Patient and public involvement in the early stages of clinical trial development: a systematic cohort investigation Comparison of registered and published intervention fidelity assessment in cluster randomised trials of public health interventions in low- and middle-income countries: systematic review protocol Tackling inequalities in obesity: a protocol for a systematic review of the effectiveness of public health interventions at reducing socioeconomic inequalities in obesity amongst children Sudden cardiac death in low- and middle-income countries. Obstacles to researching the researchers: A case study of the ethical challenges of undertaking methodological research investigating the reporting of randomised controlled trials 'The public is too subjective': public involvement at different levels of health-care decision making. A systematic review of online interventions for mental health in low and middle income countries: a neglected field Systematic reviews in public health: old chestnuts and new challenges. Improving mental health among people living with HIV: a review of intervention trials in low- and middle-income countries A Systematic Review of The Impact of Improved Housing Interventions on Health In Low And Middle Income Tropical Settings. Defining and measuring health equity effects in research on task shifting interventions in high-income countries: a systematic review protocol Understanding factors associated with the translation of cardiovascular research: a multinational case study approach Interventions for domestic violence among pregnant women in low- and middle-income countries: a systematic review protocol Commentary: Replication of influential trial helps international policy Translating research into policy: lessons learned from eclampsia treatment and malaria control in three southern African countries Women's entrepreneurship and intimate partner violence: A cluster randomized trial of microenterprise assistance and partner participation in post-conflict Uganda (SSM-D-14-01580R1). Intracluster correlation coefficients and coefficients of variation for perinatal outcomes from five cluster-randomised controlled trials in low and middle-income countries: results and methodological implications The GRADE approach and Bradford Hill's criteria for causation Ethical challenges in cluster randomized controlled trials: experiences from public health interventions in Africa and Asia. Improving antiretroviral therapy adherence in resource‐limited settings at scale: a discussion of interventions and recommendations Development of a core outcome set for disease modification trials in mild to moderate dementia: a systematic review, patient and public consultation and consensus recommendations. Systematic reviews in endodontics--examples of GIGO? Improving the reporting of public health intervention research: advancing TREND and CONSORT.
Background R and omised controlled trials ( RCTs ) are considered particularly likely to benefit from patient and public involvement ( PPI ) . Decisions made by professional research ers at the outset may go on to have a significant impact on the potential for PPI contributions . Objective To increase knowledge of PPI within the early development of RCTs by systematic ally describing the reported level , nature and acceptability of proposed PPI to the funders . Methods Documentation from the outline application process for all RCTs that received funding from the Health Technology Assessment ( HTA ) Programme 2006–2010 was requested . For each application , data were extracted on trial characteristics , references to PPI in the development of the outline application and funding Board feedback , and plans for PPI in the full application and after the trial was funded . Results 110 applications were eligible with outline applications available for 90 ( 82 % ) . The cohort covered a wide range of interventions and conditions . 54 % ( 49/90 ) provided some information about PPI . 26 ( 28.9 % ) indicated PPI within the development of the outline application itself ; 32 ( 35.6 % ) planned involvement in the full application and 43 ( 48 % ) once the trial was funded . Recruitment at diagnosis and surgical interventions were less likely to describe PPI . Blinded trials and trials in which participants may receive placebo only , more frequently described PPI activity . The HTA commissioning Board feedback rarely referred to PPI . Conclusions Incorporation of PPI within the development of the outline application or specification of plans for future involvement was low . Funder requests for applicants to provide information on PPI and justification for its absence should be welcomed but further research is needed to identify the impact of this on its contributions to research . Comments on PPI by review ers should be directional rather than state that an increase is required . Challenges facing applicants in initiating PPI prior to funding need to be addressed Background Cluster r and omised trials ( CRTs ) are a key instrument to evaluate public health interventions , particularly in low- and middle-income countries ( LMICs ) . Fidelity assessment examines study processes to gauge whether an intervention was delivered as initially planned . Evaluation of implementation fidelity ( IF ) is required to establish whether the measured effects of a trial are due to the intervention itself and may be particularly important for CRTs of complex interventions . Current CRT reporting guidelines offer no guidance on IF assessment . We will systematic ally review the scientific literature to study current practice s concerning the assessment of IF in CRTs of public health interventions in LMICs . Methods We will include  CRTs of public health interventions in LMICs that planned or assessed IF in either the trial protocol or the main trial report ( or an associated document ) . Search strategies use Medical Subject Headings ( MESH ) and text words related to CRTs , developing countries , and public health interventions . The electronic data base search was developed first for MEDLINE and adapted for the following data bases : EMBASE , CINAHL , PubMed , and EMB Review s , to identify CRT reports in English , Spanish , or French published on or after January 1 , 2012 . To ensure availability of a study protocol , we will include CRTs reporting a registration number in the abstract . For each included study , we will compare planned versus reported assessment of IF , and consider the dimensions of IF studied , and data collection methods used to evaluate each dimension . Data will be synthesis ed using quantitative and narrative techniques . Risk of bias for individual studies will be assessed using the Cochrane Collaboration Risk of Bias Tool criteria and additional criteria related to CRT methods . We will investigate possible sources of heterogeneity by performing subgroup analysis . This review was not eligible for inclusion in the PROSPERO registry . Discussion Fidelity assessment may be a key tool for making studies more reliable , internally valid , and externally generalizable . This review will provide a portrait of current practice s related to the assessment of intervention fidelity in CRTs and offer suggestions for improvement . Results will be relevant to research ers , those who finance health interventions , and for decision-makers who seek the best evidence on public health interventions Background There is growing evidence of the impact of overweight and obesity on short- and long-term functioning , health and well-being . Internationally , childhood obesity rates continue to rise in some countries ( for example , Mexico , India , China and Canada ) , although there is emerging evidence of a slowing of this increase or a plateauing in some age groups . In most European countries , the United States and Australia , however , socioeconomic inequalities in relation to obesity and risk factors for obesity are widening . Addressing inequalities in obesity , therefore , has a very high profile on the public health and health services agendas . However , there is a lack of accessible policy-ready evidence on what works in terms of interventions to reduce inequalities in obesity . Methods and design This article describes the protocol for a National Health Service Trust ( NHS ) National Institute for Health Research -funded systematic review of public health interventions at the individual , community and societal levels which might reduce socioeconomic inequalities in relation to obesity amongst children ages 0 to 18 years . The studies will be selected only if ( 1 ) they included a primary outcome that is a proxy for body fatness and ( 2 ) examined differential effects with regard to socioeconomic status ( education , income , occupation , social class , deprivation and poverty ) or the intervention was targeted specifically at disadvantaged groups ( for example , children of the unemployed , lone parents , low income and so on ) or at people who live in deprived areas . A rigorous and inclusive international literature search will be conducted for r and omised and nonr and omised controlled trials , prospect i ve and retrospective cohort studies ( with and /or without control groups ) and prospect i ve repeat cross-sectional studies ( with and /or without control groups ) . The following electronic data bases will be search ed : MEDLINE , Embase , CINAHL , PsycINFO , Social Science Citation Index , ASSIA , IBSS , Sociological Abstract s and the NHS Economic Evaluation Data base . Data base search es will be supplemented with website and grey literature search es . No studies will be excluded on the basis of language , country of origin or publication date . Study inclusion , data extraction and quality appraisal will be conducted by two review ers . Meta- analysis and narrative synthesis will be conducted . The main analysis will examine the effects of ( 1 ) individual , ( 2 ) community and ( 3 ) societal level public health interventions on socioeconomic inequalities in childhood obesity . Interventions will be characterised by their level of action and their approach to tackling inequalities . Context ual information on how such public health interventions are organised , implemented and delivered will also be examined . Discussion In this review , we consider public health strategies which reduce and prevent inequalities in the prevalence of childhood obesity , highlight any gaps in the evidence base and seek to establish how such public health interventions are organised , implemented and delivered . PROSPERO registration number : Cardiovascular disease , and the incidence of sudden cardiac death ( SCD ) , will increase significantly in low- and middle-income countries ( LMIC ) . Thus , SCD threatens to become a global public health problem . We present a summary of the current research that has investigated the epidemiology of SCD in LMIC . Few studies of SCD in LMIC exist , and they are of variable method ological quality . Risk factors for SCD are described , taking into account recent global burden of disease and risk factor statistics . We describe 1 proposal for a community-based , prospect i ve , multiple- source methodology for SCD monitoring and surveillance that can be implemented in LMIC . Further research into the epidemiology of SCD in LMIC , using st and ardized methodology , would allow investigators and policy makers to determine the regions , communities , and individuals most at need for SCD prevention . Focusing on SCD and its prevention in LMIC should be a priority for the global health community Background Recent cohort studies of r and omised controlled trials have provided evidence of within- study selective reporting bias ; where statistically significant outcomes are more likely to be more completely reported compared to non-significant outcomes . Bias result ing from selective reporting can impact on meta-analyses , influencing the conclusions of systematic review s , and in turn , evidence based clinical practice guidelines .In 2006 we received funding to investigate if there was evidence of within- study selective reporting in a cohort of RCTs su bmi tted to New Zeal and Regional Ethics Committees in 1998/99 . This research involved accessing ethics applications , their amendments and annual reports , and comparing these with corresponding publications . We did not plan to obtain informed consent from trialists to view their ethics applications for practical and scientific reasons .In November 2006 we sought ethical approval to undertake the research from our institutional ethics committee . The Committee declined our application on the grounds that we were not obtaining informed consent from the trialists to view their ethics application . This initiated a seventeen month process to obtain ethical approval . This publication outlines what we planned to do , the issues we encountered , discusses the legal and ethical issues , and presents some potential solutions . Discussion and conclusion Method ological research such as this has the potential for public benefit and there is little or no harm for the participants ( trialists ) in undertaking it . Further , in New Zeal and , there is freedom of information legislation , which in this circumstance , unambiguously provided rights of access and use of the information in the ethics applications . The decision of our institutional ethics committee defeated this right and did not recognise the nature of this observational research . Method ological research , such as this , can be used to develop processes to improve quality in research reporting . Recognition of the potential benefit of this research in the broader research community , and those who sit on ethics committees , is perhaps needed . In addition , changes to the ethical review process which involve separation between those who review proposals to undertake method ological research using ethics applications , and those with responsibility for review ing ethics applications for trials , should be considered . Finally , we contend that the research community could benefit from quality improvement approaches used in allied sectors There are a number of impulses towards public participation in health care decision making including instrumentalist , communitarian , educative and expressive impulses and the desire for increased accountability . There has , however , been little research looking systematic ally at the public 's preferences for being involved in particular types of rationing decisions , nor indeed , has there been a critical examination of the degree of involvement desired by the public . The research reported here uses findings from focus groups and in-depth interviews to explore these questions . Eight focus groups were conducted with a total of 57 informants , four amongst r and omly selected members of the public and four with informants from health and non-health related organisations . Nineteen interviews were conducted to allow the elaboration of focus group comments , to probe views more deeply and to pursue emerging themes . The findings show variations in the willingness of members of the public to be involved in health care decisions and consistency across the different forms of the public as represented by the focus groups with r and omly selected citizens and pre-existing organisations . There was a strong desire in all the groups for the public to be involved both at the system and programme levels , with much less willingness to be involved at the individual level . At the system and programme levels informants generally favoured consultation , without responsibility for decisions , but with the guarantee that their contribution would be heard and that decisions taken following consultation would be explained . At the patient level informants felt that the public should participate only by setting criteria for deciding between potential beneficiaries of treatment . The public has much to contribute , particularly at the system and programme levels , to supplement the inputs of health care professionals Background . Low and middle income countries ( LMICs ) are facing an increase of the impact of mental health problems while confronted with limited re sources and limited access to mental health care , known as the ‘ mental health gap ’ . One strategy to reduce the mental health gap would be to utilize the internet to provide more widely-distributed and low cost mental health care . We undertook this systematic review to investigate the effectiveness and efficacy of online interventions in LMICs . Methods . We systematic ally search ed the data -bases PubMed , PsycINFO , JMIR , and additional