The 212th meeting of the National Advisory Dental and Craniofacial Research Council (NADCRC) was convened on May 24, 2016, at 8:33 a.m., in Building 31, Conference Room 10, National Institutes of Health (NIH), Bethesda, Maryland. The meeting was open to the public from 8:33 a.m. to 12:10 p.m.; it was followed by the closed session for Council business and consideration of grant applications from 1:30 p.m. until adjournment at 2:34¬ p.m. Dr. Martha Somerman presided as Chair.
Dr. Robert J. Burns, Manager, Legislative and Regulatory Policy, ADA, Washington, D.C.
Dr. Margherita Fontana, Professor, Department of Cariology, Restorative Sciences, and Endodontics, School of Dentistry, University of Michigan, Ann Arbor, MI
Dr. Christopher H. Fox, Executive Director, International Association for Dental Research (IADR) and American Association for Dental Research (AADR), Alexandria, VA
Dr. Raul I. Garcia, Professor and Chair, Department of Health Policy and Health Services Research, and Co-Director, Center for Research to Evaluate and Eliminate Dental Disparities (CREEDD), Henry M. Goldman School of Dental Medicine, Boston, MA, and President-Elect, AADR
Dr. XinBin Gu, Associate Dean of Research, Howard University College of Dentistry, Washington, D.C.
Dr. Michelle M. Henshaw, Professor, Health Policy and Health Services Research, Co-Director, CREEDD, and Dean, Community Partnerships and Extramural Affairs, Henry M. Goldman School of Dental Medicine, Boston University, MA
Dr. Yvonne Knight, Chief Advocacy Officer, and Senior Vice President, Advocacy and Governmental Relations, American Dental Education Association (ADEA), Washington, D.C.
Mr. B. Timothy Leeth, Senior Director for Federal Relations, ADEA Policy Center - Advocacy and Governmental Relations, ADEA, Washington, D.C.
Dr. Britta E. Magnuson, ADEA/Sunstar Americas, Inc./Harry W. Bruce, Jr., Legislative Fellow, ADEA, Washington, D.C., and Assistant Professor, Tufts University School of Dental Medicine, Boston, MA
Dr. Molly Martin, Associate Professor of Pediatrics, University of Illinois at Chicago (UIC) College of Medicine, and
Principal Investigator, Coordinated Oral Health Promotion (CO-OP) Chicago, UIC College of Dentistry and UIC Institute for Health Research and Policy, Chicago, IL
Dr. Sarah Martin, Director of Advocacy and Scientific Affairs, Sjögren’s Syndrome Foundation, Bethesda, MD
Mrs. Carolyn Mullen, Director of Government Affairs, IADR and AADR, Alexandria, VA
Dr. Indra Mustapha, Assistant Professor, Howard University College of Dentistry, Washington, D.C.
Dr. Tongxin Wang, Associate Professor, Howard University College of Dentistry, Washington, D.C.
Dr. Jeffrey J. Kim, Project Leader, Clinical Research, ADA Foundation, Dr. Anthony Volpe Research Center, NIST, DOC, Gaithersburg, MD
Dr. Eliseo J. Pérez-Stable, Director, National Institute on Minority Health and Health Disparities, NIH
Mrs. Sandra San Miguel-Majors, Center to Reduce Cancer Health Disparities, National Cancer Institute, NIH
Mr. Matthew Sierra, NIH Presidential Management Fellow
II. FUTURE MEETING DATES
V. REPORT OF THE DIRECTOR, NIDCR
Dr. Somerman reported on the NIDCR budget and activities for fiscal year (FY) 2015, FY 2016, and FY 2017 and on NIDCR funding of health disparities research. Her written Director’s Report to the Council: May 2016 was provided to the Council members and is available on the NIDCR website. She thanked the NIDCR staff for their continuing hard work and noted that, on May 23, the NIDCR hosted a full-day meeting with Congressman Paul Gosar (R-AZ), one of three dentists in the U.S. Congress. Dr. Somerman also thanked the Council for its advocacy on behalf of the NIDCR.
NIDCR FY 2015 Budget: “That Was the Year That Was”
Dr. Somerman noted that the NIDCR FY 2015 budget totaled $397,672,000, of which 78 percent was allocated to the extramural program, 16 percent to the intramural program, and 6 percent for research management and support. The NIDCR supported 171 competing research project grants (RPGs), out of approximately 800 grant applications submitted—for a success rate of 22 percent. The total number of RPGs supported (noncompeting and competing RPGs and small business awards) was 591. She noted that the NIDCR increased the visibility and support of its Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs in response to current opportunities and was also able to fund 28 of these awards. In addition, the NIDCR supported research career awards and other related research, to yield a total of 655 research grants supported in FY 2015. The NIDCR also supported 257 research training awards.
Dr. Somerman said that RPGs are the “bread and butter” of NIDCR activities and comprised 63 percent of the total NIDCR budget. And, she noted that although the intramural program comprised 16 percent of the budget, 37 percent of this was for central NIH assessments. Dr. Somerman added that the percentage of funds supporting research training (3 percent) and career development (1 percent) was higher than that for many other NIH institutes and centers (ICs). Other support went for research centers (2 percent), research careers (1 percent), contracts (5 percent), and SBIR/STTR programs (3 percent).
Dr. Somerman reported that RPGs constituted 82 percent of the extramural budget and continued to be the drivers of the extramural program. She shared data showing that between FY 2011 and FY 2015, there was little change in the total dollar amount and support of various award mechanisms [e.g., small research grants and new investigator awards (R03s), exploratory/developmental grants (R21s), merit awards (R37s), investigator-initiated RPGs (R01s), and research project‒cooperative agreements (U01s)]. Since FY 2001, the success rate for RPGs has remained relatively steady (19 percent to 22 percent) and slightly higher than that for the NIH as a whole. Between FY 2011 and FY 2015, the NIDCR success rate for R01s has been relatively steady, while those for R21s and R03s have decreased or increased, depending on the applications received. Dr. Somerman noted that the NIDCR is very supportive of R21s and R03s, which support, respectively, higher-risk research and new investigators.
