NIH Health Disparities Strategic Plan Fiscal Years 2009-2013
NATIONAL EYE INSTITUTE
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- Mission/Vision Statement
- Strategy for Addressing Health Disparities
- Areas of Emphasis in Research
- Areas of Emphasis in Research Capacity
- Areas of Emphasis in Community Outreach, Information Dissemination, and Public Health Education
- Integration of Research, Research Capacity Building, and Community Outreach, Information Dissemination and Public Health Education
- References
Mission/Vision Statement
Congress established the National Eye Institute (NEI) in 1968 with the mission to "conduct and support research, training, health information dissemination, and other programs with respect to blinding eye diseases, visual disorders, mechanisms of visual function, preservation of sight, and the special health problems and requirements of the blind." Inherent in the NEI's mission is the investigation of normal visual processes and prevention of blindness through public and professional education programs and through the encouragement of regular eye examinations.
NEI will continue to protect and improve the visual health of the Nation by supporting high-quality laboratory and clinical research aimed at increasing our understanding of the eye and visual system and developing the most appropriate and effective means of prevention, treatment, and rehabilitation, and disseminating research findings and information that will promote visual health.
Strategy for Addressing Health Disparities
NEI is the principal Federal agency concerned with the support of basic and clinical research aimed at the improved prevention, diagnosis, and treatment of eye diseases and visual disorders that cause visual impairment and blindness. Vision research is supported by the NEI through approximately 1600 research grants and training awards made to scientists at more than 250 medical centers, hospitals, universities, and other institutions across the country and around the world. NEI also conducts laboratory and patient-oriented research at its own facilities located on the National Institutes of Health (NIH) campus in Bethesda, Maryland.
The NEI strategic plan, the National Plan for Eye and Vision Research, was developed with input from vision research experts. In addition, the National Eye Health Education Program (NEHEP) Partnership met to review and evaluate progress, identify new critical areas for applied research, and make recommendations regarding the NEHEP. Both the research priorities and NEHEP recommendations were included in the strategic plan. Several of the priority recommendations made by these groups were related to health disparities. They included research on glaucoma, diabetic retinopathy, health services research, and eye health education. Over 60 professional, scientific, or advocacy organizations that support vision research were asked to review the draft plan to ensure that important areas of vision research had not been overlooked. The final plan reflects the comments and input received during that process and can be found on the NEI website at http://www.nei.nih.gov/strategicplanning.
NEI national plan research priorities related to health disparities have been included in this document. In 2010, NEI will be engaging the vision research community to develop a new strategic plan. In a workshop scheduled for October 2010, panels of biomedical scientists and clinicians will establish research priorities for the core programs supported by the NEI, as well as cross-cutting topics in vision research including health disparities in ocular health. The plan will be available for public comment by patients and patient advocate groups prior to final publication. In addition, NEI's role as lead agency for vision in the Department's Healthy People 2020 will be highlighted.
An NIH committee developed strict definitions of minority health and health disparities research so that funding levels can be tracked for clinical or basic research related to diseases, conditions, or biological processes that are either exclusively or almost exclusively found in specific minority or health disparities populations. Specific eye diseases and conditions, however, are not found exclusively or nearly exclusively in minority or health disparities populations. Nonetheless, some eye diseases, such as glaucoma, diabetic retinopathy, and cataract, have a greater prevalence in minority populations resulting in increased visual impairment and blindness compared to other populations. A recent study of causes and prevalence of visual impairment suggested that glaucoma and cataract account for over 60 percent of the blindness in black adults in this country.1 The study also found that despite highly effective surgical treatment, cataract causes approximately 50 percent of the bilateral low vision in Blacks, Hispanics, and Whites. By conducting basic and clinical research into these diseases and ensuring that NEI-supported clinical trials have appropriate inclusion of minority populations, NEI and the vision research community are trying to improve treatment of those afflicted, particularly those who have a disproportionate share of the disease burden.
NEI developed a collaborative research network for diabetic retinopathy. This partnership between NEI, academic research scientists, community-based practices, industry, and private research foundations builds research capacity for testing multiple protocols. Because two thirds of this extensive network is comprised of community clinics, it can conduct comparative effectiveness trials in a wide variety of patient populations to obtain information about the full spectrum of diabetic eye diseases. The network also contributes to the training and knowledge of the ophthalmologic community with regard to rigorous clinical trials and to the state-of-the-science in diabetic eye disease. Other disease specialists (ophthalmic and non-ophthalmic) are considering using the diabetic retinopathy network as a model for community-based research collaboration. Finally, creation of this network is consistent with an Institute of Medicine (IOM) recommendation from its 2006 report to address health disparities in community-based participatory research partnerships (Examining the Health Disparities Research Plan of the National Institutes of Health: Unfinished Business).
