ArticleInternational journal of clinical pharmacy2015
Evaluating performance of electronic healthcare records and spontaneous reporting data in drug safety signal detection.
Article in International journal of clinical pharmacy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 1 of them a synthesis that pooled it.
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Who cites it
25 citing papers in PubMed, 1 synthesis or guideline 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
- Exploring Risks of Adverse Drug Events From Single Drug to Three-Drug Combination.Clinical and translational science · 2026Article
- Recommendations to Enable Broader Use of Real-World Evidence to Inform Decision-Making Throughout Pharmacovigilance Signal Management.Pharmacoepidemiology and drug safety · 2025Review
- Comparative Safety Analysis of Avastin and Bevacizumab Biosimilars Based on Food and Drug Administration Adverse Event Reporting System.Basic & clinical pharmacology & toxicology · 2025Article
- Signal detection statistics of adverse drug events in hierarchical structure for matched case-control data.Biostatistics (Oxford, England) · 2024Article
- An innovative method to strengthen evidence for potential drug safety signals using Electronic Health Records.Journal of medical systems · 2024Article
- Review
- A discovery and verification approach to pharmacovigilance using electronic healthcare data.Frontiers in pharmacology · 2024Article
- Integrating electronic health records with other data sources for postmarket drug safety signal identification: a review.Frontiers in drug safety and regulation · 2024Review
- Use of Electronic Health Record Data for Drug Safety Signal Identification: A Scoping Review.Drug safety · 2023Article
- An Early Adverse Drug Event Detection Approach with False Discovery Rate Control.medRxiv : the preprint server for health sciences · 2023Article
- Enhancing antidepressant safety surveillance: comparative analysis of adverse drug reaction signals in spontaneous reporting and healthcare claims databases.Frontiers in pharmacology · 2023Article
- Detection of pediatric drug-induced kidney injury signals using a hospital electronic medical record database.Frontiers in pharmacology · 2022Article
- Random control selection for conducting high-throughput adverse drug events screening using large-scale longitudinal health data.CPT: pharmacometrics & systems pharmacology · 2021Article
- Identifying Drugs Inducing Prematurity by Mining Claims Data with High-Dimensional Confounder Score Strategies.Drug safety · 2020Article
- Integrating Electronic Health Record Data into the ADEpedia-on-OHDSI Platform for Improved Signal Detection: A Case Study of Immune-related Adverse Events.AMIA Joint Summits on Translational Science proceedings. AMIA Joint Summits on Translational Science · 2020Article
- Exploratory Study of Signals for Asthma Drugs in Children, Using the EudraVigilance Database of Spontaneous Reports.Drug safety · 2020Article
- Hypothesis-free signal detection in healthcare databases: finding its value for pharmacovigilance.Therapeutic advances in drug safety · 2019Article
- Can Electronic Health Records Databases Complement Spontaneous Reporting System Databases? A Historical-Reconstruction of the Association of Rofecoxib and Acute Myocardial Infarction.Frontiers in pharmacology · 2018Article
- An Ontology to Improve Transparency in Case Definition and Increase Case Finding of Infectious Intestinal Disease: Database Study in English General Practice.JMIR medical informatics · 2017Article
Corrections and comments
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundElectronic reporting and processing of suspected adverse drug reactions (ADRs) is increasing and has facilitated automated screening procedures. It is crucial for healthcare professionals to understand the nature and proper use of data available in pharmacovigilance practice.
objectivesTo (a) compare performance of EU-ADR [electronic healthcare record (EHR) exemplar] and FAERS [spontaneous reporting system (SRS) exemplar] databases in detecting signals using "positive" and "negative" drug-event reference sets; and (b) evaluate the impact of timing bias on sensitivity thresholds by comparing all data to data restricted to the time before a warning/regulatory action.
methodsTen events with known positive and negative reference sets were selected. Signals were identified when respective statistics exceeded defined thresholds. Main outcome measure Performance metrics, including sensitivity, specificity, positive predictive value and accuracy were calculated. In addition, the effect of regulatory action on the performance of signal detection in each data source was evaluated.
resultsThe sensitivity for detecting signals in EHR data varied depending on the nature of the adverse events and increased substantially if the analyses were restricted to the period preceding the first regulatory action. Across all events, using data from all years, a sensitivity of 45-73 % was observed for EU-ADR and 77 % for FAERS. The specificity was high and similar for EU-ADR (82-96 %) and FAERS (98 %). EU-ADR data showed range of PPV (78-91 %) and accuracy (78-72 %) and FAERS data yielded a PPV of 97 % with 88 % accuracy.
conclusionUsing all cumulative data, signal detection in SRS data achieved higher specificity and sensitivity than EHR data. However, when data were restricted to time prior to a regulatory action, performance characteristics changed in a manner consistent with both the type of data and nature of the ADR. Further research focusing on prospective validation of is necessary to learn more about the performance and utility of these databases in modern pharmacovigilance practice.
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Registered trials
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