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Clinical Trials and Outcome Measures in Adults With Hearing Loss

Munro, Kevin J.; Whitmer, William M.; Heinrich, Antje


Kevin J. Munro

Antje Heinrich


Clinical trials are designed to evaluate interventions that prevent, diagnose or treat a health condition and provide the evidence base for improving practice in health care. Many health professionals, including those working within or allied to hearing health, are expected to conduct or contribute to clinical trials. Recent systematic reviews of clinical trials reveal a dearth of high quality evidence in almost all areas of hearing health practice. By providing an overview of important steps and considerations concerning the design, analysis and conduct of trials, this article aims to give guidance to hearing health professionals about the key elements that define the quality of a trial. The article starts out by situating clinical trials within the greater scope of clinical evidence, then discusses the elements of a PICO-style research question. Subsequently, various methodological considerations are discussed including design, randomization, blinding, and outcome measures. Because the literature on outcome measures within hearing health is as confusing as it is voluminous, particular focus is given to discussing how hearing-related outcome measures affect clinical trials. This focus encompasses how the choice of measurement instrument(s) affects interpretation, how the accuracy of a measure can be estimated, how this affects the interpretation of results, and if differences are statistically, perceptually and/or clinically meaningful to the target population, people with hearing loss.


Munro, K. J., Whitmer, W. M., & Heinrich, A. (2021). Clinical Trials and Outcome Measures in Adults With Hearing Loss. Frontiers in Psychology, 12, Article 733060.

Journal Article Type Article
Acceptance Date Oct 20, 2021
Online Publication Date Nov 5, 2021
Publication Date Nov 5, 2021
Deposit Date Nov 5, 2021
Publicly Available Date Nov 5, 2021
Journal Frontiers in Psychology
Electronic ISSN 1664-1078
Publisher Frontiers Media
Peer Reviewed Peer Reviewed
Volume 12
Article Number 733060
Public URL
Publisher URL


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