Clinical Trials and Outcome Measures in Adults With Hearing Loss
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...
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Frontiers Media S.A.
2021
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oai:doaj.org-article:3b942b271a204190ab6e0ece85eba3162021-11-05T05:33:59ZClinical Trials and Outcome Measures in Adults With Hearing Loss1664-107810.3389/fpsyg.2021.733060https://doaj.org/article/3b942b271a204190ab6e0ece85eba3162021-11-01T00:00:00Zhttps://www.frontiersin.org/articles/10.3389/fpsyg.2021.733060/fullhttps://doaj.org/toc/1664-1078Clinical 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.Kevin J. MunroKevin J. MunroWilliam M. WhitmerWilliam M. WhitmerAntje HeinrichFrontiers Media S.A.articleclinical trialsoutcome measuresminimal important differenceinterventionshearing losshearing-related outcomesPsychologyBF1-990ENFrontiers in Psychology, Vol 12 (2021) |
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clinical trials outcome measures minimal important difference interventions hearing loss hearing-related outcomes Psychology BF1-990 |
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clinical trials outcome measures minimal important difference interventions hearing loss hearing-related outcomes Psychology BF1-990 Kevin J. Munro Kevin J. Munro William M. Whitmer William M. Whitmer Antje Heinrich Clinical Trials and Outcome Measures in Adults With Hearing Loss |
description |
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. |
format |
article |
author |
Kevin J. Munro Kevin J. Munro William M. Whitmer William M. Whitmer Antje Heinrich |
author_facet |
Kevin J. Munro Kevin J. Munro William M. Whitmer William M. Whitmer Antje Heinrich |
author_sort |
Kevin J. Munro |
title |
Clinical Trials and Outcome Measures in Adults With Hearing Loss |
title_short |
Clinical Trials and Outcome Measures in Adults With Hearing Loss |
title_full |
Clinical Trials and Outcome Measures in Adults With Hearing Loss |
title_fullStr |
Clinical Trials and Outcome Measures in Adults With Hearing Loss |
title_full_unstemmed |
Clinical Trials and Outcome Measures in Adults With Hearing Loss |
title_sort |
clinical trials and outcome measures in adults with hearing loss |
publisher |
Frontiers Media S.A. |
publishDate |
2021 |
url |
https://doaj.org/article/3b942b271a204190ab6e0ece85eba316 |
work_keys_str_mv |
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