Year: 2026
Type: article
Study design: Observational Study
Abstract: Investigator-initiated studies that include information collected by patients are rising, but limited data is available on patient and investigator experience in this setting. The I-CARE cohort included patients with inflammatory bowel disease (IBD) monthly collecting clinical information in 15 countries for up to 6 years. We describe patients and investigators' involvement in I-CARE and identify predictors of early withdrawal due to patient non-engagement. Patients' characteristics according to the number of electronic Patient-reported outcomes (ePRO) completed during follow-up were assessed. Predictors of early withdrawal due to patient non-engagement were identified using logistic regression. The coding of outcomes reported by patients and corrections by investigators on patients' ePROs were assessed. Among 12,846 patients included by 502 investigators, 79.3% and 77.3% filled more than one ePRO and at least one ePRO within 6 months before the study end date, respectively. All ePROs were completed in 72.8% and 56.4% of patients during year 1 and 3, respectively. Male gender, younger age (< 20), being unemployed or a student, and no previous history of abdominal surgery were associated with early withdrawal. Investigators corrected 52.5% of cancer or dysplasia reported by patients compared to 10% of serious infections. Investigators added or removed a treatment sequence in 19.6% of the 6708 patients treated with biologics. These results highlight the implication of patients in research and the importance of data validation by investigators alongside the challenge and potential of collecting medical data from patients. These findings can inform similar future initiatives in other diseases. (EudraCT, Number: 2014-004728-23; ClinicalTrials.gov, Number: NCT02377258).
DOI: 10.1002/cpt.70231
Authors: Julien Kirchgesner, Laurent Beaugerie, Cédric Baumann, Filip Baert, Jean‐François Rahier, Daniel Bergemalm, Fiorella Cañete, Bénédicte Caron, Marta Cossignani, Sandra Dias, Klaudia Farkas, Parker Girod, Idan Goren, Tom Holvoet, Susanne Krasz, Aditi Kumar, Peter Rimmer, Juliette Sheridan, Jessica Thut, Mathieu Uzzan, Nikos Viazis, Petra Weimers, Edyta Zagórowicz, Anne Buisson, Luisa Avedano, Helene Rousseau, Laurent Peyrin‐Biroulet, Shaji Sebastian, I‐CARE Collaborator Group
Institutions: Inserm, Sorbonne Université, Assistance Publique – Hôpitaux de Paris, Hôpital Saint-Antoine, Institut Pierre Louis d‘Épidémiologie et de Santé Publique, Centre Hospitalier Régional et Universitaire de Nancy, Interdisciplinarité en Santé Publique Interventions et Instruments de mesure complexes – Région Est, Université de Lorraine, AZ Delta, UCLouvain, Örebro University, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Hospital Universitari Germans Trias i Pujol, Nutrition-Génétique et Exposition aux Risques Environnementaux, University of Szeged, University College Dublin, St. Vincent's University Hospital, Tel Aviv University, SUNY Upstate Medical University, Rabin Medical Center, University Hospital Carl Gustav Carus, The Royal Wolverhampton NHS Trust, University Hospitals Birmingham NHS Foundation Trust, Hull Royal Infirmary, Université Paris-Est Créteil, Hôpitaux Universitaires Henri-Mondor, Evangelismos Hospital, The Maria Sklodowska-Curie National Research Institute of Oncology, Association François Aupetit, University of Hull
Language: English
Subfield: General Health Professions
Field: Health Professions
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,410
Funders: Amgen, Pfizer, Gilead Sciences
OpenAlex ID: W7129040701