Misdiagnosis-related harm quantification through mixture models and harm measures

Biometrics. 2023 Sep;79(3):2633-2648. doi: 10.1111/biom.13759. Epub 2022 Oct 11.


Investigating and monitoring misdiagnosis-related harm is crucial for improving health care. However, this effort has traditionally focused on the chart review process, which is labor intensive, potentially unstable, and does not scale well. To monitor medical institutes' diagnostic performance and identify areas for improvement in a timely fashion, researchers proposed to leverage the relationship between symptoms and diseases based on electronic health records or claim data. Specifically, the elevated disease risk following a false-negative diagnosis can be used to signal potential harm. However, off-the-shelf statistical methods do not fully accommodate the data structure of a well-hypothesized risk pattern and thus fail to address the unique challenges adequately. To fill these gaps, we proposed a mixture regression model and its associated goodness-of-fit testing. We further proposed harm measures and profiling analysis procedures to quantify, evaluate, and compare misdiagnosis-related harm across institutes with potentially different patient population compositions. We studied the performance of the proposed methods through simulation studies. We then illustrated the methods through data analyses on stroke occurrence data from the Taiwan Longitudinal Health Insurance Database. From the analyses, we quantitatively evaluated risk factors for being harmed due to misdiagnosis, which unveiled some insights for health care quality research. We also compared general and special care hospitals in Taiwan and observed better diagnostic performance in special care hospitals using various new evaluation measures.

Keywords: electronic health records; health care quality; profile analysis.

Publication types

  • Research Support, Non-U.S. Gov't
  • Research Support, N.I.H., Extramural
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Computer Simulation
  • Diagnostic Errors
  • Disease Susceptibility
  • Hospitals*
  • Humans
  • Taiwan / epidemiology