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

Abstract

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.

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©)

“… 5 The SPACE-Q was developed following a rigorous methodology compatible with regulatory authorities’ standard requirements for patient-reported outcome instruments. 13 , 14 In this study, we found that the final version of the SPACE-Q demonstrated good psychometric properties, including good clinical and concurrent validity, good internal consistency and test–retest reliability, and good responsiveness.…”

“…The SPACE-Q was recently developed to evaluate satisfaction with anti-TNF treatments of patients with severe Crohn’s disease. 13 In this multicenter, longitudinal, noninterventional study, we have shown that this questionnaire is well accepted by patients with severe Crohn’s disease and is a valid, reliable, and responsive tool to assess their satisfaction with respect to the specificities of anti-TNF treatment.…”

“…14 The multistep development process is reported in a previous manuscript. 13 Briefly, a literature review was performed to identify existing questionnaires and concepts of interest. Then, exploratory interviews were conducted in France with patients with severe Crohn’s disease to create the conceptual model of the questionnaire and generate the items.…”

“… 12 To address this issue, the Satisfaction for PAtients in Crohn’s diseasE Questionnaire (SPACE-Q © ) was recently developed. 13 …”