Evidence map›Paper›PMID 37725533›Full record

ArticleJMIRx med2021

Finding Potential Adverse Events in the Unstructured Text of Electronic Health Care Records: Development of the Shakespeare Method.

Roselie A Bright, Summer K Rankin, Katherine Dowdy, Sergey V Blok, Susan J Bright, Lee Anne M Palmer

Abstract read
In one paragraph

Article in JMIRx med, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

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

  1. Pooled it
  2. Trial
  3. Article
  4. Review
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

6 authors.

Roselie A BrightUS Food and Drug Administration, Silver Spring, MD, United States.ORCID https://orcid.org/0000-0002-7565-1284
Summer K RankinBooz Allen Hamilton, McLean, VA, United States.ORCID https://orcid.org/0000-0002-6886-3983
Katherine DowdyBooz Allen Hamilton, McLean, VA, United States.ORCID https://orcid.org/0000-0002-5187-5160
Sergey V BlokBooz Allen Hamilton, McLean, VA, United States.ORCID https://orcid.org/0000-0003-0286-7612
Susan J BrightUS Food and Drug Administration, Rockville, MD, United States.ORCID https://orcid.org/0000-0002-1696-239X
Lee Anne M PalmerUS Food and Drug Administration, Rockville, MD, United States.ORCID https://orcid.org/0000-0003-4198-845X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBig data tools provide opportunities to monitor adverse events (patient harm associated with medical care) (AEs) in the unstructured text of electronic health care records (EHRs). Writers may explicitly state an apparent association between treatment and adverse outcome ("attributed") or state the simple treatment and outcome without an association ("unattributed"). Many methods for finding AEs in text rely on predefining possible AEs before searching for prespecified words and phrases or manual labeling (standardization) by investigators. We developed a method to identify possible AEs, even if unknown or unattributed, without any prespecifications or standardization of notes. Our method was inspired by word-frequency analysis methods used to uncover the true authorship of disputed works credited to William Shakespeare. We chose two use cases, "transfusion" and "time-based." Transfusion was chosen because new transfusion AE types were becoming recognized during the study data period; therefore, we anticipated an opportunity to find unattributed potential AEs (PAEs) in the notes. With the time-based case, we wanted to simulate near real-time surveillance. We chose time periods in the hope of detecting PAEs due to contaminated heparin from mid-2007 to mid-2008 that were announced in early 2008. We hypothesized that the prevalence of contaminated heparin may have been widespread enough to manifest in EHRs through symptoms related to heparin AEs, independent of clinicians' documentation of attributed AEs.

objectiveWe aimed to develop a new method to identify attributed and unattributed PAEs using the unstructured text of EHRs.

methodsWe used EHRs for adult critical care admissions at a major teaching hospital (2001-2012). For each case, we formed a group of interest and a comparison group. We concatenated the text notes for each admission into one document sorted by date, and deleted replicate sentences and lists. We identified statistically significant words in the group of interest versus the comparison group. Documents in the group of interest were filtered to those words, followed by topic modeling on the filtered documents to produce topics. For each topic, the three documents with the maximum topic scores were manually reviewed to identify PAEs.

resultsTopics centered around medical conditions that were unique to or more common in the group of interest, including PAEs. In each use case, most PAEs were unattributed in the notes. Among the transfusion PAEs was unattributed evidence of transfusion-associated cardiac overload and transfusion-related acute lung injury. Some of the PAEs from mid-2007 to mid-2008 were increased unattributed events consistent with AEs related to heparin contamination.

conclusionsThe Shakespeare method could be a useful supplement to AE reporting and surveillance of structured EHR data. Future improvements should include automation of the manual review process.

Indexed as

big datacritical careelectronic health care recordelectronic health recordepidemiologynatural language processingpatient harmpatient safetyproduct surveillance, postmarketingproof-of-concept studypublic health

Identifiers

PMID37725533
PMCPMC10414364

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.