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Randomized Controlled Trial
. 2023 May 8:9:e39700.
doi: 10.2196/39700.

Comparing the Use of a Mobile App and a Web-Based Notification Platform for Surveillance of Adverse Events Following Influenza Immunization: Randomized Controlled Trial

A Brianne Bota  1 , Julie A Bettinger  2 , Shirley Sarfo-Mensah  1 , Jimmy Lopez  2 , David P Smith  1 , Katherine M Atkinson  3 , Cameron Bell  4 , Kim Marty  2 , Mohamed Serhan  1 , David T Zhu  1   5 , Anne E McCarthy  6 , Kumanan Wilson  1   4   6   7
Affiliations
Randomized Controlled Trial

Comparing the Use of a Mobile App and a Web-Based Notification Platform for Surveillance of Adverse Events Following Influenza Immunization: Randomized Controlled Trial

A Brianne Bota et al. JMIR Public Health Surveill. .

Abstract

Background: Vaccine safety surveillance is a core component of vaccine pharmacovigilance. In Canada, active, participant-centered vaccine surveillance is available for influenza vaccines and has been used for COVID-19 vaccines.

Objective: The objective of this study is to evaluate the effectiveness and feasibility of using a mobile app for reporting participant-centered seasonal influenza adverse events following immunization (AEFIs) compared to a web-based notification system.

Methods: Participants were randomized to influenza vaccine safety reporting via a mobile app or a web-based notification platform. All participants were invited to complete a user experience survey.

Results: Among the 2408 randomized participants, 1319 (54%) completed their safety survey 1 week after vaccination, with a higher completion rate among the web-based notification platform users (767/1196, 64%) than among mobile app users (552/1212, 45%; P<.001). Ease-of-use ratings were high for the web-based notification platform users (99% strongly agree or agree) and 88.8% of them strongly agreed or agreed that the system made reporting AEFIs easier. Web-based notification platform users supported the statement that a web-based notification-only approach would make it easier for public health professionals to detect vaccine safety signals (91.4%, agreed or strongly agreed).

Conclusions: Participants in this study were significantly more likely to respond to a web-based safety survey rather than within a mobile app. These results suggest that mobile apps present an additional barrier for use compared to the web-based notification-only approach.

Trial registration: ClinicalTrials.gov NCT05794113; https://clinicaltrials.gov/show/NCT05794113.

Keywords: active participant–centered reporting; adverse event reporting; apps; campaign; health technology; immunization; influenza; mobile; mobile apps; pharmacovigilance; safety; surveillance; vaccine.

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Conflict of interest statement

Conflicts of Interest: KW, KA, and CB were cofounders and shareholders of CANImmunize Inc, a corporation that provides consumer facing solutions to immunization information systems. KW has served on the Medicago Independent Data Monitoring Committee and is a member of the Moderna Global Safety Core Consultancy Group. All other authors have no conflicts of interest to disclose.

Figures

Figure 1
Figure 1
Overview of participant recruitment, randomization, and survey completion. RCT: randomized controlled trial.
See this image and copyright information in PMC

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