Protocol refinement for a diabetes pragmatic trial using the PRECIS-2 framework.
Protocol refinement for a diabetes pragmatic trial using the PRECIS-2 framework.
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DOI：
10.1186/s12913-021-07084-x
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发表时间：
2021-10-02
影响因子：
2.8
通讯作者：
Kwan BM
中科院分区：
文献类型：
--
作者：
Glasgow RE;Gurfinkel D;Waxmonsky J;Rementer J;Ritchie ND;Dailey-Vail J;Hosokawa P;Dickinson LM;Kwan BM
本报告描述了我们如何为两种循证糖尿病共享医疗预约干预模式的实用比较有效性研究改进方案，并使用PRECIS-2评级系统评估这些适应性。我们报告了2019年6月至8月收集的原始数据，以及2018年至2020年完成的协议改进。研究小组22名成员合作完善方案，完成研究实用主义PRECIS-2评分。我们讨论了为实现九个PRECIS-2维度中的每个维度的实用主义与实验控制的期望水平而进行的研究设计改进。研究小组成员接受了PRECIS-2评分方面的培训，并被要求根据PRECIS-2的九个维度对研究方案进行评分。评分采用描述性统计进行比较。一般来说，PRECIS-2的评分显示出高度的实用主义，但在交付和组织（费用和资源）类别上的评分则不那么实用。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主义水平的基本原理和采取的步骤，以及为a)使设计更实用和b)解决COVID-19问题而进行的详细设计更改。团队成员和不同类型的利益相关者对PRECIS-2评级达成了普遍共识。我们讨论了从使用PRECIS-2中获得的经验教训，以及在改进研究以使其在某些维度上最大限度地实用而在其他维度上较少实用的经验。本文通过描述实现更高层次实用主义的行动来扩展先前的研究，并修改我们的协议以适应变化的环境。我们就今后使用PRECIS-2提出建议，以帮助处理不断变化的背景和其他战略，以便规划和透明地报告务实研究和比较有效性研究。Clinicaltrials.gov注册编号：NCT03590041。在线版本包含补充材料，可在10.1186/s12913-021-07084-x获得。
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. The online version contains supplementary material available at 10.1186/s12913-021-07084-x.
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DOI：
10.3122/jabfm.2020.05.200049
发表时间：
2020-09-01
影响因子：
2.9
作者：
Kwan, Bethany M.;Rementer, Jenny;Waxmonsky, Jeanette A.
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