Effectiveness of Feeding Tubes Among Person with Advanced Cognitive Impairment

描述（由申请人提供）： 喂食管在重度认知障碍患者中的有效性本申请解决了广泛的挑战领域（05）比较有效性研究，挑战主题05-AG-101：上市后比较有效性研究的数据基础设施。晚期痴呆症是一种常见的生命定义疾病，其疾病轨迹包括饮食问题，体重减轻和复发性感染。目前在晚期认知障碍患者中使用经皮内窥镜下烹饪法（PEG）饲管引起了两个问题。首先，各州、医院转诊地区和医院的使用情况存在显著差异。这种变化与广泛引用的对现有观察数据的解释形成对比，这些数据质疑喂食管在痴呆症患者中的有效性。其次，这个证据基础本身是不完善的。这些研究依赖于观察数据，但没有一个试图控制选择偏倚，这是任何非随机对照试验中的一个潜在问题。此外，除了两个例外，这项工作没有充分调整混杂因素。最近的两项研究发现，痴呆症不是生存的独立预测因素，相应的社论呼吁更好的结果数据来判断饲管在痴呆症患者中的疗效。我们先前的研究和初步研究发现，医院是晚期痴呆老年人插入饲管的关键护理场所和最终决策场所。我们发现，大多数PEG喂养管的决定是在急性护理住院期间进行的感染，医院插入PEG喂养管的比率从0%到31%不等，占住院的疗养院居民的晚期认知障碍。拟议的研究有两个总体目标。首先，我们的目标是使用先进的方法来解释选择偏倚，以提供更明确的研究潜在的好处（生存，体重变化，预防和压疮的愈合），风险（使用限制，抗精神病药或苯二氮卓类药物的处方，并过渡到ER和急性护理医院），和医疗保健支出。这一目标将通过链接1999-2008年的四个文件（医疗保险索赔、最低数据集、美国医院协会数据和达特茅斯卫生保健地图集）和2006-2008年的医疗保险D部分数据来实现。该分析将检查患有晚期认知障碍的人以及在PEG饲管插入率不同的机构接受医疗护理的人的个人水平结果。第二个目标是了解PEG饲管在医院插入率的变化。在这个目标中，我们将研究潜在的可修改的医院特征，市场因素，和国家政策与这种变化的医院的PEG喂养管插入率。所获得的知识将用于为公共政策提供信息，并制定基于医院的干预措施，以确保在晚期认知障碍患者中插入PEG管在伦理上是适当的，并与其有效性的最佳可用数据一致。饮食问题是患有痴呆症的人的常见问题。使用饲管有两个问题。首先，尽管有两篇被广泛引用的关于质疑饲管有效性的证据的评论，但医院的饲管插入率各不相同。第二，关于饲管有效性的证据存在争议。拟议的研究将提供饲管有效性的权威证据，并确定可修改的医院特征和国家政策，这些特征和政策解释了饲管使用中观察到的显著变化。

DESCRIPTION (provided by applicant): Effectiveness of Feeding Tubes Among Persons with Advanced Cognitive Impairment This application addresses broad challenge area (05) Comparative Effectiveness Research, Challenge Topic 05-AG-101: Data Infrastructure for Post-Marketing Comparative Effectiveness Studies. Advanced dementia is a common life-defining illness with a disease trajectory of eating problems, weight loss, and recurrent infections. The current use of percutaneous endoscopic gastronomy (PEG) feeding tubes in persons with advanced cognitive impairment raises two concerns. First, there is striking variation in use by states, hospital referral regions, and hospitals. This variation is in contrast to the widely cited interpretation of the existing observational data that questions the effectiveness of feeding tubes in persons with dementia. Second, this evidence base itself is imperfect. These studies rely on observational data, yet none have attempted to control for selection bias, a potential problem in any non- randomized controlled trial. Furthermore, with only two exceptions, this work has not adequately adjusted for confounders. Two recent studies have found dementia not to be an independent predictor of survival with a corresponding editorial calling for better outcomes data to judge the efficacy of feeding tubes in persons with dementia. Our previous research and preliminary studies have found that hospitals are a key locus of care and final site of decision making for feeding tube insertions among the elderly with advanced dementia. We have found that the majority of PEG feeding tube decisions are made during an acute care hospitalization for an infection, and the rate at which hospitals insert PEG feeding tubes varies from 0% to 31% of hospital admissions of nursing home residents with advanced cognitive impairment. The proposed research has two overarching goals. First, we aim to use advanced methods to account for selection bias to provide a more definitive study of the potential benefits (survival, weight change, prevention and healing of pressure ulcers), risks (use of restraints, prescription of antipsychotics or benzodiazepines, and transitions to the ER and acute care hospital), and health care expenditures. This goal will be accomplished through the linkage of four files (Medicare Claims, Minimum Data Set, American Hospital Association data, and Dartmouth Atlas of Health Care) from 1999-2008 and Medicare Part D data from 2006-2008. This analysis will examine individual-level results among persons with advanced cognitive impairment, as well as persons who receive their medical care at institutions with varying rates of PEG feeding tube insertion. A second goal is to understand the variation in hospital insertion rates of PEG feeding tubes. In this goal, we will examine potentially modifiable hospital characteristics, market factors, and state policies associated with this variation in hospitals' rate of PEG feeding tube insertion. Knowledge gained will be used to inform public policy and formulate hospital-based interventions to ensure that PEG tube insertion in persons with advance cognitive impairment is ethically appropriate and consistent with the best available data on their effectiveness. Eating problems are common issues with persons afflicted with dementia. There are two concerns with the use of feeding tubes. First, hospitals vary in their rate of feeding tube insertion despite two widely cited reviews of the evidence that question the effectiveness of feeding tubes. Second, there is controversy about the evidence of effectiveness of feeding tubes. The proposed research will provide authoritative evidence of the effectiveness of feeding tubes and identify modifiable hospital characteristics and state policies that account for the observed striking variation in feeding tube use.