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Obesity/Nutrition

(3.14) Qualitative Insights on Meaningful Change in Physical Functioning in SURMOUNT-4 Participants

Thursday, May 9, 2024
11:05 AM – 11:20 AM CDT
Location: ePoster Showcase, Empire Ballroom Foyer, Level 2
Objective : SURMOUNT-4 was a Phase 3 clinical trial evaluating the safety and efficacy of tirzepatide in adults living with obesity or overweight. Three patient-reported outcome (PRO) measures were included to assess physical functioning: The Short Form-36 Health Survey (v2 Acute) –Physical Functioning domain (SF-36v2-PF), the Impact of Weight on Quality of Life-Clinical Trials Version – Physical Function domain (IWQOL-Lite-CT-PF) and a Patient Global Impression of Status (PGIS) for Physical Activity. This qualitative study aimed to understand meaningful change in physical functioning from the perspective of adults living with obesity or overweight.

Methods: Qualitative interviews were conducted with a random sample of US-based participants who had completed their primary endpoint and safety follow-up visits in SURMOUNT-4. Following cognitive debriefing of each PRO measure, participants were asked to consider how their responses may have changed throughout the clinical trial and whether any improvements experienced were meaningful. Participants who had not experienced improvements on an item were asked to consider the smallest change which would be meaningful to them.

Results:

N=34 interviews were conducted (mean age=49 years, standard deviation [SD]=14.6; n=24 females; n=7 with a high school diploma or lower education level) with n=20 participants randomized to tirzepatide and n=14 participants randomized to placebo. Nearly all participants (SF36v2-PF: n=33/34; IWQOL-Lite-CT-PF: n=32/34; PGIS for Physical Activity: n=32/34) reported that they had experienced an improvement on ≥1 item in each PRO during their participation in SURMOUNT-4; these improvements were consistently described as meaningful.

For all PROs, the majority of participants (across both treatment arms) described a 1-point or 1-category change as the smallest improvement at the item-level that they would consider meaningful. This appeared broadly consistent across the SF36v2-PF items, the IWQOL-Lite-CT-PF items, and the PGIS for Physical Activity, with at least 80% of participants endorsing a 1-point improvement as being meaningful, regardless of any changes they had experienced during the trial.

Discussion/Conclusion: The study supports existing literature that a 1-point change on each item of the SF-36v2-PF is meaningful to adults living with obesity. One-point/category changes on each item of the IWQOL-Lite-CT-PF and the PGIS for Physical Activity were also considered to be meaningful.