title: Measuring patients' satisfaction with their anti-TNF treatment in severe Crohn's disease: scoring and psychometric validation of the Satisfaction for PAtients in Crohn's diseasE Questionnaire (SPACE-Q(©)).
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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: HEOR and Strategic Market Access, Mapi, Lyon, France.
authors.forename: Hélène
authors.initials: H
authors.lastname: Gilet
authors.affiliation: HEOR and Strategic Market Access, Mapi, Lyon, France.
authors.forename: Benoit
authors.initials: B
authors.lastname: Arnould
authors.affiliation: HEOR and Strategic Market Access, Mapi, Lyon, France.
authors.forename: Fatoumata
authors.initials: F
authors.lastname: Fofana
authors.affiliation: Orgamétrie, Roubaix, France.
authors.forename: Pierre
authors.initials: P
authors.lastname: Clerson
authors.affiliation: Icahn School of Medicine at Mount Sinai, New York, NY, USA.
authors.forename: Jean-Frédéric
authors.initials: JF
authors.lastname: Colombel
authors.affiliation: Orgamétrie, Roubaix, France.
authors.forename: Olivier
authors.initials: O
authors.lastname: D'Hondt
authors.affiliation: Clinique Saint-Jean du Languedoc, Toulouse, France.
authors.forename: Patrick
authors.initials: P
authors.lastname: Faure
authors.affiliation: Centre Hospitalier Intercommunal, Créteil, France.
authors.forename: Hervé
authors.initials: H
authors.lastname: Hagège
authors.affiliation: Hôpital Claude Huriez, Lille, France.
authors.forename: Maria
authors.initials: M
authors.lastname: Nachury
authors.affiliation: Centre Hospitalier Intercommunal, Le Raincy Montfermeil, France.
authors.forename: Stéphane
authors.initials: S
authors.lastname: Nahon
authors.affiliation: Gastroenterologist, Private Clinical Practice, Paris, France.
authors.forename: Gilbert
authors.initials: G
authors.lastname: Tucat
authors.affiliation: Gastroenterologist, Private Clinical Practice, Reims, France.
authors.forename: Luc
authors.initials: L
authors.lastname: Vandromme
authors.affiliation: Abbvie France, Rungis, France.
authors.forename: Ines
authors.initials: I
authors.lastname: Cazala-Telinge
authors.affiliation: Abbvie France, Rungis, France.
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Thibout
keywords: Crohn’s disease; anti-TNF treatment; questionnaire; satisfaction