TY - JOUR
T1 - Understanding patient and physician global assessments in rheumatoid arthritis
T2 - A meta-epidemiological study of core outcome set performance
AU - Lage-Hansen, Philip Rask
AU - Haugegaard, Tobias
AU - Sofíudóttir, Bjørk Khaliqi
AU - Svendsen, Nikoletta
AU - Kirkham, Jamie J
AU - Amris, Kirstine
AU - de Wit, Maarten
AU - Boers, Maarten
AU - Kragsnaes, Maja Skov
AU - Choy, Ernest
AU - Ellingsen, Torkell
AU - Christensen, Robin
N1 - Copyright © 2026 The Author(s). Published by Elsevier Inc. All rights reserved.
PY - 2026/8
Y1 - 2026/8
N2 - 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): ΔSMDGlobal = -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 (ΔSMDGlobal). 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.
AB - 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): ΔSMDGlobal = -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 (ΔSMDGlobal). 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.
KW - Core outcome set
KW - Meta-analysis
KW - Patient perspective
KW - Physician perspective
KW - Disability Evaluation
KW - Severity of Illness Index
KW - Physicians
KW - Humans
KW - Arthritis, Rheumatoid/drug therapy
KW - Treatment Outcome
KW - Randomized Controlled Trials as Topic
KW - Antirheumatic Agents/therapeutic use
KW - Patient Reported Outcome Measures
U2 - 10.1016/j.semarthrit.2026.153023
DO - 10.1016/j.semarthrit.2026.153023
M3 - Review
C2 - 42330661
SN - 0049-0172
VL - 79
JO - Seminars in Arthritis and Rheumatism
JF - Seminars in Arthritis and Rheumatism
M1 - 153023
ER -