Greater San Francisco Bay Area Spina Bifida Partnership

描述（由申请人提供）：本提案的目的是与CDC和其他SB诊所合作，建立一个疾病特异性国家登记处，以改善SB患者的护理。拟议目标：作为参与SB诊所的国家网络的一部分，大旧金山弗朗西斯科湾区SB伙伴关系将：a）使用标准表格招募并收集项目三年中每年至少125名SB患者的标准数据; B）使用基于网络的电子病历（EMR）系统将去识别数据提交给中央储存库; d）参加国家协调委员会，以促进对登记的改进，提出研究问题，制定分析计划，并根据数据结果颁布临床实践标准的变更。背景资料：SB是最常见的永久性致残性出生缺陷，估计有70，000人患有这种神经管缺陷的更重要形式。关于SB护理如何因地点而异的了解相对较少，目前，与SB相关的研究并不多。因此，目前SB治疗所依据的证据很薄弱。预计国家SB患者登记处（由CDC，SB协会和医疗保健研究和质量机构牵头）的建立将提高所有SB患者的护理质量，并将确定和支持合作研究的机会。拟议中的大旧金山弗朗西斯科湾区SB合作伙伴关系是两个高质量SB项目与非常多样化的患者人群之间的合作：一个在奥克兰儿童医院和研究中心，另一个在加州大学旧金山弗朗西斯科贝尼科夫儿童医院。这些网站一起跟踪了255名从新生儿到21岁的不同患者，其中大约一半是拉丁美洲人。研究方法：根据CDC制定的方案，大弗朗西斯科湾区SB合作伙伴关系将尝试招募所有新生儿、儿童、青少年和年轻人在SB诊所就诊期间参加登记。将使用标准表格收集每例患者的数据至少三年。不可识别的数据将输入CDC维护的基于网络的EMR中。该项目的协调委员会将确定研究主题和数据分析。

DESCRIPTION (provided by applicant): The purpose of this proposal is to work collaboratively with the CDC and other SB clinics to build a disease specific national registry to improve care for individuals with SB. Proposed Aims: As part of the national network of participating SB clinics, the Greater San Francisco Bay Area SB Partnership will: a) Recruit and collect standard data on at least 125 SB patients for each of three years of the project using standard forms; b) Submit the de-identified data to a central repository using a web based electronic medical record (EMR) system; c) Adopt the EMR for ongoing clinical use; d) Participate in the national Coordinating Committee to promote improvements to the registry, propose research questions, develop an analytical plan, and promulgate changes to clinical practice standards based on data findings. Background: SB is the most common permanently disabling birth defect, with an estimated 70,000 individuals living with the more significant forms of this neural tube defect. Relatively little is known about how SB care varies by location, and currently, not much research is occurring related to SB. Consequently, the evidence based on which the current treatment of SB occurs is weak. It is anticipated that the establishment of a National SB Patient Registry (spearheaded by CDC, the SB Association, and Agency for Healthcare Research and Quality) will result in improved quality of care for all individuals with SB, and will identify and support opportunities for collaborative research. The proposed Greater San Francisco Bay Area SB Partnership is a collaboration between two high quality SB programs with very diverse patient populations: one at Children's Hospital & Research Center Oakland and the other at the University of California at San Francisco Benicoff Children's Hospital. Together, the sites follow 255 diverse patients in their clinics from newborn to age 21; about one half of these patients are Latino. Methods: Following protocol established by the CDC, the Greater San Francisco Bay Area SB Partnership will attempt to recruit all newborns, children, adolescents, and young adults to participate in the registry during their visits to SB clinic. Data will be collected on each patient for a minimum of three years using standard forms. Non-identifiable data will be entered into a web based EMR maintained by CDC. The project's Coordinating Committee will determine research topics and data analysis.