A new standardized format for reporting hearing outcome in clinical trials.

ABSTRACT

The lack of an adequate standardized method for reporting level of hearing function in clinical trials has hampered the ability of investigators to draw comparisons across studies. Variability in data reported and presentation format inhibits meta-analysis and makes it impossible to accumulate the large patient cohorts needed for statistically significant inference. Recognizing its importance to the field and after a widely inclusive discussion, the Hearing Committee of the American Academy of Otolaryngology-Head and Neck Surgery endorsed a new minimal standard for reporting hearing results in clinical trials, consisting of a scattergram relating average pure-tone threshold to word recognition score. Investigators remain free to publish their hearing data in any format they believe is interesting and informative, as long as they include the minimal data set to facilitate interstudy comparability.