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

To promote establishment of more uniformly effective ototoxicity monitoring programs (OMPs), this report reviews the U.S. national audiology guidelines in relation to “real world” OMP application. A secondary aim is to review the mechanisms, risk and clinical presentation of hearing loss associated with major classes of ototoxic medications. 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PubMed, national and international agency websites, personal communications between ototoxicity experts, and results of unpublished research.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). 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 and tabulated 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. Protocols of the OMPs examined vary, reflecting the diverse settings in which they exist. 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. Most sites routinely used abbreviated or screening methods to facilitate monitoring. The most effective OMPs integrated audiological management into the care pathways of the clinical specialties that prescribe ototoxic medications. More OMP guidance is needed to inform evaluation schedules, outcome reporting, and determination of an actionable ototoxic change. Guidance is also lacking on the potential 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 the organizations governing medical specialty stakeholders in OMP such as medical oncologists, pulmonologists, infectious disease specialists, and ototolaryngologists.

为推动建立更统一有效的耳毒性监测项目（OMPs），本报告回顾了美国国家听力学指南与“现实世界”中OMP应用的相关情况。第二个目的是回顾与主要类别耳毒性药物相关的听力损失机制、风险和临床表现。 这是一篇非系统性综述，使用了PubMed、国家和国际机构网站、耳毒性专家之间的个人交流以及未发表研究的结果。文中提供了美国民用部门、国防部（DoD）和退伍军人事务部（VA）不同医疗环境中OMPs的实例。 本报告中比较的五个OMPs是作者所属项目的便利样本。通过两次关于OMP障碍和促进因素的半结构化电话会议征求了他们的意见，随后是一份关于OMP特征和实践的自填式问卷，在此对回复进行了综合和制表。在其中一个OMP站点正在进行的VA临床试验提供了初步结果。参与者是2014 - 2017年接受顺铂化疗的40名VA患者。研究分组对比了在治疗单元接受OMP护理与在听力学诊所接受常规护理的就医情况。 所研究的OMPs方案各不相同，反映了它们所处的不同环境。服务提供方面的问题包括基线测试在初始治疗后未进行或完成较晚，以及监测测试不频繁或仅在治疗停止后进行。感知到的障碍涉及患者就诊和检测相关的后勤问题，例如缺乏帮助患者加入项目的流程、患者的时间和日程安排限制以及听力学诊所位置不便。大多数站点常规使用简化或筛查方法来促进监测。 最有效的OMPs将听力学管理纳入了开具耳毒性药物的临床专科的护理路径。需要更多的OMP指导来告知评估时间表、结果报告以及确定可采取行动的耳毒性变化。对于支持大规模OMP工作所需的大量检测可能适用的听力保护方法的潜在用途，也缺乏指导。如果OMP中医疗专科利益相关者（如肿瘤内科医生、肺科医生、传染病专家和耳鼻喉科医生）所属的管理组织正式认可，指南的遵循情况可能会改善。