英国重度至极重度听力损失成人的人工耳蜗转诊（CIRCA-2）：重复全国多中心回顾性观察研究的方案。

文献信息

中文摘要

背景： 人工耳蜗植入（CI）是治疗重度至极重度听力损失成人的高效干预措施，然而尽管有明确的英国国家卫生与临床优化研究所（NICE 2019）指南和已确立的临床获益，英国各地的使用率仍然较低。最初的“人工耳蜗植入转诊标准审计”（CIRCA-1）在2022年发现了人工耳蜗植入可及性方面存在显著不平等，老年人、男性和社会经济贫困地区个体的转诊率较低，同时少数族裔背景个体更不可能被告知其转诊资格。此后，全国性宣传活动和现有地方“CI Champions”计划的扩展旨在解决这些不平等问题，提高对人工耳蜗植入候选资格的认识，并改善与患者关于人工耳蜗植入转诊选择的讨论质量。这项重复评估旨在评估这些干预措施的成功程度，以识别人工耳蜗植入可及性的改善以及持续存在的障碍。
目的： CIRCA-2是一项全国性、多中心、回顾性观察审计，旨在重新评估成人人工耳蜗植入转诊路径并衡量自第一个审计周期以来的进展。
方法： 该研究将纳入2025年7月至12月期间在二级保健耳鼻喉科和听力学部门接受评估、其听阈符合NICE TA566标准的成人。参与中心将使用Auditbase内的英国人工耳蜗植入组Crystal报告识别符合条件的患者，并提取匿名人口统计学、听力学和服务层面数据。主要结局是符合NICE TA566标准的患者中被告知其资格并转诊进行人工耳蜗植入评估的比例，并与CIRCA-1数据进行比较。次要分析将使用多变量模型检查对国家标准的依从性以及讨论和转诊的预测因素。此外，该研究将评估符合“成人人工耳蜗植入与助听器比较”（COACH）试验标准的患者数量，以及仅单耳符合人工耳蜗植入标准的患者数量。
结果： 2025年7月1日至12月31日期间的回顾性数据于2026年1月至3月期间收集。83个中心提交了涉及15,060名患者的数据。数据分析预计于2026年10月完成，最终结果预计于2027年初发表。
结论： 通过量化随时间的变化，CIRCA-2将提供人工耳蜗植入转诊实践的最新全国图景，突出任何持续存在的障碍，并为促进人工耳蜗植入公平可及的未来策略提供信息。

英文摘要

BACKGROUND: Cochlear implantation (CI) is a highly effective intervention for adults with severe-to-profound hearing loss, yet uptake across the United Kingdom remains low despite clear National Institute for Health and Care Excellence (NICE 2019) guidance and well-established clinical benefits. The original Cochlear Implant Referral Criteria Audit (CIRCA-1) identified marked inequities in access to CIs in 2022, with lower referral rates among older adults, males, and individuals from socioeconomically deprived areas, alongside individuals from minority ethnic backgrounds being less likely to be informed of their eligibility for referral. Since then, national awareness initiatives and the expansion of the existing local "CI Champions" scheme have aimed to address these inequities, improve awareness of CI candidacy, and improve the quality of discussions with patients about options for CI referral. This repeat assessment aims to assess the success of these interventions to identify improvements in access to CIs as well as persisting barriers.
OBJECTIVE: CIRCA-2 is a national, multicenter, retrospective observational audit designed to re-evaluate adult CI referral pathways and measure progress since the first audit cycle.
METHODS: The study will include adults assessed in secondary-care ear, nose, throat, and audiology departments between July and December 2025 whose audiometric thresholds meet NICE TA566 criteria. Participating centers will identify eligible patients using the British Cochlear Implant Group Crystal Report within Auditbase, and anonymized demographic, audiometric, and service-level data will be extracted. The primary outcomes are the proportions of patients meeting NICE TA566 criteria who were informed of their eligibility and referred for CI assessment, with comparisons made to CIRCA-1 data. Secondary analyses will examine adherence to national standards and predictors of discussion and referral using multivariable modeling. In addition, the study will assess the number of patients within criteria for the Comparing Cochlear Implants With Hearing Aids in Adults (COACH) trial and those meeting CI criteria in one ear only.
RESULTS: Retrospective data for the period July 1 to December 31, 2025, were collected between January and March 2026. Eighty-three sites submitted data relating to 15,060 patients. Data analysis is projected to be complete by October 2026, with publication of final results expected in early 2027.
CONCLUSIONS: By quantifying change over time, CIRCA-2 will provide an updated national picture of CI referral practice, highlight any persisting barriers, and inform future strategies to promote equitable access to CIs.