1. Dental Practice-Based Research
VA PCS Grand Rounds Nov
3/31/2017
Dental Practice-Based Research
Donald J. DeNucci D.D.S., M.S.
Research Consultant/VA Office of Dentistry
Program Officer/NIH/Practice-based Research Networks

2. Dental Practice-Based Research
VA PCS Grand Rounds Nov
3/31/2017
Dental Practice-Based Research
Dental Practice-based Research:
Conducted in the “real world” of clinical dentistry and designed to improve oral health and to support the adoption of evidence-based clinical practice
I am delighted to have this opportunity to participate in this CyberSeminar on Practice-based Research and to have an opportunity to share with you the experiences of VADER, VA Dentists Engaged in Research, which was established as an oral health research entity in 2007 through the VA Office of Dentistry. 2

3. What is Practice-based Research?
VA PCS Grand Rounds Nov
3/31/2017
What is Practice-based Research?
Practice-based research is research conducted in clinical practices by practitioners/clinicians
Designed to answer questions practitioners face in the routine care of their patients.
The VA Office of Dentistry has established three entities to support its mission of provide excellent oral health care to Veterans. These are the Quality Group, the VADER PBRN, and the an Educational Initiative.

4. What is Practice-based
VA PCS Grand Rounds Nov
3/31/2017
What is Practice-based
Research? (cont.)
Practice-based research holds great potential for answering clinical questions and expediting the translation of research findings into clinical practice.
The VA Office of Dentistry has established three entities to support its mission of provide excellent oral health care to Veterans. These are the Quality Group, the VADER PBRN, and the an Educational Initiative.

5. What is a Practice-based Research Network (PBRN)?
VA PCS Grand Rounds Nov
3/31/2017
What is a Practice-based Research Network (PBRN)?
A group of practitioners engaged in practice-base research constitutes a Practice-based Research Network (PBRN).
The VA Office of Dentistry has established three entities to support its mission of provide excellent oral health care to Veterans. These are the Quality Group, the VADER PBRN, and the an Educational Initiative.

6. Institutionally-based Research
VA PCS Grand Rounds Nov
3/31/2017
Institutionally-based Research
Publications
Policy Development
Clinical Guidelines

7. Analysis of Data Generated by Patient Care
VA PCS Grand Rounds Nov
3/31/2017
Analysis of Data Generated by Patient Care
Policy Development
Clinical Guidelines
Publications

8. Practice-based Research
VA PCS Grand Rounds Nov
3/31/2017
Practice-based Research
Publications
Policy Development
Clinical Guidelines

9. History of Practice-based
VA PCS Grand Rounds Nov
3/31/2017
History of Practice-based
Research
Practice-based research began when small groups of European medical practitioners began sharing information pertinent to patient care and clinical outcomes
These early precursors to today’s practice-based research networks can be traced back to the European sentinel networks of the 1970’s.
The VA Office of Dentistry has established three entities to support its mission of provide excellent oral health care to Veterans. These are the Quality Group, the VADER PBRN, and the an Educational Initiative.

10. History of Practice-based
VA PCS Grand Rounds Nov
3/31/2017
History of Practice-based
Research (cont.)
This sentinel model soon took hold in the United States as the Ambulatory Sentinel Practice Network (ASPN)
Followed closely by the establishment of the Pediatric Research in Office Settings (PROS) in 1984
The VA Office of Dentistry has established three entities to support its mission of provide excellent oral health care to Veterans. These are the Quality Group, the VADER PBRN, and the an Educational Initiative.

11. History of Practice-based
VA PCS Grand Rounds Nov
3/31/2017
History of Practice-based
Research (cont.)
Currently there are over 120 primary care PBRNs known to be active in the U.S. which include about 20,000 practices of pediatrics, family medicine, and general internal medicine located in all 50 States
These practices provide care for more than 20 million Americans (Agency for Healthcare Research and Quality 2008).
The VA Office of Dentistry has established three entities to support its mission of provide excellent oral health care to Veterans. These are the Quality Group, the VADER PBRN, and the an Educational Initiative.

