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首页> 外文期刊>Trials >Reducing the confusion and controversies around pragmatic trials: using the Cardiovascular Health Awareness Program (CHAP) trial as an illustrative example
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Reducing the confusion and controversies around pragmatic trials: using the Cardiovascular Health Awareness Program (CHAP) trial as an illustrative example

机译：减少实用性试验周围的困惑和争议：以“心血管健康意识计划”（CHAP）试验为例

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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).
机译：知识翻译（KT）涉及在实践中实施基于证据的策略和指南，以改善患者的护理过程和健康结果。实用试验的结果可能会在KT中用于为患者，医疗保健提供者和政策制定者提供信息，以根据给定的策略或干预措施在现实世界中的表现如何优化医疗保健决策。但是，实用主义试验因存在以下问题而受到批评：i）随访失误率高; ii）不坚持学习干预; iii）盲法治疗和患者自我评估，可能会产生偏见; iv）比功效试验还不够完善; v）牺牲内部有效性以实现可概括性; vi）通常需要大样本量才能检测出异质人群中的较小治疗效果。在本文中，我们讨论了这些批评是否值得，还是仅仅是由于对实用主义审判目的的困惑而引起的。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，提供高度有组织的，基于社区的CHAP干预措施是否可以减少与心血管疾病相关的结果-解决这些具体的批评并说明如何减少这种混乱。审判注册目前进行的对照试验为ISRCTN50550004（2007年5月9日）。

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