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Case contamination in electronic health records based case‐control studies
Author(s) -
Wang Lu,
Schnall Jill,
Small Aeron,
Hubbard Rebecca A.,
Moore Jason H.,
Damrauer Scott M.,
Chen Jinbo
Publication year - 2021
Publication title -
biometrics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.298
H-Index - 130
eISSN - 1541-0420
pISSN - 0006-341X
DOI - 10.1111/biom.13264
Subject(s) - sample size determination , computer science , a priori and a posteriori , data mining , control (management) , property (philosophy) , identification (biology) , data collection , health records , sample (material) , odds ratio , data science , statistics , medicine , mathematics , health care , artificial intelligence , philosophy , botany , chemistry , epistemology , chromatography , economics , biology , economic growth
Clinically relevant information from electronic health records (EHRs) permits derivation of a rich collection of phenotypes. Unlike traditionally designed studies where scientific hypotheses are specified a priori before data collection, the true phenotype status of any given individual in EHR‐based studies is not directly available. Structured and unstructured data elements need to be queried through preconstructed rules to identify case and control groups. A sufficient number of controls can usually be identified with high accuracy by making the selection criteria stringent. But more relaxed criteria are often necessary for more thorough identification of cases to ensure achievable statistical power. The resulting pool of candidate cases consists of genuine cases contaminated with noncase patients who do not satisfy the control definition. The presence of patients who are neither true cases nor controls among the identified cases is a unique challenge in EHR‐based case‐control studies. Ignoring case contamination would lead to biased estimation of odds ratio association parameters. We propose an estimating equation approach to bias correction, study its large sample property, and evaluate its performance through extensive simulation studies and an application to a pilot study of aortic stenosis in the Penn medicine EHR. Our method holds the promise of facilitating more efficient EHR studies by accommodating enlarged albeit contaminated case pools.