Development and Validation of a Delirium Severity Toolkit

描述(申请人提供)：精神错乱，由注意力不集中的急性发作、全球认知障碍和其他神经精神症状组成，是住院和住院老年人中常见的、严重的、通常可以预防的综合征。精神错乱每年的成本超过1180亿美元，与包括持续性认知下降、丧失独立性和死亡在内的不良后果有关。推进治疗试验和预后研究的一个主要挑战是目前对妄想严重程度的测量存在不足，例如倾向于过重多动特征或需要高技能的临床医生评分员。为了解决这些局限性，我们的目标是开发Delirium严重性工具包，这是一套动态的六种新测量方法，使用现代心理测量学理论开发了专家临床判断和患者/家人/护士的输入。我们的测量方法将捕捉各种现象学陈述中的精神错乱的严重程度(例如，活动不足、过度活动)，纳入多个视角(患者、家庭成员和护士)，将对广泛的利益相关者(医生、护士、患者、家庭护理人员、研究人员和政策制定者)有用，并将使用最先进的程序来开发，这些方法结合了定性和定量方法，例如那些在当前NIH支持的主要测量倡议(例如PROMIS、NIH工具箱、Neuro-QOL)中开发和使用的方法。此外，我们的开发工作将符合FDA关于仪器开发的指导方针，以确保适用于未来的临床试验。我们的目标是(1)发展临床测量的妄想严重程度， 评估的结果包括：(1)反映多个维度症状的存在和强度；(2)将这些与患者、家属和护士对精神错乱严重程度的主观评级进行比较；以及(3)确定衡量精神错乱严重程度的措施对不良临床结果(例如，功能下降、住院或急性发作后的住院时间、制度化、医疗利用和费用)的预测有效性。在工具开发的过程中，我们将展示表面、内容和标准的有效性，并测试对变化的响应性和可靠性。为了实现我们的目标，我们将召集临床专家小组，对30名患者、30名家庭成员和30名护士进行深入的定性采访；开发和改进精神错乱严重程度仪器；对300名患者进行3项服务(内科、外科和急性后护理)的实地研究；校准并发布我们的6项精神错乱严重程度测量的最终版本(短、长和计算机化的自适应版本)，这些版本随时可在临床和研究环境中使用。我们的方法是创新的，因为它将从根本上推进妄想严重程度的概念化，产生解决当前严重程度测量中的局限性的新措施，并为持续改进、验证和传播提供一个公开可用的题库。我们相信，拟议的测量对于促进我们对精神错乱综合征的理解和有效治疗这一重要问题的能力是至关重要的。

DESCRIPTION (provided by applicant): Delirium, consisting of the acute onset of inattention, global cognitive impairment, and other neuropsychiatric symptoms, is a common, serious, and often preventable syndrome among hospitalized and institutionalized elders. At a cost of over $118 billion per year, delirium is associated with adverse outcomes including persistent cognitive decline, loss of independence, and death. A major challenge in advancing treatment trials and prognostic studies has been inadequacies in the current measurement of delirium severity, such as a tendency to overweight hyperactive features or to require highly skilled clinician raters. To address these limitations, our goal is to develop a Delirium Severity Toolkit,a dynamic set of six new measures developed with expert clinical judgment and patient/family/nurse input using modern psychometric theory. Our measures will capture the severity of delirium in various phenomenological presentations (e.g., hypoactive, hyperactive), incorporate multiple perspectives (patient, family member, and nurse), will be useful to a broad array of stakeholders (physicians, nurses, patients, family caregivers, researchers, and policy-makers), and will be developed using state-of-the-art procedures that combine qualitative and quantitative approaches such as those developed and utilized in current major NIH-supported measurement initiatives (e.g., PROMIS, NIH Toolbox, Neuro-QOL). Moreover, our development work will be in compliance with FDA guidance on instrument development to assure applicability for future clinical trials. Our aims are to (1) develop clinical measures of delirium severity that reflect the presence and intensity of multiple dimensions of symptoms; (2) compare these against subjective ratings of delirium severity by patient, family, and nurses; and (3) determine the predictive validity of the measures of delirium severity against adverse clinical outcomes (e.g., functional decline, hospital or post-acute length of stay, institutionalization, healthcare utilization and costs). In the course of instrument development we will demonstrate face, content, and criterion validity, and test responsiveness to change and reliability. To accomplish our aims, we will convene panels of clinical experts, conduct in-depth qualitative interviews with 30 patients, 30 family members, and 30 nurses; develop and refine delirium severity instruments, conduct a field study in 300 patients on 3 services (medicine, surgery, and post-acute care), calibrate and publish final versions (short, long, and computerized adaptive versions) of our 6 delirium severity measures that are ready to use in clinical and research settings. Our approach is innovative since it will fundamentally advance the conceptualization of delirium severity, result in new measures that address limitations in current severity measures, and provide a publicly available item bank for ongoing improvement, validation, and dissemination. We believe that the proposed measurement is essential to advance our understanding of the syndrome of delirium and our ability to effectively treat this important problem.