Evidence map›Paper›PMID 37005701›Full record

ArticlePharmacoepidemiology and drug safety2023

Using pooled electronic health records data to conduct pharmacoepidemiology safety studies: Challenges and lessons learned.

Timothy Beukelman, Lang Chen, Narender Annapureddy, Jim Oates, Megan E B Clowse, Millie Long, Michael D Kappelman, Rennie L Rhee, Peter A Merkel, William Benjamin Nowell and 3 more

Abstract read
In one paragraph

Article in Pharmacoepidemiology and drug safety, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

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

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Observational
  4. 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

13 authors.

Timothy BeukelmanDivision of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, Alabama, USA.ORCID 0000-0001-9463-6306
Lang ChenDivision of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, Alabama, USA.
Narender AnnapureddyDivision of Rheumatology and Immunology, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Jim OatesDivision of Rheumatology, Medical University of South Carolina, Charleston, South Carolina, USA.
Megan E B ClowseDivision of Rheumatology and Immunology, Duke University, Durham, North Carolina, USA.
Millie LongDivision of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, North Carolina, USA.
Michael D KappelmanDivision of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, North Carolina, USA.
Rennie L RheeDivision of Rheumatology, Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Peter A MerkelDivision of Rheumatology, Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
William Benjamin NowellGlobal Healthy Living Foundation, Upper Nyack, New York, USA.
Fenglong XieDivision of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, Alabama, USA.ORCID 0000-0002-7365-4801
Cassie ClintonDivision of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, Alabama, USA.
Jeffrey R CurtisDivision of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, Alabama, USA.

Funding

Resource CoreP30AR072582 · NIAMS · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI JAMES C OATES · 2017 to 2026
$8.5M
NIAMS NIH HHS P30 AR072582
6 · The paper itself

Abstract

purposeWe assessed the suitability of pooled electronic health record (EHR) data from clinical research networks (CRNs) of the patient-centered outcomes research network to conduct studies of the association between tumor necrosis factor inhibitors (TNFi) and infections.

methodsEHR data from patients with one of seven autoimmune diseases were obtained from three CRNs and pooled. Person-level linkage of CRN data and Centers for Medicare and Medicaid Services (CMS) fee-for-service claims data was performed where possible. Using filled prescriptions from CMS claims data as the gold standard, we assessed the misclassification of EHR-based new (incident) user definitions. Among new users of TNFi, we assessed subsequent rates of hospitalized infection in EHR and CMS data.

resultsThe study included 45 483 new users of TNFi, of whom 1416 were successfully linked to their CMS claims. Overall, 44% of new EHR TNFi prescriptions were not associated with medication claims. Our most specific new user definition had a misclassification rate of 3.5%-16.4% for prevalent use, depending on the medication. Greater than 80% of CRN prescriptions had either zero refills or missing refill data. Compared to using EHR data alone, there was a 2- to 8-fold increase in hospitalized infection rates when CMS claims data were added to the analysis.

conclusionsEHR data substantially misclassified TNFi exposure and underestimated the incidence of hospitalized infections compared to claims data. EHR-based new user definitions were reasonably accurate. Overall, using CRN data for pharmacoepidemiology studies is challenging, especially for biologics, and would benefit from supplementation by other sources.

Indexed as

Electronic Health RecordsPharmacoepidemiologyAgedCenters for Medicare and Medicaid Services, U.S.HumansMedicarePrescriptionsUnited Statesbiological therapyelectronic health recordsinfectionspharmacoepidemiology

Identifiers

PMID37005701
PMCPMC11246592

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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.