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

Drug Safety : an International Journal of Medical Toxicology and Drug Experience
Ingrid OosterhuisLinda Härmark

Abstract

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. The objective of this study was to evaluate the characteristics, quality and contribution to signals of reports submitted via the WEB-RADR app. 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. 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 wer...Continue Reading

References

May 13, 2006·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Lorna Hazell, Saad A W Shakir
Jan 10, 2009·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Elena Lopez-GonzalezAdolfo Figueiras
Oct 4, 2012·Pharmacoepidemiology and Drug Safety·Chieko IshiguroGerald Dal Pan
Dec 18, 2013·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Tomas BergvallMarie Lindquist
Mar 15, 2014·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Philip Michael TregunnoG Niklas Norén
Jul 24, 2014·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Ola CasterG Niklas Norén
Nov 16, 2014·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Alexandra C PacurariuSabine M J M Straus
Dec 31, 2016·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Sieta T de VriesUNKNOWN IMI Web-RADR Work Package 3b Consortium
Apr 22, 2017·Journal of Medical Internet Research·Jennifer K CarrollKevin Fiscella
Aug 18, 2017·Pharmacoepidemiology and Drug Safety·Kristina JuhlinG Niklas Norén

❮ Previous
Next ❯

Citations

Mar 27, 2019·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Carrie E PiercePeter G M Mol
Oct 14, 2020·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Gilles DeferUNKNOWN Société Francophone de la Sclérose en Plaques (SFSEP)
Jun 20, 2021·BMJ : British Medical Journal·Vincent Lo ReAlmut G Winterstein
Aug 1, 2020·Current Drug Safety·Kirandeep KaurSandeep Kaushal
Aug 10, 2021·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Sieta T de VriesUNKNOWN IMI Web-RADR Work Package 3b Consortium and SCOPE Joint Action Work Package 4
Oct 13, 2021·Trends in Pharmacological Sciences·Andrew Bate, Jens-Ulrich Stegmann

❮ Previous
Next ❯

Software Mentioned

vigiMatch
WEB
vigiGrade
Medwatcher
vigiRank
RADR
ClinDoc
vigiPoint
European Issues Tracking Tool EPITT

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.

© 2022 Meta ULC. All rights reserved