Replication of the OMOP Experiment in Europe: Evaluating Methods for Risk Identification in Electronic Health Record Databases

• Published in: Drug safety 2013-10, Vol.36 (Suppl 1), p.159-169
• Main Authors: Schuemie, Martijn J., Gini, Rosa, Coloma, Preciosa M., Straatman, Huub, Herings, Ron M. C., Pedersen, Lars, Innocenti, Francesco, Mazzaglia, Giampiero, Picelli, Gino, van der Lei, Johan, Sturkenboom, Miriam C. J. M.
• Format: Article
• Language: English
• Subjects: Drug Safety and Pharmacovigilance; Drugs; Medical research; Medicine; Medicine & Public Health; Original Research Article; Pharmaceutical industry; Pharmacology/Toxicology; Prescription drugs; Studies
• ISSN: 0114-5916; 1179-1942
• DOI: 10.1007/s40264-013-0109-8

Background The Observational Medical Outcomes Partnership (OMOP) has just completed a large scale empirical evaluation of statistical methods and analysis choices for risks identification in longitudinal observational healthcare data. This experiment drew data from four large US health insurance claims databases and one US electronic health record (EHR) database, but it is unclear to what extend the findings of this study apply to other data sources. Objective To replicate the OMOP experiment in six European EHR databases. Research Design Six databases of the EU-ADR (Exploring and Understanding Adverse Drug Reactions) database network participated in this study: Aarhus (Denmark), ARS (Italy), HealthSearch (Italy), IPCI (the Netherlands), Pedianet (Italy), and Pharmo (the Netherlands). All methods in the OMOP experiment were applied to a collection of 165 positive and 234 negative control drug–outcome pairs across four outcomes: acute liver injury, acute myocardial infarction, acute kidney injury, and upper gastrointestinal bleeding. Area under the receiver operator characteristics curve (AUC) was computed per database and for a combination of all six databases using meta-analysis for random effects. We provide expected values of estimation error as well, based on negative controls. Results Similarly to the US experiment, high predictive accuracy was found (AUC >0.8) for some analyses. Self-controlled designs, such as self-controlled case series, IC temporal pattern discovery and self-controlled cohort achieved higher performance than other methods, both in terms of predictive accuracy and observed bias. Conclusions The major findings of the recent OMOP experiment were also observed in the European databases.