Development of the Reporting recommendations Intended for pharmaceutical risk Minimization Evaluation Studies-Standards for Reporting of Implementation Studies Extension (RIMES-SE)

Background: The Reporting recommendations Intended for pharmaceutical risk Minimization Evaluation Studies (RIMES), a 43-item checklist designed to guide standardized and comprehensive reporting of risk minimization (RM) evaluation studies, was developed in 2018. Continued evidence of critical shortfalls in the implementation of RM programs as well as the reporting of RM studies prompted an update of the RIMES in 2023 to incorporate relevant constructs from the field of implementation research.

Objectives: To extend the RIMES to incorporate relevant implementation constructs and items from the Standards for Reporting of Implementation Studies (StaRI), a best practice reporting guideline for implementation research.

Methods: A study protocol was developed and registered on the EQUATOR Network. We recruited an international pool of experts (n=29) in pharmacoepidemiology, drug safety, risk minimization and implementation science to participate in a 2-round e-Delphi exercise between May-August 2023. Items on the RIMES were mapped against the StaRI to identify gaps; results yielded an initial pool of 34 items that formed the basis for the Round 1 questionnaire. Each item was rated for inclusion in terms of importance and understandability on an 11-point scale; the median, std dev., and IQR were calculated. Items that met the pre-defined success threshold for importance and understandability were retained. Items falling below the pre-defined success threshold for either importance or understandability were reviewed and reworded to improve understandability for Round 2; redundant or irrelevant items were removed. Comments from open text fields were analyzed thematically. Following Round 2, the revised Checklist was presented at a BRACE SIG workshop and was posted for comment on the SIG listserv.

Results: Fifteen experts participated in both e-Delphi rounds (53.6% of the original panel). In Round 1, 85.3% of items reached the inclusion threshold for importance and 52.9% for understandability. 19 items were modified and reassessed. In Round 2, 94.7% reached inclusion threshold for importance, and 78.9% for understandability. The final RIMES-SE consisted of 27 items arranged in a dual strand focusing on 1) the risk minimization program (intervention) and 2) the strategy used to implement it (as in the StaRI).

Conclusions: The RIMES-SE sets forth a standard, minimum set of items to be reported in every risk minimization evaluation study. Its’ consistent use can assist regulators and researchers in assessing the quality of the research, help identify RM evaluation studies in the published literature, and increase awareness regarding good practices in RM program design and evaluation.