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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Autores principales: Kevin J. Munro, William M. Whitmer, Antje Heinrich
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Lenguaje:EN
Publicado: Frontiers Media S.A. 2021
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Acceso en línea:https://doaj.org/article/3b942b271a204190ab6e0ece85eba316
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spelling 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)
institution DOAJ
collection DOAJ
language EN
topic clinical trials
outcome measures
minimal important difference
interventions
hearing loss
hearing-related outcomes
Psychology
BF1-990
spellingShingle 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
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