sources . MeSH terms , Thesaurus , and free text keywords were used . We included all r and omized controlled trials ( RCTs ) of online interventions in LMICs . Results . We found only three articles reported results of RCTs on  online interventions for mental health conditions in LMICs , but none of these interventions was compared with an active control condition . Also , the mental health conditions were diverse across the three studies . Conclusions . There is a dearth of studies examining the effect of online interventions  in LMICs , so we can not draw a firm conclusion on its effectiveness . However , given the effectiveness of  online interventions in high income countries and sharp increase of internet access in LMICs , online interventions may offer a potential to help reduce the ‘ mental health gap ’ . More studies are urgently needed in LMICs The Bulletin ’s editorial team has decided to encourage systematic review s. This is an important decision and is to be welcomed . However it is possible that it will not be received positively by all . Some may feel that systematic review s are not suitable for answering wider public health questions , and that the new section will simply result in the publication of systematic review s addressing narrowly focused , clinical questions with a focus on r and omized controlled trials alone.1 There is no reason why this should be so , and there are far too many examples of systematic review s of non- clinical interventions ( including government policies ) , which include non-r and omized studies , to list.2 Systematic review s of qualitative research are also becoming more common.3 Nonetheless misconceptions about the scope and flexibility of systematic review s still surface occasionally and it never fails to surprise me when I stumble across one of these hoary old chestnuts . If it really were true that systematic review s were only for simple , individual-level interventions , systematic review ers working in public health would be very concerned . After all , public health problems require us to draw on complex sets of qualitative as well as quantitative evidence ; and some policy interventions have never been subjected to r and omized controlled trials ( RCTs ) but have been evaluated using other approaches ; everything from controlled and uncontrolled before- and -after studies , to time series analyses , to qualitative methods . In such cases , systematic review s that focused on RCTs alone would have little to say and we would end up producing many “ empty review s ” , which contain no studies at all . These would be undoubtedly quicker to do and quicker to read than the typical systematic review , but would be of limited use for making policy . However this is not the case . In public health we already have a wealth of review s that prioritize RCTs where they are available , but which draw upon a range of other evidence where they are appropriate to answering the review question .2 Take , as an example , transport policies , an important social determinant of health.4 Public health decision-makers have been interested in the effects on health of building new roads for decades , but there has never been a r and omized controlled trial , for obvious reasons . Yet it would make no sense to cl aim that there is no evidence to be review ed ; rather , there have been many controlled and uncontrolled studies that have examined the effects of new roads on respiratory symptoms , injuries , community severance , disturbance and a variety of other outcomes of public health importance . These studies have in fact been systematic ally review ed.5 Many other examples of review s of complex interventions that impact on public health could be given , which appear on the Cochrane Data base and elsewhere,6,7 and such review s are the main focus of the recently-established Cochrane Public Health Review Group . It is also worth noting that both the Cochrane and Campbell Collaboration include increasing numbers of review s that are relevant to low- and middle- income countries,8 though there is a particular need for more systematic review s that consider the effects on equity of the interventions that they include.9 Currently systematic review s have a “ utilitarian bias ” – they tend to be concerned more with the effects on population s and average effects than with distributional effects and impacts in disadvantaged subgroups . It is to be hoped that systematic review s su bmi tted to the Bulletin will routinely consider the effects of interventions on health inequities . The Cochrane Health Equity Field ( http://equity.cochrane.org/en/index.html ) was set up explicitly to further this agenda , to encourage systematic review authors to explicitly assess the effects of interventions not only on the whole population , but on the disadvantaged . So where does this leave non- systematic review s ? Should every review be a systematic review ? This is a difficult question to answer in a short editorial . My own view is that not all review s need to be systematic review s ; there is still a place for review papers that provide a broad overview , and that discuss a range of evidence and make a contribution to wider debates about what might work in particular setting s. However , while such discussion s help place evidence in context and suggest how it may be used , they should not be confused with the evidence -based conclusions of a transparent , scientific review , which systematic ally attempts to find all the relevant evidence , appraises its strengths and limitations in a transparent fashion , and draws that evidence together in such a way that the more robust studies are given greater weight . Finally , the challenges are many . Evidence on interventions to improve public health is in short supply , particularly evidence on social determinants . Systematic review ers therefore face a real challenge in making best use of the sometimes poor , often sparse and usually heterogeneous evidence available to them . It is easy to set narrow inclusion criteria for a review and then sift through the evidence before concluding that there is n’t enough – and what there is , is n’t very good anyway . Such “ evidential nihilism ” is probably not helpful to decision-makers , and public health systematic review ers need to continue to develop new methods and better frameworks within which different types of research evidence can be integrated to inform decision-making . Publishing systematic review s in the Bulletin should give an added impetus to this ongoing work . People living with HIV ( PLWH ) experience greater psychological distress than the general population . Evidence from high-incomes countries suggests that psychological interventions for PLWH can improve mental health symptoms , quality of life , and HIV care engagement . However , little is known about the effectiveness of mental health interventions for PLWH in low- and middle-income countries ( LMICs ) , where the large majority of PLWH reside . This systematized review aims to synthesize findings from mental health intervention trials with PLWH in LMICs to inform the delivery of mental health services in these setting s. A systematic search strategy was undertaken to identify peer- review ed published papers of intervention trials addressing negative psychological states or disorders ( e.g. depression , anxiety ) among PLWH in LMIC setting s. Search results were assessed against pre-established inclusion and exclusion criteria . Data from papers meeting criteria were extracted for synthesis . Twenty-six papers , published between 2000 and 2014 , describing 22 unique interventions were identified . Trials were implemented in sub-Saharan Africa ( n = 13 ) , Asia ( n = 7 ) , and the Middle East ( n = 2 ) , and addressed mental health using a variety of approaches , including cognitive-behavioral ( n = 18 ) , family-level ( n = 2 ) , and pharmacological ( n = 2 ) treatments . Four r and omized controlled trials reported significant intervention effects in mental health outcomes , and 11 preliminary studies demonstrated promising findings . Among the limited mental health intervention trials with PLWH in LMICs , few demonstrated efficacy .  