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.
This application is a response to FOA # RFA-DD-011-001. The purpose of this project is for the Greater San Francisco Bay Area Spina Bifida Partnership to work collaboratively with CDC and other demonstration sites to establish the National Spina Bifida Registry (NSBR), with the ultimate goal of advancing our understanding of spina bifida and improving outcomes for spina bifida patients. Please note that FOA # RFA-DD-011-001does not call for a separate narrative to be entered onto the Research &Related form, and subsequent communication with CDC has confirmed this understanding.