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.

项目摘要/摘要 患者报告的结果测量(PROMS)对于理解人工耳蜗术(CI)的影响至关重要。 关于真实世界的功能能力，以及随着时间的推移而监测变化。然而，CI临床结果衡量标准 传统上只关注CI用户的语音识别能力，缺乏生态有效性，依赖于 结果与现实世界的功能性沟通能力联系不大，忽视了重要的 CI的好处，如提高社交参与度和倾听努力。因此，我们目前的临床实践 标准不是以证据为基础的，因为关键的知识差距限制了我们对广泛的 顺铂对患者日常生活的功能影响。语音识别方面的改进代表着 这是CI后康复进程的基本早期步骤。进一步持久的实际功能改进 可能会发生，但取决于CI用户在日常生活中部署增强的语音识别技能的情况 活着。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 目的：全面评价人工耳蜗术中以患者为中心的益处。增强的现代风格的严格性 PROM开发方法学在新型人工耳蜗术的开发和验证中的应用 生活质量-35概况(CIQOL-35概况)，有可能改善对CI用户进展的监测 并为临床决策提供信息。拟议的项目包括对信息系统的好处进行严格的评估。 使用多点纵向研究设计对广泛的功能能力进行研究，这将提供 第一次，全面了解对患者有意义的结果，并实现 遵循目标。Aim 1将应用一种新的CIQOL功能分级系统，该系统为 CIQOL评分同时保持量化评分的层次性，在基于群体的轨迹模型中进行识别 纵向研究中通过CIQOL功能分期跟踪相似进展的患者群 系统并识别与每个轨迹簇相关联的患者因素。目标2将首先确定 被认为对CI用户有临床意义的CIQOL-35简档评分的变化幅度，然后应用这些 更好地理解植入后早期有意义的改善与长期的 期末功能结局。具体地说，我们的目标是迅速识别长期疗效较差的风险患者 谁可能受益于额外的资源。最后，目标3将应用实施科学方法来 将纵向研究结果转化为临床实践，加强CIQOL的整合 将仪器转化为常规CI护理。总之，拟议的研究计划将加强对 为个别患者应用真实的CI结果，告知患者关于预期的讨论 结果并展示了PROMS个性化和改善患者护理的潜力。