Development of a Controlled Vocabulary-Based Adverse Drug Reaction Signal Dictionary for Multicenter Electronic Health Record-Based Pharmacovigilance
DC Field | Value | Language |
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dc.contributor.author | Lee, Suehyun | - |
dc.contributor.author | Han, Jongsoo | - |
dc.contributor.author | Park, Rae Woong | - |
dc.contributor.author | Kim, Grace Juyun | - |
dc.contributor.author | Rim, John Hoon | - |
dc.contributor.author | Cho, Jooyoung | - |
dc.contributor.author | Lee, Kye Hwa | - |
dc.contributor.author | Lee, Jisan | - |
dc.contributor.author | Kim, Sujeong | - |
dc.contributor.author | Kim, Ju Han | - |
dc.date.accessioned | 2023-06-17T08:42:45Z | - |
dc.date.available | 2023-06-17T08:42:45Z | - |
dc.date.created | 2023-06-17 | - |
dc.date.issued | 2019-05 | - |
dc.identifier.issn | 0114-5916 | - |
dc.identifier.uri | https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/88144 | - |
dc.description.abstract | Integration of controlled vocabulary-based electronic health record (EHR) observational data is essential for real-time large-scale pharmacovigilance studies. To provide a semantically enriched adverse drug reaction (ADR) dictionary for post-market drug safety research and enable multicenter EHR-based extensive ADR signal detection and evaluation, we developed a comprehensive controlled vocabulary-based ADR signal dictionary (CVAD) for pharmacovigilance. A CVAD consists of (1) administrative disease classifications of the International Classification of Diseases (ICD) codes mapped to the Medical Dictionary for Regulatory Activities Preferred Terms (MedDRA(A (R)) PTs); (2) two teaching hospitals' codes for laboratory test results mapped to the Logical Observation Identifiers Names and Codes (LOINC) terms and MedDRA(A (R)) PTs; and (3) clinical narratives and ADRs encoded by standard nursing statements (encoded by the International Classification for Nursing Practice [ICNP]) mapped to the World Health Organization-Adverse Reaction Terminology (WHO-ART) terms and MedDRA(A (R)) PTs. Of the standard 4514 MedDRA(A (R)) PTs from Side Effect Resources (SIDER) 4.1, 1130 (25.03%), 942 (20.86%), and 83 (1.83%) terms were systematically mapped to clinical narratives, laboratory test results, and disease classifications, respectively. For the evaluation, we loaded multi-source EHR data. We first performed a clinical expert review of the CVAD clinical relevance and a three-drug ADR case analyses consisting of linezolid-induced thrombocytopenia, warfarin-induced bleeding tendency, and vancomycin-induced acute kidney injury. CVAD had a high coverage of ADRs and integrated standard controlled vocabularies to the EHR data sources, and researchers can take advantage of these features for EHR observational data-based extensive pharmacovigilance studies to improve sensitivity and specificity. | - |
dc.language | 영어 | - |
dc.language.iso | en | - |
dc.publisher | ADIS INT LTD | - |
dc.relation.isPartOf | DRUG SAFETY | - |
dc.title | Development of a Controlled Vocabulary-Based Adverse Drug Reaction Signal Dictionary for Multicenter Electronic Health Record-Based Pharmacovigilance | - |
dc.type | Article | - |
dc.type.rims | ART | - |
dc.description.journalClass | 1 | - |
dc.identifier.wosid | 000467742700008 | - |
dc.identifier.doi | 10.1007/s40264-018-0767-7 | - |
dc.identifier.bibliographicCitation | DRUG SAFETY, v.42, no.5, pp.657 - 670 | - |
dc.description.isOpenAccess | N | - |
dc.identifier.scopusid | 2-s2.0-85060177781 | - |
dc.citation.endPage | 670 | - |
dc.citation.startPage | 657 | - |
dc.citation.title | DRUG SAFETY | - |
dc.citation.volume | 42 | - |
dc.citation.number | 5 | - |
dc.contributor.affiliatedAuthor | Lee, Suehyun | - |
dc.type.docType | Article | - |
dc.subject.keywordPlus | NURSING STATEMENTS | - |
dc.subject.keywordPlus | KNOWLEDGE-BASE | - |
dc.subject.keywordPlus | CARE DATA | - |
dc.subject.keywordPlus | EVENTS | - |
dc.subject.keywordPlus | CLASSIFICATION | - |
dc.subject.keywordPlus | IDENTIFICATION | - |
dc.subject.keywordPlus | TERMINOLOGIES | - |
dc.subject.keywordPlus | CONSTRUCTION | - |
dc.subject.keywordPlus | ALGORITHM | - |
dc.subject.keywordPlus | DATABASE | - |
dc.relation.journalResearchArea | Public, Environmental & Occupational Health | - |
dc.relation.journalResearchArea | Pharmacology & Pharmacy | - |
dc.relation.journalResearchArea | Toxicology | - |
dc.relation.journalWebOfScienceCategory | Public, Environmental & Occupational Health | - |
dc.relation.journalWebOfScienceCategory | Pharmacology & Pharmacy | - |
dc.relation.journalWebOfScienceCategory | Toxicology | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
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