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
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
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 .