The Feasibility of Implementing a National Spina Bifida Registry in Wisconsin

描述：（由申请人提供）脊柱裂（SB）是儿童和成人致残的最常见原因之一。在威斯康辛州，大约有1400人与SB一起生活。SB患者的医疗保健是复杂的，涉及多种身体、学习和社会心理问题。然而，关于SB临床护理的综合数据很少。本项目的总体目标是测试利用国家标准化登记工具收集威斯康星州儿童医院脊柱裂项目中SB患者数据的可行性。该项目的具体目标是：具体目标1：每年招募125-175名SB项目患者参与国家SB患者登记。具体目标2：以有效的方式捕获CHW脊柱裂诊所年度临床就诊的患者数据，并将其传输到中央数据存储库。具体目标3：在CDC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首席研究员Kathleen Sawin， DNS， CPNP， FAAN的领导下进行，并与SB项目的医学主任John Thometz医学博士合作。具体而言，该项目将确定125-175个家庭在CHW同意SB项目的可行性，以有效的方式获取年度临床就诊的注册数据，并将数据上传到CDC网站。PI、医疗主任和研究护士将与SB项目提供者合作，引导他们了解所需的组成部分和研究定义。数据将在每年访问时从现有的医疗记录中提取。收集的数据元素将包括参与者的人口统计、医疗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。所有上传到该注册中心的数据将被去识别，并且唯一的CDC编号将用于提交第2年和第3年的数据，这些数据可以链接到第1年。数据分析和总体项目方向的指导将由CDC协调委员会提供。在威斯康星州实施国家脊柱裂登记处的可行性项目叙述建立国家脊柱裂登记处将获取脊柱裂儿童、成人和家庭的关键临床信息，将产生几个重要的结果。国家登记将提高对脊柱裂患者及其家属的护理质量，并确定未来研究的领域。威斯康星儿童医院对该登记处的贡献将增加有价值的内容，并参与项目的总体方向。

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.