NEI, through NEHEP, convenes work groups and conducts focus groups and key informant interviews to ensure the sensitivity of its education programs in addressing the needs and perspectives of minority populations. These activities have resulted in culturally appropriate educational materials for the Glaucoma Education Program, the Low Vision Program and the Diabetic Eye Disease Program, which includes American Indian and Alaska Native outreach. The ¡Ojo Con Su Visión Program! (Watch Out for Your Vision) provides Spanish-language outreach on diabetic eye disease, glaucoma, and low vision.
The goal of strengthening the capacity of minority communities is being addressed through NEHEP with their efforts to expand the number of partnership organizations involved in the planning and conduct of its educational and outreach activities. NEI efforts for Healthy People 2020, the Department of Health and Human Services (HHS) health promotion and disease prevention initiative, are also aimed at strengthening the capacity of minority communities. NEI provides leadership to promote health and prevent disease among Americans through management and coordination of the vision objectives in Healthy People 2020, the Nation's health agenda.
NEI recognizes the importance of strengthening the capacity of community-based organizations by providing "seed money" to begin or continue vision-related health education projects. NEI has established a Healthy Vision Community Awards Program that is intended to stimulate collaborative community health education initiatives. These awards provide NEI with opportunities to establish partnerships that extend the reach and effectiveness of its work.
Areas of Emphasis in Research
Area of Emphasis One: Glaucoma
Glaucoma is not a single disease but a heterogeneous group of disorders that share a distinct type of optic nerve damage that can lead to blindness caused by the death of retinal ganglion cells. Most glaucoma is associated with increased eye pressure, known as intraocular pressure (IOP). Glaucoma often begins with a defect in the front (anterior portion) of the eye where fluid, the aqueous humor, circulates to provide nutrients to various tissues. Aqueous humor enters the anterior chamber via the ciliary body epithelium (inflow), bathing the lens, iris, and cornea, and then leaves the eye via the trabecular meshwork and Schlemm's canal to flow into the venous system (outflow). Normal IOP is maintained by a balance between fluid inflow and outflow. Almost all high IOP glaucomas are associated with defects that interfere with aqueous humor outflow. The consequence of this elevation in IOP is that optic nerve function is compromised. The result is a distinctive optic nerve atrophy, which is characterized by excavation and cupping of the optic nerve, indicating destruction of optic nerve axons.
Rationale and Priority
Primary open-angle glaucoma (POAG) is usually characterized by high IOP believed to arise from a blockage of the aqueous humor outflow through trabecular meshwork in the front of the eye. POAG is the most common glaucoma subtype in the Western world. Among people 70 years of age or older, the prevalence of open-angle glaucoma is 6 percent in Caucasians, 16 percent among African-derived populations, and 3 percent in Asians.2 Alternatively, another form of POAG, normal-tension glaucoma, is characterized by a severe optic neuropathy with IOP within the normal range, albeit often in the high normal range. Both forms of POAG first appear in midlife or later. However, among African-Americans, the disease may begin earlier in middle age. In contrast, juvenile open-angle glaucoma is a primary glaucoma that affects children and young adults. This rare, earlier onset form of glaucoma also is distinguished from POAG by very high IOP. Although there are a number of other forms of glaucoma, the major focus of NEI-supported research remains on POAG because of the public health impact from the large number of affected people.
POAG is a progressive optic neuropathy that, if left untreated, will lead to blindness. If detected, disease progression can frequently be arrested or slowed with medical and surgical treatment. However, without treatment, the disease can result in irreversible blindness. Even though the initially blocked outflow of fluid occurs in the front of the eye, vision loss is caused by damage to the retinal ganglion cells, whose axons form the optic nerve at the back of the eye.
