Forbes Gordon, Loudon Kirsty, Treweek Shaun, Taylor Stephanie J C, Eldridge Sandra
Centre for Primary Care and Public Health, Queen Mary University of London, Yvonne Carter Building, 58 Turner Street, London E1 2AB, UK.
Nursing, Midwifery and Allied Health Professions Research Unit, University of Stirling, Stirling FK9 4LA, UK.
J Clin Epidemiol. 2017 Oct;90:119-126. doi: 10.1016/j.jclinepi.2017.06.007. Epub 2017 Jun 17.
To compare two approaches for trial teams to apply PRECIS-2 to pragmatic trials: independent scoring and scoring following a group discussion.
We recruited multidisciplinary teams who were conducting or had conducted trials in primary care in collaboration with the Pragmatic Clinical Trials Unit, Queen Mary University of London. Each team carried out two rounds of scoring on the nine PRECIS-2 domains: first independently using an online version of PRECIS-2 and second following a discussion.
Seven teams took part in the study. Before the discussion, within-team agreement in scores was generally poor and not all raters were able to score all domains; agreement improved after the discussion. The PRECIS-2 wheels suggested that the trials were pragmatic, although some domains were more pragmatic than others.
PRECIS-2 can facilitate information exchange within trial teams. To apply PRECIS-2 successfully, we recommend a discussion between those with detailed understanding of what usual care is for the intervention, the trial's design including operational and technical aspects, and the PRECIS-2 domains. For some cluster-randomized trials, greater insight may be gained by plotting two PRECIS-2 wheels, one at the individual participant level and another at the cluster level.
比较试验团队将PRECIS-2应用于实用性试验的两种方法：独立评分和小组讨论后评分。
我们招募了多学科团队，这些团队与伦敦玛丽女王大学实用临床试验单位合作，正在或已经在初级保健领域开展试验。每个团队对PRECIS-2的九个领域进行两轮评分：第一轮独立使用PRECIS-2的在线版本，第二轮在讨论后进行。
七个团队参与了该研究。讨论前，团队内部评分的一致性普遍较差，并非所有评分者都能对所有领域进行评分；讨论后一致性有所提高。PRECIS-2轮显示这些试验具有实用性，尽管有些领域比其他领域更具实用性。
PRECIS-2可促进试验团队内部的信息交流。为了成功应用PRECIS-2，我们建议对干预措施的常规护理、试验设计（包括操作和技术方面）以及PRECIS-2领域有详细了解的人员之间进行讨论。对于一些整群随机试验，通过绘制两个PRECIS-2轮（一个在个体参与者层面，另一个在整群层面）可能会获得更深入的见解。
