ArticleDrug safety2013
A comparison of the empirical performance of methods for a risk identification system.
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 53 papers, 2 of them syntheses that pooled it.
What it found
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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.
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.
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Who cites it
53 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Methods for drug safety signal detection using routinely collected observational electronic health care data: A systematic review.Pharmacoepidemiology and drug safety · 2023Pooled it
- Pooled it
- Performance of the Self-Controlled Case Series for Drug Safety Signal Detection: A Multi-Database Study.Pharmacoepidemiology and drug safety · 2026Article
- Adverse drug-event detection using the tree-based scan statistics (TreeScan) and comparison with common mining methods: new user, propensity score-matched cohorts.European journal of clinical pharmacology · 2026Article
- Performance of the Self-Controlled Case Series With Active Comparators for Drug Safety Signal Detection Using the Clinical Practice Research Datalink (CPRD).Pharmacoepidemiology and drug safety · 2025Article
- Performance of the Self-Controlled Case Series With Active Comparators for Drug Safety Signal Detection Using the French Administrative Healthcare Database (SNDS).Pharmacoepidemiology and drug safety · 2025Article
- Performance of the Self-Controlled Case Series With Active Comparators for Drug Safety Signal Detection Using Merative MarketScan Research Databases.Pharmacoepidemiology and drug safety · 2025Article
- Recommendations to Enable Broader Use of Real-World Evidence to Inform Decision-Making Throughout Pharmacovigilance Signal Management.Pharmacoepidemiology and drug safety · 2025Review
- Artificial intelligence in pharmacovigilance: a narrative review and practical experience with an expert-defined Bayesian network tool.International journal of clinical pharmacy · 2025Review
- Article
- Foundational model aided automatic high-throughput drug screening using self-controlled cohort study.medRxiv : the preprint server for health sciences · 2024Article
- The State of Use and Utility of Negative Controls in Pharmacoepidemiologic Studies.American journal of epidemiology · 2024Review
- Supporting Pharmacovigilance Signal Validation and Prioritization with Analyses of Routinely Collected Health Data: Lessons Learned from an EHDEN Network Study.Drug safety · 2023Article
- Use of Electronic Health Record Data for Drug Safety Signal Identification: A Scoping Review.Drug safety · 2023Article
- Using Existing Clinical Information Models for Dutch Quality Registries to Reuse Data and Follow COUMT Paradigm.Applied clinical informatics · 2023Article
- Article
- High-Dimensional Propensity Score-Adjusted Case-Crossover for Discovering Adverse Drug Reactions from Computerized Administrative Healthcare Databases.Drug safety · 2022Article
- Evaluating the performance of temporal pattern discovery: new application using statins and rhabdomyolysis in OMOP databases.BMC medical informatics and decision making · 2022Article
- Revealing Unknown Benefits of Existing Medications to Aid the Discovery of New Treatments for Post-Traumatic Stress Disorder.Psychiatric research and clinical practice · 2022Article
- Transforming Anesthesia Data Into the Observational Medical Outcomes Partnership Common Data Model: Development and Usability Study.Journal of medical Internet research · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundObservational healthcare data offer the potential to enable identification of risks of medical products, and the medical literature is replete with analyses that aim to accomplish this objective. A number of established analytic methods dominate the literature but their operating characteristics in real-world settings remain unknown.
objectivesTo compare the performance of seven methods (new user cohort, case control, self-controlled case series, self-controlled cohort, disproportionality analysis, temporal pattern discovery, and longitudinal gamma poisson shrinker) as tools for risk identification in observational healthcare data. RESEARCH
designThe experiment applied each method to 399 drug-outcome scenarios (165 positive controls and 234 negative controls across 4 health outcomes of interest) in 5 real observational databases (4 administrative claims and 1 electronic health record). MEASURES: Method performance was evaluated through Area Under the receiver operator characteristics Curve (AUC), bias, mean square error, and confidence interval coverage probability.
resultsMultiple methods offer strong predictive accuracy, with AUC > 0.70 achievable for all outcomes and databases with more than one analytical approach. Self-controlled methods (self-controlled case series, temporal pattern discovery, self-controlled cohort) had higher predictive accuracy than cohort and case-control methods across all databases and outcomes. Methods differed in the expected value and variance of the error distribution. All methods had lower coverage probability than the expected nominal properties.
conclusionsObservational healthcare data can inform risk identification of medical product effects on acute liver injury, acute myocardial infarction, acute renal failure and gastrointestinal bleeding. However, effect estimates from all methods require calibration to address inconsistency in method operating characteristics. Further empirical evaluation is required to gauge the generalizability of these findings to other databases and outcomes.
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Registered trials
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.