Impact of Certificate of Need on the Use of Revascularization for AMI

描述(由申请人提供)：需要证明(CON)是国家管理的管理计划，要求提供者在建立某些临床服务之前获得批准。CON的一个主要关注点是血运重建(冠状动脉搭桥手术[CABG]和经皮冠状动脉介入[PCT])，它在20世纪90年代作为一种治疗缺血性心脏病的方法激增。1984年，要求所有州都有CON的联邦立法被废除。自那时以来，已有25个州废除了心脏手术和心导管术的CON。有证据表明，废除CON的血运重建可能会导致新项目数量的戏剧性上升。然而，废除CON对血管重建的总体使用和老年人预后的影响还没有得到充分的研究。建议的研究将会： 确定急性心肌梗死(AMI)入院患者的CON与冠状动脉血运重建的关系。 确定慢性心绞痛与急性心肌梗死患者预后的关系。 这项为期12个月的回顾性队列研究将对1994年至2002年间因治疗急性心肌梗死(AMI)而在美国所有非联邦医院住院的68岁及以上的连续患者进行检查。这项研究将涉及对医疗保险管理数据(MedPAR和分母文件)的二次分析。此外，还将使用其他几个公开可用的数据库来评估个别CON计划的严格性和范围，并控制可能影响每个终点并与CON有关的医院和市场因素(例如，医院竞争、管理保健渗透率、医生专业)。 研究终点将包括：1)因急性心肌梗死入院后30、90、365天使用血管重建术和重新血管重建术的时间；2)30、90或365天内死亡和死亡的时间；以及3)因缺血性心脏病再次入院30、90或365天和重新入院的时间。将使用控制患者、医院和市场因素的多变量模型来评估CON对每个终端的影响。分析将考虑医院和市场内患者的分组，使用针对二分结果(例如，血运重建、死亡率)的通用混合模型，以及针对事件发生时间结果(例如，重新入院时间)的COX回归。

DESCRIPTION (provided by applicant): Certificate of need (CON) is a state-administered regulatory program requiring providers to obtain approval before establishing certain clinical services. A key focus on CON has been revascularization (coronary artery bypass graft surgery [CABG] and percutaneous coronary intervention [PCT]), which proliferated during the 1990s as a treatment for ischemic heart disease. In 1984, federal legislation that mandated CON for all states was repealed. Since then, 25 states have repealed CON for cardiac surgery and cardiac catheterization. There is some evidence that repeal of Con for revascularization may lead to dramatic rises in the number of new programs. However, the impact of the repeal of CON on the overall use of revascularization and on outcomes in older adults has not been adequately investigated. The proposed study will: Determine relationships between CON and use of coronary revascularization for patients admitted for Acute Myocardial Infarction (AMI). Determine relationships between CON and outcomes of patients admitted for AMI. The 12-month retrospective cohort study will examine consecutive patients 68 years and older admitted to all non-federal hospitals in the US for the treatment of acute myocardial infraction (AMI) during 1994 through 2002. The study will involve secondary analyses of Medicare administration data (MedPAR and Denominator Files). In addition, several other publicly available databases will be used to assess the stringency and scope of the individual CON programs and to control for hospital and market-level factors that may influence each endpoint and be endogenous with CON (e.g., hospital competition, managed care penetration, physician specialty). Study endpoints will include: 1) use of revascularization 30,90,365 days after admission for AMI and time to revascularization; 2) death within 30,90, or 365 days and time to death; and 3) readmission for ischemic heart disease within 30,90, or 365 days and time to readmission. The impact of CON on each endpoint will be evaluated using multivariable models that control for patient, hospital, and market factors. Analyses will account for clustering of patient within hospitals and markets using generalized mixed models for dichotomous outcomes (e.g., revascularization, mortality) and Cox regression with stratification for time-to-event outcomes (e.g., time to readmission).