Introduction & Objective: Trials in obesity have traditionally focused on weight loss and resolution of comorbidities as primary outcomes. However, secondary outcomes, such as the impact of weight reduction on the patient experience like health-related quality of life (HRQoL), have increasingly been recognized as important. Therefore, a review was conducted to determine the clinical outcome assessments (COAs) and digital health technologies (DHTs) used in clinical trials to assess patient experience.

Methods: Two clinical trial databases (US & EU) were reviewed to identify phase 2-4 obesity clinical trials (2018-2023). A literature review was also conducted using the OVID database to identify obesity clinical trial publications which included COAs/DHTs (2010-2023).

Results: Trials from the databases (n=53) and publications (n=42) were included in data extraction. This resulted in identification of 111 COAs, the majority being patient-reported outcomes (PROs; n=86), and 2 DHTs. The most frequent COAs were the Short Form 36 (SF-36v2) and Impact of Weight on Quality of Life-Lite Clinical Trials (IWQoL-Lite-CT), although 24 performance outcomes (PerfOs) were also identified, with the 6-minute walk test (6MWT) being most common. These measures were used as either confirmatory or supportive secondary endpoints, with physical function (PF) being the most frequently specified domain. Measures of eating-related thoughts and behaviours and disordered eating were also frequently included, although individual measures varied widely across trials.

Conclusion: Review of COAs/DHTs in registered clinical trials and publications found that multidimensional PRO measures assessing HRQoL were most often used in obesitytrials with limited use currently of DHTs. PROs were typically used as secondary (confirmatory and supportive) endpoints to assess PF. Further work is warranted to assess how these PRO data were viewed by regulators and payers.

Disclosure

I.A. Goetz: Employee; Eli Lilly and Company. C. Sutter: Consultant; Eli Lilly and Company. T.H. Abraham: Consultant; Eli Lilly and Company. C. Kanu: None. K. Boye: Employee; Eli Lilly and Company. T. Symonds: None.

© 2024 by the American Diabetes Association
2024
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