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.

2019 Update of the American College of Rheumatology Recommended Rheumatoid Arthritis Disease Activity Measures

“…Abstracted data on psychometric properties and study quality were synthesized as others have previously reported . The psychometric properties for each RA disease activity measure received a level of evidence of strong (rating of +++ or ‐ ‐ ‐), moderate (rating of ++ or ‐ ‐), limited (rating of + or ‐), conflicting (rating of ±), or unknown (rating of ?).…”

2019 American College of Rheumatology Recommended Patient‐Reported Functional Status Assessment Measures in Rheumatoid Arthritis

“…We provided the level of evidence for each individual FSAM psychometric property, considering all studies evaluating each property and their result using criteria proposed by Hendrikx et al (Table ). Each RA FSAM psychometric property received a level of evidence rating of strong (+++ or − − −), moderate (++ or − −), limited (+ or −), conflicting (±), or unknown (?)…”

Routine Assessment of Patient Index Data 3 (RAPID3) alone is insufficient to monitor disease activity in rheumatoid arthritis in clinical practice

“…One example of a composite disease activity PROM is the Routine Assessment of Patient Index Data 3 (RAPID3), which is considered the best validated PROM in RA 9 10. In contrast to the Disease Activity Score in 28 joints that includes the erythrocyte sedimentation rate (DAS28-ESR) and the presence of swelling in 28 joints, RAPID3 is solely based on three (subjective) patient-reported domains: physical function, pain and PGA.…”

“…Thus, it has been suggested that RAPID3 (similar to other PROMs) could mostly translate factors other than inflammation, such as fatigue, depression or even symptoms driven by comorbidities 11 12. In reality, the question if whether or not RAPID3 truly captures inflammation-driven disease activity in clinical practice is still unanswered 10. If not, this means that if RAPID3 is used to guide treatment decisions on drugs mainly targeting inflammation, clinicians may expose patients to unnecessary risks with only little or no benefit.…”