12. History of Practice-based
VA PCS Grand Rounds Nov
3/31/2017
History of Practice-based
Research (cont.)
The dental profession has only recently recognized the value of practice-based research with the establishment of the Community Research for Oral Health Wellness Network (CROWN) in 2001
NIDCR/NIH funded the establishment of three large dental practice-based research networks in 2005.
The VA Office of Dentistry has established three entities to support its mission of provide excellent oral health care to Veterans. These are the Quality Group, the VADER PBRN, and the an Educational Initiative.

13. NIDCR Dental Practice-Based Research Networks
VA PCS Grand Rounds Nov
3/31/2017
NIDCR 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

14. Dental Practice-based Research Networks
VA PCS Grand Rounds Nov
Dental Practice-based Research Networks
Current Status: Year 5
3/31/2017
Engages over 700 practitioners in several diverse geographic regions
Conducting or completed over 30 studies including a CONDOR case-control study of ONJ
Produced several manuscripts including the first book chapter on practice-based research*
Multiple abstracts, symposia, and invited presentations
*DeNucci DJ and CONDOR Dental Practice-Based Research Networks.
“Dental Practice-based Research”. Clinical Research in Oral Health.
Eds. Gainnobile, Burt, and Genco. Wiley Blackwell

15. Snapshot of Dental PBRNs’ Current Membership, by State
VA PCS Grand Rounds Nov
3/31/2017
Snapshot of Dental PBRNs’ Current Membership, by State

16. Examples of the types of clinical studies being conducted by the NIDCR Funded PBRNS:
VA PCS Grand Rounds Nov
3/31/2017
Effectiveness of various strategies for the diagnosis of dental caries, periodontal disease, and oral cancer
Effectiveness of strategies to prevent progression of caries and periodontal disease
Natural history of untreated oral conditions, such as partially erupted third molars or cracked teeth
Effectiveness of interventions for treating and managing periodontal disease and caries

17. Assessing patient compliance with treatment recommendations
Examples of the types of clinical studies being conducted by the NIDCR Funded PBRNS (cont.)
VA PCS Grand Rounds Nov
3/31/2017
Assessing variations associated with the delivery of dental health care
Assessing patient compliance with treatment recommendations
Effectiveness of various strategies for managing acute and chronic orofacial pain
Assessing the outcomes of various treatments such as endodontic therapy, dental implants, and other prosthetics and restorative modalities

18. NIDCR PBRN Research Activities Year Five
VA PCS Grand Rounds Nov
3/31/2017
NIDCR PBRN Research Activities Year Five
DPBRN: Studies are focusing on treatment strategies for treating early carious lesions, patient satisfaction with dental restorations, reasons for replacing dental restoration, diabetes screening, smoking cessation
PEARL: Studies are focusing on treatment strategies for advanced dental caries, survival of endo treated teeth , sensitive teeth, analgesic prescribing practices, periodontal disease diagnosis, oral cancer screening
PRECEDENT: Studies focusing on caries risk assessment, dental pulp capping, wisdom tooth removal, orthodontic anchorage devices, white spot lesions (early caries)

19. VA PRACTICE-BASED RESEARCH NETWORK
VA PCS Grand Rounds Nov
3/31/2017
VA PRACTICE-BASED RESEARCH NETWORK
I am delighted to have this opportunity to participate in this CyberSeminar on Practice-based Research and to have an opportunity to share with you the experiences of VADER, VA Dentists Engaged in Research, which was established as an oral health research entity in 2007 through the VA Office of Dentistry. 19

20. VA Dental Practice-Based Research Network (VADER)
VA PCS Grand Rounds Nov
3/31/2017
VA Dental Practice-Based Research Network (VADER)
Deployed in September 2007
A virtual network open to all 750+ VA Dental Professionals
Governed by an executive committee of “volunteers” composed of VA practitioners, researchers, IT experts, educators, residents, and fellows

21. VADER Participants 204 dental clinics VA wide
VA PCS Grand Rounds Nov
3/31/2017
VADER Participants
204 dental clinics VA wide
127 facilities (hospitals)
77 outpatient clinics
Oral Health Research Officers (OHRO)
44 Officers: Certified VA Researchers VA wide
37 Dentists
7 Dental Hygienists
Oral Health Research Officers facilitate the conduct of studies at each of their locations and sites. 21

22. VA PCS Grand Rounds Nov
3/31/2017
VA Mission Statement
Our Mission... The mission of the Veterans Healthcare System is to serve the needs of America's veterans by providing primary care, specialized care, and related medical and social support services.
To accomplish this mission, VHA needs to be a comprehensive, integrated healthcare system that provides excellence in health care value, excellence in service as defined by its customers, and excellence in education and research,………
Our VA mission stated concisely is to provide excellence in health care. The VA has a rich and distinguished research history. Research has always been an important and integral aspect of performing the health care mission in the VA.

