Clinical Meaningfulness and Improvement Thresholds of Myositis Core Set Measures: Association With Patient-Reported Outcomes
Authors' conclusion
CSMs demonstrate robust validity and responsiveness, closely aligning with patients' symptoms, function, and QOL and supporting their utility in IIM trials. We established CIDs for CSMs and TIS.
Study context
- Population
- Adults with IIM60% female
- Participants
- 50 adults
- Outcome
- Clinical meaningfulness and improvement thresholds (clinically important differences (CIDs)) of myositis core set measures, with associations with PROMs
- Follow-up
- 6 months
Methodological details6-month, Spearman correlation and linear mixed models, anchor-based (PGIC and PhGIC)
- 6-month
- Spearman correlation and linear mixed models
- Anchor-based (PGIC and PhGIC)
Main finding
As reported in the abstract
CIDs according to PGIC
- CID for PGA
- 2.1
- CID for ExGLB
- 1.4
- CID for patient global assessment (PtGA)
- 1.7
- CID for MMT9
- 4.2
- CID for Health Assessment Questionnaire- Disability Index (HAQ-DI)
- 0.5
- CID for creatine kinase
- 1475 IU/L
- CID for Total Improvement Score (TIS)
- 28.0
Observational data: associations, not effects.
Further findings
Associations of Core Set Measures (CSMs) with Patient-reported Outcome Measures (PROMs)
- Most CSMs showed strong baseline and longitudinal associations with PROMs, incl. pain, fatigue, physical function and quality of life (QOL)
Responsiveness
- Significant improvements in most CSMs with moderate to large effect sizes, using PGIC and PhGIC as anchors
Original publication
Clinical Meaningfulness and Improvement Thresholds of Myositis Core Set Measures: Association With Patient-Reported Outcomes. J Rheumatol. Published 1 August 2026. doi:10.
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