financing on primary health care services in Haiti. Communication training and patient satisfaction: A randomized trial study from Mashhad, Iran Efficacy of in-service nutrition training for mid-level providers to improve feeding practices among HIV-positive children in Tanga, Tanzania: study protocol for a cluster randomized controlled trial Strengthening health human resources and improving clinical outcomes through an integrated guideline and educational outreach in resource-poor settings: a cluster-randomized trial Implementation of evidence-based antenatal care in Mozambique: a cluster randomized controlled trial: study protocol Improving Facility Performance in Infectious Disease Care in Uganda: A Mixed Design Study with Pre/Post and Cluster Randomized Trial Components The impact of supervision on stock management and adherence to treatment guidelines: a randomized controlled trial. Exploring the transparency mechanism and evaluating the effect of public reporting on prescription: a protocol for a cluster randomized controlled trial Effect on tuberculosis outcomes of educational outreach to South African clinics during two randomised trials. Changing antibiotics prescribing practices in health centers of Khartoum State, Sudan Improving quality and efficiency of facility-based child health care through Integrated Management of Childhood Illness in Tanzania. Cluster-randomized Trial of Infant Nutrition Training for Caries Prevention Newborn-care training and perinatal mortality in developing countries. Effect of provision of home-based curative health services by public sector health-care providers on neonatal survival: a community-based cluster-randomised trial in rural Pakistan Effect of the Integrated Management of Childhood Illness strategy on childhood mortality and nutrition in a rural area in Bangladesh: a cluster randomised trial In a rural area of Bangladesh, traditional birth attendant training improved early infant feeding practices: a pragmatic cluster randomized trial Improving adherence to family planning guidelines in Kenya: an experiment. Depression care management for adults older than 60 years in primary care clinics in urban China: a cluster-randomised trial. A multifaceted intervention to improve health worker adherence to integrated management of childhood illness guidelines in Benin. Practical approach to lung health in Nepal: better prescribing and reduction of cost. CONSORT-Equity 2017 extension and elaboration for better reporting of health equity in randomised trials Effectiveness of the WHO Safe Childbirth Checklist program in reducing severe maternal, fetal, and newborn harm in Uttar Pradesh, India: study protocol for a matched-pair, cluster-randomized controlled trial
abstract: Background Inappropriate use and overuse of antibiotics is a serious concern in the treatment of  upper respiratory tract infections ( URTIs )  , especially in developing countries . In recent decades , information disclosure and public reporting ( PR ) has become an instrument for encouraging good practice in healthcare . This study evaluated the impact of PR on antibiotic prescribing for URTIs in a sample of primary care institutions in China . Methods A matched-pair cluster-r and omized trial was undertaken in QJ city , with 20 primary care institutions participating in the trial . Participating institutions were matched into pairs before being r and omly assigned into a control and an intervention group . Prescription statistics were disclosed to patients , health authorities , and health workers monthly within the intervention group , starting from October 2013 . Outpatient prescriptions for URTIs were collected from both groups before ( 1st March to 31st May , 2013 ) and after the intervention ( 1st March to 31st May , 2014 ) . A total of 34,815 URTI prescriptions were included in a difference-in-difference analysis using multivariate linear or logistic regression models , controlling for patient attributes as well as institutional characteristics . Results Overall , 90 % URTI prescriptions required antibiotics and 21 % required combined use of antibiotics . More than 77 % of URTI prescriptions required intravenous ( IV ) injection or infusion of drugs . PR result ed in a 9 percentage point ( 95 % CI -17 to -1 ) reduction in the use of oral antibiotics ( adjusted RR = 39 % , P = 0.027 ) , while the use of injectable antibiotics remained unchanged . PR led to a 7 percentage point reduction ( 95 % CI -14 to 0 ; adjusted RR = 36 % ) in combined use of antibiotics ( P = 0.049 ) , which was largely driven by a significant reduction in male patients ( -7.5 % , 95 % CI -14 to -1 , P = 0.03 ) . The intervention had little impact on the use of IV injections or infusions , or the total prescription expenditure . Conclusions The results suggest that PR could improve prescribing practice s in terms of reducing oral antibiotics and combined use of antibiotics ; however , the impacts were limited . We suggest that PR would probably be enhanced by provider payment reform , management and training for providers , and health education for patients Maternal health services continue to favour the wealthiest in lower and middle income countries . Debate about the potential of performance-based financing ( PBF ) to address these disparities continues . As PBF is adopted by countries , it is critical to underst and the equity effects for maternal services . The aim of this study is to examine the effects of PBF on equity in maternal health service use when no specific provisions target the poorest in the population . In Rw and a , PBF was design ed to increase health service use , which was universally low . Paired districts were r and omly assigned to intervention and control for PBF implementation . Using Rw and a 's Demographic Health Survey data from 2005 ( pre-intervention ) and 2007 - 8 ( post-intervention ) , a cluster-level panel data set of 7899 women 15 - 49 years of age from intervention ( 4477 ) and control districts ( 3422 ) was created . The impact of PBF on reported use of facility deliveries , antenatal care ( ANC ) and modern contraceptive use was estimated using a difference-in-differences model with community fixed effects . Interaction terms between wealth quintiles and PBF were estimated to identify the differential effect of PBF among poorer women . The probability of a facility delivery increased by 10 percentage points in the intervention when compared with the control districts ( P = 0.014 ) , while no significant effects were noted for ANC visits or modern contraceptive use . Service use increased for intervention and control population s and across all wealth quintiles from 2005 to 2007 , with no evidence that PBF was a pro-poor or a pro-rich strategy . Insurance remained a positive predictor of service use . This research suggests that if service use is uniformly low then a PBF programme that incentivizes select services , such as facility deliveries , may improve service use overall . However , if the equity gap is extreme , then a PBF programme without equity targets will do little to alleviate disparities Background Malaria continues to be a prominent global public health challenge . This study tested the effectiveness of two service delivery models for reducing the malaria burden , e.g. supportive supervision of community health workers ( CHW ) and community mobilization in promoting appropriate health-seeking behaviour for febrile illnesses in Odisha , India . Methods The study population comprised 120 villages from two purposively chosen malaria-endemic districts , with 40 villages r and omly assigned to each of the two treatment arms , one with both supportive supervision and community mobilization and one with community mobilization alone , as well as an observational control arm . Outcome measures included changes in the utilization of bed nets and timely care-seeking for fever from a trained provider compared to the control group . Analysis was by intention-to-treat . Results Significant improvements were observed in the reported utilization of bed nets in both intervention arms ( 84.5 % in arm A and 82.4 % in arm B versus 78.6 % in the control arm ; p < 0.001 ) . While overall rates of treatment-seeking were equal across study arms , treatment-seeking from a CHW was higher in both intervention arms ( 28 % ; p = 0.005 and 27.6 % ; p = 0.007 ) than in the control arm ( 19.2 % ) . Fever cases were significantly more likely to visit a CHW and receive a timely diagnosis of fever in the combined interventions arm than in the control arm ( 82.1 % vs. 67.1 % ; p = 0.025 ) . Care-seeking from trained providers also increased with a substitution away from untrained providers . Further , fever cases from the combined interventions arm ( 60.6 % ; p = 0.004 ) and the community mobilization arm ( 59.3 % ; p = 0.012 ) were more likely to have received treatment from a skilled provider within 24 hours than fever cases from the control arm ( 50.1 % ) . In particular , women from the combined interventions arm were more likely to have received timely treatment from a skilled provider ( 61.6 % vs. 47.2 % ; p = 0.028 ) . Conclusion A community-based intervention combining the supportive supervision of community health workers with intensive community mobilization and can be effective in improving care-seeking and preventive behaviour and may be used to strengthen the national malaria control programme High antibiotic prescribing and antimicrobial resistance in patients attending primary care have been reported in South America . Very few interventions targeting general practitioners ( GPs ) to decrease inappropriate antibiotic prescribing have been investigated in this region . This study assessed the effectiveness of online feedback on reducing antibiotic prescribing in patients with suspected respiratory tract infections ( RTIs ) attending primary care . The aim was to reduce antibiotic prescribing in patients with acute bronchitis and acute otitis media . Both are RTIs for which antibiotics have a very limited effect . A cluster r and omized two-arm control trial was implemented . Healthcare centres from Bolivia , Argentina , Paraguay and Uruguay participating in the quality improvement program HAPPY AUDIT were r and omly allocated to either intervention or control group . During ten consecutive weeks , GPs in the intervention group received evidence -based online feedback on the management of suspected RTIs . In patients with acute bronchitis , the intervention reduced the antibiotic prescribing rate from 71.6 % to 56 % ( control group from 61.2 % to 52 % ) . In patients with acute otitis media , the intervention reduced the antibiotic prescribing from 94.8 % to 86.2 % ( no change in the control group ) . In all RTIs , the intervention reduced antibiotic prescribing rate from 37.4 % to 28.1 % ( control group from 29 % to 27.2 % ) . Online evidence -based feedback is effective for reducing antibiotic prescribing in patients with RTIs attending primary care in South America Background and objectives Many clinical management guidelines for chronic diseases have been published , but they have not been put into practice by busy clinicians at primary care levels . This study evaluates the implementation of national guidelines incorporated within a structured diabetes and hypertension clinical record ( SR ) in Cape Town in a r and omised controlled trial ( RCT ) . Methods Eighteen public sector community health centres ( CHC ) were r and omly selected and allocated as intervention or control CHC . At each clinic , 25 patients with diabetes and 35 patients with hypertension were enrolled at baseline . Question naires were completed , blood sample s were collected , blood pressure ( BP ) and anthropometric measures were taken and patient records were audited . SR with clinical guideline prompts were introduced at the intervention clinics after training doctors in their use and suggestions to incorporate them in regular patient records . Contact was maintained during the year of intervention with the clinic staff . A follow-up survey was conducted 1 year later to assess BP and HbA1c , and the patient records were examined to ascertain the extent of use of the SR in the intervention clinics . In-depth interviews were conducted with doctors and nurses to record their response to the intervention . Results The intervention evaluated in this RCT had no impact on either diabetes or hypertension control . In the intervention clinics , less than 60 % of the patient folders contained the SR and when present was seldom used . Although the staff were well disposed to the research team , their workload prohibited them from undertaking a true evaluation of the SR , and overall they did not perceive the SR as supporting their current process of patient care . Conclusions No benefit to diabetes of hypertension care by introducing and availability of the staff in the use of the SR was shown in this RCT . The process measures suggest that the SR was not widely used by the healthcare provided in the primary care clinics Background : Studies regarding the effectiveness of CME programmes on physicians ’ behaviour and communication skills showed inconsistent results . Few r and omized controlled trials have been conducted in Asia . Methods : To evaluate the effectiveness of a 4 2-hour education programme to improve GP interviewing behaviours , 16 general practitioners were r and omized to the intervention and control groups , respectively . Physicians assigned to the intervention group received 8 hours of training emphasizing interviewing behaviours in the diagnosis and treatment of depression and generalized anxiety disorders ( GDS ) . Those assigned to the control group did not receive any training until the completion of study . St and ardized patients were used to evaluate the performance of physicians .  