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.
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 focussed studies, which will generate the pilot data needed to plan prospective trials in the future.
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