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

Author

Listed:
  • Gilles Defer

    (Caen University Hospital)

  • Sophie Fedrizzi

    (Caen University Hospital)

  • Damien Chevanne

    (Caen University Hospital)

  • François Montastruc

    (University of Toulouse
    University Paul Sabatier Toulouse III Joint Research Unit)

  • Anais R. Briant

    (Caen University Hospital)

  • Jean-Jacques Parienti

    (Caen University Hospital
    University of Caen Normandy)

  • Laure Peyro-Saint-Paul

    (Caen University Hospital)

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

Suggested Citation

  • Gilles Defer & Sophie Fedrizzi & Damien Chevanne & François Montastruc & Anais R. Briant & Jean-Jacques Parienti & Laure Peyro-Saint-Paul, 2021. "Adverse Drug Reaction Reporting Using a Mobile Device Application by Persons with Multiple Sclerosis: A Cluster Randomized Controlled Trial," Drug Safety, Springer, vol. 44(2), pages 223-233, February.
    • Handle: RePEc:spr:drugsa:v:44:y:2021:i:2:d:10.1007_s40264-020-01009-z
    DOI: 10.1007/s40264-020-01009-z
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    References listed on IDEAS

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    1. Marin Banovac & Gianmario Candore & Jim Slattery & Francois Houÿez & David Haerry & Georgy Genov & Peter Arlett, 2017. "Patient Reporting in the EU: Analysis of EudraVigilance Data," Drug Safety, Springer, vol. 40(7), pages 629-645, July.
    2. Ingrid Oosterhuis & Henric Taavola & Philip M. Tregunno & Petar Mas & Sara Gama & Victoria Newbould & Ola Caster & Linda Härmark, 2018. "Characteristics, Quality and Contribution to Signal Detection of Spontaneous Reports of Adverse Drug Reactions Via the WEB-RADR Mobile Application: A Descriptive Cross-Sectional Study," Drug Safety, Springer, vol. 41(10), pages 969-978, October.
    3. Leàn Rolfes & Florence Hunsel & Laura Linden & Katja Taxis & Eugène Puijenbroek, 2017. "The Quality of Clinical Information in Adverse Drug Reaction Reports by Patients and Healthcare Professionals: A Retrospective Comparative Analysis," Drug Safety, Springer, vol. 40(7), pages 607-614, July.
    4. Linda Härmark & June Raine & Hubert Leufkens & I. Ralph Edwards & Ugo Moretti & Viola Macolic Sarinic & Agnes Kant, 2016. "Patient-Reported Safety Information: A Renaissance of Pharmacovigilance?," Drug Safety, Springer, vol. 39(10), pages 883-890, October.
    5. Sarah Watson & Rebecca E. Chandler & Henric Taavola & Linda Härmark & Birgitta Grundmark & Alem Zekarias & Kristina Star & Florence Hunsel, 2018. "Safety Concerns Reported by Patients Identified in a Collaborative Signal Detection Workshop using VigiBase: Results and Reflections from Lareb and Uppsala Monitoring Centre," Drug Safety, Springer, vol. 41(2), pages 203-212, February.
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