The Reporting Recommendations Intended for Pharmaceutical Risk Minimization Evaluation Studies: Standards for Reporting of Implementation Studies Extension (RIMES-SE)

• Published in: Drug safety 2024-07, Vol.47 (7), p.655-671
• Main Authors: Smith, Meredith Y., Morrato, Elaine H., Mora, Nallely, Nguyen, Viviana, Pinnock, Hilary, Winterstein, Almut G.
• Format: Article
• Language: English
• Subjects: Check lists; Drug Safety and Pharmacovigilance; Intervention; Medicine; Medicine & Public Health; Optimization; Original; Original Research Article; Pharmaceuticals; Pharmacology/Toxicology; Pharmacovigilance; Product safety; Program evaluation; Public health; Research methodology; Risk assessment; Risk reduction; Science
• ISSN: 0114-5916; 1179-1942
• DOI: 10.1007/s40264-024-01417-5

Introduction The Reporting recommendations Intended for pharmaceutical risk Minimization Evaluation Studies (RIMES) was developed to improve the quality of reporting of risk minimization program evaluations. In light of continued inadequacies in study reporting, and high-profile program implementation failures, we updated the RIMES Checklist to incorporate additional concepts from the Standards for Reporting of Implementation studies (StaRI). Methods The development of the updated checklist, the RIMES-StaRI Extension (RIMES-SE), entailed developing a study protocol and drafting an initial pool of items based on a mapping of the RIMES against the StaRI checklist. A modified e-Delphi exercise was then conducted to determine the importance and understandability of items for checklist inclusion. An expert workshop and an online commentary period for additional feedback followed. Results The RIMES-SE contains 27 items. It includes two signature features of the StaRI Checklist: 1) a dual strand of items (represented in two columns) describing the risk minimization program (the ‘intervention’) and the corresponding implementation strategy; and 2) applicable to an array of different research methodologies. Conclusions The RIMES-SE Statement and Checklist extends the reporting guidelines set forth in the original RIMES Checklist via inclusion of key implementation science concepts. It is intended to improve the quality and transparency of reporting of risk minimization evaluation studies so as to advance drug safety science.