In FY 2015, the NIDCR awarded grants in five research areas targeted by Requests for Applications (RFAs) and funded through various mechanisms. The titles of the RFAs are: Approaches to Eliminate HIV and Opportunistic Pathogens from Oral Reservoirs, Multidisciplinary and Collaborative Research Consortium to Reduce Oral Health Disparities in Children, Planning Grants for Dental, Oral, and Craniofacial Tissue Regeneration Consortium, Targeting Co-Dependent Molecular Pathways in Oral Cancer, and Next-Gen Rapid Testing and Point-of-Care Diagnosis for Oral Pathogens.
Dr. Somerman reported that, in FY 2016, the Council already has reviewed applications received in response to three RFAs—for research on approaches to eliminate HIV and opportunistic pathogens, studies of the pharmacogenomics of orofacial pain, and basic research on the biological and physiological effects of e-cigarette aerosol mixtures. At the present meeting, the Council will review applications received in response to three more RFAs—for research on oral immune system plasticity in chronic HIV infection under treatment and oral co-infections, oral mucosal immunization approaches (oral HIVacc), and novel or enhanced dental restorative materials class V lesions. The awards include four R01s, two High Priority Short-term Project Awards (R56s), and one R21. She noted in addition that the NIDCR has issued three Program Announcements (PAs)—to foster research on outcome measures for clinical studies of oral and craniofacial diseases and conditions, immune system plasticity in the pathogenesis and treatment of complex dental, oral, and craniofacial diseases, and imaging diagnostics of dental diseases and conditions.
Dr. Somerman highlighted three activities for support in the near future, depending on the response received to NIDCR’s Funding Opportunity Announcements (FOAs). These are (i) the NIDCR award for Sustaining Outstanding Achievement in Research (SOAR), an 8-year award for which applications have been received, but not yet reviewed; (ii) the Dental, Oral, and Craniofacial Tissue Regeneration Consortium – Stage 2, for which the NIDCR plans to support 2-year awards for one to three resource centers; and (iii) the tailoring of dental treatment guidelines for individuals with systemic diseases that compromise oral health.
Three additional areas of interest include factors underlying gender differences in dental, oral, and craniofacial diseases and conditions (e.g., temporomandibular joint disorders and oral cancer) and, aligned with the President’s Precision Medicine Initiative (PMI), development of biosensors in the oral cavity and 3-dimensional tissue/organ models to mimic health and disease.
NIDCR FY 2016 and FY 2017 Budgets
Dr. Somerman reported that President Obama signed the FY 2016 spending bill on December 18, 2015. The NIH appropriation for FY 2016 totals $32.3 billion (or about a 6.5 percent increase over FY 2015), and the NIDCR portion is $413,396,000 (a 4.0 percent increase). Dr. Somerman noted that while the NIDCR appropriation has increased from FY 2013 to FY 2016, the purchasing power of these dollars has decreased. She thanked the Council for its continued advocacy of the NIDCR.
Dr. Somerman reported that the FY 2017 budget is unknown at this time. The President’s Budget for FY 2017, which was released on February 9, 2016, requests $33.1 billion for the NIH, or approximately $825 million more than the FY 2016 budget. Dr. Somerman listed a number of budget items of interest to the NIH and the NIDCR. These include the PMI, the BRAIN initiative, research on Alzheimer’s Disease and to combat antimicrobial resistance, support to the Common fund for the Gabriella Miller Pediatric Research Initiative, the Institutional Development Award (IDeA) program (for which the NIDCR does not currently provide funding), training awards, and HIV/AIDS research priorities and guideline changes. She noted that the NIDCR is actively involved in the Zika Virus initiative, particularly regarding use of blood and saliva for diagnosis.
Health Disparities Research: NIDCR Funding
Dr. Somerman presented data on FY 2011‒FY 2015 NIDCR support for health disparities research through consortia/centers and other research. She said that this support, which amounted to 13 percent of the total NIDCR budget in FY 2015, is substantial and reflects the Institute’s concern for addressing health disparities. She noted that the Multidisciplinary and Collaborative Research Consortium to Reduce Oral Health Disparities in Children: A Multilevel Approach (UH2/UH3) is critical for developing strategies to overcome oral health disparities and received 23 percent of the FY 2015 funding. Most of NIDCR’s support in health disparities is for investigator-initiated research.
VI. CONCEPT CLEARANCE
Dr. Dombroski stated that the NIDCR is required to present the purpose, scope, and objectives of staff-developed concepts for NIDCR initiatives in a public forum for the Council’s discussion, review, and approval. The NIDCR staff presented one concept for the Council’s review.
Targeting Head and Neck Cancers for Immunotherapy
Dr. Sundar Venkatachalam, program director of the Oral and Salivary Cancer Biology Program, Integrative Biology and Infectious Diseases Branch (IBIDB), DER, presented a proposed initiative to encourage basic and preclinical studies to identify and test tumor-specific neoantigens arising from somatic mutations which could be used as targets for immunotherapy for head and neck cancers (HNC). He noted that the concept is driven by gaps and opportunities in HNC research. During the past decade, only marginal gains have been made in survival rates for HNC, and current therapies are moderately effective and yield high morbidity. Moreover, targeted monotherapies, while specific, are limited by drug resistance and cancer recurrence.
