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NIDCR - Sponsored Practice-Based Research Networks (PBRN)

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  • 1. NIDCR - Sponsored Practice-Based Research Networks (PBRN) Designed to gather “real-world” evidence for the prevention and treatment of oral diseases Donald J. DeNucci, DDS, MS Program Director Practice-Based Research Networks National Institute of Dental and Craniofacial Research
  • 2. Dental Practice-Based Research Networks - Purpose
    • Answer questions facing general dental practitioners in the routine care of their patients
    • Strengthen knowledge base for making clinical decisions
      • Observational studies
      • Clinical trials
      • Establish/use a flexible, adaptable electronic network/platform for connectivity, data sharing, & communication within and between dental and medical networks
  • 3. Dental Practice-Based Research Networks-Objectives
    • Stimulate research proposals from practicing dentists and dental hygienists (i.e., practitioner-investigators)
    • Primary objectives:
    • • Conduct 16-22 short-term clinical studies over 7 years
    • • Emphasis on effectiveness of oral health treatment & disease prevention
    • • Clear & clinically meaningful outcomes
    • Secondary objective: Provide data on disease and treatment trends and obtain estimates of the prevalence of less common conditions
  • 4. Dental Practice-Based Research Networks-Outcomes
    • Draw on experience & insight of practitioners to help identify and frame questions
    • Establishes partnership between practitioners and experienced researchers
    • Rapid translation of findings into clinical practice
    • May reduce costs for certain types of studies when compare with traditional research models
  • 5. General Dental Practice-Based Research Networks
    • Cooperative Agreements
    • Awarded 5/01/2005
    • $75 Million over 7 years
    • Awardees
    • NYU PEARL Network
    • Universities of Alabama / Florida DPBRN Network
    • Permanente Dental Associates
    • Health Partners
    • Georgia
    • Mississippi
    • Scandinavia
    • Universities of Washington / Oregon NW PRECEDENT Network
    • TransPBRN entity comprising all three networks CONDOR Network
  • 6. Dental Practice-Based Research Networks-Goals Year One
    • At least 100 dental practices per Dental PBRN will be recruited to participate during the first year of operations.
    • Each PBRN will involve large numbers of practitioner-investigators in at least two population centers.
  • 7. Dental Practice-Based Research Networks-Present Status
    • Presently over 600 dental practices participating after 3 years
    • Each PBRN involves large numbers of practitioner-investigators in at four population centers.
  • 8. Snapshot of PBRNs’ Current Membership, by State
  • 9. Dental Practice-Based Research Networks – Organization
    • Network Chair
    • Coordinating Center
    • Executive Committee
    • NIDCR Staff
    • Protocol Review Committee
    • IRB
    • DSMB (Phase III Trials)
  • 10. Dental Practice-Based Research Networks – Executive Committee
    • Composition
      • Network Chair
      • PI of Coordinating Center
      • *5-6 elected practitioner-investigators
      • NIDCR staff
    * Comprise the majority membership
  • 11. Dental Practice-Based Research Networks – Executive Committee
    • Responsibilities
      • Provides governance and administrative support for the PBRN
      • Prioritizes research topics for submission to Protocol Review Committee
      • Reviews and approves protocols prior to
      • submission to Protocol Review Committee
  • 12. Dental Practice-Based Research Networks – Practitioner Profiles
    • PBRN trained and certified dentists and dental hygienists engaged in daily practice
    • From more than one state and population center
    • Representative of gender / racial / ethnic
    • distribution of PBRN region
    • Limited number may be from outside U.S. if
    • standard of dental care is comparable to that in U.S
  • 13. Dental Practice-Based Research Networks – Practitioner Investigators
    • Roles and Responsibilities
      • Participate in Annual Meeting
      • Elect representatives to Executive Committee
      • Suggest studies to Executive Committee
      • Contribute to protocol development
      • Conduct studies in their practices
      • Conform to IRB, DSMB, HIPAA regulations
      • Contribute to manuscript preparation
  • 14. Dental Practice-Based Research Networks – Review Process
    • Ideas for individual studies proposed to the PBRN Executive Committee
    • After review by the PBRN Executive Committee, all protocols must be approved by:
      • Protocol Review Committee
      • IRB
      • DSMB for Phase III Trials
  • 15. Dental Practice-Based Research Networks-Typical Studies
  • 16. PBRN Research Activities – Year Four
    • PEARL: Studies are focusing on treatment strategies for advanced dental caries, root canal therapy, sensitive teeth, periodontal disease, dental implant survival
    • DPBRN: Studies are focusing on treatment strategies for treating early carious lesions, reasons for replacing dental restoration
    • PRECEDENT: Studies focusing on caries risk assessment, dental pulp capping, wisdom tooth removal, orthodontic retention
  • 17. PBRN Collaborative Research Activities Year Four
      • Networks collaborating on a study of the risk factors for osteonecrosis of the jaw in relation to a variety of factors including use of bisphosphonate drugs
  • 18. PBRN Collaborative Research Activities Year Four
      • Networks are collaborating with the NIH National Cancer Institute’s Center for Bioinformatics in defining common data elements and establishing a common data vocabulary repository
  • 19. PBRN Collaborative Research Activities Year Four
      • Networks collaboratively established a Practice Impact Research Group (PIRG)
      • Designed to measure and assess the impact of practice-based research on translation and ultimately changes in clinical practice leading to improvements in patient care and oral health
  • 20. PBRN Collaborative Research Activities Year Four
      • Collaborating with the VA Dental Practice-based Research Network (VADER)
      • VADER comprised of over 600 dental professional using one integrated electronic medical and dental record
  • 21. PBRN Collaborative Research Activities Year Four VADER ONJ Study in Veterans VADER Cranial Implant Study
  • 22. PBRN Research Activities Potential for collaboration with medicine
    • PEARL: Analgesic prescribing practices of dentists, drugs impacting oral health (xerostomia, gingival hyperplasia), impact of periodontal therapy on diabetes and cardiovascular disease
    • DPBRN: Infection after surgical procedures in diabetic patients, glycemic screening in dental offices, tobacco cessation
    • PRECEDENT: Computer assisted program for needle phobia, anxiety management
  • 23. General Dental Practice-Based Research Networks
    • NYU PEARL Network
    • Universities of Alabama / Florida DPBRN Network
    • Permanente Dental Associates
    • Health Partners
    • Georgia
    • Mississippi
    • Scandinavia
    • Universities of Washington / Oregon
    • NW PRECEDENT Network
    • TransPBRN CONDOR Network comprising
    • all three networks
  • 24. NIDCR Funded Oral Health Disparities Program Established Community Networks Configured to Conduct Interventional Trials
    • University of Washington
    • University of Florida
    • University of California - San Francisco
    • University of Colorado - Denver
    • Boston University
    • *University of Michigan
      • *Pilot Program in Detroit inner city
  • 25. Donald J. DeNucci, D.D.S., M.S. Program Director Practice Based Research Networks Center for Clinical Research National Institute of Dental and Craniofacial Research 6701 Democracy Blvd., Room 632 Telephone: 301-451-5096 Fax: 301-480-8322 E-mail:   [email_address]