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Randomized Controlled Trial
. 2024 Dec 28;14(1):31161.
doi: 10.1038/s41598-024-82474-9.

Effectiveness of the modified TaWai mobile application for reporting adverse drug reaction in Lao PDR: a cluster randomized controlled trial

Niphonh Mongkhonmath  1 , Phayom Sookaneknun Olson  2   3 , Panupong Puttarak  4   5 , Soulyvanh Keokinnaly  6 , Ratree Sawangjit  7
Affiliations
Randomized Controlled Trial

Effectiveness of the modified TaWai mobile application for reporting adverse drug reaction in Lao PDR: a cluster randomized controlled trial

Niphonh Mongkhonmath et al. Sci Rep. .

Abstract

Spontaneous adverse drug reactions (ADRs) reporting by health care professionals (HCPs) plays a vital role in pharmacovigilance (PV). However, under-reporting remain a major challenge worldwide, especially in low and middle-income countries, including Lao PDR. This cluster-randomized controlled trial evaluated the effectiveness of the modified TaWai mobile app for ADR reporting compared with the usual practice in hospitals. Two tertiary hospitals in Lao PDR (cluster units) were randomized into two groups: the intervention group (16 HCPs), which used the modified TaWai mobile app along with an educational workshop, and the control group (18 HCPs), which followed usual practice with the same educational workshop. The intervention group reported more ADR cases (28 vs. 3), and produced a higher number of high-quality reports (28 vs. 2) than the control group. The modified TaWai mobile app was highly rated by all participating HCPs. Questionnaire responses indicated that the tool is user-friendly, time-efficient, and well-suited for ADR reporting in hospitals in Lao PDR. In conclusion, these findings highlight the potential of the modified TaWai mobile app to enhance ADR reporting practices in hospitals, and its features make it a promising solution for strengthening PV in Lao PDR and similar settings.

Keywords: ADR reporting; Lao PDR; Low/middle-income countries; Pharmacovigilance; TaWai mobile App.

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Conflict of interest statement

Declarations. Competing interests: The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Example of TaWai mobile app for ADRs reporting.
Fig. 2
Fig. 2
Study flow chart for randomization HCPs.
See this image and copyright information in PMC

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