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Case contamination in electronic health records based case‐control studies

Author

Listed:
  • Lu Wang
  • Jill Schnall
  • Aeron Small
  • Rebecca A. Hubbard
  • Jason H. Moore
  • Scott M. Damrauer
  • Jinbo Chen

Abstract

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.

Suggested Citation

  • Lu Wang & Jill Schnall & Aeron Small & Rebecca A. Hubbard & Jason H. Moore & Scott M. Damrauer & Jinbo Chen, 2021. "Case contamination in electronic health records based case‐control studies," Biometrics, The International Biometric Society, vol. 77(1), pages 67-77, March.
    • Handle: RePEc:bla:biomet:v:77:y:2021:i:1:p:67-77
    DOI: 10.1111/biom.13264
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    References listed on IDEAS

    as
    1. Carlos Daniel Paulino & Paulo Soares & John Neuhaus, 2003. "Binomial Regression with Misclassification," Biometrics, The International Biometric Society, vol. 59(3), pages 670-675, September.
    2. Robert H. Lyles, 2002. "A Note on Estimating Crude Odds Ratios in Case–Control Studies with Differentially Misclassified Exposure," Biometrics, The International Biometric Society, vol. 58(4), pages 1034-1036, December.
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    Cited by:

    1. Guorong Dai & Yanyuan Ma & Jill Hasler & Jinbo Chen & Raymond J. Carroll, 2023. "A robust approach for electronic health record–based case‐control studies with contaminated case pools," Biometrics, The International Biometric Society, vol. 79(3), pages 2023-2035, September.

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