Interpreting Functional Cochlear Implant Outcomes for Individual Patients

解读个体患者的功能性人工耳蜗植入结果

• 批准号: 10734815
• 负责人: Theodore Richardson McRackan
• 金额: $ 52.45万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-01 至 2028-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10734815
• 关键词: Activities of Daily Living; Adult; Benchmarking; Caring; Clinical; Cochlear Implants; Cochlear implant procedure; Communication; Counseling; Data; Development; Early identification; Evaluation; Goals; Guidelines; Hearing; Hearing Aids; Human; Individual Differences; Institution; Intervention; Interview; Knowledge; Language; Left; Life; Longitudinal Studies; Longitudinal cohort study; Measures; Methodology; Methods; Mission; Modeling; Modernization; Monitor; Operative Surgical Procedures; Outcome; Outcome Measure; Pathologist; Patient Care; Patient Outcomes Assessments; Patients; Personal Satisfaction; Phase; Postoperative Period; Process; Protocols documentation; Psyche structure; Psychometrics; Quality of life; Rehabilitation therapy; Reporting; Research; Research Design; Resources; Risk; Sampling; Sensorineural Hearing Loss; Site; Speech; Staging System; Standardization; Surgeon; Testing; Time; Translating; United States National Institutes of Health; Validation; clinical care; clinical decision-making; clinical outcome measures; clinical practice; cohort; deaf; design; digital platform; evidence base; experience; functional improvement; functional outcomes; hearing loss treatment; implantation; implementation science; improved; individual patient; instrument; interest; novel; novel strategies; patient oriented; personalized care; precision medicine; preimplantation; programs; real world application; response; shared decision making; skills; social engagement; sound; speech recognition; standard care; tool

PROJECT SUMMARY/ABSTRACT Patient-reported outcome measures (PROMs) are crucial for understanding the impact of cochlear implants (CIs) on real-world functional abilities and for monitoring changes over time. However, CI clinical outcome measures traditionally focus solely on CI users’ speech recognition ability, which lacks ecological validity, relies on outcomes that are weakly associated with real-world functional communication ability, and disregards important CI benefits such as improved social engagement and listening effort. Therefore, our current clinical practice standards are not evidence based due to a critical knowledge gap that limits our understanding of the broad functional impact of CIs on patients’ everyday lives. Improvement in speech recognition represents a fundamental early step in the post-CI rehabilitation process. Further lasting real-world functional improvements may occur but depend on how well CI users deploy their enhanced speech recognition skills in their everyday lives. This two-phase process emphasizes the value of combining PROMs with measures of speech recognition to comprehensively assess the patient-centered benefits of cochlear implantation. The enhanced rigor of modern PROM development methodologies, as applied in the development and validation of the new Cochlear Implant Quality of Life-35 Profile (CIQOL-35 Profile), have the potential to improve the monitoring of CI user progress and inform clinical decision making. The proposed project includes a rigorous evaluation of the benefits of CIs on a broad range of functional abilities conducted using a multi-site, longitudinal study design, which will provide, for the first time, a comprehensive understanding of outcomes meaningful to patients and accomplish the following Aims. Aim 1 will apply a novel CIQOL functional staging system, which provides real-world context to CIQOL scores while maintaining the hierarchy of quantitative scores, in a group-based trajectory model to identify clusters of patients in the longitudinal study who follow similar progressions through the CIQOL functional staging system and identify patient factors associated with each trajectory cluster. Aim 2 will first determine the magnitude of change in CIQOL-35 Profile scores considered clinically meaningful to CI users, then apply these findings to better understand the association between early meaningful improvement after implantation and long- term functional outcomes. Specifically, we aim to promptly identify patients at risk of poorer long-term outcomes who may benefit from additional resources. Finally, Aim 3 will apply an implementation science approach to translate the findings from our longitudinal study into clinical practice and enhance the integration of CIQOL instruments into routine CI care. Together, the proposed research program will enhance the interpretation and application of real-world CI outcomes for individual patients, inform patient discussions regarding expected results and demonstrate the potential for PROMs to personalize and improve patient care.

项目总结/摘要 患者报告结局指标（PROM）对于了解人工耳蜗植入体（CI）的影响至关重要 对现实世界的功能能力和监测变化随着时间的推移。然而，CI临床结局指标 传统上只关注CI用户的语音识别能力，缺乏生态有效性， 结果与现实世界的功能沟通能力弱相关，忽视了重要的 CI的好处，如改善社会参与和倾听的努力。因此，我们目前的临床实践 标准不是基于证据的，因为关键的知识差距限制了我们对广泛的 CI对患者日常生活的功能影响。语音识别的改进代表了 这是CI后康复过程中的基本早期步骤。进一步持久的现实世界功能改进 可能会发生，但取决于CI用户如何在日常生活中部署其增强的语音识别技能 生活这两个阶段的过程强调了将PROM与语音识别措施相结合的价值 全面评估人工耳蜗植入术的患者受益。现代建筑的严谨性 PROM开发方法学，用于新的髋关节植入物的开发和确认 生活质量-35概况（CIQOL-35概况），有可能改善CI用户进展的监测 并为临床决策提供信息。拟议的项目包括对CI的好处进行严格评估 使用多中心纵向研究设计进行广泛的功能能力，这将提供， 第一次，全面了解对患者有意义的结果， 遵循目标。Aim 1将应用一种新的CIQOL功能分期系统，该系统提供真实世界的背景， CIQOL评分同时保持了量化评分的层次性，在一个基于组的轨迹模型中识别 纵向研究中CIQOL功能分期进展相似的患者群 系统并识别与每个轨迹聚类相关联的患者因素。目标2将首先确定 认为对CI用户具有临床意义的CIQOL-35特征评分的变化幅度，然后应用这些 研究结果旨在更好地了解植入后早期有意义的改善与长期 长期功能性成果。具体来说，我们的目标是及时识别出长期预后较差的患者 他们可以从额外的资源中受益。最后，目标3将采用实施科学方法， 将我们的纵向研究结果转化为临床实践，并加强CIQOL的整合 常规CI护理。总之，拟议的研究计划将加强解释和 应用个体患者的真实CI结局，告知患者关于预期 结果，并展示了潜在的PROMs个性化和改善病人护理。