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Publications

Journal Article Systematic Review Meta-Analysis Review Ppublish

PubMed: 42330661 DOI: 10.1016/j.semarthrit.2026.153023

Understanding patient and physician global assessments in rheumatoid arthritis: A meta-epidemiological study of core outcome set performance.

Semin Arthritis Rheum 79:153023

Authors: Philip Rask Lage-Hansen, Tobias Haugegaard, Bjørk Khaliqi Sofíudóttir, Nikoletta Svendsen, Jamie J Kirkham, Kirstine Amris, Maarten de Wit, Maarten Boers, Maja Skov Kragsnaes, Ernest Choy, Torkell Ellingsen, Robin Christensen

Affiliations

  • Department of Rheumatology, Esbjerg Hospital, Denmark; Department of Rheumatology, Slagelse Hospital, Denmark; Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital, Denmark; Section for Biostatistics and Evidence-Based Research, the Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.
  • Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital, Denmark; Section for Biostatistics and Evidence-Based Research, the Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.
  • Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital, Denmark.
  • Department of Rheumatology, Esbjerg Hospital, Denmark.
  • Centre for Biostatistics, The University of Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom.
  • Section for Biostatistics and Evidence-Based Research, the Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.
  • OMERACT Patient Research Partner, the Netherlands.
  • Department of Epidemiology and Data Science, Amsterdam Public Health Research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, the Netherlands.
  • Cardiff Regional Experimental Arthritis Treatment and Evaluation (CREATE) Centre at Cardiff University School of Medicine, Cardiff, Wales, UK.

Abstract

OBJECTIVE

To assess agreement between physician and patient global assessment improvements in randomised controlled trials (RCT) of targeted therapies for rheumatoid arthritis and to identify which core outcome domains best explain changes in each assessment and their discrepancies.

METHODS

We conducted a systematic review and meta-epidemiological analysis of RCTs comparing targeted therapies with placebo. Standardised mean differences (SMDs) were calculated for all eight RA-COS domains: Physician global assessment, Patient global assessment, Disability, Tender joint count (TJC), Swollen joint count (SJC), Pain, Acute phase reactants, and Fatigue. Agreement between physician and patient assessments was assessed as ΔSMD Global (i.e., SMD Physician global assessment - SMD Patient global assessment). Multivariate meta-analyses were performed to calculate SMD for the remaining domains. Multiple imputation followed by meta-regression analyses identified domain-level predictors of global assessment changes.

RESULTS

We identified 73 double-blind RCTs (165 randomised comparisons) involving 33,956 RA patients. Physician assessments demonstrated slightly greater treatment effects (SMD -0.60; 95% CI -0.65 to -0.55) compared with patient assessments (SMD -0.50; 95% CI -0.54 to -0.46): ΔSMD Global = -0.09 (95% CI -0.12 to -0.05). Univariable meta-regression identified disability, TJC and SJC as the strongest associations of both assessments, yet SJC was the only domain significantly associated with the contrast between these (ΔSMD Global). Pain was independently associated only with patient global assessment.

CONCLUSION

Targeted therapies show larger improvements in physician-assessed outcomes than on patient-reported outcomes, largely driven by SJC. Pain remains a distinct determinant of patient assessments, underscoring the need to better integrate patient-reported outcomes into RA trial design.

REGISTRATION

The protocol was registered on PROSPERO (2025-02-14).

REGISTRATION NUMBER

CRD420250652342.

MeSH

Arthritis, Epidemiologic Studies, Rheumatic Diseases, Physicians, Arthritis, Rheumatoid, Therapeutics