An estimated 60.5 million people worldwide have glaucoma, and it is estimated that by the year 2020, 5.9 million people will be blind as a result.3 Glaucoma is a major public health problem in the United States. The most recent analysis of population-based data from several studies estimated that 2.2 million Americans had glaucoma in 2000, and by the year 2020 this number is expected to increase to nearly 3.4 million.4 Furthermore, the study found that glaucoma is three times more prevalent in African-Americans than in white individuals3 and is the leading cause of blindness in African-Americans.5 Epidemiological studies conducted in the United States and the West Indies have improved the prevalence and incidence estimates of POAG among white and black populations. These studies are strengthened by using definitions of POAG that focus on visual field loss or optic disc damage but not IOP. The Beaver Dam (Wisconsin) Eye Study of nearly 5,000 individuals between the ages of 43 and 84 reported a prevalence rate of 2.1 percent in a predominantly Caucasian sample.6 The Baltimore Eye Study, with over 5,000 participants age 40 and older, reported a prevalence rate of 1.7 percent among Caucasian-Americans and 5.6 percent among African-Americans.7 The Barbados Eye Study, which studied over 4,000 black Barbadians ages 40 to 84, reported a prevalence rate of 7 percent.8 Thus, these two studies confirmed substantially higher prevalence of POAG in Caribbean Blacks and African-Americans than in Whites. Recent prevalence estimates of POAG in Hispanics indicate rates slightly lower than African-Americans but higher than Whites.3
Although treatments to slow the progression of the disease are available, at least half of those who have glaucoma are not receiving treatment because they are unaware of their condition.9 In some patients, the beneficial effect of the eye drops lessens with time, and "advanced glaucoma" develops. Findings from the NEI-supported Advanced Glaucoma Intervention Study suggest that black and white patients with advanced glaucoma respond differently to two surgical treatments for the disease. Although both groups benefit from treatment, scientists found that Blacks with advanced glaucoma benefit more from a regimen that begins with laser surgery, while Whites benefit more from one that begins with trabeculectomy surgery.10
Results from three other clinical trials confirmed the value of reducing IOP in patients with ocular hypertension or glaucoma to prevent the onset of glaucoma in the former case and the progression of disease in the latter. The Ocular Hypertension Treatment Study (OHTS) cosponsored by the NEI and National Center for Minority Health Disparities (NCMHD) noted that a 20 percent decrease of IOP produced a 50 percent protective benefit over baseline among those individuals who had elevated IOP without optic disc or visual field deterioration.11 Analysis of the African-American subgroup in the OHTS revealed that daily pressure-lowering eye drops also reduced the development of POAG in African-Americans by almost 50 percent.12 The Early Manifest Glaucoma Trial determined that patients with newly diagnosed glaucoma progressed less often than untreated patients when IOP was reduced at least 20 percent compared with baseline.13 The Collaborative Initial Glaucoma Treatment Study demonstrated that either pharmacological or surgical therapy are equally effective in delaying progression of disease for at least 5 years.14
Analyses of key baseline factors among ocular hypertensive patients enrolled in the OHTS also described a number of risk factors for the development of glaucomatous damage, including IOP, large cup-to-disc ratio, age, and central corneal thickness.15
Genetic studies have identified a dozen glaucoma loci and the cloning of more than a half dozen glaucoma genes.16 New studies involving genome-wide screening are beginning to identify multiple alleles that may play a role in glaucoma. Identification of trabecular meshwork glucocorticoid response/myocilin, optineurin, cytochrome P450 1B1 (CYP1B1), probably play a less prominent role in causing disease but will provide a better understanding of normal eye development and the molecular pathophysiology of glaucoma. Defining roles for these genes with respect to glaucoma should indicate pathways that are disrupted and increase our understanding of the pathology of all forms of glaucoma.
Elevated IOP is frequently associated with glaucoma, and explanations for how axons become damaged are usually based on the mechanical effects of elevated IOP. However, optic nerve damage abnormally high pressures is observed, and conversely, elevated pressure does not necessarily lead to optic nerve damage. Discovering the basis of optic nerve degeneration is essential for developing the next generation of neuroprotective agents as drugs for treating glaucoma. Recent evidence suggests that nitric oxide is directly involved in mediating the degeneration of axons in the optic nerve head.17 Thus, it is possible that antagonists of nitric oxide could form a new class of neuroprotective agents for treating glaucoma.
