Department of Neurobiology, Care Sciences and Society, KI Alzheimer's Disease Research Center, Karolinska Institutet, Stockholm, Sweden; i3 Innovus, Stockholm, Sweden.
Alzheimers Dement. 2011 Jul;7(4):466-73. doi: 10.1016/j.jalz.2010.06.002.
Costs of care are frequently included as secondary endpoint in Alzheimer clinical trials because payers demand evidence of the budgetary effects of novel therapies. Future clinical trial protocols can be optimized on the basis of the currently available data, including what are the key resources and how are they correlated to disease severity measures.
Primary patient-level data from two 18 months clinical trials of a putative disease modifier in mild-to-moderate Alzheimer's disease (n = 2,744) were analyzed to identify key components of costs of care and their determinants in a clinical trial setting. Costs of care were assessed with the resource utilization in dementia Lite (RUD) instrument, which includes patient accommodation, informal care, community care, and hospitalizations. The contribution of each component to total costs of care and their correlation with one another and key disease severity measures (Alzheimer's Disease Assessment Scale--Cognitive Subscale, Mini-Mental State Examination, Clinical Dementia Rating-Sum of Boxes, Alzheimer's Disease Cooperative Study--Activities of Daily Living Inventory, and Neuropsychiatric Inventory Questionnaire) was explored.
Informal care constituted 82% to 86% of the total costs of care over the 18-months trial and community care services and patient accommodation contributed 6% to 8% each. Informal care was positively correlated with hospitalizations but negatively to patient accommodation, indicating that these services are supplements. Informal care also had the strongest pair-wise correlation with key disease severity measures, suggesting a higher chance of identifying a treatment effect on this component. ADL-ability (Alzheimer's Disease Cooperative Study--Activities of Daily Living Inventory) was the strongest predictor of costs of care of all disease severity measures.
Informal care is the most important component of costs of care in a mild-to-moderate Alzheimer clinical trial sample, and it is primarily driven by the ADL-ability of the patient. Investigators should focus on the assessment of this economic endpoint because a significant treatment effect on this resource is likely to also affect total costs of care.
在阿尔茨海默病临床试验中，经常将护理成本作为次要终点，因为支付方要求提供新型疗法对预算影响的证据。未来的临床试验方案可以基于当前可用数据进行优化，包括哪些是关键资源以及它们与疾病严重程度测量指标的相关性如何。
分析了两项针对轻度至中度阿尔茨海默病（n = 2,744）潜在疾病修饰剂的 18 个月临床试验的患者一级数据，以确定临床试验环境下护理成本的关键组成部分及其决定因素。使用资源利用在痴呆 Lite（RUD）工具评估护理成本，该工具包括患者住宿、非专业护理、社区护理和住院治疗。探讨了每个组成部分对总护理成本的贡献及其彼此之间以及与关键疾病严重程度测量指标（阿尔茨海默病评估量表认知子量表、简易精神状态检查、临床痴呆评定总和框、阿尔茨海默病合作研究日常生活活动量表和神经精神问卷）之间的相关性。
在 18 个月的试验中，非专业护理占护理总成本的 82%至 86%，社区护理服务和患者住宿各占 6%至 8%。非专业护理与住院治疗呈正相关，与患者住宿呈负相关，表明这些服务是补充性的。非专业护理与关键疾病严重程度测量指标之间也具有最强的两两相关性，表明在该组成部分上更有可能确定治疗效果。ADL 能力（阿尔茨海默病合作研究日常生活活动量表）是所有疾病严重程度测量指标中护理成本的最强预测因子。
在轻度至中度阿尔茨海默病临床试验样本中，非专业护理是护理成本的最重要组成部分，主要由患者的 ADL 能力驱动。研究人员应重点评估这一经济终点，因为对该资源的显著治疗效果也可能影响总护理成本。
