National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre (BRC), Ropewalk House, 113 The Ropewalk, Nottingham, NG1 5DU, United Kingdom.
Department of Audiology, Mater Misericordiae University Hospital, Dublin, D07 R2WY, Ireland.
Trials. 2020 Mar 4;21(1):238. doi: 10.1186/s13063-020-4094-9.
Single-sided deafness (SSD) describes the presence of a unilateral severe to profound sensorineural hearing loss. SSD disrupts spatial hearing and understanding speech in background noise. It has functional, psychological and social consequences. Potential options for rehabilitation include hearing aids and auditory implants. Benefits and harms of these interventions are documented inconsistently in the literature, using a variety of outcomes ranging from tests of speech perception to quality of life questionnaires. It is therefore difficult to compare interventions when rehabilitating SSD. The Core Rehabilitation Outcome Set for Single Sided Deafness (CROSSSD) study is an international initiative that aims to develop a minimum set of core outcomes for use in future trials of SSD interventions.
METHODS/DESIGN: The CROSSSD study adopts an international two-round online modified Delphi survey followed by a stakeholder consensus meeting to identify a patient-centred core outcome domain set for SSD based on what is considered critical and important for assessing whether an intervention for SSD has worked.
The resulting core outcome domain set will act as a minimum standard for reporting in future clinical trials and could have further applications in guiding the use of outcome measures in clinical practice. Standardisation will facilitate comparison of research findings.
单侧聋(SSD)是指单侧严重至极重度感音神经性听力损失。SSD 会破坏空间听觉并影响背景噪声下的言语理解。它会产生功能、心理和社会方面的后果。康复的潜在选择包括助听器和听觉植入物。这些干预措施的益处和危害在文献中记录不一致,使用的结果范围从言语感知测试到生活质量问卷不等。因此,在 SSD 康复中比较干预措施比较困难。单侧聋核心康复结局研究(CROSSSD)是一项国际倡议,旨在为 SSD 干预措施的未来试验开发一套最小的核心结局,这些结局基于对评估 SSD 干预是否有效的关键和重要因素的考虑。
方法/设计:CROSSSD 研究采用国际两轮在线改良 Delphi 调查,随后进行利益相关者共识会议,根据评估 SSD 干预是否有效的关键和重要因素,确定一个以患者为中心的 SSD 核心结局领域集。
由此产生的核心结局领域集将作为未来临床试验报告的最低标准,并可能进一步应用于指导临床实践中结局测量的使用。标准化将有助于比较研究结果。