It is important to develop methods of diagnosis to detect the disease in the early stages, when treatment is most effective in minimizing irreversible vision loss. This is also critical because of the absence of symptoms in the early stages of glaucoma. Most recently, the diagnosis of glaucoma emphasizes the presence of visual field loss and observable characteristic optic nerve damage rather than simple changes of IOP. Individuals with ocular hypertension present a unique dilemma for clinicians. In the absence of any overt pathology, clinicians must decide whether or not to treat these individuals with IOP-lowering medications that can pose a considerable expense and often have side effects. This dilemma can be avoided with a more thorough understanding of the natural history of the disease and whether early treatment can prevent the onset of glaucoma.
Clinical and laboratory research will continue to provide a greater understanding of the normal functions of the ocular tissues involved in glaucoma. Such studies will continue to lead to the introduction of new drugs to reduce IOP, the development of new diagnostic tools, better estimates of disease prevalence and incidence, and the identification of glaucoma genes.
Objective One: Understanding Glaucoma
Elucidate the prevalence, pathophysiology, natural history, and history of intervention results of optic neuropathies such as glaucoma and optic neuritis over the full time course of these diseases and within ethnic subgroups.
Action Plan
Improve our understanding of the nature and course of glaucoma, incorporating studies of comorbidity, natural history, and genetics. Results from the Baltimore Eye Study, the Beaver Dam Eye Study, and the Barbados Eye Study firmly established race as a significant risk factor for POAG. Although disease prevalence differed in the populations studied, all of these studies confirm a substantially higher prevalence of POAG in African-Americans. Furthermore, the rates for blindness due to POAG in African-Americans are six times higher than for the Caucasian population. A recent report estimated the prevalence of glaucoma in Latinos of Mexican ancestry to be higher than Whites at ages older than 65 years3 which could partly account for the high age-specific rates of visual impairment seen in the Los Angeles Latino Eye Study.18 More research is needed to increase our understanding of the nature and course of the disease and to provide new knowledge upon which to base preventive measures or improved treatments.
Two independent, but complimentary, large-scale genotyping efforts with a harmonized definition for POAG are currently underway. The GENEVA (Gene Environment Association) genome-wide association study represents the largest prospective, population-based study sample where blood samples were collected before the first sign of glaucoma. The NEIGHBOR (NEI Glaucoma Human Genetics Collaboration) consortium consists of clinic-based POAG cases and controls drawn from 15 institutions. In parallel, a new whole genome association technique is utilized for genome-wide association study of POAG in African-Americans. This approach, called admixture mapping, takes advantage of the unique genetic structure of admixed populations such as African-Americans, and has recently been used to map genes for complex diseases.
The availability of these diverse datasets with detailed genotype and phenotype information will accelerate the discovery of gene-gene and gene-environment interactions in POAG that are related to gender and to specific population groups. The discovery of the combination of genetic and environment factors that link normal biologic pathways and pathophysiology to POAG could lead to more rational treatments for the disease, and perhaps to lifestyle modification strategies to prevent or delay POAG.
Questions of comorbidity have not been adequately resolved. Studies that sought to investigate the relationship between glaucoma and myopia have yielded ambiguous results. NEI is supporting the International Collaborative Twin Study of Refractive and Glaucoma Endophenotypes to look at genetic factors that play a common role in these conditions. There is also incomplete and equivocal epidemiologic information available on the relationship between glaucoma and vascular disease. The need to examine comorbidity is highlighted by the fact that the rate of hypertension is often high in minority populations.
Risk factors for glaucoma need to be identified and verified. The question of whether there are susceptibility genes that can affect the course of the disease is being actively pursued. With advances in genetics, environmental effects also need to be understood so that researchers can better determine the interaction of genetics and environment in the natural history of this disease. Currently, important known risk factors for glaucoma include elevated IOP, advanced age, optic disc abnormalities, and family history of POAG. However, the contribution of each of these known risk factors to the progression of glaucoma is unknown. Questions remain concerning whether or not a compromised vascular system contributes to glaucomatous pathology. The difficulty of measuring ocular blood flow hampers progress in understanding its impact on the survival of retinal neurons and visual function.