Mental health interventions for PLWH in LMICs must be further developed and adapted for re source -limited setting s to improve effectiveness PHP289 A SyStemAtic Review of tHe imPAct of imPRoved HouSing inteRventionS on HeAltH in low And middle income tRoPicAl Setting S Butt T1 , Von Seidlein L2 1University College London , London , UK , 2Mahidol Oxford Tropical Medicine Research Unit , Bangkok , Thail and Objectives : Housing has a major impact on human health and wellbeing in the developing world directly ( e.g. through household accidents ) and indirectly ( e.g. through mediating contact between occupants and disease vectors ) . The objective of this review was to investigate the impact of improved housing on health in tropical zones of low and middle income countries . MethOds : A systematic review of major health and architecture data bases was conducted in order to identify records reporting the impact of housing features on the health of people living in tropical regions . Information was extracted and reported using a st and ardised form . Results were classified by study characteristics and qualitative trends explored . Results : We identified 120 studies that met the inclusion criteria . Studies covered vector-borne , gastrointestinal and respiratory diseases and household injuries . 76 were observational , 27 were trials ( including 11 r and omised controlled trials ) , 9 were models and 7 were studies considering economic aspects of  housing interventions . Of the economic studies identified , 3 were cost benefit analysis , 3 were cost per disability-adjusted life year ( DALY ) , while 1 measured burden of disease in DALYs . Outcomes were classified as economic ( 7 ) such as DALYs , direct health ( 57 ) such as incidence of diarrhoea , indirect health such as question naires ( 16 ) or surrogate ( 39 ) such as mosquito counts in a house . cOnclusiOns : There have been a considerable number of studies investigating the impact of housing features on health in tropical regions . Most focused on the impact of one or more housing feature on one or more health outcome . A smaller number of studies looked at whole house interventions and there have been few economic evaluations of improved housing interventions . A holistic approach to assessing health in the context of housing and consideration of issues of economics and implementation would be valuable topics for future research Introduction Task shifting interventions are intended to both deliver clinical ly effective treatments to reduce disease burden and address health inequities or population vulnerability . Little is known about how health equity and population vulnerability are defined and measured in research focused on task shifting . This systematic review will address the following questions : Among  task shifting interventions in high-income setting s that have been studied using r and omised controlled trials or variants , how are health inequity or population vulnerability identified and defined ? What methods and indicators are used to describe , characterise and measure the population ’s baseline status and the intervention ’s impacts on inequity and vulnerability ? Methods and analysis Studies were identified through data base search es ( MEDLINE , Embase , CINAHL , PsycINFO and Web of Science ) . Eligible studies will be r and omised controlled trials published since 2004 , conducted in high-income countries , concerning task shifting interventions to treat any disease , in any population that may face health disadvantage as defined by the PROGRESS-Plus framework ( place of residence , race/ethnicity/culture/ language , occupation , gender/sex , religion , social capital , socioeconomic position , age , disability , sexual orientation , other vulnerable groups ) . We will conduct independent and duplicate title and abstract screening , then identify related papers from the same programme of research through further data base and manual search ing . From each programme of research , we will extract study details , and definitions and measures of health equity or population vulnerability based on the PROGRESS-Plus framework . Two investigators will assess the quality of reporting and measurement related to health equity and vulnerability using a scale developed for this study . A narrative synthesis will highlight similarities and differences between the gathered studies and offer critical analyses and implication s. Ethics and dissemination This review does not involve primary data collection , does not constitute research on human subjects and is not subject to additional institutional ethics review or informed consent procedures . Dissemination will include open-access peer- review ed publication and academic conference presentations . PROSPERO Registration Number CRD42017049959 Background Funders of health research increasingly seek to underst and how best to allocate re sources in order to achieve maximum value from their funding . We built an international consortium and developed a multinational case study approach to assess benefits arising from health research . We used that to facilitate analysis of factors in the production of research that might be associated with translating research findings into wider impacts , and the complexities involved . Methods We built on the Payback Framework and exp and ed its application through conducting co-ordinated case studies on the payback from cardiovascular and stroke research in Australia , Canada and the United Kingdom . We selected a stratified r and om sample of projects from leading medical research funders . We devised a series of innovative steps to : minimize the effect of research er bias ; rate the level of impacts identified in the case studies ; and interrogate case study narratives to identify factors that correlated with achieving high or low levels of impact . Results Twenty-nine detailed case studies produced many and diverse impacts . Over the 15 to 20 years examined , basic biomedical research has a greater impact than clinical research in terms of academic impacts such as knowledge production and research capacity building . Clinical research has greater levels of wider impact on health policies , practice , and generating health gains . There was no correlation between knowledge production and wider impacts . We identified various factors associated with high impact . Interaction between research ers and practitioners and the public is associated with achieving high academic impact and translation into wider impacts , as is basic research conducted with a clinical focus . Strategic thinking by clinical research ers , in terms of thinking through pathways by which research could potentially be translated into practice , is associated with high wider impact . Finally , we identified the complexity of factors behind research translation that can arise in a single case . Conclusions We can systematic ally assess research impacts and use the findings to promote translation . Research funders can justify funding research of diverse types , but they should not assume academic impacts are proxies for wider impacts . They should encourage research ers to consider pathways towards impact and engage potential research users in research processes Background Violence during pregnancy is a global problem , associated with serious health risks for both the mother and baby . Evaluation of interventions targeted for reducing or controlling domestic violence ( DV ) is still in its infancy , and the majority of findings are primarily from high-income countries ( HICs ) . Therefore , there is an urgent need for generating evidence of DV interventions among pregnant women in low- and middle-income countries ( LMICs ) . Methods Preferred Reporting Items for Systematic Review s and Meta-Analyses ( PRISMA ) guidelines will be employed to structure the review . A comprehensive search will be carried out via electronic data bases including MEDLINE , CINAHL , Scopus , Embase , Web of Science , PsycINFO , and The Cochrane library . Gray literature will also be scrutinized for potential articles . An optimal search strategy has been developed following consultations with subject-matter experts and librarians . This search strategy will be adapted to the different data bases . Experimental studies evaluating DV interventions among pregnant women from LMICs will be included in the review . The review will only include literature written in English . Two review ers will independently screen and assess studies for inclusion in the review . A third author will resolve any discrepancies between the review ers . Risk of bias will be assessed based on the Cochrane risk of bias assessment tool , and overall quality of the evidence will be judged using Grading of Recommendations , Assessment , Development , and Evaluation ( GRADE ) criteria . Findings will be presented with the narrative synthesis , and if applicable , they will be further quantified using r and om-effects meta- analysis . Effect size , risk ratio for dichotomous variables , and st and ardized mean differences for continuous variables will be calculated for each outcome using Review Manager 5.3 . Discussion Systematic review s to evaluate the efficacy of interventions to address DV within the perinatal context have been limited . Hence , no one intervention has emerged as substantially effective towards addressing perinatal DV and associated health consequences . The evidence generated from this systematic review will inform research ers and policy makers about the effectiveness of existing DV interventions among pregnant women in LMICs and provide recommendations for future research in this area . This in turn will contribute towards violence prevention in LMICs . Systematic review registration PROSPERO The World Bank , the Gates Foundation and the World Health Organization promote national child deworming programmes in developing countries.1 They assert these programmes will improve nutritional status , health and school performance , and hence contribute to economic growth . Indeed , the World Health Organization states that deworming contributed to Japan ’s economic boom in the 1950s,2 and Nobel Laureates meeting in Copenhagen ranked deworming as the fourth most important intervention to solve the health problems of the whole world.3 Surprisingly , the evidence base for these cl aims from controlled studies is limited . Critically , according to the Cochrane review which two of us author , there is quite good evidence of no effect for the main biomedical outcomes in deworming , making the broader societal benefits on economic development barely credible ( Figure 1).4 Nevertheless , the advocates increasingly rely on a single large quasi-r and omized trial carried out in Kenya , published in 2004 in Econometrica,5 which reports school attendance . Figure 1 . Conceptual framework used to underpin the effects of deworming programmes on economic growth  in developing countries . Contemporary evidence questions this model , as there is now quite good contemporary evidence , summarized in the Cochrane review , that ... This study has been highly influential . The International Initiative for Impact Evaluation commissioned the London School of Hygiene and Tropical Medicine ( LSHTM ) to replicate the analysis , as the original analysis is ‘ based on econometric approaches and used a language and format that would be unfamiliar to many health care research ers’.6 The replication aim ed to provide detail of the methods and reporting in line with the CONSORT statement . The team are internationally recognized , independent and meticulous in their approach . They agreed a protocol , carefully checked and corrected the raw data , and then re-ran their prespecified analysis .6 Their first paper is a pure replication,7 exactly repeating the authors ’ original analysis . This paper clarifies some method ological details not provided in the original paper , but it also uncovers a series of important coding and analysis errors . Some of the corrected results are consistent with the original findings , but others are quite different . Most notably , the much quoted ‘ positive externalities’—where the benefits of treating children in one school ‘ spill over ’ to benefit children in adjacent schools — vanish in their corrected analysis . Their second paper uses approaches more familiar to epidemiologists , and allows a more thorough exploration of the data .8 There are substantial amounts of missing information , and some unexpected patterns that are difficult to explain . For example , there is a correlation between the number of observations in each school and the reported attendance , with more observations associated with lower attendance reported — except in some of the intervention groups , where more frequent observation is associated with better attendance . This raises the possibility that the process of observation influenced outcome reporting and this was different in control and intervention groups . The second paper confirms an association with higher attendance in the deworming schools when stratified by year , but found the combined estimate across years was much larger , and the authors caution the validity of the combined year estimate : this may be due to the stepped-wedge design where the combined year estimate includes a before and after comparison ; or it may be due to the problems with secular and group effects of the number of observations of school attendance varying . To further complicate matters , there was also a concurrent ‘ School Assistance Program ’ ( SAP ) evaluating five other interventions in 27/75 of the study schools , which was not part of the r and omized intervention . Attendance patterns differed on the basis of involvement in the SAP , which the authors suggest could well lead to bias.8 One of the critical points the LSHTM papers make is that the administration of the deworming drugs was part of a ‘ complex health education and drug treatment intervention’.8 The intervention schools also received regular public health lectures , wall charts and teacher training on worm prevention . Interestingly , the pure replication shows very similar impacts of the intervention on children in the intervention schools irrespective of whether they took the deworming medicine or not.7 For Miguel and colleagues , they term this as ‘ indirect within-school effects ’ of deworming , but equally the effects could be due to the non-specific effects of the health promotion interventions in the intervention schools . So where does this take us ? There is a small effect on school attendance for sure , but this should not be over-interpreted , as the LSHTM authors say , given the concerns raised regarding the risk of bias , and the independent effects on school attendance of the programme of health promotion . In addition , the study shows that allocation to the deworming group does not influence student progress , as the re- analysis shows clearly no evidence of a difference in examination performance between deworming and control groups.7,8 In the context of the global evidence base , there is only one other study that has examined school attendance with no obvious effect shown.4 Given all these uncertainties , we simply do n’t know if there is truly an effect on school attendance from the data , in taking all these factors into account formally in a GRADE analysis .4 But what weakens the case of deworming still further is that there is now quite good evidence of no effect for most of the main outcomes ( Figure 1 ) , including nutritional status , haemoglobin , cognition and school performance . This is important because without these effects it seems implausible that deworming itself would have an independent effect on school attendance or economic development . Obviously children infected with worms should be treated . Trials from over 20 years ago in an area of Kenya where all the children were heavily infected showed benefit . Another trial in India showed benefit , but subsequent trials in the same area failed to show an effect.4,9 So deworming may have helped in these exceptional , heavily infected , untreated population s from another decade , but this is scarcely a solid base for contemporary policy : public health nutrition has changed , worm burden has declined and this probably accounts for the lack of effect on biomedical outcomes in contemporary studies .10 We have been perplexed by the un question ing belief behind deworming in the advocates , and have found it is deep rooted in American history . The Rockefeller Sanitary Commission in 1909 sought to eradicate hookworm in the Southern USA population , where it was seen as a cause of ‘ some of the proverbial laziness of the poorer classes ’ and to improve