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

Fédrizzi, Sophie; Chevanne, Damien; Montastruc, François; Briant, Anaïs R; Parienti, Jean‐Jacques; Paul, Laure Peyro Saint; Defer, Gilles; Derache, Nathalie; Branger, Pierre; Casez, Olivier; Vaillant, M.-F.; Labauge, Pierre; Magy, Laurent; Montcuquet, Alexis; Castelnovo, Giovanni; Cohen, Mikaël; Bourre, Bertrand; Kwiatkowski, Arnaud; Broucker, T. de; Créange, Alain; Heinzlef, Olivier; Wiertlewski, Sandrine; Guéguen, A.; Romero, Jorge; Devos, Paul; Planque, Evelyne; Schaeffer, S.; Collongues, Nicolas; Sèze, Jérôme De; Sénant, J; Bonnan, Mickaël; Ciocanu, Doina; Pittion, Sophie; Douay, X.; Zephir, Hélène; Peaureaux, D.

doi:10.1007/s40264-020-01009-z

Cited by 8 publications

(15 citation statements)

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“…Despite the abundance of healthcare-related applications very little research has been undertaken to investigate the validity and efficacy of these tools as well as their potential risks [ 16 ]. A randomized clinical trial demonstrated that a mobile device application enhances reporting of adverse drug reactions by pwMS compared to traditional reporting by phone or e-mail [ 17 ]. A small study of an MS custom application designed to gather both PROs and objective performances (motor, cognitive and visual) reported high attrition among patients with visual as well as with subjective cognitive difficulties [ 18 ].…”

Section: Introductionmentioning

confidence: 99%

Mobile-phone-based e-diary derived patient reported outcomes: Association with clinical disease activity, psychological status and quality of life of patients with multiple sclerosis

et al. 2021

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Background The applicability of mobile digital technology to promote clinical care of people with multiple sclerosis (pwMS) is gaining increased interest as part of the implementation of patient-centered approaches. We aimed at assessing adherence to a smartphone-based e-diary, which was designed to collect patient-reported outcomes (PROs). Secondary objectives were to evaluate the construct and predictive validity of e-diary derived PROs and to explore the various factors that were associated with changes in PROs over time. Materials and methods In this observational cohort study patients downloaded an MS tailored e-diary into their personal smartphones. Report of PROs was enquired once monthly for a period of one year through a smartphone-based application, using previously validated tools. An e-diary derived bodily function summary score (eBF) was defined as the sum of scores depicting vision, limbs function, pain, bowl/ bladder dysfunction, pseudobulbar affect and spasticity. Multiple linear regression and analysis of covariance were used to determine the association between PROs, clinician-reported outcomes (ClinROs) of disease activity and quality of life (QoL). Regression coefficient analysis was used to compare the slope of change in eBF before and after a relapse. Results 97 pwMS downloaded the e-diary [Female: 64 (66%), EDSS 3.4±2.1]. 76 patients (78%) completed the 12-month study period. 53 patients (55%) submitted ≥75% of requested surveys. Anxiety was negatively associated with adherence to periodic PROs assessments by the e-diary. E-diary derived PROs were significantly correlated with corresponding functional system scores (0.38< r <0.8, P<0.001). eBF score significantly predicted QoL (β = -0.36, P = 0.001) while EDSS did not. Change in eBF score over time was independently associated with the occurrence of an MS relapse (F = 4.4, P = 0.04), anxiety (F = 6.4, P = 0.01) and depression (F = 5.1, P = 0.03). Individual regression slopes of eBF scores were significantly higher pre-relapse than post-relapse (3.0±3.3 vs. -0.8±2.0, P = 0.007). Conclusion Adherence of pwMS to recording in an e-diary collecting PROs was high. Changes in e-diary derived PROs over time predict clinical MS relapses on the group level and thus carry the potential of usage in clinical research as well as for improved MS care in real world setting.

