DEVELOPMENT OF THE EATING BEHAVIOR PATIENT-REPORTED OUTCOME MEASURE: CONTENT VALIDATION IN EUROPE
Author(s)
Donald M. Bushnell, III, MA1, Milenka Jean-Baptiste, PhD, MPH2, Carl Cooper, MSc3, Carel le Roux, MBChB, PhD4, Ahmad Alhussein, BSPharm5, Anastasia Uster, MD, PhD6.
1Thermo Fisher Scientific, Wilmington, NC, USA, 2University of North Carolina, Chapel Hill, NC, USA, 3Thermo Fisher, London, United Kingdom, 4University College Dublin School of Medicine, Dublin, Ireland and Ulster University, Coleraine, United Kingdom, 5Boehringer Ingelheim International GmbH, Ingelheim, Germany, 6Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.
1Thermo Fisher Scientific, Wilmington, NC, USA, 2University of North Carolina, Chapel Hill, NC, USA, 3Thermo Fisher, London, United Kingdom, 4University College Dublin School of Medicine, Dublin, Ireland and Ulster University, Coleraine, United Kingdom, 5Boehringer Ingelheim International GmbH, Ingelheim, Germany, 6Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.
OBJECTIVES: The Eating Behavior Patient-Reported Outcome (EB PRO) measure, comprising 12 items across two domains (Desire to Eat, Capacity to Resist), comprehensively assesses eating behaviours of people with obesity. As the EB PRO measure was developed from research in the United States (US), we assessed concordance of concepts and content validity in a European population.
METHODS: Key eligibility criteria were age ≥18 years, body mass index ≥27 kg/m2, and weight-related complication(s). Focus group discussions (FGDs) of ≤90 minutes were conducted in Germany, Spain or Sweden using open-ended questions to elicit concepts from participants’ lived experience of obesity and eating behaviour and to assess concordance with the EB PRO measure. Content validity and participant understanding of the measure was assessed via 1:1 cognitive interviews (≤60 min). Concepts from each FGD were identified and compared to the US EB PRO model constructs and domains.
RESULTS: Fifteen FGDs were conducted with 88 participants (55.7% female, mean age 47.8 years). Participants agreed that their weight management was affected by concepts relating to Desire to Eat which they described as impulse (in 87% of FGDs), emotional characteristics (67%), and social cues (20%). Relating to the Capacity to Resist domain, participants in 67% of FGDs agreed that self-restraint was relevant for weight management and all FGDs reported a constant need to control eating behaviour. All individual items were endorsed by the FGDs. Participants in cognitive interviews (n=15; 66.7% female, mean age 46.0 years) demonstrated comprehension of all EB PRO items and most agreed that all items were relevant to weight loss (≥62.3% of participants for each item).
CONCLUSIONS: This qualitative study supports the content validity of the EB PRO measure for people living with obesity in the European Union. Thus, EB PRO appears suitable for use in clinical trials and clinical practice in Europe.
METHODS: Key eligibility criteria were age ≥18 years, body mass index ≥27 kg/m2, and weight-related complication(s). Focus group discussions (FGDs) of ≤90 minutes were conducted in Germany, Spain or Sweden using open-ended questions to elicit concepts from participants’ lived experience of obesity and eating behaviour and to assess concordance with the EB PRO measure. Content validity and participant understanding of the measure was assessed via 1:1 cognitive interviews (≤60 min). Concepts from each FGD were identified and compared to the US EB PRO model constructs and domains.
RESULTS: Fifteen FGDs were conducted with 88 participants (55.7% female, mean age 47.8 years). Participants agreed that their weight management was affected by concepts relating to Desire to Eat which they described as impulse (in 87% of FGDs), emotional characteristics (67%), and social cues (20%). Relating to the Capacity to Resist domain, participants in 67% of FGDs agreed that self-restraint was relevant for weight management and all FGDs reported a constant need to control eating behaviour. All individual items were endorsed by the FGDs. Participants in cognitive interviews (n=15; 66.7% female, mean age 46.0 years) demonstrated comprehension of all EB PRO items and most agreed that all items were relevant to weight loss (≥62.3% of participants for each item).
CONCLUSIONS: This qualitative study supports the content validity of the EB PRO measure for people living with obesity in the European Union. Thus, EB PRO appears suitable for use in clinical trials and clinical practice in Europe.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
RWD42
Topic
Organizational Practices, Patient-Centered Research, Real World Data & Information Systems
Disease
Diabetes/Endocrine/Metabolic Disorders (including obesity)