Archive | 2021
Protocol Refinement for a Diabetes Pragmatic Trial using the PRECIS-2 Framework
Abstract
\n Background: 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. Methods: 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 and refinements 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 are compared using descriptive statistics.Results: 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 enhance pragmatism and address COVID-19 issues. There was general agreement among team members and across different types of stakeholders on PRECIS-2 ratings.Conclusions: We discuss lessons learned from use of PRECIS-2 and challenges in refining the study to be maximally pragmatic on some dimensions, yet well controlled on other dimensions. This paper expands on prior research by describing experimental design efforts to achieve targeted levels of pragmatism and describes our refinements for protocol fit to 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