Evidence map›Paper›PMID 30074538›Full record

ArticleEpidemiology (Cambridge, Mass.)2018

Data Mining for Adverse Drug Events With a Propensity Score-matched Tree-based Scan Statistic.

Shirley V Wang, Judith C Maro, Elande Baro, Rima Izem, Inna Dashevsky, James R Rogers, Michael Nguyen, Joshua J Gagne, Elisabetta Patorno, Krista F Huybrechts and 6 more

Abstract read
In one paragraph

Article in Epidemiology (Cambridge, Mass.), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing 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

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

  1. Pooled it
  2. Article
  3. Article
  4. Generative Transformers for Pharmacovigilance Signal Detection using Electronic Health Records.AMIA Joint Summits on Translational Science proceedings. AMIA Joint Summits on Translational Science · 2026
    Article
  5. Article
  6. Article
  7. Article
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  9. Article
  10. Article
  11. Article
  12. An open-source implementation of tree-based scan statistics.Pharmacoepidemiology and drug safety · 2024
    Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. The US Food and Drug Administration Sentinel System: a national resource for a learning health system.Journal of the American Medical Informatics Association : JAMIA · 2022
    Article
  18. Article
  19. Article
  20. 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

16 authors.

Shirley V WangFrom the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Harvard Medical School and Brigham and Women's Hospital, Boston, MA.
Judith C MaroDepartment of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA.
Elande BaroOffice of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration.
Rima IzemOffice of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration.
Inna DashevskyDepartment of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA.
James R RogersFrom the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Harvard Medical School and Brigham and Women's Hospital, Boston, MA.
Michael NguyenOffice of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD.
Joshua J GagneFrom the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Harvard Medical School and Brigham and Women's Hospital, Boston, MA.
Elisabetta PatornoFrom the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Harvard Medical School and Brigham and Women's Hospital, Boston, MA.
Krista F HuybrechtsFrom the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Harvard Medical School and Brigham and Women's Hospital, Boston, MA.
Jacqueline M MajorOffice of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD.
Esther ZhouOffice of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD.
Megan ReidyDepartment of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA.
Austin CosgroveDepartment of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA.
Sebastian SchneeweissFrom the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Harvard Medical School and Brigham and Women's Hospital, Boston, MA.
Martin KulldorffFrom the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Harvard Medical School and Brigham and Women's Hospital, Boston, MA.

Funding

Methods for studying treatment heterogeneity using large observational databasesR00HS022193 · AHRQ · BRIGHAM AND WOMEN'S HOSPITAL · PI WANG, SHIRLEY · 2015 to 2017
$747k
Novel Approaches to Monitor the Safety and Effectiveness of Newly Marketed Diabetes Medications in Older Adults Considering Frailty and MultimorbidityK08AG055670 · NIA · BRIGHAM AND WOMEN'S HOSPITAL · PI PATORNO, ELISABETTA · 2018 to 2021
$661k
AHRQ HHS R00 HS022193FDA HHS HHSF223200910006INIA NIH HHS K08 AG055670
6 · The paper itself

Abstract

The tree-based scan statistic is a statistical data mining tool that has been used for signal detection with a self-controlled design in vaccine safety studies. This disproportionality statistic adjusts for multiple testing in evaluation of thousands of potential adverse events. However, many drug safety questions are not well suited for self-controlled analysis. We propose a method that combines tree-based scan statistics with propensity score-matched analysis of new initiator cohorts, a robust design for investigations of drug safety. We conducted plasmode simulations to evaluate performance. In multiple realistic scenarios, tree-based scan statistics in cohorts that were propensity score matched to adjust for confounding outperformed tree-based scan statistics in unmatched cohorts. In scenarios where confounding moved point estimates away from the null, adjusted analyses recovered the prespecified type 1 error while unadjusted analyses inflated type 1 error. In scenarios where confounding moved point estimates toward the null, adjusted analyses preserved power, whereas unadjusted analyses greatly reduced power. Although complete adjustment of true confounders had the best performance, matching on a moderately mis-specified propensity score substantially improved type 1 error and power compared with no adjustment. When there was true elevation in risk of an adverse event, there were often co-occurring signals for clinically related concepts. TreeScan with propensity score matching shows promise as a method for screening and prioritization of potential adverse events. It should be followed by clinical review and safety studies specifically designed to quantify the magnitude of effect, with confounding control targeted to the outcome of interest.

Indexed as

Confounding Factors, EpidemiologicData MiningDrug-Related Side Effects and Adverse ReactionsHumansPropensity ScoreSoftwareStatistics as Topic

Identifiers

PMID30074538
PMCPMC6167151

What OpenQuestion holds

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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.