Development and Validation of a Delirium Severity Toolkit

描述（由申请人提供）：谵妄，包括注意力不集中、整体认知障碍和其他神经精神症状的急性发作，是住院和机构化老年人中常见、严重且通常可预防的综合征。谵妄每年的成本超过1180亿美元，与不良后果相关，包括持续的认知下降，丧失独立性和死亡。推进治疗试验和预后研究的一个主要挑战是目前对谵妄严重程度的测量不足，例如倾向于过度活跃或需要高度熟练的临床评估者。为了解决这些局限性，我们的目标是开发一个谵妄严重程度工具包，一套动态的六个新的措施，专家的临床判断和病人/家属/护士输入，使用现代心理测量学理论。我们的措施将捕捉谵妄的严重程度在各种现象学的介绍（例如，多动，多动），纳入多个角度（病人，家庭成员和护士），将是有用的广泛的利益相关者（医生，护士，病人，家庭护理人员，研究人员和决策者），并将开发使用国家的最先进的程序，联合收割机定性和定量的方法，如开发和利用目前主要的NIH支持的测量倡议（例如，PROMIS、NIH、Neuro-QOL）。此外，我们的开发工作将符合FDA关于仪器开发的指南，以确保未来临床试验的适用性。我们的目标是（1）开发临床措施谵妄的严重程度， 反映症状的多个维度的存在和强度;（2）将这些与患者、家属和护士对谵妄严重程度的主观评级进行比较;以及（3）确定谵妄严重程度的测量对不良临床结果的预测有效性（例如，功能衰退、住院或急性期后的住院时间、机构化、医疗保健利用和成本）。在仪器开发的过程中，我们将展示面，内容和标准的有效性，并测试响应变化和可靠性。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名家属和30名护士进行深入的定性访谈;开发和完善谵妄严重程度工具，在3个服务部门的300名患者中进行实地研究（内科、外科和急性期后护理），校准并发布最终版本（短，长，和计算机化的自适应版本），我们的6谵妄严重程度的措施，准备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谵妄严重程度的概念化，导致新的措施，解决目前的严重程度措施的局限性，并提供一个公开的项目库进行持续的改进，验证和传播。我们相信，所提出的测量是必不可少的，以促进我们的理解，谵妄综合征和我们的能力，有效地治疗这一重要问题。

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.