Dr. Venkatachalam noted that exciting data have emerged in the past year showing that somatic mutations in carcinogen-induced tumors (e.g., lung cancers and melanomas) express tumor-specific neoantigens that can induce robust immune responses. The HNCs are in this category. He suggested that the “tide is turning” in the war on cancer in some areas, as cancer immunotherapy has been shown to overcome many problems associated with conventional therapies. Specific areas of interest that the NIDCR proposes to support include identification of HNC-specific neoantigens and validation of their expression in head and neck tumors, development of model systems to functionally test HNC-specific neoantigens as targets for immunotherapy, and analyses of the efficacy of combination approaches that would couple neoantigen-based immunotherapy with traditional radio-chemotherapy, targeted therapy, or immune checkpoint inhibitor blockade.
The Council’s lead discussants, Dr. Yang Chai and Dr. Richard Darveau, supported the concept. Dr. Chai said that the initiative would stimulate research on the new hypothesis—that there are HNC-specific neoantigens that could be targeted for diagnosis and treatment of HNC. He noted that salivary gland cancers have unique aspects and that the concept aligns perfectly with the NIDCR mission. In agreement, Dr. Darveau noted that the concept rests on evidence in the research literature and would exploit new technologies to identify the antigens. Dr. Yvonne Kapila, former Council member and Professor and Vice Chair, Division of Periodontology, Department of Orofacial Sciences, University of California San Francisco School of Dentistry, provided written comments, which Dr. Venkatachalam read to the Council. She expressed excitement about the initiative and noted that the research would fill a gap in knowledge about HNC antigens and somatic antigens and aligns with the PMI, the White House’s recently announced Cancer Moonshot, and the NIDCR Strategic Plan.
The Council unanimously approved the concept.
VII. NIMHD SCIENCE VISION: REDUCING HEALTH DISPARITIES AS A NATIONAL PRIORITY
Dr. Eliseo J. Pérez-Stable, Director, National Institute on Minority Health and Health Disparities (NIMHD), presented the NIMHD vision for research on minority health and health disparities. He described the Institute’s history and mission, minority health and health disparities, populations served, a research framework, and NIMHD priorities and organization. He also noted key issues in oral health disparities and NIMHD support in these areas.
The NIMHD was first established in 1990 as the Office of Research on Minority Health in the Office of the Director, NIH. In 2000, it transitioned to become the National Center on Minority Health and Health Disparities, and in 2010, became the NIMHD, with authorization under the Patient Protection and Affordable Care Act. Dr. John Ruffin led all these entities until his retirement in March 2014, and he was succeeded by Dr. Yvonne T. Maddox, who served as acting director until Dr. Pérez-Stable became director on September 1, 2015. The NIMHD is the second smallest Institute at the NIH (second to the National Institute of Nursing Research), with a budget of approximately $280 million in FY 2016.
Definitions, Populations, and Research Framework
The NIMHD has a broad mission—“to lead scientific research that advances understanding of minority health and health disparities.” It supports research in these two areas, as well as training of a diverse scientific workforce, translation and dissemination of research information, and innovative collaborations and partnerships. Dr. Pérez-Stable noted that the NIH definition of minority health is independent of health outcomes and relates to distinctive health characteristics and attributes of minority racial and/or ethnic groups in the United States, social disadvantages and/or discrimination, and historically underrepresented racial and/or ethnic groups in biomedical research and the scientific workforce. The NIH follows the Office of Management and Budget (OMB) classification of minority racial/ethnic populations, as based on the U.S. Census. Changes to this classification are being proposed for 2020.
Dr. Pérez-Stable said that the NIH definition of health disparity populations also accords with the current OMB classification, which includes racial/ethnic minorities, persons of low socioeconomic status (SES), underserved rural residents, and/or others subject to discrimination who have poorer health outcomes often attributed to being socially disadvantaged, which results in being underserved in the full spectrum of health care. He noted that specific inclusion of other populations with health disparities (e.g., women, urban poor, sexual and gender minorities, children and adolescents, immigrants and migrants, and those with special needs), which are identified as priorities in the 2015 National Healthcare Quality and Disparities Report published by the Agency for Healthcare Research and Quality (AHRQ), is under discussion.
Dr. Pérez-Stable stated that a health disparity is defined as a health difference that adversely affects disadvantaged populations, based on one or more health outcomes [i.e., higher incidence and/or prevalence, premature and/or excessive mortality in diseases where populations differ, global burden of disease measured by disability-adjusted life years (DALYs), and poorer health-related quality of life and/or daily functioning using standardized measures]. Health disparities research is devoted to advancing scientific knowledge of the influence of health determinants and to defining mechanisms and how this knowledge is translated into interventions to reduce disparities. Research is focused on four risk areas—risks to well-being (e.g., stress, low SES), biological/epigenetic risks (e.g., gene variants, susceptibility), clinical event risks (e.g., differential treatments, poor communication, adverse events), and utilization of care (e.g., lack of access, hospitalization and readmissions)—and it links with new technologies and the rapidly evolving health care system.
Dr. Pérez-Stable noted that research on minority health and on health disparities are each independent (unique) and overlap, as do research on race/ethnicity and on social class. He depicted an overall research framework that incorporates fundamental risk factors (e.g., race/ethnicity, low SES), domains of health determinants over the life course (e.g., biological, behavioral, health care system), and levels of influence (individual, interpersonal, community, and societal)—all of which impact health outcomes.
Dr. Pérez-Stable stated that inclusion of minorities in clinical studies is a separate important domain that should not be confused with minority health and is relevant to social justice and good science. He noted that diversity in the biomedical workforce is an urgent societal issue for both clinicians and scientists. For example, African Americans and Latinos comprise only 10 percent to 12 percent of lead clinicians and less than 5 percent of applicants for NIH research grants. Data on racial and ethnic categories of principal investigators (PIs) supported by the NIH in FY 2015 show that the percentage of PIs supported by the NIMHD who were African American or Black, or Latino or Hispanic, was 19.6 percent and 12.9 percent, respectively (compared with 2.2 percent and 4.7 percent, respectively, for the NIH as a whole).
