Management and evaluation of the effects of misclassification in a controlled clinical trial

by Robert M. Bell, Stephen P. Klein

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This paper reviews the authors' findings regarding collecting and reporting examiner reliability data in controlled clinical caries trials, based on their comprehensive review of the dental examination reliability literature and their own work on the National Preventive Dentistry Demonstration Program. They identify two types of examiner errors (systematic and random), and discuss types of reliability data. They review problems created by examiner errors and present reasons for collecting examiner reliability data. Finally, they offer minimum standards for collecting and reporting reliability data. Among their conclusions, the authors find that every clinical trial should include collection of concurrent inter-examiner reliability data as part of the regular examination process.

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