Thabane Lehana, Kaczorowski Janusz, Dolovich Lisa, Chambers Larry W, Mbuagbaw Lawrence
Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada.
Biostatistics Unit, Father Sean O'Sullivan Research Centre, St Joseph's Healthcare, Hamilton, ON, Canada.
Trials. 2015 Sep 2;16:387. 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).
知识转化（KT）涉及将基于证据的策略和指南应用于实践，以改善患者的护理过程和健康结局。实用试验的结果可用于知识转化，为患者、医疗保健提供者和政策制定者提供信息，以便根据给定策略或干预措施在现实世界条件下的表现优化医疗保健决策。然而，实用试验因存在以下问题而受到批评：i）随访失访率高；ii）不遵守研究干预措施；iii）治疗和患者自我评估未设盲，这可能会产生偏差；iv）不如疗效试验那样完美；v）为实现普遍性而牺牲内部有效性；vi）在异质性人群中检测微小治疗效果通常需要大样本量。在本文中，我们讨论这些批评是否有道理，或者它们是否仅仅是由于对实用试验目的的混淆所致。我们使用心血管健康意识计划（CHAP）试验——一项社区随机实用试验，旨在评估与常规护理相比，提供高度组织化的社区CHAP干预措施是否能降低心血管疾病相关结局——来回应这些具体批评，并说明如何减少这种混淆。
当前对照试验ISRCTN50550004（2007年5月9日）。