Oral Health Disparities
Dr. Pérez-Stable highlighted four issues in oral health disparities of concern and interest to both the NIMHD and the NIDCR. These are caries prevention (specifically, application of fluoride varnish); lack of access to care (50 percent of minority rural and poor children have dental decay); untreated periodontal disease (which can potentially lead to tooth extractions); and periodontal diseases associated with vascular events (stroke) and possibly chronic kidney disease.
Dr. Pérez-Stable reported that the NIMHD currently supports oral health grants in five areas. In research training and career development, the NIMHD is supporting research training for doctoral students in dentistry in Puerto Rico and initiation of a D.D.S./Ph.D. program at Meharry Medical College School of Dentistry for underrepresented minorities, primarily African Americans. The NIMHD also supports SBIR research on dental biologics for underserved populations, a collaborative NIH (U24) study of the effectiveness of a rural, school-based caries prevention program, and an ancillary R01 on the effect of treating periodontal disease in stroke survivors, as part of the project entitled Reasons for Geographic and Racial Differences in Stroke (REGARDS) under way in the Deep South.
Priorities and Organization
Dr. Pérez-Stable noted the following five NIHMD priorities: (i) define the science on health disparities and minority health, (ii) establish a program of health services and research in clinical settings, (iii) emphasize population and community health, (iv) support innovative, investigator-initiated research through R01s in a balanced portfolio that includes centers, and (v) promote diversity in the workforce. He said that the NIMHD’s extramural and intramural programs are being reorganized and that new staff are being recruited. The extramural program comprises three branches (Clinical and Health Services, Integrative Biological and Behavioral Sciences, and Community Health and Population Sciences), and the intramural program combines population science with a clinical component. Dr. Pérez-Stable noted that the NIMHD is recruiting for a scientific director and, subsequently, will seek senior scientists in epidemiology, clinical, and social and behavioral research. Further, the Institute is exploring the possibility of a new cohort study of immigrant populations in coordination with other ICs.
Dr. Pérez-Stable highlighted five new areas for NIMHD research support in FY 2017. He noted that a PA has already been issued for health services research on minority health and health disparities and that FOAs are being finalized in the following four areas: research centers on retaining youth and young adults from health disparity populations in the HIV treatment cascade, health disparities among immigrant populations: etiologies and interventions, disparities in surgical care and outcomes, and social epigenomics for minority health and health disparities.
Dr. Pérez-Stable noted that the NIMHD is hosting a series of scientific workshops. Two recent workshops, on Measurement and Methods (held April 22) and Etiologies and Interventions (held May 19‒20) concluded the Institute’s scientific visioning effort. Three more workshops, which are being proposed in partnership with others, are: Use of IT Technologies in Minority Health and Health Disparities (with the National Science Foundation), Self-Identified Race and Ethnicity in Genomic and Biomedical Research (with the National Human Genome Research Institute), and Structural Racism and Cultural Competence: Impact on Minority Health and Health Disparities (with the Department of Health and Human Services’ Office of Minority Health).
Dr. Pérez-Stable said that the Institute will hold its 2016 NIMHD Health Disparities Research Institute at the NIH campus on August 15‒19 and that applications for the 1-week course are due June 1. The goal this year is to attract up to 50 senior postdoctoral scientists and researchers in disciplines supported by the science of minority health and health disparities to network with IC scientists and stimulate research.
In response to questions from the Council, Dr. Pérez-Stable said that while the NIMHD focus is driven by societal factors and race/ethnicity status, the health disparities lens applies to many groups, including persons with rare diseases. He noted that the health of immigrant populations (e.g., elderly Asian American and young Latino Hispanic populations) suggests intriguing research opportunities to study the intersection of individual biology and behavior and social/cultural factors affecting health outcomes. Clinical data are particularly needed, to explain, for example, an apparently greater resilience for health among immigrant populations. Dr. Pérez-Stable noted that Latina Hispanic women have the highest life expectancy in the United States despite increased obesity and diabetes and that minority groups have low mortality rates for Alzheimer’s disease. He mentioned that the National Institute on Aging is supporting resource centers (two of which are in Southern California) to foster research on minority Asian populations.
Dr. Pérez-Stable distinguished the terms cultural competence (cultural humility) and structural racism (discrimination). He noted that cultural competence pertains to the feeling of being welcomed in a social system or setting, as evident by the language used and the diversity of individuals in health care settings, whereas structural racism links with state policies related to different populations. He said that both are relevant to disease incidence, mortality rates, diagnosis and treatment, and health outcomes and that measuring and determining these effects are avenues for research.
VIII. SPECIAL SESSION ON HEALTH DISPARITIES RESEARCH
Dr. Jane Atkinson, director, CCR, DER, presented an overview of NIDCR’s oral health disparities research program and introduced the presenters for the session. She noted that Oral Health in America: A Report of the Surgeon General, which was published in 2000, focused attention on disparities in oral health in the United States and the “silent epidemic” of oral diseases among those most vulnerable. Since 2003, the NIDCR has included a goal to reduce oral health disparities in its Strategic Plan, and goal 3 in the NIDCR Strategic Plan 2014‒2019 specifically states, “Apply rigorous, multidisciplinary research approaches to overcome disparities and inequalities in dental, oral, and craniofacial health.” The vulnerable populations targeted are socioeconomically disadvantaged populations, racial/ethnic minorities, poor rural residents, persons with acquired or developmental disabilities, and frail and functionally dependent elders.
