Evidence map›Paper›PMID 37340238›Full record

ArticleDrug safety2023

Use of Electronic Health Record Data for Drug Safety Signal Identification: A Scoping Review.

Sharon E Davis, Luke Zabotka, Rishi J Desai, Shirley V Wang, Judith C Maro, Kevin Coughlin, José J Hernández-Muñoz, Danijela Stojanovic, Nigam H Shah, Joshua C Smith

Abstract readScoping Review
In one paragraph

Article in Drug safety, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 1 pooled it
–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

25 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
  6. Review
  7. Article
  8. Mitigation of outcome conflation in predicting patient outcomes using electronic health records.Journal of the American Medical Informatics Association : JAMIA · 2025
    Article
  9. Article
  10. Article
  11. New Function for Safety Signal Monitoring in MID-NETClinical and translational science · 2025
    Article
  12. Review
  13. Article
  14. Article
  15. Article
  16. Review
  17. Article
  18. Article
  19. Article
  20. An open-source implementation of tree-based scan statistics.Pharmacoepidemiology and drug safety · 2024
    Article
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

10 authors.

Sharon E DavisDepartment of Biomedical Informatics, Vanderbilt University Medical Center, 2525 West End Ave, Suite 1475, Nashville, TN, 37203, USA.
Luke ZabotkaBrigham and Women's Hospital, Boston, MA, USA.
Rishi J DesaiBrigham and Women's Hospital, Boston, MA, USA.
Shirley V WangBrigham and Women's Hospital, Boston, MA, USA.
Judith C MaroHarvard Medical School, Boston, MA, USA.
Kevin CoughlinHarvard Pilgrim Health Care Institute, Boston, MA, USA.
José J Hernández-MuñozUS FDA, Silver Spring, MD, USA.
Danijela StojanovicUS FDA, Silver Spring, MD, USA.
Nigam H ShahSchool of Medicine, Stanford University, Stanford, CA, USA.
Joshua C SmithDepartment of Biomedical Informatics, Vanderbilt University Medical Center, 2525 West End Ave, Suite 1475, Nashville, TN, 37203, USA. joshua.smith@vumc.org.

Funding

Overall: Eunice Kennedy Shriver Intellectual and Developmental Disabilities Research Center at VanderbiltP50HD103537 · NICHD · VANDERBILT UNIVERSITY MEDICAL CENTER · PI Jeffrey L Neul · 2020 to 2026
$10.3M
NICHD NIH HHS P50 HD103537
6 · The paper itself

Abstract

introductionPharmacovigilance programs protect patient health and safety by identifying adverse event signals through postmarketing surveillance of claims data and spontaneous reports. Electronic health records (EHRs) provide new opportunities to address limitations of traditional approaches and promote discovery-oriented pharmacovigilance.

methodsTo evaluate the current state of EHR-based medication safety signal identification, we conducted a scoping literature review of studies aimed at identifying safety signals from routinely collected patient-level EHR data. We extracted information on study design, EHR data elements utilized, analytic methods employed, drugs and outcomes evaluated, and key statistical and data analysis choices.

resultsWe identified 81 eligible studies. Disproportionality methods were the predominant analytic approach, followed by data mining and regression. Variability in study design makes direct comparisons difficult. Studies varied widely in terms of data, confounding adjustment, and statistical considerations.

conclusionDespite broad interest in utilizing EHRs for safety signal identification, current efforts fail to leverage the full breadth and depth of available data or to rigorously control for confounding. The development of best practices and application of common data models would promote the expansion of EHR-based pharmacovigilance.

Indexed as

Adverse Drug Reaction Reporting SystemsElectronic Health RecordsData MiningHumansPharmacovigilance

Identifiers

PMID37340238
PMCPMC11635839

What Socratic holds

Textmetadata
LicenceTDM
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 Socratic graph.