ArticleTrials2018
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.
Article in Trials, 2018. 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 12 papers.
What it found
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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.
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.
Impact of E-reporting by Patients With Relapsing-remitting Multiple Sclerosis on the Reporting of Adverse Drug Reactions in France: a Randomized Controlled Trial.
Who cites it
12 citing papers in PubMed.
- Adverse Drug Reaction Reporting Using a Mobile Device Application by Persons with Multiple Sclerosis: A Cluster Randomized Controlled Trial.Drug safety · 2021Trial
- Design Principles for Interactive Dashboards in Drug Safety Surveillance: Design Science Research.JMIR medical informatics · 2026Article
- Employing bibliometrics and natural language processing (NLP) to analyse real-world applications of adverse drug reaction.Exploratory research in clinical and social pharmacy · 2025Article
- Measuring Disease Progression in Multiple Sclerosis Clinical Drug Trials and Impact on Future Patient Care.CNS drugs · 2025Review
- Mobile apps for quick adverse drug reaction report: A scoping review.Pharmacoepidemiology and drug safety · 2023Article
- Article
- Smartphone-based mobile applications for adverse drug reactions reporting: global status and country experience.BMC medical informatics and decision making · 2022Article
- The Importance of Direct Patient Reporting of Adverse Drug Reactions in the Safety Monitoring Process.International journal of environmental research and public health · 2021Review
- Wearable technologies to measure clinical outcomes in multiple sclerosis: A scoping review.Multiple sclerosis (Houndmills, Basingstoke, England) · 2021Article
- Digital Technology in Clinical Trials for Multiple Sclerosis: Systematic Review.Journal of clinical medicine · 2021Review
- The value of direct patient reporting in pharmacovigilance.Therapeutic advances in drug safety · 2020Article
- Current trends in pharmacovigilance: value and gaps of patient reporting.International journal of clinical pharmacy · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe 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/
designWe 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 registrationClinicalTrials.gov , ID: NCT03029897 . Registered on 20 January 2017.
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