Dr. Atkinson noted that disparities continue in the United States even though oral health has improved overall. Data from the National Health and Nutrition Examination Survey (NHANES) show that, in 2011‒2012, the prevalence of untreated dental caries in permanent teeth of adults ages 65 years and older was 2.5 times higher among African Americans and almost 2.0 times higher among Hispanic Americans and Asian Americans than among Caucasians. The prevalence of untreated dental caries in primary teeth of children ages 6‒8 was approximately 2.0 times higher among African Americans and Hispanic Americans and 1.5 times higher among Asian Americans. NHANES data on periodontal disease among persons ages 30 years and older show that, in 2009‒2012, the prevalence of any periodontitis was1.5 times higher among African Americans and even higher among Hispanic Americans, compared with Caucasians, and that the prevalence of severe periodontitis was 2.0 times higher for both African Americans and Hispanics than for Caucasians. And although 5-year survival rates for oral and pharyngeal cancer have improved for both African Americans and Caucasians from 1987‒1989 to 2004‒2010, differences in the rates persist (45 percent for African Americans, and 67 percent for Caucasians).
Dr. Atkinson noted that in response to the Surgeon General’s report, the NIDCR issued sequential RFAs and funded two rounds of Oral Health Disparities Research Centers, in 2001‒2007 and 2008‒2010. The aims for the first “cohort” were to establish community partnerships, explore determinants of oral health disparities, conduct an intervention study, support pilot studies, and facilitate training and career development. The aims for the second cohort differed somewhat; in addition to community partnerships and training and career development, they were to conduct major interventional studies with multidisciplinary research teams and to support two developmental projects in preparation for additional intervention studies.
Dr. Atkinson noted, in particular, NIDCR support of the Early Childhood Caries Collaborating Center (EC4) program, in which research teams at three universities [Boston University, the University of Colorado Denver, and the University of California San Francisco (UCSF)] and a data coordinating center (at UCSF) are testing interventions to reduce early childhood caries in health disparities communities and are using common data elements to collect study data when possible. This research facilitates future studies examining how similar interventions work in different populations. She noted also that the NIDCR supports a number of investigator-initiated research projects (R01s) focused on oral health disparities. These range, for example, from a study of how oral health literacy influences oral health, to a longitudinal study of dental caries in very low birthweight infants, studies of how to prevent caries in Early Head Start children, factors contributing to differences in oral health in rural older adults, role of cognition in oral health among older Americans, and factors contributing to oral health disparities in Appalachia. Among the research findings from center and individual project grants are advances in clinical care, identification of risk factors, and a better understanding of mechanisms of disease.
Dr. Atkinson highlighted a major new initiative, noted earlier by Dr. Somerman, which was developed and recently funded by the NIDCR—the Multidisciplinary and Collaborative Research Consortium to Reduce Oral Health Disparities in Children: A Multilevel Approach (UH2/UH3) 2015‒2020. This initiative builds on the concept that health status is determined by many complex factors, as outlined in Healthy People 2010. The consortium, which is distributed nationwide, consists of nine projects: three program or policy evaluations and six interventional studies. The overall goal is to establish effective interventions or programs to reduce or eliminate oral health disparities and inequalities in vulnerable U.S. children and youth between 0 and 21 years of age. Each project is either a multi-level intervention or an evaluation of the impact of an intervention or program/policy on three levels influencing children’s oral health (such as individual, family, and health care system). The projects comprise both a developmental phase and an implementation phase, are supported by a data coordinating center (UCSF), and use common data elements when possible.
Dr. Atkinson concluded by introducing four extramural investigators participating in the multidisciplinary consortium. As summarized below, the presenters described their research and offered perspectives on the complexity of addressing and reducing oral health disparities among vulnerable U.S. children and youth.
IX. INTERPROFESSIONAL RESEARCH AND PRACTICE – ROLE IN REDUCING HEALTH DISPARITIES IN CARIES EXPERIENCE
Dr. Margherita Fontana, Professor, Department of Cariology, Restorative Sciences, and Endodontics, School of Dentistry, University of Michigan, Ann Arbor, MI, described her research on predicting caries risk in underserved toddlers in primary health care settings. The focus of this consortium project is to develop a self-administered, simple-to-score tool to assess caries risk in this population and setting. Dr. Fontana thanked the NIDCR for supporting her research, which includes collaboration with a multidisciplinary team of health professionals at six U.S. universities. She said that with third-party funding from industry, she is collecting additional data to combine with and enrich the consortium data.
Dr. Fontana noted that reducing disparities in caries, which has been her focus for the past decade, aligns with goals 2 and 3 of the NIDCR Strategic Plan—to engage primary care providers in individualized oral health care and to apply multidisciplinary research approaches to overcome disparities. She emphasized that targeted health care is paramount in today’s health care system, particularly for dental caries because of the large disparities in their distribution and the access to care, especially among young children. Expanded participation with the medical community is a necessary strategy, and data indicate that involvement of pediatricians and family physicians as partners in oral health results in reduced caries experience. This strategy is supported by recommendations from professional organizations, Medicaid reimbursement, new technologies such as phone apps for training non-dental providers, standardization of interprofessional education and care, and data showing a high probability of correctly identifying young children at risk of caries.
Dr. Fontana noted that her research to develop an effective, simple-to-use tool to assess caries risk could have a large impact on practice and policy. The research addresses a number of current problems—for example, tools have been developed primarily for dental settings, but not medical settings; no validated multivariate caries-risk screening tools are used in primary care settings; there is no consensus on which tool is most effective; and better evidence is needed on the effectiveness of an assessment tool for caries prevention in at-risk groups. As a result, assessment, prevention, and referral can be neither personalized nor targeted.
