Evidence map›Paper›PMID 23717437›Full record

ArticlePloS one2013

Practice-based evidence: profiling the safety of cilostazol by text-mining of clinical notes.

Nicholas J Leeper, Anna Bauer-Mehren, Srinivasan V Iyer, Paea Lependu, Cliff Olson, Nigam H Shah

Open access · goldAbstract read
In one paragraph

Article in PloS one, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 1 pooled it
9.1field-weighted citation impact, top 2% of its field
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

35 citing papers in PubMed, 1 synthesis or guideline pooled it, 76 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Review
  5. Natural Language Processing: from Bedside to Everywhere.Yearbook of medical informatics · 2022
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  6. Review
  7. Noise-tolerant similarity search in temporal medical data.Journal of biomedical informatics · 2021
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  8. Article
  9. Review
  10. Article
  11. Use of big data in drug development for precision medicine: an update.Expert review of precision medicine and drug development · 2019
    Article
  12. Article
  13. Observational
  14. Review
  15. Article
  16. Review
  17. Article
  18. 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

6 authors at 1 institution in 1 country.

Nicholas J LeeperDivision of Vascular Surgery and Cardiovascular Medicine, Stanford University, Stanford, California, United States of America.
Anna Bauer-Mehren
Srinivasan V Iyer
Paea Lependu
Cliff Olson
Nigam H Shah
Stanford University · US

Funding

STANFORD COMPOSITE(RMI)U54HG004028 · NHGRI · STANFORD UNIVERSITY · PI MUSEN, MARK A · 2005 to 2014
$36.2M
Stanford Career Development in Vascular MedicineK12HL087746 · NHLBI · STANFORD UNIVERSITY · PI DALMAN, RONALD L · 2007 to 2012
$3.5M
NHGRI NIH HHS U54 HG004028NHLBI NIH HHS K12 HL087746
6 · The paper itself

Abstract

backgroundPeripheral arterial disease (PAD) is a growing problem with few available therapies. Cilostazol is the only FDA-approved medication with a class I indication for intermittent claudication, but carries a black box warning due to concerns for increased cardiovascular mortality. To assess the validity of this black box warning, we employed a novel text-analytics pipeline to quantify the adverse events associated with Cilostazol use in a clinical setting, including patients with congestive heart failure (CHF). METHODS AND

resultsWe analyzed the electronic medical records of 1.8 million subjects from the Stanford clinical data warehouse spanning 18 years using a novel text-mining/statistical analytics pipeline. We identified 232 PAD patients taking Cilostazol and created a control group of 1,160 PAD patients not taking this drug using 1:5 propensity-score matching. Over a mean follow up of 4.2 years, we observed no association between Cilostazol use and any major adverse cardiovascular event including stroke (OR = 1.13, CI [0.82, 1.55]), myocardial infarction (OR = 1.00, CI [0.71, 1.39]), or death (OR = 0.86, CI [0.63, 1.18]). Cilostazol was not associated with an increase in any arrhythmic complication. We also identified a subset of CHF patients who were prescribed Cilostazol despite its black box warning, and found that it did not increase mortality in this high-risk group of patients.

conclusionsThis proof of principle study shows the potential of text-analytics to mine clinical data warehouses to uncover 'natural experiments' such as the use of Cilostazol in CHF patients. We envision this method will have broad applications for examining difficult to test clinical hypotheses and to aid in post-marketing drug safety surveillance. Moreover, our observations argue for a prospective study to examine the validity of a drug safety warning that may be unnecessarily limiting the use of an efficacious therapy.

Indexed as

Data MiningAgedAged, 80 and overCilostazolCohort StudiesFemaleHeart FailureHumansMaleMatched-Pair AnalysisMiddle AgedPeripheral Arterial DiseasePhosphodiesterase 3 InhibitorsPlatelet Aggregation InhibitorsPropensity ScoreRiskCilostazolPhosphodiesterase 3 InhibitorsPlatelet Aggregation InhibitorsTetrazolesVasodilator Agents

Identifiers

PMID23717437
PMCPMC3662653
OpenAlexW1990467158

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.