Two consultations before and after enrolling in the education programme were videotaped . Independent evaluations of consultations were made by a trained clinical psychologist and a social worker blinded to the study status of physicians . The rating schedule for the videotapes was based on the tasks listed on the Calgary Cambridge Observation Guide . Results : The change of score between the intervention and control physicians was significantly different in ‘ active listening and facilitating patients ’ response ’ ( p = 0.011 ) with the intervention physicians having improvement of score . For ‘ non-verbals ’ , ‘ underst and ing patient 's perspective ’ and ‘ negotiating mutual plan of action ’ , positive change of score in the intervention physicians were seen when compared to that of the control , although the difference did not reach statistical significance ( p = 0.06 , p = 0.05 , p = 0.06 , respectively ) . However , for ‘ opening ’ , ‘ structuring the consultation ’ , ‘ explanation and planning ’ and ‘ closure ’ , there were no statistical significant differences between control and intervention group . Conclusions : Our results showed that only certain communication skills , such as active listening and facilitating patient 's response , can be taught in the management of depression and generalized anxiety disorder ( GAD ) in Chinese primary care physicians Background : Retention in care is critical for improving HIV-infected maternal outcomes and reducing vertical transmission . Health systems ' interventions such as continuous quality improvement ( CQI ) may support health services to address factors that affect the delivery of HIV-related care and thereby influence rates of retention-in-care . Methodology : We evaluated the effect of a CQI intervention on retention-in-care at 6 months postpartum of pregnant women and mothers living with HIV who had been started on lifelong antiretroviral treatment . Thirty-two health care facilities were r and omized to either implement the intervention or not . We considered women fully retained in care when they attended the 6-month postpartum visit and did not miss any previous scheduled visit by more than 30 days . Results : Five hundred eleven women living with HIV attending antenatal clinics at 26 facilities were included in the analysis . Median age at enrolment was 27 years and gestational age was 20 weeks . Seventy-one percent of women were seen at 6-month postpartum irrespective of missing any scheduled visit . However , 43 % of women were fully retained at 6-month postpartum and did not miss any scheduled visit based on our stringent study definition of retention . There was no significant difference in retention at 6 months between the intervention and control arms [ 44 % vs. 41 % , relative risk : 1.08 ; 95 % confidence interval ( CI ) : 0.78 to 1.49 ] . Initiation of ARV prophylaxis among infants within 72 hours was not different by study arm ( 66.0 % vs. 74.7 % , relative risk = 0.95 ; 95 % CI : 0.84 to 1.07 ) but rates of early infant testing at 4–6 weeks were higher in intervention sites ( 48.8 % vs. 25.3 % , adjusted relative risk : 1.76 ; 95 % CI : 1.27 to 2.42 ) . Conclusions : CQI as implemented in this study did not differ across study arms in the rates of retention . Several intervention design or implementation issues or other context ual constraints may explain the absence of effect Delivering health care to mystery patients Many families in developing countries do not have access to medical doctors and instead receive health care from informal providers . Das et al. used “ mystery ” patients ( trained actors ) to test whether a 9-month training program  improved the quality of care delivered by informal providers in West Bengal ( see the Perspective by Powell-Jackson ) . The patients did not identify themselves to the providers and were not told which providers had participated in the training program . The results of this blinded assessment showed that medical doctors delivered better care than informal providers but that the training program closed much of the gap . Science , this issue p. 80 ; see also p. 34 Training helped informal providers deliver better care for angina , diarrhea , and asthma . [ Also see Perspective by Powell-Jackson ] INTRODUCTION In rural India , health care providers without formal medical training and self-declared “ doctors ” are sought for up to 75 % of primary care visits . The frequent use of such informal providers , despite legal prohibitions on their practice s , in part reflects the absence of trained medical professionals in rural locations . For example , in the majority of villages in the Indian states of Rajasthan , Madhya Pradesh , and West Bengal , informal providers are the only proximate source of health care . RATIONALE The status of informal providers in the complex Indian health system is the subject of a highly charged debate among policy-makers and the medical establishment . The official view of the establishment is that fully trained providers are the only legitimate source of health care , and training informal providers legitimizes an illegal activity and worsens population health outcomes . In contrast , given the lack of availability of trained providers and the fact that informal providers are tightly linked with the communities that they serve , others believe that training can serve as a stopgap measure to improve health care in t and em with better regulation and reform of the public health care system . However , despite the policy interest and important ramifications for the country , there is little evidence regarding the benefits ( or lack thereof ) of training informal providers . We report on the impact of a multitopic training program for informal providers in the Indian state of West Bengal that provided 72 sessions of training over 9 months . We used a r and omized controlled trial design , together with visits by unannounced st and ardized patients ( “ mystery clients ” ) , to measure the extent to which training could improve the clinical practice of informal providers over the range of conditions that they face . The conditions presented by st and ardized patients were blinded from program implementers . Therefore , we view the evaluation of this multitopic training program as a measure of impact on primary care in general . St and ardized patient data are accompanied by data from day-long clinical observations , providing a comprehensive picture of provider practice . Our study also benchmarks the impact of training against the performance of doctors in public primary health centers serving the same region . Lastly , it explores whether the training affected patient dem and for informal providers .  RESULTS Mean attendance at each training session was 56 % [ 95 % confidence interval ( CI ) : 51 , 62 % ] , with no contamination from the control group . Using st and ardized patient data , we find that providers allocated to the training group were 4.1 ( 1.7 , 6.5 ) percentage points , or 15.2 % , more likely to adhere to condition-specific checklists than those in the control group . The training increased rates of correct case management by 7.9 ( 0.4 , 15.5 ) percentage points , or 14.2 % , and patient caseload by 0.8 to 1.8 ( 0.13 , 3.57 ) patients per day , or 7.6 to 17.0 % . Data from clinical observations show similar patterns . Although correct case management among doctors in public clinics was 14.7 ( –0.1 , 30.4 ) percentage points , or 28.3 % , higher than among untrained informal providers , the training program reduced this gap by half for providers with mean attendance and reduced the gap almost entirely for providers who completed the full course . However , the training had no effect on the use of unnecessary medicines and antibiotics , although both training- and control-group informal providers prescribed 18.8 ( 7.7 , 28.9 ) percentage points , or 28.2 % , fewer unnecessary antibiotics than public-sector providers . CONCLUSION Training informal providers increased correct case management rates but did not reduce the use of unnecessary medicines or antibiotics . At the same time , training did not lead informal providers to violate rules with greater frequency or worsen their clinical practice , both of which are concerns that have been raised by representatives of the Indian Medical Association . Our findings thus suggest that multitopic medical training may offer an effective short-run strategy to improved health care provision and complement critical investments in the quality of public care . Informal health care providers are the backbone of India ’s primary health care system . In rural India , up to 75 % of primary care visits are to informal providers . We evaluated a training program for these informal providers by using a r and omized controlled design . In our sample of 200 villages in West Bengal , there are 30 informal providers for every public-sector doctor . Health care providers without formal medical qualifications provide more than 70 % of all primary care in rural India . Training these informal providers may be one way to improve the quality of care where few alternatives exist . We report on a r and omized controlled trial assessing a program that provided 72 sessions of training over 9 months to 152 informal providers ( out of 304 ) . Using st and ardized patients ( “ mystery clients ” ) , we assessed clinical practice for three different conditions to which both providers and trainers were blinded during the intervention , representative of the range of conditions that these providers normally diagnose and treat . Training increased correct case management by 7.9 percentage points ( 14.2 % ) but did not affect the use of unnecessary medicines and antibiotics . At a program cost of $ 175 per trainee , our results suggest that multitopic medical training offers an effective short-run strategy to improve health care Background Maternal , perinatal and neonatal mortality remains high in low-income countries . We evaluated community and facility-based interventions to reduce deaths in three districts of Malawi . Methods We evaluated a rural participatory women ’s group community intervention ( CI ) and a quality improvement intervention at health centres ( FI ) via a two-by-two factorial cluster r and omized controlled trial . Consenting pregnant women were followed-up to 2 months after birth using key informants . Primary outcomes were maternal , perinatal and neonatal mortality . Clusters were health centre catchment areas assigned using stratified computer-generated r and omization . Following exclusions , including non-birthing facilities , 61 clusters were analysed : control ( 17 clusters , 4912 births ) , FI ( 15 , 5335 ) , CI ( 15 , 5080 ) and FI + CI ( 14 , 5249 ) . This trial was registered as International St and ard R and omised Controlled Trial [ IS RCT N18073903 ] . Outcomes for 14 576 and 20 576 births were recorded during baseline ( June 2007–September 2008 ) and intervention ( October 2008–December 2010 ) periods . Results For control , FI , CI and FI + CI clusters neonatal mortality rates were 34.0 , 28.3 , 29.9 and 27.0 neonatal deaths per 1000 live births and perinatal mortality rates were 56.2 , 55.1 , 48.0 and 48.4 per 1000 births , during the intervention period . Adjusting for clustering and stratification , the neonatal mortality rate was 22 % lower in FI + CI than control clusters ( OR = 0.78 , 95 % CI 0.60–1.01 ) , and the perinatal mortality rate was 16 % lower in CI clusters ( OR = 0.84 , 95 % CI 0.72–0.97 ) . We did not observe any intervention effects on maternal mortality . Conclusions Despite implementation problems , a combined community and facility approach using participatory women ’s groups and quality improvement at health centres reduced newborn mortality in rural Malawi Background Nutrition training can boost competence of health workers to improve children ’s feeding practice s. In this way , child undernutrition can be ameliorated in general population s. However , evidence is lacking on efficacy of such interventions among Human Immunodeficiency Virus (HIV)-positive children . We aim ed to examine the efficacy of a nutrition training intervention to improve midlevel providers ’ ( MLPs ) nutrition knowledge and feeding practice s and the nutrition statuses of HIV-positive children in Tanga , Tanzania . Methods This cluster-r and omized controlled trial was conducted in 16 out of 32 care and treatment centers ( CTCs ) in Tanga . Eight CTCs were assigned to the intervention arm and a total of 16 MLPs received nutrition training and provided nutrition counseling and care to caregivers of HIV-positive children . A total of 776 pairs of HIV-positive children and their caregivers were recruited , of whom 397 were in the intervention arm . Data were analyzed using instrumental variable r and om effects regression with panel data to examine the efficacy of the intervention on nutrition status through feeding practice s. Results Mean nutrition knowledge scores were higher post-training compared to pre-training among MLPs ( 37.1 vs. 23.5 , p < 0.001 ) . A mean increment weight gain of 300 g was also observed at follow-up compared to baseline among children of the intervention arm . Feeding frequency and dietary diversity improved following the intervention and a 6 months follow-up ( p < 0.001 ) . An increase in each unit of feeding frequency and dietary diversity were associated with a 0.15-unit and a 0.16-unit respectively decrease in the child underweight ( p < 0.001 ) . Conclusions Nutrition training improved nutrition knowledge among MLPs caring for HIV-positive children attending CTCs in Tanga , Tanzania . Caregivers ’ feeding practice s also improved , which in turn led to a modest weight gain among HIV-positive children . To sustain weight gain , efforts should be made to also improve households ’ food security and caregivers ’ education in addition to inservice nutrition trainings . The protocol was registered on 15/02/2013 , before the recruitment at IS RCT N trial registry with the trial registration number : IS RCT N65346364 Complementary feeding practice s are often inadequate in developing countries , result ing in a significant nutritional decline between 6 and 18 mo of age . We assessed the effectiveness of an educational intervention to promote adequate complementary feeding practice s that would be feasible to sustain with existing re sources . The study was a cluster r and omized controlled trial in communities in the state of Haryana in India . We developed the intervention through formative research . Eight communities were pair matched on their baseline characteristics ; one of each pair was r and omly assigned to receive the intervention and the other to no specific feeding intervention . Health and nutrition workers in the intervention communities were trained to counsel on locally developed feeding recommendations .  