23. VA Office of Dentistry (OOD)
VA PCS Grand Rounds Nov
3/31/2017
VA Office of Dentistry (OOD)
Integrated approach to research,
education, and quality measures
VA OOD Quality Group
VA OOD Education Initiative
VA Dental Practice-based Research Network (PBRN)
The VA Office of Dentistry has established three entities to support its mission of provide excellent oral health care to Veterans. These are the Quality Group, the VADER PBRN, and the an Educational Initiative.

24. VA PCS Grand Rounds Nov
3/31/2017
VA OOD Quality Group
Mission is to improve the oral health of veterans by promoting clinical practice based on the best evidence available
Develops Quality Indicators and Scorecards
Develops Information Papers
Develops Clinical Guidelines
The group draws above expertise in the VA community as well as from experts within the community.

25. VA PCS Grand Rounds Nov
3/31/2017
VA OOD Education Group
Mission is to improve the oral health of veterans by enhancing the translation and implementation of evidence into clinical practice
Provides monthly VA wide webinars on topics of interest to the VA Dental Team
Maintains a VA website with educational materials, archived webinars, and links to educational resources for Program Directors and others

26. VA Dental Practice-based
VA PCS Grand Rounds Nov
3/31/2017
VA Dental Practice-based
Research Network
Mission is to conduct research and provide answers to the questions facing VA Dentists in their daily practices
Strengthen the knowledge base for making clinical decisions.
Provide data to the VA Quality Group to assist them in addressing issues of greatest importance to the oral health of veterans
Provide information to the Educational Group to guide the development of education and training
for the VA Dental Team
The VADER network was modeled after the three large NIH funded practice-based research networks which were established in 2005

27. Integrated Approach to Research, Education, and Quality Care
VA PCS Grand Rounds Nov
3/31/2017
Integrated Approach to Research,
Education, and Quality Care
Oral Health Providers
VA Leadership
Informs
Improved Veteran Oral Health
VADER PBRN
Education Group
These groups working closely together develop a particular synergy which enables VA providers and VA leadership the opportunity to make improvement in the quality of care delivered to veterans
Informs
Informs
Quality Group

28. VA Dental Practice-Based Research Network (VADER)
VA PCS Grand Rounds Nov
3/31/2017
VA Dental Practice-Based Research Network (VADER)
Primary objectives:
Conduct clinical studies to improve the health of Veterans
Emphasize effectiveness of oral health treatment and disease prevention
Facilitate clear and clinically meaningful outcomes
Secondary objectives:
Surveillance: Provide data on disease and treatment trends
Obtain estimates of the prevalence of less common conditions

29. Dental Practice-Based Research Network in the VA
VA Research Update AADR GAAC Oct
VA PCS Grand Rounds Nov
3/31/2017
Dental Practice-Based Research Network in the VA
Research Ideas:
Stimulated by the clinical challenges faced by VA practitioners
Generated by practicing dentists and dental hygienists (i.e. practitioner - investigators)
Accepted from sources outside the VA PBRN (academia, individuals, etc…) 29

30. Unique Aspects of the VADER PBRN
VA Research Update AADR GAAC Oct
VA PCS Grand Rounds Nov
3/31/2017
Unique Aspects of the
VADER PBRN
A virtual network with no defined budget and staffed by volunteer VA dental professionals!
The first VA practice-based research network! 30

31. Establishing A Research Network in the VA
VA Research Update AADR GAAC Oct
VA PCS Grand Rounds Nov
3/31/2017
Establishing A Research Network in the VA
STRENGTHS
Electronic Health Records
Uniform Practice Environment
Relatively Stable Research Population
Access to the superb VA Research Culture
Potential Access to the VA Central IRB 31

32. VA Dental Record Manager Module: CPRS
VA PCS Grand Rounds Nov
VA Research Update AADR GAAC Oct
3/31/2017
VA Dental Record Manager Module: CPRS
By using DRM to its fullest potential a great deal of information is at our fingertips 32

