2021
DOI: 10.1002/jac5.1524
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Current and recommended practices for evaluating adverse drug events using electronic health records: A systematic review

Abstract: Electronic health records (EHR) are widely used sources of real-world data in pharmacoepidemiologic research. As there is no end-to-end guidance for generating medication safety evidence with EHR, this study conducted a systematic review to determine the current and recommended practices in the literature. PubMed, Scopus, and CINAHL were searched for English articles published between 1 January 2010 and 11 June 2020. Selected articles were published in peer-reviewed journals, conducted in the United States, an… Show more

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Cited by 4 publications
(3 citation statements)
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“…46 A previous report recommended not to use category III ADE labels. 79 However, we argue that—when applied in a causal prediction modeling framework —category III ADE labels could serve as rapidly accessible indicators of actual ADEs. Moreover, this approach does not require formal causality assessments prior to fitting the models (as is the case for category II).…”
Section: Discussionmentioning
confidence: 95%
“…46 A previous report recommended not to use category III ADE labels. 79 However, we argue that—when applied in a causal prediction modeling framework —category III ADE labels could serve as rapidly accessible indicators of actual ADEs. Moreover, this approach does not require formal causality assessments prior to fitting the models (as is the case for category II).…”
Section: Discussionmentioning
confidence: 95%
“…Poor quality data collected from EHR sources designed for non-research methods, or missing data, may lead to selection bias and information bias. Therefore, we applied recommended practices to address these inherent limitations, employing strategies such as defining the index date as the first drug exposure date to reduce the risk of immortal time bias [ 28 ]. We also designed the follow-up period carefully and treated drug exposure as a time-varying feature, considering factors such gaps in medication records and initiation of other drugs, rather than assuming initial exposure remains the same throughout the follow-up period.…”
Section: Discussionmentioning
confidence: 99%
“…All healthcare data were stored using appropriate standard OMOP concept IDs across different domains (e.g., SNOMED codes for “Condition” domain, and RxNorm for active ingredients in the “Drug” domain). Thus, the appropriate OMOP concept IDs for bleeding were translated from validated ICD-9-CM and ICD-10-CM codes for bleeding [ 25 , 26 ], excluding trauma-related bleeding events, using the concept set builder toolkit in the Observational Health Data Sciences and Informatics ATLAS program [ 27 ] and applying the recommended practices to define ADEs [ 28 ]. The OMOP concept IDs are presented in eTable 2 of the Supplement.…”
Section: Methodsmentioning
confidence: 99%