worker productivity ; these were extended with the Rockefeller International Health Commission established in 1913.11 The beliefs and assumptions appear to continue , with ‘ Deworm the World ’ aim ing to deworm 220 million children in India during 2015.12 What have we learned from this ? Certainly that replication is a valuable process , not least for errors that have the potential to mislead , but also to provide a much better interpretation of the potential biases in studies . In terms of policies in deworming , it suggests donors and Nobel Prize winners need to be aware of their prior assumptions , and base decisions on the all the evidence from reliable studies within a systematic review , not just select a single study . They need to look at all relevant outcomes , not just one . They need to consider bias and confounding . Our view is that current promotion of community deworming is certainly a panacea : a single solution to multiple problems in low- and middle-income countries , and that the belief that deworming will impact substantially on economic development seems delusional when you look at the results of reliable controlled trials . This is a view , based on over 15 years of engagement with critically appraising the literature in this field.13 We recommend anyone responsible for public or philanthropic money going to large scale deworming to read these replication studies , the original publication , the authors ’ responses to the replication and the 2015 version of the Cochrane review that includes corrections from these replications plus data from five further studies , including the recently published DEVTA study of 2 million children.4,14 Then make up your own mind . Conflict of interest : PG and DTR are authors of a Cochrane review of community deworming programmes . PG is funded by the Department for International Development to provide reliable independent systematic review s for the benefit of developing countries ; PG receives salary support from Countdown , a DFID-supported research grant in programmatic implementation of neglected tropical disease programmes Background Little is known about the process of knowledge translation in low- and middle-income countries . We studied policymaking processes in Mozambique , South Africa and Zimbabwe to underst and the factors affecting the use of research evidence in national policy development , with a particular focus on the findings from r and omized control trials ( RCTs ) . We examined two cases : the use of magnesium sulphate ( MgSO4 ) in the treatment of eclampsia in pregnancy ( a clinical case ) ; and the use of insecticide treated bed nets and indoor residual household spraying for malaria vector control ( a public health case ) . Methods We used a qualitative case- study methodology to explore the policy making process . We carried out key informants interviews with a range of research and policy stakeholders in each country , review ed documents and developed timelines of key events . Using an iterative approach , we undertook a thematic analysis of the data . Findings Prior experience of particular interventions , local champions , stakeholders and international networks , and the involvement of research ers in policy development were important in knowledge translation for both case studies . Key differences across the two case studies included the nature of the evidence , with clear evidence of efficacy for MgSO4 and ongoing debate regarding the efficacy of bed nets compared with spraying ; local research er involvement in international evidence production , which was stronger for MgSO4 than for malaria vector control ; and a long-st and ing culture of evidence -based health care within obstetrics . Other differences were the importance of bureaucratic processes for clinical regulatory approval of MgSO4 , and regional networks and political interests for malaria control . In contrast to treatment policies for eclampsia , a diverse group of stakeholders with varied interests , differing in their use and interpretation of evidence , was involved in malaria policy decisions in the three countries . Conclusion Translating research knowledge into policy is a complex and context sensitive process . Research ers aim ing to enhance knowledge translation need to be aware of factors influencing the dem and for different types of research ; interact and work closely with key policy stakeholders , networks and local champions ; and acknowledge the roles of important interest groups Intimate partner violence is widespread and represents an obstacle to human freedom and a significant public health concern . Poverty alleviation programs and efforts to economically " empower " women have become popular policy options , but theory and empirical evidence are mixed on the relationship between women 's empowerment and the experience of violence . We study the effects of a successful poverty alleviation program  on women 's empowerment and intimate partner relations and violence from 2009 to 2011 . In the first experiment , a cluster-r and omized superiority trial , 15 marginalized people ( 86 % women ) were identified in each of 120 villages ( n = 1800 ) in Gulu and Kitgum districts in Ug and a. Half of villages were r and omly assigned via public lottery to immediate treatment : five days of business training , $ 150 , and supervision and advising . We examine intent-to-treat estimates of program impact and heterogeneity in treatment effects by initial quality of partner relations . 16 months after the initial grants , the program doubled business ownership and incomes ( p < 0.01 ) ; we show that the effect on monthly income , however , is moderated by initial quality of intimate partner relations . We also find small increases in marital control ( p < 0.05 ) , self-reported autonomy ( p < 0.10 ) , and quality of partner relations ( p < 0.01 ) , but essentially no change in intimate partner violence . In a second experiment , we study the impact of a low-cost attempt to include household partners ( often husb and s ) in the process . Participants from the 60 waitlist villages ( n = 904 ) were r and omly assigned to participate in the program as individuals or with a household partner . We observe small , non-significant decreases in abuse and marital control and large increases in the quality of relationships ( p < 0.05 ) , but no effects on women 's attitudes toward gender norms and a non-significant reduction in autonomy . Involving men and changing framing to promote more inclusive programming can improve relationships , but may not change gender attitudes or increase business success . Increasing women 's earnings has no effect on intimate partner violence Background Public health interventions are increasingly evaluated using  cluster-r and omised trials in which groups rather than individuals are allocated r and omly to treatment and control arms . Outcomes for individuals within the same cluster are often more correlated than outcomes for individuals in different clusters . This needs to be taken into account in sample size estimations for planned trials , but most estimates of intracluster correlation for perinatal health outcomes come from hospital-based studies and may therefore not reflect outcomes in the community . In this study we report estimates for perinatal health outcomes from community-based trials to help research ers plan future evaluations . Methods We estimated the intracluster correlation and the coefficient of variation for a range of outcomes using data from five community-based cluster r and omised controlled trials in three low-income countries : India , Bangladesh and Malawi . We also performed a simulation exercise to investigate the impact of cluster size and number of clusters on the reliability of estimates of the coefficient of variation for rare outcomes . Results Estimates of intracluster correlation for mortality outcomes were lower than those for process outcomes , with narrower confidence intervals throughout for trials with larger numbers of clusters . Estimates of intracluster correlation for maternal mortality were particularly variable with large confidence intervals . Stratified r and omisation had the effect of reducing estimates of intracluster correlation . The simulation exercise showed that estimates of intracluster correlation are much