Assessing patients’ satisfaction with anti-TNFα treatment in Crohn’s disease: qualitative steps of the development of a new questionnaire

Abstract

Claire Marant1, Benoit Arnould1, Alexia Marrel1, Céderic Spizak1, Jean-Frédéric Colombel2, Patrick Faure3, Hervé Hagege4, Marc Lemann5†, Stéphane Nahon6, Gilbert Tucat7, Luc Vandromme8, Emmanuel Thibout9, Gérard Goldfarb91Mapi Values, Patient-Reported Outcomes, 27 rue de la Villette, Lyon, France; 2Hepatology and Gastroenterology Department, Hôpital Claude Huriez, Lille, France; 3Hepatology and Gastroenterology Department, Clinique Saint-Jean du Languedoc, Gastrologie, Toulouse, France; 4Hepatology and Gastroenterology Department, Centre Hospitalier Intercommunal, Créteil, France; 5Hepatology and Gastroenterology Department, Hôpital Saint Louis, Paris, France; 6Hepatology and Gastroenterology Department, Centre Hospitalier Intercommunal, Le Raincy Montfermeil, France; 7Gastroenterologist, Clinical practice, Paris, France; 8Gastroenterologist, Clinique de Courlancy, Reims, France; 9Abbott France, Rungis, France †Deceased.Purpose: To develop a self-administered questionnaire assessing patients’ satisfaction with treatments in Crohn’s disease for use in clinical research and epidemiological studies.Patients and methods: Semi-directive interviews (16) were conducted with patients with severe Crohn’s disease treated with anti-tumor necrosis factor alpha (anti-TNFα). Transcripts were analyzed and concepts related to satisfaction with treatment were extracted and organized into a model. Items were generated using patients’ words. The resulting test version was tested for relevance and comprehension with 7 patients and revised accordingly; the new version was tested with 5 other patients and revised to provide the pilot version. A clinician advisory board was involved at each milestone of the development.Results: The test questionnaire assessed treatment satisfaction through 67 items, organized into 5 sections: treatment efficacy, side-effects, convenience and constraints, overall impact, and satisfaction. Conceptual content of the questionnaire includes comparison with prior state and with expectations, satisfaction, acceptability, and intentions. The questionnaire was generally well accepted and understood by patients; few modifications were made in the structure and item formulation. After the second round of comprehension tests, the pilot version contained 62 items; the questionnaire was named Satisfaction of PAtients in Crohn’s diseasE (SPACE©).Conclusion: The questionnaire is a unique tool to assess treatment satisfaction in patients with Crohn’s disease. A scoring and validation study is currently being performed to finalize and establish its scoring, as well as its psychometric properties.Keywords: Crohn’s disease, anti-TNF treatment, questionnaire, patient satisfaction, patient-reported outcome