Evidence map›Paper›PMID 38449051›Full record

ArticleNeurological research and practice2024

Prospective study validating a multidimensional treatment decision score predicting the 24-month outcome in untreated patients with clinically isolated syndrome and early relapsing-remitting multiple sclerosis, the ProVal-MS study.

Antonios Bayas, Ulrich Mansmann, Begum Irmak Ön, Verena S Hoffmann, Achim Berthele, Mark Mühlau, Markus C Kowarik, Markus Krumbholz, Makbule Senel, Verena Steuerwald and 28 more

Open access · diamondAbstract read
In one paragraph

Article in Neurological research and practice, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
3.0field-weighted citation impact, top 9% of its field
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

6 citing papers in PubMed, 7 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Article
  5. Article
  6. 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

38 authors at 11 institutions in 1 country.

Antonios Bayas *Department of Neurology and Clinical Neurophysiology, Medical Faculty, University of Augsburg, Stenglinstrasse 2, 86156, Augsburg, Germany. antonios.bayas@uk-augsburg.de.ORCID http://orcid.org/0000-0002-7418-9040
Ulrich Mansmann *Institute of Medical Information Processing, Biometry, and Epidemiology, Faculty of Medicine, LMU Munich, Munich, Germany.
Begum Irmak ÖnInstitute of Medical Information Processing, Biometry, and Epidemiology, Faculty of Medicine, LMU Munich, Munich, Germany.
Verena S HoffmannInstitute of Medical Information Processing, Biometry, and Epidemiology, Faculty of Medicine, LMU Munich, Munich, Germany.
Achim BertheleDepartment of Neurology, School of Medicine, Technical University of Munich, Klinikum rechts der Isar, Munich, Germany.
Mark MühlauDepartment of Neurology, School of Medicine, Technical University of Munich, Klinikum rechts der Isar, Munich, Germany.
Markus C KowarikDepartment of Neurology and Stroke, and Hertie-Institute for Clinical Brain Research, Eberhard-Karls University of Tübingen, Tübingen, Germany.
Markus KrumbholzDepartment of Neurology and Stroke, and Hertie-Institute for Clinical Brain Research, Eberhard-Karls University of Tübingen, Tübingen, Germany.
Makbule SenelDepartment of Neurology, University Hospital Ulm, Ulm, Germany.
Verena SteuerwaldDepartment of Neurology and Clinical Neurophysiology, Medical Faculty, University of Augsburg, Stenglinstrasse 2, 86156, Augsburg, Germany.
Markus NaumannDepartment of Neurology and Clinical Neurophysiology, Medical Faculty, University of Augsburg, Stenglinstrasse 2, 86156, Augsburg, Germany.
Julia HartbergerDepartment of Neurology, School of Medicine, Technical University of Munich, Klinikum rechts der Isar, Munich, Germany.
Martin KerschensteinerInstitute of Clinical Neuroimmunology, LMU Hospital, Ludwig-Maximilians-Universität München, Munich, Germany.
Eva OswaldInstitute of Clinical Neuroimmunology, LMU Hospital, Ludwig-Maximilians-Universität München, Munich, Germany.
Christoph RuschilDepartment of Neurology and Stroke, and Hertie-Institute for Clinical Brain Research, Eberhard-Karls University of Tübingen, Tübingen, Germany.
Ulf ZiemannDepartment of Neurology and Stroke, and Hertie-Institute for Clinical Brain Research, Eberhard-Karls University of Tübingen, Tübingen, Germany.
Hayrettin TumaniDepartment of Neurology, University Hospital Ulm, Ulm, Germany.
Ioannis VardakasDepartment of Neurology, University Hospital Ulm, Ulm, Germany.
Fady AlbashitiMedical Data Integration Center, University Hospital, LMU Munich, Munich, Germany.
Frank KramerIT-Infrastructure for Translational Medical Research, University of Augsburg, Augsburg, Germany.
Iñaki Soto-ReyMedical Data Integration Center, Institute of Digital Medicine, University Hospital Augsburg, Augsburg, Germany.
Helmut SpenglerMedical Data Integration Center, Medical Center rechts der Isar, School of Medicine, Technical University of Munich, Munich, Germany.
Gerhard MayerHeidelberg Institute for Theoretical Studies (HITS), Heidelberg, Germany.
Hans Armin KestlerInstitute of Medical Systems Biology, Ulm University, Ulm, Germany.
Oliver KohlbacherInstitute for Translational Bioinformatics, University Hospital Tübingen, Tübingen, Germany.
Marlien HagedornMedical Data Integration Center, University Hospital, LMU Munich, Munich, Germany.
Martin BoekerInstitute for Artificial Intelligence and Informatics in Medicine, Medical Center rechts der Isar, School of Medicine, Technical University of Munich, Munich, Germany.
Klaus KuhnInstitute for Artificial Intelligence and Informatics in Medicine, Medical Center rechts der Isar, School of Medicine, Technical University of Munich, Munich, Germany.
Stefan BuchkaInstitute of Medical Information Processing, Biometry, and Epidemiology, Faculty of Medicine, LMU Munich, Munich, Germany.
Florian KohlmayerBitcare GmbH, Munich, Germany.
Jan S KirschkeDepartment of Diagnostic and Interventional Neuroradiology, School of Medicine, Klinikum rechts der Isar, Technical University of Munich, Munich, Germany.
Lars BehrensDiagnostic and Interventional Neuroradiology, Faculty of Medicine, University of Augsburg, Augsburg, Germany.
Hanna ZimmermannInstitute of Neuroradiology, LMU Hospital, Ludwig-Maximilians-Universität München, Munich, Germany.
Benjamin BenderDepartment of Diagnostic and Interventional Neuroradiology, University Hospital Tübingen, Tübingen, Germany.
Nico SollmannDepartment of Diagnostic and Interventional Radiology, University Hospital Ulm, Ulm, Germany.
Joachim Havla *Institute of Clinical Neuroimmunology, LMU Hospital, Ludwig-Maximilians-Universität München, Munich, Germany.
Bernhard Hemmer *Department of Neurology, School of Medicine, Technical University of Munich, Klinikum rechts der Isar, Munich, Germany.
ProVal-MS study group
Ludwig-Maximilians-Universität München · DETUM Klinikum · DEUniversity of Augsburg · DEHertie Institute for Clinical Brain Research · DEUniversity Hospital Ulm · DEZimmer Biomet (Germany) · DETechnical University of Munich · DEHeidelberg Institute for Theoretical Studies · DEUniversität Ulm · DEUniversity Hospital Augsburg · DEUniversity of Tübingen · DE

