Newman Craig W, Sandridge Sharon A, Jacobson Gary P
Head and Neck Institute, Cleveland Clinic.
Division of Audiology, Vanderbilt Bill Wilkerson Center for Otolaryngology and Communication Sciences.
J Am Acad Audiol. 2014 Jan;25(1):76-105. doi: 10.3766/jaaa.25.1.6.
It has been estimated that as many as 50 million Americans do experience or have experienced tinnitus. For approximately 12 million of these individuals, tinnitus makes it impossible for them to carry out normal everyday activities without limitation. These are the patients that present to audiology clinics for assessment and management. The tinnitus evaluation includes the measurement of acoustical characteristics of tinnitus and the impact that this impairment has on health-related quality of life (HRQoL). Tinnitus is a disorder that often occurs as a result of auditory system impairment. The impairment for some can impart an activity limitation and a participation restriction (i.e., tinnitus-related disability or handicap, respectively). The goal of tinnitus management is to reduce, or eliminate, activity limitations and participation restrictions by reducing or eliminating a patient's perception of tinnitus or their reaction to tinnitus. Implicit in this statement is the assumption that there exist standardized measures for quantifying the patient's tinnitus perception and their reaction to it. If there existed stable and responsive standardized tinnitus measures, then it would be possible to compare a patient's tinnitus experience at different time points (e.g., before and after treatment) to assess, for example, treatment efficacy.
The purposes of the current review are to (1) describe psychometric standards used to select outcome measurement tools; (2) discuss available measurement techniques and their application to tinnitus evaluation and treatment-related assessment within the domains established by the World Health Organization's International Classification of Functioning, Disability and Health; (3) list and briefly describe self-report tinnitus questionnaires; (4) describe how valuation of tinnitus treatment can be assessed using economic models of treatment effectiveness; and (5) provide future directions including the development of a tinnitus outcomes test battery and treatment-related study designs.
Retrospective literature review
Although psychometrically robust measures of tinnitus HRQoL do exist, there is no unanimity in, for example, what tests should be included in the tinnitus assessment, and how studies of HRQoL should be conducted. The current authors suggest that future studies employ more rigorous designs and contain (minimally) the following characteristics: (1) utilization of randomized control groups and blinding; (2) appropriate statistical testing including "dropouts" that should be used in an "intention to treat" analysis rather than elimination from the final data set; (3) long-term follow-up assessment to evaluate responsiveness; (4) appropriate inclusion criteria to avoid "ceiling" and "floor" effects; and (5) suitable sample sizes based on the application of power analyses.
据估计，多达5000万美国人正在经历或曾经经历过耳鸣。在这些人中，约有1200万患者因耳鸣而无法不受限制地进行正常的日常活动。这些患者会前往听力诊所进行评估和治疗。耳鸣评估包括测量耳鸣的声学特征以及这种损伤对健康相关生活质量（HRQoL）的影响。耳鸣是一种常因听觉系统损伤而发生的疾病。对一些人来说，这种损伤会导致活动受限和参与受限（即分别为耳鸣相关的残疾或障碍）。耳鸣治疗的目标是通过减少或消除患者对耳鸣的感知或其对耳鸣的反应，来减少或消除活动受限和参与受限。这句话隐含的假设是，存在用于量化患者耳鸣感知及其反应的标准化测量方法。如果存在稳定且灵敏的标准化耳鸣测量方法，那么就有可能比较患者在不同时间点（例如治疗前后）的耳鸣经历，以评估治疗效果等。
本次综述的目的是：（1）描述用于选择结局测量工具的心理测量标准；（2）讨论可用的测量技术及其在世界卫生组织《国际功能、残疾和健康分类》所确立的领域内应用于耳鸣评估和治疗相关评估的情况；（3）列出并简要描述耳鸣自评问卷；（4）描述如何使用治疗效果的经济模型来评估耳鸣治疗的价值；（5）提供未来的方向，包括开发耳鸣结局测试组和与治疗相关的研究设计。
回顾性文献综述
虽然确实存在心理测量学上可靠的耳鸣HRQoL测量方法，但在例如耳鸣评估应包括哪些测试以及应如何进行HRQoL研究等方面并没有达成一致。本文作者建议未来的研究采用更严谨的设计，并至少具备以下特征：（1）使用随机对照组和盲法；（2）进行适当的统计测试，包括“退出者”，应在“意向性分析”中使用，而不是从最终数据集中剔除；（3）进行长期随访评估以评估反应性；（4）采用适当的纳入标准以避免“天花板”和“地板”效应；（5）根据功效分析应用确定合适的样本量。
