Treatment evaluation in otitis media research

Abstract

Objective: An application of the clinical otitis media profile is proposed for the evaluation of treatments in clinical studies of otitis media.

Methods: Methods include a statistical test of significance and measures of "treatment difference." This article focuses on the method, not any particular study; however, an example is given to illustrate the ideas.

Conclusions: The proposed method substantially increases powers of statistical tests, as compared with the use of a two-point scale algorithm, when applied to study changes of the middle ear condition over time or to compare treatment effects. The proposed evaluation method is applicable to any medical drug treatment for groups that may not be comparable, even with randomization, for baseline severity. Applied to surgical treatment, it can be used for long-term evaluation; however, short-term evaluation is impossible because the needed tympanometric, static admittance, and width measurements cannot be obtained in the presence of functioning tubes. To achieve this objective, it is necessary to use another profile or diagnostic procedure.