Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

Dedicated mobile application for drug adverse reaction reporting by patients with relapsing remitting multiple sclerosis (Vigip-SEP study): study protocol for a randomized controlled trial

Authors: Gilles Defer, Florian Le Caignec, Sophie Fedrizzi, François Montastruc, Damien Chevanne, Jean-Jacques Parienti, Laure Peyro-Saint-Paul

Published in: Trials | Issue 1/2018

Login to get access

Abstract

Background

The reporting of adverse drug reactions (ADR) by patients represents an interesting challenge in the field of pharmacovigilance, but the reporting system is not adequately implemented in France. In 2015, only 20 MS patients in France reported ADR due to first-line disease-modifying drugs (DMD), while more than 3000 patients were initiated on DMD.
The aim of this study is to validate a proof-of-concept as to whether the use of a mobile application (App) increases ADR reporting among patients with relapsing-remitting multiple sclerosis (RR-MS) receiving DMD.

Methods/design

We designed a multi-centric, open cluster-randomized controlled trial, called the Vigip-SEP study (NCT03029897), using the App My eReport France® to report ADR to the appropriate authorities in E2B language, in accordance with European regulations. RR-MS patients who were initiated on, or switched, first-line DMD will be included. In the experimental arm, a neurologist will introduce the patient to the App to report ADR to the appropriate French authorities. In the control arm, the patient will be informed of the existence of the App but will not be introduced to its use and will then report ADR according to the usual reporting procedures. Primary assessment criteria are defined as the average number of ADR per patient and per center. We assume that the App will increase patient reporting by 10-fold. Therefore, we will require 24 centers (12 per arm: 6 MS academic expert centers, 3 general hospitals, 3 private practice neurologists), allowing for an expected enrollment of 180 patients (alpha risk 5%, power 90% and standard deviation 4%).

Discussion

Increasing patient reporting of ADR in a real-life setting is extremely important for therapeutic management of RR-MS, particularly for monitoring newly approved DMD to gain better knowledge of their safety profiles. To increase patient involvement, teaching patients to use tools, such as mobile applications, should be encouraged, and these tools should be tested rigorously.