Newborns were enrolled in all of the communities ( 552 in the intervention and 473 in the control ) and followed up every 3 mo to the age of 18 mo . The main outcome measures were weights and lengths at 6 , 9 , 12 , and 18 mo and complementary feeding practice s at 9 and 18 mo . All analyses were by intent to treat . In the overall analyses , there was a small but significant effect on length gain in the intervention group ( difference in means 0.32 cm , 95 % CI , 0.03 , 0.61 ) . The effect was greater in the subgroup of male infants ( difference in mean length gain 0.51 cm , 95 % CI 0.03 , 0.98 ) . Weight gain was not affected . Energy intakes from complementary foods overall were significantly higher in the intervention group children at 9 mo ( mean + /- SD : 1556 + /- 1109 vs. 1025 + /- 866 kJ ; P < 0.001 ) and 18 mo ( 3807 + /- 1527 vs. 2577 + /- 1058 kJ ; P < 0.001 ) . Improving complementary feeding practice s through existing services is feasible but the effect on physical growth is limited . Factors that limit physical growth in such setting s must be better understood to plan more effective nutrition programs In China , health care providers have traditionally been paid fee-for-service and overprescribing and high out-of-pocket spending are common . In this study , township health centers in two counties were assigned almost r and omly to two groups : in one , fee-for-service was replaced by a global capitated budget ; in the other , by a mix of global capitated budget and pay-for-performance . Performance captured inter alia " irrational " drug prescribing ; 20 percent of the global capitated budget was withheld each quarter , points were deducted for failure to meet targets , and some of the withheld budget was returned in line with the points deducted . Outcomes included appropriate prescribing and prescription cost , data on which were obtained by digitizing prescriptions from a month just before the reform and from the same month a year later . Impacts were assessed via multivariate differences-in-differences with township health center fixed effects . To reduce bias from non-r and omness in assignment , the sample was trimmed by coarsened exact matching . Pay-for-performance reduced inappropriate prescribing significantly and substantially in the county where the initial level was above the penalty threshold , but end-line rates were still appreciable ; no effects were seen in the county where initial levels were around or below the threshold , or on out-of-pocket spending in either county Background Health worker compliance with established best- practice clinical and public health guidelines may be enhanced by customized checklists of care and clinical decision support driven by point-of-care data entry into an electronic health registry . The public health system of Palestine is currently implementing a national electronic registry ( eRegistry ) for maternal and child health . This trial is embedded in the national implementation and aims to assess the effectiveness of the eRegistry ’s interactive checklists and clinical decision support , compared with the existing paper based records , on improving the quality of care for pregnant women . Methods This two-arm cluster r and omized controlled trial is conducted in the West Bank , Palestine , and includes 120 clusters ( primary healthcare clinics ) with an average annual enrollment of 60 pregnancies . The intervention tool is the eRegistry ’s interactive checklists and clinical decision support implemented within the District Health Information System 2 ( DHIS2 ) Tracker software , developed and customized for the Palestinian context . The primary outcomes reflect the processes of essential interventions , namely timely and appropriate screening and management of : 1 ) anemia in pregnancy ; 2 ) hypertension in pregnancy ; 3 ) abnormal fetal growth ; 4 ) and diabetes mellitus in pregnancy . The composite primary health outcome encompasses five conditions representing risk for the mother or baby that could have been detected or prevented by high- quality antenatal care : moderate or severe anemia at admission for labor ; severe hypertension at admission for labor ; malpresentation at delivery undetected during pregnancy ; small for gestational age baby at delivery undetected during pregnancy ; and large for gestational age baby at delivery . Primary analysis at the individual level taking the design effect of the clustering into account will be performed as intention-to-treat . Discussion This trial , embedded in the national implementation of the eRegistry in Palestine , allows the assessment of process and health outcomes in a large-scale pragmatic setting . Findings will inform the use of interactive checklists and clinical decision support driven by point-of-care data entry into an eRegistry as a health systems-strengthening approach . Trial registration IS RCT N trial registration number , IS RCT N18008445 . Registered on 6 April 2017 Background Newborn health is a key issue in addressing the survival of children under five years old , particularly in low and middle income countries , and the evidence base for newborn health interventions continues to evolve . Over the last decade , maternal and under five-year-old mortality and morbidity rates have been successfully reduced in Cambodia , but newborn health has lagged behind . Evidence suggests that an important proportion of newborn mortality both globally and in Cambodia is attributable to infections and sepsis . While initiatives are being implemented to address some causes of newborn illness ( related to pre-term birth and asphyxia ) , a country-level approach to reducing infections has not been formulated . The Newborn Infection Control and Care Initiative ( NICCI ) is a community and health facility linked intervention to improve health outcomes for newborns . Methods / Design The present study applies a cluster r and omized trial , using a stepped wedge design , to assess the impact of a package intervention on  newborn health . The intervention components include addressing infection control in the perinatal period in health facilities , promoting infection prevention and control practice s in health center and home environments , and improving the timeliness of referrals for newborns with suspected infections to appropriate health facilities , by linking families to the medical system through a network of community based volunteers who will make home visits to families in the first week of a newborn ’s life . Discussion The NICCI trial is design ed to complement and enhance the Cambodian Ministry of Health strategies and objectives for maternal and newborn care . Results of the study will help to inform policy and the possible scale-up of newborn health interventions in the country . Trial registration This trial was registered with Clinical trials.gov ( identifier : NCT02271737 ) on 5 October 2014 Background Fetal and neonatal mortality rates in low-income countries are at least 10-fold greater than in high-income countries . These differences have been related to poor access to and poor quality of obstetric and neonatal care . Methods This trial tested the hypothesis that teams of health care providers , administrators and local residents can address the problem of limited access to quality obstetric and neonatal care and lead to a reduction in perinatal mortality in intervention compared to control locations . In seven geographic areas in five low-income and one middle-income country , most with high perinatal mortality rates and substantial numbers of home deliveries , we performed a cluster r and omized non-masked trial of a package of interventions that included community mobilization focusing on birth planning and hospital transport , community birth attendant training in problem recognition , and facility staff training in the management of obstetric and neonatal emergencies . The primary outcome was perinatal mortality at ≥28 weeks gestation or birth weight ≥1000 g. Results Despite extensive effort in all sites in each of the three intervention areas , no differences emerged in the primary or any secondary outcome between the intervention and control clusters . In both groups , the mean perinatal mortality was 40.1/1,000 births ( P = 0.9996 ) . Neither were there differences between the two groups in outcomes in the last six months of the project , in the year following intervention cessation , nor in the clusters that best implemented the intervention . Conclusions This cluster r and omized comprehensive , large-scale , multi-sector intervention did not result in detectable impact on the proposed outcomes . While this does not negate the importance of these interventions , we expect that achieving improvement in pregnancy outcomes in these setting s will require substantially more obstetric and neonatal care infrastructure than was available at the sites during this trial , and without them provider training and community mobilization will not be sufficient . Our results highlight the critical importance of evaluating outcomes in r and omized trials , as interventions that should be effective may not be . Trial registration Clinical Trials.gov Background Pneumonia is a leading cause of death among children under five years of age . The Integrated Management of Childhood Illness strategy can improve the quality of care for pneumonia and other common illnesses in developing countries , but adherence to these guidelines could be improved . We evaluated an intervention in Benin to support health worker adherence to the guidelines after training , focusing on pneumonia case management . Methods We conducted a r and omized trial . After a health facility survey in 1999 to assess health care quality before Integrated Management of Childhood Illness training , health workers received training plus either study supports ( job aids , non-financial incentives and supervision of workers and supervisors ) or " usual " supports . Follow-up surveys were conducted in 2001 , 2002 and 2004 . Outcomes were indicators of health care quality for Integrated Management-defined pneumonia . Further analyses included a graphical pathway analysis and multivariable logistic regression modelling to identify factors influencing case-management quality . Results We observed 301 consultations of children with non-severe pneumonia that were performed by 128 health workers in 88 public and private health facilities . Although outcomes improved in both intervention and control groups , we found no statistically significant difference between groups . However , training proceeded slowly , and low- quality care from untrained health workers diluted intervention effects . Per- protocol analyses suggested that health workers with training plus study supports performed better than those with training plus usual supports ( 20.4 and 19.2 percentage-point improvements for recommended treatment [ p = 0.08 ] and " recommended or adequate " treatment [ p = 0.01 ] , respectively ) . Both groups tended to perform better than untrained health workers . Analyses of treatment errors revealed that incomplete assessment and difficulties processing clinical findings led to missed pneumonia diagnoses , and missed diagnoses led to inadequate treatment . Increased supervision frequency was associated with better care ( odds ratio for recommended treatment = 2.1 [ 95 % confidence interval : 1.1 - 3.9 ] per additional supervisory visit ) . Conclusion Integrated Management of Childhood Illness training was useful , but insufficient , to achieve high- quality pneumonia case management . Our study supports led to additional improvements , although large gaps in performance still remained . A simple graphical pathway analysis can identify specific , common errors that health workers make in the case-management process ; this information could be used to target quality improvement activities , such as supervision ( Clinical Trials.gov number NCT00510679 ) Optimizing quality of care for malaria and other febrile illnesses is a complex challenge of major public health importance . To evaluate the impact of an intervention aim ing to improve malaria case management on the health of community children , a cluster-r and omized trial was conducted from 2010–2013 in Tororo , Ug and a , where malaria transmission is high . Twenty public health centers were included ; 10 were r and omized in a 1:1 ratio to intervention or control . Households within 2 km of health centers provided the sampling frame for the evaluation . The PRIME intervention included training in fever case management using malaria rapid diagnostic tests ( mRDTs ) , patient-centered services , and health center management ; plus provision of mRDTs and artemether – lumefantrine . Cross-sectional community surveys were conducted at baseline and endline ( N = 8,766 ) , and a cohort of children was followed for approximately 18 months ( N = 992 ) . The primary outcome was prevalence of anemia ( hemoglobin < 11.0 g/dL ) in children under 5 years of age in the final community survey . The intervention was delivered successfully ; however , no differences in prevalence of anemia or parasitemia were observed between the study arms in the final community survey or the cohort . In the final survey , prevalence of anemia in children under 5 years of age was 62.5 % in the intervention versus 63.1 % in control ( adjusted risk ratio = 1.01 ; 95 % confidence interval = 0.91–1.13 ; P = 0.82 ) . The PRIME intervention , focusing on training and commodities , did not produce the expected health benefits in community children in Tororo . This challenges common assumptions that improving quality of care and access to malaria diagnostics will yield health gains Objective To evaluate the Indian Integrated Management of Neonatal and Childhood Illness ( IMNCI ) programme , which integrates improved treatment of illness for children with home visits for newborn care  , to inform its scale-up . Design Cluster r and omised trial . Setting 18 clusters ( population 1.1 million ) in Haryana , India . Participants 29 667 births in intervention clusters and 30 813 in control clusters . Intervention Community health workers were trained to conduct postnatal home visits and women ’s group meetings ; physicians , nurses , and community health workers were trained to treat or refer sick newborns and children ; supply