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一项利用自动化技术改善退伍军人事务部肿瘤患者耳毒性监测的随机对照试验。

A Randomized Controlled Trial Using Automated Technology for Improving Ototoxicity Monitoring in VA Oncology Patients.

机构信息

National Center for Rehabilitative Auditory Research, VA Portland Health Care System, OR.

Department of Otolaryngology-Head & Neck Surgery, Oregon Health & Science University, Portland.

出版信息

Am J Audiol. 2021 Oct 11;30(3S):870-886. doi: 10.1044/2021_AJA-21-00032. Epub 2021 Sep 28.

Abstract

Purpose Determine the efficacy of ototoxicity monitoring (OM) administered as automated protocols with the Oto-ID mobile audiometer (automated ototoxicity monitoring [A-OM]), compared with usual care (UC) OM in cancer patients receiving cisplatin. Method Participants were patients ( = 46, mean age 64.7 years; range: 30-78 years) receiving cisplatin-based chemotherapy at the Department of Veterans Affairs Portland Health Care System. A randomized controlled trial contrasted A-OM and UC at up to three program evaluations (PEs) conducted by the study audiologist who was blinded to arm through PE1. PE1 occurred before randomization or oncology treatment; PE2 and PE3 occurred during and/or after treatment at 35 and 365 days postrandomization. The A-OM group ( = 24) used Oto-ID to screen their hearing before each cisplatin dose. Oto-ID results were sent to the study audiologist for interpretation, follow-up, and care coordination. The UC group ( = 22) received a consult for OM services through the audiology clinic. Outcomes included hearing shift near each patient's high-frequency hearing limit, revised hearing-handicap inventory score, and survival time from the start of treatment. Adherence to OM protocols, patients' use of aural rehabilitation services, and oncologists' treatment decisions were also examined. Results Ototoxicity was identified at a high overall rate (46% and 76% at 35 and 365 days, respectively, postrandomization). Adherence to monitoring prior to each cisplatin dose was 83.3% for those randomized to A-OM compared with 4.5% for UC. Randomization to A-OM was not associated with reduced ototoxic hearing shifts or self-reported hearing handicap relative to UC; neither did it compromise participants' survival. Half of participants in each arm accessed aural rehabilitation services. One in each arm had a documented ototoxicity-related cisplatin dose reduction. Conclusions Auditory impairment was an actionable concern for the participants and their oncology providers. A dedicated surveillance program using the Oto-ID's automated protocols improved adherence to OM recommendations over a traditional UC service delivery model. Supplemental Material https://doi.org/10.23641/asha.16649602.

摘要

目的 评估使用 Oto-ID 移动听力计进行自动方案的耳毒性监测(自动化耳毒性监测[A-OM])与癌症患者接受顺铂治疗时的常规护理(UC)耳毒性监测相比的疗效。

方法 参与者为在退伍军人事务部波特兰医疗保健系统接受基于顺铂的化疗的患者(=46 例,平均年龄 64.7 岁;范围:30-78 岁)。一项随机对照试验通过研究听力学家在首次评估(PE1)中对 A-OM 和 UC 进行了对比,该听力学家在 PE1 期间对臂进行了盲法,PE1 发生在随机分组或肿瘤治疗之前;PE2 和 PE3 在随机分组后 35 和 365 天期间和/或之后进行。A-OM 组(=24 例)在每次顺铂剂量前使用 Oto-ID 筛查听力。Oto-ID 结果发送给研究听力学家进行解释、随访和护理协调。UC 组(=22 例)通过听力学诊所获得 OM 服务咨询。结果包括接近每位患者高频听力极限的听力移位、修订后的听力障碍清单评分以及从治疗开始起的生存时间。还检查了 OM 方案的依从性、患者使用听觉康复服务以及肿瘤学家的治疗决策。

结果 耳毒性的总体发生率较高(分别为随机分组至 A-OM 组的患者在 35 天和 365 天的 46%和 76%)。与 UC 组相比,随机分组至 A-OM 组的患者在每次顺铂剂量前的监测依从率为 83.3%,而 UC 组的监测依从率为 4.5%。与 UC 相比,随机分组至 A-OM 组与降低顺铂致耳毒性听力移位或自我报告听力障碍无关;也未影响参与者的生存。每组中有一半的参与者使用了听觉康复服务。每组中有一人记录了与顺铂相关的剂量减少。

结论 听觉损伤是参与者及其肿瘤学提供者需要关注的问题。使用 Oto-ID 自动方案的专门监测计划提高了对 OM 建议的依从性,优于传统的 UC 服务提供模式。

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