Administrative Supplement for A New Quality-of-Life Instrument to Assess Functional Outcomes of Cochlear Implantation in Adults

项目总结/摘要 髋关节植入术是治疗双侧重度至极重度感觉神经性麻痹患者的标准治疗方法。 听力损失CI结果主要使用单词和句子识别进行评估，尽管 重要的是，不要捕捉CI用户的不同倾听和沟通体验。此外，委员会认为， 使用这些测试组合报告的结果通常与CI用户自我报告的真实的相关性很差。 世界沟通能力。缺乏普遍接受的CI特异性患者报告结局 评估功能结局和生活质量（QOL）的PROM是进一步研究的关键障碍。 了解人工耳蜗植入影响沟通、社会、情感和 成人CI用户的其他体验。这项研究的长期目标是扩大与以下方面有关的成果： 人工耳蜗植入超越了那些狭义的语音识别，提供了一个更全面的 了解人工耳蜗植入对其使用者的影响。本提案的总体目标是 通过验证和应用一种新的疾病- 特定CI-QOL工具。我们的中心假设是，通过本研究揭示的CI特异性QOL的变化 新的工具将与疾病特异性结局指标密切相关，但仅与 语音识别的变化。基于令人信服的初步结果，我们的假设将通过 完成两个具体目标：1）为成人CI用户提供一个新开发的QOL工具， 符合严格的心理测量标准的既定程序; 2）评估CI的纵向变化- CI激活后第一年的相关结果及其关联。目标1将于 根据NIH的患者报告结局测量信息制定的指南， 系统（PROMIS）。在目标2中，参与者将完成新的CIQOL工具和其他结果 植入前和植入后， 在植入后的前12个月内，这项工作是创新的，因为它创造了一个新的生活质量 使用从未应用于成人CI的理论框架和方法的工具 人口此外，我们的纵向研究是创新的，因为研究了 包括CI人群中的QOL，并确定每个人如何影响整体QOL以前没有 研究了这些结果还将为未来的研究提供关键的初步数据， 影响CI结局的个体患者特征，制定患者特定策略和依据 用于性能改进（例如新的植入技术、听模态和处理 战略），并更好地估计人工耳蜗植入的健康效用和经济影响。 本行政补充文件将通过以下方式支持主要研究者向研究独立性的过渡 协助上述工作的效率，并确保其及时完成。

PROJECT SUMMARY/ABSTRACT Cochlear implantation is the standard of care for patients with bilateral severe-to-profound sensorineural hearing loss. CI outcomes are primarily assessed using word and sentence recognition, which, although important, do not capture the diverse listening and communication experiences of CI users. Moreover, outcomes reported using these test batteries are often are poorly correlated with CI user self-report of real- world communication abilities. The lack of a universally accepted CI-specific patient reported outcome measure (PROM) to assess functional outcomes and quality of life (QOL) is a critical barrier to further our understanding of the way in which cochlear implantation influences communication, social, emotional, and other experiences of adult CI users. The long term goal of this research is to expand outcomes related to cochlear implantation beyond those narrowly defined by speech recognition, to provide a more comprehensive understanding of how cochlear implantation impacts its users. The overall objective of the current proposal is to determine the impact of cochlear implantation on patient QOL by validating and applying a new, disease- specific CI-QOL instrument. Our central hypothesis is that changes in CI-specific QOL as revealed through this novel instrument will strongly correlate with disease-specific outcome measures, but only weakly correlate with changes in speech recognition. Based on compelling preliminary results, our hypothesis will be tested by completing two specific aims: 1) Validate a newly developed QOL instrument for adult CI users following established procedures that meet rigorous psychometric standards; and 2) Assess longitudinal changes in CI- related outcomes and their associations during the first year after CI activation. Aim 1 will be completed in accordance with the guidelines developed by NIH’s Patient-Reported Outcomes Measurement Information System (PROMIS). In Aim 2, participants will complete the new CIQOL instrument and other outcome measures corresponding to the final domains of the validated CIQOL instrument before implantation and at intervals throughout the first 12 months post implantation. This work is innovative as it creates a new QOL instrument using a theoretical framework and approaches that have never been applied to the adult CI population. Additionally, our longitudinal study is innovative as studying the individual components that comprise QOL in the CI population and determining how each impacts overall QOL has not previously been investigated. The results will also provide critical preliminary data for future research aimed at identifying individual patient characteristics that impact CI outcomes, developing patient-specific strategies and rationale for performance improvements (such as new implantation techniques, listening modalities, and processing strategies), and making better estimates of the health utility and economic impact of cochlear implantation. This administrative supplement will support the primary investigator’s transition to research independence by aiding in the efficiency of the above work and ensure its timely completion.