of drugs and supervision were strengthened . Main outcome measures Neonatal and infant mortality ; newborn care practice s. Results The infant mortality rate ( adjusted hazard ratio 0.85 , 95 % confidence interval 0.77 to 0.94 ) and the neonatal mortality rate beyond the first 24 hours ( adjusted hazard ratio 0.86 , 0.79 to 0.95 ) were significantly lower in the intervention clusters than in control clusters . The adjusted hazard ratio for neonatal mortality rate was 0.91 ( 0.80 to 1.03 ) . A significant interaction was found between the place of birth and the effect of the intervention for all mortality outcomes except post-neonatal mortality rate . The neonatal mortality rate was significantly lower in the intervention clusters in the subgroup born at home ( adjusted hazard ratio 0.80 , 0.68 to 0.93 ) but not in the subgroup born in a health facility ( 1.06 , 0.91 to1.23 ) ( P value for interaction=0.001 ) . Optimal newborn care practice s were significantly more common in the intervention clusters . Conclusions Implementation of the IMNCI result ed in substantial improvement in infant survival and in neonatal survival in those born at home . The IMNCI should be a part of India ’s strategy to achieve the millennium development goal on child survival . Trial registration Clinical trials NCT00474981 ; ICMR Clinical Trial Registry CTRI/2009/091/000715 Background Adolescent-friendly policies aim to tailor HIV services for adolescents and young adults aged 10–24 years ( AYA ) to promote health outcomes and improve retention in HIV care and treatment . However , few interventions focus on improving healthcare worker ( HCW ) competencies and skills for provision of high- quality adolescent care . St and ardized patients ( SPs ) are trained actors who work with HCWs in mock clinical encounters to improve clinical assessment , communication , and empathy skills . This stepped-wedge r and omized controlled trial will evaluate a clinical training intervention utilizing SPs to improve HCW skills in caring for HIV-positive AYA , result ing in increased retention in care . Methods / design The trial will utilize a stepped-wedge design to evaluate a training intervention using SPs to train HCWs in assessment , communication , and empathy skills for AYA HIV care . We will recruit 24 clinics in Kenya with an active electronic medical record ( EMR ) system and at least 40 adolescents enrolled in HIV care per site . Stratified r and omization by county will be used to assign clinics to one of four waves – time periods when they receive the intervention – with each wave including six clinics . From each clinic , up to 10 HCWs will participate in the training intervention . SP training includes didactic sessions in adolescent health , current guidelines , communication skills , and motivational interviewing techniques . HCW participants will rotate through seven st and ardized SP scenarios , followed by SP feedback , group debriefing , and remote expert evaluation . AYA outcomes will be assessed using routine clinic data . The primary outcome is AYA retention in HIV care , defined as returning for first follow-up visit within 6 months of presenting to care , or returning for a first follow-up visit after re-engagement in care in AYA with a previous history of being lost to follow-up . Secondary outcomes include HCW competency scores , AYA satisfaction with care , and AYA clinical outcomes including CD4 and viral load . Additional analyses will determine cost-effectiveness of the intervention . Discussion This trial will contribute valuable information to HIV programs in Kenya and other low-re source setting s , providing a potentially scalable strategy to improve quality of care and retention in critical HIV services in this population .Trial registration Clinical Trials.gov , ID : NCT02928900 . Registered 26 August 2016 Background Nearly 3 million people in re source -poor countries receive antiretrovirals for the treatment of HIV/AIDS , yet millions more require treatment . Key barriers to treatment scale up are shortages of trained health care workers , and challenges integrating HIV/AIDS care with primary care . The research PALM PLUS ( Practical Approach to Lung Health and HIV/AIDS in Malawi ) is an intervention design ed to simplify and integrate existing Malawian national guidelines into a single , simple , user-friendly guideline for mid-level health care workers . Training utilizes a peer-to-peer educational outreach approach . Research is being undertaken to evaluate this intervention to generate evidence that will guide future decision-making for consideration of roll out in Malawi . The research consists of a cluster r and omized trial in 30 public health centres in Zomba District that measures the effect of the intervention on staff satisfaction and retention , quality of patient care , and costs through quantitative , qualitative and health economics methods . Results and outcomes In the first phase of qualitative inquiry respondents from intervention sites demonstrated in-depth knowledge of PALM PLUS compared to those from control sites . Participants in intervention sites felt that the PALM PLUS tool empowered them to provide better health services to patients . Interim staff retention data shows that there were , on average , 3 to 4 staff departing from the control and intervention sites per month . Additional qualitative , quantitative and economic analyses are planned . The partnershipDignitas International and the Knowledge Translation Unit at the University of Cape Town Lung Institute have led the adaptation and development of the PALM PLUS intervention , using experience gained through the implementation of the South African precursor , PALSA PLUS . The Malawian partners , REACH Trust and the Research Unit at the Ministry of Health , have led the qualitative and economic evaluations . Dignitas and Ministry of Health have facilitated interaction with implementers and policy-makers . Challenges and successesThis initiative is an example of South-South knowledge translation between South Africa and Malawi , mediated by a Canadian academic-NGO hybrid . Our success in developing and rolling out PALM PLUS in Malawi suggests that it is possible to adapt and implement this intervention for use in other re source -limited setting IN THE EARLY 1890S , DR WILLIAM HALSTED DEVELOPED radical mastectomy for breast cancer . Surgeons performed the Halsted procedure for more than 80 years even though there was little systematic evidence for its success . Then a new breed of scholars subjected the procedure to formal methods of evaluation unknown to Halsted . The methods —r and omized controlled trials ( RCTs ) principal among them — led to a surprise : radical mastectomy had no advantage over simpler forms of treatment . This is but 1 example of the hard-won victory of evidence over belief in medicine . The pioneers of the formal evaluation of medical practice s raised questions that traditional practitioners did not welcome . But in time , formal evaluation prevailed . The pioneers developed a hierarchy of evidentiary rigor relating the design of a study to the confidence that could be placed in the findings , from the lowly , nearly valueless anecdote to the royalty of evidence , the RCT . Concurrently , a similar story of hard-won learning unfolded in the so-called quality movement . Scholars illuminated the scale and types of defects in the processes of care and the outcomes , including high rates of unscientific care , inappropriate care , geographic variations in practice , latent disagreements among specialists , and oftenunrecognized medical injury to patients . Like the pioneers of evidence -based medicine , students of medical quality were at first largely ignored , but no longer . In 1999 and 2001 , the Institute of Medicine published 2 l and mark reports on the evidence for quality failures and called urgently for re design of care systems to achieve improvements . The story could end here happily with 2 great streams of endeavor merging into a framework for conjoint action : improving clinical evidence and improving the process of care . Instead , the 2 endeavors are often in unhappy tension . Neither disputes that progress toward health care ’s main goal , the relief of illness and pain , requires research of many kinds : basic , clinical , systems , epidemiologic . The disagreement centers on epistemology — ways to get at “ truth ” and how those ways should vary depending on the knowledge sought . Individuals most involved in day-to-day improvement work fear that if “ evidence ” is too narrowly defined and the approach to gathering evidence too severely constrained , progress may be the victim . For example , the RCT is a powerful , perhaps unequaled , research design to explore the efficacy of conceptually neat components of clinical practice —tests , drugs , and procedures . For other crucially important learning purpose s , however , it serves less well . Recent controversies about the evaluation of rapid response  teams  provide a case in point . These controversies show the importance of adjusting research methods to fit research questions . Although only 10 % to 15 % of in patients resuscitated outside intensive care units survive to hospital discharge , early warning signs are present in a large percentage of patients who ultimately experience cardiac arrest .  Rapid response team systems bring expert clinicians to the bedsides of deteriorating patients before arrest occurs . In the mid 1990s , based largely on reports from Australian investigators , the Institute for Healthcare Improvement and others began introducing the concept to willing hospitals . Local experience strongly suggested that these systems often , although not always , were associated with improved outcomes , including reduced anxiety among nursing staff ; increased interdisciplinary teamwork ; decreased cardiac arrests outside of intensive care units ; and , in some cases , declines in mortality . The evidence base took a turn in June 2005 with the publication of the Medical Early Response Intervention and Therapy ( MERIT ) Study , a cluster r and omized prospect i ve trial that cl aim ed to find no beneficial effect of these teams on several primary outcomes . Controversy has continued since then regarding the scientific evidence for rapid response systems . In fact , the MERIT trial was not negative ; it was inconclusive . The study team encountered an array of serious problems in execution , common in social science . For example , although the study ’s power calculation assumed a baseline rate of 30 events per 1000 admissions , the actual rate proved to be fewer than 7 events per 1000 admissions ; thus , the study was ef fect ively underpowered by 500 % . Crosscontamination abounded ; some control hospitals implemented rapid response protocol s , and several study Objective To develop and test a distance-learning programme to improve the quality and efficiency of family planning services in Guatemala . Methods The setting was rural family planning services in Guatemala . The study design was quasi-experimental with one intervention and one control group and with pre- and post-intervention measures . Two staff members from each of 20 r and omly selected health districts were trained as leaders of the training programme . In turn , the 40 trainers trained a total of 240 service providers , under the supervision of four health area facilitators . The results were compared with 20 r and omly selected control health districts . The intervention was a distance-learning programme including 40 in-class hours followed by 120 inservice practice hours spread over a 4-month period . Distinctively , the programme used a cascade approach to training , intensive supervision , and close monitoring and evaluation . Patient flow analysis was used to determine number of contacts , waiting times , and the interaction time between service providers and clients . Consultation observations were used to assess the quality and completeness of reproductive health information and services received by clients . Results The intervention showed a positive impact on reducing the number of contacts before the consultation and client waiting times . More complete services and better quality services were provided at intervention clinics . Some , but not all , of the study objectives were attained . The long-term impact of the intervention is as yet unknown . Conclusion Distance-learning programmes are an effective methodology for training health professionals in rural areas Hypertension control rates are unacceptably low in China . The present study demonstrates if a customized , guideline -oriented training program can cost-effectively improve hypertension management in primary healthcare . Four typical community health centers in Beijing were selected and r and omized to intervention or control ( one urban and one rural each ) . A sample of 140 patients with hypertension and blood pressure uncontrolled was recruited from each center . Primary healthcare providers in intervention centers provided management to the recruited patients for 1 year after receiving training with customized hypertension management guidelines , and primary healthcare providers in control provided with usual care . Intention-to-treat analysis showed that hypertension control ( systolic blood pressure ( SBP ) < 140 mm Hg and diastolic blood pressure ( DBP ) < 90 mm Hg ) ) rate was significantly higher in interventions than controls at month 3 ( 42.1 % vs. 34.3 % in urban and 30.7 % vs. 10.0 % in rural centers ) and the trend increased to month 12 ( 70.7 % vs. 40.0 % in urban and 72.9 % vs. 27.9 % in rural ) ; P-values by logistic mixed model were all < 0.001 for both urban and rural after adjustment for baseline multiple variables including blood pressure . Mean reductions of SBP and DBP were significantly larger in interventions . The intervention was cost-saving , with an average incremental cost-saving of US$ 20.3 per patient in urban sites and $ 7.0 per patient in rural sites . Corresponding results from per- protocol analysis were very similar . The customized , guideline -oriented hypertension management program in primary healthcare in China effectively improved blood pressure control and was cost-saving Background Globally , almost 4 million newborns die during the first 4 weeks of life