This grant proposal is to continue with the collection of data started under FOA DD08-001 aimed at improving the care of individuals with spina bifida in the United States. Standardized data will be collected at this site, along with other funded sites in a longitudinal sample of study subjects. Riley Hospital for Children will maintain a minimum of 125 subjects throughout the funding of the project. However, we will recruit as many subjects from our clinic census as funding will allow. New subjects will be recruited during visits to the Spina Bifida Clinic. Data from new subjects as well as subjects already enrolled in the project will be collected via information obtained during clinic visits and from retrospective chart reviews using a standardized data collection forms provided by the Centers for Disease Control (CDC). Data will be entered into the Spina Bifida Electronic Medical Record (SB EMR). The information entered from this site will be used for decisions about clinical care and quality improvement initiatives within our own clinic. De-identified data will also be submitted to the CDC under the auspices of the project Coordinating Committee. Data analysis and plans for reporting of results will be determined by the Clinical Data Quality Committee (CDQC).
A survey in 2005 and 2006 of spina bifida clinics around the country done by the Spina Bifida Association, in conjunction with the Delmarva Foundation and the Agency for Healthcare Research and Quality, along with qualitative interviews with persons with spina bifida indicate that care is extremely variable. The research evidence base upon which current treatment of spina bifida occurs is relatively weak, and nationally, very little research is occurring related to spina bifida. The Professional Advisory Council of the Spina Bifida Association endorsed methods to study current aspects of care, and the development of an infrastructure to promote research and improve the quality of care that individuals with spina bifida receive. FOA -DD08-001 was first funded to promote a clinical patient registry. This current FOA is to continue with longitudinal data collection on patients already enrolled in the registry project along with the addition of new enrollees. This project will advance care for persons with spina bifida by allowing better understanding of the current clinical interventions, availability to begin to look at variances of care across sites, and the influence of demographic and other population characteristics on patient outcomes. In addition these data will be able to form the basis for further development of more effective quality measures, best practices and eventual development of standards of care related to spina bifida. In addition this body of work will serve to support future research to better inform future clinical practice.