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Observational Study
. 2025 Dec 22;273(1):39.
doi: 10.1007/s00415-025-13581-4.

Harmonized magnetic resonance imaging protocols for multiple sclerosis: HARMONY-MS, a pilot project

Andrea Surcinelli  1 , Ilaria Massa  2 , Nicola Gentili  3 , Ivan Panzera  4 , Susanna Malagù  5 , Luca Mancinelli  6 , Cristiana Ganino  7 , Marco Masullo  5 , Rossella Infante  6 , Sara Iolanda Piras  7 , Claudia Rinaldi  7 , Stefano Ruzza  4 , Anna Tassinari  8 , Giada Ciotta  8 , Majlinda Fejzo  9 , Federico Menetti  10 , Maria Grazia Piscaglia  4 , Patrizia Cenni  11 , Elena Amadori  11 , Oriana Nanni  12 , Matteo Foschi  4   13
Affiliations
Observational Study

Harmonized magnetic resonance imaging protocols for multiple sclerosis: HARMONY-MS, a pilot project

Andrea Surcinelli et al. J Neurol. .

Abstract

Introduction: Magnetic 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.

Methods: We 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 χ2 tests, and time to initiation of high-efficacy therapy (HET) was assessed by Kaplan-Meier analysis, log-rank test, and Cox proportional-hazards regression.

Results: Among 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 χ2 = 0.005, p = 0.90; Wilcoxon V = 14,634, p = 0.50), while NEDA-3 increased from 57.4% to 70.1% (McNemar χ2 = 35, p < 0.0001). Among newly diagnosed patients, first-line high-efficacy DMT use rose from 47.7% to 75.4% (χ2 = 5.5168, p = 0.0188), with shorter time to initiation (HR 1.84, 95% CI 1.09-3.08, p = 0.022).

Conclusions: HARMONY-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.

Keywords: Gadolinium; Harmonization; Health care efficiency; Magnetic resonance imaging; Multiple sclerosis; Sustainability.

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Conflict of interest statement

Declarations. Conflicts of interest: The authors declare that they have no competing interests. Ethical approval and consent to participate: This study was conducted in accordance with the Declaration of Helsinki and national regulations on the use of anonymized healthcare data. The analysis was based exclusively on administrative and radiological information routinely collected within the AUSL Romagna healthcare system. All data were fully anonymized before access by the investigators; therefore, formal approval by an ethics committee and individual informed consent were not required according to institutional and national guidelines. Consent for publication: Not applicable. The study does not contain any individual person’s data in any form.

References

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