every year . By increased use of evidence -based knowledge in the healthcare system a large proportion of these neonatal deaths could be prevented . But there is a severe lack of knowledge on effective methods for successful implementation of evidence into practice , particularly in low- and middle-income countries . Recent studies have demonstrated promising results with increased survival among both mothers and newborns using community-based approaches . In Vietnam  evidence -based guidelines on reproductive health were launched in 2003 and revised in 2009 . The overall objective of the current project is to evaluate if a facilitation intervention on the community level , with a problem-solving approach involving local representatives if the healthcare system and the community , results in improvements of neonatal health and survival . Methods / Design The study , which has been given the acronym NeoKIP ( Neonatal Health - Knowledge Into Practice ) , took place in 8 districts composed by 90 communes in a province in northern Vietnam , where neonatal mortality rate was 24/1000 in 2005 . A cluster r and omised design was used , allocating clusters , as defined as a commune and its correponding Commune Health Center ( CHC ) to either intervention or control arm . The facilitation intervention targeted staff at healthcare centres and key persons in the communes . The facilitator role was performed by lay women ( Women 's Union representatives ) using quality improvement techniques to initiate and sustain improvement processes targeting identified problem areas . The intervention has been running over 3 years and data were collected on the facilitation process , healthcare staff knowledge in neonatal care and their behaviour in clinical practice , and reproductive and perinatal health indicators . Primary outcome is neonatal mortality . Discussion The intervention is participatory and dynamic , focused on developing a learning process and a problem-solving cycle . The study recognises the vital role of the local community as actors in improving their own and their newborns ' health , and applies a bottom-up approach where change will be accomplished by an increasing awareness at and dem and from grass root level . By utilising the existing healthcare structure this intervention may , if proven successful , be well suited for scaling up . Trial registration Current Controlled Trials IS RCT Malnutrition is common among children aged 6–24 months in developing countries . It increases the risk of mortality .  Interventions to improve infant-feeding hold the promise of reducing malnutrition among these children . A study in Brazil has shown the success of training in communication and counselling skills among health workers in improving the nutritional status of young children . Questions were raised whether the method used in the study in Brazil would also be effective when applied in other countries . The aim of the present study was to reduce growth faltering in young children through proper nutrition-promotion techniques . The objective of the study was to determine the efficacy of training health workers in nutrition counselling in enhancing their communication skills and performance , improving feeding practice s , and reducing  growth faltering in children aged 6–24 months . A cluster-r and omized controlled trial was carried out . The method used in this study was a replica of the method in a similar study in Pelotas , Brazil . Forty health centres were paired , and one centre of each pair was r and omly allocated to the intervention group , and the other to the control group . The Integrated Management of Childhood Illness ( IMCI ) module—‘Counsel the mother'—was used for training health workers in the health centres in the intervention group . Data from 36 paired health centres and 375 mothers and their children aged 6–24 months recruited from these health centres following consultation with health workers were included in analysis . Independent observers , masked to the intervention status , examined the performance of health workers within the first month after training . Mother-child pairs were visited at home within two weeks , 45 days , and 180 days after recruitment . Information was recorded on the feeding practice s , recall of the recommendations of health workers , and sociodemographic variables at these home-visits . Weight and length of the child were measured at each contact . The communication skills and consultation performance of health workers were significantly better in the intervention group than in the control group . The mothers ' recall of the recommendation of health workers and reported infant-feeding practice s were also significantly better in the intervention group than in the control group , even 180 days after the recruitment consultation . Growth faltering was less in the intervention group , with the largest effect observed among children in the age-group of 12 + months . These results indicate that training in IMCI feeding counselling can enhance the communication skills and performance of health workers . Improved feeding practice s of counselled mothers can , in turn , reduce growth faltering in their children Background Diarrhoea and pneumonia contribute 30 % of deaths in children under 5 in Pakistan . Pakistan ’s Lady Health Workers Programme ( LHW-P ) covers about 60 % of the population but has had little impact in reducing morbidity and mortality related to these major childhood killers . An external evaluation of the LHW-P suggests that lack of supportive supervision of LHWs by lady health supervisors ( LHSs ) is a key determinant of this problem . Project NIGRAAN aims to improve knowledge and skills of LHWs and community caregivers through supervisory strategies employed by LHSs . Ultimately , community case management ( CCM ) of childhood pneumonia and diarrhoea will improve . Methods / Design NIGRAAN is a cluster-r and omised trial in District Badin , Pakistan . There are approximately 1100 LHWs supervised by 36 LHSs in Badin . For this study , each LHS serves as a cluster . All LHSs working permanently in Badin who regularly conduct and report field visits are eligible . Thirty-four LHSs have been allocated to either intervention or control arms in a ratio of 1:1 through computer-generated simple r and omisation technique . Five LHWs from each LHSs are also r and omly picked . All 34 LHSs and 170 LHWs will be actively monitored . The intervention consists of training to build LHS knowledge and skills , clinical mentorship and written feedback to LHWs . Pre- and post-intervention assessment s of LHSs , LHWs and community caregivers will be conducted via focus group discussion s , in-depth interviews , knowledge assessment question naires , skill assessment scorecards and household surveys . Primary outcome is improvement in CCM practice s of childhood diarrhoea and pneumonia and will be assessed at the cluster level . Discussion NIGRAAN takes a novel approach to implementation research and explores whether training of LHSs in supervisory skills results in improving the CCM practice s of childhood diarrhoea and pneumonia . No significant harm to participants is anticipated . The enablers and barriers towards improved CCM would provide recommendations to policymakers for scale up of this intervention nationally and regionally . Trial registration NIGRAAN is registered with the ‘ Australian New Zeal and Clinical Trials Registry ’ . Registration Number : Background In developing countries like Malawi , further investigation is rare after patients with chronic cough test negative for tuberculosis . Chronic airways disease has presentations that overlap with tuberculosis . However , chronic airways disease is often unrecognised due to a lack of diagnostic services . Within developing countries , referral systems at primary health care level are weak and patients turn to unskilled informal health providers to seek health care . Delayed diagnosis and treatment of these diseases facilitates increased severity and tuberculosis transmission . The World Health Organisation developed the Practical Approach to Lung Health strategy which has been shown to improve the management of both tuberculosis and chronic airways disease . The guidelines address the need for integrated guidelines for tuberculosis and chronic airways disease . Engaging with informal health providers has been shown to be effective in improving health services uptake . However , it is not known whether engaging community informal health providers would have a positive impact in the implementation of the Practical Approach to Lung Health strategy . We will use a cluster r and omised controlled trial to determine the effect of using the two interventions to improve case detection and treatment of patients with tuberculosis and chronic airways disease . Methods A three-arm cluster r and omised trial design will be used . A primary health centre catchment population will form a cluster , which will be r and omly allocated to one of the arms . The first arm personnel will receive the Practical Approach to Lung Health strategy intervention . In addition to this strategy , the second arm personnel will receive training of informal health providers . The third arm is the control . The effect of interventions will be evaluated by community surveys . Data regarding the diagnosis and management of chronic cough will be gathered from primary health centres . Discussion This trial seeks to determine the effect of Informal Health Provider and Practical Approach to Lung Health interventions on the detection and management of chronic airways disease and tuberculosis at primary care level in Malawi . Trial registration The unique identification number for the registry is PACTR201411000910192 – 21 November To strengthen Haiti 's primary health care ( PHC ) system , the country first piloted performance-based financing ( PBF ) in 1999 and subsequently exp and ed the approach to most internationally funded non-government organizations . PBF complements support ( training and technical assistance ) . This study evaluates ( a ) the separate impact of PBF and international support on PHC 's service delivery ; ( b ) the combined impact of PBF and technical assistance on PHC 's service delivery ; and ( c ) the costs of  PBF  implementation in Haiti . To minimize the risk of facilities neglecting potential non-incentivized services , the incentivized indicators were r and omly chosen at the end of each year . We obtained quantities of key services from four departments for 217 health centres ( 15 with PBF and 202 without ) from 2008 through 2010 , computed quarterly growth rates and analysed the results using a difference-in-differences approach by comparing the growth of incentivized and non-incentivized services between PBF and non-PBF facilities . To interpret the statistical analyses , we also interviewed staff in four facilities . Whereas international support added 39 % to base costs of PHC , incentive payments added only 6 % . Support alone increased the quantities of PHC services over 3 years by 35 % ( 2.7%/quarter ) . However , support plus incentives increased these amounts by 87 % over 3 years ( 5.7%/quarter ) compared with facilities with neither input . Incentives alone was associated with a net 39 % increase over this period , and more than doubled the growth of services ( P < 0.05 ) . Interview findings found no adverse impacts and , in fact , indicated beneficial impacts on quality . Incentives proved to be a relatively inexpensive , well accepted and very effective complement to support , suggesting that a small amount of money , strategically used , can substantially improve PHC .  Haiti 's experience , after more than a decade of use , indicates that incentives are an effective tool to strengthen PHC Background In many healthcare systems , client satisfaction has been considered as an important indicator of primary healthcare quality . Hence communication education might be leading to better quality of family planning services and higher client satisfaction . This study aim ed to evaluate to what extent the communication skills training program could improve client satisfaction . Methods This was a r and omized controlled trial undertaken in health centers of Mashhad University Medical Sciences , Mashhad , Iran from July to September 2004 . Eligible participants were from two population targets , including healthcare providers and their clients . All 35 health centers were r and omly divided into intervention ( n = 17 ) and control groups ( n = 18 ) . The healthcare providers were working in intervention centers ( n = 24 ) not in control centers ( n = 27 ) received an additional communication skills training program in spite of routine education . Data regarding communication knowledge , attitude , and skills from healthcare providers and the satisfaction rate from the their clients ( n = 47 client for each group ) were collected at two time points . Results This study showed that communication knowledge and skills of health workers improved significantly in the intervention group ( P < 0.05 ) . Furthermore the score of client satisfaction was significantly improved in the intervention group after 1 month follow-up ( p < 0.05 ) . Conclusion The communication skills training program is an effective intervention and may improve the satisfaction rate of clients Background Feeding practice s and child undernutrition can be improved when trained health workers provide proper nutrition counseling to caregivers . However , this important management component is difficult to achieve in countries where trained health workers are limited ; Tanzania is no exception . In rural and semi-urban areas , mid-level providers ( MLPs ) are left to manage diseases such as HIV/AIDS.Training health workers in nutrition has been shown to be an effective intervention among HIV-negative children elsewhere , but no studies have been conducted among HIV-positive children . Furthermore , in Tanzania and other countries with MLPs , no evidence currently exists demonstrating an improvement in nutrition among children who receive health services given by MLPs . This study thus aims to examine the efficacy of nutrition training of MLPs on feeding practice s and the nutrition status of HIV-positive children in Tanga , Tanzania . Methods / Design We will conduct