Canadian Journal of Statistics

When exposure is subject to nondifferential misclassification, are validation data helpful in testing for an exposure–disease association?

Journal Article

Abstract Consider assessing the evidence for an exposure variable and a disease variable being associated, when the true exposure variable is more costly to obtain than an error‐prone but nondifferential surrogate exposure variable. From a study design perspective, there are choices regarding the best use of limited resources. Should one acquire the true exposure status for fewer subjects or the surrogate exposure status for more subjects? The issue of validation is also central, i.e., should we simultaneously measure the true and surrogate exposure variables on a subset of study subjects? Using large‐sample theory, we provide a framework for quantifying the power of testing for an exposure–disease association as a function of study cost. This enables us to present comparisons of different study designs under different suppositions about both the relative cost and the performance (sensitivity and specificity) of the surrogate variable. We present simulations to show the applicability of our theoretical framework, and we provide a case‐study comparing results from an actual study to what could have been seen had true exposure status been ascertained for a different proportion of study subjects. We also describe an extension of our ideas to a more complex situation involving covariates. The Canadian Journal of Statistics 47: 222–237; 2019 © 2019 Statistical Society of Canada

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