University of Colorado Anschutz Medical Campus, 13199 E Montview Blvd Ste 210, Aurora, CO, 80045, USA.
VA Eastern Colorado QUERI and Geriatric Research Centers, 1055 Clermont St, Denver, CO, 80220, USA.
BMC Health Serv Res. 2021 Oct 2;21(1):1039. doi: 10.1186/s12913-021-07084-x.
This report describes how we refined a protocol for a pragmatic comparative effectiveness study of two models of an evidence-based diabetes shared medical appointment intervention and used the PRECIS-2 rating system to evaluate these adaptations.
We report primary data collected between June and August 2019, and protocol refinements completed between 2018 and 2020. Twenty-two members of the study team collaborated in protocol refinement and completed the PRECIS-2 ratings of study pragmatism. We discuss study design refinements made to achieve the desired level of pragmatism vs. experimental control for each of the nine PRECIS-2 dimensions. Study team members received training on PRECIS-2 scoring and were asked to rate the study protocol on the nine PRECIS-2 dimensions. Ratings were compared using descriptive statistics.
In general, the PRECIS-2 ratings revealed high levels of pragmatism, but somewhat less pragmatic ratings on the categories of Delivery and Organization (costs and resources). This variation was purposeful, and we provide the rationale for and steps taken to obtain the targeted level of pragmatism on each PRECIS-2 dimension, as well as detail design changes made to a) make the design more pragmatic and b) address COVID-19 issues. There was general agreement among team members and across different types of stakeholders on PRECIS-2 ratings.
We discuss lessons learned from use of PRECIS-2 and experiences in refining the study to be maximally pragmatic on some dimensions and less so on other dimensions. This paper expands on prior research by describing actions to achieve higher levels of pragmatism and revise our protocol fit to the changed context. We make recommendations for future use of PRECIS-2 to help address changing context and other strategies for the planning of and transparent reporting on pragmatic research and comparative effectiveness research.
Clinicaltrials.gov Registration ID: NCT03590041 .
本报告介绍了我们如何改进一项基于证据的糖尿病共享医疗预约干预措施的实用对比效果研究方案，并使用 PRECIS-2 评分系统来评估这些调整。
我们报告了 2019 年 6 月至 8 月间收集的主要数据，以及 2018 年至 2020 年间完成的方案改进。研究团队的 22 名成员合作进行了方案改进，并对研究实用性的 PRECIS-2 评分进行了评估。我们讨论了为实现每个 PRECIS-2 维度所需的实用水平与实验控制而进行的研究设计改进。研究团队成员接受了 PRECIS-2 评分培训，并被要求对研究方案的九个 PRECIS-2 维度进行评分。使用描述性统计方法比较评分。
一般来说，PRECIS-2 评分显示出高度的实用性，但在交付和组织（成本和资源）类别中则略显不够实用。这种变化是有目的的，我们提供了在每个 PRECIS-2 维度上获得目标实用性水平的理由和步骤，以及为使设计更实用和解决 COVID-19 问题而对设计进行的更改细节。团队成员之间以及不同类型的利益相关者之间对 PRECIS-2 评分的看法基本一致。
我们讨论了使用 PRECIS-2 以及在改进研究以在某些维度上最大化实用性而在其他维度上则减少实用性方面所获得的经验教训。本文通过描述实现更高实用性水平的措施以及对方案进行调整以适应变化的背景，扩展了之前的研究。我们为未来使用 PRECIS-2 提出了建议，以帮助应对不断变化的背景以及实用研究和对比效果研究的规划和透明报告的其他策略。
Clinicaltrials.gov 注册号：NCT03590041。
