Outcomes Reported in Prospective Long‐Term Observational Studies and Registries of Patients With Rheumatoid Arthritis Worldwide: An Outcome Measures in Rheumatology Systematic Review

Abstract

Objective Prospective long‐term observational studies (LOS) in rheumatoid arthritis (RA) lack a core set of universally collected outcome measures, particularly patient‐centered outcomes, 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 2 groups: disease‐based (52 [59%]) and therapy‐based (36 [41%]). Methodologic 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 using 28 joints. Of the patient‐centered outcomes 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 patient‐centered outcomes 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 patient‐centered outcomes that measure symptom burden and mental and social ramifications of RA.

Refractory inflammatory arthritis definition and model generated through patient and multi-disciplinary professional modified Delphi process

“…This lack of reporting for treatment history would also be a limitation for the other definitions that are based on multiple bDMARDs [ 2 , 4 ]. The findings fit well with a systematic review of outcome measures used in 88 RA registries and long-term observational studies where disease activity (mainly DAS28) and physical functioning (mainly HAQ) was consistently recorded in included studies whilst there was heterogeneity in the patient-centred outcomes for symptom burden and psychosocial ramifications [ 2 , 122 ]. This type of validation was not conducted with the original definition of Refractory Disease [ 3 ], nor to the same degree with the most recent definitions [ 2 ].…”

Cut-off value to identify a flare using the Flare Assessment in Rheumatoid Arthritis (FLARE-RA) questionnaire: analysis of the TOSCA study

“…Disease activity measures such as the DAS28, the most widely used [43], are not quite adequate to determine flares in RA, and fluctuations in disease activity may lead to radiologic progression [7]. In this longitudinal study, we found a moderate correlation between DAS28ESR and FLARE-RA score, which indicates that data on flare can be missed when using only DAS28ESR.…”

Psychosocial Burden Predicts Sustained Remission in Early Rheumatoid Arthritis: Unraveling the Complex Interplay of Well‐Being and Disease Activity

“…Additionally, PROs like pain and physical function appear to be stronger predictors of remission than traditional prognostic factors such as autoantibodies or radiographic erosions (9,10). However, while pain, fatigue and physical function are now widely collected as PROs for RA, less attention is often given to mental health and psychosocial wellbeing (11). Research has shown that suboptimal mental health persists in many patients with RA, despite successful treatment (7,12).…”

“…However, although pain, fatigue, and physical function are now widely collected as patient-reported outcomes for RA, less attention is often given to mental health and psychosocial wellbeing (11). Research has shown that suboptimal mental health persists in many patients with RA, despite successful treatment (7,12).…”