Quality of Life in Caregivers of Traumatic Brain Injury: The TBI-CareQOL

描述（由申请人提供）：尽管正在努力优先研究和干预军事和军事相关TBI的护理人员，但目前没有措施 健康相关的生活质量（HRQOL），这是特定于这些照顾者。相反，HRQOL的患者报告结局（PRO）指标已在其他人群中开发。例如，美国国立卫生研究院（NIH）通过PROMIS（为慢性病开发的）和补充倡议，为改善PRO进行了大量投资。PROMIS和这些补充措施的目的是让一个措施的分数，通过纳入两个措施的共同项目，以估计对其他的;这些“共同的数据元素”在目前的临床和研究实践的影响越来越大。这些举措涉及在一般人群和多个临床人群中制定措施。尽管这项创新工作的范围，这些举措都没有检查HRQOL在照顾者。这是令人担忧的，因为一个有效的个体特异性HRQOL测量是必要的，以准确地评估临床和研究结果。本研究将解决这个遗漏测试PROMIS项目银行在大样本的TBI照顾者。本研究还将开发新的特定于患者的项目库（TBI-CareQOL），该项目库将通过assessmentcenter.net与PROMIS集成。具体而言，项目将通过定性分析，从焦点小组在个人的照顾者无论是军事或TBI（n=12组）。这些新开发的项目，然后将在一个大的，不同的样本与军事和TBI（n=600）个人的照顾者进行测试。在该测试之后，采用经典和当代测试构建和验证方法（包括项目反应理论和计算机化自适应测试技术）的最先进方法将用于开发计算机化自适应测试，该测试允许对临床相关症状和功能限制进行简短和精确的测量。然后，该拟议项目将在军人和军人TBI患者的护理人员中验证TBI-CareQOL和PROMIS（n=200）。此外，我们将研究这些措施的敏感性和随着时间的推移变化的反应。由此产生的规模将适用于民用和军用TBI护理人员，将被用作国会授权的15年军事护理人员纵向研究的主要评估措施，并将在年度TBI模型系统会议上介绍，作为纳入其纵向研究的潜在措施。最终，本研究的结果将为提供者提供临床相关信息，允许对干预相关变化进行更敏感的评估，并最大限度地提高临床干预的效率。

DESCRIPTION (provided by applicant): Despite ongoing efforts to prioritize research and interventions for caregivers of military- and civilian-related TBI, there are currently no measures of health-related quality of life (HRQOL) that are specific to these caregivers. Conversely, patient reported outcomes (PROs) measures of HRQOL have been developed in other populations. For example, the National Institutes of Health (NIH) has made a significant investment to improve PROs through both PROMIS (developed for use in chronic disease) and complementary initiatives. PROMIS and these complementary initiatives are designed to allow scores on one measure to be estimated on the other by the inclusion of common items on both measures; these "common data elements" are gaining influence in current clinical and research practice. These initiatives have involved development of measures in both the general population and multiple clinical populations. Despite the scope of this innovative work, none of these initiatives has examined HRQOL in caregivers. This is concerning given that a valid caregiver-specific measure of HRQOL is necessary to accurately evaluate clinical and research outcomes. This study will address this omission by testing PROMIS item banks in a large sample of TBI caregivers. This study will also develop new caregiver-specific item banks (TBI-CareQOL) that will be integrated with PROMIS through assessmentcenter.net. Specifically, items will be developed through qualitative analysis from focus groups in caregivers of individuals with either military- or civilian-TBI (n=12 groups). These newly developed items will then be tested in a large, diverse sample of caregivers of individuals with military- and civilian-TBI (n=600). After this testing, a state-of-the-art approach employing both classical and contemporary methods of test construction and validation - including Item Response Theory and computerized adaptive testing technology - will be used to develop a computerized adaptive test that permits brief and precise measurement of clinically relevant symptoms and functional limitations. This proposed project will then validate the TBI-CareQOL and PROMIS in caregivers of individuals with military- and civilian-TBI (n=200). Further, we will examine these measures' sensitivity and responsiveness to change over time. The resulting scale will be appropriate for use with both civilian- and military-TBI caregivers, will be utilized as a primary assessment measure in the Congressionally mandated 15-year longitudinal study of caregivers in the military, and will be introduced at the annual TBI model system meetings as a potential measure for inclusion in their longitudinal study. Ultimately, the findings from this study will provide clinically relevant information to providers, allow for more sensitive assessment of intervention-related change, and maximize the efficiency of clinical interventions.