Outcomes of beta blockers after myocardial infarction in nursing home residents

疗养院居民心肌梗死后β受体阻滞剂的结果

• 批准号: 8534810
• 负责人: MICHAEL A. STEINMAN
• 金额: $ 54.53万
• 依托单位: NORTHERN CALIFORNIA INSTITUTE/RES/EDU
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-08-22 至 2015-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8534810
• 关键词: Acute; Address; Adrenergic beta-Antagonists; Adult; Adverse effects; Adverse event; Affect; Age; Cardiovascular system; Caring; Cessation of life; Clinical; Clinical assessments; Communities; Data; Data Set; Databases; Development; Diagnostic Services; Drug Utilization; Drug usage; Dyspnea; Elderly; Elements; Event; Fatigue; Frail Elderly; Hospitalization; Hospitals; Individual; Inpatients; Lightheadedness; Longevity; Medicare; Medicare Part A; Methods; Minor; Modeling; Myocardial Infarction; Nursing Homes; Observational Study; Orthostasis; Outcome; Patients; Pattern; Persons; Pharmaceutical Preparations; Physicians; Physiological; Play; Population; Population Study; Quality of life; Randomized Controlled Trials; Rehabilitation therapy; Relative Risks; Research; Research Design; Resources; Risk; Role; Secondary Prevention; Series; Solid; Statistical Methods; Sum; Symptoms; Testing; United States; clinical decision-making; cohort; evidence base; falls; functional decline; functional disability; functional outcomes; functional status; improved; indexing; interest; mortality; older patient; public health relevance

DESCRIPTION (provided by applicant): Background: The use of beta blockers for secondary prevention after myocardial infarction (heart attack) is supported by a solid evidence base for many ambulatory populations. However, virtually no data exist on outcomes of beta blockers in older nursing home patients, who may be particularly susceptible to adverse events from beta blockers and yield less benefit from these drugs. Aims: (1) To describe patterns and predictors of beta blocker use in older nursing home patients after myocardial infarction; and (2 and 3) to determine the impact of beta blockers on functional outcomes, rehospitalization, and death in this population. Methods: Using an observational study design that combines clinical and administrative data, the study population will comprise long-term residents in a large, national nursing home chain who were hospitalized for myocardial infarction between May 2007 and March 2010 and had not been using beta blockers prior to this event. Subjects will be followed for outcomes for 6 to 32 months after hospital discharge, comparing those who were and were not started on beta blockers after the index hospitalization. Data for this study will come from (1 the Minimum Data Set, a comprehensive database of standardized clinical assessment data that is completed at regular intervals by clinicians for nearly all nursing home residents in the United States; (2) claims data on inpatient diagnoses and services from Medicare Part A; and (3) drug utilization data from Medicare Part D and from a private nursing home chain (Manor Care), which captures drug use during periods where claims data from Part D are unavailable. Propensity score approaches and other causal inference methods will be employed to control for potential confounding in the relationship between beta blocker use and the outcomes of interest. Recognizing that no single approach can conclusively address all potential confounders, a series of estimates from related approaches will be used to converge on a clinically meaningful range of effect sizes. To further test and cross-validate results, the analyses will be repeated in two other cohorts. First, results will be analyzed for all Medicare patients nationwide who returned from hospital to nursing home without an intermediary period of post-acute rehabilitation (the period invisible to Medicare Part D). Second, analyses will be repeated for patients in VA nursing homes. VA data contain additional elements not available through Medicare, allowing testing of modeling assumptions and potential biases that can be used to refine analyses in the primary cohort. Relevance / public health significance: Better understanding the benefits and harms of beta blockers in frail nursing home residents after myocardial infarction will substantially improve the evidence base and help guide treatment decisions for this important population.

描述（由申请人提供）： 背景：使用β受体阻滞剂进行心肌梗塞（心脏病发作）后的二级预防得到了许多流动人群的坚实证据基础的支持。然而，实际上没有关于老年疗养院患者使用β受体阻滞剂的结果的数据，这些患者可能特别容易受到β受体阻滞剂不良事件的影响，并且从这些药物中获得的益处较少。目的：(1) 描述心肌梗死后老年疗养院患者使用 β 受体阻滞剂的模式和预测因素； （2和3）确定β受体阻滞剂对该人群的功能结果、再住院和死亡的影响。方法：采用结合临床和管理数据的观察性研究设计，研究人群将包括大型全国连锁疗养院的长期居民，他们在 2007 年 5 月至 2010 年 3 月期间因心肌梗塞住院，并且在此事件之前未使用 β 受体阻滞剂。出院后将对受试者进行 6 至 32 个月的随访，比较住院后开始服用和未服用 β 受体阻滞剂的受试者。本研究的数据将来自（1 最小数据集，标准化临床评估数据的综合数据库，由临床医生定期为美国几乎所有疗养院居民完成；(2) Medicare A 部分的住院诊断和服务的索赔数据；(3) Medicare D 部分和私人疗养院连锁店 (Manor Care) 的药物使用数据，该数据捕获 D 部分的索赔数据期间的药物使用情况 不可用。将采用倾向评分方法和其他因果推理方法来控制β受体阻滞剂的使用和感兴趣的结果之间的关系中潜在的混杂因素。认识到没有一种方法可以最终解决所有潜在的混杂因素，因此将使用相关方法的一系列估计来收敛到具有临床意义的效应大小范围。为了进一步测试和交叉验证结果，将在另外两个队列中重复分析。 首先，将对全国范围内所有从医院返回疗养院而没有经过急性后康复中间期（即 Medicare D 部分不可见的时期）的 Medicare 患者的结果进行分析。其次，将对退伍军人管理局疗养院的患者进行重复分析。 VA 数据包含 Medicare 无法提供的其他元素，允许测试建模假设和潜在偏差，可用于完善主要队列中的分析。相关性 / 公共卫生意义：更好地了解β受体阻滞剂对心肌梗死后体弱的疗养院居民的益处和危害，将大大改善证据基础，并有助于指导这一重要人群的治疗决策。