Background: Systematic reviews and meta-analyses of randomized trials that include patient-reported outcomes measures (PROMs) provide crucial information for patients and clinicians facing challenging healthcare decisions. Based on emerging methods, guidance on combining PROMs in meta-analyses and interpreting results will likely enhance their usefulness for decision-makers.
Objectives: In the context of GRADE summary of findings tables in Cochrane reviews, participants will be able to 1. identify the issues in retrieving, analyzing, and interpreting PRO results in clinical trials; 2. discuss preferred alternatives with an emphasis on the minimal important difference (MID) for aggregating across different PRO instruments measuring the same construct; 3. describe how to retrieve MIDs and introduce the concept of judging the credibility of MID estimates; and 4. present PRO results in GRADE summary of findings tables.
Description: This workshop will use interactive lectures with questions to participants and small group discussions to address the challenges in including and interpreting PROs in Cochrane Reviews. Participants and facilitators will explore methods in analyzing and making PROs readily understandable to users and consumers of Cochrane reviews. These challenges involve making decisions on interpreting the magnitude of an effect (e.g., whether differences are trivial, small but important, or large). We will introduce approaches to pooling across different instruments measuring the same construct with emphasis on the concept of the MID (the smallest difference that would motivate a patient to use an intervention), allowing the dichotomization of continuous outcomes (e.g., the proportion of patients who achieve a MID). We will present methods for identifying and evaluating the credibility of MID estimates. During the workshop, issues will arise for discussion in breakout groups. At the end of these breakout sessions, each group will report back with the group’s conclusions. This workshop is also recommended for participants attending a second workshop that will focus on evaluating MID credibility and the application of presentation approaches that rely on the MID in systematic reviews and clinical practice guidelines.