文章基本信息

标题：Reducing the confusion and controversies around pragmatic trials: using the Cardiovascular Health Awareness Program (CHAP) trial as an illustrative example
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作者：Lehana Thabane ; Janusz Kaczorowski ; Lisa Dolovich 等
期刊名称：Trials
印刷版ISSN：1745-6215
电子版ISSN：1745-6215
出版年度：2015
卷号：16
期号：1
页码：1
DOI：10.1186/s13063-015-0919-3
语种：English
出版社：BioMed Central
摘要： 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).
关键词：Pragmatic trials ; Criticism ; Knowledge translation ; Cluster randomized trials