For her research project, children are recruited at age 1 through their medical care “homes” and are followed through age 4 through the medical (Medicaid) network. They are examined clinically at baseline (age 1), 18 months (age 2.5), and 36 months (age 4) and are monitored continuously every 4 months. Primary clinical data are obtained by dentists or hygienists who assess and score (from 0 to 6) each child’s caries experience. In addition, the primary caregiver for each child (94 percent are mothers) completes a validated, self-administered caries-risk questionnaire encompassing four multivariate domains: bacteria, diet, environment/oral hygiene, and treatment/sociodemographic.
Dr. Fontana reported that enrollment concluded March 6, 2014. Of 2,173 children approached, 1,326 were enrolled (49 percent female, 51 percent male) at completion of their baseline visit (for an enrollment rate of 1.6). Among the variety of recruitment strategies used, face-to-face contact between provider and caregiver yielded the highest percentage (25.3) of enrollees. Dr. Fontana noted that retention is high (80 percent at the 18-month visit and even higher at intermediate times), owing to frequent contact between the three clinical exams. Of the enrolled participants, 37 percent are Caucasian, 37 percent are African American, 13 percent are Hispanic, and 13 percent are multiracial or other; 61 percent are enrolled in Medicaid.
Dr. Fontana reported that the subject-level primary outcome for the study is that children who develop and/or have lesions progress to cavitation [defined based on the International Caries Detection and Assessment System (ICDAS)] as ≥ 3 decayed, filled, or missing teeth due to caries). Elaborating on the data emerging, she noted that baseline data from the questionnaires show statistically significant different responses by Medicaid status (e.g., 40 percent of caregivers enrolled in Medicaid said they give their child sugary drinks daily, versus 12 percent of those not enrolled in Medicaid) and by race/ethnicity (e.g., 24 percent of African American, 13 percent of Hispanic, and 4 percent of Caucasian caregivers said they eat sugary snacks 3 or more times a day). The data also show that caregivers perceived they took better care of their infant’s medical health than their dental health. Clinical data from the intermediate exam (at 18 months) show that 7 percent of the children (age 2.5 years) had cavitated caries lesions (mostly in anterior teeth) and that the caries experience differed across race/ethnicity, Medicaid status, and urban‒rural residence. Analysis of the association between caregivers’ responses to the questionnaire and their children’s caries status at age 2.5 years yielded odds ratios of less than 1 for children who had dental insurance, additional health insurance, or were delivered by C-section—and for caregivers who had health and dental insurance, higher ratings of taking good care of their children’s medical health, and higher frequency of getting regular dental checkups themselves. Comparison of data on tooth eruption time, which may play a role in early childhood caries, with data from the NIDCR-supported Northern Plains American Indian Study showed that American Indian children had twice the median number of teeth (8) at approximately 11 months of age than did Caucasian or African American children (4) participating in the present study.
Dr. Fontana listed the following next steps for research: determination of the role of biomarkers, temperament, and quality-of-life measures in risk analysis; validation of a tool(s) to assess caries risk; delineation of caries risk in mixed dentition; and modeling of risk-based use of fluoride varnish, education and referrals in medical settings, and implementation and dissemination strategies to reduce disparities in the caries experience. She mentioned that she is a recipient of a Health Care Innovation Award from the Centers for Medicare and Medicaid Services (CMS) to support reducing the burden of childhood dental disease in Michigan. The objective of this implementation project, The Michigan Caries Prevention Program, is to increase the proportion of low-income children who receive preventive dental services through medical settings. Dr. Fontana suggested that while there are many structural barriers to implementation, clinical culture (i.e., clinicians’ personal values) can overcome these and influence outcomes positively. In closing, she emphasized that in this era of personalized caries management, better risk assessment tools are needed and interprofessional care is crucial to risk assessment, prevention, and referral.
X. THE BOSTON UNIVERSITY CREEDD
Dr. Raul I. Garcia, Professor and Chair, Department of Health Policy and Health Services Research, and Co-Director, Center for Research to Evaluate and Eliminate Dental Disparities (CREEDD), Henry M. Goldman School of Dental Medicine, Boston University, MA, described the organization and development of the initial Boston University center (CREEDD-1), from 2001 to the present. Following his presentation, Dr. Michelle M. Henshaw, Professor, Health Policy and Health Services Research, Co-Director, CREEDD, and Dean, Community Partnerships and Extramural Affairs, Henry M. Goldman School of Dental Medicine, Boston University, MA, presented an overview of ongoing projects in CREEDD-2, the center’s second iteration. The Boston center also leads two of the nine projects in the NIDCR-supported Multidisciplinary and Collaborative Research Consortium to Reduce Oral Health Disparities in Children: A Multilevel Approach.
CREED-1: Where We’ve Been, Where We Are, Where We’re Going
Dr. Garcia stated that over the past 15 years, the Boston CREEDD has had two overall themes: community engagement and capacity building. He noted that with NIDCR funding of two initial U54 awards, the center sought to build a community of scholars in oral health disparities research and that now with two consortium awards, the investment can be more fully realized. He recognized in particular the efforts of Dr. Ruth Nowjack-Raymer, who directed the NIDCR Oral Health Disparities Research Program during these years and who recently retired.
Dr. Garcia remarked on the development of interest in oral health disparities, from the 2000 Surgeon General’s report, Oral Health in America, which drew attention to profound disparities in oral health, to the World Health Organization’s definition of health disparities as “differences which are unnecessary and avoidable but, in addition, are also considered unfair and unjust,” and the Surgeon General’s 2000 report, A National Call to Action to Promote Oral Health, which encouraged funding to build the science base and accelerate science transfer in oral health disparities research. He noted that the NIDCR initiative and support of Centers for Research to Reduce Oral Health Disparities (CCROHD) provided U54 funds for the initial Boston CREEDD beginning in 2001. With a second U54 award that extended funding through 2014, CREEDD-1 was able to transition from observation research to intervention research and from single-center studies to participation in a multicenter collaboration.