Explore differences in biomechanics that may factor into racial differences in glaucoma susceptibility. NEI is funding research exploring racial variations in optic nerve structure and biomechanics among glaucoma patients of African descent who are at increased risk for glaucoma relative to Caucasians with similar intraocular pressures. The results of several randomized prospective trials have identified multiple risk factors associated with the development or progression of glaucoma.19, 20, 21, 22, 23 Across these studies, IOP, age, central corneal thickness (CCT), increased optic disc cupping, and African ancestry are associated with glaucomatous progression. It is important to note that all of these risk factors have a biologically plausible association with either the level of IOP, the severity of disease (visual field loss), or biomechanical properties of the optic nerve head (ONH).24, 25 In all studies that included individuals of African descent, there has been a significant association of these factors with progression of the disease in this population. Analysis of data from the Ocular Hypertension Treatment Study demonstrated that this racial predilection for progression is largely explained by differences in CCT and in the cup-to-disc ratio, a measure of optic nerve structure. In addition to prospective trials in glaucoma and ocular hypertension, both the Baltimore Eye Survey and Salisbury Eye Evaluation Survey demonstrated a higher prevalence of glaucoma in African-Americans despite minimal differences in IOP. Furthermore, the Barbados Eye Study has also demonstrated rapid progression of glaucoma in an Afro-Caribbean population. Taken together, these findings indicate that the eyes of individuals of African descent are more vulnerable to glaucomatous injury at similar levels of IOP than other racial groups. In the African Descent and Glaucoma Evaluation Study, NEI plans to further explore these differences and develop techniques to quantify the biomechanical behavior of the ONH in individuals of African and European descent to determine how this increase in vulnerability to IOP-related injury is mediated in the causality of glaucomatous injury.
Performance Measures
The NEI will continue to support the highest quality research identified through the peer-review process. The NEI research portfolio is evaluated periodically through the strategic planning process to determine whether the needs and opportunities for glaucoma research are being adequately addressed. When necessary to stimulate research areas not adequately addressed in the portfolio, research solicitations in the form of program announcements, requests for proposals, or requests for applications are issued. Research advances in the form of scientific publications are reviewed yearly and assessed for progress in the following areas: adding to the body of knowledge about normal and abnormal biological functions related to glaucoma; developing new or improved approaches for preventing or delaying the onset of glaucoma and associated visual disability; developing new or improved methods for diagnosing glaucoma and related visual disability; and, developing new or improved approaches for treating glaucoma and its related visual disability.
Outcome Measures
The NEI will support research that will build on the knowledge gained from its investment in the highest quality science and translate the findings of this research program to develop new treatments and diagnosis for glaucoma. The outcome of this support should be significant progress towards improving our understanding of the nature and course of glaucoma, incorporating studies of comorbidity, natural history, and genetics.
Area of Emphasis Two: Health Services Research
To understand the impact of eye disease and visual impairment on the Nation's health, data are needed on the number and characteristics of people with various eye conditions, the effects of these conditions on quality of life, and the economic burden of these conditions. This information will serve to increase public awareness of the personal and societal costs of visual impairment and be useful to those who are interested in allocating adequate resources to Americans most in need of vision care services.
Health services also depend on the health delivery capacity. Telemedicine is a new means of health care diagnosis and delivery that has the potential to reduce access disparities in rural, underserved and geographically isolated communities such as American Indian communities. Research is needed to compare the feasibility, safety, and effectiveness of telemedicine with standard care.
Rationale and Priority
The NEI defines the field of health services research broadly to include such diverse topics as: increasing patient access to and utilization of vision care services, improving the delivery of vision services by eye care professionals, and measuring the visual health of patients receiving eye care services. Various studies have demonstrated the need to ensure patient access and utilization of vision care services particularly where treatments are available to improve or preserve vision. In Blacks, under-treatment has been reported for cataract, diabetic retinopathy, and glaucoma.26, 27, 28, 29
A number of different scientific methodologies are used in conducting health services research projects. These include, but are not limited to, clinical outcomes research of new or existing data survey research techniques, translational research methods, decision and utility analytic methods, health economics, traditional epidemiologic methods, and randomized clinical trials, including comparative effectiveness research. The selection of design methodology should be scientifically justified as appropriate for the research objectives of a given study.
In 2007, NEI engaged the ocular epidemiology research community in a strategic planning effort. Epidemiologic techniques in diverse groups of people has advanced our understanding of infectious, environmental, behavioral, and sociocultural factors that underlie disease incidence, progression, and outcome, and has produced the evidence for effective prevention and treatment strategies. Epidemiological findings inform social science researchers who contribute to developing improved strategies for public health interventions. Recently epidemiological studies are enhanced by applying genetic and molecular biological tools in the context of populations. Combined with behavioral, environmental, and social factors, these tools broaden the potential contribution of epidemiology to our understanding of the major blinding diseases. The epidemiological goals that relate to health disparities are included in this plan.
