Development of a Controlled Vocabulary-Based Adverse Drug Reaction Signal Dictionary for Multicenter Electronic Health Record-Based Pharmacovigilance

被引：15

作者：

Lee, Suehyun ^{[1
,2
]}

Han, Jongsoo ^{[1
]}

Park, Rae Woong ^{[3
]}

Kim, Grace Juyun ^{[1
]}

Rim, John Hoon ^{[4
,5
,6
]}

Cho, Jooyoung ^{[5
,7
]}

Lee, Kye Hwa ^{[1
,8
]}

Lee, Jisan ^{[9
]}

Kim, Sujeong ^{[10
]}

Kim, Ju Han ^{[1
,8
]}

机构：

[1] Seoul Natl Univ, Coll Med, SNUBI, Div Biomed Informat, Seoul, South Korea

[2] Konyang Univ, Coll Med, Dept Biomed Informat, Daejeon, South Korea

[3] Ajou Univ, Dept Biomed Informat, Sch Med, Suwon, South Korea

[4] Yonsei Univ, Severance Hosp, Dept Lab Med, Coll Med, Seoul, South Korea

[5] Yonsei Univ, Dept Med, Phys Scientist Program, Grad Sch Med, Seoul, South Korea

[6] Yonsei Univ, Dept Pharmacol, Coll Med, Seoul, South Korea

[7] Yonsei Univ, Wonju Severance Christian Hosp, Dept Lab Med, Wonju Coll Med, Wonju, South Korea

[8] Seoul Natl Univ Hosp, Precis Med Ctr, Seoul, South Korea

[9] Catholic Univ Pusan, Coll Nursing, Busan, South Korea

[10] Seattle Univ, Coll Nursing, Seattle, WA 98122 USA

来源：

DRUG SAFETY | 2019年 / 42卷 / 05期

基金：

新加坡国家研究基金会;

关键词：

NURSING STATEMENTS; KNOWLEDGE-BASE; CARE DATA; EVENTS; CLASSIFICATION; IDENTIFICATION; TERMINOLOGIES; CONSTRUCTION; ALGORITHM; DATABASE;

D O I：

10.1007/s40264-018-0767-7

中图分类号：

R1 [预防医学、卫生学];

学科分类号：

1004 ; 120402 ;

摘要：

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.

引用

页码：657 / 670

页数：14

共 52 条

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