Real-World-Data Analysis of Patient-Reported Outcomes Collected Through the H2O Consortium From Patients With Inflammatory Bowel Disease

Speaker(s)

Serra-Ruiz X1, Galan G2, Ferri M2, Gimenez E3, Fierens L4, Ferrante M5, Novacek G6, Long P7, Rogge A8, Borruel N9
1Hospital Vall d’Hebron. Digestive System Research Unit (VHIR), Barcelona, B, Spain, 2Vall d’Hebron Institut de Recerca (VHIR), Vall d'Hebron Barcelona Hospital Campus, Barcelona, B, Spain, 3Hospital Vall d'Hebron, Barcelona, Catalonia, Spain, 4KU Leuven, Heist-op-den-Berg, Belgium, 5Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven, Belgium, 6Medical University of Vienna, Vienna, Vienna, Austria, 7Medical University of Vienna, Vienna, 9, Austria, 8Charité – Universitätsmedizin Berlin, Berlin, Berlin, Germany, 9Hospital Vall d’Hebron. Digestive System Research Unit (VHIR), CIBEREHD, Barcelona, Barcelona, Spain

Presentation Documents

OBJECTIVES: The collection of patient-reported outcomes (PROs) in clinical practise is becoming increasingly important. However, lack of standardisation limits their usefulness. The Health Outcome Observatory (H2O) project aims to standardise and facilitate the collection of PROs and clinical outcomes by developing multi-stakeholder agreed Core Outcome Sets (COS), including one for patients with inflammatory bowel diseases (IBD). This study analyses preliminary data from three centres implementing the H2O-COS for IBD.

METHODS: Three university hospitals - Vall d'Hebron, Barcelona (HUVH), Charité, Berlin and MedUni, Vienna (MUW) – implemented the H2O-COS for IBD, using PRO-2 for Crohn’s disease (CD) and ulcerative colitis (UC) symptoms and IBD-Control for quality of life and treatment satisfaction. Data were collected from December 2023 to June 2024.

RESULTS: Data from 400 patients were analysed: 28 from HUVH, 20 from Charité and 352 from MUW. All UC and CD patients in HUVH were in symptomatic remission. Rectal bleeding and increased bowel movements were reported by 10% and 50% in Charité UC patients, and 13% and 45% in MUW. CD patients reported moderate or severe abdominal pain in 60% (Charité) and 12% (MUW). In the IBD-Control questionnaire, 11%, 65% and 30% of HUVH, Charité and MUW patients reported fatigue, and 11%, 40% and 20% reported anxiety or depression associated with IBD, respectively. The most anticipated topics for upcoming visits were “side effects or difficulties with using my medication” in HUVH (47%) and “ways to adjust my own treatment” in MUW (30%). Overall, 87% of patients believed that their current treatment is useful in controlling IBD.

CONCLUSIONS: Integrating PRO collection into routine care improves personalised treatment and facilitates patient-physician discussion. Standardised data collection allows inter-center comparison and supports multicenter research and quality improvement initiatives. Expanding patient enrolment in future phases will further demonstrate the feasibility and value of H2O-COS.

Code

PCR319

Topic

Clinical Outcomes, Medical Technologies, Patient-Centered Research

Topic Subcategory

Clinical Outcomes Assessment, Patient-reported Outcomes & Quality of Life Outcomes

Disease

Gastrointestinal Disorders, No Additional Disease & Conditions/Specialized Treatment Areas