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Introduction <p>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.</p> Methods <p>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.</p> <p>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<sup>2</sup> tests, and time to initiation of high-efficacy therapy (HET) was assessed by Kaplan–Meier analysis, log-rank test, and Cox proportional-hazards regression.</p> Results <p>Among 143,592 MRI examinations, 2734 were MS-related. Contrast-enhanced MRI decreased by &gt; 90% in Jan–Jun 2025 vs Jan–Jun 2023 (IRR 0.07, 95% CI 0.04–0.12, p &lt; 0.0001). Combined brain + whole spinal gadolinium studies similarly declined by &gt; 90% (IRR 0.08, 95% CI 0.06–0.11, p &lt; 0.0001). Total MRI volume decreased by 86% (IRR 0.14, 95% CI 0.12–0.16, p &lt; 0.0001).</p> <p>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 &lt; 0.001).</p> <p>Total time per semester declined from 274 to 29&#xa0;h, while total gadolinium expenditure per semester declined from €15 730 to €1 678.</p> <p>ARR decreased from 0.048 to 0.018 (IRR 0.37, 95% CI 0.21–0.66, p &lt; 0.001). MRI inflammatory activity remained stable (13.8% vs 13.6%; McNemar χ<sup>2</sup> = 0.005, p = 0.90; Wilcoxon V = 14,634, p = 0.50), while NEDA-3 increased from 57.4% to 70.1% (McNemar χ<sup>2</sup> = 35, p &lt; 0.0001).</p> <p>Among newly diagnosed patients, first-line high-efficacy DMT use rose from 47.7% to 75.4% (χ<sup>2</sup> = 5.5168, p = 0.0188), with shorter time to initiation (HR 1.84, 95% CI 1.09–3.08, p = 0.022).</p> Conclusions <p>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.</p>

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

  • 期刊论文

  • 发表日期：

    2025年12月22日

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  • Andrea Surcinelli,
  • Ilaria Massa,
  • Nicola Gentili,
  • Ivan Panzera,
  • Susanna Malagù,
  • Luca Mancinelli,
  • Cristiana Ganino,
  • Marco Masullo,
  • Rossella Infante,
  • Sara Iolanda Piras,
  • Claudia Rinaldi,
  • Stefano Ruzza,
  • Anna Tassinari,
  • Giada Ciotta,
  • Majlinda Fejzo,
  • Federico Menetti,
  • Maria Grazia Piscaglia,
  • Patrizia Cenni,
  • Elena Amadori,
  • Oriana Nanni,
  • Matteo Foschi

摘要

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.