Protocol refinement for a diabetes pragmatic trial using the PRECIS-2 framework.

ABSTRACT:

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 and used the PRECIS-2 rating system to evaluate these adaptations.

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 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-

SUBMITTER: Glasgow RE 

PROVIDER: S-EPMC8486627 | biostudies-literature | 2021 Oct

REPOSITORIES: biostudies-literature