S940 Development of a Patient Reported Outcome Measure for Barrett’s Esophagus (PROBE): Concept Elicitation and Item Generation

Introduction: Barrett’s esophagus (BE) lacks a disease-specific patient-reported outcome (PRO) instrument to assess health-related quality of life (HRQOL) to capture the patient voice and serve as an outcome in clinical research. Therefore, we aimed to develop a BE-specific PRO instrument (PROBE). Methods: We conducted semi-structured concept elicitation interviews with 36 patients stratified by management stage: surveillance (N = 13), active endoscopic eradication therapy (EET) (N = 11), and post-complete eradication of intestinal metaplasia (CEIM) surveillance (N = 12). Interviews were transcribed and analyzed using a Framework approach to generate codes and themes. Based on identified concepts, a preliminary item pool was drafted, refined iteratively for clarity and content validity, and grouped into conceptual domains to reflect HRQOL in BE. Results: Patients (mean age 65.9 ± 9.0 years, 66.7% men, 56% with smoking history) reported baseline histologies: nondysplastic BE (30.6%), indefinite dysplasia (11.1%), low-grade dysplasia (16.7%), high-grade dysplasia (30.6%), and intramucosal carcinoma (11.1%). Gastroesophageal reflux disease symptom frequency on medications varied: none (47.2%), monthly (27.8%), and weekly/daily (25%). Surveillance Phase: Patients described long-term management burdens, altered dietary and sleep habits, and persistent anxiety about cancer risk and proton pump inhibitor side effects. Some reported logistical/financial challenges and medication costs. Active EET Phase: Patients recalled procedural pain, post-treatment dietary limitations, and lifestyle changes to minimize symptoms. Emotional impacts included fear of cancer and concerns about long-term medication use. Some had access issues. Post-CEIM Surveillance Phase: Patients reported lasting discomfort from ablation or dilation, dietary restrictions, concerns about recurrence, financial concerns, and a need for clearer post-treatment guidance. From these insights, 40 candidate items were drafted and categorized into 7 domains: physical symptoms, procedural impact, lifestyle modification, emotional well-being, medication concerns, healthcare access/logistics, and disease understanding. Twenty-five items were chosen for evaluation in a patient validation cohort sample. Conclusion: Themes of physical discomfort, lifestyle disruption, emotional distress, and care-related burdens across all treatment stages were common and informed the development of a patient-centered item pool. Future steps include psychometric validation, and finalization of the BE-PRO instrument for use in clinical and research settings.