Development of a self-report measure of living with cochlear implants (LivCI): a content evaluation

To develop items and evaluate content validity of a new patient-reported outcome measure, Living with Cochlear Implants (LivCI), designed to assess personal and psychosocial factors relevant to adult cochlear implant (CI) users and candidates. The LivCI was developed following COSMIN best practice guidelines and involved extensive stakeholder engagement. Items (n = 87) were initially generated within five key themes: convenience and management, function and participation, stigma and identity, visibility and aesthetics, and psychosocial wellbeing. Content validity was assessed via cognitive interviews with CI users (n = 7) and candidates (n = 7), and an online survey of CI professionals (n = 15) that evaluated item relevance, clarity and theme fit. Lived experience participants found most items relevant and clear, with some revised or removed based on ambiguity or redundancy. Experts rated items highly (mean 3.6–3.9 out of 4), following removal of seven items and reclassification of several others. Readability scores met recommended standards for public-facing health measures. Further psychometric testing has reduced items and validated the LivCI. Content validity with stakeholders was a key stage in the development of the LivCI. The LivCI was shown to assess personal and psychosocial factors relevant to adult CI users and candidates.为开发一款全新的患者报告结局量表（Patient-Reported Outcome Measure）并验证其内容效度，本研究设计了《人工耳蜗植入生活量表》（Living with Cochlear Implants, LivCI），用于评估成人人工耳蜗植入（Cochlear Implant, CI）使用者与候选使用者的相关个人及社会心理因素。LivCI的开发遵循COSMIN最佳实践指南（Consensus-based Standards for the selection of health Measurement Instruments, COSMIN），并纳入了广泛的利益相关方参与环节。初始生成的87个条目涵盖5个核心主题：便利性与管理、功能与参与、污名化与身份认同、可见性与美学、社会心理健康。内容效度评估通过两项流程开展：其一为对7名CI使用者与7名CI候选使用者开展认知访谈；其二为针对15名CI领域专业人员开展线上调查，以评估条目的相关性、清晰度及主题契合度。拥有实际植入体验的参与者认为绝大多数条目具备相关性且清晰易懂，研究人员基于表述模糊或冗余的问题对部分条目进行了修订或删除。在删除7个条目并对其余若干条目进行重新分类后，专家对条目的评分较高（满分4分，平均分3.6~3.9）。该量表的可读性评分符合面向公众的健康测量工具的推荐标准。后续开展的进一步心理测量学测试精简了条目数量并验证了LivCI的性能。利益相关方参与的内容效度验证环节是LivCI开发过程中的关键步骤。研究证实，LivCI可有效评估成人CI使用者与候选使用者的相关个人及社会心理因素。