Medications and Weight Gain in PCORnet: The MedWeight Study

PCORnet 中的药物和体重增加：MedWeight 研究

基本信息

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
项目类别：
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

项目摘要

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项目摘要/摘要几项先前的研究已经评估了个人处方药是否与体重有关糖尿病和高胆固醇等疾病的风险增加并增加。这些负面的健康影响药物是针对治疗慢性疾病的药物特别关注的问题，通常需要长期或终身治疗。患者还确定体重增加是药物的常见原因不遵守，导致健康状况较差。先前研究的局限性包括有限的长期跟进 - UP，缺乏对班级中所有子类或常见的个人药物的比较，以及缺乏因果方法的使用，可以帮助管理患者的基线和时变差异规定了不同的药物。先前的研究通常不够大，无法确定是否关联因开始或其他患者特征（例如种族）的年龄而有所不同性别和体重状况。在大型医疗机构网络中使用有关患者的数据，这项研究将是启动药物后，对体重增加和代谢风险的全面评估最多可用于治疗糖尿病，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疾病的所有类别，并且与体重增加和代谢风险有关；这些班级中的每一个都有几种可用于治疗的选择。该研究将包括孩子和成人，将涉及对6种药物类别的分别评估，比较每个班级中的子类和常规的个人药物。研究的设置将是 19种不同的医疗机构参加了国家以患者为中心的临床研究网络（PCORNET）。 PCORNET促进了跨机构的，比较有效性研究，尽管使用了通用数据模型，在该模型中，每个机构都以相同格式组织其临床信息，以允许跨站点的数据直接合并。第一个研究目标将是详细的数据质量评估，将衡量与预期的体重和身高和药物处方率的偏差每个班级。此目标将调整现有数据质量方法以进行故障排除和补救数据问题并将产生可以在PCORNET和其他医疗保健网络中缩放的方法。这第二个目的是检查药物启动和体重结局，事件糖尿病和变化在胆固醇中，第三个目标将评估更多的药物使用。在这些后一个目标中，我们将合并高级统计方法，可以以新颖的方式解释患者的差异基线和随访过程。这项大规模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，可行的信息以帮助患者和临床医生对药物做出最明智的选择。