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

Author(s):  
Kathryn Foti ◽  
Randi E. Foraker ◽  
Pamela Martyn-Nemeth ◽  
Cheryl A.M. Anderson ◽  
Nancy R. Cook ◽  
...  

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.

2021 ◽  
Vol 14 ◽  
pp. 117863292199965
Author(s):  
Temitope Ojo ◽  
Laetitia Kabasele ◽  
Bethanny Boyd ◽  
Scholastica Enechukwu ◽  
Nessa Ryan ◽  
...  

Low- and middle-income countries (LMICs) bear the brunt of communicable and non-communicable diseases and experience higher mortality and poor health outcomes compared to resource-rich countries. Chronic resource deficits in LMICs impede their ability to successfully address vexing health issues. Implementation science provides researchers with an approach to develop specific interventions that can generate and/or maximize resources to facilitate the implementation of other public health interventions, in resource-constrained LMIC settings. Resources generated from these interventions could be in the form of increased health workers’ skills, task shifting to free up higher-skilled health workers, increasing laboratory capacity, and using supply chain innovations to make medications available. Pivotal to the success of such interventions is ensuring feasibility in the LMIC context. We selected and appraised three case studies of evidence-based resource-generating health interventions based in LMICs (Zambia, Zimbabwe, and Madagascar), which generated or maximized resources to facilitate ongoing health services. We used a determinant implementation framework—Consolidated Framework for Implementation Research (CFIR) to identify and map contextual factors that are reported to influence implementation feasibility in an LMIC setting. Contextual factors influencing the feasibility of these interventions included leadership engagement, local capacity building and readiness for research and implementing evidence-based practices (EBPs), infrastructural support for multilevel scale-up, and cultural and contextual adaptations. These factors highlight the importance of utilizing implementation science frameworks to evaluate, guide, and execute feasible public health interventions and projects in resource-limited settings. Within LMICs, we recommend EBPs incorporate feasible resource-generating components in health interventions to ensure improved and sustained optimal health outcomes.


2020 ◽  
Vol 11 (1) ◽  
Author(s):  
Gage K. Moreno ◽  
Katarina M. Braun ◽  
Kasen K. Riemersma ◽  
Michael A. Martin ◽  
Peter J. Halfmann ◽  
...  

Abstract Evidence-based public health approaches that minimize the introduction and spread of new SARS-CoV-2 transmission clusters are urgently needed in the United States and other countries struggling with expanding epidemics. Here we analyze 247 full-genome SARS-CoV-2 sequences from two nearby communities in Wisconsin, USA, and find surprisingly distinct patterns of viral spread. Dane County had the 12th known introduction of SARS-CoV-2 in the United States, but this did not lead to descendant community spread. Instead, the Dane County outbreak was seeded by multiple later introductions, followed by limited community spread. In contrast, relatively few introductions in Milwaukee County led to extensive community spread. We present evidence for reduced viral spread in both counties following the statewide “Safer at Home” order, which went into effect 25 March 2020. Our results suggest patterns of SARS-CoV-2 transmission may vary substantially even in nearby communities. Understanding these local patterns will enable better targeting of public health interventions.


2020 ◽  
pp. 102-129
Author(s):  
Vivian Lin ◽  
James Smith ◽  
Sally Fawkes ◽  
Priscilla Robinson ◽  
Sandy Gifford

2015 ◽  
Vol 43 (S1) ◽  
pp. 99-102 ◽  
Author(s):  
Daniel G. Orenstein ◽  
Y. Tony Yang

Used appropriately, reliance on science distinguishes public health from policymaking driven more by theory and opinion and enhances trust in public health interventions. Evidence-based vaccine policymaking aims to control communicable disease by urging decision makers to base policies on the best available evidence rather than politics or personal views. The results of this approach, such as smallpox eradication, have been dramatic. Historically, mandatory childhood vaccination has been perhaps the most successful evidence-based tool in combating many epidemics. Philosophically, vaccination mandates correspond to the legal system’s dual role in codifying what society deems undesirable behavior (non-vaccination) and declaring beneficial social norms and values consistent with understandings of the social contract. Despite their effectiveness and philosophical grounding, vaccination mandates present serious legal and ethical questions. Public health policymakers have a continuing responsibility to rely on evidence not only as a basis for generating policy, but also for evaluating and improving elements of its legal design.


Sign in / Sign up

Export Citation Format

Share Document