Validity and reliability of the Cochlear Implant Quality of Life (CIQOL)-35 Profile and CIQOL-10 Global instruments in comparison to legacy instruments.
Validity and reliability of the Cochlear Implant Quality of Life (CIQOL)-35 Profile and CIQOL-10 Global instruments in comparison to legacy instruments.
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DOI：
10.1097/aud.0000000000001022
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发表时间：
2021
期刊：
影响因子：
3.7
通讯作者：
Cochlear Implant Quality of Life Consortium
中科院分区：
文献类型：
--
作者：
McRackan TR;Hand BN;Velozo CA;Dubno JR;Cochlear Implant Quality of Life Consortium
经过验证和可靠的患者报告结果测量（PROMs）可以对人工耳蜗（CI）使用者的真实体验进行全面和准确的评估，并补充从语音识别结果中获得的信息。为了解决这一未满足的临床需求，根据患者报告的结果信息系统（PROMIS）和基于共识的健康状况测量仪器选择标准（COSMIN）指南，开发了人工耳蜗生活质量(CIQOL)-35轮廓仪和CIQOL-10全球测量仪。CIQOL-35 Profile由6个领域的35个项目组成（沟通、情感、娱乐、环境、倾听努力和社交），CIQOL-10 Global包含10个项目，提供CIQOL的总体得分。目前的研究比较了新开发的CIQOL仪器的心理测量特性和两种在成人CI用户中常用的传统prom。采用前瞻性队列设计，从美国各地招募了334名成年CI用户，提供了对以下问题的回应：(1)CIQOL工具；(2) ci特异性PROM (Nijmegen Cochlear Implant Questionnaire， NCIQ)；(3)一般健康PROM （Health Utilities Index-3, HUI-3）。1个月后再次获得应答。将CIQOL-35 Profile和CIQOL-10 Global仪器的信度和效度与传统的prom （NCIQ和HUI-3）进行比较。在适当的情况下，使用验证性因子分析（CFA）、项目反应理论（IRT）和重测信度（使用Pearson相关）分析每种工具的心理测量特性和结构效度。所有6个CIQOL-35 Profile domain和CIQOL-10 Global instrument都显示出足够强的结构效度。大多数NCIQ子域和NCIQ总分存在严重的CFA模型失拟，表明结构效度较差。因此，IRT分析只能应用于NCIQ的基本声音性能和活动限制子域。IRT结果显示，所有CIQOL-35 Profile域、CIQOL-10 Global instrument域以及NCIQ的基本声音表现和活动限制子域具有较强的心理测量特性。CIQOL-35 Profile、CIQOL-10 Global和NCIQ的重测信度较强，而ui -3的重测信度较弱；HUI-3的听力评分信度最低。在评估成人CI使用者的生活质量方面，CIQOL-35 Profile和CIQOL-10 Global比NCIQ和HUI-3在心理测量学上更为健全和全面。由于可靠性差，我们不建议使用HUI-3来测量这一人群的生活质量。随着验证和心理测量分析的完成，CIQOL-35 Profile测量和CIQOL-10 Global仪器现已准备好用于临床和研究环境，以测量成人CI用户的生活质量和现实世界的功能能力。
Validated and reliable patient-reported outcome measures (PROMs) may provide a comprehensive and accurate assessment of the real-world experiences of cochlear implant (CI) users and complement information obtained from speech recognition outcomes. To address this unmet clinical need, the Cochlear Implant Quality of Life (CIQOL)-35 Profile instrument and CIQOL-10 Global measure were developed according to the Patient-Reported Outcomes Information System (PROMIS) and COnsensus-based Standards for the Selection of health status Measurement INstruments (COSMIN) guidelines. The CIQOL-35 Profile consists of 35 items in 6 domain constructs (communication, emotional, entertainment, environment, listening effort, and social) and the CIQOL-10 Global contains 10 items that provide an overall CIQOL score. The current study compares psychometric properties of the newly developed CIQOL instruments to two legacy PROMs commonly used in adult CI users. Using a prospective cohort design, a sample of 334 adult CI users recruited from across the United States provided responses to: (1) the CIQOL instruments; (2) a CI-specific PROM (Nijmegen Cochlear Implant Questionnaire, NCIQ); and (3) a general-health PROM (Health Utilities Index-3, HUI-3). Responses were obtained again after 1 month. The reliability and validity of the CIQOL-35 Profile and CIQOL-10 Global instruments were compared to the legacy PROMs (NCIQ and HUI-3). Psychometric properties and construct validity of each instrument were analyzed using confirmatory factor analysis (CFA), item response theory (IRT), and test-retest reliability (using Pearson’s correlations), where appropriate. All six CIQOL-35 Profile domains and the CIQOL-10 Global instrument demonstrated adequate to strong construct validity. The majority of the NCIQ subdomains and NCIQ total score had substantial CFA model misfit, representing poor construct validity. Therefore, IRT analysis could only be applied to the basic sound performance and activity limitation subdomains of the NCIQ. IRT results showed strong psychometric properties for all CIQOL-35 Profile domains, the CIQOL-10 Global instrument, and the basic sound performance and activity limitation subdomains of the NCIQ. Test-retest reliability was strong for the CIQOL-35 Profile, CIQOL-10 Global, and NCIQ, but moderate to weak for the HUI-3; the hearing score of the HUI-3 demonstrated the weakest reliability. The CIQOL-35 Profile and CIQOL-10 Global are more psychometrically sound and comprehensive than the NCIQ and the HUI-3 for assessing QOL in adult CI users. Due to poor reliability, we do not recommend using the HUI-3 to measure QOL in this population. With validation and psychometric analyses complete, the CIQOL-35 Profile measure and CIQOL-10 Global instrument are now ready for use in clinical and research settings to measure QOL and real-world functional abilities of adult CI users.
影响因子：
2.7
作者：
Stika CJ;Hays RD
通讯作者：
Hays RD