Patient Involvement in the Development of Obesity and Weight Loss-Specific Patient-Reported Outcome Measures
Author(s)
Natalia Zdorovtsova, PhD1, Saniya Deshpande, MSc2, Matthew Hankins, PhD3.
1Health Analytics Associate Consultant, Lane Clark and Peacock, London, United Kingdom, 2Health Analytics, Lane Clark & Peacock, London, United Kingdom, 3Health Analytics, LCP Health Analytics, London, United Kingdom.
1Health Analytics Associate Consultant, Lane Clark and Peacock, London, United Kingdom, 2Health Analytics, Lane Clark & Peacock, London, United Kingdom, 3Health Analytics, LCP Health Analytics, London, United Kingdom.
OBJECTIVES: Obesity significantly impairs quality of life (QoL), and numerous instruments have been developed to quantify obesity-specific QoL. However, the development processes for these patient-reported outcome measures (PROMs) have historically involved patients to varying degrees, raising concerns about content validity and the applicability of these measures to challenges associated with obesity and weight loss treatments. In the current study, we evaluated thirteen obesity QoL instruments based on the inclusion of patients in their development, and we discuss the increasing importance of patient involvement in the age of GLP-1 therapies.
METHODS: We systematically evaluated the extent of patient involvement in the development of thirteen obesity-specific QoL instruments, adapting a four-stage framework (concept identification, item generation, item reduction, psychometric validation) previously applied by Frew et al. (2013). For each of the stages, two independent reviewers gave each instrument a score ranging between 0 and 3—with a score of 0 representing no patient involvement, 1 representing patient consultation, 2 representing collaboration with patients, and 3 representing a patient-led process.
RESULTS: We found that most instruments had minimal patient input during development: over half had no documented involvement at any stage, and none exceeded a consultative role (Level 1 involvement) at any given stage of the development process. Even instruments with strong reliability and validity often lacked patient involvement.
CONCLUSIONS: Here, we argue that current QoL instruments, many of which were developed before the GLP-1 era, risk becoming outdated in content—and, indeed, may already be limited in the extent to which they capture the full breadth of patient experiences. We argue that even psychometrically sound instruments may fail to reflect what matters most to patients today unless they are continuously updated through patient-centred design. Patient involvement in PROM development is needed to ensure content validity in the context of modern obesity treatments.
METHODS: We systematically evaluated the extent of patient involvement in the development of thirteen obesity-specific QoL instruments, adapting a four-stage framework (concept identification, item generation, item reduction, psychometric validation) previously applied by Frew et al. (2013). For each of the stages, two independent reviewers gave each instrument a score ranging between 0 and 3—with a score of 0 representing no patient involvement, 1 representing patient consultation, 2 representing collaboration with patients, and 3 representing a patient-led process.
RESULTS: We found that most instruments had minimal patient input during development: over half had no documented involvement at any stage, and none exceeded a consultative role (Level 1 involvement) at any given stage of the development process. Even instruments with strong reliability and validity often lacked patient involvement.
CONCLUSIONS: Here, we argue that current QoL instruments, many of which were developed before the GLP-1 era, risk becoming outdated in content—and, indeed, may already be limited in the extent to which they capture the full breadth of patient experiences. We argue that even psychometrically sound instruments may fail to reflect what matters most to patients today unless they are continuously updated through patient-centred design. Patient involvement in PROM development is needed to ensure content validity in the context of modern obesity treatments.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
PCR172
Topic
Patient-Centered Research
Topic Subcategory
Instrument Development, Validation, & Translation, Patient-reported Outcomes & Quality of Life Outcomes
Disease
Diabetes/Endocrine/Metabolic Disorders (including obesity)