The Feasibility of Implementing a National Spina Bifida Registry in Wisconsin

说明：（由申请人提供） 脊柱裂（SB）是儿童和成人残疾的最常见原因之一。大约有1,400人与SB一起生活在威斯康星州。SB患者的医疗保健很复杂，涉及多种身体、学习和心理社会问题。然而，很少有全面的数据是关于SB的临床护理。本项目的总体目标是测试的可行性，利用一个国家标准化的注册工具，收集数据的SB患者在脊柱裂计划在威斯康星州儿童医院（CHW）。本项目的具体目标是：具体目标1：每年招募125-175例SB计划患者并获得同意参加国家SB患者登记研究。具体目标二：以有效的方式采集CHW脊柱裂诊所年度临床就诊的患者数据，并传输到中央数据库。具体目标3：在疾病预防控制中心协调委员会中提供代表，为国家项目的总体方向做出贡献，并确定研究机会。这项为期3年的纵向描述性研究将在研究主要研究者（PI）Kathleen Sawin（DNS，CPNP，FAAN）的领导下与SB项目的医学总监John Thometz（MD）合作进行。具体而言，该项目将确定CHW SB计划中125-175个家庭同意的可行性，以有效的方式获取年度临床就诊的登记数据，并将数据上传到CDC网站。主要研究者、医学总监和研究护士将与SB计划提供者合作，使其了解所需的组成部分和研究定义。将在年度访视时从现有病历中提取数据。收集的数据元素将包括受试者人口统计学、病史和手术史以及选择的测量值。此外，将报告任何死亡的具体数据。上传至本登记研究的所有数据都将去识别化，并将使用唯一的CDC编号提交第2年和第3年的数据，这些数据可与第1年相关联。CDC协调委员会将提供数据分析指南和总体项目方向。在威斯康星州实施国家脊柱裂登记的可行性项目叙述建立国家脊柱裂登记中心将收集儿童、成人和脊柱裂家庭的关键临床信息，这将产生几个重要的结果。国家登记处将提高脊柱裂患者及其家属的护理质量，并确定未来研究的领域。威斯康星州儿童医院对该登记的贡献将增加有价值的内容，并参与该项目的总体方向。

DESCRIPTION: (Provided by applicant.) Spina Bifida (SB) is one of the most common causes of disability among children and adults. Approximately 1,400 people are living with SB in Wisconsin. Health care for persons with SB is complex and involves multiple physical, learning, and psychosocial issues. Yet little comprehensive data is available regarding clinical care in SB. The overall goal of this project is to test the feasibility of utilizing a national standardized registry tool to collect data on patients with SB in the Spina Bifida Program at Children's Hospital of Wisconsin (CHW). The specific aims of this project are to: Specific Aim 1: To recruit and consent 125-175 SB Program patients annually to participate in the national SB patient registry. Specific Aim 2: To capture patient data for annual clinical encounters at the Spina Bifida Clinic at CHW in an efficient manner and transmit to a central data repository. Specific Aim 3: To provide representation on the CDC Coordinating Committee to contribute to the overall direction of the national project and identify research opportunities. This 3-year longitudinal descriptive study will be carried out under the leadership of study Principal Investigator (PI) Kathleen Sawin, DNS, CPNP, FAAN in collaboration with the Medical Director of the SB Program, John Thometz, MD. Specifically, this project will determine the feasibly of consenting 125-175 families in the SB Program at CHW, capturing the registry data on annual clinical encounters in an efficient manner, and uploading data to the CDC site. The PI, medical director and research nurse will work with SB Program providers to orient them to the required components and study definitions. The data will be extracted at annual visits from existing medical records. Data elements collected will include participant demographics, medical and surgical history, and select measurements. In addition, specific data will be reported for any deaths. All data uploaded to this registry will be de-identified and a unique CDC number will be used to submit data in year 2 and 3 that can be linked to year 1. Guidance for data analysis as well as overall project direction will be provided by CDC Coordinating Committee The Feasibility of Implementing a National Spina Bifida Registry in Wisconsin Project Narrative The establishment of a national Spina Bifida registry that will capture critical clinical information for children, adults and families with spina bifida will result in several important outcomes. The national registry will lead to improved quality of care for patients with spina bifida and their families and identification of areas for future research. Children's Hospital of Wisconsin's contribution to this registry will add valuable content and participate in overall direction to the project.