Medications and Weight Gain in PCORnet: The MedWeight Study

7项目摘要/摘要 先前的几项研究已经评估了个别处方药是否与体重有关 增加体重，增加糖尿病和高胆固醇等疾病的风险。这些对健康的负面影响 对于用于治疗慢性病的药物来说，从药物中分离是一个特别令人担忧的问题，这通常需要 非常长期或终身的治疗。患者也认为体重增加是服药的常见原因。 不遵守，导致更糟糕的健康结果。先前研究的局限性包括有限的长期随访-- UP，缺乏一个类别内所有亚类或常用个别药物的比较，以及 缺乏可帮助管理患者基线和时变差异的因果方法学 开了不同的药。以前的研究通常不够大，不足以确定 相关关系因开始用药的年龄或其他患者特征而不同，如种族， 性别和体重状况。使用大型医疗机构网络中患者的数据，这项研究将是 开始服药后10.5年内体重增加和代谢风险的综合评估 用于治疗糖尿病、高血压、癫痫、抑郁症、精神病以及避孕药。这些 是否所有的药物都用于治疗慢性病，并与体重增加和代谢风险有关； 这些类别中的每一个也都有几个可用于治疗的选择。这项研究将包括儿童 和成人，并将涉及6个药物类别的单独评估，比较 亚类和每类中常用的个别药物。这项研究的背景是 19家不同的医疗机构参与国家以患者为中心的临床研究网络 (PCORnet)。PCORnet通过使用 公共数据模型，其中每个机构以相同的格式组织其临床信息，从而允许 跨站点直接合并数据。第一个研究目标将是详细的数据质量评估， 将测量与预期体重和身高模式的偏差以及 每节课。这一目标将调整现有的数据质量方法，以便对数据进行故障排除和补救 问题，并将产生一种方法，可以在PCORnet和其他医疗保健网络中进行扩展。这个 第二个目标将是检查用药开始和体重结果、糖尿病事件和变化。 第三个目标将评估更持续的药物使用。在后两个目标中，我们将 采用先进的统计方法，以新颖的方式解释患者之间的差异， 在基线和随访过程中。这项大规模研究将是迄今为止最全面的研究。 并将提供重要的、可操作的信息来帮助 患者和临床医生对药物的选择是最明智的。

7 Project Summary/Abstract Several prior studies have assessed whether individual prescription medications are associated with weight gain and increased risk for conditions such as diabetes and high cholesterol. These negative health effects from medications are a particular concern for medications used to treat chronic disease, which often require very long term or lifelong treatment. Patients also identify weight gain as a common reason for medication nonadherence, leading to worse health outcomes. Limitations of prior studies include limited long-term follow- up, lack of comparison of all subclasses or commonly-prescribed individual medications within a class, and lack of use of causal methodologies that can help manage baseline and time-varying differences in patients prescribed different medications. Prior studies have typically not been large enough to determine whether associations differ by age when medications are initiated or by other patient characteristics, such as race, gender, and weight status. Using data on patients in a large network of healthcare institutions, this study will be a comprehensive assessment of weight gain and metabolic risk up to 10.5 years after initiating medications used to treat diabetes, high blood pressure, epilepsy, depression, psychoses, as well as contraceptives. These are all classes used to treat chronic diseases and have been associated with weight gain and metabolic risk; each of these classes also have several choices that can be used for treatment. The study will include children and adults and will involve separate evaluations of the 6 medication classes, comparing effects between subclasses and commonly-prescribed individual medications within each class. The setting for the study will be 19 diverse healthcare institutions participating in the National Patient-Centered Clinical Research Network (PCORnet). PCORnet facilitates cross-institutional, comparative effectiveness studies though use of a Common Data Model, in which each institution organizes its clinical information in the same format allowing for straightforward merging of data across sites. The first study Aim will be a detailed data quality assessment that will measure deviations from expected patterns of weight and height and rates of medication prescriptions in each class. This Aim will adapt existing data quality methods to allow for troubleshooting and remediating data issues and will produce an approach that can be scaled across PCORnet and other healthcare networks. The second Aim will be an examination of medication initiation and weight outcomes, incident diabetes, and change in cholesterol, and the third Aim will assess more sustained use of medications. In these latter Aims, we will incorporate advanced statistical methods that can account for differences in patients in novel ways, both at baseline and over the course of follow-up. This large-scale study will be the most comprehensive study to date of medication-induced weight gain and metabolic risk and will provide important, actionable information to help patients and clinicians make the most informed choices about medications.