Quality-of-life assessments have been incorporated into the design of several NEI-funded epidemiologic studies and clinical trials and are considered important in assessing visual health. In response to the need to more completely understand the impact of clinical interventions specifically on vision-related quality of life from a patient perspective, the NEI fostered the development and testing of a questionnaire, the NEI-Visual Functioning Questionnaire (NEI-VFQ), to collect this information.
The NEI and NCMHD supported a major research project in Los Angeles County, California, the Los Angeles Latino Eye Study, to gain a greater understanding of the prevalence and incidence of eye disease among Latinos. Researchers have conducted in-depth interviews with study participants on their medical and ophthalmic histories, use of medications, tobacco and alcohol consumption, and utilization of health care services. Because so little is known about the visual health needs of this segment of the population, the data collected from this study have been instrumental in determining the prevalence of cataract, glaucoma, age-related macular degeneration, and diabetic retinopathy among Latinos in this community. The study is also determining the proportion of blindness and visual impairment that is caused by these diseases, and will explore the association of various risk factors, such as smoking or sun exposure with ocular disease. The study is also examining the effect of eye disease and disorders on quality of life and will assess the cost/benefit of eye care services and the utilization of those services in the Los Angeles Latino community.
Visual impairment in Asian-Americans has not been examined as closely as other racial or ethnic groups in the U.S. The Chinese American Eye Study is a new epidemiological study focusing on the largest Asian subgroup in the U.S. Although reported rates of myopia have been higher in Asian countries than in the U.S., recent studies have questioned whether the prevalence difference between Asians and non-Asians persists in the U.S.30 A standardized study design and methodology will allow direct comparisons with previously obtained estimates in Whites, Blacks, and Latinos. Research findings will help in planning preventive, rehabilitative, and eye care services.
The NEI and NCMHD are currently supporting the Multiethnic Pediatric Eye Disease Survey, a population based study designed to improve understanding of the extent and the causes of eye diseases in African-American, Latino, Asian, and Non-Hispanic White children. This survey will assess the demographic, biological and behavioral risk factors associated with refractive error, strabismus, and amblyopia and the consequences of these diseases from a health related quality of life perspective.
Lack of access to health professionals is a considerable factor behind many health disparities, particularly in rural, geographically isolated, and underserved communities. Telemedicine for limited diagnostic, consultative, and treatment applications is beginning to bridge geographic access barriers to improve patient care. In telemedicine, health information is exchanged from one site to another using electronic communications. In rural areas, for example, technicians can scan a patient's retina and electronically send the images to an ophthalmologist who can read and diagnose the conditions remotely. In some cases, patients have access to physicians, but not specialists who are more likely to properly diagnose and treat a rare condition. Instead of patients travelling long distances to consult experts, telemedicine enables remote consultations. This burgeoning field is primed for public-private partnerships to develop the enabling technologies, but will likely require public sector investment to provide the evidence base for using telemedicine, with the potential to greatly reduce health disparities in underserved communities.
Objective One: Impact of Vision Impairment on the Nation's Visual Health
Assess the impact of eye disease and visual impairment on the Nation's health and determine the most appropriate use of diagnostic strategies and treatments scientifically demonstrated to improve vision and preserve sight.
Action Plan
Determine the burden of eye diseases and their visual outcomes in a changing population, particularly disparities in the burden and the influences of sociocultural and demographic factors. Measure the impact on medical costs and costs to society associated with these conditions. Identify the factors associated with the most effective delivery and use of vision care services. In an effort to establish stable national estimates of vision impairment, the NEI has collaborated with the Centers for Disease Control and Prevention (CDC) to extend the vision component of the National Health and Nutrition Examination Survey (NHANES). NHANES is a biannual health survey national representative of Americans with both interview and examination components. The NEI will work with biostatisticians to analyze the data to provide accurate estimates of the burden of vision impairment and impact of vision on quality of life. Basic information on the visual health of the U.S. population is critical for increasing public awareness of the effects and costs of visual impairment, assessing the need for eye care services, evaluating the delivery of vision care, and setting priorities for vision research. However, gathering detailed ophthalmic data on a large, nationally representative sample, while scientifically preferred, is not practical. Over the past decade, studies on five large ethnically and geographically different populations have generated information on the prevalence of and risk factors associated with eye disease and vision loss. Long-term follow-up of these groups of Caucasians, African-Americans, Hispanics, and now Asian-Americans is providing additional information on the frequency of new cases of eye disease. The ocular epidemiology plan also identified priorities to determine sociocultural factors associated with disparities in diabetic retinopathy, macular degeneration, cataract, glaucoma, and access to care for these conditions. Another priority is to determine sociocultural and behavioral factors, in addition to other risk factors, that influence progression of disease to vision loss. The plan also identifies strategies to improve methodologies for ophthalmic epidemiology: developing efficient data management software for integrating diverse high dimensional data sources; developing new methodologies for querying and analyzing these multiple data sources, with a focus on integration of multiple data types to address critical hypotheses; and developing rigorous quality assurance protocols and standards.
