Statistical Inference for Association Studies in the Presence of Binary Outcome Misclassification

• Published in: Statistics in medicine Vol. 44; no. 5; pp. e10316 - n/a
• Main Authors: Hochstedler Webb, Kimberly A., Wells, Martin T.
• Format: Journal Article
• Language: English
• Published: Hoboken, USA John Wiley & Sons, Inc 28.02.2025; Wiley Subscription Services, Inc
• Subjects: Algorithms; association studies; Bias; bias correction; Computer Simulation; Data Interpretation, Statistical; EM algorithm; Estimates; Humans; identification; label‐switching; Likelihood Functions; MCMC; Models, Statistical; Regression Analysis; Software; MCMC; identification; association studies; bias correction; EM algorithm; label‐switching
• DOI: 10.1002/sim.10316
• ISSN: 0277-6715; 1097-0258

ABSTRACT In biomedical and public health association studies, binary outcome variables may be subject to misclassification, resulting in substantial bias in effect estimates. The feasibility of addressing binary outcome misclassification in regression models is often hindered by model identifiability issues. In this paper, we characterize the identifiability problems in this class of models as a specific case of “label‐switching” and leverage a pattern in the resulting parameter estimates to solve the permutation invariance of the complete data log‐likelihood. Our proposed algorithm in binary outcome misclassification models does not require gold standard labels and relies only on the assumption that the sum of the sensitivity and specificity exceeds 1. A label‐switching correction is applied within estimation methods to recover unbiased effect estimates and to estimate misclassification rates. Open‐source software is provided to implement the proposed methods. We give a detailed simulation study for our proposed methodology and apply these methods to data from the 2020 Medical Expenditure Panel Survey (MEPS).