Van de Heyning Paul, Távora-Vieira Dayse, Mertens Griet, Van Rompaey Vincent, Rajan Gunesh P, Müller Joachim, Hempel John Martin, Leander Daniel, Polterauer Daniel, Marx Mathieu, Usami Shin-Ichi, Kitoh Ryosuke, Miyagawa Maiko, Moteki Hideaki, Smilsky Kari, Baumgartner Wolf-Dieter, Keintzel Thomas Georg, Sprinzl Georg Mathias, Wolf-Magele Astrid, Arndt Susan, Wesarg Thomas, Zirn Stefan, Baumann Uwe, Weissgerber Tobias, Rader Tobias, Hagen Rudolf, Kurz Anja, Rak Kristen, Stokroos Robert, George Erwin, Polo Ruben, Medina María Del Mar, Henkin Yael, Hilly Ohad, Ulanovski David, Rajeswaran Ranjith, Kameswaran Mohan, Di Gregorio Maria Fernanda, Zernotti Mario E
University Department of Otorhinolaryngology, Head and Neck Surgery, Antwerp University Hospital, and University of Antwerp, Antwerp, Belgiu.
Audiol Neurootol. 2016;21(6):391-398. doi: 10.1159/000455058. Epub 2017 Mar 21.
While hearing aids for a contralateral routing of signals (CROS-HA) and bone conduction devices have been the traditional treatment for single-sided deafness (SSD) and asymmetric hearing loss (AHL), in recent years, cochlear implants (CIs) have increasingly become a viable treatment choice, particularly in countries where regulatory approval and reimbursement schemes are in place. Part of the reason for this shift is that the CI is the only device capable of restoring bilateral input to the auditory system and hence of possibly reinstating binaural hearing. Although several studies have independently shown that the CI is a safe and effective treatment for SSD and AHL, clinical outcome measures in those studies and across CI centers vary greatly. Only with a consistent use of defined and agreed-upon outcome measures across centers can high-level evidence be generated to assess the safety and efficacy of CIs and alternative treatments in recipients with SSD and AHL.
This paper presents a comparative study design and minimum outcome measures for the assessment of current treatment options in patients with SSD/AHL. The protocol was developed, discussed, and eventually agreed upon by expert panels that convened at the 2015 APSCI conference in Beijing, China, and at the CI 2016 conference in Toronto, Canada.
A longitudinal study design comparing CROS-HA, BCD, and CI treatments is proposed. The recommended outcome measures include (1) speech in noise testing, using the same set of 3 spatial configurations to compare binaural benefits such as summation, squelch, and head shadow across devices; (2) localization testing, using stimuli that rove in both level and spectral content; (3) questionnaires to collect quality of life measures and the frequency of device use; and (4) questionnaires for assessing the impact of tinnitus before and after treatment, if applicable.
A protocol for the assessment of treatment options and outcomes in recipients with SSD and AHL is presented. The proposed set of minimum outcome measures aims at harmonizing assessment methods across centers and thus at generating a growing body of high-level evidence for those treatment options.
虽然对侧信号路由助听器（CROS-HA）和骨传导装置一直是单侧耳聋（SSD）和不对称听力损失（AHL）的传统治疗方法，但近年来，人工耳蜗（CI）越来越成为一种可行的治疗选择，特别是在有监管批准和报销计划的国家。这种转变的部分原因是，人工耳蜗是唯一能够恢复听觉系统双侧输入并因此可能恢复双耳听力的装置。尽管多项研究已独立表明人工耳蜗对SSD和AHL是一种安全有效的治疗方法，但这些研究以及各人工耳蜗中心的临床结局指标差异很大。只有在各中心一致使用明确且商定的结局指标，才能产生高级别证据来评估人工耳蜗及其他治疗方法对SSD和AHL患者的安全性和有效性。
本文介绍了一项比较研究设计以及评估SSD/AHL患者当前治疗选择的最小结局指标。该方案由在中国北京召开的2015年亚太人工耳蜗植入者大会以及在加拿大多伦多召开的2016年人工耳蜗大会上召集的专家小组制定、讨论并最终商定。
提出了一项比较CROS-HA、骨传导装置和人工耳蜗治疗的纵向研究设计。推荐的结局指标包括：（1）噪声中的言语测试，使用同一组3种空间配置来比较双耳益处，如各装置间的累加、静噪和头影效应；（2）定位测试，使用在强度和频谱内容上均随机变化的刺激；（3）收集生活质量指标和装置使用频率的问卷；以及（4）在适用情况下，用于评估治疗前后耳鸣影响的问卷。
本文介绍了一项评估SSD和AHL患者治疗选择及结局的方案。所提议的这组最小结局指标旨在统一各中心的评估方法，从而为这些治疗选择生成越来越多的高级别证据。