Dr. Garcia noted that CREEDD-1 included both cores and R01-type projects. Investigators developed, tested, and validated a broad set of instruments, which are in use now, to assess oral health-related quality of life in children and adolescents. They also studied the microbiota of children with oral health disparities, developed an intervention for health care providers to decrease rates of early childhood caries, and examined the effect of severe early childhood caries and how diet impacts the oral health of children. Six other Boston institutions participated as partners in this research, which was funded by both the NIDCR and the former National Center on Minority Health and Health Disparities. Through community engagement and capacity building, the center focused on oral health promotion and disease prevention by non-dentists in non-dental settings. Research training and career development were supported in part by three minority health supplements to attract underrepresented minorities into the research workforce.
Dr. Garcia highlighted two outcomes from CREEDD-1: (i) integration of oral health promotion into pediatric well-child visits—a behavioral intervention that resulted in a lower incidence of early childhood caries over 2 years in the intervention group compared with the control group; and (ii) development of new instruments to measure pediatric oral health-related quality of life before and after treatment of early childhood caries.
NIDCR funding also supported the second iteration, CREEDD-2, from 2008 through 2015. In addition, the Boston researchers are collaborating with two other sites (University of California Davis and UCSF) and a data coordinating center (at UCSF) in the NIDCR-supported EC4 program which, guided by a steering committee, includes five working groups. Dr. Garcia reported that the products from this collaboration so far include development of standardized caries assessment, examiner training, calibration protocols, and cost-analyses methods; a common questionnaire [the Basic Research Factors Questionnaire (BRFQ)]; and a clinical trials management system.
CREEDD-2 and Beyond
Dr. Henshaw noted that CREEDD-2 was focused on translating interventions for prevention of early childhood caries from the clinical setting into community health and public housing settings. The study showed, for example, that pediatric teams in community health centers (CHCs) can be trained to integrate oral health into well-child visits; messages counseling about early childhood caries can be developed and tailored for low-income, public housing residents; public health residents can be successfully trained to use motivational interviewing for counseling about early childhood caries; and participants prefer to communicate via texts and emails. Barriers to implementation included limited time available with patients and the intensive research needed to translate interventions to nonclinical settings.
Dr. Henshaw described two NIDCR-supported projects building on CREEDD-1 and CREEDD-2. In one, for which she serves as co-PI, the research team will integrate interactive parent text messaging and oral health guidelines into pediatric CHCs to reduce early childhood caries among urban children. The target populations will be (a) parents of children under 6 years of age who are recruited during pediatric well-child visits at urban CHCs, and (b) pediatric care providers in CHCs who are trained to adopt the American Academy of Pediatrics’ oral health guidelines. Dr. Henshaw noted that use of text messaging to deliver an intervention is a “provider extender” and aligns perfectly with widespread use of this technology among populations at greatest risk of oral health disparities. She highlighted the benefits of text messaging, which include, for example, the ability to tailor the content of an intervention to an individual’s risk factors and behaviors. During the current, developmental, phase, the research team is refining the oral health text message and developing and testing the software platform.
In a second project, for which Dr. Garcia serves as PI, researchers are building on prior CREEDD research in public housing settings. The aim is to use social networks to improve oral health among populations residing in Boston public housing. Also in the developmental phase, this project will involve enrolling a network sample to pilot-test recruitment strategies, data collection tools, message acceptability, and potential targets; identifying behavioral norms in the population using the BRFQ, conducting focus groups among community members identified in the network who are successful in using their own strategies to address health issues, and developing culturally appropriate health promotion messages for this sample; and identifying community resources (programs and services) that may influence behavioral norms.
In closing, Dr. Henshaw noted that the two projects continue the CREEDD emphasis on community engagement and capacity building and will develop “true” community partners who are involved in all aspects of the research, from design to intervention. In discussion, the Council encouraged the researchers to engage foundations as partners in this work.
XI. COMMUNITY HEALTH WORKERS IN THE UNITED STATES:
PAST, PRESENT, AND FUTURE
Dr. Molly Martin, Associate Professor of Pediatrics, University of Illinois at Chicago (UIC) College of Medicine, and Principal Investigator, Coordinated Oral Health Promotion (CO-OP) Chicago, UIC College of Dentistry and UIC Institute for Health Research and Policy, Chicago, IL, entitled her presentation, “community health workers 101.” She discussed community-level health care in the United States, the definition and role of community health workers (CHWs), evidence of CHWs impact on improving health, policies and implementation of CHW interventions, and research questions to address. She also described the aims, design, and anticipated outcomes of the CO-OP Chicago program, for which she is PI. CO-OP Chicago is one of the nine projects in NIDCR’s new multidisciplinary consortium.
Dr. Martin showed data from the Organization for Economic Cooperation and Development (OECD) highlighting two challenges facing U.S. health care: high costs and low life expectancy. In the United States, average spending on health per capita and total health expenditures as a percent of the gross domestic product are the highest among nine most-developed OECD countries, whereas life expectancy is lower than that in 19 other rich OECD countries. She also noted that while the U.S. health care system has strong tertiary-level care and good outpatient clinical care, it has almost no community-level care.
Dr. Martin suggested that these challenges present an opportunity for building up the function and role of CHWs in the U.S. health care system. CHWs are defined as frontline public health workers who are trusted members of and/or have an unusually close understanding of the community served and who build individual and community capacity by increasing health knowledge and self-sufficiency through activities such as outreach, community education, informal counseling, social support, and advocacy. They empower community members to identify their own needs and implement their own solutions and because they are not “experts,” they may be most effective. And, although CHWs often are known by other names (e.g., lay health advisors, community health advisors or aids, peer or outreach educators, patient navigators), they are not the same as promotores and promotoras, which is a different concept utilized in Latino communities and derived from social change movements in Latin America.
