意大利版早期认知与听觉联结（EarlyCaLL）框架的翻译、跨文化适应及初步验证

文献信息

中文摘要

背景/目的： 患有重度至极重度听力损失并伴有其他残疾、接受人工耳蜗（CI）植入的儿童，需要超越常规听觉感知和口语评估的多维结局测量工具。早期认知与听觉联结（EarlyCaLL）框架最初由英国诺丁汉听觉植入项目团队在Datta及其同事的领导下开发，旨在为期望咨询提供支持，并监测伴有复杂需求的CI儿童植入后的进展。该框架旨在捕捉更广泛的发展结局，包括认知、社交与情感参与、聆听与理解、发声与早期言语、以及辅助与替代沟通（AAC），同时涵盖CI设备使用和信号耐受性。然而，迄今为止尚无经过验证的意大利语版框架。本研究旨在翻译、跨文化适应并对意大利版EarlyCaLL进行初步心理测量学验证。方法：按照翻译和跨文化适应的国际指南开展了一项方法学研究。开发阶段包括正向翻译、专家委员会审查、回译、开发者审查和预验证完善。验证阶段涉及20名经验丰富的专业人员。结果：专家小组展现出丰富的临床经验，应答率为100%。全部六个领域的表面效度均极佳（≥90%的评定为充分；Gwet's AC1 = 0.82）。90%的专家认为该问卷无需实质性修改即可接受，10%的专家仅建议进行小幅修订。全部25个描述条目均达到完美的内容效度，整体量表指数也表明对该工具的相关性和充分性达成一致意见。结论：我们的结果支持意大利版EarlyCaLL的表面效度和内容效度，支持进一步开展临床验证，将其作为一种经文化适应的多维观察性工具，用于评估伴有其他残疾的CI儿童的康复结局。该框架提供了对功能发展的全面评估，可能促进儿科CI中的个体化康复、多学科协作和以家庭为中心的照护。

英文摘要

Background/Objectives: Children with severe-to-profound hearing loss and additional disabilities, receiving cochlear implant (CI), require multidimensional outcome measures that extend beyond conventional assessments of auditory perception and spoken language. The Early Cognitive and Listening Links (EarlyCaLL) framework was originally developed by the Nottingham Auditory Implant Programme team, in the United Kingdom, led by Datta and colleagues, to support expectation counselling and to monitor post-cochlear implantation progress in children with CI and associated complex needs. The framework was designed to capture broader developmental outcomes, including cognition, social and emotional engagement, listening and understanding, vocalisations and early talk, and augmentative and alternative communication (AAC), alongside CI equipment use and signal tolerance. However, to date, no validated Italian version of the Framework has been available. This study aims to translate, culturally adapt, and perform a preliminary psychometric validation of the Italian version of the EarlyCaLL. Methods: A methodological study was conducted following international guidelines for translation and cross-cultural adaptation. The development phase included forward translation, expert committee review, back-translation, developer review, and pre-validation refinement. The validation phase involved 20 experienced professionals. Results: The expert panel demonstrated extensive clinical experience, with a 100% response rate. Face validity was excellent across all six domains (≥90% adequate ratings; Gwet's AC1 = 0.82). Ninety percent of experts considered the questionnaire acceptable without substantial modifications, and 10% recommended only minor revisions. All 25 descriptors achieved perfect content validity, while the overall scale indices also indicated unanimous agreement regarding the relevance and adequacy of the instrument. Conclusions: Our results support the face and content validity of the Italian version of the EarlyCaLL, supporting further clinical validation as a culturally adapted multidimensional observational instrument for evaluating rehabilitation outcomes in children with CI and additional disabilities. The framework provides a comprehensive assessment of functional development and may facilitate individualized rehabilitation, multidisciplinary collaboration, and family-centred care in pediatric CI.