It is important to study ethnically diverse populations since there are both genetic and environmental determinants of eye disease. Additional epidemiologic studies on Hispanic, East Asian, and American Indian and Alaska Native populations are needed to provide regional estimates of disease and to identify risk factors, quality-of-life considerations, and access to care issues, which may differ by ethnic group. National estimates of disease burden among Caucasians and African-Americans may be more readily available using methods like mathematical modeling techniques to extrapolate these data from rates of disease found in NEI-funded, community-based studies. In expanding epidemiology studies such as the Los Angeles Latino Eye Study, investigators are using longer term follow-up to understand environmental, behavioral and genetic risk factors influencing incidence and progression of ocular disease. Genomic technologies that did not exist a few years ago now make it cost-effective to scan and sequence DNA from thousands of individuals. To leverage the investment in large epidemiological and clinical trials, NEI promotes collection of DNA samples from existing population cohorts. Genomic knowledge, coupled with phenotypic data and long-term follow-up (in some cases), lays the groundwork for developing personalized medicine.
Research to examine the health economics and the delivery and utilization of vision care is of the utmost importance due to the increasing number of Americans covered by managed care plans. Little is known about the quantity and quality of eye care services offered to different segments of the American population, or how the changing patterns of delivering vision care services influence a person's access to and utilization of appropriate, high-quality vision care. With a characterization of the eye care services offered by providers in different health systems, it may be possible to design and test specific interventions to improve the delivery and utilization of vision care and thereby reduce rates of blindness and visual impairment. NEI plans to build a new research portfolio in health economics to investigate health care delivery and utilization research questions. NIH is interested in health disparity topics such as evaluating economic burden and personal costs as they relate to disproportionate use, availability, and satisfaction with health services among health disparity groups and medically underserved populations. Another important health economics topic is exploring the impact of health delivery system practices (in private systems, public policy, and Medicare reimbursements) on health care workforce issues.
Identify and assess the strategies that will overcome barriers to eye care and convert evidence-based findings into improved patient and population outcomes. Health service inequalities drive some health disparities. For example, despite a highly effective surgical treatment covered largely by Medicare, cataracts cause approximately 37 percent of blindness in African-Americans.31 The ocular epidemiology plan identified priorities to address access questions: develop and evaluate methods to overcome disparities in access to care and enhance compliance for patients needing care for cataract, diabetic retinopathy, and glaucoma; develop and validate techniques to assist providers to better implement the lessons of best-evidence medicine in their care of patients.
Analytical studies are needed to evaluate the movement toward fully automated medical records. These analyses may provide a cost-efficient opportunity to study patterns of care across a variety of healthcare delivery settings. Automated systems may be especially useful for monitoring changes in the content, cost, and use of vision care services. It is important to note, however, that persons in systems of care with automated records may be different from the general population.
Develop methodology for decision making tools for clinicians, patients and policy makers. Comparative effectiveness research is very useful for helping decision makers evaluate between different medical interventions. However, the research is very costly. NEI supports research on developing methodology called mixed-treatment comparison meta-analysis that synthesizes existing data on interventions to reduce the need for, and setting the priorities of new comparative effectiveness trials with available resources. The initial research is examining this model to primary open-angle glaucoma, focusing on the burden on patients and health care resources.
Performance Measures
The NEI will continue to support the highest quality research identified through the peer-review process. The NEI research portfolio is evaluated periodically through the strategic planning process to determine whether the needs and opportunities for health services research are being adequately addressed. When necessary to stimulate research areas not adequately addressed in the portfolio, research solicitations in the form of program announcements, requests for proposals, or requests for applications are issued. Furthermore, to build a new health economics portfolio, NEI plans to recruit and hire appropriate expertise to the NEI faculty.
