Lenarz Thomas, Muller Lida, Czerniejewska-Wolska Hanna, Vallés Varela Hector, Orús Dotú César, Durko Marcin, Huarte Irujo Alicia, Piszczatowski Bartosz, Zadrożniak Marek, Irwin Colin, Graham Petra L, Wyss Josie
Medizinische Hochschule Hannover, Hannover, Germany.
Audiol Neurootol. 2017;22(2):61-73. doi: 10.1159/000477533. Epub 2017 Jul 19.
To assess subjectively perceived, real-world benefits longitudinally for unilateral cochlear implant (CI) recipients in a multinational population treated routinely. To identify possible predictors of self-reported benefits.
This was a prospective, multicenter, repeated-measures study. Self-assessment of performance at preimplantation and postimplantation at 1, 2, and 3 years using standardized, validated, local language versions of the Speech, Spatial, and Qualities of Hearing Scale (SSQ), and the Health Utilities Index Mark 3 (HUI3) was performed. Outcomes were analyzed using a longitudinal mixed-effects model incorporating country effect. Patient demographics were explored for associations with change over time.
Two hundred ninety-one routinely treated, unilateral CI recipients, aged 13-81 years, from 9 clinics across 4 countries.
Highly significant improvements were observed for all outcome measures (p < 0.0001). Postimplantation, mean outcome scores remained stable beyond 1 year, with notable individual variability. A significant association for one or more outcomes with preimplantation contralateral hearing aid use, telephone use, age at implantation, implantation side, preimplantation comorbidities, dizziness, and tinnitus was observed (p < 0.004).
Longitudinal benefits of CI treatment can be measured using clinically standardized self-assessment tools to provide a holistic view of patient-related benefits in routine clinical practice for aggregated data from multinational populations. Self-reported outcomes can provide medical-based evidence regarding CI treatment to support decision-making by health service providers.
纵向评估在常规治疗的多国人群中单侧人工耳蜗（CI）接受者主观感受到的现实世界益处。确定自我报告益处的可能预测因素。
这是一项前瞻性、多中心、重复测量研究。使用标准化、经过验证的当地语言版本的言语、空间和听力质量量表（SSQ）以及健康效用指数第3版（HUI3），在植入前以及植入后1年、2年和3年进行自我表现评估。使用纳入国家效应的纵向混合效应模型分析结果。探讨患者人口统计学特征与随时间变化的关联。
来自4个国家9家诊所的291名接受常规治疗的单侧CI接受者，年龄在13 - 81岁之间。
所有结局指标均观察到高度显著改善（p < 0.0001）。植入后，平均结局得分在1年后保持稳定，但个体差异显著。观察到一个或多个结局与植入前对侧助听器使用、电话使用、植入年龄、植入侧、植入前合并症、头晕和耳鸣之间存在显著关联（p < 0.004）。
CI治疗的纵向益处可以使用临床标准化的自我评估工具来衡量，以便在常规临床实践中为来自多国人群的汇总数据提供与患者相关益处的整体视图。自我报告的结局可以提供关于CI治疗的基于医学的证据，以支持卫生服务提供者的决策。
