Evidence map›Paper›PMID 33048319›Full record

Trial reportDrug safety2021

Adverse Drug Reaction Reporting Using a Mobile Device Application by Persons with Multiple Sclerosis: A Cluster Randomized Controlled Trial.

Gilles Defer, Sophie Fedrizzi, Damien Chevanne, François Montastruc, Anais R Briant, Jean-Jacques Parienti, Laure Peyro-Saint-Paul, French VigipSEP Study Group, Société Francophone de la Sclérose en Plaques (SFSEP)

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Drug safety, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03029897 (Impact of E-reporting by Patients With Relapsing-remitting Multiple Sclerosis on the Reporting of Adverse Drug Reactions in France), which is not on this map. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 pooled it
–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.

NCT03029897 nacompletednot on this map

Impact of E-reporting by Patients With Relapsing-remitting Multiple Sclerosis on the Reporting of Adverse Drug Reactions in France: a Randomized Controlled Trial.

TypeinterventionalSponsorUniversity Hospital, CaenRan2017 to 2019Enrolled161ConditionsMultiple SclerosisArmsMy eReport France
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Observational
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

9 authors.

Gilles DeferNeurology Department, Caen University Hospital, Caen, France.
Sophie FedrizziPharmacology Department, Caen University Hospital, Caen, France.
Damien ChevanneNeurology Department, Caen University Hospital, Caen, France.
François MontastrucDepartment of Medical and Clinical Pharmacology, Centre of Pharmacovigilance and Pharmacoepidemiology, Toulouse University Hospital, Faculty of Medicine, University of Toulouse, Toulouse, France.
Anais R BriantClinical Research Department, Caen University Hospital, 14033, Caen Cedex 9, France.
Jean-Jacques ParientiClinical Research Department, Caen University Hospital, 14033, Caen Cedex 9, France.
Laure Peyro-Saint-PaulClinical Research Department, Caen University Hospital, 14033, Caen Cedex 9, France. peyrosaintpaul-l@chu-caen.fr.ORCID 0000-0003-0301-1058
French VigipSEP Study Group
Société Francophone de la Sclérose en Plaques (SFSEP)

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPatient reporting adds value to pharmacovigilance. Encouraging it to be done through a mobile device application (App) is a method that should be evaluated.

objectiveThis study aimed to determine whether the use of an App, compared to traditional use through e-mail, telephone, or the national website, increased suspected adverse drug reaction (ADR) reporting by persons with multiple sclerosis receiving a first-line disease-modifying drug.

methodsAn open multi-centric, cluster-randomized controlled trial was conducted (VigipSEP study). Clusters were centers allocated (1:1) to the use of the My eReport France

resultsTwenty-four centers (12 per arm: six public neurologists from the multiple sclerosis academic expert centers, three public neurologists from general hospitals, and three private practice neurologists) were randomized, including 159 patients. The mean number of ADR reports per patient was significantly higher in centers that used the App: 0.47 vs 0.03 in control centers (p = 0.002). At an individual-level analysis, the experimental arm was significantly associated with a relative risk of ADR reports at 18.6 (95% confidence interval 4.1-84.2; p < 0.001), compared to the control arm, adjusted for sex and type of disease-modifying drug.

conclusionsThe use of a mobile App increased the ADR reporting by persons with multiple sclerosis receiving a first-line disease-modifying drug. CLINICALTRIALS. GOV IDENTIFIER: NCT03029897, registered in 2017.

Indexed as

Adverse Drug Reaction Reporting SystemsMobile ApplicationsMultiple SclerosisHumans

Identifiers

PMID33048319

What OpenQuestion holds

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Registered trials

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.