Journal of neurology · 2025
Harmonized magnetic resonance imaging protocols for multiple sclerosis: HARMONY-MS, a pilot project.
СтатьяНаблюдательное исследованиеНазвание и аннотация: Перевод в очереди
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Surcinelli Andrea, Massa Ilaria, Gentili Nicola, Panzera Ivan, Malagù Susanna, Mancinelli Luca, Ganino Cristiana, Masullo Marco, Infante Rossella, Piras Sara Iolanda, Rinaldi Claudia, Ruzza Stefano, Tassinari Anna, Ciotta Giada, Fejzo Majlinda, Menetti Federico, Piscaglia Maria Grazia, Cenni Patrizia, Amadori Elena, Nanni Oriana, Foschi Matteo
Аннотация
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.
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.