Improving the reporting of pragmatic trials: an extension of the CONSORT statement.
Improving the reporting of pragmatic trials: an extension of the CONSORT statement.
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DOI：
10.1136/bmj.a2390
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发表时间：
2008-11-11
期刊：
影响因子：
--
通讯作者：
Pragmatic Trials in Healthcare (Practihc) group
中科院分区：
文献类型：
--
作者：
Zwarenstein M;Treweek S;Gagnier JJ;Altman DG;Tunis S;Haynes B;Oxman AD;Moher D;CONSORT group;Pragmatic Trials in Healthcare (Practihc) group
CONSORT声明旨在改进随机对照试验的报告，并侧重于最小化偏倚风险（内部效度）。试验结果的适用性（普遍性或外部有效性）也很重要，特别是对于实用试验。实用试验（这个词最早由Schwartz和Lellouch在1967年使用）可以被广义地定义为一种随机对照试验，其目的是为实践决策提供信息。CONSORT声明的扩展旨在改进此类试验的报告，并侧重于适用性。方法在2005年和2008年于多伦多举行的两次为期两天的会议上，我们回顾了CONSORT声明及其扩展、有关语用试验和适用性的文献以及我们开展语用试验的经验。我们建议将CONSORT清单中的八个项目扩展到实用试验的报告中：背景、参与者、干预措施、结果、样本量、盲法、参与者流量和研究结果的普遍性。本文介绍了这些扩展，并提供了报告的说明性示例，以及对每个扩展的解释。遵守这些报告标准将使决策者更容易判断随机对照试验的结果在多大程度上适用于他们自己的条件。需要实证研究来确定这些CONSORT清单项目扩展的有效性和全面性。与此同时，我们建议那些支持、实施和报告实用试验的人应使用CONSORT声明的这一扩展，以促进在有关卫生保健的决策中使用试验结果。实用试验的目的是为实践决策提供信息，但是糟糕的报告会降低它们的有用性。CONSORT和practice小组描述了CONSORT指南的修改，以帮助读者评估结果的适用性
Background The CONSORT statement is intended to improve reporting of randomised controlled trials and focuses on minimising the risk of bias (internal validity). The applicability of a trial’s results (generalisability or external validity) is also important, particularly for pragmatic trials. A pragmatic trial (a term first used in 1967 by Schwartz and Lellouch) can be broadly defined as a randomised controlled trial whose purpose is to inform decisions about practice. This extension of the CONSORT statement is intended to improve the reporting of such trials and focuses on applicability. Methods At two, two-day meetings held in Toronto in 2005 and 2008, we reviewed the CONSORT statement and its extensions, the literature on pragmatic trials and applicability, and our experiences in conducting pragmatic trials. Recommendations We recommend extending eight CONSORT checklist items for reporting of pragmatic trials: the background, participants, interventions, outcomes, sample size, blinding, participant flow, and generalisability of the findings. These extensions are presented, along with illustrative examples of reporting, and an explanation of each extension. Adherence to these reporting criteria will make it easier for decision makers to judge how applicable the results of randomised controlled trials are to their own conditions. Empirical studies are needed to ascertain the usefulness and comprehensiveness of these CONSORT checklist item extensions. In the meantime we recommend that those who support, conduct, and report pragmatic trials should use this extension of the CONSORT statement to facilitate the use of trial results in decisions about health care. Pragmatic trials are designed to inform decisions about practice, but poor reporting can reduce their usefulness. The CONSORT and Practihc groups describe modifications to the CONSORT guidelines to help readers assess the applicability of the results
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