Evidence map›Paper›PMID 24166225›Full record

ArticleDrug safety2013

Empirical performance of the case-control method: lessons for developing a risk identification and analysis system.

David Madigan, Martijn J Schuemie, Patrick B Ryan

Abstract read
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In one paragraph

Article in Drug safety, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 3 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

21 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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  8. Adverse Drug Reaction Discovery from Electronic Health Records with Deep Neural Networks.Proceedings of the ACM Conference on Health, Inference, and Learning · 2020
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  11. Pharmacovigilance via Baseline Regularization with Large-Scale Longitudinal Observational Data.KDD : proceedings. International Conference on Knowledge Discovery & Data Mining · 2017
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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

3 authors.

David MadiganDepartment of Statistics, Columbia University, 1255 Amsterdam Avenue, New York, NY, 10027, USA, david.madigan@columbia.edu.
Martijn J Schuemie
Patrick B Ryan

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundConsiderable attention now focuses on the use of large-scale observational healthcare data for understanding drug safety. In this context, analysts utilize a variety of statistical and epidemiological approaches such as case-control, cohort, and self-controlled methods. The operating characteristics of these methods are poorly understood.

objectiveEstablish the operating characteristics of the case-control method for large scale observational analysis in drug safety. RESEARCH

designWe empirically evaluated the case-control approach in 5 real observational healthcare databases and 6 simulated datasets. We retrospectively studied the predictive accuracy of the method when applied to a collection of 165 positive controls and 234 negative controls across 4 outcomes: acute liver injury, acute myocardial infarction, acute kidney injury, and upper gastrointestinal bleeding.

resultsIn our experiment, the case-control method provided weak discrimination between positive and negative controls. Furthermore, the method yielded positively biased estimates and confidence intervals that had poor coverage properties.

conclusionsFor the four outcomes we examined, the case-control method may not be the method of choice for estimating potentially harmful effects of drugs.

Indexed as

Case-Control StudiesResearch DesignAcute Kidney InjuryArea Under CurveChemical and Drug Induced Liver InjuryDrug-Related Side Effects and Adverse ReactionsGastrointestinal HemorrhageHumansMyocardial InfarctionProbabilityRetrospective StudiesRisk Assessment

Identifiers

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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.