Departments of Physical Therapy and Orthopaedic Surgery, Virginia Commonwealth University, Richmond, VA, USA.
J Clin Epidemiol. 2010 Nov;63(11):1271-5. doi: 10.1016/j.jclinepi.2010.03.006. Epub 2010 Jun 17.
A recently published instrument (PRECIS) was designed to assist investigative teams in understanding the various design decisions that need to be made regarding pragmatic vs. explanatory trials. Our team used this instrument during an investigators' meeting to organize our discussion regarding the design of a planned trial and to determine the extent of consensus among the study investigators.
The study was descriptive in nature and occurred during an investigator meeting. After reading and reviewing the 10 PRECIS criteria, the team made quantitative judgments of the planned study regarding each PRECIS criteria to reflect initial, ideal, and final study design perceptions.
Data indicated that the final study design was more explanatory in nature than the preliminary plan. Evidence of consensus was obtained.
The investigative team found that applying PRECIS principles were useful for (1) detailing points of discussion related to trial design, (2) making revisions to the design to be consistent with the project goals, and (3) achieving consensus. We believe our experiences with PRECIS may prove valuable for trial researchers in much the same way that case reports can provide valuable insights for clinicians.
最近发布的一种工具（PRECIS）旨在帮助研究团队理解在实用主义和解释性试验之间需要做出的各种设计决策。我们的团队在一次研究者会议上使用了这个工具，以组织我们对计划试验设计的讨论，并确定研究参与者之间的共识程度。
该研究本质上是描述性的，发生在一次研究者会议期间。在阅读和审查了 10 个 PRECIS 标准后，团队对计划研究的每个 PRECIS 标准进行了定量判断，以反映初始、理想和最终研究设计的看法。
数据表明，最终的研究设计比初步计划更具解释性。达成了共识的证据。
研究团队发现，应用 PRECIS 原则有助于：（1）详细说明与试验设计相关的讨论要点，（2）对设计进行修订以符合项目目标，（3）达成共识。我们相信，我们在 PRECIS 方面的经验可能对试验研究人员非常有价值，就像病例报告可以为临床医生提供有价值的见解一样。
