Objectives To develop and validate an outcome measure for assessing fears in patients with rheumatoid arthritis (RA) and axial spondyloarthritis (axSpA).
Methods Fears were identified in a qualitative study, and reformulated as assertions with which participants could rate their agreement (on a 0–10 numeric rating scale). A cross-sectional validation study was performed including patients diagnosed with RA or axSpA. Redundant items (correlation >0.65) were excluded. Internal consistency (Cronbach’s α) and factorial structure (principal component analysis) were assessed. Patients were classified into fear levels (cluster analysis). Associations between patient variables and fear levels were evaluated using multiple logistic regression.
Results 672 patients were included in the validation study (432 RA, 240 axSpA); most had moderate disease activity and were prescribed biologics. The final questionnaire included 10 questions with high internal consistency (α: 0.89) and a single dimension. Mean scores (±SD) were 51.2 (±25.4) in RA and 60.5 (±22.9) in axSpA. Groups of patients with high (17.2%), moderate (41.1%) and low (41.7%) fear scores were identified. High fear scores were associated with high Arthritis Helplessness Index scores (OR 6.85, 95% CI (3.95 to 11.87)); high Hospital Anxiety and Depression Scale anxiety (OR 5.80, 95% CI (1.19 to 4.22)) and depression (OR 2.37, 95% CI (1.29 to 4.37)) scores; low education level (OR 3.48, 95% CI (1.37 to 8.83)); and high perceived disease activity (OR 2.36, 95% CI (1.10 to 5.04)).
Conclusions Overall, 17.2% of patients had high fear scores, although disease was often well controlled. High fear scores were associated with psychological distress. This questionnaire could be useful both in routine practice and clinical trials.
- rheumatoid arthritis
- ankylosing spondylitis
- patient perspective
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Handling editor Tore K Kvien
Contributors All authors were involved in drafting and in final approval of the publication, and revising it critically for important intellectual content.
Funding UCB Pharma and Fondation Arthritis (France).
Competing interests LG, PC, AS, CH, CD, ST, FB: no competing interests.
GC and J-MJ are employees of UCB Pharma; TdC was an employee of UCB Pharma at the time of the study; VS and FR-M are employees of Fondation Arthritis.
Ethics approval The Ethics Committee of the St Antoine Hospital, Paris (session of 7 October 2014), the National Advisory Committee on Medical Research Information (CCTIRS) and the French national data protection agency (CNIL).
Provenance and peer review Not commissioned; externally peer reviewed.
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