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Elodie de Bock,1 Kevin Dolgin,2 Léa Kombargi,2 Benoit Arnould,1 Tanguy Vilcot,1 Guillaume Hubert,2 Marie-Eve Laporte,3 Lydiane Nabec,4 Gérard Reach5 1Patient Centred Outcomes, ICON plc, Lyon, France; 2Observia, Paris, France; 3IAE Paris - Sorbonne Business School, Université Paris 1 Panthéon-Sorbonne, Paris, France; 4Université Paris-Saclay, RITM (Réseaux, Innovation, Territoire et Mondialisation), Paris, France; 5Health Education and Practices Laboratory (LEPS), Sorbonne Paris-Nord University, Bobigny, FranceCorrespondence: Elodie de Bock, ICON plc, 27 rue de la Villette, Lyon, 69003, France, Tel + 33 472 13 59 81, Email Elodie.deBock@iconplc.comPurpose: The SPUR (Social, Psychological, Usage and Rational) Adherence Profiling Tool is a recently developed adaptive instrument for assessing key patient-level drivers for non-adherence. This study describes the SPUR questionnaire’s finalization and psychometric evaluation.Patients and Methods: Data were collected through an online survey among patients with type 2 diabetes included by general practitioners and diabetologists in France. The survey included four questionnaires, SPUR and three validated adherence measures: BMQ, MARS and ACCEPT. Item-level analysis and a partial credit model (PCM) were performed to refine the response option coding of SPUR items. The final item selection of SPUR was defined using a PCM and a principal component analysis (PCA). Construct validity, concurrent validity and known-groups validity were assessed on the final SPUR questionnaire.Results: A total of 245 patients (55% men, mean age of 63 years) completed the survey remotely and were included in this analysis. Refining response option coding allowed a better discrimination of patients on the latent trait. After item selection, a short, an intermediate, and a long form composed the final SPUR questionnaire. The short form will be used to screen patients for risk and then the other forms will allow the collection of further information to refine the risk assessment and decide the best levers for action. Results obtained were supportive of the construct validity of the forms. Their concurrent validity was demonstrated: moderate to high significant correlations were obtained with BMQ, MARS and ACCEPT scores. Their known-groups validity were shown with a logical pattern of higher scores obtained for patients considered non-adherent and significant differences between the scores obtained for patients considered adherent versus non-adherent.Conclusion: SPUR is a valid tool to evaluate the risk of non-adherence of patients, allowing effective intervention by providing insights into the respective individual reasons for lack of adherence.Keywords: digital questionnaire, non-adherence drivers, psychometric validation, Rasch modelling

Hélène Gilet,1 Benoit Arnould,1 Fatoumata Fofana,1 Pierre Clerson,2 Jean-Frédéric Colombel,10 Olivier D’Hondt,2 Patrick Faure,4 Hervé Hagège,5 Maria Nachury,3 Stéphane Nahon,6 Gilbert Tucat,7 Luc Vandromme,8 Ines Cazala-Telinge,9 Emmanuel Thibout9 1HEOR and Strategic Market Access, Mapi, Lyon, France; 2Orgamétrie, Roubaix, France; 3Hôpital Claude Huriez, Lille, France; 4Clinique Saint-Jean du Languedoc, Toulouse, France; 5Centre Hospitalier Intercommunal, Créteil, France; 6Centre Hospitalier Intercommunal, Le Raincy Montfermeil, France; 7Gastroenterologist, Private Clinical Practice, Paris, France; 8Gastroenterologist, Private Clinical Practice, Reims, France; 9Abbvie France, Rungis, France; 10Icahn School of Medicine at Mount Sinai, New York, NY, USA 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. Keywords: Crohn’s disease, satisfaction, anti-TNF treatment, questionnaire

B Aguilaniu1, J Gonzalez-Bermejo2, A Regnault3, C Dias Barbosa3, B Arnould3, M Mueser4, G Granet5, M Bonnefoy6, T Similowski2,71HYLAB, Physiologie Clinique, Grenoble, France; 2Assistance Publique – Hôpitaux de Paris, Groupe Hospitalier Pitié-Salpêtrière, Service de Pneumologie et Réanimation, Paris, France; 3Mapi Values, Lyon, France; 4Formerly Boehringer Ingelheim, Paris, France; 5General Practitioner, Sainte-Foy-lès-Lyon, Paris, France; 6Centre Hospitalier Lyon Sud, Lyon, France; 7Université Paris 6 Pierre et Marie Curie, ER10, Paris, FranceBackground: Chronic Obstructive Pulmonary Disease (COPD) is a worldwide public health concern. It is also a major source of disability that is often overlooked, depriving patients of effective treatments. This study describes the development and validation of a questionnaire specifically assessing COPD-related disability.Methods: The DIsability RElated to COPD Tool (DIRECT) was developed according to reference methods, including literature review, patient and clinician interviews and test in a pilot study. A 12-item questionnaire was included for finalization and validation in an observational cross-sectional study conducted by 60 French pulmonologists, who recruited 275 COPD patients of stage II, III and IV according to the GOLD classification. Rasch modeling was conducted and psychometric properties were assessed (internal consistency reliability; concurrent and clinical validity).Results: The DIRECT score was built from the 10 items retained in the Rasch model. Their internal consistency reliability was excellent (Cronbach's alpha = 0.95). The score was highly correlated with the Saint George's Respiratory Questionnaire Activity score (r = 0.83) and the London Handicap Scale (r = –0.70), a generic disability measure. It was highly statistically significantly associated to four clinical parameters (P < 0.001): GOLD classification, BODE index, FEV1 and 6-minute walk distance.Conclusion: DIRECT is a promising tool that could help enhance the management of COPD patients by integrating an evaluation of the COPD-related disability into daily practice.Keywords: chronic obstructive pulmonary disease, daily medical practice, disability, disease management, questionnaires

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