Leveraging Case Narratives to Enhance Patient Age Ascertainment from Adverse Event Reports.
INTRODUCTION: Missing age presents a significant challenge when evaluating individual case safety reports (ICSRs) in the FDA Adverse Event Reporting System (FAERS). When age is missing in an ICSR's structured field, it may be in the report's free-text narrative.
OBJECTIVES: This study aimed to evaluate the performance and assess the potential impact of a rule-based natural language processing (NLP) tool that utilizes a text string search to identify patients' numerical age from unstructured narratives.
METHODS: Using FAERS ICSRs from 2002 to 2018, we evaluated the annual proportion of ICSRs with age missing in the structured field before and after NLP application. Reviewers manually identified patients' age from ICSR narratives (gold standard) from a random sample of 1500 ICSRs. The gold standard was compared to the NLP-identified age.
RESULTS: During the study period, the percentage of ICSRs missing age in the structured field increased from 21.9 to 43.8%.
The NLP tool performed well among the random sample: sensitivity 98.5%, specificity 92.9%, positive predictive value (PPV) 94.9%, and F-measure 96.7%. It also performed well for the subset of ICSRs missing age in the structured field; when applied to these cases, NLP identified age for an additional one million ICSRs (10% of the total number of ICSRs from 2002 to 2018) and decreased the percentage of ICSRs missing age to 27% overall.
CONCLUSIONS: NLP has potential utility to extract patients' age from ICSR narratives. Use of this tool would enhance pharmacovigilance and research using FAERS data.
|投稿者||Pham, Phuong; Cheng, Carmen; Wu, Eileen; Kim, Ivone; Zhang, Rongmei; Ma, Yong; Kortepeter, Cindy M; Munoz, Monica A|
|組織名||Department of Pharmaceutical Outcomes and Policy, College of Pharmacy, University;of Florida, Gainesville, FL, USA.;Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research,;US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD,;20993, USA.;20993, USA. Carmen.Cheng@fda.hhs.gov.;Office of Translational Sciences, Center for Drug Evaluation and Research, US;Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD,|