Medications and Weight Gain in PCORnet: The MedWeight Study

PCORnet 中的药物和体重增加：MedWeight 研究

• 批准号: 10348172
• 负责人: Jason Perry Block
• 金额: $ 69.66万
• 依托单位: HARVARD PILGRIM HEALTH CARE, INC.
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-02-20 至 2024-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10348172
• 关键词: Adult; Affect; Age; Antidepressive Agents; Antiepileptic Agents; Antihypertensive Agents; Antipsychotic Agents; Benchmarking; Characteristics; Child; Cholesterol; Chronic; Chronic Disease; Clinical; Clinical Data; Clinical Research; Complex; Contraceptive Agents; Data; Diabetes Mellitus; Drug Prescriptions; Electronic Health Record; Ensure; Epilepsy; Ethnic group; Evaluation; Exposure to; Fluoxetine; Frequencies; Gender; Geographic Locations; Geography; Health; Healthcare; Healthcare Systems; Height; Heterogeneity; Hypertension; Incidence; Individual; Institution; Investigation; Joints; Length; Longterm Follow-up; Measures; Mental Depression; Metabolic; Methodology; Methods; Outcome; Patients; Pattern; Pharmaceutical Preparations; Population; Population Heterogeneity; Psychoses; Race; Reporting; Research; Risk; Selective Serotonin Reuptake Inhibitor; Sertraline; Site; Source; Statistical Methods; Structure; Subgroup; Time; Weight; Weight Gain; clinical encounter; comorbidity; comparative; comparative effectiveness study; data modeling; data quality; diabetes risk; follow-up; longitudinal analysis; medication nonadherence; novel; patient oriented; randomized trial; remediation; scale up; side effect; treatment choice; treatment effect

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.

7项目概要/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 增加并增加患糖尿病和高胆固醇等疾病的风险。这些负面的健康影响 对于用于治疗慢性疾病的药物，这通常需要 长期或终身治疗。患者也将体重增加确定为药物治疗的常见原因 不遵守，导致更糟糕的健康结果。先前研究的局限性包括长期随访有限- 向上，缺乏对所有子类或一类内常用处方药的比较，以及 缺乏使用因果关系方法来帮助管理患者的基线和随时间变化的差异 开了不同的药以前的研究通常不足以确定是否 相关性因开始用药时的年龄或其他患者特征，如种族， 性别和体重状况使用大型医疗机构网络中的患者数据，本研究将 开始用药后长达10.5年的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 都是用于治疗慢性病的药物，与体重增加和代谢风险有关; 这些类别中的每一个也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种药物类别的单独评估，比较 亚类和每个类别内的常用处方药。研究的背景将是 19个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 通用数据模型，其中每个机构以相同的格式组织其临床信息， 跨站点直接合并数据。第一项研究的目的是进行详细的数据质量评估， 将测量体重和身高与预期模式的偏差以及药物处方率， 每个班级。该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修复 问题，并将产生一种方法，可以在PCORnet和其他医疗保健网络的规模。的 第二个目标将是检查药物治疗开始和体重结果，糖尿病事件和变化 第三个目标将评估更持续的药物使用。在这些目标中，我们将 结合先进的统计方法，可以以新的方式解释患者的差异， 基线和随访过程中。这项大规模的研究将是迄今为止最全面的研究 药物引起的体重增加和代谢风险，并将提供重要的，可操作的信息，以帮助 患者和临床医生会对药物做出最明智的选择。