Development and Validation of a Delirium Severity Toolkit

谵妄，包括急性发作的注意力不集中、全面认知障碍和其他神经精神障碍。 症状，是一种常见的，严重的，往往是可预防的综合征住院和机构 长老每年的费用超过1180亿美元，谵妄与不良后果有关，包括 持续的认知能力下降，丧失独立能力，甚至死亡。推进治疗试验的主要挑战 和预后的研究一直是不足的，在目前的测量谵妄的严重程度，如 倾向于过度活跃的特征或需要高度熟练的临床评定者。解决这些 局限性，我们的目标是开发一个谵妄严重性工具包，一套动态的六个新的措施开发 专家的临床判断和病人/家庭/护士输入使用现代心理测量理论。我们的措施 将在各种现象学表现中捕捉谵妄的严重性（例如，活动减退、活动过度）， 结合多个视角（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），并将 采用最先进的程序开发，该程序结合了联合收割机定性和定量方法，例如 在当前主要NIH支持的测量计划中开发和使用的那些（例如，PROMIS，NIH 工具箱，神经生活质量）。此外，我们的开发工作将符合FDA的指导， 仪器开发，以确保未来临床试验的适用性。我们的目标是（1）发展临床 反映多维度症状的存在和强度的谵妄严重程度指标;（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 下降、住院或急性期后住院时间、机构化、医疗保健利用和成本）。过程中 我们将展示仪表开发的面孔，内容和标准效度，并测试对 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名家庭成员和30名护士进行定性访谈;制定并细化谵妄严重程度 仪器，对300名患者进行3项服务（内科、外科和急性后护理）的现场研究， 校准并发布我们6种谵妄严重程度的最终版本（短版、长版和计算机化自适应版本） 在临床和研究环境中随时可用的措施。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， 当前严重性措施的局限性，并提供一个公开可用的项目库以供持续改进， 验证和传播。我们认为，拟议的衡量标准对推进我们的 对谵妄综合征的理解以及我们有效治疗这一重要问题的能力。

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.