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Section: Introductionmentioning

confidence: 99%

Mobile-phone-based e-diary derived patient reported outcomes: Association with clinical disease activity, psychological status and quality of life of patients with multiple sclerosis

et al. 2021

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“…Initiative Web-Recognising Adverse Drug Reactions (WEB-RADR) project, reported in a recent paper [46], suggest that the patient's increased interest in improving knowledge about drug safety, combined with recent technological advances in information communication, make it possible to improve Over the past few years, studies have increasingly focused on the development and usage of mobile apps as additional tools to pharmacovigilance for improving and facilitating reporting of ADRs, as reported by Defer et al [47], Ahn et al [48], Prakash et al [49], Montastruc et al [50], and de Vries et al [51]. Indeed, in contrast to classical surveillance systems, mobile devices offer a platform for improving the accessibility of data and increasing the speed at which they are transmitted between institutions.…”

Section: The Results Of the European Union's Innovative Medicinesmentioning

confidence: 99%

“…Over the past few years, studies have increasingly focused on the development and usage of mobile apps as additional tools to pharmacovigilance for improving and facilitating reporting of ADRs, as reported by Defer et al [ 47 ], Ahn et al [ 48 ], Prakash et al [ 49 ], Montastruc et al [ 50 ], and de Vries et al [ 51 ]. Indeed, in contrast to classical surveillance systems, mobile devices offer a platform for improving the accessibility of data and increasing the speed at which they are transmitted between institutions.…”

Section: Introductionmentioning

confidence: 99%

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A Mobile App Leveraging Citizenship Engagement to Perform Anonymized Longitudinal Studies in the Context of COVID-19 Adverse Drug Reaction Monitoring: Development and Usability Study

Filippo¹,

Avellone²,

Belingheri³

et al. 2022

JMIR Hum Factors

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Background Over the past few years, studies have increasingly focused on the development of mobile apps as complementary tools to existing traditional pharmacovigilance surveillance systems for improving and facilitating adverse drug reaction (ADR) reporting. Objective In this research, we evaluated the potentiality of a new mobile app (vaxEffect@UniMiB) to perform longitudinal studies, while preserving the anonymity of the respondents. We applied the app to monitor the ADRs during the COVID-19 vaccination campaign in a sample of the Italian population. Methods We administered vaxEffect@UniMiB to a convenience sample of academic subjects vaccinated at the Milano-Bicocca University hub for COVID-19 during the Italian national vaccination campaign. vaxEffect@UniMiB was developed for both Android and iOS devices. The mobile app asks users to send their medical history and, upon every vaccine administration, their vaccination data and the ADRs that occurred within 7 days postvaccination, making it possible to follow the ADR dynamics for each respondent. The app sends data over the web to an application server. The server, along with receiving all user data, saves the data in a SQL database server and reminds patients to submit vaccine and ADR data by push notifications sent to the mobile app through Firebase Cloud Messaging (FCM). On initial startup of the app, a unique user identifier (UUID) was generated for each respondent, so its anonymity was completely ensured, while enabling longitudinal studies. Results A total of 3712 people were vaccinated during the first vaccination wave. A total of 2733 (73.6%) respondents between the ages of 19 and 80 years, coming from the University of Milano-Bicocca (UniMiB) and the Politecnico of Milan (PoliMi), participated in the survey. Overall, we collected information about vaccination and ADRs to the first vaccine dose for 2226 subjects (60.0% of the first dose vaccinated), to the second dose for 1610 subjects (43.4% of the second dose vaccinated), and, in a nonsponsored fashion, to the third dose for 169 individuals (4.6%). Conclusions vaxEffect@UniMiB was revealed to be the first attempt in performing longitudinal studies to monitor the same subject over time in terms of the reported ADRs after each vaccine administration, while guaranteeing complete anonymity of the subject. A series of aspects contributed to the positive involvement from people in using this app to report their ADRs to vaccination: ease of use, availability from multiple platforms, anonymity of all survey participants and protection of the submitted data, and the health care workers’ support.

