使用国际功能、残疾和健康分类（ICF）框架对西班牙和澳大利亚人工耳蜗比较结局的研究

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中文摘要

目的： 使用言语感知和患者报告获益比较澳大利亚和西班牙队列之间的人工耳蜗（CI）结局，并评估国际功能、残疾和健康分类（ICF）框架用于跨中心功能分类的潜在效用。
方法： 这项回顾性横断面研究纳入了2001年至2022年间植入的508例成人CI接受者（澳大利亚n=266；西班牙n=242）。各中心的言语感知评分被映射至ICF言语辨别（b2304）限定词，而非作为原始评分直接比较。患者报告获益使用格拉斯哥获益量表（GBI）评估。采用按中心分层的相关性分析检验言语感知与GBI之间的关联。在调整植入时年龄、性别、植入体型号、电极阵列以及（在敏感性模型中）植入年份之前和之后，评估中心间GBI差异。
结果： 经ICF分类的功能性听力结局在各中心之间无显著差异（χ²=2.28，df=4，p=0.685）。316名参与者（马德里n=202；澳大利亚n=114）具有完整GBI数据。马德里的平均GBI总分为34.77±23.38，澳大利亚为28.62±24.19；未调整差异具有显著性（t(314)=2.22，p=0.027）。在调整年龄、性别、植入体型号和电极阵列后，中心系数减弱且不再具有常规显著性（澳大利亚 vs 马德里：B=-7.09，95% CI -14.48至0.31，p=0.060）。以植入年份替代植入体型号的敏感性模型同样未显示显著的中心效应（B=-4.78，95% CI -11.48至1.93，p=0.162）。言语感知与GBI在马德里（r=0.146，p=0.068）或澳大利亚（r=-0.037，p=0.737）内均无显著相关性。
结论： 将语言特异性言语感知测量映射至ICF限定词为跨中心比较提供了共同的功能分类，但不应被解释为确立了 underlying tests 之间的心理测量学等效性。患者报告获益的中心间未调整差异在调整基线和设备相关差异后减弱，提示中心层面的GBI差异应谨慎解释。功能性听力和患者报告获益仍是CI结局的互补维度。

英文摘要

OBJECTIVE: To compare cochlear implant (CI) outcomes between cohorts in Australia and Spain using speech perception and patient-reported benefit, and to evaluate the potential utility of the International Classification of Functioning, Disability and Health (ICF) framework for cross-centre functional classification.
METHODS: This retrospective cross-sectional study included 508 adult CI recipients (Australia n=266; Spain n=242) implanted between 2001 and 2022. Centre-specific speech perception scores were mapped to ICF speech discrimination (b2304) qualifiers rather than directly compared as raw scores. Patient-reported benefit was assessed with the Glasgow Benefit Inventory (GBI). Centre-stratified correlations examined associations between speech perception and GBI. Between-centre GBI differences were evaluated before and after adjustment for age at implantation, sex, implant model, electrode array and, in a sensitivity model, implantation year.
RESULTS: ICF-classified functional hearing outcomes did not differ significantly between centres (χ²=2.28, df=4, p=0.685). Complete GBI data were available for 316 participants (Madrid n=202; Australia n=114). Mean total GBI scores were 34.77±23.38 in Madrid and 28.62±24.19 in Australia; the unadjusted difference was significant (t(314)=2.22, p=0.027). After adjustment for age, sex, implant model and electrode array, the centre coefficient was attenuated and no longer conventionally significant (Australia vs Madrid: B=-7.09, 95% CI -14.48 to 0.31, p=0.060). A sensitivity model replacing implant model with implantation year likewise showed no significant centre effect (B=-4.78, 95% CI -11.48 to 1.93, p=0.162). Speech perception and GBI were not significantly correlated within Madrid (r=0.146, p=0.068) or Australia (r=-0.037, p=0.737).
CONCLUSIONS: Mapping language-specific speech perception measures to ICF qualifiers provided a common functional classification for cross-centre comparison, but should not be interpreted as establishing psychometric equivalence between the underlying tests. The unadjusted between-centre difference in patient-reported benefit was attenuated after adjustment for baseline and device-related differences, suggesting that centre-level GBI differences should be interpreted cautiously. Functional hearing and patient-reported benefit remained complementary dimensions of CI outcome.