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: 10282884
• 负责人: Ghadeer k. Dawwas
• 金额: $ 9.19万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-01 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10282884
• 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; Flare; Fright; Future; Gastroenterology; Goals; Hematology; Hemorrhage; Hemostatic function; Heparin; Hospitals; Inflammatory Bowel Diseases; Inpatients; International; Knowledge; 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; Randomized Clinical Trials; Recommendation; Recurrence; Research; Research Personnel; Research Priority; Risk; Risk Factors; Role; Safety; Secondary Prevention; Societies; Source; Subgroup; Techniques; Thrombosis; Time; Training; Training and Infrastructure; Ulcerative Colitis; Universities; Use Effectiveness; Warfarin; alternative treatment; appropriate dose; base; 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; skills; subcutaneous; success; 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.

项目概要/摘要 迫切需要改善静脉血栓栓塞 [VTE] 的治疗和预防，特别是在 炎症性肠病 [IBD] 患者已提交此独立之路奖申请。 由药物流行病学家致力于改善以下人群的 VTE 预防和治疗 在 300 万美国人的随机临床试验 [RCT] 中经常被排除或代表性不足。 受 IBD 影响，约 1-7% 的患者会发生 VTE，这是门诊患者发病率和死亡率的重要来源 抗凝剂在 IBD 预防 VTE 中的作用已引起人们的关注。 对于此类患者，在该人群中处方抗凝药物存在主要障碍，包括：(1) 缺乏数据 抗凝剂预防 IBD 患者 VTE 的有效性；（2）对出血的恐惧； 并发症；(3) 缺乏抗凝剂在高危亚组（例如患者）中安全性的证据 患有活动性疾病发作或产后 IBD 患者，这些患者发生不良并发症的风险增加。 本研究的总体目标是评估抗凝剂在 IBD 中的使用、有效性和安全性 申请人将实现本 K99/R00 的拟议目标。 该奖项是在流行病学、生物统计学、 首先，申请人将结合使用宾夕法尼亚大学的胃肠病学和血液学。 机器学习和先进的方法技术来检查使用、有效性和使用的预测因素 住院环境中抗凝剂的安全性（K99 阶段） 在 R00 阶段，申请人将使用链接的。 电子健康记录/索赔数据库，用于检查直接口服治疗的相对有效性和安全性 本研究提出在门诊 IBD 患者中使用抗凝剂、华法林和肝素。 K99/R00 至关重要，因为它及时提供了有关抗凝剂的风险和益处的所需信息。 IBD 患者，在可预见的将来不会从大型随机对照试验中获得数据。 发展和培训目标将为申请人提供预测建模、时变模型等方面的培训 调整和机器学习的成功完成。 宾夕法尼亚大学的机构支持将保证申请人的成功和过渡 科学的独立性。