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

Lehana Thabane, Janusz Kaczorowski, Lisa Dolovich, Larry W Chambers, Lawrence Mbuagbaw, CHAP Investigators, Janusz Kaczorowski, Larry W Chambers, Lisa Dolovich, J Michael Paterson, Tina Karwalajtys, Tracy Gierman, Barbara Farrell, Beatrice McDonough, Lehana Thabane, Karen Tu, Brandon Zagorski, Ron Goeree, Cheryl A Levitt, William Hogg, Stephanie Laryea, Megan Ann Carter, Dana Cross, Rolf J Sabaldt, Lehana Thabane, Janusz Kaczorowski, Lisa Dolovich, Larry W Chambers, Lawrence Mbuagbaw, CHAP Investigators, Janusz Kaczorowski, Larry W Chambers, Lisa Dolovich, J Michael Paterson, Tina Karwalajtys, Tracy Gierman, Barbara Farrell, Beatrice McDonough, Lehana Thabane, Karen Tu, Brandon Zagorski, Ron Goeree, Cheryl A Levitt, William Hogg, Stephanie Laryea, Megan Ann Carter, Dana Cross, Rolf J Sabaldt

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 usual care can reduce cardiovascular disease-related outcomes--to address these specific criticisms and illustrate how to reduce this confusion.

Trial registration: Current controlled trials ISRCTN50550004 (9 May 2007).

Figures

Fig. 1
Fig. 1
PRECIS score for the CHAP trial at the end of trial. The green dots represent the investigators’ scores along the pragmatic-explanatory continuum (4 = explanatory; 0 = pragmatic). All investigators scored the CHAP trial as pragmatic

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