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Evidence-Based Policy Making for Public Health Interventions in Cardiovascular Diseases: Formally Assessing the Feasibility of Clinical Trials.

ABSTRACT: Implementation of prevention policies has often been impeded or delayed due to the lack of randomized controlled trials (RCTs) with hard clinical outcomes (eg, incident disease, mortality). Despite the prominent role of RCTs in health care, it may not always be feasible to conduct RCTs of public health interventions with hard outcomes due to logistical and ethical considerations. RCTs may also lack external validity and have limited generalizability. Currently, there is insufficient guidance for policymakers charged with establishing evidence-based policy to determine whether an RCT with hard outcomes is needed before policy recommendations. In this context, the purpose of this article is to assess, in a case study, the feasibility of conducting an RCT of the oft-cited issue of sodium reduction on cardiovascular outcomes and then propose a framework for decision-making, which includes an assessment of the feasibility of conducting an RCT with hard clinical outcomes when such trials are unavailable. We designed and assessed the feasibility of potential individual- and cluster-randomized trials of sodium reduction on cardiovascular outcomes. Based on our assumptions, a trial using any of the designs considered would require tens of thousands of participants and cost hundreds of millions of dollars, which is prohibitively expensive. Our estimates may be conservative given several key challenges, such as the unknown costs of sustaining a long-term difference in sodium intake, the effect of differential cotreatment with antihypertensive medications, and long lag time to clinical outcomes. Thus, it would be extraordinarily difficult to conduct such a trial, and despite the high costs, would still be at substantial risk for a spuriously null result. A robust framework, such as the one we developed, should be used to guide policymakers when establishing evidence-based public health interventions in the absence of trials with hard clinical outcomes.

SUBMITTER: Foti K

PROVIDER: S-EPMC7674216 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:IntroductionContamination occurs when participants allocated to trial control arms receive elements of the active intervention. Randomisation at cluster level, rather than individual level, may reduce or eliminate contamination, avoiding the dilution of intervention effectiveness that it may cause. However, cluster randomisation can result in selection bias and may not be feasible to deliver. We explored the extent of contamination in a qualitative study nested within a feasibility study of HENRY (Health, Exercise and Nutrition for the Really Young); a UK community-based child obesity prevention programme. We aimed to determine the nature and impact of contamination to inform a larger planned trial and other trials in community based public health settings.MethodWe invited participants to take part in the nested qualitative study who were already involved in the HENRY feasibility study. Semi-structured interviews/focus groups were conducted with children's centre managers (n=7), children's centre staff (n=15), and parents (n=29). Data were transcribed and analysed using an integrative approach. First, deductively organised using a framework guided by the topic guide and then organised using inductive thematic analysis.ResultsPotential for contamination between treatment arms was recognised by all stakeholder groups. Staff within the intervention centres presented the greatest risk of contamination, predominantly because they were often asked to work in other children centre's (including control group centres). 'Sharing of best practice' by staff was reported to be a common and desirable phenomenon within community based settings. Parental sharing of HENRY messages was reported inconsistently; though some parents indicated a high degree of knowledge transfer within their immediate circles.ConclusionsThe extent of contamination identified has influenced the design of a future effectiveness trial of HENRY which will be clustered at the centre level (with geographically distinct clusters). The common practice of knowledge sharing amongst community teams means that this clustering approach is also likely to be most suitable for other trials based within these settings. We provide recommendations (e.g. cluster randomisation, training intervention facilitators on implications of contamination) to help reduce the impact of contamination in public health intervention trials with or without clustering, whilst enabling transfer of knowledge where appropriate.Trial registrationClinicalTrials.gov Identifier NCT03333733 registered 6th November 2017.

Project description:BACKGROUND:Ensuring health policies are informed by evidence still remains a challenge despite efforts devoted to this aim. Several tools and approaches aimed at fostering evidence-informed policy-making (EIPM) have been developed, yet there is a lack of availability of indicators specifically devoted to assess and support EIPM. The present study aims to overcome this by building a set of measurable indicators for EIPM intended to infer if and to what extent health-related policies are, or are expected to be, evidence-informed for the purposes of policy planning as well as formative and summative evaluations. METHODS:The indicators for EIPM were developed and validated at international level by means of a two-round internet-based Delphi study conducted within the European project 'REsearch into POlicy to enhance Physical Activity' (REPOPA). A total of 82 researchers and policy-makers from the six European countries (Denmark, Finland, Italy, the Netherlands, Romania, the United Kingdom) involved in the project and international organisations were asked to evaluate the relevance and feasibility of an initial set of 23 indicators developed by REPOPA researchers on the basis of literature and knowledge gathered from the previous phases of the project, and to propose new indicators. RESULTS:The first Delphi round led to the validation of 14 initial indicators and to the development of 8 additional indicators based on panellists' suggestions; the second round led to the validation of a further 11 indicators, including 6 proposed by panellists, and to the rejection of 6 indicators. A total of 25 indicators were validated, covering EIPM issues related to human resources, documentation, participation and monitoring, and stressing different levels of knowledge exchange and involvement of researchers and other stakeholders in policy development and evaluation. CONCLUSION:The study overcame the lack of availability of indicators to assess if and to what extent policies are realised in an evidence-informed manner thanks to the active contribution of researchers and policy-makers. These indicators are intended to become a shared resource usable by policy-makers, researchers and other stakeholders, with a crucial impact on fostering the development of policies informed by evidence.

Project description:BackgroundAlthough important syntheses and theoretical works exist in relation to understanding the organisational factors that facilitate research use, these contributions differ in their scope and object of study as well as their theoretical underpinnings. Therefore, from an exploratory angle, it may be useful to map out the current literature on organisational factors of research use in public health policy-making when revisiting existing theories and frameworks to gain further theoretical insights.MethodsHerein, a scoping review technique and thematic content analysis were used to bring together findings from both synthesised and empirical studies of different types to map out the organisational factors that facilitate research use in public health policy-making.ResultsA total of 14 reviews and 40 empirical studies were included in the analysis. These were thematically coded and the intra-organisational factors reported as enabling research use were examined. Five main categories of organisational factors that advance research use in policy organisations - (1) individual factors, (2) the management of research integration, (3) organisational systems and infrastructures of research use, (4) institutional structures and rules for policy-making, and (5) organisational characteristics - were derived as well as 18 subcategories and a total of 64 specific factors, where 27 factors were well supported by research.ConclusionsUsing a scoping review methodology, the intra-organisational factors influencing research use in policy-making (including individual factors) were systematically mapped and the theories applied in this area of research were assessed. The review findings confirm the importance of an intra-organisational perspective when exploring research use, showing that many organisational factors are critical facilitators of research use but also that many factors and mechanisms are understudied. The synthesis shows a lack of studies on politicians and the need for more theoretically founded research. Despite increased efforts to update the existing evidential and theoretical basis of research use, we still need frameworks that combine different approaches and theories to help us grasp the complex organisational mechanisms that facilitate research use in policy settings.

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Evidence-Based Policy Making for Public Health Interventions in Cardiovascular Diseases: Formally Assessing the Feasibility of Clinical Trials.

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