The proposed Coordinating Center to Help Eliminate/Reduce Oral health Inequalities in Children (CC HEROIC; CC for short) will provide collaborative research and coordinating center expertise and services to 8 two-phase UH2/UH3 NIDCR-funded community-engaged projects (RFA-DE-15-006) to assess multilevel interventions, programs or policies to reduce or eliminate oral health disparities in diverse, vulnerable populations of children aged 0 to 21 years. The UH2/UH3 project PD/PIs, the NIDCR, and the CC will form a collaborative research consortium. The 8 projects will address a range of multilevel mechanisms of action with multidisciplinary teams. The proposed CC investigator and staff team possesses relevant transdisciplinary expertise in oral health, social and behavioral sciences, microbiology, genetics, epidemiology, health policy, health economics, and biostatistics, plus data coordinating center experience serving multiple health and oral health projects within NIH research consortia. As the NIDCR Early Child Caries Collaborating Centers Data Coordinating Center (NIDCR EC4 DCC) the team has demonstrated its ability to collaboratively and creatively support large-scale, clinically-relevant, and community-engaged oral health disparities research simultaneously in 6 UH2-like studies and then in 4 UH3-like randomized clinical trials in 6 institutions across 3 time zones to meet the overall scientific and project community partner goals. We will utilize both the NHLBI Compendium of Best Practices for Data Coordinating Centers as well as the Community-Campus Partnership in Health's Position Statement on Authentic Partnerships. The CC will establish ongoing, collaborative relationships with each UH2/UH3 project to provide services and expertise in the following areas: (a) oral health-related clinical knowledge; (b) qualitative and quantitative research design with particular emphasis on oral health outcomes in diverse, community-based, pediatric populations; (c) selecting cost measures and designing cost analyses; (d) selecting, developing, and refining measurement instruments, including harmonizing measures across the 8 UH2/UH3 projects; (e) informatics, including providing secure, customized data acquisition systems and project and clinical research management systems; (f) training in the use of those systems; (g) participant safety monitoring and reporting to the project investigators, NIDCR, the clinical operations contractor, and an independent Data and Safety Monitoring Board (DMSB); (h) data management, processing, and quality control; (i) developing qualitative and quantitative data analysis plans; (j) reporting on project progress to the project investigators, NIDCR, and the Data and Safety Monitoring Board; and (k) coordinate and participate in consortium meetings including regular Steering Committee, ad hoc Collaborating Working Group, and annual External Scientific Advisory Committee (ESAC) meetings. Our experienced children's oral health coordinating center team can provide efficient, comprehensive support to these UH2/UH3 projects to assure scientific rigor and meet community needs.
The proposed 'Coordinating Center to Help Eliminate/Reduce Oral health Inequalities in Children' (CC HEROIC; CC for short) will provide research and coordinating center expertise and services to 8 separate UH2/UH3 community-engaged projects to be funded by the National Institute for Dental and Craniofacial Research (NIDCR). The collaborative services we will provide fall under three broad domains: (i) clinical and scientific expertise, including optimizing study design, measurement, and data analysis; (ii) informatics and project management, including secure data collection and management systems, data quality assurance/control, project and safety monitoring, and progress reporting; and (iii) coordination of distance- collaborating teams.
