ArticleDrug safety2014
Performance of the standardised MedDRA® queries for case retrieval in the French spontaneous reporting database.
Article in Drug safety, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
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Who cites it
11 citing papers in PubMed.
- Pharmacovigilance analysis of myopathy associated with azoles and nonstatins interactions based on US FAERS database.Scientific reports · 2025Article
- Emerging cardiovascular toxicity associated with CDK4/6 inhibitors: real-world insights from the FDA adverse event reporting system.Frontiers in pharmacology · 2025Article
- Cardiac arrhythmias of BCR-ABL inhibitors with or without triazole antifungal agents: A real-world pharmacovigilance study based on the food and drug administration adverse event reporting system database.SAGE open medicine · 2025Article
- Development of a text mining algorithm for identifying adverse drug reactions in electronic health records.JAMIA open · 2024Article
- Withdrawal syndrome after antipsychotics discontinuation: an analysis of the WHO database of spontaneous reports (Vigibase) between 2000 and 2022.Psychopharmacology · 2024Article
- Exploring the impact of design criteria for reference sets on performance evaluation of signal detection algorithms: The case of drug-drug interactions.Pharmacoepidemiology and drug safety · 2023Article
- Identifying adverse drug reactions from free-text electronic hospital health record notes.British journal of clinical pharmacology · 2022Article
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- A Method for the Minimization of Competition Bias in Signal Detection from Spontaneous Reporting Databases.Drug safety · 2016Article
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveThe objective of this study was to evaluate the performance of Standardised MedDRA® Queries (SMQs) in adverse drug reaction (ADR) identification.
methodsADR cases included in the last complete year of the French Pharmacovigilance database for research were used to test four SMQs (narrow and broad): agranulocytosis, demyelination, osteonecrosis and psychosis. Reference cases were identified by free-text search and validated by two authors. Sensitivity (Se), specificity (Sp), positive predictive value (PPV) and negative predictive value (NPV) of narrow and broad searches of each SMQ were calculated and reported as proportions with 95% exact confidence interval (CI).
resultsAmong 20,830 cases reported in 2009, 337 validated cases of agranulocytosis, 17 of demyelination, 52 of osteonecrosis and 230 of psychosis were included in the reference sets. Estimations of SMQ narrow search performance were as follows: Se 62.9% (95% CI 57.5-68.1) and PPV 46.8% (95% CI 42.1-51.5) for agranulocytosis; Se 88.2% (95% CI 63.6-98.5) and PPV 34.1% (95% CI 20.5-49.9) for demyelination; Se 94.2% (95% CI 84.1-98.8) and PPV 74.2% (95% CI 62.0-84.2) for osteonecrosis; and Se 75.1% (95% CI 69.0-80.6) and PPV 87.8% (95% CI 82.3-92.0) for psychosis. Results obtained using the broad search were similar except for PPV concerning osteonecrosis (52.7% [95% CI 42.1-63.1]) and psychosis (61.4% [95% CI 55.7-66.8]). For all selected SMQs, Sp and NPV were greater than 98% for both narrow and broad searches.
conclusionHeterogeneous performance of SMQs for case retrieval was found and seems to be related to the characteristics of the condition of interest. It could therefore be expected that for other SMQs, performance may be affected in the same manner.
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