Evidence map›Paper›PMID 24293456›Full record

ReviewMultiple sclerosis (Houndmills, Basingstoke, England)2014

Risk evaluation and monitoring in multiple sclerosis therapeutics.

Michel C Clanet, Jerry S Wolinsky, Raymond J Ashton, Hans-Peter Hartung, Stephen C Reingold

Open access · hybridAbstract readReview
In one paragraph

Review in Multiple sclerosis (Houndmills, Basingstoke, England), 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
2.3field-weighted citation impact, top 12% 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

13 citing papers in PubMed, 24 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Article
  5. Review
  6. Review
  7. Article
  8. Article
  9. Review
  10. Review
  11. Advances in and Algorithms for the Treatment of Relapsing-Remitting Multiple Sclerosis.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2016
    Review
  12. Alemtuzumab: a new therapy for active relapsing-remitting multiple sclerosis.Multiple sclerosis (Houndmills, Basingstoke, England) · 2015
    Review
  13. 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

5 authors at 3 institutions in 3 countries.

Michel C ClanetDepartment of Neurosciences University Hospital Toulouse, France michel.clanet@inserm.fr.
Jerry S WolinskyDepartment of Neurology, The University of Texas Health Science Center at Houston, USA.
Raymond J AshtonAshtonMediCom, UK.
Hans-Peter HartungDepartment of Neurology and Center for Neuropsychiatry, Medical Faculty, Heinrich-Heine-Universität im UKD, Germany.
Stephen C ReingoldScientific and Clinical Review Associates LLC, USA.
Heinrich Heine University Düsseldorf · DEThe University of Texas Health Science Center at Houston · USUniversité de Toulouse · FR

Funding

Extension of Combination Therapy for Multiple Sclerosis (eCombiRx)U01NS045719 · NINDS · MOUNT SINAI SCHOOL OF MEDICINE OF NYU · PI LUBLIN, FRED D · 2003 to 2012
$44.7M
MR Image Analysis in MS: Identification of a SurrogateR01EB002095 · NIBIB · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI NARAYANA, PONNADA A · 2003 to 2011
$5.2M
NIBIB NIH HHS R01 EB002095NINDS NIH HHS U01 NS045719
6 · The paper itself

Abstract

backgroundRisk for multiple sclerosis (MS) disease-modifying therapies (DMT) must be assessed on an ongoing basis. Early concerns regarding the first-approved DMTs for MS have been mitigated, but recently licensed therapies have been linked to possibly greater risks.

objectivesThe objective of this review is to discuss risk assessment in MS therapeutics based on an international workshop and comprehensive literature search and recommend strategies for risk assessment/monitoring.

resultsAssessment and perception of therapeutic risks vary between patients, doctors and regulators. Acceptability of risk depends on the magnitude of risk and the demonstrated clinical benefits of any agent. Safety signals must be distinguishable from chance occurrences in a clinical trial and in long-term use of medications. Post-marketing research is crucial for assessing longer-term safety in large patient cohorts. Reporting of adverse events is becoming more proactive, allowing more rapid identification of risks. Communication about therapeutic risks and their relationship to clinical benefit must involve patients in shared decision making.

conclusionsIt is difficult to produce a general risk-assessment algorithm for all MS therapies. Specific algorithms are required for each DMT in every treated-patient population. New and evolving risks must be evaluated and communicated rapidly to allow patients and physicians to be well informed and able to share treatment decisions.

Indexed as

Decision Support TechniquesPatient SelectionAdverse Drug Reaction Reporting SystemsAlgorithmsAttitude of Health PersonnelCommunicationDrug MonitoringEvidence-Based MedicineHealth Knowledge, Attitudes, PracticeHumansImmunosuppressive AgentsMultiple SclerosisPatient Acceptance of Health CarePatientsPerceptionPhysician-Patient RelationsImmunosuppressive Agentsbenefitdisease-modifying therapymultiple sclerosisRisksafetysurveillance

Identifiers

PMID24293456
PMCPMC4232326
OpenAlexW2109947581

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.