33. Establishing A Research Network in the VA
VA Research Update AADR GAAC Oct
VA PCS Grand Rounds Nov
3/31/2017
Establishing A Research Network in the VA
CHALLENGES
Integration of research into a patient care environment
Providing incentives to participate in research
Managing fluctuations in fiscal and other support resources 33

34. VADER PBRN Research Portfolio Projects in development or deployed
VA PCS Grand Rounds Nov
VA Research Update AADR GAAC Oct
3/31/2017
VADER PBRN Research Portfolio Projects in development or deployed
VADER Study One: Assessment of Caries Diagnosis and Caries Treatment
Risk factors for ONJ in Veterans
Survival Root Canal Treated Teeth
Xerostomia Treatment Survey
VALPLAST Prosthodontic Survey
Oral Cancer Screening
VA/DOD Registry of Cranial Implants
ADA Professional Products Review
VADER is presently engaged in three initiatives and projects 34

35. VADER Study One: Assessment of Caries Diagnosis and Treatment
VA PCS Grand Rounds Nov
3/31/2017
VADER Study One: Assessment of Caries Diagnosis and Treatment
A Quality Survey
The first of these studies is a quality survey the is attempting to determine how VA dentists diagnose and treat dental care, something that is fundamental to the practice of dentistry. Earlier research in this area suggests wide variability in how dental caries are diagnosed and treated

36. VADER Study One: Assessment of Caries Diagnosis and Treatment
VA PCS Grand Rounds Nov
3/31/2017
VADER Study One: Assessment of Caries Diagnosis and Treatment
A Quality Survey
This survey will also provide insights in to how dentist restore teeth using dental amalgam, composite resins, or other material. As an aside, the FDA this week issued a statement that dental amalgam remains a safe material for restoration of teeth.

37. Osteonecrosis of the Jaw: VADER/UAB/ IOWA City VA/
VA PCS Grand Rounds Nov
VA Research Update AADR GAAC Oct
3/31/2017
Osteonecrosis of the Jaw: VADER/UAB/ IOWA City VA/
VA Pharmacy
Retrospective Case-Control study of ONJ in Veterans (VA funded)
VADER has partnered with investigators from UAB, the Iowa City VA , and VA Pharmacy on a VA funded study to evaluate the risk factors for osteonecrosis of the jaws or ONJ. ONJ appears to be more prevalent in patients treated with a class of drugs call bisphosphonates which are used to treat low bone density, osteoporosis and certain malignancies and metastases of these malignancies to bone. An example of such a drug would be Fosamax. Some dentists have concerns about treating patients on bisphosphonates because of the possibility that the patient may develop ONJ after a simple dental procedure such as periodontal treatment or a tooth extraction. This retrospective case control study aims to determine whether or not dental procedures pose a risk to patients on biphosponates. One of the issues that has slowed the deployment of this important patient safety study is IRB approval. Regrettably the VA Central IRB has chosen not to become involved in this VA funded project and hence IRB approval must be obtained at over 15 separate locations. Ironically this additional challenge resulting for the need to obtain multiple IRB approvals may pose a safety risk by delaying the dissemination and implementation of vital information to clinicians. 37

38. VADER PBRN Research Portfolio Studies in Development
VA PCS Grand Rounds Nov
VA Research Update AADR GAAC Oct
3/31/2017
VADER PBRN Research Portfolio Studies in Development
Endodontic Outcomes Study
VADER is developing a study that will evaluated the longevity and survival of teeth treated with root canals in the VA. The literature suggests that endodontic treatment in and unto itself is 90% successful. However tooth survival may be contingent on not only having a successful root canal but also whether or not the tooth is properly filled or restored after the procedure. This project will leverage rich extant VA data collected over the past several years to provide guidance to VA practitioner when deciding on which forms of treatment are best for their patients and also to VA leadership in the allocation and targeting of resources for the treatment of common dental conditions. 38

