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

描述(由申请人提供)：尽管正在努力优先为军事和民事相关创伤性脑损伤的照顾者进行研究和干预，但目前还没有任何措施 这些照顾者所特有的健康相关生活质量(HRQOL)。相反，患者报告结果(PROS)的HRQOL测量已经在其他人群中发展起来。例如，美国国立卫生研究院(NIH)通过PROMIS(专为慢性病开发)和补充倡议进行了大量投资，以改善PRO。PROMIS和这些相辅相成的举措旨在通过包括两个衡量标准上的共同项目来评估一种衡量标准的分数；这些“共同数据元素”在当前的临床和研究实践中正在获得影响。这些举措涉及在普通人群和多种临床人群中制定措施。尽管这项创新工作的范围很广，但这些倡议都没有检查照顾者的HRQOL。这一点令人担忧，因为有效的护理人员特定的HRQOL测量对于准确评估临床和研究结果是必要的。这项研究将通过在大样本的脑损伤照顾者中测试PROMIS题库来解决这一疏漏。这项研究还将开发新的照顾者特定题库(TBI-CareQOL)，将通过评估中心网与PROIS集成。具体地说，将通过对军人或平民创伤性脑损伤患者(n=12组)的照顾者的焦点小组的定性分析来制定项目。然后，这些新开发的项目将在军事和民用创伤性脑损伤患者(n=600)的照顾者中进行大样本测试。在这项测试之后，将使用一种最先进的方法来构建和验证测试-包括项目反应理论和计算机化自适应测试技术-使用最先进的方法来开发一种计算机化的自适应测试，允许对临床相关症状和功能限制进行简短和精确的测量。这个拟议的项目随后将在军人和平民脑外伤患者(n=200)的照顾者中验证TBI-CareQOL和PROMIS。此外，我们将研究这些措施对变化的敏感度和反应能力。由此产生的量表将适用于文职和军事的脑外伤照顾者，将作为国会授权的对军队照顾者的15年纵向研究的主要评估措施，并将在一年一度的脑损伤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，这项研究的结果将向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.