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首页> 外文期刊>Trends in Hearing >The COMiT’ID Study: Developing Core Outcome Domains Sets for Clinical Trials of Sound-, Psychology-, and Pharmacology-Based Interventions for Chronic Subjective Tinnitus in Adults
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The COMiT’ID Study: Developing Core Outcome Domains Sets for Clinical Trials of Sound-, Psychology-, and Pharmacology-Based Interventions for Chronic Subjective Tinnitus in Adults

机译：COMiT’ID研究：开发针对成人慢性主观性耳鸣的基于声音，心理学和药理学干预的临床试验的核心结果域集

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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.
机译：主观耳鸣是一种慢性异质性疾病，通常使用基于声音设备，心理咨询疗法或药品的干预方法进行管理。对于临床试验，目前尚没有用于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确定哪些特定的耳鸣相关主诉（“结果领域”）对于确定干预是否有效至关重要。通过有目的的抽样，招募了719名国际医疗保健使用者，包括耳鸣，医疗保健专业人员，临床研究人员，商业代表和资助人。资格主要取决于感兴趣的三种干预措施之一的经验。按照获得共识的推荐程序，在线进行了三项针对特定干预措施的三轮Delphi调查。每次进行Delphi调查后，都要进行面对面的共识会议。观点和投票涉及所有利益相关者群体，医疗保健用户与专业人员的比例约为1：1。三种干预措施均被评选为“耳鸣侵入性”。对于基于声音的干预措施，最低要求包括“忽略能力”，“专注力”，“睡眠质量”和“控制感”。对于基于心理学的干预措施，最低要求包括“接受耳鸣”，“情绪”，“消极的思想和信念”和“控制感”。对于基于药理学的干预措施，“耳鸣响度”是唯一的核心结果域。第二步将下一步确定如何最好地衡量那些结果域。在临床试验中采用这些特定于干预措施的标准将提高研究质量，增强临床决策水平并促进系统评价中的荟萃分析。

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