1 National Institute for Health Research Nottingham Biomedical Research Centre, Ropewalk House, UK.
2 Hearing Sciences, Division of Clinical Neuroscience, School of Medicine, University of Nottingham, UK.
Trends Hear. 2018 Jan-Dec;22:2331216518814384. doi: 10.1177/2331216518814384.
Subjective tinnitus is a chronic heterogeneous condition that is typically managed using intervention approaches based on sound devices, psychologically informed therapies, or pharmaceutical products. For clinical trials, there are currently no common standards for assessing or reporting intervention efficacy. This article reports on the first of two steps to establish a common standard, which identifies what specific tinnitus-related complaints ("outcome domains") are critical and important to assess in all clinical trials to determine whether an intervention has worked. Using purposive sampling, 719 international health-care users with tinnitus, health-care professionals, clinical researchers, commercial representatives, and funders were recruited. Eligibility was primarily determined by experience of one of the three interventions of interest. Following recommended procedures for gaining consensus, three intervention-specific, three-round, Delphi surveys were delivered online. Each Delphi survey was followed by an in-person consensus meeting. Viewpoints and votes involved all stakeholder groups, with approximately a 1:1 ratio of health-care users to professionals. "Tinnitus intrusiveness" was voted in for all three interventions. For sound-based interventions, the minimum set included "ability to ignore," "concentration," "quality of sleep," and "sense of control." For psychology-based interventions, the minimum set included "acceptance of tinnitus," "mood," "negative thoughts and beliefs," and "sense of control." For pharmacology-based interventions, "tinnitus loudness" was the only additional core outcome domain. The second step will next identify how those outcome domains should best be measured. The uptake of these intervention-specific standards in clinical trials will improve research quality, enhance clinical decision-making, and facilitate meta-analysis in systematic reviews.
主观性耳鸣是一种慢性异质性疾病，通常采用基于声音设备、心理信息治疗或药物产品的干预方法进行治疗。对于临床试验，目前没有评估或报告干预效果的通用标准。本文报告了建立通用标准的两个步骤中的第一步，该标准确定了在所有临床试验中评估哪些特定与耳鸣相关的投诉（“结局领域”）是至关重要和重要的，以确定干预是否有效。通过有针对性的抽样，招募了 719 名国际耳鸣患者、医疗保健专业人员、临床研究人员、商业代表和资助者。资格主要由对三种感兴趣的干预措施之一的经验决定。在遵循获得共识的建议程序后，在线进行了三轮特定于干预的德尔菲调查。每轮德尔菲调查后，都进行了现场共识会议。观点和投票涉及所有利益相关者群体，患者和专业人员的比例约为 1:1。“耳鸣侵入性”在所有三种干预措施中都被投票通过。对于基于声音的干预措施，最小集合包括“忽略能力”、“注意力”、“睡眠质量”和“控制感”。对于基于心理学的干预措施，最小集合包括“接受耳鸣”、“情绪”、“负面想法和信念”和“控制感”。对于基于药理学的干预措施，“耳鸣响度”是唯一额外的核心结局领域。下一步将确定如何最好地衡量这些结局领域。这些特定于干预的标准在临床试验中的采用将提高研究质量，增强临床决策，并促进系统评价中的荟萃分析。
