Department of Otolaryngology-Head and Neck Surgery, Medical University of South Carolina, Charleston, South Carolina, USA.
School of Health and Rehabilitation Sciences, The Ohio State University, Columbus, Ohio, USA.
Laryngoscope. 2022 Nov;132 Suppl 12(Suppl 12):S1-S13. doi: 10.1002/lary.30381. Epub 2022 Sep 9.
The purpose of this study is to develop and implement a functional staging system using the Cochlear Implant Quality of Life (CIQOL) framework. The CIQOL-35 Profile was developed and validated following a rigorous research design and found to be more comprehensive and psychometrically sound than previous patient-reported outcome measures (PROMs) applied to adult CI users. However, interpreting the CIQOL-35 Profile (and all PROMs) relative to real-world functioning remains difficult for patients and clinicians, which limits the capacity of PROMs to direct clinical care. To address this limitation, a functional staging system based on PROM scores was developed to provide detailed descriptions of patients' self-reported abilities (clinical vignettes) without sacrificing the inherent value of the psychometrically derived scores. The current study (1) creates an evidence-based CIQOL functional staging system using advanced psychometric techniques, (2) confirms the clarity and meaningfulness of the staging system with patients, and (3) implements the staging system to measure CIQOL stage progression using data from a longitudinal study design.
Item response theory (IRT) analyses of CIQOL-35 Profile data from 705 experienced adult CI users and expert opinion were used to determine the cut-scores that separated adjacent stages for the six CIQOL-35 domains (communication, emotional, entertainment, environment, listening effort, and social). The research team then created clinical vignettes based on item response patterns for each stage. Semi-structured key informant interviews were conducted with 10 adult CI users to determine the clarity and meaningfulness of the CIQOL stages and associated clinical vignettes. Finally, we prospectively collected CIQOL-35 Profile scores from 42 CI users prior to cochlear implantation and then at 3- and 6-months post-CI activation to measure CIQOL stage progression.
Psychometric analyses identified five statistically distinct stages for the communication domain and three stages for all other domains. Using IRT analysis results for guidance, research team members independently identified the cut-scores that represented transitions between the functional stages for each domain with excellent agreement (κ = 0.98 [95% confidence interval 0.96-0.99]). Next, the key informant interviews revealed that CI users found the clinical vignettes to be clear and only minor changes were required. Participants also agreed that stage progression represented meaningful improvements in functional abilities. Finally, 88.1% of 42 patients in the prospective cohort (n = 37) improved from pre-CI functional stage by at least one functional stage in one or more domains. The communication domain had the greatest number of patients improve by one or more stages (59.5%) and the social domain the fewest (25.6%). There was also a trend for less improvement at 3- and 6-months post-CI activation for patients at higher pre-CI functional stages, even though higher stages were achievable.
The new CIQOL functional staging system provides an evidence-based understanding of the real-world functional abilities of adult CI users from pre-CI to 3- to 6-months post-CI activation across multiple domains. In addition, study results provide the proportion of CI users in each stage at each timepoint. Results can be used during discussions of expectations with potential CI users to provide enhanced insight regarding realistic outcomes and the anticipated timing for improvements. The use of the CIQOL functional staging system also presents an opportunity to develop individualized goal-based rehabilitation strategies that target barriers to stage advancement faced by CI users.
2 Laryngoscope, 132:S1-S13, 2022.
本研究旨在使用人工耳蜗植入者生活质量问卷（CIQOL）框架制定和实施一种功能分期系统。CIQOL-35 简表是在严格的研究设计基础上开发和验证的，与之前应用于成人人工耳蜗使用者的患者报告结局测量（PROM）相比，该量表更全面，具有更好的心理测量学特性。然而，对于患者和临床医生来说，解释 CIQOL-35 简表（和所有 PROM）与现实生活功能之间的关系仍然很困难，这限制了 PROM 指导临床护理的能力。为了解决这一限制，我们开发了一种基于 PROM 评分的功能分期系统，该系统提供了患者自我报告能力的详细描述（临床案例），同时又不牺牲心理测量学衍生评分的固有价值。本研究（1）使用先进的心理测量技术创建了一个基于证据的 CIQOL 功能分期系统，（2）通过患者确认了分期系统的清晰度和意义，（3）使用来自纵向研究设计的数据来实施分期系统，以衡量 CIQOL 阶段进展。
对 705 名经验丰富的成年人工耳蜗使用者的 CIQOL-35 简表数据进行项目反应理论（IRT）分析，并结合专家意见，确定了将六个 CIQOL-35 领域（沟通、情感、娱乐、环境、聆听努力和社会）的相邻阶段分开的临界值。研究团队随后根据每个阶段的项目反应模式创建了临床案例。对 10 名成年人工耳蜗使用者进行了半结构化关键知情者访谈，以确定 CIQOL 阶段及其相关临床案例的清晰度和意义。最后，我们前瞻性地收集了 42 名人工耳蜗使用者在植入前、植入后 3 个月和 6 个月的 CIQOL-35 简表评分，以测量 CIQOL 阶段进展。
心理测量分析确定了沟通领域有五个统计学上不同的阶段，其他领域各有三个阶段。使用 IRT 分析结果作为指导，研究团队成员独立确定了每个领域代表功能阶段之间转换的临界值，一致性非常好（κ=0.98[95%置信区间 0.96-0.99]）。接下来，关键知情者访谈显示，人工耳蜗使用者认为临床案例很清楚，只需进行一些小的修改。参与者还认为，阶段进展代表了功能能力的有意义的改善。最后，前瞻性队列中的 42 名患者中有 37 名（88.1%）在一个或多个领域的功能阶段至少提高了一个阶段。沟通领域有最多的患者（59.5%）提高了一个或多个阶段，社会领域最少（25.6%）。对于较高预 CI 功能阶段的患者，在 CI 激活后 3 个月和 6 个月时的改善趋势较小，尽管仍有可能达到较高的阶段。
新的 CIQOL 功能分期系统为成年人工耳蜗使用者在预 CI 至 CI 激活后 3 至 6 个月期间的多个领域的现实世界功能能力提供了基于证据的理解。此外，研究结果提供了每个时间点每个阶段的人工耳蜗使用者比例。结果可用于与潜在人工耳蜗使用者讨论期望，从而增强对现实结果和预期改善时间的了解。CIQOL 功能分期系统的使用也为制定以个体化目标为基础的康复策略提供了机会，这些策略可以针对人工耳蜗使用者在阶段进展中面临的障碍。
2 级喉镜，132：S1-S13，2022 年。