less reliable for rare outcomes such as maternal mortality . The size of the cluster had a greater impact than the number of clusters on the reliability of estimates for rare outcomes . Conclusions The breadth of intracluster correlation estimates reported here in terms of outcomes and context s will help research ers plan future community-based public health interventions around maternal and newborn health . Our study confirms previous work finding that estimates of intracluster correlation are associated with the prevalence of the outcome of interest , the nature of the outcome of interest ( mortality or behavioural ) and the size and number of clusters . Estimates of intracluster correlation for maternal mortality need to be treated with caution and a range of estimates should be used in planning future trials This article describes how the Grading of Recommendations Assessment , Development and Evaluation ( GRADE ) approach to grading the quality of evidence and strength of recommendations considers the Bradford Hill criteria for causation and how GRADE may relate to questions in public health . A primary concern in public health is that evidence from non-r and omised studies may provide a more adequate or best available measure of a public health strategy 's impact , but that such evidence might be grade d as lower quality in the GRADE framework . GRADE , however , presents a framework that describes both criteria for assessing the quality of research evidence and the strength of recommendations that includes considerations arising from the Bradford Hill criteria . GRADE places emphasis on recommendations and in assessing quality of evidence ; GRADE notes that r and omisation is only one of many relevant factors . This article describes how causation may relate to developing recommendations and how the Bradford Hill criteria are considered in GRADE , using examples from the public health literature with a focus on immunisation Public health interventions usually operate at the level of groups rather than individuals , and cluster r and omized controlled trials ( RCTs ) are one means of evaluating their effectiveness . Using examples from six such trials in Bangladesh , India , Malawi and Nepal , we discuss our experience of the ethical issues that arise in their conduct . We set cluster RCTs in the broader context of public health research , highlighting debates about the need to reconcile individual autonomy with the common good and about the ethics of public health research in low-income setting s in general . After a brief introduction to cluster RCTs , we discuss particular challenges we have faced . These include the nature of - and responsibility for - group consent , and the need for consent by individuals within groups to intervention and data collection . We discuss the timing of consent in relation to the implementation of public health strategies , and the problem of securing ethical review and approval in a complex domain . Finally , we consider the debate about benefits to control groups and the st and ard of care that they should receive , and the issue of post-trial adoption of the intervention under test Abstract Introduction : Successful population ‐level antiretroviral therapy ( ART ) adherence will be necessary to realize both the clinical and prevention benefits of antiretroviral scale‐up and , ultimately , the end of AIDS . Although many people living with HIV are adhering well , others struggle and most are likely to experience challenges in adherence that may threaten virologic suppression at some point during lifelong therapy . Despite the importance of ART adherence , supportive interventions have generally not been implemented at scale . The objective of this review is to summarize the recommendations of clinical , research , and public health experts for scalable ART adherence interventions in re source ‐limited setting s. Methods : In July 2015 , the Bill and Melinda Gates Foundation convened a meeting to discuss the most promising ART adherence interventions for use at scale in re source ‐limited setting s. This article summarizes that discussion with recent up date s. It is not a systematic review , but rather provides practical considerations for programme implementation based on evidence from individual studies , systematic review s , meta‐analyses , and the World Health Organization Consoli date d Guidelines for HIV , which include evidence from r and omized controlled trials in low‐ and middle‐income countries . Interventions are categorized broadly as education and counselling ; information and communication technology‐enhanced solutions ; healthcare delivery restructuring ; and economic incentives and social protection interventions . Each category is discussed , including descriptions of interventions , current evidence for effectiveness , and what appears promising for the near future . Approaches to intervention implementation and impact assessment are then described . Results and discussion : The evidence base is promising for currently available , effective , and scalable ART adherence interventions for re source ‐limited setting s. Numerous interventions build on existing health care infrastructure and leverage available re sources . Those most widely studied and implemented to date involve peer counselling , adherence clubs , and short message service ( SMS ) . Many additional interventions could have an important impact on ART adherence with further development , including st and ardized counselling through multi‐media technology , electronic dose monitoring , de central ized and differentiated models of care , and livelihood interventions . Optimal targeting and tailoring of interventions will require improved adherence measurement . Conclusions : The opportunity exists today to address and resolve many of the challenges to effective ART adherence , so that they do not limit the potential of ART to help bring about the end of AIDS BACKGROUND There is currently no disease-modifying treatment available to halt or delay the progression of the disease pathology in dementia . An agreed core set of the best-available and most appropriate outcomes for disease modification would facilitate the design of trials and ensure consistency across disease modification trials , as well as making results comparable and meta-analysable in future trials . OBJECTIVES To agree a set of core outcomes for disease modification trials for mild to moderate dementia with the UK dementia research community and patient and public involvement ( PPI ) . DATA SOURCES We included disease modification trials with quantitative outcomes of efficacy from ( 1 ) references from related systematic review s in workstream 1 ; ( 2 ) search es of the Cochrane Dementia and Cognitive Improvement Group study register , Cochrane Central Register of Controlled Trials , Cumulative Index to Nursing and Allied Health Literature , EMBASE , Latin American and Caribbean Health Sciences Literature and PsycINFO on 11 December 2015 , and clinical trial registries [ International St and ard R and omised Controlled Trial Number ( IS RCT N ) and clinical trials.gov ] on 22 and 29 January 2016 ; and ( 3 ) h and - search es of reference lists of relevant systematic review s from data base search es . REVIEW METHODS The project consisted of four workstreams . ( 1 ) We obtained related core outcome sets and work from co-applicants . ( 2 ) We systematic ally review ed published and ongoing disease modification trials to identify the outcomes used in different domains . We extracted outcomes used in each trial , recording how many used each outcome and with how many participants . We divided outcomes into the domains measured and search ed for validation data . ( 3 ) We consulted with PPI participants about recommended outcomes . ( 4 ) We presented all the synthesis ed information at a conference attended by the wider body of National Institute for Health Research ( NIHR ) dementia research ers to reach consensus on a core set of outcomes . RESULTS We included 149 papers from the 22,918 papers screened , referring to 125 individual trials . Eighty-one outcomes were used across trials , including 72 scales [ 31 cognitive , 12 activities of daily living ( ADLs ) , 10 global , 16 neuropsychiatric and three quality of life ] and nine biological techniques . We