Abstract
Background
Severe Crohn’s disease management includes anti-tumor necrosis factor (anti-TNF) drugs that differ from early-stage treatments regarding efficacy, safety, and convenience. This study aimed to finalize and psychometrically validate the Satisfaction for PAtients in Crohn’s diseasE Questionnaire (SPACE-Q©), developed to measure satisfaction with anti-TNF treatment in patients with severe Crohn’s disease.
Methods
A total of 279 patients with severe Crohn’s disease receiving anti-TNF therapy completed the SPACE-Q 62-item pilot version at inclusion and 12 and 13 weeks after first anti-TNF injection. The final SPACE-Q scoring was defined using multitrait and regression analyses and clinical relevance considerations. Psychometric validation included clinical validity against Harvey–Bradshaw score, concurrent validity against Treatment Satisfaction Questionnaire for Medication (TSQM), internal consistency reliability, test–retest reliability, and responsiveness against the patient global impression of change (PGIC).
Results
Quality of completion was good (55%–67% of patients completed all items). Four items were removed from the questionnaire. Eleven scores were defined within the final 58-item SPACE-Q: disease control; symptoms, anal symptoms, and quality of life transition scales; tolerability; convenience; expectation confirmation toward efficacy, side effects, and convenience; satisfaction with treatment; and motivation. Scores met standards for concurrent validity (correlation between SPACE-Q satisfaction with treatment and TSQM satisfaction scores =0.59), internal consistency reliability (Cronbach’s α=0.67–0.93), test–retest reliability (intraclass correlations =0.62–0.91), and responsiveness (improvement in treatment experience assessed by the SPACE-Q for patients reporting improvement on the PGIC). Significantly different mean scores were observed between groups of patients with different Harvey–Bradshaw disease severity scores.
Conclusion
The SPACE-Q is a valid, reliable, and responsive instrument to measure satisfaction with anti-TNF treatment in patients with severe Crohn’s disease and for use in future studies.
Acknowledgments
We are extremely grateful to the patients who contributed to this study and we thank all the participating investigators: Abitbol Vered, Service de Gastroentérologie, Hôpital Cochin, Paris; Allez Matthieu, Service d’Hépato-Gastro-entérologie, Hôpital Saint-Louis, Paris; Bonaz Bruno and Mathieu Nicolas, Service d’Hépato-Gastroentérologie, CHU Hôpital Michallon, Grenoble; Bonnaud Guillaume, Service de Gastroentérologie, Clinique des Cèdres, Cornebarrieu; Bouhnik Yoram, Service de Gastroentérologie et Assistance Nutritive, Hôpital Beaujon, Clichy; Bourreille Arnaud and Flamant Mathurin, Service d’Hépato-Gastroentérologie – IMAD, CHU Hôtel Dieu, Nantes; Cadiot Guillaume and Brixi Hedia, Service d’Hépato-Gastroentérologie, CHU Hôpital Robert Debré, Reims; Carbonnel Franck, Service d’Hépato-Gastroentérologie-Nutrition, Centre Hospitalier de Bicêtre, Le Kremlin Bicêtre; Colombel Jean-Frédéric and Nachury Maria, Hôpital Claude Huriez, Lille; Cuillerier Emmanuel, Service d’Hépato-Gastroentérologie, Centre Hospitalier Victor Jousselin, Dreux; Dupas Jean-Louis, Service d’Hépato-Gastroentérologie, CHU Amiens; Faure Patrick, Clinique Saint-Jean du Languedoc, Toulouse; Flourié Bernard and Nancey Stéphane, Service d’Hépato-Gastroentérologie, CHU Hôpital Lyon Sud, Lyon; Grimaud Jean-Charles, Service d’Hépato-Gastroentérologie, CHU Hôpital Nord, Marseille; Hagège Hervé, Centre Hospitalier Intercommunal, Créteil; Hebuterne Xavier, Service de Gastroentérologie et Nutrition, CHU Hôpital de l’Archet 2, Nice; Laharie David, Service d’Hépato-Gastroentérologie et Nutrition, CHU Hôpital Haut-Lévêque, Pessac; Lerebours Eric and Savoye Guillaume, Service d’Hépato-Gastroentérologie et Nutrition, CHU Hôpital Charles-Nicolle, Rouen; Levy Patrick, Strasbourg; Moreau Jacques, Service de Gastroentérologie et Nutrition, CHU de Rangueil, Toulouse; Nahon Stéphane, Centre Hospitalier Intercommunal, Le Raincy Montfermeil; Peyrin-Biroulet Laurent, Service d’Hépato-Gastroentérologie, CHU Hôpital du Brabois, Nancy; Pingannaud Marie-Pierre, Marseille; Reimund Jean-Marie, Service d’Hépato-Gastroentérologie et Nutrition, CHU Caen; Roblin Xavier, Service de Gastroentérologie, CHU Saint Etienne; Tucat Gilbert, Paris; Vandromme Luc, Reims; and Veyrac Michel, Service d’Hépato-Gastroentérologie, CHU Hôpitaux Saint-Eloi, Montpellier. Jérémy Lambert (Mapi) was compensated by Abbvie for his medical writing skills.
Disclosure
Financial support for the observational study was provided by Abbvie Laboratories. JFC, PF, HH, MN, SN, GT, and LV have served as consultants for Abbvie Laboratories and have received research funding from Abbvie Laboratories. BA, FF, and HG, employees of Mapi, and PC and ODH, employees of Orgamétrie, received financial support from Abbvie. ICT and ET are employees of Abbvie and may own Abbvie stock.