BASIL - Better Assessment of Illness: Delirium Severity Measures for Persons with and without Dementia

BASIL - 更好地评估疾病：痴呆症患者和非痴呆症患者的谵妄严重程度测量

• 批准号: 10263174
• 负责人: SHARON K. INOUYE
• 金额: $ 78.51万
• 依托单位: HEBREW REHABILITATION CENTER FOR AGED
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-06-15 至 2025-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10263174
• 关键词: Acute; Affect; Alzheimer' s disease related dementia; American; Cessation of life; Classification; Clinical; Clinical Trials; Cognition; Cognitive; Communication; Complex; Complication; Confusion; Data; Delirium; Dementia; Diagnosis; Disease; Distress; Elderly; Enrollment; Evaluation; Face; Family; Frequencies; Goals; Health Care Costs; Health care facility; Hospitals; Impaired cognition; Institutionalization; Lead; Length of Stay; Long-Term Care; Measurement; Measures; Medical; Medicine; Methods; Monitor; Normal Range; Older Population; Operative Surgical Procedures; Outcome; Outcome Measure; Participant; Patients; Performance; Persons; Population; Prospective cohort; Prospective cohort study; Psychometrics; Publications; Quality of life; Reference Standards; Risk; Sampling; Services; Severities; Site; Subgroup; Testing; Validation; Validity and Reliability; Work; acute care; adjudication; advanced dementia; associated symptom; clinically relevant; cognitive function; cohort; cost; design; experience; field study; health care quality; improved; instrument; member; novel; prospective; risk stratification; systematic review; tool; treatment response

Delirium is a common, serious, and often fatal disorder, affecting up to 60% of hospitalized seniors, and costing over $164 billion per year. The significance of delirium is heightened in Alzheimer’s disease and related dementias (ADRD), where it occurs with increased frequency (4-5 fold risk) and severity, compared to those without ADRD. Delirium severity is directly correlated with poor clinical outcomes, and its measurement is essential to stratify risk, target treatments, and monitor as an outcome for pathophysiologic studies and clinical trials. In our successful first cycle, we developed a new 17-item instrument for DELirium Severity, the DEL-S. With this proposal, we will extend this work with the novel concept that measurement of delirium severity should be distinct among persons with and without ADRD. Preexisting ADRD is well-known to lead to substantial over-estimation of delirium severity, and none of the >40 current delirium severity instruments were specifically developed or validated for use in persons with ADRD. Thus, our specific aims are: (1) to identify key items that assess the important domains of delirium severity among persons with ADRD, and to develop a new instrument, the DEL-S-AD (DELirium Severity in ADRD); (2) to conduct a multi-site prospective cohort study of 500 older adults (225 with CDR of 0, 50 with CDR of 0.5, and 225 with CDR 1-2) for validation of both the DEL-S and DEL-S-AD with a simultaneous reference standard rating; and (3) to compare the performance of the DEL-S and DEL-S-AD across different levels cognitive function, ranging from normal cognition to moderate ADRD. We will also harmonize DEL-S and DEL-S-AD scores, providing a framework to compare results on a unified metric. For these aims, we will focus on clarifying the construct of delirium severity in ADRD using our prior data and an expert panel. Second, we will validate distinct delirium severity instruments for those with and without ADRD in a multi-site cohort drawn from 3 unique yet complementary sites (BASIL II) with 500 older adults (225 with ADRD), who will be enrolled from medical and surgical populations, and long- term care. All participants will also have concurrent evaluation by skilled clinicians for a reference standard assessment, and all final diagnoses will be made by an experienced, interdisciplinary Adjudication Team. Performance of each instrument will be assessed for internal reliability, face and content validity, convergent validity (against legacy instruments), criterion validity (against reference standard) and predictive validity for relevant clinical outcomes. Finally, we will compare and harmonize the DEL-S and DEL-S-AD scores, to test whether the DEL-S will have superior performance in those with normal cognition or very mild degrees of cognitive impairment, and whether the DEL-S-AD will perform best in those with mild to moderate ADRD. This application will catalyze a paradigm shift in how delirium severity is measured in persons with and without ADRD. This work will yield the first validated instrument specifically for delirium severity in ADRD, and ultimately will help to advance our pathophysiologic understanding and testing of effective new treatments.

谵妄是一种常见的，严重的，往往是致命的疾病，影响高达60%的住院老年人， 每年花费超过1640亿美元。谵妄的重要性在阿尔茨海默病和相关疾病中被提高 痴呆（ADRD），与那些发生频率增加（4-5倍风险）和严重程度相比， 没有ADRD。谵妄的严重程度与不良的临床结果直接相关，其测量方法是 对风险分层、靶向治疗和监测作为病理生理学研究和临床 审判在我们成功的第一个周期中，我们开发了一种新的17项DELirium严重度工具DEL-S。 有了这个建议，我们将扩展这项工作的新概念，谵妄严重程度的测量 在有和没有ADRD的人之间应该是不同的。已知既存ADRD会导致 对谵妄严重程度的实质性高估，并且当前>40种谵妄严重程度工具中没有一种 专门开发或验证用于ADRD患者。因此，我们的具体目标是：（1）识别 评估ADRD患者谵妄严重程度的重要领域的关键项目，并制定一个 新工具，DEL-S-AD（ADRD中的DELirium严重程度）;（2）进行多中心前瞻性队列研究 对500名老年人（225名CDR为0，50名CDR为0.5，225名CDR为1-2）进行的研究，以验证两者 DEL-S和DEL-S-AD与同时参考标准评级;以及（3）比较性能 DEL-S和DEL-S-AD在不同水平的认知功能，从正常认知到 中度ADRD。我们还将协调DEL-S和DEL-S-AD分数，提供一个比较框架 统一度量的结果。为了达到这些目的，我们将着重阐明谵妄严重程度的概念， 使用我们先前的数据和专家小组进行ADRD。其次，我们将验证不同的谵妄严重程度的工具， 对于从3个独特但互补的研究中心（BASIL II）抽取的多中心队列中的ADRD患者和非ADRD患者 有500名老年人（225名患有ADRD），他们将从内科和外科人群中招募，并长期 长期护理所有参与者还将由熟练的临床医生进行同步评价，以获得参考标准 评估和所有最终诊断将由经验丰富的跨学科裁定团队进行。 将评估每种工具的内部可靠性、表面和内容效度、收敛性、 有效性（针对遗留工具）、标准有效性（针对参考标准）和预测有效性， 相关临床结果。最后，我们将比较和协调DEL-S和DEL-S-AD分数，以测试 DEL-S是否在认知正常或非常轻度的认知障碍患者中具有上级性能， 认知障碍，以及DEL-S-AD是否在轻度至中度ADRD患者中表现最佳。 这一应用将促进如何在谵妄严重程度的人， 没有ADRD。这项工作将产生第一个专门用于ADRD中谵妄严重程度的经验证的仪器， 最终将有助于推进我们的病理生理学理解和有效的新治疗方法的测试。