Evidence map›Paper›PMID 39704409›Full record

Trial reportMultiple sclerosis (Houndmills, Basingstoke, England)2025

Neurostatus-SMARTCARE clinical trial: Enabling health care professionals to assess EDSS for decentralized trials in multiple sclerosis.

Giulia Mallucci, Andrea Zimmer, Nikolaos Sfikas, Nuria Cerdá-Fuertes, Simon Wunderlin, Ioanna Athanasopoulou, Magdalena Mroczek, Vanny Phavanh, Lisa Sanak, Jolanda Suter and 10 more

Abstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Multiple sclerosis (Houndmills, Basingstoke, England), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Review
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

20 authors.

Giulia MallucciResearch Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), Basel, Switzerland.ORCID 0000-0002-0031-9594
Andrea ZimmerResearch Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), Basel, Switzerland.
Nikolaos SfikasNovartis Pharma AG, Basel, Switzerland.
Nuria Cerdá-FuertesResearch Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), Basel, Switzerland.ORCID 0000-0001-8753-5267
Simon WunderlinResearch Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), Basel, Switzerland.
Ioanna AthanasopoulouResearch Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), Basel, Switzerland.
Magdalena MroczekResearch Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), Basel, Switzerland.
Vanny PhavanhResearch Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), Basel, Switzerland.
Lisa SanakNeurocenter, Lucerne Cantonal Hospital, Lucerne, Switzerland.
Jolanda SuterNeurocenter, Lucerne Cantonal Hospital, Lucerne, Switzerland.
Bernadette FriedliNeurocenter, Lucerne Cantonal Hospital, Lucerne, Switzerland.
Jakob KelResearch Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), Basel, Switzerland.
Thomas TrouilletResearch Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), Basel, Switzerland.
Sarah SimmenResearch Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), Basel, Switzerland.
Alex OcampoNovartis Pharma AG, Basel, Switzerland.
Wenjia WeiNovartis Pharma AG, Basel, Switzerland.
Bernd KieseierNovartis Pharma AG, Basel, Switzerland.
Christian P KammNeurocenter, Lucerne Cantonal Hospital, Lucerne, Switzerland.
Ludwig KapposResearch Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), Basel, Switzerland.ORCID 0000-0003-4175-5509
Marcus D'SouzaResearch Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), Basel, Switzerland.ORCID 0000-0001-5175-9541

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNeurostatus-Expanded Disability Status Scale (EDSS) is the standard measure used to assess impairment and disability in multiple sclerosis (MS) trials but requires trained expert neurologists.

objectivesThis study aims to evaluate the concordance of Neurostatus-EDSS assessments from specially trained health care professionals (HCPs) and standardized trained neurologists.

methodsA Swiss multicenter, randomized, cross-over study with 100 people with MS. HCPs were trained to assess the Neurostatus-EDSS based on the newly developed SMARTCARE-EDSS training method.

resultsThe concordance rate between HCPs and neurologists was 0.87 (95% confidence interval (CI) = 0.815-0.925).

conclusionTrained HCPs can reliably perform Neurostatus-EDSS assessments, supporting broader implementation and improved trial access.

Indexed as

Disability EvaluationHealth PersonnelMultiple SclerosisNeurologistsAdultCross-Over StudiesFemaleHumansMaleMiddle AgedSeverity of Illness IndexSwitzerlandclinical trialsdecentralized trialsEDSShealth care professionalsMultiple sclerosis

Identifiers

PMID39704409
PMCPMC11956382

What OpenQuestion holds

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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.