Evidence map›Paper›PMID 32445187›Full record

ArticleDrug safety2020

Information Visualization Platform for Postmarket Surveillance Decision Support.

Jonathan Spiker, Kory Kreimeyer, Oanh Dang, Debra Boxwell, Vicky Chan, Connie Cheng, Paula Gish, Allison Lardieri, Eileen Wu, Suranjan De and 5 more

Abstract read
PubMed Publisher
In one paragraph

Article in Drug safety, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing 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

10 citing papers in PubMed.

  1. Article
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  4. Article
  5. Article
  6. Review
  7. Review
  8. 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

15 authors.

Jonathan SpikerThe Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Kory KreimeyerThe Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Oanh DangOffice of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US FDA, Silver Spring, MD, USA.
Debra BoxwellOffice of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US FDA, Silver Spring, MD, USA.
Vicky ChanOffice of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US FDA, Silver Spring, MD, USA.
Connie ChengOffice of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US FDA, Silver Spring, MD, USA.
Paula GishOffice of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US FDA, Silver Spring, MD, USA.
Allison LardieriOffice of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US FDA, Silver Spring, MD, USA.
Eileen WuOffice of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US FDA, Silver Spring, MD, USA.
Suranjan DeOffice of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US FDA, Silver Spring, MD, USA.
Jarushka NaidooThe Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Harold LehmannDivision of Health Sciences Informatics, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Gary L RosnerThe Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Robert BallOffice of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US FDA, Silver Spring, MD, USA.
Taxiarchis BotsisThe Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA. tbotsis1@jhmi.edu.ORCID 0000-0001-7848-2570

Funding

U.S. Food and Drug Administration 2U01FD005942-03 REVISED
6 · The paper itself

Abstract

introductionThe US FDA receives more than 2 million postmarket reports each year. Safety Evaluators (SEs) review these reports, as well as external information, to identify potential safety signals. With the increasing number of reports and the size of external information, more efficient solutions for data integration and decision making are needed.

objectivesThe aim of this study was to develop an interactive decision support application for drug safety surveillance that integrates and visualizes information from postmarket reports, product labels, and biomedical literature.

methodsWe conducted multiple meetings with a group of seven SEs at the FDA to collect the requirements for the Information Visualization Platform (InfoViP). Using infographic design principles, we implemented the InfoViP prototype version as a modern web application using the integrated information collected from the FDA Adverse Event Reporting System, the DailyMed repository, and PubMed. The same group of SEs evaluated the InfoViP prototype functionalities using a simple evaluation form and provided input for potential enhancements.

resultsThe SEs described their workflows and overall expectations around the automation of time-consuming tasks, including the access to the visualization of external information. We developed a set of wireframes, shared them with the SEs, and finalized the InfoViP design. The InfoViP prototype architecture relied on a javascript and a python-based framework, as well as an existing tool for the processing of free-text information in all sources. This natural language processing tool supported multiple functionalities, especially the construction of time plots for individual postmarket reports and groups of reports. Overall, we received positive comments from the SEs during the InfoViP prototype evaluation and addressed their suggestions in the final version.

conclusionsThe InfoViP system uses context-driven interactive visualizations and informatics tools to assist FDA SEs in synthesizing data from multiple sources for their case series analyses.

Indexed as

Decision Support TechniquesGeographic Information SystemsImage Processing, Computer-AssistedProduct Surveillance, PostmarketingHumansNatural Language ProcessingUnited StatesUnited States Food and Drug Administration

Identifiers

PMID32445187

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.