Validation of a pediatric thrombosis risk assessment model and characterization of bleeding in hospitalized children through the Children's Hospital Acquired Thrombosis (CHAT) Consortium

通过儿童医院获得性血栓 (CHAT) 联盟验证儿科血栓风险评估模型和住院儿童出血特征

• 批准号: 10673606
• 负责人: Julie Ann Jaffray
• 金额: $ 17.13万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-01 至 2027-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10673606
• 关键词: Address; Adult; Anticoagulants; Anticoagulation; Area; Award; Biological Assay; Blood coagulation; Calibration; California; Case/Control Studies; Characteristics; Child; Child Care; Childhood; Clinical; Clinical Research; Clinical Trials; Computerized Medical Record; Data; Development; Diagnosis; Discrimination; Disease; Dose; Drug Monitoring; Enrollment; Environment; Event; Faculty; Focus Groups; Funding; Future; Goals; Health; Health Care Costs; Hemoglobin; Hemorrhage; Hospitalization; Hospitalized Child; Hospitals; Incidence; Information Technology; Inpatients; Institution; Intervention Trial; Interview; Knowledge; Knowledge acquisition; Laboratories; Life; Location; Logistic Regressions; Los Angeles; Lung; Measures; Medical; Mentored Patient-Oriented Research Career Development Award; Mentors; Methods; Mission; Modeling; Monitor; Morbidity - disease rate; Multicenter Studies; Multivariate Analysis; Names; Newly Diagnosed; Nurses; Outcome; Pain; Patients; Pediatric Hospitals; Pediatrics; Pharmaceutical Preparations; Phase; Physicians; Populations at Risk; Prevention; Prevention strategy; Provider; Publishing; Qualitative Research; ROC Curve; Random Allocation; Randomized, Controlled Trials; Registries; Research; Research Design; Research Personnel; Risk; Risk Assessment; Risk Factors; Safety; Sampling; Severities; Signs and Symptoms; Specialist; Standardization; Structure; Target Populations; Thrombosis; Time; Training; Transcript; United States National Institutes of Health; Universities; Validation; Venous Insufficiency; aged; blood product; career; career development; cohort; deep vein; demographics; density; design; disability; effective intervention; efficacy evaluation; experience; high risk; implementation science; improved; indexing; inpatient service; large datasets; member; mortality; pediatric patients; prevent; prophylactic; prospective; skill acquisition; skills; standard of care; success; training opportunity; uptake; venous thromboembolism

PROJECT SUMMARY/ABSTRACT Venous thromboembolism (VTE), a serious and life-threatening condition, has increased in incidence for hospitalized pediatric patients by 70-200%. This has led to increased morbidity, mortality and longer hospitalizations, and is thought to be due to more effective care of children with serious and life-threatening disorders. Unfortunately, it is unclear which children are at the highest risk of hospital acquired (HA) VTE and how to prevent these events due to many studies being single center with small case numbers. This study addresses the critical need to identify children at a high risk of HA-VTE using a risk assessment model (RAM), but a low risk of bleeding. This cohort will be used as the target population for trials evaluating the efficacy and safety of prophylactic anticoagulation in order to progress towards the long term goal of HA-VTE prevention in children. The overall objectives of this study are to (1) prospectively validate a pediatric HA-VTE RAM created through Dr. Jaffray’s multi-center Children’s Hospital Acquired Thrombosis (CHAT) Consortium using a case-control study design and electronic medical record review (EMR); (2) evaluate the incidence and characterization of bleeding in hospitalized children on and off anticoagulation through EMR review; and (3) explore barriers to provider engagement with RAM implementation by conducting focus groups and semi- structured interviews of inpatient medical teams using qualitative thematic analysis strategies. To achieve these research aims, Dr. Jaffray has the immediate career goals to obtain new knowledge, skills, and experience that will allow her to (1) analyze data from large datasets from multicenter studies and build and validate risk models through multivariate analysis; (2) develop qualitative research skills to design and analyze focus groups and semi-structured interviews; and (3) acquire the knowledge to plan and conduct randomized controlled trials. Achieving these career goals will support her long term career goal of becoming an independently funded, leader in the effort to determine efficacious and safe VTE prevention strategies in children through multicenter randomized controlled trials. Dr. Jaffray will accomplish her research and training aims with the support of her primary mentor, Dr. Guy Young (pediatric thrombosis clinical research), and co-mentors, Dr. Neil Goldenberg (pediatric clinical trial research), Dr. Ernest Amankwah (biostatics), Dr. Neil Zakai (adult thrombosis clinical research) and Dr. Elizabeth Burner (qualitative research). Dr. Jaffray’s plan for career development is enhanced by the outstanding research environment at Children’s Hospital Los Angeles and The University of Southern California, which provides junior faculty members with numerous didactic and training opportunities designed specifically to facilitate the transition to research career independence. By completing her research and training aims, Dr. Jaffray will take the first necessary step in identifying children at high risk of HA- VTE who may safely benefit from prevention strategies and subsequently reduce the incidence of pediatric VTE.

项目摘要/摘要 静脉血栓栓塞（VTE）是一种严重且威胁生命的状况，发生率增加了 住院的小儿患者高70-200％。这导致发病率增加，死亡率更长 住院，被认为是由于对严重和威胁生命的儿童的更有效的护理 疾病。不幸的是，目前尚不清楚哪些儿童处于获得医院（HA）VTE的最高风险和 如何防止这些事件，因为许多研究是单一中心，案例数很小。这项研究 解决了使用风险评估模型识别高VTE风险高风险的儿童的关键需求 （RAM），但出血的风险很低。该队列将用作评估试验的目标人群 预防性抗凝治疗的功效和安全性，以朝着HA-VTE的长期目标发展 儿童预防。这项研究的总体目标是（1）前瞻性验证儿科HA-VTE RAM通过Jaffray博士的多中心儿童医院获得了血栓形成（CHAT）财团 使用病例对照研究设计和电子病历审查（EMR）； （2）评估事件和 通过EMR审查在抗凝治疗中和关闭抗凝治疗的住院儿童中出血的表征； （3） 通过举办焦点小组和半决赛来探索提供者参与RAM实施的障碍 使用定性主题分析策略对住院医疗团队的结构化访谈。实现 这些研究的目的是，贾夫雷博士的职业目标是获得新知识，技能和 将使她能够（1）从多中心研究和构建和 通过多元分析验证风险模型； （2）发展定性研究技能来设计和分析 焦点小组和半结构化访谈； （3）获取知识以计划和进行随机进行 对照试验。实现这些职业目标将支持她成为一个长期职业目标 独立资助的领导者，努力确定儿童有效且安全的预防策略 通过多中心随机对照试验。 Jaffray博士将完成她的研究和培训目标 她的主要导师盖伊·杨（Guy Young）的支持（小儿血栓形成临床研究）和联合给予者， Neil Goldenberg博士（小儿临床试验研究），Ernest Amankwah博士（Biostatics），Neil Zakai博士（成人 血栓形成临床研究）和伊丽莎白·伯恩（Elizabeth Burner）博士（定性研究）。 Jaffray博士的职业计划 洛杉矶儿童医院的杰出研究环境增强了发展 南加州大学，为初级教师提供许多教学和培训 专门设计的机会是为了促进向研究职业独立性的过渡。通过完成 她的研究和培训目的是，贾夫雷博士将迈出第一步，以确定具有高风险的儿童 可以安全地从预防策略中受益并随后减少小儿的事件的人 VTE。