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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:BackgroundNoncommunicable diseases are major contributors to morbidity and mortality worldwide. Modifying the risk factors for these conditions, such as physical inactivity, is thus essential. Addressing the context or circumstances in which physical activity occurs may promote physical activity at a population level. We assessed the effects of infrastructure, policy or regulatory interventions for increasing physical activity.MethodsWe searched PubMed, Embase and clinicaltrials.gov to identify randomised controlled trials (RCTs), controlled before-after (CBAs) studies, and interrupted time series (ITS) studies assessing population-level infrastructure or policy and regulatory interventions to increase physical activity. We were interested in the effects of these interventions on physical activity, body weight and related measures, blood pressure, and CVD and type 2 diabetes morbidity and mortality, and on other secondary outcomes. Screening and data extraction was done in duplicate, with risk of bias was using an adapted Cochrane risk of bias tool. Due to high levels of heterogeneity, we synthesised the evidence based on effect direction.ResultsWe included 33 studies, mostly conducted in high-income countries. Of these, 13 assessed infrastructure changes to green or other spaces to promote physical activity and 18 infrastructure changes to promote active transport. The effects of identified interventions on physical activity, body weight and blood pressure varied across studies (very low certainty evidence); thus, we remain very uncertain about the effects of these interventions. Two studies assessed the effects of policy and regulatory interventions; one provided free access to physical activity facilities and showed that it may have beneficial effects on physical activity (low certainty evidence). The other provided free bus travel for youth, with intervention effects varying across studies (very low certainty evidence).ConclusionsEvidence from 33 studies assessing infrastructure, policy and regulatory interventions for increasing physical activity showed varying results. The certainty of the evidence was mostly very low, due to study designs included and inconsistent findings between studies. Despite this drawback, the evidence indicates that providing access to physical activity facilities may be beneficial; however this finding is based on only one study. Implementation of these interventions requires full consideration of contextual factors, especially in low resource settings.Trial registrationPROSPERO 2018 CRD42018093429.

Project description:BackgroundEnsuring 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.MethodsThe 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.ResultsThe 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.ConclusionThe 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.

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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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