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The effects of outcome misclassification and measurement error on the design and analysis of therapeutic equivalence trials
Author(s) -
Kim Mimi Y.,
Goldberg Judith D.
Publication year - 2001
Publication title -
statistics in medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.996
H-Index - 183
eISSN - 1097-0258
pISSN - 0277-6715
DOI - 10.1002/sim.847
Subject(s) - equivalence (formal languages) , outcome (game theory) , type i and type ii errors , statistics , observational error , imperfect , word error rate , sample size determination , clinical trial , econometrics , computer science , mathematics , medicine , artificial intelligence , linguistics , philosophy , mathematical economics , discrete mathematics
In any clinical trial, the use of imperfect diagnostic procedures or laboratory techniques may lead to misclassification and measurement error in the primary outcome. Although the effects of non‐differential outcome misclassification and measurement error on conventional superiority trials have been extensively investigated, less is known about the impact of these errors on the results and interpretation of therapeutic equivalence trials. In this paper we formally investigate the effects of outcome misclassification and measurement error on the estimates of treatment effects, type I error rate, and power of equivalence trials. Our results indicate that, contrary to what one may expect based on the well known attenuating effects of non‐differential error in conventional studies, these errors do not always favour the goal of demonstrating equivalence. The magnitude and direction of the influence depend on a number of factors including the nature of the outcome variable, specific formulation of equivalence, size of the error rates, and assumptions regarding the true treatment effect. Copyright © 2001 John Wiley & Sons, Ltd.