Methodological guidance for real world evidence to assess the effects of deprescribing

Background: The lack of evidence on the effects of withdrawing medications in generalizable populations is a barrier to deprescribing in clinical practice. Pharmacoepidemiologic studies can begin to address these knowledge gaps, but they are subject to many methodological issues. With ISPE manuscript funding, we conducted a systematic review and developed draft guidance for pharmacoepidemiologic studies of deprescribing, which was refined with ISPE member input.

Objectives: This workshop session will: 1) summarize the state of methods used in pharmacoepidemiologic studies related to deprescribing; 2) discuss common challenges in pharmacoepidemiologic studies of deprescribing; 3) introduce the draft guidance for conducting pharmacoepidemiologic studies to estimate the effects of deprescribing; and 4) engage the audience in discussing and updating the guidance document. The session will be of broad interest to those keen to understand and improve the design, measurement, application, reporting, and interpretation of pharmacoepidemiologic studies on deprescribing or medication discontinuation.

Description: Part I (40 min) of the session will provide an overview of the methods used in observational studies of deprescribing, including common challenges and pitfalls. First, Dr. Frank Moriarty will introduce the session and outline methodological challenges for pharmacoepidemiology studies of deprescribing (5 min). Dr. Joshua Niznik will then present results from a scoping review and conceptual framework for conducting observational studies of deprescribing using routinely collected healthcare data. (10 min). Dr. Matthew Maciejewski will present work conducted by US Deprescribing Research Network on data harmonization for defining medication discontinuation outcomes based on electronic health records (10 min). Dr. Kaley Hayes will then present results from an ISPE-funded systematic review on the use of observational studies to evaluate the effects of deprescribing in older adults with a focus on exposure measurement, and introduce the draft methodological guidance (15 min). Part II (50 min) will be an interactive workshop session to receive feedback on methodological guidance. The session will open with a Q&A session on the presentations moderated by Dr. Daniela Moga. Then, the audience will participate in a live survey with the assistance of Ms. Clare Johnson. This survey will allow participants to have input on key methodological aspects of deprescribing research for the draft methodological guidance document for observational studies of deprescribing.