Thorpe Kevin E, Zwarenstein Merrick, Oxman Andrew D, Treweek Shaun, Furberg Curt D, Altman Douglas G, Tunis Sean, Bergel Eduardo, Harvey Ian, Magid David J, Chalkidou Kalipso
Dalla Lana School of Public Health, University of Toronto, Ontario, Canada.
J Clin Epidemiol. 2009 May;62(5):464-75. doi: 10.1016/j.jclinepi.2008.12.011.
To propose a tool to assist trialists in making design decisions that are consistent with their trial's stated purpose.
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.
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.
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.
提出一种工具，以协助试验者做出与其试验既定目的相一致的设计决策。
随机试验大致可分为具有务实或阐释性态度两类。务实性试验旨在回答“这种干预措施在通常情况下是否有效？”这一问题，而阐释性试验则聚焦于“这种干预措施在理想条件下能否有效？”这一问题。设计决策会使试验更具（或更不具）务实性或阐释性，但目前尚无工具可帮助研究人员根据试验的主要目标做出尽可能最佳的决策。在两次国际会议期间，具有临床护理、研究委托、医疗保健融资、试验方法和报告经验的参与者界定并完善了区分务实态度与阐释性态度的试验设计方面。
我们开发了一种具有10个关键领域的工具（称为PRECIS），该工具确定了有助于研究人员确定其试验务实或阐释程度的标准。评估以图表形式汇总。
我们认为，PRECIS是迈向一种工具的有益的第一步，该工具可帮助试验者确保其设计决策与试验的既定目的相一致。
