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

PURPOSE: To develop a self-administered questionnaireassessing patients' satisfaction with treatments in Crohn's diseasefor use in clinical research and epidemiological studies. PATIENTS AND METHODS: Semi-directive interviews (16) were conducted with patients with severe Crohn's diseasetreated 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 questionnaireassessed treatment satisfaction through 67 items, organized into 5 sections: treatment efficacy, side-effects, convenience and constraints, overall impact, and satisfaction. Conceptual content of the questionnaireincludes comparison with prior state and with expectations, satisfaction, acceptability, and intentions. The questionnairewas 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 questionnairewas named Satisfaction of PAtients in Crohn's diseasE(SPACE(©)). CONCLUSION: The questionnaireis 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.