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Published on: December 18, 2016
Harmonized magnetic resonance imaging protocols for multiple sclerosis: HARMONY-MS, a pilot project
Andrea Surcinelli1, Ilaria Massa2, Nicola Gentili3
1Department of Neuroscience, Multiple Sclerosis Center-Neurology Unit, S. Maria Delle Croci Hospital, AUSL Romagna, Viale Vincenzo Randi 5, 48121, Ravenna, Italy. andrea.surcinelli@auslromagna.it.
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.
Insights
Implementing harmonized Magnetic Resonance Imaging (MRI) protocols in multiple sclerosis (MS) care significantly reduced contrast use and costs. This approach improved scanner efficiency while maintaining stable clinical outcomes and supporting earlier high-efficacy treatment initiation.
Area of Science:
- Neuroimaging
- Clinical Practice Guidelines
- Health Services Research
Background:
- Magnetic Resonance Imaging (MRI) is crucial for multiple sclerosis (MS) management.
- Current MRI practices in MS often deviate from established guidelines.
- Large-scale studies evaluating harmonized MRI protocols are limited.
Purpose of the Study:
- To assess the impact of harmonized MRI referral and acquisition protocols in MS care.
- To evaluate changes in MRI utilization, costs, and clinical outcomes.
- To determine the feasibility of a scalable model for guideline-concordant MS imaging.
Main Methods:
- Retrospective observational study of CNS MRI examinations in a large Italian healthcare system (N=143,592).
- Analysis of MRI volumes, scanner time, and gadolinium expenditure using statistical models (Poisson, Gamma, ITS).
- Evaluation of clinical outcomes including relapse rates, MRI inflammatory activity, and No Evidence of Disease (NEDA-3), and disease-modifying therapy (DMT) initiation.
Main Results:
- Contrast-enhanced MRI and gadolinium studies decreased by over 90%; total MRI volume reduced by 86%.
- Significant reductions in scanner time and gadolinium expenditure were observed.
- Annualized relapse rate (ARR) decreased, while NEDA-3 and first-line high-efficacy DMT use increased significantly.
Conclusions:
- The HARMONY-MS program successfully reduced contrast use, unnecessary imaging, and healthcare costs.
- The study demonstrates a scalable model for guideline-adherent MS MRI practices.
- This approach supports stable clinical outcomes and promotes earlier initiation of effective DMTs.
