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

描述(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的患者。如果这些患者发生不良事件的风险更大，如果严格控制的好处因预期寿命缩短而受到限制，那么可能就没有理由严格控制A1c和心血管风险因素，如升高的低密度脂蛋白(LDL)和血压(BP)。为了解决这个问题，指南建议对复杂的患者进行个体化治疗。不幸的是，几乎没有证据支持这些个体化治疗决定。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，现有的指南将得到显著加强，但对复杂患者进行严格控制或药物治疗试验的新研究将极不可能进行。这一新信息尤其重要，因为治疗指南越来越多地被用于制定公开报告的质量指标和指导按业绩支付(P4P)努力。如果没有证据基础来适当修改指南，医生严格遵守建议的动机可能会产生反常效果，可能会损害患者。我们的具体目标是考察患者复杂性在以下关系中的作用：(1)患者对A1c、低密度脂蛋白和血压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)长期和短期的A1c、低密度脂蛋白和血压控制与特定的健康结果(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控制的典型药物方案以及可能的药物相关发病率。我们的样本包括大约8,300名糖尿病患者，他们在2003-2012年间由一个大型的中西部多专科医生小组护理。我们将电子健康记录中的临床数据(例如A1c、LDL、BP值)与Medicare和两个大型地方健康维护组织(HMO)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。总体而言，我们的调查结果将影响糖尿病治疗指南、质量指标的发展、按绩效支付阈值的构建以及干预措施的针对性。

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.