Guideline Adherence and Short/Long-term Health Outcomes in Patients with Diabetes

描述（由申请人提供）：目前对糖尿病患者的治疗建议认识到严格控制糖化血红蛋白（A1c）和心血管疾病（CVD）危险因素可能不适合复杂患者。如果这些患者发生不良事件的风险更大，并且由于预期寿命缩短而严格控制的益处有限，则可能没有理由追求严格控制A1c和CVD危险因素，如低密度脂蛋白（LDL）和血压（BP）升高。为了解决这个问题，指南建议对复杂患者进行个体化治疗。不幸的是，几乎没有证据支持这些个性化的治疗决定。由于大多数药物治疗试验排除了复杂的患者，严格控制的结果和用于实现严格控制的典型药物方案的效果都不为人所知。有了这些信息，现有的指导方针将得到显著加强，但在复杂患者中进行严格控制或药物治疗试验的新研究是极不可能的。随着治疗指南越来越多地用于制定公开报告的质量指标和指导按绩效付费（P4P）工作，这一新信息尤为重要。如果没有适当修改指南的证据基础，医生严格遵守建议的动机可能会产生可能伤害患者的反常效果。我们的具体目的是研究患者复杂性在以下关系中的作用：(1)患者A1c、LDL和BP的长期和短期控制水平与总体健康结果（急诊室就诊、住院和死亡），(2)长期和短期A1c、LDL和BP控制与特定健康结果（糖尿病并发症和可能的药物相关发病率），以及(3)用于实现A1c、LDL和BP控制和可能的药物相关发病率的典型药物方案。我们的样本包括大约8300名糖尿病患者，他们在2003-2012年期间接受了中西部一个大型多专科医生小组的治疗。我们将电子健康记录中的临床数据（如糖化血红蛋白、低密度脂蛋白、血压值）与医疗保险和两家大型当地健康维护组织（HMOs）的管理数据联系起来。我们的分析方法包括使用边际结构建模来利用我们数据的纵向性质。总的来说，我们的研究结果将影响糖尿病治疗指南、质量指标的制定、按绩效付费阈值的构建以及干预措施的目标。

DESCRIPTION (Provided by Applicant): Current treatment recommendations for patients with diabetes recognize that tight control of glycosylated hemoglobin (A1c) and cardiovascular disease (CVD) risk factors may not be appropriate for complex patients. If the risks of adverse events are greater for these patients and if the benefits of tight control are limited due to shortened life expectancy, there may be little reason to pursue tight control of A1c and CVD risk factors such as elevated low-density lipoprotein (LDL) and blood pressure (BP). To address this, guidelines recommend individualizing treatment for complex patients. unfortunately, little evidence exists to support these individualized treatment decisions. Because most drug treatment trials excluded complex patients, neither the outcomes of tight control nor the effects of the typical drug regimens used to achieve tight control are known. Existing guidelines would be significantly strengthened with this information, but it is extremely unlikely that new studies of tight control or drug treatment trials in complex patients will ever be conducted. This new information is particularly important as treatment guidelines are increasingly used to develop publicly-reported quality metrics and guide pay-for-performance (P4P) efforts. Without an evidence base to modify guidelines appropriately, physician incentives to adhere tightly to recommendations could have perverse effects that might harm patients. Our specific aims examine the role of patient complexity in the relationship between: (1) patients' long-term and short-term control levels for A1c, LDL, and BP and overall health outcomes (ER visits, hospitalizations, and death), (2) long-term and short-term A1c, LDL, and BP control and specific health outcomes (diabetes complications and possible drug-related morbidity), and (3) typical drug regimens used to achieve A1c, LDL, and BP control and possible drug-related morbidity. Our sample includes approximately 8,300 patients with diabetes who were cared for by a large Midwestern multi-specialty physician group during 2003-2012. We link clinical data (e.g., A1c, LDL, BP values) from the electronic health record to administrative data from Medicare and two large local health maintenance organizations (HMOs). Our analytic approach involves the use of marginal structural modeling to take advantage of the longitudinal nature of our data. Overall, the results from our investigation will impact diabetes treatment guidelines, development of quality metrics, construction of pay-for-performance thresholds, and targeting of interventions.