consulted with 18 people for PPI . The conference decided that only cognition and biological markers are core measures of disease modification . Cognition should be measured by the Mini Mental State Examination ( MMSE ) or the Alzheimer 's Disease Assessment Scale - Cognitive subscale ( ADAS-Cog ) , and brain changes through structural magnetic resonance imaging ( MRI ) in a subset of participants . All other domains are important but not core . We recommend using the Neuropsychiatric Inventory for neuropsychiatric symptoms : the Disability Assessment for Dementia for ADLs , the Dementia Quality of Life Measure for quality of life and the Clinical Dementia Rating scale to measure dementia globally . LIMITATIONS Most of the trials included participants with Alzheimer 's disease , so recommendations may not apply to other types of dementia . We did not conduct economic analyses . The PPI consultation was limited to members of the Alzheimer 's Society Research Network . CONCLUSIONS Cognitive outcomes and biological markers form the core outcome set for future disease modification trials , measured by the  MMSE or ADAS-Cog , and structural MRI in a subset of participants . FUTURE WORK We envisage that the core set may be superseded in the future , particularly for other types of dementia . There is a need to develop an algorithm to compare scores on the MMSE and ADAS-Cog . STUDY REGISTRATION The project was registered with Core Outcome Measures in Effectiveness Trials [ www.comet-initiative.org/ studies /details/819 ? result = true ( accessed 7 April 2016 ) ] . The systematic review protocol is registered as PROSPERO CRD42015027346 . FUNDING The National Institute for Health Research Health Technology Assessment programme In many areas of medicine the amount of published information is increasing at an exponential rate , making it difficult for the clinician to condense the data to a manageable amount of valuable and useful information . Systematic review s have been suggested as a remedy for this information overload . Such review s are regarded as the highest level of evidence . Certain statistical methods , e.g. , meta- analysis , have also been introduced for the calculation of a more comprehensive summation of the compiled results from studies with small sample sizes . These findings would then serve as an authoritarian guide for evidence -based practice . Endodontists have lately jumped on the b and wagon of systematic review s and meta-analyses , and papers on various topics are being published . Well done , such comprehensive information would be very useful and authoritative for the practitioner . Alarmingly , the quality of these recent publications is negatively correlated to the frequency . This can have serious consequences in the clinical arena if spurious information is given a seal of approval when communicated as facts in refereed journals . A systematic literature review is design ed to focus on a single question and to synthesize all high- quality research reports relevant to the question . In these studies , however , sources of bias are often not controlled . Therefore , even the best review and meta- analysis becomes useless if it is based on poorly design ed research . Furthermore , these review s are mostly based on published data which are too often biased toward studies that show significant differences in results and /or outcome . “ Uninteresting ” conclusions tend not to be published . Endodontic literature , thus far , is short on well design ed and executed r and omized clinical trials . Furthermore , clinical protocol s often have many important “ proprietary ” modifications that make comparison difficult . This makes it very hard to undertake a systematic review to answer a narrow question . Such GIGO ( garbage in , garbage out ) can easily lead to biased conclusions and reinforce already existing biased comclusions . An example of such bias can be illustrated by a meta- analysis recently published . The study focused on assessing if there were differences in outcome between 1 and 2 treatment visits when treating teeth with apical periodontitis . Relevant publications on this topic are rare , and with the narrow inclusion criteria only 3 investigations were available for the review . However , the only factors connecting these 3 studies was the words “ single ” and “ two visits ” in the title . Beyond that , the selected studies are too different and inadequate for the study . Only 1 study is somewhat demonstrably r and omized , and outcome assessment s are based on 3 vastly different criteria . Two of the studies use calcium hydroxide as intracanal dressing , whereas the third uses no intervisit medication . Complexity of initial pathology and healing time are also clearly factors of great importance but not controlled . In addition , sample sizes in the component studies as well as the final cohort are all too small for the conclusions that there was no significant difference between 1or 2-visit treatment protocol s. To undertake and publish a meta- analysis on such an incomplete sample is counterproductive . Although the publication noted its numerous limitations , it will still communicate erroneous conclusions with a poor scientific foundation to the less informed reader . There are other examples of recently published systematic review s that are very ambiguous and tend to communicate spurious facts . One of these studies looks at the effect of smear-layer removal on sealing ability of root canal obturation . The study is entirely limited to laboratory experiments , with the majority of evaluations using dye leakage which is generally considered to be unreliable . This is an example of review ers lacking content expertise . The authors draw the conclusion , using defective review material , that removal of smear layer enhances the seal of the root filling . We may generally believe that this is the truth BACKGROUND Evidence -based public health decision-making depends on high quality and transparent accounts of what interventions are effective , for whom , how and at what cost . Improving the quality of reporting of r and omized and non-r and omized study design s through the CONSORT and TREND statements has had a marked impact on the quality of study design s. However , public health users of systematic review s have been concerned with the paucity of synthesized information on context , development and rationale , implementation processes and sustainability factors . METHODS This paper examines the existing reporting frameworks for research against information sought by users of systematic review s of public health interventions and suggests additional items that should be considered in future recommendations on the reporting of public health interventions . RESULTS Intervention model , theoretical and ethical considerations , study design choice , integrity of intervention/process evaluation , context , differential effects and inequalities and sustainability are often overlooked in reports of public health interventions . CONCLUSION Population health policy makers need synthesized , detailed and high quality a priori accounts of effective interventions in order to make better progress in tackling population morbidities and inequalities . Adding simple criteria to reporting st and ards will significantly improve the quality and usefulness of published evidence and increase its impact on public health program planning
The review revealed the most common stage for PPI was in research planning , and the most common level of involvement was collaboration .
Most studies did not provide evidence of effectiveness or elaborate on the impact of PPI , and they tended to report impact from the research er 's perspective .
Where impact was mentioned , this generally related to increased relevance to the community , empowerment of participants and alterations in study design .
OBJECTIVES Patient and public involvement ( PPI ) is argued to lead to higher quality health research , which is more relatable to and helps empower the public .
We synthesis ed the evidence to look for examples of PPI in health research in low/middle-income countries ( LMICs ) , looking at levels of involvement and impact .
Additionally , we considered the impact of who was undertaking the research on the level of involvement and reported impact .