Development and Initial Validation of a Caregiver-Report Measure

摘要 创伤性脑损伤(TBI)后预后的不明原因的异质性排除了准确 预测，并被认为是一个关键障碍，部分解释了数十年来失败的试验 神经保护性疗法。为了解决这一关键障碍，几个国际研究联盟 建立的目的是更好地了解影响儿童和成人脑外伤康复的因素。这些努力是 通过采用通用数据元素(CDE)得到加强，CDE是心理测量学的“黄金标准” 经过验证的结果衡量标准及其预测因素。一个可能解释不清的因素 结果的异质性是康复利用；然而，由于没有科学的研究，对它的研究还不是很好。 目前存在严格的、全面的、标准化的或有效的康复利用措施。TBI 康复服务涵盖范围广泛的多学科服务，涵盖从 社区的重症监护室。儿童脑外伤后康复服务的利用具有很高的变异性。我们的长- 学期目标是检查康复利用的差异是否解释了一些无法解释的原因 儿童脑外伤后预后的异质性。如果我们能减少TBI模型中的异质性 恢复后，我们可以提供更准确的预测，并提高我们测试疗效的能力 治疗。作为关键的第一步，我们将开发、完善和进行护理者报告的初步验证 康复利用措施，康复利用措施(朗姆)。我们将把质的结合起来 以及量化方法，让护理人员、临床医生和科学家利益相关者参与测量开发 和改进，并进行初步措施验证。该提案涉及NCMRR的研究优先事项： (1)了解现实世界的卫生服务可获得性；(2)制定可预测的客观措施 康复治疗反应；(3)识别、预防和治疗关键继发性疾病， 包括认知障碍。成功完成将产生创新、严谨、初步验证的 和改进的照顾者-报告康复利用的衡量标准，可以进一步验证和调整 来自广泛康复人群的儿童或成人的研究和临床应用 将其作为CDE纳入未来的TBI研究。PI将使用此R03数据直接支持具有AIMS的R01 为：(1)开发rum的mHealth版本；(2)检查护理者报告的准确性和附加值 与保险索赔数据相关的康复利用情况；以及(3)检查康复的相关性 关于朗姆酒的使用情况及其环境(例如，康复的可用性)和患者的报告 特征(例如，颅脑损伤的严重性、功能状态、心理社会逆境、 医疗服务准入 )决定因素， 以及神经行为结果。这项研究的潜在影响是增加我们对 脑外伤结局的异质性，改进研究脑外伤结局和治疗的研究方法，以及 优化对脑外伤后神经行为损害风险最大的个体的护理。

ABSTRACT Unexplained heterogeneity in outcomes following traumatic brain injury (TBI) precludes accurate prognostication and is cited as a critical barrier that partially accounts for decades of failed trials of neuroprotective therapies. To address this critical barrier, several international research consortia were established to better understand factors influencing recovery from pediatric and adult TBI. These efforts are strengthened by the adoption of common data elements (CDEs), the “gold standard” of psychometrically validated measures of outcomes and their predictors. One factor that may account for unexplained heterogeneity in outcomes is rehabilitation utilization; however, it is not well studied because no scientifically rigorous, comprehensive, standardized, or validated measure of rehabilitation utilization currently exists. TBI rehabilitation encompasses a wide range of multidisciplinary services spanning the care continuum from the ICU to the community. Utilization of rehabilitation services following pediatric TBI is highly variable. Our long- term goal is to examine whether variance in rehabilitation utilization accounts for some of the unexplained heterogeneity in outcomes following pediatric TBI. If we can reduce heterogeneity in our models of TBI recovery, we can provide more accurate prognostication and improve our ability to test the efficacy of treatments. As a critical first step, we will develop, refine, and conduct initial validation of a caregiver-report measure of rehabilitation utilization, the Rehabilitation Utilization Measure (RUM). We will combine qualitative and quantitative methods to engage caregiver, clinician, and scientist stakeholders in measure development and refinement and to conduct initial measure validation. This proposal addresses NCMRR research priorities: (1) understanding real-world health service access; (2) developing objective measures that may predict rehabilitation treatment response; and (3) identifying, preventing, and treating key secondary conditions, including cognitive impairment. Successful completion will result in an innovative, rigorous, initially validated and refined caregiver-report measure of rehabilitation utilization that can be further validated and adapted for research and clinical use in children or adults from wide-ranging rehabilitation populations and considered for inclusion as a CDE in future TBI studies. The PIs will use this R03 data in direct support of an R01 with aims to: (1) develop an mHealth version of the RUM; (2) examine accuracy and added value of caregiver reporting of rehabilitation utilization relative to insurance claims data; and (3) examine associations of rehabilitation utilization as reported on the RUM with its environmental (e.g. rehabilitation availability) and patient characteristic (e.g. TBI severity, functional status, psychosocial adversity, healthcare access ) determinants, and with neurobehavioral outcomes. The potential impact of this research is to increase our understanding of heterogeneity in TBI outcomes, improve research methods for investigating TBI outcomes and treatment, and optimize the care of individuals at greatest risk of neurobehavioral impairment following TBI.