Citation

Collin LJ, Maclehose RF, Ahern TP, Gradus JL, Getahun D, Silverberg MJ, Goodman M, Lash TL. Am. J. Epidemiol. 2022; ePub(ePub): ePub.

Copyright

(Copyright © 2022, Oxford University Press)

DOI

10.1093/aje/kwac025

PMID

35136909

Abstract

Data collected from a validation substudy permit calculation of a bias-adjusted estimate of effect that is expected to equal the estimate that would have been observed had the gold standard measurement been available for the entire study population. In this study, we developed and applied a framework for adaptive validation to determine when sufficient validation data have been collected to yield a bias-adjusted estimate of effect with a prespecified level of precision. Prespecified levels of precision are decided a priori by the investigator, based on the precision of the conventional estimate and allowing for wider confidence intervals that would still be substantively meaningful. We further present an applied example of using this method to address exposure misclassification in a study of transmasculine/transfeminine youth and self-harm. Our method provides a novel approach to effective and efficient estimation of classification parameters as validation data accrue, with emphasis on the precision of the bias-adjusted estimate. This method can be applied within the context of any parent epidemiologic study design in which validation data will be collected and modified to meet alternative criteria given specific study or validation study objectives.

Language: en

Keywords

quantitative bias analysis; study design; Validation substudy