A New Standardized Format for Reporting Hearing Outcome in Clinical Trials
Department of Otolaryngology-Head and Neck Surgery, Stanford University, Stanford, California, USA.Otolaryngology Head and Neck Surgery (Impact Factor: 2.02). 08/2012; 147(5):803-7. DOI: 10.1177/0194599812458401
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.
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ABSTRACT: Objective This study aims to assess the hearing outcomes of patients undergoing surgical management of petrous apex cholesterol granuloma and to discuss the role of otic capsule-sparing approaches in drainage of petrous apex cholesterol granulomas. Design Retrospective case series. Setting Tertiary care medical center. Participants Eight patients underwent surgery for presumed or definitive cholesterol granuloma between 2002 and 2011 and met the inclusion criteria for this study. Main Outcome Measures Pre- and postoperative audiogram results as measured by pure tone thresholds and word recognition scores. Results Four patients (50%) demonstrated improvement in speech discrimination. One patient had an increase from 0 to 67% in word recognition scores. Four patients (50%) demonstrated worsening of pure tone thresholds, including two patients with anacusis. Conclusion Perilabyrinthine drainage of petrous apex cholesterol granulomas may result in hearing preservation or hearing improvement, even in the setting of otic capsule erosion. Patients should be counseled about the potential risk of significant hearing loss.
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