Abstract
ObjectiveTo test the longitudinal association between patient-reported outcome, Routine Assessment of Patient Index Data 3 (RAPID3) and the Disease Activity Score in 28 joints that includes the erythrocyte sedimentation rate (DAS28-ESR) in routine-care patients with rheumatoid arthritis (RA).MethodsPatients with RA treated with disease-modifying antirheumatic drugs were included in this prospective observational cohort. The longitudinal association between RAPID3 (0–10) and DAS28-ESR and its individual components (swollen joint count (SJC), erythrocyte sedimentation rate (ESR) (mm/hour), tender joint count (TJC) and patient global assessment (PGA)) was tested using generalised estimating equations in patients with more than two consecutive visits with data on RAPID3 and DAS28-ESR. Interactions between RAPID3 and gender, pain, PGA and age at baseline were tested, and if significant (p<0.20) and clinically relevant, models were fit in the corresponding strata.ResultsIn total, 330 patients were included (mean follow-up 10.7 (SD 9.7) months, female gender 67.9%). The longitudinal association between RAPID3 and DAS28-ESR was weak (β=0.29 (95% CI 0.24 to 0.35), n=207), meaning that one unit increase in RAPID3 corresponded to a 0.29 unit increase in Disease Activity Score in 28 joints (DAS28). RAPID3 was most strongly associated with subjective (TJC: β=0.89 (95% CI 0.61 to 1.17); PGA: β=0.94 (95% CI 0.84 to 1.04)) and not with objective components of DAS28 (SJC: β=0.29 (95% CI 0.17 to 0.41), n=172). The association between RAPID3 and ESR was poor but modified by gender, being only significant in men (β=0.37 (95% CI 0.08 to 0.67)).ConclusionsThese data suggest that RAPID3 does not sufficiently capture changes in objective inflammatory signs. Monitoring by RAPID3 alone is therefore insufficient to follow disease activity in patients wth RA in clinical practice.
Funder
Fundação para a Ciência e a Tecnologia
Subject
Immunology,Immunology and Allergy,Rheumatology
Reference22 articles.
1. U.S . Department of health and human services FDA center for drug evaluation and research. guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance. Health Qual Life Outcomes 2006;4:79.doi:10.1186/1477-7525-4-79
2. European Medicines Agency . Committee for medicinal products for human use (CHMP). reflection paper on the regulatory guidance for the use of health-related quality of life (HRQL) measures in the evaluation of medicinal products, 2005.
3. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis
4. 2017 EULAR recommendations for a core data set to support observational research and clinical care in rheumatoid arthritis
5. International Consortium for Health Outcome Measurement . Inflammatory Arthritis data collection reference guide version 1.0.0 [Internet]. Cambridge USA: ICHOM, 2018. Available: https://ichom.org/files/medical-conditions/inflammatory-arthritis/inflammatory-arthritis-reference-guide.pdf [Accessed updated 2018 April 27; cited 2019 September 27].
Cited by
15 articles.
订阅此论文施引文献
订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献