Hydrocephalus Clinical Research Network: a consortium for pediatric hydrocephalus

脑积水临床研究网络：小儿脑积水联盟

• 批准号: 7827852
• 负责人: John Kestle
• 金额: $ 49.73万
• 依托单位: UNIVERSITY OF UTAH
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2011-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7827852
• 关键词: Address; Adherence; Admission activity; Area; Case Series; Catheters; Cerebrospinal fluid shunts procedure; Child; Childhood; Clinical; Clinical Research; Collaborations; Data; Data Analyses; Data Coordinating Center; Data Set; Diagnosis; Future; Goals; Hospital Charges; Hospitals; Human Resources; Hydrocephalus; Infection; Institution; Lead; Length of Stay; Neurosciences; Operative Surgical Procedures; Outcome; Patients; Pilot Projects; Prevention; Problem Solving; Procedures; Prospective Studies; Protocols documentation; Reporting; Research; Research Ethics Committees; Research Infrastructure; Research Personnel; Research Support; Resources; Risk; Safety; Secure; Shunt Device; Structure; System; Techniques; Treatment Efficacy; Ultrasonography; Utah; Variant; Ventricular; Very Low Birth Weight Infant; Writing; base; clinical practice; cohort; comparative effectiveness; design; effectiveness research; effectiveness trial; electronic data; experience; interest; meetings; member; patient population; prospective

DESCRIPTION (provided by applicant): This application addresses broad challenge area 05 Comparative Effectiveness Research and specific challenge topic 05-NS-101 Consortia Building for Comparative Effectiveness Research in Clinical Neuroscience. The long-term objective is to shift the current research paradigm from single center retrospective case series reports to prospective multicenter protocol driven focused studies using modern electronic data capture systems and to establish a network infrastructure as a lasting resource for the conduct of comparative effectiveness research in pediatric hydrocephalus. The approach will be to: a. Establish a collaboration group of member institutions and investigators with dedicated research support personnel, b. supported by an experienced data coordinating center, c. conduct a core data project, which will characterize the patient population and their management in detail, d. conduct focused studies in specific areas of pediatric hydrocephalus. Early Progress Interested parties began meeting in the last summer of 2006 and developed a relationship with the Utah Data Coordinating Center, developed the Hydrocephalus Clinical Research Network (HCRN) committee structure and governance documents and developed the initial study protocols. These are: 1. The Core Data Project, which is designed to characterize children with hydrocephalus and their management in detail. It has accrued 605 patients in the first 10 months. 2. A protocol to reduce shunt infections, which has accrued 1,162 procedures in the first 17 months. Preliminary analysis suggests decreased infection rates with adherence to the protocol. 3. A protocol to evaluate the management of post-hemorrhagic hydrocephalus. A retrospective pilot study has been conducted across the Network and a prospective protocol is planned to compare two surgical techniques for the management of post- hemorrhagic hydrocephalus. 4. A protocol to evaluate ultrasound guided shunt placement has been written, obtained IRB approval at all centers and has just started patient accrual. The two year goal for the Network is to complete these projects and based on their findings, developed R01 applications for prospective trials in 2011. Pediatric hydrocephalus is a very common problem resulting in almost 40,000 hospital admissions, more than 400,000 hospital days and $2,000,000,000 in hospital charges in 2003. With very few exceptions, clinical research has been conducted at a single center with retrospective data, which do not allow strong conclusions about treatment efficacy. This proposal is to establish a coordinated network to identify the areas of most urgent need in hydrocephalus research and conduct prospective studies to solve these problems. In the first 18 months of collaboration, the Network has developed a Core Data Project and three focused studies, which will generate the pilot data needed to plan prospective trials in the future.

描述（由申请人提供）：本申请涉及广泛挑战领域05比较有效性研究和特定挑战主题05-NS-101临床神经科学比较有效性研究联盟建设。长期目标是将当前的研究范式从单中心回顾性病例系列报告转变为使用现代电子数据采集系统的前瞻性多中心方案驱动的重点研究，并建立网络基础设施作为儿科脑积水比较有效性研究的持久资源。办法是：a.建立一个由成员机构和研究人员组成的协作小组，配备专门的研究支持人员，B。由有经验的数据协调中心支持，c.进行核心数据项目，该项目将详细描述患者群体及其管理，d.在小儿脑积水的特定领域进行重点研究。早期进展感兴趣的各方于2006年最后一个夏天开始开会，并与犹他州数据协调中心建立了关系，制定了脑积水临床研究网络（HCRN）委员会结构和管理文件，并制定了初始研究方案。这些是：1.核心数据项目，旨在详细描述脑积水儿童及其管理。在头10个月里，它已经积累了605名病人。2.一项减少分流感染的协议，在前17个月已经累计了1,162例手术。初步分析表明，遵守方案可降低感染率。3.出血后脑积水治疗的评价方案。在整个网络中进行了一项回顾性初步研究，并计划制定一项前瞻性方案，以比较两种手术技术治疗出血后脑积水。4.已经编写了一份评价超声引导分流放置的方案，并在所有中心获得了IRB批准，并且刚刚开始招募患者。该网络的两年目标是完成这些项目，并根据他们的研究结果，在2011年开发R 01应用程序进行前瞻性试验。小儿脑积水是一个非常常见的问题，2003年导致近40，000例住院，超过400，000个住院日和2，000，000，000美元的住院费用。除了极少数例外情况，临床研究是在一个单一的中心进行的，具有回顾性数据，无法得出关于治疗疗效的强有力的结论。该建议旨在建立一个协调网络，以确定脑积水研究中最迫切需要的领域，并进行前瞻性研究以解决这些问题。在合作的头18个月里，该网络制定了一个核心数据项目和三项重点研究，将产生规划未来前瞻性试验所需的试点数据。