ArticleDrug safety2013
Empirical performance of the self-controlled case series design: lessons for developing a risk identification and analysis 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 26 papers, 2 of them syntheses that pooled 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.
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.
Who cites it
26 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
- 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 Merative MarketScan Research Databases.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
- 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
- Implementation of a Taxonomy-Based Framework for the Selection of Appropriate Drugs and Outcomes for Real-World Data Signal Detection Studies.Drug safety · 2024Review
- The use of real-world data in drug repurposing.Translational and clinical pharmacology · 2021Review
- Framework for identifying drug repurposing candidates from observational healthcare data.JAMIA open · 2020Article
- Risk of Hospitalization With Hemorrhage Among Older Adults Taking Clarithromycin vs Azithromycin and Direct Oral Anticoagulants.JAMA internal medicine · 2020Article
- Adverse Drug Reaction Discovery from Electronic Health Records with Deep Neural Networks.Proceedings of the ACM Conference on Health, Inference, and Learning · 2020Article
- Article
- How Confident Are We about Observational Findings in Healthcare: A Benchmark Study.Harvard data science review · 2020Article
- Article
- Pharmacovigilance via Baseline Regularization with Large-Scale Longitudinal Observational Data.KDD : proceedings. International Conference on Knowledge Discovery & Data Mining · 2017Article
- A Multiagent System for Integrated Detection of Pharmacovigilance Signals.Journal of medical systems · 2016Article
- Computational approaches for pharmacovigilance signal detection: toward integrated and semantically-enriched frameworks.Drug safety · 2015Article
- Similarity-based modeling applied to signal detection in pharmacovigilance.CPT: pharmacometrics & systems pharmacology · 2014Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe self-controlled case series (SCCS) offers potential as an statistical method for risk identification involving medical products from large-scale observational healthcare data. However, analytic design choices remain in encoding the longitudinal health records into the SCCS framework and its risk identification performance across real-world databases is unknown.
objectivesTo evaluate the performance of SCCS and its design choices as a tool for risk identification in observational healthcare data. RESEARCH
designWe examined the risk identification performance of SCCS across five design choices using 399 drug-health outcome pairs in five real observational databases (four administrative claims and one electronic health records). In these databases, the pairs involve 165 positive controls and 234 negative controls. We also consider several synthetic databases with known relative risks between drug-outcome pairs. MEASURES: We evaluate risk identification performance through estimating the area under the receiver-operator characteristics curve (AUC) and bias and coverage probability in the synthetic examples.
resultsThe SCCS achieves strong predictive performance. Twelve of the twenty health outcome-database scenarios return AUCs >0.75 across all drugs. Including all adverse events instead of just the first per patient and applying a multivariate adjustment for concomitant drug use are the most important design choices. However, the SCCS as applied here returns relative risk point-estimates biased towards the null value of 1 with low coverage probability.
conclusionsThe SCCS recently extended to apply a multivariate adjustment for concomitant drug use offers promise as a statistical tool for risk identification in large-scale observational healthcare databases. Poor estimator calibration dampens enthusiasm, but on-going work should correct this short-coming.
Indexed as
Identifiers
24166226What OpenQuestion holds
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.