The Reporting and Methodological Recommendations for Observational Studies Estimating the Effects of Deprescribing Medications (REMROSE-D) ISPE-Endorsed Guidance

Purpose: Pharmacoepidemiologic studies on deprescribing are challenging to implement, yet little guidance exists on methods to avoid bias and minimum reporting for replicability and appraisal. We developed consensus recommendations for the methods and reporting of observational studies that aim to examine the effects of deprescribing. Methods: We formed candidate recommendations based on our prior systematic review that methodologically appraised observational studies on deprescribing. We then conducted a two-round modified Delphi process with researchers working in deprescribing pharmacoepidemiology to refine, select, and reach consensus on recommendations for a checklist based on > 70% agreement of their importance. We termed this list the REMROSE-D (Reporting and Methodological Recommendations for Observational Studies estimating the Effects of Deprescribing medications) guidance. Results: Twenty-three candidate recommendations were presented to the Delphi panel. The round 1 survey was completed by 55 participants, and 18 of the 23 candidate recommendations were selected for inclusion. Five candidate recommendations without consensus plus two additional items suggested by participants were included in a round 2 survey of 25 deprescribing researchers. Five of these seven items garnered consensus for inclusion, and two were excluded. The final REMROSE-D guidance contains 23 recommendations for the methods and reporting of observational research on deprescribing. Conclusion: To ensure rigor and reproducibility in observational studies of the effects of deprescribing, the REMROSE-D guidance provides recommendations for important reporting and methods considerations, including time zero, precise definitions of deprescribing, addressing confounding by indication, and careful consideration of follow-up to avoid immortal time bias.