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Characteristics, Quality and Contribution to Signal Detection of Spontaneous Reports of Adverse Drug Reactions Via the WEB-RADR Mobile Application: A Descriptive Cross-Sectional Study
INTRODUCTION: Spontaneous reporting of suspected adverse drug reactions is key for efficient post-marketing safety surveillance. To increase usability and accessibility of reporting tools, the Web-Recognising Adverse Drug Reactions (WEB-RADR) consortium developed a smartphone application (app) based...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6153975/ https://www.ncbi.nlm.nih.gov/pubmed/29761281 http://dx.doi.org/10.1007/s40264-018-0679-6 |
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author | Oosterhuis, Ingrid Taavola, Henric Tregunno, Philip M. Mas, Petar Gama, Sara Newbould, Victoria Caster, Ola Härmark, Linda |
author_facet | Oosterhuis, Ingrid Taavola, Henric Tregunno, Philip M. Mas, Petar Gama, Sara Newbould, Victoria Caster, Ola Härmark, Linda |
author_sort | Oosterhuis, Ingrid |
collection | PubMed |
description | INTRODUCTION: Spontaneous reporting of suspected adverse drug reactions is key for efficient post-marketing safety surveillance. To increase usability and accessibility of reporting tools, the Web-Recognising Adverse Drug Reactions (WEB-RADR) consortium developed a smartphone application (app) based on a simplified reporting form. OBJECTIVE: The objective of this study was to evaluate the characteristics, quality and contribution to signals of reports submitted via the WEB-RADR app. METHODS: The app was launched in the UK, the Netherlands and Croatia between July 2015 and May 2016. Spontaneous reports submitted until September 2016 with a single reporter were included. For each country, app reports and reports received through conventional means in the same time period were compared to identify characteristic features. A random subset of reports was assessed for clinical quality and completeness. The contribution to signal detection was assessed by a descriptive analysis. RESULTS: Higher proportions of app reports were submitted by patients in the UK (28 vs. 18%) and Croatia (32 vs. 7%); both p < 0.01. In the Netherlands, the difference was small (60 vs. 57%; p = 0.5). The proportion of female patients and the median patient ages in app reports submitted by patients were similar to the reference. The proportion of reports of at least moderate quality was high in both samples (app: 78–85%, reference: 78–98%), for all countries. App reports contributed to detecting eight potential safety signals at the national level, four of which were eventually signalled. CONCLUSION: The WEB-RADR app offers a new route of spontaneous reporting that shows promise in attracting reports from patients and that could become an important tool in the future. Patient demographics are similar to conventional routes, report quality is sufficient despite a simplified reporting form, and app reports show potential in contributing to signal detection. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s40264-018-0679-6) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-6153975 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | Springer International Publishing |
record_format | MEDLINE/PubMed |
spelling | pubmed-61539752018-10-04 Characteristics, Quality and Contribution to Signal Detection of Spontaneous Reports of Adverse Drug Reactions Via the WEB-RADR Mobile Application: A Descriptive Cross-Sectional Study Oosterhuis, Ingrid Taavola, Henric Tregunno, Philip M. Mas, Petar Gama, Sara Newbould, Victoria Caster, Ola Härmark, Linda Drug Saf Original Research Article INTRODUCTION: Spontaneous reporting of suspected adverse drug reactions is key for efficient post-marketing safety surveillance. To increase usability and accessibility of reporting tools, the Web-Recognising Adverse Drug Reactions (WEB-RADR) consortium developed a smartphone application (app) based on a simplified reporting form. OBJECTIVE: The objective of this study was to evaluate the characteristics, quality and contribution to signals of reports submitted via the WEB-RADR app. METHODS: The app was launched in the UK, the Netherlands and Croatia between July 2015 and May 2016. Spontaneous reports submitted until September 2016 with a single reporter were included. For each country, app reports and reports received through conventional means in the same time period were compared to identify characteristic features. A random subset of reports was assessed for clinical quality and completeness. The contribution to signal detection was assessed by a descriptive analysis. RESULTS: Higher proportions of app reports were submitted by patients in the UK (28 vs. 18%) and Croatia (32 vs. 7%); both p < 0.01. In the Netherlands, the difference was small (60 vs. 57%; p = 0.5). The proportion of female patients and the median patient ages in app reports submitted by patients were similar to the reference. The proportion of reports of at least moderate quality was high in both samples (app: 78–85%, reference: 78–98%), for all countries. App reports contributed to detecting eight potential safety signals at the national level, four of which were eventually signalled. CONCLUSION: The WEB-RADR app offers a new route of spontaneous reporting that shows promise in attracting reports from patients and that could become an important tool in the future. Patient demographics are similar to conventional routes, report quality is sufficient despite a simplified reporting form, and app reports show potential in contributing to signal detection. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s40264-018-0679-6) contains supplementary material, which is available to authorized users. Springer International Publishing 2018-05-14 2018 /pmc/articles/PMC6153975/ /pubmed/29761281 http://dx.doi.org/10.1007/s40264-018-0679-6 Text en © The Author(s) 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. |
spellingShingle | Original Research Article Oosterhuis, Ingrid Taavola, Henric Tregunno, Philip M. Mas, Petar Gama, Sara Newbould, Victoria Caster, Ola Härmark, Linda Characteristics, Quality and Contribution to Signal Detection of Spontaneous Reports of Adverse Drug Reactions Via the WEB-RADR Mobile Application: A Descriptive Cross-Sectional Study |
title | Characteristics, Quality and Contribution to Signal Detection of Spontaneous Reports of Adverse Drug Reactions Via the WEB-RADR Mobile Application: A Descriptive Cross-Sectional Study |
title_full | Characteristics, Quality and Contribution to Signal Detection of Spontaneous Reports of Adverse Drug Reactions Via the WEB-RADR Mobile Application: A Descriptive Cross-Sectional Study |
title_fullStr | Characteristics, Quality and Contribution to Signal Detection of Spontaneous Reports of Adverse Drug Reactions Via the WEB-RADR Mobile Application: A Descriptive Cross-Sectional Study |
title_full_unstemmed | Characteristics, Quality and Contribution to Signal Detection of Spontaneous Reports of Adverse Drug Reactions Via the WEB-RADR Mobile Application: A Descriptive Cross-Sectional Study |
title_short | Characteristics, Quality and Contribution to Signal Detection of Spontaneous Reports of Adverse Drug Reactions Via the WEB-RADR Mobile Application: A Descriptive Cross-Sectional Study |
title_sort | characteristics, quality and contribution to signal detection of spontaneous reports of adverse drug reactions via the web-radr mobile application: a descriptive cross-sectional study |
topic | Original Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6153975/ https://www.ncbi.nlm.nih.gov/pubmed/29761281 http://dx.doi.org/10.1007/s40264-018-0679-6 |
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