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 registrationCurrent controlled trials ISRCTN50550004 (9 May 2007).
Highlights
Confusions and controversies about pragmatic trials and how to deal with them Pragmatic trials have been heavily criticized in the literature [9] for the following reasons: 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
The Canadian Institutes of Health Research (CIHR) defines knowledge translation (KT) as a “dynamic and iterative process that includes synthesis, dissemination, exchange and ethically sound application of knowledge to improve the health of Canadians, provide more effective health services and products and strengthen the health care system” [1]
How did we address the key criticisms about pragmatic trials in the Cardiovascular Health Awareness Program (CHAP) trial? Criticism 1: High rate of loss to follow-up It is important to note that loss to follow-up is a fundamental feature of pragmatic trials because loss to follow-up is a normal process of clinical care in the real world
Summary
The Canadian Institutes of Health Research (CIHR) defines knowledge translation (KT) as a “dynamic and iterative process that includes synthesis, dissemination, exchange and ethically sound application of knowledge to improve the health of Canadians, provide more effective health services and products and strengthen the health care system” [1]. Explanatory trials, known as efficacy trials are designed to test whether an intervention can work under ideal, tightly controlled conditions in patients who receive it [5, 6]. They are intentionally designed not to be pragmatic. A key advantage of a pragmatic trial is that, if its result is positive (that is, the intervention is shown to cause more good than harm), one can be reasonably sure that the therapy being tested really works and can be successfully implemented in real practice.
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