Abstract：
OBJECTIVE: Clinical registries have great potential for quality control of medical procedures regarding the indications, therapeutic processes and results, including their possible complications. This is particularly true when providing patients with severe hearing loss or deafness with a cochlear implant (CI). This treatment represents a lifelong care process that requires continuous quality control over time. On the initiative of the Executive Committee of the German Society of Otorhinolaryngology (Deutsche Gesellschaft für Hals-Nasen-Ohren-Heilkunde, Kopf- und Hals-Chirurgie e.V., DGHNO-KHC), a national German CI registry (Deutsches Cochlear Implant Register, DCIR) was established in January 2022. This article focuses on the first demographic and baseline data of the DCIR.
METHODS: The DCIR covers the complete therapeutic process from indication, surgery, fitting and lifelong aftercare in CI therapy. By the end of 2022, 75 hospitals in Germany had agreed to contribute to the DCIR.
RESULTS: During the year 2022, 63 hospitals actively contributed data to the DCIR. Pseudonymized data from 2,292 CI implantations (2,176 primary implantations, 99 explantations with immediate re-implantations and 17 re-implantations following an earlier explantation) in 2,108 patients were documented. Cochlear implantation was accomplished in 1,807 adults (≥ 18 years) and 301 children (< 18 years). Fourty patients (1,9%) were children < 1 year of age and 55 (2,6%) were patients > 85 years. From the total of 2,292 implantations, 226 (9.9%) were performed as simultaneous bilateral implantations (CI implantation in both ears of 113 patients on the same day of surgery) and 412 implantations (19.1% of 2,162 implantations with data provided on the contralateral ear\'s hearing status) were in patients with single sided deafness (normal hearing in the contralateral ear). In addition, the reported complications in 2022 were also evaluated. Seven reports (0.4%) of mild to moderate severe facial nerve dysfunctions were documented. No reports of severe or total facial nerve dysfunction (House-Brackmann grade V/VI), meningitis or death related to CI therapy were documented.
CONCLUSIONS: Although still in the start-up phase, these initial DCIR data already provide an interesting first insight into the demographic structure and baseline data of CI therapy in Germany. The successful implementation of the DCIR represents an important step towards continuous quality control of CI care.
METHODS: The DCIR covers the complete therapeutic process from indication, surgery, fitting and lifelong aftercare in CI therapy. By the end of 2022, 75 hospitals in Germany had agreed to contribute to the DCIR.
RESULTS: During the year 2022, 63 hospitals actively contributed data to the DCIR. Pseudonymized data from 2,292 CI implantations (2,176 primary implantations, 99 explantations with immediate re-implantations and 17 re-implantations following an earlier explantation) in 2,108 patients were documented. Cochlear implantation was accomplished in 1,807 adults (≥ 18 years) and 301 children (< 18 years). Fourty patients (1,9%) were children < 1 year of age and 55 (2,6%) were patients > 85 years. From the total of 2,292 implantations, 226 (9.9%) were performed as simultaneous bilateral implantations (CI implantation in both ears of 113 patients on the same day of surgery) and 412 implantations (19.1% of 2,162 implantations with data provided on the contralateral ear\'s hearing status) were in patients with single sided deafness (normal hearing in the contralateral ear). In addition, the reported complications in 2022 were also evaluated. Seven reports (0.4%) of mild to moderate severe facial nerve dysfunctions were documented. No reports of severe or total facial nerve dysfunction (House-Brackmann grade V/VI), meningitis or death related to CI therapy were documented.
CONCLUSIONS: Although still in the start-up phase, these initial DCIR data already provide an interesting first insight into the demographic structure and baseline data of CI therapy in Germany. The successful implementation of the DCIR represents an important step towards continuous quality control of CI care.
摘要：
目的：临床注册在适应证的医疗程序质量控制方面具有巨大潜力，治疗过程和结果，包括可能的并发症。当向患有严重听力损失或耳聋的患者提供耳蜗植入物(CI)时尤其如此。这种治疗代表了终身护理过程，需要随着时间的推移进行持续的质量控制。在德国耳鼻喉科学会执行委员会的倡议下（DeutscheGesellschaftfürHals-Nasen-Ohren-Heilkunde，Kopf-undHals-Chirurgiee.V.，DGHNO-KHC),国家GermanCI登记处(Deutsches人工耳蜗植入登记处，DCIR）成立于2022年1月。本文重点介绍DCIR的第一个人口统计学和基线数据。
方法：DCIR涵盖了从适应症开始的完整治疗过程，手术,CI治疗中的拟合和终身护理。到2022年底，德国已有75家医院同意为DCIR捐款。
结果：在2022年，63家医院积极为DCIR提供数据。来自2,292CI植入的假名数据(2,176次初次植入，记录了2,108例患者的99例立即重新植入和17例早期植入后重新植入）。1,807名成人（≥18岁）和301名儿童（<18岁）完成了人工耳蜗植入。40例(1.9%)为<1岁的儿童,55例(2.6%)为>85岁的患者。在总共2292次植入中，226例（9.9％）同时进行双侧植入（手术当天在113例患者的双耳中植入CI）和412例植入（2162例植入中的19.1％提供了有关对侧耳听力状态的数据）单侧耳聋（对侧耳听力正常）的患者。此外,还评估了2022年报告的并发症.记录了7例（0.4％）轻度至中度严重面神经功能障碍的报告。无严重或完全面神经功能障碍的报告（House-BrackmannV/VI级），记录与CI治疗相关的脑膜炎或死亡.
结论：尽管仍处于启动阶段，这些初始DCIR数据已经为德国CI治疗的人口结构和基线数据提供了有趣的初步见解.DCIR的成功实施代表了CI护理持续质量控制的重要一步。
方法：DCIR涵盖了从适应症开始的完整治疗过程，手术,CI治疗中的拟合和终身护理。到2022年底，德国已有75家医院同意为DCIR捐款。
结果：在2022年，63家医院积极为DCIR提供数据。来自2,292CI植入的假名数据(2,176次初次植入，记录了2,108例患者的99例立即重新植入和17例早期植入后重新植入）。1,807名成人（≥18岁）和301名儿童（<18岁）完成了人工耳蜗植入。40例(1.9%)为<1岁的儿童,55例(2.6%)为>85岁的患者。在总共2292次植入中，226例（9.9％）同时进行双侧植入（手术当天在113例患者的双耳中植入CI）和412例植入（2162例植入中的19.1％提供了有关对侧耳听力状态的数据）单侧耳聋（对侧耳听力正常）的患者。此外,还评估了2022年报告的并发症.记录了7例（0.4％）轻度至中度严重面神经功能障碍的报告。无严重或完全面神经功能障碍的报告（House-BrackmannV/VI级），记录与CI治疗相关的脑膜炎或死亡.
结论：尽管仍处于启动阶段，这些初始DCIR数据已经为德国CI治疗的人口结构和基线数据提供了有趣的初步见解.DCIR的成功实施代表了CI护理持续质量控制的重要一步。
