[Development and validation of a satisfaction questionnaire in patients with rheumatoid arthritis]

Objective: The aim of this study was to develop and validate a specific tool to assess satisfaction with treatment in patients with rheumatoid arthritis (RA).

Material and methods: The questionnaire was developed in three stages: firstly, a literature review was performed by experts in developing patient-centered measures; secondly, items selected by 4 experts in RA were assessed for comprehensibility, format and applicability, and thirdly, administration of the questionnaire was evaluated through a personal interview of a group of 14 patients with RA under treatment with infliximab. Validation of the questionnaire was performed in patients with RA who met the ACR criteria, were older than 18 years, and had started treatment with infliximab due to inadequate disease control. Questionnaires were administered at the baseline visit (beginning of treatment) and at 2, 6 and 14 weeks, coinciding with infliximab infusions. The questionnaire validity was evaluated in terms of construct validity (factorial analysis) and content validity. Content validity was assessed by analysing the relationship between satisfaction and different measures used for treatment effectiveness as well as fulfillment of treatment expectations.

Results: Validation of the questionnaire was performed in a sample of 180 patients with a mean (SD) age of 52 (13) years. A total of 80.7% were women. In 72.4% disease duration was longer than 3 years. The scores obtained on the satisfaction questionnaire were related to the aspects defined as ACR criteria (except ESR and CRP), fulfillment of ACR20, ACR50 and ACR70 response criteria, and fulfillment of treatment expectations (p<0,01).

Discussion: The results confirm the questionnaire's validity in assessing patient satisfaction with RA treatment, both in routine clinical practice and in research conditions.