Dental Practice-Based Research VA PCS Grand Rounds Nov 23 2009 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

Dental Practice-Based Research VA PCS Grand Rounds Nov 23 2009 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

What is Practice-based Research? VA PCS Grand Rounds Nov 23 2009 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.

What is Practice-based VA PCS Grand Rounds Nov 23 2009 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.

What is a Practice-based Research Network (PBRN)? VA PCS Grand Rounds Nov 23 2009 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.

Institutionally-based Research VA PCS Grand Rounds Nov 23 2009 3/31/2017 Institutionally-based Research Publications Policy Development Clinical Guidelines

Analysis of Data Generated by Patient Care VA PCS Grand Rounds Nov 23 2009 3/31/2017 Analysis of Data Generated by Patient Care Policy Development Clinical Guidelines Publications

Practice-based Research VA PCS Grand Rounds Nov 23 2009 3/31/2017 Practice-based Research Publications Policy Development Clinical Guidelines

History of Practice-based VA PCS Grand Rounds Nov 23 2009 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.

History of Practice-based VA PCS Grand Rounds Nov 23 2009 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.

History of Practice-based VA PCS Grand Rounds Nov 23 2009 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.

History of Practice-based VA PCS Grand Rounds Nov 23 2009 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.

NIDCR Dental Practice-Based Research Networks VA PCS Grand Rounds Nov 23 2009 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

Dental Practice-based Research Networks VA PCS Grand Rounds Nov 23 2009 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. 2010. 265-30

Snapshot of Dental PBRNs’ Current Membership, by State VA PCS Grand Rounds Nov 23 2009 3/31/2017 Snapshot of Dental PBRNs’ Current Membership, by State

Examples of the types of clinical studies being conducted by the NIDCR Funded PBRNS: VA PCS Grand Rounds Nov 23 2009 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

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 23 2009 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

NIDCR PBRN Research Activities Year Five VA PCS Grand Rounds Nov 23 2009 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)

VA PRACTICE-BASED RESEARCH NETWORK VA PCS Grand Rounds Nov 23 2009 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

VA Dental Practice-Based Research Network (VADER) VA PCS Grand Rounds Nov 23 2009 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

VADER Participants 204 dental clinics VA wide VA PCS Grand Rounds Nov 23 2009 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

VA PCS Grand Rounds Nov 23 2009 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.

VA Office of Dentistry (OOD) VA PCS Grand Rounds Nov 23 2009 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.

VA PCS Grand Rounds Nov 23 2009 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.

VA PCS Grand Rounds Nov 23 2009 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

VA Dental Practice-based VA PCS Grand Rounds Nov 23 2009 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

Integrated Approach to Research, Education, and Quality Care VA PCS Grand Rounds Nov 23 2009 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

VA Dental Practice-Based Research Network (VADER) VA PCS Grand Rounds Nov 23 2009 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

Dental Practice-Based Research Network in the VA VA Research Update AADR GAAC Oct 14 2008 VA PCS Grand Rounds Nov 23 2009 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

Unique Aspects of the VADER PBRN VA Research Update AADR GAAC Oct 14 2008 VA PCS Grand Rounds Nov 23 2009 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

Establishing A Research Network in the VA VA Research Update AADR GAAC Oct 14 2008 VA PCS Grand Rounds Nov 23 2009 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

VA Dental Record Manager Module: CPRS VA PCS Grand Rounds Nov 23 2009 VA Research Update AADR GAAC Oct 14 2008 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

Establishing A Research Network in the VA VA Research Update AADR GAAC Oct 14 2008 VA PCS Grand Rounds Nov 23 2009 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

VADER PBRN Research Portfolio Projects in development or deployed VA PCS Grand Rounds Nov 23 2009 VA Research Update AADR GAAC Oct 14 2008 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

VADER Study One: Assessment of Caries Diagnosis and Treatment VA PCS Grand Rounds Nov 23 2009 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

VADER Study One: Assessment of Caries Diagnosis and Treatment VA PCS Grand Rounds Nov 23 2009 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.

Osteonecrosis of the Jaw: VADER/UAB/ IOWA City VA/ VA PCS Grand Rounds Nov 23 2009 VA Research Update AADR GAAC Oct 14 2008 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

VADER PBRN Research Portfolio Studies in Development VA PCS Grand Rounds Nov 23 2009 VA Research Update AADR GAAC Oct 14 2008 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

VADER PBRN Research Portfolio Studies in Development VA PCS Grand Rounds Nov 23 2009 VA Research Update AADR GAAC Oct 14 2008 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

VADER PBRN Research Portfolio Studies in Development VA PCS Grand Rounds Nov 23 2009 VA Research Update AADR GAAC Oct 14 2008 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

VA Cranial Implant Registry: VA PCS Grand Rounds Nov 23 2009 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.

ADA Professional Product Review (PPR) – VADER VA PCS Grand Rounds Nov 23 2009 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.

ADA Professional Product Review (PPR) – VADER VA PCS Grand Rounds Nov 23 2009 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

ADA Professional Product Review (PPR) – VADER VA PCS Grand Rounds Nov 23 2009 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.

VADER PBRN Research Portfolio Studies under Consideration VA PCS Grand Rounds Nov 23 2009 VA Research Update AADR GAAC Oct 14 2008 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

Integrated Approach to Research, Education, and Quality Care VA PCS Grand Rounds Nov 23 2009 3/31/2017 Integrated Approach to Research, Education, and Quality Care Improved Patient Oral Health

VA Office of Dentistry (OOD) VA PCS Grand Rounds Nov 23 2009 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: 301-451-5096 Preferred E-mail:  denuccid@nidcr.nih.gov VA Outlook: denucci.donald@va.gov Thanks for your attention and I would be delighted to entertain your questions as time permits. My preferred email is at NIH but I am also in VA outlook.