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Health-related quality of life improvements and response thresholds of myositis outcome measures and response criteria
M. Almackenzie1, A. Aggarwal2, S. Keret3, T. Chandra4, R. Lomanto Silva5, E. Gkiaouraki6, N. Pongtarakulpanit7, S. Moghadam-Kia8, C.V. Oddis9, R. Aggarwal10
- Division of Rheumatology, Medical Cities of the Ministry of the Interior, Riyadh, Saudi Arabia.
- Department of Rheumatology, Indraprastha Apollo Hospital, New Delhi, India.
- Rheumatology Unit, Bnai-Zion Medical Center, Faculty of Medicine, Technion, Haifa, Israel.
- Division of Rheumatology and Clinical Immunology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
- Department of Rheumatology, Allergy and Immunology, Massachusetts General Hospital, Boston, MA, USA.
- Division of Rheumatology and Clinical Immunology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
- Division of Rheumatology and Clinical Immunology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA; and Division of Allergy, Immunology and Rheumatology, Department of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.
- Division of Rheumatology and Clinical Immunology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
- Division of Rheumatology and Clinical Immunology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
- Division of Rheumatology and Clinical Immunology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA. aggarwalr@upmc.edu
CER19063
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PMID: 41328608 [PubMed]
Received: 01/07/2025
Accepted : 23/10/2025
In Press: 20/11/2025
Abstract
OBJECTIVES:
Limited data exist on the clinical associations and responsiveness of myositis core set measures (CSMs) and response criteria using health-related quality of life (HRQoL) assessments like the Short Form Health Survey (SF-36). This study evaluates the associations and improvement thresholds of CSMs and Total Improvement Score (TIS) using SF-36 in idiopathic inflammatory myopathies (IIM).
METHODS:
Adults with IIM enrolled in two clinical trials and one observational study were assessed. Demographics and myositis CSMs including patient-global assessment (PtGA), physician-global assessment (PhGA), extra global disease activity score (EXGLB), manual muscle testing (MMT-8), Health Assessment Questionnaire (HAQ), creatine kinase (CK), and SF-36 were collected longitudinally. TIS was calculated at 6 months. Spearman’s correlation assessed associations between SF-36 domains and summary scores for physical health (PCS) and mental health (MCS) with all CSMs and TIS. A mixed linear model examined longitudinal association. Minimal clinically important difference (MCID) was determined using the anchor method.
RESULTS:
The study included 105 IIM patients. Most SF-36 domains showed moderate to strong correlations with all CSMs at baseline as well as 6-month changes (delta change), except CK levels at baseline. TIS exhibited significant correlations with delta changes in most SF-36 domains. Longitudinally, significant associations were observed between SF-36 and most CSMs (except MMT-8). Higher thresholds in CSMs and TIS aligned with incremental improvements in PCS. MCIDs for PhGA, PtGA, EXGLB, HAQ, MMT-8 and TIS were 1.1, 1.84, 0.85, 0.65, 3.7, 23.7, respectively.
CONCLUSIONS:
Most CSMs and TIS in IIM significantly correlated with SF-36 domains, reflecting concurrent HRQoL improvements.