a cluster r and omized controlled trial in care and treatment centers ( CTCs ) in Tanga , Tanzania . The CTCs will be the unit of r and omization . We will select 16 CTCs out of 32 for this study , of which we will r and omly assign 8 to the intervention arm and 8 to the control arm by coin flipping . From the selected CTCs we will attempt to recruit a total of 800 HIV-positive children aged 6 months to 14 years , half of whom will be receiving care and /or treatment in the CTCs of the intervention arm , and the other half of whom will be receiving care and /or treatment in the CTCs of the control arm ( 400 children in each condition).We will provide nutrition training to MLPs of the CTCs selected for the intervention arm . In this intervention , we will use the World Health Organization guidelines on nutrition training of health workers for HIV-positive children aged 6 months to 14 years . The trained MLPs will then provide tailored nutrition counseling to caregivers of children being treated at the 8 CTCs of the intervention arm . We will measure nutrition status and child feeding practice s monthly for a total of six months . Conclusions Results of this trial will help exp and ing undernutrition interventions among HIV-positive children in Tanzania and other countries . Trial registration Current Controlled Trials : IS RCT N65346364 Background In low-income countries , only about a third of Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome ( HIV/AIDS ) patients eligible for anti-retroviral treatment currently receive it . Providing de central ized treatment close to where patients live is crucial to a faster scale up , however , a key obstacle is limited health system capacity due to a shortage of trained health-care workers and challenges of integrating HIV/AIDS care with other primary care services ( e.g. tuberculosis , malaria , respiratory conditions ) . This study will test an adapted primary care health care worker training and guideline intervention , Practical Approach to Lung Health and HIV/AIDS Malawi ( PALM PLUS ) , on staff retention and satisfaction , and quality of patient care . Methods / Design A cluster-r and omized trial design is being used to compare usual care with a st and ardized clinical guideline and training intervention , PALM PLUS . The intervention targets middle-cadre health care workers ( nurses , clinical officers , medical assistants ) in 30 rural primary care health centres in a single district in Malawi .  PALM PLUS is an integrated , symptom-based and user-friendly guideline consistent with Malawian national treatment protocol s. Training is st and ardized and based on an educational outreach approach . Trainers will be front-line peer healthcare workers trained to provide outreach training and support to their fellow front-line healthcare workers during focused ( 1 - 2 hours ) , intermittent , interactive sessions on-site in health centers . Primary outcomes are health care worker retention and satisfaction . Secondary outcomes are clinical outcomes measured at the health centre level for HIV/AIDS , tuberculosis , prevention-of-mother-to-child-transmission of HIV and other primary care conditions . Effect sizes and 95 % confidence intervals for outcomes will be presented . Assessment of outcomes will occur at 1 year post- implementation . Discussion The PALM PLUS trial aims to address a key problem : strengthening middle-cadre health care workers to support the broader scale up of HIV/AIDS services and their integration into primary care . The trial will test whether the PALM PLUS intervention improves staff satisfaction and retention , as well as the quality of patient care , when compared to usual practice .Trial Registration Current controlled Trials : IS RCT Background Antenatal care ( ANC ) reduces maternal and perinatal morbidity and mortality directly through the detection and treatment of pregnancy-related illnesses , and indirectly through the detection of women at increased risk of delivery complications . The potential benefits of quality antenatal care services are most significant in low-re source countries where morbidity and mortality levels among women of reproductive age and neonates are higher . WHO developed an ANC model that recommended the delivery of services scientifically proven to improve maternal , perinatal and neonatal outcomes . The aim of this study is to determine the effect of an intervention design ed to increase the use of the package of evidence -based services  included in the WHO ANC model in Mozambique . The primary hypothesis is that the intervention will increase the use of evidence -based practice s during ANC visits in comparison to the st and ard dissemination channels currently used in the country . Methods This is a demonstration project to be developed through a facility-based cluster r and omized controlled trial with a stepped wedge design . The intervention was tailored , based on formative research findings , to be readily applicable to local prenatal care services and acceptable to local pregnant women and health providers . The intervention includes four components : the provision of kits with all necessary medicines and laboratory supplies for ANC ( medical and non-medical equipment ) , a storage system , a tracking system , and training sessions for health care providers .  Ten clinics were selected and will start receiving the intervention in a r and om order . Outcomes will be computed at each time point when a new clinic starts the intervention . The primary outcomes are the delivery of selected health care practice s to women attending the first ANC visit , and secondary outcomes are the delivery of selected health care practice s to women attending second and higher ANC visits as well as the attitude of midwives in relation to adopting the practice s. This demonstration project is pragmatic in orientation and will be conducted under routine conditions . Discussion There is an urgent need for effective and sustainable scaling-up approaches of health interventions in low-re source countries . This can only be accomplished by the engagement of the country ’s health stakeholders at all levels . This project aims to achieve improvement in the quality of antenatal care in Mozambique through the implementation of a multifaceted intervention on three levels : policy , organizational and health care delivery levels . The implementation of the trial will probably require a change in accountability and behaviour of health care providers and we expect this change in ‘ habits ’ will contribute to obtaining reliable health indicators , not only related to research issues , but also to health care outcomes derived from the new health care model . At policy level , the results of this study may suggest a need for revision of the supply chain management system . Given that supply chain management is a major challenge for many low-re source countries , we envisage that important lessons on how to improve the supply chain in Mozambique and other similar setting s , will be drawn from this study .Trial registration Pan African Clinical Trial Registry data base . Identification number : PACTR201306000550192 Background The effects of two interventions , Integrated Management of Infectious Disease ( IMID ) training program and On-Site Support ( OSS ) , were tested on 23 facility performance indicators for emergency triage assessment and treatment ( ETAT ) , malaria , pneumonia , tuberculosis , and HIV . Methods The trial was implemented in 36 primary care facilities in Ug and a. From April 2010 , two mid-level practitioners per facility participated in IMID training .  Eighteen of 36 facilities were r and omly assigned to Arm A , and received OSS in 2010 ( nine monthly two-day sessions ) ; 18 facilities assigned to Arm B did not receive OSS in 2010 . Data were collected from Nov 2009 to Dec 2010 using a revised Ministry of Health outpatient medical form and nine registers . We analyzed the effect of IMID training alone by measuring changes before and during IMID training in Arm B , the combined effect of IMID training and OSS by measuring changes in Arm A , and the incremental effect of OSS by comparing changes across Arms A and B. Results IMID training was associated with statistically significant improvement in three indicators : out patients triaged ( adjusted relative risks ( aRR ) = 1.29 , 99%CI = 1.01,1.64 ) , emergency and priority patients admitted , detained , or referred ( aRR = 1.59 , 99%CI = 1.04,2.44 ) , and pneumonia suspects assessed ( aRR = 2.31 , 99%CI = 1.50,3.55 ) . IMID training and OSS combined was associated with improvements in six indicators : three ETAT indicators ( out patients triaged ( aRR = 2.03 , 99%CI = 1.13,3.64 ) , emergency and priority patients admitted , detained or referred ( aRR = 3.03 , 99%CI = 1.40,6.56 ) , and emergency patients receiving at least one appropriate treatment ( aRR = 1.77 , 99%CI = 1.10,2.84 ) ) ; two malaria indicators ( malaria cases receiving appropriate antimalarial ( aRR = 1.50 , 99%CI = 1.04,2.17 ) , and patients with negative malaria test results prescribed antimalarial ( aRR = 0.67 , 99%CI = 0.46,0.97 ) ) ; and enrollment in HIV care ( aRR = 1.58 , 99%CI = 1.32,1.89 ) . OSS was associated with incremental improvement in emergency patients receiving at least one appropriate treatment ( adjusted ratio of RR = 1.84,99%CI = 1.09,3.12 ) . Conclusion The trial showed that the OSS intervention significantly improved performance in one of 23 facility indicators Ensuring the availability of essential drugs and using them appropriately are crucial if limited re sources for health care are to be used optimally . While training of health workers throughout Zimbabwe in drug management ( including stock management and rational drug use ) result ed in significant improvements in a variety of drug use indicators , these achievements could not be sustained , and a new strategy was introduced based on the supervision of primary health care providers . This was launched in 1995 with a training course in supervisory skills for district pharmacy staff . In order to evaluate the impact of the supervision and the effectiveness of the training programme , adherence to st and ard treatment guidelines ( STG ) and stock management protocol s was evaluated in a r and omized controlled trial . The study compared three different groups of health facilities : those that received supervision for either use of STG ( n = 23 ) or stock management ( n = 21 ) - each facility acting as control for the other area of supervision - and a comparison group of facilities which received no supervision ( n = 18 ) . On-the-spot supervision by a specially trained pharmacy staff , based around identified deficiencies , took place at the start of the study and 3 months later . The evaluation compared performance on a variety of drug management indicators at baseline and 6 - 8 months after the second supervisory visit . The results of the study showed that , following supervision , overall stock management improved significantly when compared with the control and comparison groups . Similar improvements were demonstrated for adherence to STG , although the effect was confounded by other interventions . The study also showed that supervision has a positive effect on improving performance in areas other than those supervised , and demonstrated that pharmacy technicians with limited clinical skills can be trained to influence primary health care workers to positively improve prescribing practice s. Allocating re sources to supervision is likely to result in improved performance of health workers with regard to the rational use of essential drugs , result ing in improved efficiency and effectiveness Background The public reporting of health outcomes has become one of the most popular topics and is accepted as a quality improvement method in the healthcare field . However , little research has been conducted on the transparency mechanism , and results are mixed with regard to the evaluation of the effect of public reporting on quality improvement . The objectives of this trial are to investigate the transparency mechanism and to evaluate the effect of public reporting on prescription at the level of individual participants . Methods / Design This study involves a cluster r and omized controlled trial conducted in 20 primary -care facilities ( clusters ) . Eligible clusters are those facilities with excellent hospital information systems and that have agreed to participate in the trial . The 20 clusters are matched into 10 pairs according to Technique for Order Preference by Similarity to Ideal Solution score . As the unit of r and omization , each pair of facilities is assigned at r and om to a control or an intervention group through coin flipping . Prescribed ranking information is publicly reported in the intervention group . The public material s include the posters of individuals and of facilities , the ranking lists of general practitioners , and brochures of patients , which are up date d monthly . The intervention began on 13th November 2013 and lasted for one year . Specifically , participants are surveyed at five points in time ( baseline , quarterly following the intervention ) through question naires , interviews , and observations . These participants include an average of 600 patients , 300 general practitioners , 15 directors , and 6 health bureau administrators . The primary outcomes are the transparency mechanism model and the changes in medicine-prescribe . Subsequently , the modifications in the transparency mechanism constructs are evaluated . The outcomes are measured at the individual participant level , and the professional who analyzes the data is blind to the r and omization status . Discussion This study protocol outlines a design that aims to examine the transparency mechanism and to evaluate the effect of public reporting on prescription . The research design is significant in the field of public policy . Furthermore , this study intends to fill the gap of the investigation of the transparency mechanism and the evaluation of public reporting on prescription SETTING Public sector primary care clinics in Free State Province , South Africa . OBJECTIVES To investigate the effects of on-site in-service clinical skills training for nurse practitioners on tuberculosis ( TB ) treatment outcomes in the same