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为梅尼埃病试验制定核心结局指标集，COSMED研究：两项独立的两轮德尔菲调查关于结局领域和结局指标的结果

Developing a core outcome set for Meniere's disease trials, the COSMED study: results from two separate, two-round Delphi surveys on outcome domains and outcomes.

指南共识耳科IF 3.1Q3

文献信息

PMID42970718
原文在 PubMed 查看原文 ↗
发表日期2026
作者Maud M E Boreel
查看其他 9 位作者

Niek Sauerwein；Babette F van Esch；Raymond van de Berg；Tjasse D Bruintjes；Augusto P Casani；Diego Kaski；Jose A Lopez Escamez；Bryan K Ward；Peter Paul G van Benthem

作者单位Department of Otorhinolaryngology-Head and Neck Surgery, Leiden University Medical Center, Leiden, The Netherlands.
查看其他 10 条单位信息

Apeldoorn Dizziness Centre, Gelre Hospital, Apeldoorn, The Netherlands.；Department of Otorhinolaryngology-Head and Neck Surgery, Isala, Zwolle, The Netherlands.；Department of Otorhinolaryngology-Head and Neck Surgery, Maastricht University Medical Center, Maastricht, The Netherlands.；Department of Neurosciences, Otorhinolaryngology Unit, Pisa University hospital, Pisa, Italy.；Department of Clinical and Movement Neurosciences, University College London, London, UK.；Meniere Disease Neuroscience Research Program, Faculty of Medicine & Health, School of Medical Sciences, The Kolling Institute, University of Sydney, Sydney, NSW, Australia.；Otology & Neurotology Group CTS495, Division of Otolaryngology, Department of Surgery, Instituto de Investigación Biosanitaria, ibs. GRANADA, Universidad de Granada, Granada, Spain.；Sensorineural Pathology Programme, Centro de Investigación Biomédica en Red en Enfermedades Raras, CIBERER, Madrid, Spain.；Hearing Therapeutics, Ear Science Institute Australia, Nedlands, WA, Australia.；Department of Otolaryngology- Head and Neck Surgery, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.

期刊Journal of vestibular research : equilibrium & orientation
SCI 分区Q3
IF3.1
研究类型指南共识 · 临床
所属专科耳科

中文摘要

背景： 梅尼埃病（MD）随机对照试验（RCT）中所用结局指标的不一致性使得试验结果难以比较。核心结局指标集（COS）可标准化各研究的结局指标，提高可比性并加强数据合成，从而为临床试验提供更强证据。
目的： 通过德尔菲程序确定最具临床相关性的结局领域和结局指标，为MD试验制定基于共识的COS。
方法： 在国际专家（包括耳鼻喉科专家、神经科医生、听力学家和临床研究人员）中开展了两项两轮德尔菲调查，以确定纳入COS的结局领域和结局指标。参与者在第一项德尔菲调查中评估MD相关结局领域的重要性，在第二项德尔菲调查中使用9点李克特量表评估结局指标的重要性，并以预先设定的共识阈值决定是否纳入。
结果： 共有来自35个国家的112名专家参与了本研究，每人至少完成一轮德尔菲调查。在第一项德尔菲调查中，就纳入12个预设结局领域中的6个达成共识：身体功能与结构、听力、头晕、耳鸣、耳闷胀感和生活质量。在第二项德尔菲调查中，就纳入以下额外结局指标达成共识：头晕严重程度、眩晕发作次数、眩晕发作持续时间、听力损失、纯音平均听阈、耳鸣严重程度、耳闷胀感严重程度、与头晕相关的生活质量、与听力相关的生活质量、与社会活动或工作相关的生活质量、跌倒发作和前庭功能。
结论： 本研究通过两项结构化的两轮德尔菲程序，就MD的COS应考虑的结局领域和结局指标达成共识，是COSMED研究的关键阶段。

英文摘要

BackgroundInconsistencies in outcome measures used in randomized controlled trials (RCTs) in Menière's Disease (MD) make it challenging to compare trial results. A Core Outcome Set (COS) standardizes outcome measures across studies, improving comparability and enhancing data synthesis for stronger evidence in clinical trials.ObjectiveTo develop a consensus-based COS for MD trials by identifying the most clinically relevant outcome domains and outcomes, using a Delphi procedure.MethodsTwo two-round Delphi surveys were conducted among international experts, including ENT specialists, neurologists, audiologists, and clinical researchers, to identify outcome domains and outcomes for inclusion in the COS. Participants assessed the importance of MD-related outcome domains in the first Delphi survey, and outcomes in the second Delphi survey using a 9-point Likert scale, with predefined consensus thresholds determining inclusion.ResultsA total of 112 experts from 35 countries participated in this study, each completing at least one Delphi round. In the first Delphi, consensus was reached on inclusion of six out of twelve predefined outcome domains: body function and structures, hearing, dizziness, tinnitus, aural fullness, and quality of life. In the second Delphi, consensus was reached on the inclusion of the following additional outcomes: dizziness severity, number of vertigo attacks, duration of vertigo attack, hearing loss, pure tone average, tinnitus severity, aural fullness severity, quality of life related to dizziness, quality of life related to hearing, quality of life related to social activity or work, drop attacks and vestibular function.ConclusionThis study represents a key phase of the COSMED-study through two structured, two-round Delphi procedures on outcome domains and outcomes to be considered in the COS for MD.