title: Assessing patients' satisfaction with anti-TNFα treatment in Crohn's disease: qualitative steps of the development of a new questionnaire.
abstract: OBJECTIVE
  To develop a self-administered questionnaire assessing patients' satisfaction with treatments in Crohn's disease for use in clinical research and epidemiological studies.
  
  
  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(©)).
  
  
  CONCLUSIONS
  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.
authors: Mapi Values, Patient-Reported Outcomes, 27 rue de la Villette, Lyon, France;
authors: Claire
authors: C
authors: Marant
authors: Benoit
authors: B
authors: Arnould
authors: Alexia
authors: A
authors: Marrel
authors: Céderic
authors: C
authors: Spizak
authors: Jean-Frédéric
authors: JF
authors: Colombel
authors: Patrick
authors: P
authors: Faure
authors: Hervé
authors: H
authors: Hagege
authors: Marc
authors: M
authors: Lemann
authors: Stéphane
authors: S
authors: Nahon
authors: Gilbert
authors: G
authors: Tucat
authors: Luc
authors: L
authors: Vandromme
authors: Emmanuel
authors: E
authors: Thibout
authors: Gérard
authors: G
authors: Goldfarb