clinics . DESIGN Analysis of TB programme data from clinics taking part in two consecutive r and omised trials of educational outreach aim ed at improving respiratory and human immunodeficiency virus/acquired immune-deficiency syndrome care based on the Practical Approach to Lung Health . We compared treatment outcomes between  control and intervention clinics among all patients diagnosed with TB during either trial . RESULTS During the two trials , participating clinics treated 4187 and 2333 TB patients , respectively . Neither intervention was associated with better outcomes overall . However , among retreatment patients , cure or completion rates in intervention clinics were significantly higher during the second trial ( OR 1.78 , 95%CI 1.13 - 2.76 ) . Patients in clinics that had received both interventions had higher cure or completion rates ( OR 1.99 , 95%CI 1.53 - 2.58 ) and lower default rates ( OR 0.25 , 95%CI 0.097 - 0.63 ) than patients in clinics that had received neither intervention . CONCLUSION Although not primarily focused on TB treatment , the interventions appeared to improve successful treatment completion rates among TB retreatment cases . Integrated care programmes support attainment of important TB programme goals Objective A major problem with inappropriate use of antibiotics is the emergence of resistance . Thus , cost-effective interventional strategies are required to improve their use . This study aim ed to evaluate the effect of multifaceted interventions on prescribing practice s of antibiotics in health centers of Khartoum State , Sudan . Methods Twenty health centers were r and omly assigned to receive : ( 1 ) no intervention ; ( 2 ) audit and feedback ; ( 3 ) audit and feedback + seminar ; or ( 4 ) audit and feedback + academic detailing . A total of 1,800 patient encounters , 30 from each health center , were r and omly collected . The total number of encounters with antibiotics prescribed were determined in each health center and they were evaluated with regard to antibiotic choice , dose and duration of therapy before the study and at 1 and 3 months post-intervention . Results In comparison to the control group , the prescriber targeted interventions involving audit and feedback , together with academic detailing ( 4 ) , reduced the mean number of encounters with an antibiotic prescribed by 6.3 and 7.7 ( p<0.001 ) at 1 and 3 months post-intervention , respectively . In addition , the mean number of encounters with an inappropriate antibiotic with respect to diagnosis , doses and / or duration of therapy was reduced by 5.3 and 5.9 ( p<0.001 ) at 1 and 3 months post-intervention , respectively . For audit and feedback together with seminars ( 3 ) and for audit and feedback alone ( 2 ) , the corresponding reductions were 5.3 , 7.1 , 4.4 and 5.1 ( p<0.001 ) and 1.4 , 2.8 , 1.8 and 1.9 ( p>0.05 ) , respectively . Conclusion Inappropriate prescribing patterns of antibiotics in health centers of Khartoum State , Sudan , are alarmingly high . Multifaceted interventions involving audit and feedback combined with either academic detailing or seminars appear more effective in changing prescribing practice s of antibiotics than audit and feedback alone OBJECTIVES To assess the effect of Integrated Management of Childhood Illness ( IMCI ) relative to routine care on the quality and efficiency of providing care for sick children in first-level health facilities in Tanzania , and to disseminate the results for use in health sector decision-making . DESIGN Non-r and omized controlled trial to compare child health care quality and economic costs in two intervention ( > 90 % of health care workers trained in IMCI ) and two comparison districts in rural Tanzania . PARTICIPANTS For quality measures , all sick children presenting for care at r and om sample s of first-level health facilities ; for costs , all national , district , facility and household costs associated with child health care , taking a societal perspective . RESULTS IMCI training is associated with significantly better child health care in facilities at no additional cost to districts . The cost per child visit managed correctly was lower in IMCI than in routine care setting s : $ 4.02 versus $ 25.70 , respectively , in 1999 US dollars and after st and ardization for variations in population size . CONCLUSION IMCI improved the quality and efficiency of child health care relative to routine child health care in the study districts . Previous study results indicated that the introduction of IMCI in these Tanzanian districts was associated with mortality levels that were 13 % lower than in comparison districts . We can therefore conclude that IMCI is also more cost-effective than routine care for improving child health outcomes . The dissemination strategy for these results led to adoption of IMCI for nationwide implementation within 12 months of study completion The objective of this study was to estimate the caries impact of providing training in infant feeding guidelines to workers at Brazilian public primary care clinics . In a cluster-r and omized controlled trial ( n = 20 clinics ) , health care workers either were trained in guidelines for infant nutrition , stressing healthful complementary feeding , or were assigned to a ‘ usual practice s ’ control , which allowed for maternal counseling at practitioner discretion . Training occurred once ; the amount of counseling provided to mothers was not assessed . Eligible pregnant women were enrolled to follow health outcomes in their children .  Early childhood caries ( ECC ) was measured at age three years ( n = 458 children ) . The overall reductions in ECC ( relative risk , 0.92 ; 95%CI , 0.75 , 1.12 ) and severe ECC ( RR , 0.87 ; 95%CI , 0.64 , 1.19 ) were not statistically significant . There was a protective effect among mothers who remained exclusively at the same health center ( S-ECC RR , 0.68 ; 95%CI , 0.47 , 0.99 ) and among those naming the health center as their principal source of feeding advice ( S-ECC RR , 0.53 ; 95%CI , 0.29 , 0.97 ) . Health care worker training did not yield a statistically significant reduction in caries overall , although caries was reduced among children of mothers more connected to their health centers ( Clinical Trials.gov NCT00635453 ) BACKGROUND Of the 3.7 million neonatal deaths and 3.3 million stillbirths each year , 98 % occur in developing countries . An evaluation of community-based interventions design ed to reduce the number of these deaths is needed . METHODS With the use of a train-the-trainer model , local instructors trained birth attendants from rural communities in six countries ( Argentina , Democratic Republic of Congo , Guatemala , India , Pakistan , and Zambia ) in the World Health Organization Essential Newborn Care course ( which focuses on routine neonatal care , resuscitation , thermoregulation , breast-feeding , " kangaroo " [ skin-to-skin ] care , care of the small baby , and common illnesses ) and ( except in Argentina ) in a modified version of the American Academy of Pediatrics Neonatal Resuscitation Program ( which teaches basic resuscitation in depth ) . The Essential Newborn Care intervention was assessed among 57,643 infants with the use of a before- and -after design . The Neonatal Resuscitation Program intervention was assessed as a cluster-r and omized , controlled trial involving 62,366 infants . The primary outcome was neonatal death in the first 7 days after birth . RESULTS The 7-day follow-up rate was 99.2 % . After birth attendants were trained in the Essential Newborn Care course , there was no significant reduction from baseline in the rate of neonatal death from all causes in the 7 days after birth ( relative risk with training , 0.99 ; 95 % confidence interval [ CI ] , 0.81 to 1.22 ) or in the rate of perinatal death ; there was a significant reduction in the rate of stillbirth ( relative risk with training , 0.69 ; 95 % CI , 0.54 to 0.88 ; P=0.003 ) . In clusters of births in which attendants had been r and omly assigned to receive training in the Neonatal Resuscitation Program , as compared with control clusters , there was no reduction in the rates of neonatal death in the 7 days after birth , stillbirth , or perinatal death . CONCLUSIONS The rate of neonatal death in the 7 days after birth did not decrease after the introduction of Essential Newborn Care training of community-based birth attendants , although the rate of stillbirths was reduced . Subsequent training in the Neonatal Resuscitation Program did not significantly reduce the mortality rates . ( Clinical Trials.gov number , NCT00136708 . Summary Background Although the effectiveness of community mobilisation and promotive care delivered by community health workers in reducing perinatal and neonatal mortality is well established , evidence in support of home-based neonatal resuscitation and infection management is mixed . We assessed the effectiveness of adding training in neonatal bag and mask resuscitation and oral antibiotic therapy for suspected neonatal infections to a basic preventive and promotive interventions package delivered by public sector community-based lady health workers ( LHWs ) in rural Pakistan . Methods We did a cluster-r and omised controlled trial in two subdistricts of Naushahro Feroze in rural Sindh , Pakistan , between April 15 , 2009 , and Dec 10 , 2012 . LHWs , trained in basic newborn resuscitation and in recognition and treatment ( with oral amoxicillin ) of suspected neonatal respiratory infections , were linked with traditional birth attendants and encouraged to attend home births . Control clusters received routine care through the existing national programme . The primary outcome was all-cause neonatal mortality . Independent data collection teams recorded data for all pregnancies and their outcomes , morbidity , mortality , and household practice s related to maternal and newborn care . Findings Of the 27 r and omised clusters with functional LHW programmes , 13 were allocated to the intervention group ( n=242 749 ) and 14 to the control group ( n=256 985 ) . In the intervention group , LHWs did 80 % of the planned community mobilisation sessions , but were able to attend only 1184 ( 14 % ) of 8425 deliveries and 4318 ( 25 % ) of 17 288 neonatal visits within 72 h of birth ( p<0·0001 for both variables compared with the control group ) . The neonatal mortality rate was 42 deaths per 1000 livebirths in intervention clusters compared with 55 per 1000 in the control group ( risk ratio 0·80 , 95 % CI 0·68–0·93 ; p=0·005 ) . Interpretation The reduction in neonatal mortality in intervention clusters occurred against a background of improvements in domiciliary practice s for maternal and newborn care . However , the poor reach of LHWs in accessing newborn infants at birth and in the early postnatal period underscores the limitations of tasking community health workers in public sector programmes working in similar circumstances with such complex interventions . Such community-based interventions in health systems should be accompanied by concerted efforts to improve quality of care in facilities and referral systems . Funding Saving Newborn Lives , Save the Children USA BACKGROUND WHO and UNICEF launched the Integrated Management of Childhood Illness ( IMCI ) strategy in the mid-1990s to reduce deaths from diarrhoea , pneumonia , malaria , measles , and malnutrition in children younger than 5 years . We assessed the effect of IMCI on health and nutrition of children younger than 5 years in Bangladesh . METHODS In this cluster r and omised trial , 20 first-level government health facilities in the Matlab subdistrict of Bangladesh and their catchment areas ( total population about 350 000 ) were paired and r and omly assigned to either IMCI ( intervention ; ten clusters ) or usual services ( comparison ; ten clusters ) . All three components of IMCI-health-worker training , health-systems improvements , and family and community activities-were implemented beginning in February , 2002 . Assessment included household and health facility surveys tracking intermediate outputs and outcomes , and nutrition and mortality changes in intervention and comparison areas . Primary endpoint was mortality in children aged between 7 days and 59 months .  