A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers
A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers
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DOI：
10.1503/cmaj.090523
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发表时间：
2009-05-01
影响因子：
7.2
通讯作者：
Chalkidou, Kalipso
中科院分区：
文献类型：
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作者：
Thorpe, Kevin E.;Zwarenstein, Merrick;Chalkidou, Kalipso
目的：提出一个工具，以帮助试验者在设计决策是一致的，他们的试验的既定目的。研究设计和设置：随机试验已被广泛归类为具有务实或解释性的态度。实用试验试图回答这样一个问题：“这种干预在通常条件下有效吗？而解释性试验则关注于这样一个问题：“这种干预在理想条件下是否有效？”“设计决策使试验更具（或更少）实用性或解释性，但目前还没有工具可以帮助研究人员根据试验的主要目标做出最佳决策。在两个国际会议的过程中，参与者的经验，临床护理，研究委托，医疗保健融资，试验方法，并报告定义和完善方面的试验设计，区分务实的态度从explanative.Results：我们已经开发出一种工具（称为PRECIS）与10个关键领域，并确定标准，以帮助研究人员确定如何务实或解释他们的审判。评估总结graphically.Conclusion：我们认为，PRECIS是一个有用的第一步，朝着一个工具，可以帮助试验，以确保他们的设计决策是一致的试验的目的。(C)2009年，作者。爱思唯尔公司出版All rights reserved.
Objective: To propose a tool to assist trialists in making design decisions that are consistent with their trial's stated purpose.Study Design and Setting: Randomized trials have been broadly categorized as either having a pragmatic or explanatory attitude. Pragmatic trials seek to answer the question, "Does this intervention work under usual conditions?," whereas explanatory trials are focused on the question, "Can this intervention work under ideal conditions?" Design decisions make a trial more (or less) pragmatic or explanatory, but no tool currently exists to help researchers make the best decisions possible in accordance with their trial's primary goal. During the course of two international meetings, participants with experience in clinical care, research commissioning, health care financing, trial methodology, and reporting defined and refined aspects of trial design that distinguish pragmatic attitudes from explanatory.Results: We have developed a tool (called PRECIS) with 10 key domains and which identifies criteria to help researchers determine how pragmatic or explanatory their trial is. The assessment is summarized graphically.Conclusion: We believe that PRECIS is a useful first step toward a tool that can help trialists to ensure that their design decisions are consistent with the stated purpose of the trial. (C) 2009 The Authors. Published by Elsevier Inc. All rights reserved.