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Statistical Issues for Combining Multiple Caries Diagnostics for Demonstrating Caries Efficacy

¹ Division of Biostatistics, Indiana University School of Medicine, 1050 Wishard Blvd, RG 4101, Indianapolis, IN 46260, USA; and
² Unilever Research, Port Sunlight, Wirral, UK;

^* corresponding author, bkatz{at}iupui.edu

Caries efficacy in clinical trials has been based primarily on visual examinations supplemented by Fiber Optic Transillumination (FOTI) and radiography, with the assessments combined at the surface level to classify each surface as to its caries status. Newer caries diagnostics techniques measure the caries process in a quantitative manner and so thus yield continuous rather than ordinal results. The objective of this study was to examine various methods for the analysis of multiple outcomes in clinical trials and to compare their usefulness for the analysis of caries trials. Four global tests (rank sum, ordinary least squares, general least squares, and generalized estimating equations) and two caries indices (based on average and maximum values of the methods) were evaluated with the use of one-year follow-up data from 1063 children in a recent caries trial. A new hybrid method was also developed and evaluated. All of the methods performed well when the diagnostic measures showed product differences in caries in the same direction. Ease of use, interpretability, and distributional assumptions must be considered before a consensus method for analysis of multiple diagnostic measures in caries trials can be determined.

KEY WORDS: statistical analysis • caries diagnostics • clinical trials

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