39. VADER PBRN Research Portfolio Studies in Development
VA PCS Grand Rounds Nov
VA Research Update AADR GAAC Oct
3/31/2017
VADER PBRN Research Portfolio Studies in Development
Xerostomia Survey
VADER is developing a study that will evaluated the longevity and survival of teeth treated with root canals in the VA. The literature suggests that endodontic treatment in and unto itself is 90% successful. However tooth survival may be contingent on not only having a successful root canal but also whether or not the tooth is properly filled or restored after the procedure. This project will leverage rich extant VA data collected over the past several years to provide guidance to VA practitioner when deciding on which forms of treatment are best for their patients and also to VA leadership in the allocation and targeting of resources for the treatment of common dental conditions. 39

40. VADER PBRN Research Portfolio Studies in Development
VA PCS Grand Rounds Nov
VA Research Update AADR GAAC Oct
3/31/2017
VADER PBRN Research Portfolio Studies in Development
Prosthetic replacement of teeth
VADER is developing a study that will evaluated the longevity and survival of teeth treated with root canals in the VA. The literature suggests that endodontic treatment in and unto itself is 90% successful. However tooth survival may be contingent on not only having a successful root canal but also whether or not the tooth is properly filled or restored after the procedure. This project will leverage rich extant VA data collected over the past several years to provide guidance to VA practitioner when deciding on which forms of treatment are best for their patients and also to VA leadership in the allocation and targeting of resources for the treatment of common dental conditions. 40

41. VA Cranial Implant Registry:
VA PCS Grand Rounds Nov
3/31/2017
VA Cranial Implant Registry:
A Joint VA / DOD project
VADER has been instrumental in promoting the establishment of a joint DOD-VA Cranial Implant Center at the future Walter Reed National Military Medical Center. This Cranial Implants are designed using CADCAM techniques at the Walter Reed Army Medical Center and then fabricated by Navy Maxillofacial Prosthodontists at the present National Naval Medical Center. The materials used include denture materials , titanium and others. Plans are to integrate this Cranial Implant Center with the pending VA Implant registry so that these patients can be effectively followed and managed. This also presents a unique opportunity for outcomes research on these procedures and the material being used to fill this large cranial defects.

42. ADA Professional Product Review (PPR) – VADER
VA PCS Grand Rounds Nov
3/31/2017
ADA Professional Product Review (PPR) – VADER
VADER with skilled and expeditious assistance of VA General Counsel is about to finalize an agreement with the American Dental Association that will enable VA dental professionals to participate in the national ADA Professional Products Review Program.

43. ADA Professional Product Review (PPR) – VADER
VA PCS Grand Rounds Nov
3/31/2017
ADA Professional Product Review (PPR) – VADER
Evaluation of dental products and equipment by VA Dental Professionals
Provided by the American Dental Association; hence no direct contact with industry
Evaluated in the real-world environment of VA clinical practice
Potential to inform VA acquisition decisions and the oral health community in general

44. ADA Professional Product Review (PPR) – VADER
VA PCS Grand Rounds Nov
3/31/2017
ADA Professional Product Review (PPR) – VADER
Electric Dental Handpieces (Drills)
Shade Guides
VADER with skilled and expeditious assistance of VA General Counsel is about to finalize an agreement with the American Dental Association that will enable VA dental professionals to participate in the national ADA Professional Products Review Program.

45. VADER PBRN Research Portfolio Studies under Consideration
VA PCS Grand Rounds Nov
VA Research Update AADR GAAC Oct
3/31/2017
VADER PBRN Research Portfolio Studies under Consideration
Web/computer based smoking cessation study
Implant outcomes study
Implact of fluoride prescriptions and treatments on dental caries in Veterans
VADER also has several additional projects under consideration., all of which are highly clinical relevant to VA practitioners and the patients they treat daily. 45

46. Integrated Approach to Research, Education, and Quality Care
VA PCS Grand Rounds Nov
3/31/2017
Integrated Approach to Research, Education, and Quality Care
Improved Patient Oral Health

47. VA Office of Dentistry (OOD)
VA PCS Grand Rounds Nov
3/31/2017
VA Office of Dentistry (OOD)
Integrated approach to research,
education, and quality measures
Donald J. DeNucci, D.D.S., M.S. Research Consultant/VA Office of Dentistry
Program Officer/NIH/Practice-based Research
Telephone: Preferred VA Outlook:
Thanks for your attention and I would be delighted to entertain your questions as time permits. My preferred is at NIH but I am also in VA outlook.