title: Systematic review of patient-reported outcome measures (PROMs) for assessing disease activity in rheumatoid arthritis.
abstract: Patient assessment of disease activity in rheumatoid arthritis (RA) may be useful in clinical practice, offering a patient-friendly, location independent, and a time-efficient and cost-efficient means of monitoring the disease. The objective of this study was to identify patient-reported outcome measures (PROMs) to assess disease activity in RA and to evaluate the measurement properties of these measures. Systematic literature searches were performed in the PubMed and EMBASE databases to identify articles reporting on clinimetric development or evaluation of PROM-based instruments to monitor disease activity in patients with RA. 2 reviewers independently selected articles for review and assessed their methodological quality based on the Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) recommendations. A total of 424 abstracts were retrieved for review. Of these abstracts, 56 were selected for reviewing the full article and 34 articles, presenting 17 different PROMs, were finally included. Identified were: Rheumatoid Arthritis Disease Activity Index (RADAI), RADAI-5, Patient-based Disease Activity Score (PDAS) I & II, Patient-derived Disease Activity Score with 28-joint counts (Pt-DAS28), Patient-derived Simplified Disease Activity Index (Pt-SDAI), Global Arthritis Score (GAS), Patient Activity Score (PAS) I & II, Routine Assessment of Patient Index Data (RAPID) 2-5, Patient Reported Outcome-index (PRO-index) continuous (C) & majority (M), Patient Reported Outcome CLinical ARthritis Activity (PRO-CLARA). The quality of reports varied from poor to good. Typically 5 out of 10 clinimetric domains were covered in the validations of the different instruments. The quality and extent of clinimetric validation varied among PROMs of RA disease activity. The Pt-DAS28, RADAI, RADAI-5 and RAPID 3 had the strongest and most extensive validation. The measurement properties least reported and in need of more evidence were: reliability, measurement error, cross-cultural validity and interpretability of measures.
authors.affiliation: Department of IQ Healthcare, Radboud University Medical Center, Radboud Institute for Health Sciences, Nijmegen, The Netherlands; Department of Rheumatology, Radboud University Medical Center, Nijmegen, The Netherlands.
authors.forename: Jos
authors.identifier: 0000-0002-8624-5871
authors.initials: J
authors.lastname: Hendrikx
authors.affiliation: Department of IQ Healthcare , Radboud University Medical Center, Radboud Institute for Health Sciences , Nijmegen , The Netherlands.
authors.forename: Marieke J
authors.initials: MJ
authors.lastname: de Jonge
authors.affiliation: Department of Rheumatology , Radboud University Medical Center , Nijmegen , The Netherlands.
authors.forename: Jaap
authors.initials: J
authors.lastname: Fransen
authors.affiliation: Department for Health Evidence , Radboud University Medical Center, Radboud Institute for Health Sciences , Nijmegen , The Netherlands.
authors.forename: Wietske
authors.initials: W
authors.lastname: Kievit
authors.affiliation: Department of IQ Healthcare , Radboud University Medical Center, Radboud Institute for Health Sciences , Nijmegen , The Netherlands.
authors.forename: Piet Lcm
authors.initials: PL
authors.lastname: van Riel
keywords: Outcomes research; Patient perspective; Rheumatoid Arthritis