Trial registration

ClinicalTrials.​gov, ID: NCT03029897. Registered on 20 January 2017.
Appendix
Available only for authorised users
Literature
1.
2.
Vilhelmsson A. Consumer narratives in ADR reporting: an important aspect of public health? Experiences from reports to a Swedish Consumer Organization. Front Public Health. 2015;3:211.CrossRefPubMedPubMedCentral
3.
van Hunsel F, de Waal S, Härmark L. The contribution of direct patient reported ADRs to drug safety signals in the Netherlands from 2010 to 2015. Pharmacoepidemiol Drug Saf. 2017;26(8):977–83.CrossRefPubMed
4.
Inácio P, Cavaco A, Airaksinen M. The value of patient reporting to the pharmacovigilance system: a systematic review. Br J Clin Pharmacol. 2017;83(2):227–46.CrossRefPubMed
5.
6.
7.
Hazell L, Cornelius V, Hannaford P, Shakir S, Avery AJ. Yellow Card Study Collaboration. How do patients contribute to signal detection?: a retrospective analysis of spontaneous reporting of adverse drug reactions in the UK’s Yellow Card Scheme. Drug Saf. 2013;36(3):199–206.CrossRefPubMed
8.
Avery AJ, Anderson C, Bond CM, Fortnum H, Gifford A, Hannaford PC, Hazell L, Krska J, Lee AJ, McLernon DJ, Murphy E, Shakir S, Watson MC. Evaluation of patient reporting of adverse drug reactions to the UK ‘Yellow Card Scheme’: literature review, descriptive and qualitative analyses, and questionnaire surveys. Health Technol Assess. 2011;15(20):1–234. iii-ivCrossRefPubMed
9.
Durrieu G, Palmaro A, Pourcel L, Caillet C, Faucher A, Jacquet A, Ouaret S, Perault-Pochat MC, Kreft-Jais C, Castot A, Lapeyre-Mestre M, Montastruc JL. French Network of Pharmacovigilance Centres. First French experience of ADR reporting by patients after a mass immunization campaign with influenza A (H1N1) pandemic vaccines: a comparison of reports submitted by patients and healthcare professionals. Drug Saf. 2012;35(10):845–54.CrossRefPubMed
10.
van Grootheest K, de Graaf L, de Jong-van den Berg LT. Consumer adverse drug reaction reporting: a new step in pharmacovigilance? Drug Saf. 2003;26(4):211–7. ReviewCrossRefPubMed
11.
Härmark L, Raine J, Leufkens H, Edwards IR, Moretti U, Sarinic VM, Kant A. Patient-reported safety information: a renaissance of pharmacovigilance? Drug Saf. 2016;39(10):883–90.CrossRefPubMed
12.
13.
Rolfes L, van Hunsel F, van der Linden L, Taxis K, van Puijenbroek E. The quality of clinical information in adverse drug reaction reports by patients and healthcare professionals: a retrospective comparative analysis. Drug Saf. 2017;40(7):607–14.CrossRefPubMedPubMedCentral
14.
Blenkinsopp A, Wilkie P, Wang M, Routledge PA. Patient reporting of suspected adverse drug reactions: a review of published literature and international experience. Br J Clin Pharmacol. 2007;63(2):148–56. ReviewCrossRefPubMed
15.
Margraff F, Bertram D. Adverse drug reaction reporting by patients: an overview of fifty countries. Drug Saf. 2014;37(6):409–19.CrossRefPubMed
16.
Banovac M, Candore G, Slattery J, Houÿez F, Haerry D, Genov G, Arlett P. Patient reporting in the EU: analysis of EudraVigilance Data. Drug Saf. 2017;40(7):629–45.CrossRefPubMed
17.
Al Dweik R, Stacey D, Kohen D, Yaya S. Factors affecting patient reporting of adverse drug reactions: a systematic review. Br J Clin Pharmacol. 2017;83(4):875–83.CrossRefPubMed
18.
Rolfes L, van Hunsel F, van Grootheest K, van Puijenbroek E. Feedback for patients reporting adverse drug reactions; satisfaction and expectations. Expert Opin Drug Saf. 2015;14(5):625–32. Epub 2015 Mar 12CrossRefPubMed
19.
Bahk CY, Goshgarian M, Donahue K, Freifeld CC, Menone CM, Pierce CE, Rodriguez H, Brownstein JS, Furberg R, Dasgupta N. Increasing patient engagement in pharmacovigilance through online community outreach and mobile reporting applications: an analysis of adverse event reporting for the Essure Device in the US. Pharmaceut Med. 2015;29(6):331–40. Epub 2015 Aug 5PubMedPubMedCentral
20.
21.
Montastruc F, Bagheri H, Lacroix I, Damase-Michel C, Chebane L, Rousseau V, Jouanjus E, Lapeyre-Mestre M, Durrieu G, Montastruc JL. Adverse drug reaction reports received through the Mobile App, VigiBIP®: a comparison with classical methods of reporting. Drug Saf; 2017. [Epub ahead of print]
Metadata
Title
Dedicated mobile application for drug adverse reaction reporting by patients with relapsing remitting multiple sclerosis (Vigip-SEP study): study protocol for a randomized controlled trial
Authors
Gilles Defer
Florian Le Caignec
Sophie Fedrizzi
François Montastruc
Damien Chevanne
Jean-Jacques Parienti
Laure Peyro-Saint-Paul
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2560-4

Other articles of this Issue 1/2018

Trials 1/2018 Go to the issue

Study protocol

Resistant Hypertension On Treatment (ResHypOT): sequential nephron blockade compared to dual blockade of the renin-angiotensin-aldosterone system plus bisoprolol in the treatment of resistant arterial hypertension – study protocol for a randomized controlled trial

Research

A study of target effect sizes in randomised controlled trials published in the Health Technology Assessment journal

Study protocol

eRegQual—an electronic health registry with interactive checklists and clinical decision support for improving quality of antenatal care: study protocol for a cluster randomized trial

Methodology

CONSORT-SPI 2018 Explanation and Elaboration: guidance for reporting social and psychological intervention trials

Update

‘Test n Treat (TnT)’: a cluster-randomised feasibility trial of frequent, rapid-testing and same-day, on-site treatment to reduce rates of chlamydia in high-risk further education college students: statistical analysis plan

Study protocol

Rapid agitation control with ketamine in the emergency department (RACKED): a randomized controlled trial protocol