Applying U.S. national guidelines for ototoxicity monitoring in adult patients: perspectives on patient populations, service gaps, barriers and solutions

Abstract

Objectives: To promote establishment of effective ototoxicity monitoring programs (OMPs), this report reviews the U.S. national audiology guidelines in relation to “real world” OMP application. Background is provided on the mechanisms, risks and clinical presentation of hearing loss associated with major classes of ototoxic medications. Design: This is a non-systematic review using PubMed, national and international agency websites, personal communications between ototoxicity experts, and results of unpublished research. Examples are provided of OMPs in various healthcare settings within the U.S. civilian sector, Department of Defense (DoD), and Department of Veterans Affairs (VA). Study Sample: The five OMPs compared in this report represent a convenience sample of the programs with which the authors are affiliated. Their opinions were elicited via two semi-structured teleconferences on barriers and facilitators of OMP, followed by a self-administered questionnaire on OMP characteristics and practices, with responses synthesized herein. Preliminary results are provided from an ongoing VA clinical trial at one of these OMP sites. Participants were 40 VA patients who received cisplatin chemotherapy in 2014–2017. The study arms contrast access to care for OMP delivered on the treatment unit versus usual care as provided in the audiology clinic. Results: Protocols of the OMPs examined varied, reflecting their diverse settings. Service delivery concerns included baseline tests missed or completed after the initial treatment, and monitoring tests done infrequently or only after cessation of treatment. Perceived barriers involved logistics related to accessing and testing patients, such as a lack of processes to help patients enter programs, patients’ time and scheduling constraints, and inconvenient audiology clinic locations. Use of abbreviated or screening methods facilitated monitoring. Conclusions: The most effective OMPs integrated audiological management into care pathways of the clinical specialties that prescribe ototoxic medications. More OMP guidance is needed to inform evaluation schedules, outcome reporting, and determination of actionable ototoxic changes. Guidance is also lacking on the use of hearing conservation approaches suitable for the mass testing needed to support large-scale OMP efforts. Guideline adherence might improve with formal endorsement from organizations governing the medical specialty stakeholders in OMP such as oncologists, pulmonologists, infectious disease specialists, ototolaryngologists and pharmacists.

Key Words:

• Otoxicity
• ototoxicity monitoring
• hearing loss
• conditions/pathology/disorders
• hearing conservation/hearing loss prevention
• medical audiology/pharmacology
• tele-audiology/tele-health

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Acknowledgements

Dawn Konrad-Martin, Marilyn Dille, Angela Garinis, Keri O’Connell Bennett and Candice Ortiz were employees of the U.S. Government during the period of time when this manuscript was written. The work was prepared as part of their official government duties. Title 17 U.S.C. §105 provides that “Copyright protection under this title is not available for any work of the United States Government”. Title 17 U.S.C. §101 defines a U.S. Government work as a work prepared by a military service member or employee of the U.S. Government as part of that person’s official duties. The contents of this publication do not represent the views of the U.S. Department of Veterans Affairs, Department of Defence or the United States Government. The authors thank the editors of this special issue, Dr Carmen Brewer and Amy Boudin, as well as Ron Maggiore, Garnett P. McMillan, Matt Hamilton-Sutherland and Kelly M. Reavis for many helpful discussions related to the topic of this manuscript.

Declaration of interest: Drs Konrad-Martin and Dille are listed as co-inventors on a patent for the OtoID portable hearing testing device mentioned in this paper. The device generates no revenue. No potential conflict of interest was reported by the other authors.

This work was supported in part by a Merit Review Award #C0239R from the United States (U.S.) Department of Veterans Affairs (VA), Office of Rehabilitation Research and Development Service, a Clinical Translational Science Award (CTSA) Oregon Clinical & translational Research Institute (OCTRI) grant (UL1TR000128), National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health (NIH) R01DC10202 and the VA National Center for Rehabilitative Auditory Research (NCRAR) Center Grant.

Notes

1. As an example, oncologic practice for clinical trials already requires standardized reporting of ototoxic “adverse events”, such as the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v 4.03, 2010). Additionally, recent guidelines for extended-interval dosing of non-tuberculosis mycobacterial pulmonary infections consider ototoxicity from aminoglycosides as a common serious adverse drug reaction and recommend baseline and periodic audiology evaluation on all patients receiving either systemic or inhaled amikacin (Egelund et al. 2015).