Objective: Prospective long-term observational studies (LOS) in rheumatoid arthritis (RA) lack a core set of universally collected outcome measures, particularly, patient-centered outcomes (PCO), precluding accurate comparisons across studies. Our aim was to identify long-term outcome measures collected and reported in these studies.
Methods: We conducted a systematic review of registries and LOS of patients with RA searching in ClinicalTrials.gov, the Agency for Healthcare Research and Quality Registry of Patient Registries, and Google Scholar. The names and acronyms of registries and LOS were further searched in the Medline and EMBASE databases to retrieve published articles. Two independent reviewers undertook data collection, quality appraisal, and data extraction.
Results: We identified 88 registries/LOS that met our eligibility criteria. These were divided into two groups: disease-based (52 [59%]) and therapy-based (36 [41%]). Methodological and reporting standards varied across the eligible studies. For clinical outcomes, disease activity was recorded in 88 (100%) of all LOS/registries. The most commonly reported measure (86 [98%]) was the composite outcome, Disease Activity Score of 28 joints (DAS28). Of the PCOs collected, physical functioning was most frequently reported 75 [85%] with the Health Assessment Questionnaire (75 [85%]) as the most commonly used instrument within this domain. Other domains of PCOs were comparatively infrequently recorded: mental (29 [33%]), social (20 [23%]), and health-related quality of life (37 [42%]).
Conclusion: Most registries/LOS collect measures of disease activity and physical function. However, there is substantial heterogeneity in the collection of relevant PCOs that measure symptom burden, mental and social ramifications of RA.
© 2020, American College of Rheumatology.
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