How to Choose Between Measures of Tinnitus Loudness for Clinical Research? A Report on the Reliability and Validity of an Investigator-Administered Test and a Patient-Reported Measure Using Baseline Data Collected in a Phase IIa Drug Trial Purpose Loudness is a major auditory dimension of tinnitus and is used to diagnose severity, counsel patients, or as a measure of clinical efficacy in audiological research. There is no standard test for tinnitus loudness, but matching and rating methods are popular. This article provides important new knowledge about the ... Research Note
Research Note  |   September 18, 2017
How to Choose Between Measures of Tinnitus Loudness for Clinical Research? A Report on the Reliability and Validity of an Investigator-Administered Test and a Patient-Reported Measure Using Baseline Data Collected in a Phase IIa Drug Trial
 
Author Affiliations & Notes
  • Deborah A. Hall
    National Institute for Health Research Nottingham Biomedical Research Centre, England
    Otology and Hearing Group, Division of Clinical Neuroscience, School of Medicine, University of Nottingham, England
  • Rajnikant L. Mehta
    National Institute for Health Research Nottingham Biomedical Research Centre, England
    Otology and Hearing Group, Division of Clinical Neuroscience, School of Medicine, University of Nottingham, England
  • Kathryn Fackrell
    National Institute for Health Research Nottingham Biomedical Research Centre, England
    Otology and Hearing Group, Division of Clinical Neuroscience, School of Medicine, University of Nottingham, England
  • Disclosure: The authors have declared that no competing interests existed at the time of publication.
    Disclosure: The authors have declared that no competing interests existed at the time of publication. ×
  • Correspondence to Deborah Hall: deborah.hall@nottingham.ac.uk
  • Editor: Sumitrajit Dhar
    Editor: Sumitrajit Dhar×
  • Associate Editor: Owen Murnane
    Associate Editor: Owen Murnane×
Article Information
Hearing Disorders / Research Note
Research Note   |   September 18, 2017
How to Choose Between Measures of Tinnitus Loudness for Clinical Research? A Report on the Reliability and Validity of an Investigator-Administered Test and a Patient-Reported Measure Using Baseline Data Collected in a Phase IIa Drug Trial
American Journal of Audiology, September 2017, Vol. 26, 338-346. doi:10.1044/2017_AJA-16-0129
History: Received December 19, 2016 , Revised March 9, 2017 , Accepted April 24, 2017
 
American Journal of Audiology, September 2017, Vol. 26, 338-346. doi:10.1044/2017_AJA-16-0129
History: Received December 19, 2016; Revised March 9, 2017; Accepted April 24, 2017

Purpose Loudness is a major auditory dimension of tinnitus and is used to diagnose severity, counsel patients, or as a measure of clinical efficacy in audiological research. There is no standard test for tinnitus loudness, but matching and rating methods are popular. This article provides important new knowledge about the reliability and validity of an audiologist-administered tinnitus loudness matching test and a patient-reported tinnitus loudness rating.

Method Retrospective analysis of loudness data for 91 participants with stable subjective tinnitus enrolled in a randomized controlled trial of a novel drug for tinnitus. There were two baseline assessments (screening, Day 1) and a posttreatment assessment (Day 28).

Results About 66%–70% of the variability from screening to Day 1 was attributable to the true score. But measurement error, indicated by the smallest detectable change, was high for both tinnitus loudness matching (20 dB) and tinnitus loudness rating (3.5 units). Only loudness rating captured a sensation that was meaningful to people who lived with the experience of tinnitus.

Conclusions The tinnitus loudness rating performed better against acceptability criteria for reliability and validity than did the tinnitus loudness matching test administered by an audiologist. But the rating question is still limited because it is a single-item instrument and is probably able to detect only large changes (at least 3.5 points).

Acknowledgments
This article presents independent research with all coauthors funded by the National Institute for Health Research under the Biomedical Research Unit program. The views expressed are those of the author(s) and not necessarily those of the NHS, the National Institute for Health Research, or the Department of Health. The authors report no conflicts of interest. Data were collected as part a clinical trial funded by INNOVATE UK, Reference 35370-247243 (Charles Large, Principal Investigator, Autifony Therapeutics Ltd and Deborah Hall, Academic Partner). We thank Alice Sharman (Autifony Therapeutics Ltd) for facilitating access to the dataset.
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