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

• Published in: Current controlled trials in cardiovascular medicine Vol. 16; no. 1; p. 387
• Main Authors: Thabane, Lehana, Kaczorowski, Janusz, Dolovich, Lisa, Chambers, Larry W, Mbuagbaw, Lawrence
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 02-09-2015; BioMed Central
• Subjects: Age Factors; Ambulatory care; Awareness; Bias; Blood pressure; Cardiovascular disease; Cardiovascular Diseases - diagnosis; Cardiovascular Diseases - epidemiology; Cardiovascular Diseases - therapy; Clinical trials; Community Health Services; Decision making; Design; Evidence-Based Medicine; Health care policy; Health insurance; Health Knowledge, Attitudes, Practice; Health Services Research - methods; Health Status; Humans; Hypertension; Intervention; Medical research; Medicine, Experimental; Ontario; Patient Education as Topic; Patients; Practice Guidelines as Topic; Primary care; Research Design; Risk Factors; Treatment Outcome; Ontario; North America
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-015-0919-3

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 usual care can reduce cardiovascular disease-related outcomes--to address these specific criticisms and illustrate how to reduce this confusion.
Current controlled trials ISRCTN50550004 (9 May 2007).