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

炎症性肠病患者预防静脉血栓栓塞的抗凝剂使用、安全性和有效性

• 批准号: 10887842
• 负责人: Ghadeer k. Dawwas
• 金额: $ 24.9万
• 依托单位: VANDERBILT UNIVERSITY MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-01 至 2026-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10887842
• 关键词: Acute; Adherence; Affect; American; American Heart Association; Anticoagulants; Attention; Award; Benefits and Risks; Biometry; Characteristics; Crohn' s disease; Data; Data Linkages; Databases; Diagnosis; Discipline; Disease; Effectiveness; Electronic Health Record; Epidemiology; Event; Exclusion; Flare; Fright; Future; Gastroenterology; Goals; Hematology; Hemorrhage; Hemostatic function; Heparin; Hospitalization; Hospitals; Inflammatory Bowel Diseases; Infrastructure; Inpatients; Institution; International; Knowledge; Learning Skill; Link; Low-Molecular-Weight Heparin; Machine Learning; Methodology; Mission; Modeling; Morbidity - disease rate; National Heart, Lung, and Blood Institute; Oral; Outpatients; Pathway interactions; Patients; Pennsylvania; Phase; Population; Postpartum Period; Prevention; Primary Prevention; Prophylactic treatment; Recommendation; Recurrence; Research; Research Personnel; Research Priority; Risk; Risk Factors; Role; Safety; Secondary Prevention; Societies; Source; Subgroup; Techniques; Thrombosis; Time; Training; Ulcerative Colitis; Universities; Warfarin; alternative treatment; appropriate dose; career development; comparative effectiveness; comparative safety; design; disorder subtype; effectiveness evaluation; experience; high risk; high risk population; hospital readmission; improved; machine learning algorithm; mortality; predictive modeling; prevent; prophylactic; randomized, clinical trials; relapse prevention; subcutaneous; success; thrombotic; venous thromboembolism

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.

项目摘要/摘要 有一个深刻的需要，以改善静脉血栓栓塞[VTE]的治疗和预防，特别是在 炎症性肠病（IBD）患者。这条独立之路奖的申请是提交 由一位致力于改善以下人群的VTE预防和治疗的药物流行病学家撰写 在随机临床试验中经常被排除或代表性极低[RCT]。在三百万美国人中 受IBD影响，约1-7%的患者将发展VTE，这是门诊患者和非门诊患者中发病率和死亡率的重要来源。 和住院病人的情况。虽然抗凝剂在IBD中预防VTE的作用已受到关注， 患者，在该人群中处方抗凝剂存在关键障碍，包括：（1）缺乏数据 抗凝剂预防IBD患者VTE的有效性;（2）害怕出血 并发症;（3）缺乏证据表明抗凝剂在高危亚组中的安全性， 活动性疾病发作或产后IBD患者，他们的不良并发症风险增加。 本研究的总体目标是评价IBD抗凝剂的使用、有效性和安全性 住院和门诊患者。申请人将实现本K99/R 00的拟议目标 在流行病学，生物统计学， 胃肠病学和血液学。首先，申请人将使用组合 机器学习和先进的方法技术，以检查使用，有效性和 抗凝剂在住院患者中的安全性（K99期）。在R 00阶段，申请人将使用链接 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 抗凝剂、华法林和肝素在IBD患者门诊环境中的应用。这项研究提出， K99/R 00至关重要，因为它及时提供了关于抗凝剂风险和获益的必要信息， IBD患者，在可预见的未来，大型RCT不会提供数据。提议的职业 开发和培训目标将为申请人提供预测建模，时变 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人的成功和过渡到 科学独立。