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耳蜗Osia系统和Baha Attract系统在传导性或混合性听力损失或单侧耳聋患者中的比较临床疗效和成本效益

Comparative Clinical Effectiveness and Cost-Effectiveness of the Cochlear Osia System and Baha Attract System in Patients with Conductive or Mixed Hearing Loss or Single-Sided Deafness.

作者信息

Brunner Matthias, Schou Manjula, Briggs Robert J, Kingsford Smith Dell

机构信息

Cochlear Limited, Macquarie University, Sydney, NSW 2109, Australia;

Departments of Surgery and Otolaryngology, University of Melbourne, Parkville, VIC 3052, Australia.

出版信息

J Mark Access Health Policy. 2024 Mar 6;12(1):5-20. doi: 10.3390/jmahp12010003. eCollection 2024 Mar.

DOI:10.3390/jmahp12010003
PMID:38544973
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10971051/
Abstract

The aim of this study was to evaluate the comparative clinical effectiveness and cost-utility of the active transcutaneous Osia System versus the passive transcutaneous Baha Attract System for patients with conductive or mixed hearing loss or single-sided deafness in an Australian healthcare setting. In the absence of direct comparative evidence, an indirect treatment comparison (ITC) of the clinical effectiveness and utility gains was needed. The ITC was informed by three studies identified through a systematic literature review. A Markov model was developed to evaluate the cost-utility of the Osia System. The literature review identified three studies suitable to inform an ITC: Mylanus et al. 2020 and Briggs et al. 2022 (Osia System) and den Besten et al. 2019 (Baha Attract System). The Osia System was found to be clinically superior to the Baha Attract System, across objective audiological outcomes resulting in a clinically meaningful utility benefit of 0.03 measured by the Health Utility Index with at least equivalent safety. In conclusion, the Osia System is more effective than the Baha Attract System, providing better hearing and health-related quality of life outcomes. In an Australian healthcare setting, the Osia System is cost-effective as demonstrated in a cost-utility analysis versus the Baha Attract System.

摘要

本研究的目的是在澳大利亚医疗环境中,评估主动式经皮Osia系统与被动式经皮Baha Attract系统对传导性或混合性听力损失或单侧耳聋患者的相对临床疗效和成本效益。由于缺乏直接的比较证据,因此需要对临床疗效和效用增益进行间接治疗比较(ITC)。通过系统文献综述确定的三项研究为ITC提供了依据。开发了一个马尔可夫模型来评估Osia系统的成本效益。文献综述确定了三项适合为ITC提供依据的研究:Mylanus等人(2020年)和Briggs等人(2022年)(关于Osia系统)以及den Besten等人(2019年)(关于Baha Attract系统)。研究发现,在客观听力学结果方面,Osia系统在临床上优于Baha Attract系统,通过健康效用指数测量,其临床意义上的效用效益为0.03,且安全性至少相当。总之,Osia系统比Baha Attract系统更有效,能提供更好的听力和与健康相关的生活质量结果。在澳大利亚医疗环境中,与Baha Attract系统相比,成本效益分析表明Osia系统具有成本效益。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/faf6/10971051/a2b9929c42da/jmahp-12-00003-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/faf6/10971051/4f85991d29c3/jmahp-12-00003-g001.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/faf6/10971051/b00eb7616cd1/jmahp-12-00003-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/faf6/10971051/a2b9929c42da/jmahp-12-00003-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/faf6/10971051/4f85991d29c3/jmahp-12-00003-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/faf6/10971051/59134d230c3c/jmahp-12-00003-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/faf6/10971051/b00eb7616cd1/jmahp-12-00003-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/faf6/10971051/a2b9929c42da/jmahp-12-00003-g004.jpg

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本文引用的文献

1
Assessment Protocol for Candidates for Bone-Anchored Hearing Devices.骨锚式助听器候选人评估方案
Int Arch Otorhinolaryngol. 2022 Jun 14;26(4):e718-e724. doi: 10.1055/s-0042-1745734. eCollection 2022 Oct.
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Clinical Performance, Safety, and Patient-Reported Outcomes of an Active Osseointegrated Steady-State Implant System.主动骨整合稳态植入系统的临床性能、安全性和患者报告结果。
Otol Neurotol. 2022 Aug 1;43(7):827-834. doi: 10.1097/MAO.0000000000003590.
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Longitudinal economic analysis of Bonebridge 601 versus percutaneous bone-anchored hearing devices over a 5-year follow-up period.
在5年随访期内对Bonebridge 601与经皮骨锚式听力装置进行的纵向经济分析。
Clin Otolaryngol. 2021 Jan;46(1):263-272. doi: 10.1111/coa.13659. Epub 2020 Nov 12.
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Otol Neurotol. 2020 Oct;41(9):1249-1257. doi: 10.1097/MAO.0000000000002794.
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Implantation of a new active bone conduction hearing device with optimized geometry.植入具有优化几何形状的新型有源骨传导听力装置。
HNO. 2020 Aug;68(Suppl 2):106-115. doi: 10.1007/s00106-020-00877-2.
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The evaluation of a surgery and the short-term benefits of a new active bone conduction hearing implant - the Osia®.手术评估及新型主动骨导听力植入物(Ossia®)的短期获益。
Braz J Otorhinolaryngol. 2022 May-Jun;88(3):289-295. doi: 10.1016/j.bjorl.2020.05.021. Epub 2020 Jul 4.
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[Implantation of a new active bone conduction hearing device with optimized geometry. German version].[植入具有优化几何形状的新型有源骨传导听力装置。德文版]
HNO. 2020 Nov;68(11):854-863. doi: 10.1007/s00106-020-00876-3.
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Results of a 2-Year Prospective Multicenter Study Evaluating Long-term Audiological and Clinical Outcomes of a Transcutaneous Implant for Bone Conduction Hearing.一项为期 2 年的前瞻性多中心研究的结果,评估了经皮植入骨导听力的长期听力学和临床结果。
Otol Neurotol. 2020 Aug;41(7):901-911. doi: 10.1097/MAO.0000000000002689.
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Implantable Devices for Single-Sided Deafness and Conductive or Mixed Hearing Loss: A Health Technology Assessment.用于单侧耳聋及传导性或混合性听力损失的植入式设备:一项卫生技术评估
Ont Health Technol Assess Ser. 2020 Mar 6;20(1):1-165. eCollection 2020.
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Extended high-frequency hearing enhances speech perception in noise.扩展高频听力可增强噪声环境下的言语感知。
Proc Natl Acad Sci U S A. 2019 Nov 19;116(47):23753-23759. doi: 10.1073/pnas.1903315116. Epub 2019 Nov 4.