Anticoagulant use, safety, and effectiveness for venous thromboembolism prevention in inflammatory bowel disease patients

项目摘要/摘要 迫切需要改进静脉血栓栓塞症的治疗和预防，特别是在 炎症性肠病患者[IBD]。这份独立之路奖的申请已提交 由一位致力于改善VTE预防和治疗的药物流行病学家 在随机临床试验[RCT]中经常被排除或被大大低估。在300万美国人中 受IBD的影响，约1-7%的患者会患上VTE，这是两个门诊患者发病率和死亡率的重要来源 和住院设置。虽然抗凝剂在预防IBD中的VTE方面的作用受到了关注 在患者中，在该人群中使用抗凝剂存在关键障碍，包括：(1)缺乏数据 抗凝剂对IBD患者静脉血栓形成的预防作用；(2)害怕出血 并发症；以及(3)缺乏抗凝剂在高危人群(如患者)中安全性的证据 有活跃的疾病症状或产后IBD患者，他们不良并发症的风险增加。 这项研究的首要目标是评估抗凝剂在IBD中的使用、有效性和安全性。 住院病人和门诊病人。申请者将达到本K99/R00的建议目标 该奖项由跨流行病学、生物统计学、 宾夕法尼亚大学的胃肠病学和血液学。首先，申请者将使用组合 机器学习和先进的方法技术，以检查使用、有效性和 住院环境中抗凝剂的安全性(K99阶段)。在R00阶段，申请者将使用链接 电子健康记录/索赔数据库，以检查直接口服的比较有效性和安全性 门诊IBD患者的抗凝剂、华法林和肝素。这项研究中提出的 K99/R00是至关重要的，因为它及时提供了关于抗凝剂的风险和好处的所需信息 IBD患者，在可预见的未来不会从大型随机对照试验中获得数据。计划中的职业 发展和培训目标将为申请者提供时变预测建模方面的培训 调整和机器学习。成功完成拟议的培训、基础设施和 宾夕法尼亚大学的机构支持将保证申请者的成功和过渡到 科学上的独立。

PROJECT SUMMARY/ABSTRACT There is a profound need to improve venous thromboembolism [VTE] treatment and prevention, particularly in patients with inflammatory bowel disease [IBD]. This Pathway to Independence Award application is submitted by a pharmacoepidemiologist committed to improving VTE prevention and treatment in populations who are often excluded or vastly under-represented in randomized clinical trials [RCTs]. Of the 3 million Americans affected by IBD, ~1–7% will develop VTE, a significant source of morbidity and mortality, in both the outpatient and inpatient settings. While attention has been paid to the role of anticoagulants for VTE prevention in IBD patients, there are key barriers to prescribing anticoagulants in this population including: (1) absence of data on the effectiveness of anticoagulants for the prevention of VTE in IBD patients; (2) fear of bleeding complications; and (3) lack of evidence on the safety of anticoagulants in high-risk subgroups such as patients with active disease flares or postpartum IBD patients, who are at an increased risk of adverse complications. The overarching goal of this research is to evaluate the use, effectiveness, and safety of anticoagulants in IBD patients in the inpatient and outpatient settings. The applicant will achieve the proposed aims of this K99/R00 award under the guidance of established researchers who span the disciplines of epidemiology, biostatistics, gastroenterology, and hematology at the University of Pennsylvania. First, the applicant will use a combination of machine learning and advanced methodological techniques to examine predictors of use, effectiveness, and safety of anticoagulants in the inpatient setting (K99 phase). In the R00 phase, the applicant will use linked electronic health records/claims database to examine the comparative effectiveness and safety of direct oral anticoagulants, warfarin, and heparins in IBD patients in the outpatient setting. The research proposed in this K99/R00 is critical since it provides timely needed information on the risks and benefits of anticoagulants in IBD patients, data that will not be forthcoming from large RCTs in the foreseeable future. The proposed career development and training goals will provide the applicant with training in predictive modeling, time-varying adjustment, and machine learning. The successful completion of the proposed training, infrastructure, and institutional support at the University of Pennsylvania will guarantee the applicant's success and transition to scientific independence.