Clinical Trials and Outcome Measures in Adults With Hearing Loss

Frontiers in Psychology

William M. Whitmer¹  Antje Heinrich²  Kevin J. Munro³ 

[1] Hearing Sciences–Scottish Section, Division of Clinical Neuroscience, University of Nottingham, Glasgow, United Kingdom;Institute of Health and Wellbeing, University of Glasgow, Glasgow, United Kingdom;Manchester Centre for Audiology and Deafness, School of Health Sciences, University of Manchester, Manchester, United Kingdom;Manchester Centre for Audiology and Deafness, School of Health Sciences, University of Manchester, Manchester, United Kingdom;Manchester Academic Health Science Centre, Manchester University Hospitals NNS Foundation Trust, Manchester, United Kingdom;

关键词: clinical trials;    outcome measures;    minimal important difference;    interventions;    hearing loss;    hearing-related outcomes;    clinically meaningful;   

DOI  :  10.3389/fpsyg.2021.733060

来源: Frontiers

【 摘 要 】

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.

【 授权许可】

CC BY