Evidence map›Paper›PMID 40034254›Full record

ArticleMultiple sclerosis journal - experimental, translational and clinical

Implementation of a safety program initiative for monitoring infusion disease modifying therapies for multiple sclerosis.

Shuvro Roy, Janel Haughton, Dhanajay Vaidya, Scott D Newsome

Abstract read
In one paragraph

Article in Multiple sclerosis journal - experimental, translational and clinical. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Shuvro RoyDepartment of Neurology, Johns Hopkins University, Baltimore, MD, USA.ORCID https://orcid.org/0000-0002-3240-7441
Janel Haughton
Dhanajay Vaidya
Scott D Newsome

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objective: To determine the efficacy of a safety program designed for monitoring infusion disease-modifying therapies (DMTs) prescribed for multiple sclerosis (MS). Background: Infusion-based high-efficacy DMTs represent a major advance in the treatment of MS. However, safe administration requires close monitoring. Non-adherence to safety monitoring can lead to DMT-related complications. Methods: A safety nurse navigator reviewed charts for infusion DMT patients from November 2020 to December 2022, and contacted them to address incomplete safety monitoring. Patients were screened for the primary outcome of incomplete safe infusion, including outdated safety labs, imaging, and/or recent follow-up with their neurologist. Logistic regression was performed for predictors of incomplete safety monitoring and of successful safety intervention. Results: Three hundred and forty-three patients were on infusible DMTs over the study time period: 75 natalizumab, 31 rituximab, and 237 ocrelizumab. Two hundred and eighty-six (83%) patients did not meet the criteria for safe infusion; 64% lacked safety labs, 47% prescriber follow-up, and 26% an MRI. The nurse succeeded in 82% of interactions. B-cell depletion was linked to outdated lab monitoring, whereas natalizumab use was associated with outdated appointments and imaging. Conclusions: This safety initiative identified gaps for managing infusion-based MS DMTs. Our safety nurse navigator successfully identified incomplete safety monitoring and intervened to avoid drug-related complications.

Indexed as

disease-modifying therapiesimplementation sciencemultiple sclerosisNatalizumaboutcome measurement

Identifiers

PMID40034254
PMCPMC11874289

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.