Analysis was by intention to treat . This study is registered , number IS RCT N52793850 . FINDINGS The yearly rate of mortality reduction in children younger than 5 years ( excluding deaths in first week of life ) was similar in IMCI and comparison areas ( 8.6%vs 7.8 % ) . In the last 2 years of the study , the mortality rate was 13.4 % lower in IMCI than in comparison areas ( 95 % CI -14.2 to 34.3 ) , corresponding to 4.2 fewer deaths per 1000 livebirths ( 95 % CI -4.1 to 12.4 ; p=0.30 ) . Implementation of IMCI led to improved health-worker skills , health-system support , and family and community practice s , translating into increased care-seeking for illnesses . In IMCI areas , more children younger than 6 months were exclusively breastfed ( 76%vs 65 % , difference of differences 10.1 % , 95 % CI 2.65 - 17.62 ) , and prevalence of stunting in children aged 24 - 59 months decreased more rapidly ( difference of differences -7.33 , 95 % CI -13.83 to -0.83 ) than in comparison areas . INTERPRETATION IMCI was associated with positive changes in all input , output , and outcome indicators , including increased exclusive breastfeeding and decreased stunting . However , IMCI implementation had no effect on mortality within the timeframe of the assessment . FUNDING Bill & Melinda Gates Foundation , WHO 's Department of Child and Adolescent Health and Development , and US Agency for International Development In rural Bangladesh , most births take place at home . There is little evidence regarding the influence of traditional birth attendants ( TBAs ) or community volunteers ( CVs ) on early infant feeding practice s. We conducted a pragmatic cluster r and omized controlled trial in Panchagarh District to examine the effects of training and post-training supervision of TBAs/CVs on early breastfeeding practice s. Nine unions were r and omized into three groups of three unions . We compared outcomes between mothers in a control group ( CG ) , those living in unions where TBAs/CVs had received a 5-day training in early feeding practice s ( TG ) and those living in unions where TBAs/CVs were both trained and supervised ( SG ) . A total of 1182 mothers of infants aged 0 - 6 months were interviewed at baseline . After 6 months of intervention , an endline survey was conducted on a different sample of 1148 mothers of infants aged 0 - 6 months in the same areas . In both intervention areas , TBAs/CVs made regular home visits and attended births whenever possible . Rates of early initiation of breastfeeding , avoidance of prelacteal feeds and exclusive breastfeeding were compared between groups using cluster-controlled mixed model logistic regression . At endline , both intervention groups had significantly higher proportions of mothers who reported early initiation of breastfeeding ( CG : 88 % , TG : 96 % , SG : 96 % ) and avoidance of prelacteal feeds ( CG : 48 % , TG : 80 % , SG : 88 % ) compared with the control group ; there were no significant differences between the two intervention groups . The endline rates of reported exclusive breastfeeding were not significantly different among groups ( CG : 67 % , TG : 76 % , SG : 83 % ) QUALITY PROBLEM Research in Kenya in the mid-1990s suggested poor quality family planning services and limited access to services . Clinical guidelines for family planning and reproductive health were published in 1991 and up date d in 1997 , but never widely distributed . CHOICE OF SOLUTION Managers and trainers chose intensive , district-level training workshops to disseminate guidelines and up date health workers on guideline content and best practice s. INTERVENTION Training workshops were held in 41 districts in 1999 . Trainees were instructed to up date their untrained co-workers afterwards . As a reinforcement , providers in r and omly selected areas received a ' cascade training package ' of instructional material s and training tips . Providers in 15 r and omly selected clinics also received ' supportive supervision ' visits as a second reinforcement . EVALUATION METHODOLOGY A cluster-r and omized experiment in 72 clinics assessed the overall impact of the training and the marginal benefits of the two reinforcing activities . Research ers and trainers created several dozen indicators of provider knowledge , attitudes , beliefs and practice s. Binomial and multivariate analyses were used to compare changes over time in indicators and in aggregated summary scores . Data from patient interviews were analysed to corroborate provider practice self-reports . Cost data were collected for an economic evaluation . RESULTS Post-test data collected in 2000 showed that quality of care and access increased after the intervention . The cascade training package showed less impact than supportive supervision , but the former was more cost-effective . LESSONS LEARNED Service delivery guidelines , when properly disseminated , can improve family planning practice s in sub-Saharan Africa BACKGROUND China 's national health policy classifies depression as a chronic disease that should be managed in primary care setting s. In some high-income countries use of chronic disease management principles and primary care-based collaborative-care models have improved outcomes for late-life depression ; however , this approach has not yet been tested in China . We aim ed to assess whether use of a collaborative-care depression care management ( DCM ) intervention could improve outcomes for Chinese adults with depression aged 60 years and older . METHODS Between Jan 17 , 2011 , [ corrected ] and Nov 30 , 2013 , we did a cluster-r and omised trial in patients from primary care centre clinics in Shangcheng district of Hangzhou city in eastern China . We r and omly assigned ( 1:1 ) clinics to either DCM ( involving training for physicians in use of treatment guidelines , training for primary care nurses to function as care managers , and consultation with psychiatrists as support ) or to give enhanced care as usual to all eligible patients aged 60 years and older with major depressive disorder . Clinics were chosen r and omly for inclusion from all primary care clinics in the district by computer algorithm and then r and omly allocated depression care interventions remotely by computer algorithm . Physicians , study personnel , and patients were not masked to clinic assignment . Our primary outcome was difference in Hamilton Depression Rating Scale ( HAMD ) score using data for clusters at baseline and 3 , 6 , and 12 month follow-up in a mixed-effects model of the intention-to-treat population . We originally aim ed to analyse outcomes at 24 months , however the difference between groups at 12 months was large and funding was insufficient to continue to 24 months , therefore we decided to end the trial at 12 months . This trial is registered with Clinical Trials.gov , number NCT01287494 . FINDINGS Of 34 primary care clinics in Shangcheng district , 16 were r and omly chosen . We r and omly assigned eight clinics to the DCM intervention ( 164 patients enrolled ) and eight primary care clinics to enhanced care as usual ( 162 patients ) . There were no major differences in baseline demographic and clinical variables between the groups of patients for each intervention . Over the 12 months , patients in clinics assigned to DCM had a significantly greater reduction in HAMD score than did those in practice s assigned to enhanced care as usual ( estimated between group difference -6·5 [ 95 % CI -7·1 to -5·9 ] ; Cohen 's d 0·8 [ 95 % CI 0·8 - 0·9 ] ; p<0·0001 ) . The intercluster correlation for change in HAMD total score was 0·07 ( 95 % CI 0·06 - 0·08 ) . There were no study -related adverse events in either group . INTERPRETATION Clinical outcomes of Chinese adults older than 60 years who had major depression were improved when their primary care clinic used DCM . Primary care-based collaborative management of depression is promising to address this pressing public health need in China . FUNDING National Institutes of Health , Program for New Century Excellent Talents in Universities of China , Ministry of Education , China OBJECTIVES We evaluated an intervention to support health workers after training in Integrated Management of Childhood Illness ( IMCI )  , a strategy that can improve outcomes for children in developing countries by encouraging workers ' use of evidence -based guidelines for managing the leading causes of child mortality . METHODS We conducted a r and omized trial in Benin . We administered a survey in 1999 to assess health care quality before IMCI training . Health workers then received training plus either study supports ( job aids , nonfinancial incentives , and supervision of workers and supervisors ) or usual supports . Follow-up surveys conducted in 2001 to 2004 assessed recommended treatment , recommended or adequate treatment , and an index of overall guideline adherence . RESULTS We analyzed 1244 consultations .  Performance improved in both intervention and control groups , with no significant differences between groups . However , training proceeded slowly , and low- quality care from health workers without IMCI training diluted intervention effects . Per- protocol analyses revealed that workers with IMCI training plus study supports provided better care than did those with training plus usual supports ( 27.3 percentage-point difference for recommended treatment ; P < .05 ) , and both groups outperformed untrained workers . CONCLUSIONS IMCI training was useful but insufficient . Relatively inexpensive supports can lead to additional improvements OBJECTIVES To assess the impact of Practical Approach to Lung Health ( PAL ) guidelines on prescription behaviour and the total cost of prescription for patients with asthma , chronic obstructive pulmonary disease and pneumonia . METHODS Pre- and post-intervention comparison in a cluster r and omized trial of primary care facilities . Seven health posts and 33 subhealth posts in Nepal were stratified by type and r and omized into intervention and control groups . Health workers from the intervention facilities received 5 days training on the adapted PAL guidelines and their use . To collect prescription details , we used carbon-copy prescription pads in both groups . To measure the impact of PAL guidelines  we used the World Health Organization 's rational use of drug indicators and drug cost indicators , in a multivariate regression analysis . RESULTS The PAL guidelines led to fewer prescriptions of multiple drugs and to more prescriptions of generic and essential drugs . The guidelines also lowered average prescription cost and wastage by disease except for chronic obstructive pulmonary disease although not to a statistically significant degree . Similarly , the prescription of antibiotics and adherence to guidelines improved , albeit not statistically significant . CONCLUSION There is evidence that the implementation of PAL guidelines promotes rational use of drugs for some respiratory diseases . The expected health effects of PAL guidelines should be compared with their implementation costs before continuing training on lung health , and strategies put in place to sustain the effects We outline CONSORT-Equity 2017 reporting st and ards , an extension to the CONSORT ( Consoli date d St and ards of Reporting Trials ) statement that aims to improve the reporting of intervention effects in r and omised trials where health equity is relevant . Health inequities are unfair differences in health that can be avoided by reasonable action . We defined a r and omised trial where health equity is relevant as one that assesses effects on health equity by evaluating an intervention focused on people experiencing social disadvantage or by exploring the difference in the effect of the intervention between two groups ( or as a gradient across more than two groups ) experiencing different levels of social disadvantage , or both . We held a consensus meeting with diverse potential users from high , middle , and low income countries , including knowledge users such as patients and method ologists . We discussed evidence for each proposed extension item from empirical studies , review s , key informant interviews , and an online survey , aim ing to improve clarity of reporting without imposing undue burden on authors . The new guidance contains equity extensions to 16 items from CONSORT 2010 plus one new item on research ethics reporting , with examples of good practice and a brief explanation and elaboration for each . Widespread uptake of this guidance for the reporting of trials where health equity is relevant will make it easier for decision makers to find and use evidence from r and omised trials to reduce unfair inequalities in health Background Effective , scalable strategies to improve maternal , fetal , and newborn health and reduce preventable morbidity and mortality are urgently needed in low- and middle-income countries . Building on the successes of previous checklist-based programs , the World Health Organization ( WHO ) and partners led the development of the Safe Childbirth Checklist ( SCC ) , a 28-item list of evidence -based practice s linked with improved maternal and newborn outcomes . Pilot-testing of the Checklist in Southern India demonstrated dramatic improvements in adherence by health workers to essential childbirth-related practice s ( EBPs ) . The BetterBirth Trial seeks to measure the effectiveness of SCC impact on EBPs , deaths , and complications at a larger scale . Methods / design This matched-pair , cluster-r and omized controlled , adaptive trial will be conducted in 120 facilities across 24 districts in Uttar Pradesh , India . Study sites , identified according to predefined eligibility criteria , were matched by measured covariates before r and omization . The intervention , the SCC embedded in a quality improvement program , consists of leadership engagement , a 2-day educational launch of the SCC , and support through placement of a trained peer “ coach ” to provide supportive supervision and real-time data feedback over an 8-month period with decreasing intensity . A facility-based childbirth quality coordinator is trained and supported to drive sustained behavior change after the BetterBirth team leaves the facility . Study participants are birth attendants and women and their newborns who present to the study facilities for childbirth at 60 intervention and 60 control sites . The primary outcome is a composite measure including maternal death , maternal severe morbidity , stillbirth , and newborn death , occurring within 7 days after birth . The sample size ( n = 171,964 ) was calculated to detect a 15 % reduction in the primary outcome . Adherence by health workers to EBPs will be measured in a subset of births ( n = 6000).The trial will be conducted in close collaboration with key partners including the Governments of India and Uttar Pradesh , the World Health Organization , an expert Scientific Advisory Committee , an experienced local implementing organization ( Population Services International , PSI ) , and frontline facility leaders and workers . Discussion If effective , the WHO Safe Childbirth Checklist program could be a powerful health facility-strengthening intervention to improve quality of care and reduce preventable harm to women and newborns , with millions of potential beneficiaries . Trial registration BetterBirth Study Protocol date d : 13 February 2014 ; Clinical Trials.gov : NCT02148952 ; Universal Trial Number : U1111 - 1131 - 5647
target: The evidence is concentrated in two types of PMM strategies : implementation strategies ( in-service training , continuing education , supervision ) and performance-based financing .
  Major gaps exist in accountability arrangements particularly the use of audit and feedback .
  The least studied types of outcomes were unintended effects , harm and social equity .
  Conclusions The evidence is clustered around interventions that are unlikely to achieve transformational change in health outcomes .
  The gaps identified suggest that routinely used PMM strategies are implemented without sufficient knowledge of their effects .
background: Introduction We mapped available evidence on  performance measurement and management ( PMM ) strategies in primary healthcare ( PHC ) systems of low-income and middle-income countries ( LMICs ) .
  Widely used , their effectiveness remains inconclusive .
  This evidence gap map characterises existing research and evidence gaps .