Rheumatoid arthritis

Responsiveness and sensitivity of patient-reported outcome measures (PROMs) to change in disease activity status in early and established rheumatoid arthritis

Rheumatology (Oxford)Published Secondary analysis of the tREACH and TARA randomised trials

Authors' conclusion

HAQ-DI, morning stiffness severity, EQ-5D, general health and joint pain are responsive to disease activity status alterations on a group level in both early and established RA. For the individual patient the responsiveness of these PROMs is poor.

Study context

Population
Patients with early RA (tREACH trial) and established RA (TARA trial)
Participants
557 vs 188
Comparison
Early RA vs established RA: PROM change vs change in disease activity status
  • Early RAn = 557
  • Established RAn = 188
Primary endpoint
Responsiveness of PROMs (HAQ-DI, morning stiffness severity, EQ-5D, general health, SF-36, joint pain, fatigue, productivity loss) to changes in disease activity status (remission, low disease activity, active disease) between two consecutive visits
Methodological detailsmulticentre, single-blinded, treat-to-target, linear mixed models, standardized response means
  • Multicentre
  • Single-blinded
  • Treat-to-target
  • Linear mixed models
  • Standardized response means

Primary result

As reported in the abstract

PROM responsiveness to disease activity status change
  • HAQ Disability Index (HAQ-DI), morning stiffness severity, general health, EQ-5D and joint pain responsive to improvement or worsening of disease activity status in both early and established RA
  • Short form (SF-36) physical and mental component scale, fatigue and productivity loss not responsive in both groups
  • Across nearly all PROMs, magnitude of change and proportion of individual observations reflecting a shift from and to active disease remained low

Original publication

Responsiveness and sensitivity of PROMs to change in disease activity status in early and established rheumatoid arthritis. Rheumatology (Oxford). Published 4 April 2024. doi:10.1093/rheumatology/keae213

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