Reducing the confusion and controversies around pragmatic trials: using the Cardiovascular Health Awareness Program (CHAP) trial as an illustrative example

Trials
Lehana ThabaneCHAP Investigators

Abstract

Knowledge translation (KT) involves implementation of evidence-based strategies and guidelines into practice to improve the process of care and health outcomes for patients. Findings from pragmatic trials may be used in KT to provide patients, healthcare providers and policymakers with information to optimize healthcare decisions based on how a given strategy or intervention performs under the real world conditions. However, pragmatic trials have been criticized for having the following problems: i) high rates of loss to follow-up; ii) nonadherence to study intervention; iii) unblinded treatment and patient self-assessment, which can potentially create bias; iv) being less perfect experiments than efficacy trials; v) sacrificing internal validity to achieve generalizability; and vi) often requiring large sample sizes to detect small treatment effects in heterogeneous populations. In this paper, we discuss whether these criticisms hold merit, or if they are simply driven by confusion about the purpose of pragmatic trials. We use the Cardiovascular Health Awareness Program (CHAP) trial--a community randomized pragmatic trial designed to assess whether offering a highly organized, community-based CHAP intervention compared to usua...Continue Reading

Associated Clinical Trials

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Citations

Oct 22, 2016·Journal of Clinical Epidemiology·Guowei LiUNKNOWN 2016 Symposium on Registry-Based Randomized Controlled Trials in Calgary
May 5, 2016·Topics in Stroke Rehabilitation·Michal Kafri, Ruth Dickstein
Jul 2, 2020·Cardiology in the Young·Brett R AndersonUNKNOWN Pediatric Heart Network

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Software Mentioned

PRECIS
CONSORT
pragmascope

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