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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.


ABSTRACT: 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?

SUBMITTER: Oosterhuis I 

PROVIDER: S-EPMC6153975 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature

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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.

Oosterhuis Ingrid I   Taavola Henric H   Tregunno Philip M PM   Mas Petar P   Gama Sara S   Newbould Victoria V   Caster Ola O   Härmark Linda L  

Drug safety 20181001 10


<h4>Introduction</h4>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.<h4>Objective</h4>The objective of this study was to evaluate the characteristics, quality and contribution to signals of reports submitted via the WEB-RADR app.  ...[more]

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