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Randomized Controlled Trial
. 2021 Feb;44(2):223-233.
doi: 10.1007/s40264-020-01009-z. Epub 2020 Oct 13.

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

Gilles Defer  1 , Sophie Fedrizzi  2 , Damien Chevanne  1 , François Montastruc  3   4 , Anais R Briant  5 , Jean-Jacques Parienti  5   6 , Laure Peyro-Saint-Paul  7 ; French VigipSEP Study Group; Société Francophone de la Sclérose en Plaques (SFSEP)
Collaborators, Affiliations
Randomized Controlled Trial

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

Gilles Defer et al. Drug Saf. 2021 Feb.

Abstract

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

Objective: This 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.

Methods: An 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® App (experimental arm), and traditional reporting (control arm). Persons with multiple sclerosis initiating or switching to a first-line disease-modifying drug between April 2017 and April 2019 were included. The primary outcome was the mean number of ADR reports per patient for the center-level analysis, and the number of ADR reports per patient for the individual-level analysis using the hierarchical Poisson regression model.

Results: Twenty-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.

Conclusions: The 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.

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References

    1. Egberts TC, Smulders M, de Koning FH, Meyboom RH, Leufkens HG. Can adverse drug reactions be detected earlier? A comparison of reports by patients and professionals. BMJ. 1996;313(7056):530–1. - DOI
    1. Margraff F, Bertram D. Adverse drug reaction reporting by patients: an overview of fifty countries. Drug Saf. 2014;37(6):409–19. - DOI
    1. van Hunsel F, Härmark L, Rolfes L. Fifteen years of patient reporting: what have we learned and where are we heading to? Expert Opin Drug Saf. 2019;18(6):477–84. - DOI
    1. Härmark L, van Hunsel F, Grundmark B. ADR reporting by the general public: lessons learnt from the Dutch and Swedish systems. Drug Saf. 2015;38(4):337–47. - DOI
    1. Härmark L, Raine J, Leufkens H, Edwards IR, Moretti U, Sarinic VM, et al. Patient-reported safety information: a renaissance of pharmacovigilance? Drug Saf. 2016;39(10):883–90. - DOI

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