Clinical trials, ototoxicity grading scales and the audiologist's role in therapeutic decision making

• Published in: International journal of audiology Vol. 57; no. sup4; pp. S19 - S28
• Main Authors: King, Kelly A., Brewer, Carmen C.
• Format: Journal Article
• Language: English
• Published: England Taylor & Francis 24.08.2018
• Subjects: Adverse Drug Reaction Reporting Systems; adverse event; Age Factors; Attitude of Health Personnel; Audiologists - psychology; Clinical Decision-Making; clinical trial; Clinical Trials as Topic - methods; Dose-Response Relationship, Drug; Drug Monitoring - methods; Health Knowledge, Attitudes, Practice; Hearing - drug effects; Hearing Loss - chemically induced; Hearing Loss - diagnosis; Hearing Loss - physiopathology; Hearing Loss - therapy; Hearing Tests; Humans; Ototoxicity; ototoxicity grading scale; ototoxicity monitoring; Predictive Value of Tests; Professional Role; Prognosis; Reproducibility of Results; Research Design; Risk Factors; Severity of Illness Index; clinical trial; adverse event; ototoxicity grading scale; ototoxicity monitoring; Ototoxicity
• ISSN: 1499-2027; 1708-8186
• DOI: 10.1080/14992027.2017.1417644

Objectives: Define clinical trials and adverse event (AE) monitoring from the perspective of the audiologist. Rationalise the importance of audiology's involvement before, during and after monitoring. Identify strengths and weaknesses in toxicity grading scales, and discuss factors that may influence these. Design: Literature involving commonly cited grading scales used to capture ototoxicity is reviewed. Current regulations and language associated with clinical trial implementation and AE monitoring are described. Personal observations based on a variety of clinical populations are drawn from years of experience developing and employing ototoxicity monitoring protocols in a complex medical setting. Results: Six commonly used grading scales for ototoxicity are systematically reviewed for strengths and weaknesses. Necessary considerations that inform selection of grading scales are presented. A review of and historical context for clinical trial development and AE monitoring is provided. Conclusions: The audiologist's role in therapeutic decision making goes beyond collection of the audiogram. Clear communication to stakeholders in ototoxicity monitoring is paramount, and toxicity grading scales are one tool to facilitate this exchange. Various factors should be considered in advance of selecting the most appropriate scale to capture hearing loss, and no scale is without limitation.