Development and Validation of a Delirium Severity Toolkit

描述（由申请人提供）：谵妄，包括急性发作的注意力不集中，整体认知障碍和其他神经精神症状，是住院和机构老年人常见的，严重的，通常可预防的综合征。谵妄每年造成的损失超过1180亿美元，其不良后果包括持续性认知能力下降、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谵妄严重程度的测量不足，例如是否有超重、多动特征的倾向或需要高技能的临床医生评分。为了解决这些限制，我们的目标是开发一个谵妄严重程度工具包，这是一套动态的六项新措施，采用现代心理测量学理论，根据专家临床判断和患者/家属/护士的输入开发。我们的措施将捕捉谵妄的严重程度在各种现象学表现（例如，低活性，多活性），结合多个角度（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，家庭照顾者，研究人员和政策制定者）有用。并将使用最先进的程序开发，结合定性和定量方法，如目前美国国立卫生研究院支持的主要测量计划（例如，PROMIS， NIH工具箱，neuroqol）中开发和使用的方法。此外，我们的开发工作将符合FDA对仪器开发的指导，以确保未来临床试验的适用性。我们的目标是(1)开发谵妄严重程度的临床测量方法

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.