Dr. Martin summarized current evidence on the effectiveness of CHWs. She noted that the Cochrane Database of Systematic Reviews in 2005 and 2010 shows a positive association between CHW interventions and childhood immunization and some infectious diseases, as well as improvements in tuberculosis treatment outcomes, breastfeeding promotion, and reduction of child morbidity and mortality, when compared to usual care. An AHRQ review of studies in 1980‒2008 indicates that evidence on the effectiveness of CHWs is mixed, although it is moderately strong for improving medical follow-up rates for elevated blood pressure and reducing unscheduled medical visits, as well as psychosocial outcomes among caregivers of children with asthma. Dr. Martin also referenced multiple recent studies which report that use of CHWs improved some clinical outcomes for patients with diabetes, asthma, cancer, and hypertension and stroke. She concluded that the evidence of effectiveness is strong in relation to many chronic disease areas, but there is a dearth of effectiveness data overall.
Dr. Martin noted that use of CHWs in oral health is weak and just getting started in the United States. Studies in other countries (Brazil, England, and Australia) show that use of CHWs results in a decreased incidence of caries in early childhood. And, preliminary results of the American Dental Association’s program utilizing community dental health coordinators (CDHCs) in underserved rural, urban, and Native American communities are promising, as they suggest that use of CDHCs’ results in fewer missed, and an overall increase, in dental appointments and high patient satisfaction.
Dr. Martin summarized the evolution of U.S. policies and regulations pertaining to CHWs—from the Federal Migrant Health Act of 1962 and the Economic Opportunities Act of 1964, which mandated outreach efforts in neighborhoods with high poverty levels and in migrant labor camps, to the recent Affordable Care Act (ACA), which authorizes grants to promote use of CHWs in the community health workforce. In 2002, the Institute of Medicine report entitled, Unequal Treatment, called for support and evaluation of CHW work and integration of CHWs into medical teams to reduce health disparities; in 2007, the American Public Health Association created a common definition of CHWs; and in 2009, the U.S. Department of Labor developed a Standard Occupational Classification for the CHW profession. In July 2013, the CMS issued a final rule implementing provisions of the ACA which allow state Medicaid programs to reimburse for preventive services by professionals that may fall outside of a state’s clinical licensure system if the services are initially recommended by a physician or licensed practitioner. Dr. Martin commented that most states may not be able to actualize this provision and whether it applies to CHWs is not entirely clear.
Dr. Martin said that implementation of CHWs in U.S. health care is moving forward and that there are many workforce and funding issues to be addressed. A webinar poll, conducted on February 23, 2015, by the National Academy for State Health Policy (NASHP), indicated that the biggest challenges or hurdles to integration of CHWs into health care systems are (a) financing the work of CHWs, and (b) defining their roles and scope of practice. National and state legislative efforts are under way: There is a national movement to promote CHWs (the CHW Core Consensus Project), and almost every state has some ongoing effort. Dr. Martin referred the Council to the CHW Core Consensus Project website (http://www.chrllc.net/id12.html) and the NASHP website (http://www.nashp.org/state-community-health-worker-models/).
Some of the big questions being considered include who CHWs are (e.g., is being “from the community” defined by race/ethnicity, socioeconomic status, disease, do they need high school or college degrees?); what they are (e.g., are they peers, outreach workers, patient navigators?); where they serve (within the existing health care delivery system and/or in community environments to which the system adapts?); and how they serve (e.g., in which types of interventions, on clinical teams?), how their skills and work are assessed (certification/licensure by whom, measures of effectiveness), and how they are paid (by whom?).
Dr. Martin noted that CO-OP Chicago is addressing these questions. CO-OP Chicago is a family-focused CHW intervention to reduce early childhood caries in low-income and minority infants and toddlers by educating families about oral hygiene at health clinics, Women, Infant, and Children (WIC) centers, and homes. In the current, planning phase, the research team is formalizing partnerships and finalizing the study design and protocol. The study will involve cluster randomized clinics, centers, and homes in which families will receive usual care or enhanced oral health care. Data will be collected at baseline and at 6 months and 12 months thereafter. During the implementation phase, investigators will evaluate the ability of a clinic-based, WIC-based, or home-based intervention to improve children’s oral health and will determine the added value of combined interventions. The outcomes to be measured include RE-AIM (reach and efficacy and adoption, implementation, and maintenance of oral health behaviors); secondary oral health variables (e.g., oral-health quality of life for children and caregivers, and family oral health behaviors and access) and other variables such as children’s body mass index, medications, and co-morbidities; caregivers’ psychological functioning, social support, and family functioning; and program costs.
In response to questions from the Council, Dr. Martin commented on state efforts concerning CHWs, supervision of CHWs, and training and coordination of CHWs in the CO-OP Chicago intervention.
XII. ADJOURNMENT OF OPEN SESSION
Dr. Somerman adjourned the open session of the Council meeting at 12:10 p.m.
This portion of the meeting was closed to the public in accordance with the determination that it was concerned with matters exempt from mandatory disclosure under Sections 552b(c)(4) and 552b(c)(6), Title 5, U.S. Code and Section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2).
XIII. REVIEW OF APPLICATIONS
The Council considered 539 applications requesting $148,853,065 in total costs. The Council recommended 358 applications for a total cost of $102,045,987 (see Attachment II).
The meeting was adjourned at 2:34 p.m. on May 24, 2016.
I hereby certify that the foregoing minutes are accurate and complete.
Dr. Martha J. Somerman Dr. Alicia Dombroski
Chairperson Executive Secretary
National Advisory Dental and National Advisory Dental and
Craniofacial Research Council =Craniofacial Research Council
I. Roster of Council Members
II. Table of Council Actions