Observational studyJournal of neurology2025
Harmonized magnetic resonance imaging protocols for multiple sclerosis: HARMONY-MS, a pilot project.
Observational study in Journal of neurology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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21 authors.
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Abstract
introductionMagnetic Resonance Imaging (MRI) is central to multiple sclerosis (MS) management, yet practice often diverges from guidelines. Large-scale evaluations of harmonized referral and acquisition protocols remain limited.
methodsWe conducted a retrospective observational study including all central nervous system (CNS) MRI examinations requested by MS centers within the AUSL Romagna healthcare system (Italy; catchment population ~ 1.3 million) between January 2023 and June 2025. MRI volumes were assessed using Poisson regression and interrupted time-series (ITS) models. Scanner time and gadolinium expenditure were analyzed with Gamma regression. Clinical outcomes included annualized relapse rate (ARR; Poisson regression), MRI inflammatory activity (McNemar's test, Wilcoxon test), and NEDA-3 (McNemar's test). Disease-modifying therapy (DMT) distributions were compared using χ
resultsAmong 143,592 MRI examinations, 2734 were MS-related. Contrast-enhanced MRI decreased by > 90% in Jan-Jun 2025 vs Jan-Jun 2023 (IRR 0.07, 95% CI 0.04-0.12, p < 0.0001). Combined brain + whole spinal gadolinium studies similarly declined by > 90% (IRR 0.08, 95% CI 0.06-0.11, p < 0.0001). Total MRI volume decreased by 86% (IRR 0.14, 95% CI 0.12-0.16, p < 0.0001). Interrupted time-series confirmed significant post-intervention slopes for contrast-enhanced MRI (-4.4 exams/month, p = 0.021) and total MRI examinations (-16 exams/month, p < 0.001). Total time per semester declined from 274 to 29 h, while total gadolinium expenditure per semester declined from €15 730 to €1 678. ARR decreased from 0.048 to 0.018 (IRR 0.37, 95% CI 0.21-0.66, p < 0.001). MRI inflammatory activity remained stable (13.8% vs 13.6%; McNemar χ
conclusionsHARMONY-MS is the first large-scale program to show reduction in contrast use, unnecessary imaging, and costs, while improving scanner efficiency. These findings provide a scalable model for guideline-concordant MS imaging, compatible with stable clinical outcomes and supporting a shift toward earlier and more frequent use of high-efficacy DMTs.
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