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The Participant-Reported Implementation Update and Score (PRIUS): A Novel Method for Capturing Implementation-Related Data Over Time

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GRADE notes 5: comparing a new intervention with an established treatment. Practical and methodological issues.

Francesco Nonino¹, Elisa Baldin¹, Nick Rijke²

¹Unit of Epidemiology and Statistics, Cochrane Review Group Multiple Sclerosis and Rare Diseases of the CNS, IRCCS Istituto delle Scienze Neurologiche di Bologna, Via Altura 3, 40139 Bologna, Italy.

Journal of Clinical Epidemiology

|March 27, 2025

Summary

Off-label azathioprine may be as effective as interferon for multiple sclerosis, challenging established treatments. Guideline development groups must be open to reconsidering standards of care when evidence is uncertain.

Keywords:

Comparative effectiveness GRADE Guideline Multiple sclerosis Recommendation Standard of care

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Area of Science:

Neurology
Pharmacology
Evidence-Based Medicine

Background:

Guideline development groups (GDGs) ideally base recommendations on direct evidence.
Challenges arise when an off-label intervention appears as effective as a widely accepted, labeled treatment.

Purpose of the Study:

To report on the experience of developing evidence-based recommendations for azathioprine in multiple sclerosis (MS) using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology.
To address the complexities of comparing interventions when direct evidence challenges established treatments.

Main Methods:

Application of the GRADE methodology for evidence-based guideline development.
Evaluation of direct and indirect evidence for azathioprine versus interferon (IFN) in multiple sclerosis treatment.
Deliberation and voting within the GDG to formulate recommendations.

Main Results:

Direct evidence, though of very low certainty, suggested azathioprine may be favored over interferon for critical MS outcomes (relapse, disability worsening).
Indirect evidence favored interferon over placebo, also with very low certainty.
GDG members experienced challenges in evaluating azathioprine against the established treatment (IFN) due to uncertain evidence for both.

Conclusions:

Recommendations must align with the guideline's scope and target questions.
GDGs need openness to re-evaluate long-standing standards of care when evidence suggests otherwise.
Assessing external evidence for established interventions and carefully considering recommendation formulation are crucial, especially in resource-limited settings.