Validating the NIH Toolbox in the Acute Neurorehabilitation Setting

描述(由申请人提供)：本申请涉及挑战领域(05)：比较有效性研究和特定挑战主题05-NS-103，验证NIH的新临床工具在患有神经疾病的人群中的有效性。在新的临床工具中，有NIH工具箱，这是一个2小时评估单元，已经开发出来，用于标准化特定临床人群的评估，以调查神经发育和变化、疾病恢复和治疗干预。工具箱将各种各样的神经学评估集成到一个单一的仪器中。评估单元包括4个广泛的神经学领域(认知、情绪、感觉和运动)，并在可能的情况下纳入计算机化测试。在对标准数据范围进行广泛的多站点开发之后，最终的工具箱测试组件将于2009年10月提供。到那时，研究可以开始在特定的神经科人群中测试工具箱的有效性和可行性。这项为期两年的挑战赠款研究将评估工具箱在急性康复住院人口中的可行性和初步验证。神经康复领域目前缺乏一种综合的、全面的、多学科的、多功能的评估工具来评估各种常见的、严重致残的神经疾病(如中风、创伤性脑损伤、肿瘤术后手术)后的损害。因此，工具箱最终可能被证明在治疗和出院计划的住院设置中有价值，并在实验上测试神经康复的综合假说。我们的研究将测试120名正在从致残性脑部疾病中恢复的成人急性康复住院患者。我们将把他们的工具箱结果与120名没有已知脑部疾病的康复住院患者进行比较，以区分住院的一般影响(例如，来自多种药物、并发内科疾病)，从而确定工具箱对急性脑部疾病的敏感性和特异性。我们还将测试120名来自住院患者照顾者的社区生活、年龄相似、大脑健康的参与者，以控制在评估患者时社会经济背景、年龄、种族和起源地区的影响。我们的受控人口还将为国家工具箱数据集贡献宝贵的规范性数据。我们的研究还将确定工具箱评估的认知障碍限度，通过确定简易精神状态检查是否可以区分哪些患者能够或不能遵守测试。这一可行性分析将有助于后续的建议，以针对最能使用工具箱进行评估的患者。 公共卫生相关性：这项为期两年的挑战拨款将在急性神经科住院康复环境中对NIH工具箱进行初步和探索性的验证研究。该工具箱在2小时的检查中评估了不同的神经功能(认知、情绪、感觉和运动)。这项拟议的研究将确定工具箱对急性神经疾病的敏感性和特异性，以及它在评估患有各种衰弱神经疾病的成人住院患者方面的可行性。

DESCRIPTION (provided by applicant): This application addresses Challenge Area (05): Comparative Effectiveness Research and the specific Challenge Topic 05-NS-103, Validating NIH's New Clinical Tools in Populations with Neurological Disorders. Among the new Clinical Tools is the NIH Toolbox, a 2-hour assessment battery that has been developed to standardize evaluations in specific clinical populations for investigations of neurological development and change, disease recovery, and therapeutic interventions. The Toolbox integrates a wide variety of neurologic evaluations into a single instrument. The assessment battery comprises 4 broad neurologic domains (cognition, emotion, sensation, and movement) and incorporates computerized testing where possible. The final Toolbox test components will be made available in October 2009 following extensive multisite development of normative data ranges. At that time, studies can begin to test the validity and feasibility of the Toolbox in specific neurologic populations. This 2-year Challenge Grant study will evaluate the feasibility and initial validation of the Toolbox in the acute rehabilitation inpatient population. The field of neurologic rehabilitation presently lacks an integrated, comprehensive, multidisciplinary and multifunction assessment instrument to evaluate the impairments that follow the diverse and common, acutely disabling neurologic disorders (e.g., stroke, traumatic brain injury, post-tumor surgery). Thus, the Toolbox may eventually prove valuable in the inpatient setting for treatment and discharge planning and to experimentally test integrated hypotheses of neurologic recovery. Our study will test 120 adult acute rehabilitation inpatients who are recovering from disabling brain disorders. We will compare their Toolbox findings to 120 rehabilitation inpatients without known brain disease to distinguish the general effects of hospitalization (e.g., from multiple medications, concurrent medical illness) and thus to determine the Toolbox's sensitivity and specificity to acute brain illness. We will also test 120 community-living, age-similar, brain-healthy participants drawn from the caregivers of the inpatients, to control for the effects of socioeconomic background, age, ethnicity, and region of origin when evaluating the patients. Our control population will also contribute valuable normative data to the national Toolbox data set. Our study will also determine the cognitive impairment limits to Toolbox assessment, by determining whether the Mini-Mental State Examination can distinguish which patients are able or unable to comply with testing. This feasibility analysis will help subsequent proposals to target the patients who are best able to be evaluated with the Toolbox. PUBLIC HEALTH RELEVANCE: This 2-year Challenge Grant will conduct an initial and exploratory validation study of the NIH Toolbox in the acute neurologic inpatient rehabilitation environment. The Toolbox assesses diverse neurologic functions (cognition, emotion, sensation, and movement) in a 2-hour examination. The proposed research will determine the sensitivity and specificity of the Toolbox to acute neurological illness and its feasibility with assessing adult inpatients with a wide variety of debilitating neurological disorders.