使用移动设备应用程序报告多发性硬化症患者的药物不良反应：一项集群随机对照试验。

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

机构信息

Neurology Department, Caen University Hospital, Caen, France.

Pharmacology Department, Caen University Hospital, Caen, France.

出版信息

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

DOI:10.1007/s40264-020-01009-z

PMID:33048319

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.

摘要

简介

患者报告为药物警戒增添了价值。鼓励通过移动设备应用程序（App）进行报告是一种值得评估的方法。

目的

本研究旨在确定与通过电子邮件、电话或国家网站进行传统报告相比，使用 App 是否能增加正在接受一线疾病修正治疗药物的多发性硬化症患者的疑似药物不良反应（ADR）报告数量。

方法

进行了一项开放的多中心、集群随机对照试验（VigipSEP 研究）。将中心（1:1）分配到使用 My eReport France App（实验组）或传统报告（对照组）。纳入 2017 年 4 月至 2019 年 4 月期间开始或转为一线疾病修正治疗药物的多发性硬化症患者。主要结局为中心水平分析的每位患者平均 ADR 报告数量，以及使用分层泊松回归模型的个体水平分析的每位患者 ADR 报告数量。

结果

24 个中心（每组 12 个：来自多发性硬化症学术专家中心的 6 名公共神经病学家、3 名来自综合医院的公共神经病学家和 3 名私人执业神经病学家）被随机分配，包括 159 名患者。使用 App 的中心每位患者的 ADR 报告数量明显更高：对照组为 0.03，实验组为 0.47（p=0.002）。在个体水平分析中，与对照组相比，实验组与 ADR 报告的相对风险显著相关，调整性别和疾病修正药物类型后，风险比为 18.6（95%置信区间 4.1-84.2；p<0.001）。