Funding

Computational Imaging Biomarkers of Multiple SclerosisR01NS112161 · NINDS · MASSACHUSETTS GENERAL HOSPITAL · PI VAN LEEMPUT, KOEN · 2019 to 2023
$1.5M
Bundesministerium für Bildung und Forschung 01ZZ1804[A-I]NINDS NIH HHS R01 NS112161
6 · The paper itself

Abstract

introductionIn Multiple Sclerosis (MS), patients´ characteristics and (bio)markers that reliably predict the individual disease prognosis at disease onset are lacking. Cohort studies allow a close follow-up of MS histories and a thorough phenotyping of patients. Therefore, a multicenter cohort study was initiated to implement a wide spectrum of data and (bio)markers in newly diagnosed patients.

methodsProVal-MS (Prospective study to validate a multidimensional decision score that predicts treatment outcome at 24 months in untreated patients with clinically isolated syndrome or early Relapsing-Remitting-MS) is a prospective cohort study in patients with clinically isolated syndrome (CIS) or Relapsing-Remitting (RR)-MS (McDonald 2017 criteria), diagnosed within the last two years, conducted at five academic centers in Southern Germany. The collection of clinical, laboratory, imaging, and paraclinical data as well as biosamples is harmonized across centers. The primary goal is to validate (discrimination and calibration) the previously published DIFUTURE MS-Treatment Decision score (MS-TDS). The score supports clinical decision-making regarding the options of early (within 6 months after study baseline) platform medication (Interferon beta, glatiramer acetate, dimethyl/diroximel fumarate, teriflunomide), or no immediate treatment (> 6 months after baseline) of patients with early RR-MS and CIS by predicting the probability of new or enlarging lesions in cerebral magnetic resonance images (MRIs) between 6 and 24 months. Further objectives are refining the MS-TDS score and providing data to identify new markers reflecting disease course and severity. The project also provides a technical evaluation of the ProVal-MS cohort within the IT-infrastructure of the DIFUTURE consortium (Data Integration for Future Medicine) and assesses the efficacy of the data sharing techniques developed. PERSPECTIVE: Clinical cohorts provide the infrastructure to discover and to validate relevant disease-specific findings. A successful validation of the MS-TDS will add a new clinical decision tool to the armamentarium of practicing MS neurologists from which newly diagnosed MS patients may take advantage. Trial registration ProVal-MS has been registered in the German Clinical Trials Register, `Deutsches Register Klinischer Studien` (DRKS)-ID: DRKS00014034, date of registration: 21 December 2018; https://drks.de/search/en/trial/DRKS00014034.

Indexed as

Clinically isolated syndromeClinical trialData integrationMultiple sclerosisProspective cohortRoutine dataTreatment decisionValidation

Identifiers

PMID38449051
PMCPMC10918966
OpenAlexW4392756390

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.