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“…The publication times ranged from January 1, 2014, to December 31, 2021. The median sample size was 169 (range 61-268), and the following chronic diseases were included in the studies: pulmonary tuberculosis [14], renal cancer or prostate cancer [15], influenza [16], multiple sclerosis [17], oral cancer [18], and multiple chronic diseases [19][20][21]. The median intervention duration was 6 (range 1-25) months.…”

Section: Characteristics Of Included Studiesmentioning

confidence: 99%

Effectiveness of Mobile Medical Apps in Ensuring Medication Safety Among Patients With Chronic Diseases: Systematic Review and Meta-analysis

Zhou

Wang

et al. 2022

JMIR Mhealth Uhealth

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Background Along with the rapid growth of the global aging society, the mobile and health digital market has expanded greatly. Countless mobile medical apps (mmApps) have sprung up in the internet market, aiming to help patients with chronic diseases achieve medication safety. Objective Based on the medication safety action plans proposed by the World Health Organization, we aimed to explore the effectiveness of mmApps in ensuring the medication safety of patients with chronic diseases, including whether mmApps can improve the willingness to report adverse drug events (ADEs), improve patients' medication adherence, and reduce medication errors. We hoped to verify our hypothesis through a systematic review and meta-analysis. Methods The meta-analysis was performed in strict accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines and included literature searched from 7 databases—PubMed, Web Of Science, Embase, CINAHL, China National Knowledge Infrastructure, Wanfang, and SinoMed. The publication time was limited to the time of database establishment to April 30, 2022. Studies were screened based on inclusion and exclusion criteria. The data extracted included authors, years of publication, countries or regions, participants’ characteristics, intervention groups, and control groups, among others. Our quality assessment followed the guidelines of the Cochrane Handbook for Systematic Reviews of Interventions, Version 6.3. RevMan 5.2 software (Cochrane Collaboration) was used to analyze the statistical data, and a sensitivity analysis was performed to assess data stability. The degree of stability was calculated by using a different statistical method and excluding large-sample studies from the analysis. Results We included 8 studies from 5 countries (China, the United States, France, Canada, and Spain) that were published from January 1, 2014, to December 31, 2021. The total number of participants was 1355, and we analyzed the characteristics of included studies, each app’s features, the risk of bias, and quality. The results showed that mmApps could increase ADE reporting willingness (relative risk [RR] 2.59, 95% CI 1.26-5.30; P=.009) and significantly improve medication adherence (RR 1.17, 95% CI 1.04-1.31; P=.007), but they had little effect on reducing medication errors (RR 1.54, 95% CI 0.33-7.29; P=.58). Conclusions We analyzed the following three merits of mmApps, with regard to facilitating the willingness to report ADEs: mmApps facilitate more communication between patients and physicians, patients attach more importance to ADE reporting, and the processing of results is transparent. The use of mmApps improved medication adherence among patients with chronic diseases by conveying medical solutions, providing educational support, tracking medications, and allowing for remote consultations. Finally, we found 3 potential reasons for why our medication error results differed from those of other studies. Trial Registration PROSPERO International Prospective Register of Systematic Reviews CRD42022322072; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=322072

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

Cited by 8 publications

References 39 publications

Mobile-phone-based e-diary derived patient reported outcomes: Association with clinical disease activity, psychological status and quality of life of patients with multiple sclerosis

Mobile-phone-based e-diary derived patient reported outcomes: Association with clinical disease activity, psychological status and quality of life of patients with multiple sclerosis

A Mobile App Leveraging Citizenship Engagement to Perform Anonymized Longitudinal Studies in the Context of COVID-19 Adverse Drug Reaction Monitoring: Development and Usability Study

Effectiveness of Mobile Medical Apps in Ensuring Medication Safety Among Patients With Chronic Diseases: Systematic Review and Meta-analysis

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