Evidence map›Paper›PMID 39487335›Full record

ArticleDrug safety2025

Views on the Development and Use of a New Digital Adverse Drug Event Reporting Platform in Australia: A Qualitative Study.

Eyob Alemayehu Gebreyohannes, Christopher Thornton, Myra Thiessen, Sieta T de Vries, Gretchen Coombs, Indae Hwang, Renly Lim

Abstract read
In one paragraph

Article in Drug safety, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Eyob Alemayehu GebreyohannesQuality Use of Medicines and Pharmacy Research Centre, UniSA Clinical and Health Sciences, University of South Australia, Adelaide, 5000, Australia. eyob.gebreyohannes@unisa.edu.au.ORCID 0000-0002-0075-4553
Christopher ThorntonUniSA Creative, University of South Australia, Adelaide, Australia.ORCID 0000-0001-8032-3691
Myra ThiessenMonash Art, Design and Architecture, Monash University, Melbourne, Australia.ORCID 0000-0003-2887-2129
Sieta T de VriesDepartment of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.ORCID 0000-0001-6090-2434
Gretchen CoombsMonash Art, Design and Architecture, Monash University, Melbourne, Australia.ORCID 0000-0002-9870-2005
Indae HwangMonash Art, Design and Architecture, Monash University, Melbourne, Australia.ORCID 0000-0002-0429-7716
Renly LimQuality Use of Medicines and Pharmacy Research Centre, UniSA Clinical and Health Sciences, University of South Australia, Adelaide, 5000, Australia.ORCID 0000-0003-4135-2523

Funding

National Health and Medical Research Council Centre of Research in Medicines Intelligence 1196900National Health and Medical Research Council Ideas Grant APP2020626
6 · The paper itself

Abstract

backgroundReporting of adverse drug events (ADEs) to regulatory authorities remains low, particularly among consumers.

objectivesTo explore stakeholders' views on the development and use of a digital platform to improve ADE reporting by consumers to the regulatory authority in Australia, i.e., the Therapeutic Goods Administration.

methodsA qualitative study was conducted using semi-structured interviews, focus group discussions (FGDs), and co-design workshops with consumers, healthcare professionals (HCPs), and regulators. The interview recordings were transcribed verbatim, coded, and analysed thematically according to the Capability, Opportunity, Motivation, Behaviour model. Findings of the FGDs and co-design workshops were incorporated to enhance and complement the insights gathered from the interviews.

resultsA total of 39 participants took part in the study (54 % consumers, 41 % HCPs, and 5 % regulators). Uncovered themes related to ADE reporting in general were: difficulty recognizing ADEs and health literacy, awareness about reporting ADEs (Capability); visibility of ADE reporting, professionals' views on consumer ADE reporting, consumer education (Opportunity); the common good, benefit to the reporter, identifying ADEs worth reporting, and concern about reporting (Motivation). Additional identified themes specific to a new digital platform were: physical abilities (Capability); features that facilitate intuitive use, convenience and accessibility, user experience, integration with existing systems, trust, sharing experiences with others (Opportunity); and concern about using a reporting platform, and feedback loop (Motivation).

conclusionsA cross-section of attitudes and values were obtained regarding ADE reporting in general and a new ADE reporting digital platform for consumers in Australia, which will inform its development, implementation and evaluation.

Indexed as

Adverse Drug Reaction Reporting SystemsDrug-Related Side Effects and Adverse ReactionsAdultAustraliaFemaleFocus GroupsHealth PersonnelHumansMaleMiddle AgedQualitative Research

Identifiers

PMID39487335
PMCPMC11785647

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.