Research advances in the form of scientific publications will be reviewed yearly and assessed for progress in the following areas: development of new or improved instruments and technologies that will aid in the delivery of medicine to all Americans; development of new or improved approaches for preventing or delaying the onset of disease and disability that will reduce the burden of disease in all ethnic and racial groups; development of new or improved methods for diagnosing disease and disability that will reduce the burden of disease in all ethnic and racial groups; and, development of new or improved approaches for treating disease and disability that will reduce the burden of disease in all ethnic and racial groups.
Outcome Measures
The NEI will support health services research that will build on the knowledge gained from its investment in the highest quality science and translate the findings of this research program to improve health services. The outcome of this research will help determine the number of Americans with eye disease and visual impairment and measure the impact on medical costs and costs to society associated with these conditions. It will also help identify the factors associated with the most effective delivery and use of vision care services.
Objective Two: Examining the Comparative Effectiveness of Telemedicine
Evaluate the requirements, feasibility, costs, safety, and outcomes associated with using telemedicine for the diagnosis and monitoring of ophthalmic conditions.
Action Plan
Develop technological capacity to diagnose and monitor ophthalmic diseases and conditions through telemedicine. Telemedicine can involve automated screening procedures, diagnostic testing, and photographic or streaming video images. Health information data must be in a digital format to send electronically to remote locations. Developing the underlying technology such as sensors, instrumentation, computational model algorithms, and display monitors requires bioengineers working in concert with clinicians. For telemedical devices to become practical, equipment must be reliable, affordable, portable, and relatively easy to use. Some applications of telemedicine are designed to be used directly by patients or family caregivers in the home. Telemedicine developers are developing telemedicine applications supported by mobile devices, such as cell phones for collecting and monitoring community clinical health data, and delivering health care information to practitioners, researchers, and patients. Telemedicine is expected to have a significant impact on low and middle income countries, but should also reduce health disparities in underserved rural and geographically isolated communities in more developed countries.
The NEI encourages the development of technology, primarily through its small business research portfolio. To stimulate private sector development of ocular screening technology for diabetic retinopathy (DR, see section 1.3), NEI recently issued a small business research solicitation to develop: inexpensive and compact ophthalmic instruments for DR detection that can be easily used by trained personnel who are not eye care specialists, methods for automated image analysis to speed screening, automated systems to aid evaluation and diagnosis in ocular screening venues in public locales and retail stores.
Establish the safety, reliability and feasibility of telemedicine procedures through pilot studies. While there are some ocular conditions particularly conducive to telemedicine for diagnosis and monitoring, there are others that will still require face-to-face examinations with an eye health specialist. The NEI funds research to determine which ophthalmic applications are amenable to telemedicine, while still preserving the accuracy, sensitivity and specificity achieved with in-person examinations. Ocular conditions in which early detection can have a large impact on health outcomes are a high priority for telemedicine screening. Recently a pilot study of telemedicine to screen for retinopathy of prematurity (ROP), the leading cause of blindness in children, was completed. In addition, NEI is exploring a novel detection method for early-stage keratoconus, a progressive thinning of the cornea forming a cone shape that severely distorts vision. Glaucoma and diabetic retinopathy are also high priority areas that NEI is seeking to promote research in telemedicine.
Compare the efficacy and outcomes of telemedicine versus traditional care through clinical trials. The widespread adoption of telemedicine will depend on the evidence base established through clinical trials, both in the academic setting, as well as in rural clinics. Many community health clinics do not have full-time eye care specialists or their eye care providers may lack expertise required for some conditions. It may not always be feasible for patients from rural communities or other underserved areas to travel to centers that can provide the care they need. For example, infants born very prematurely and underweight are at risk for ROP. Blindness is often preventable, yet requires skilled ophthalmologists visiting neonatal units to diagnose at-risk infants to determine treatment. A recent pilot clinical study found that ROP diagnoses through telemedicine were significantly faster than standard indirect ophthalmoscopy, without sacrificing quality.32 The NEI plans to start a multi-center clinical trial to evaluate the validity, reliability, feasibility, and cost-effectiveness of an ROP telemedicine evaluation system for diagnosing at-risk infants. As other opportunities for using telemedicine for vision health arise, the NEI will explore their effectiveness compared to standard practices with the goal of providing feasible alternatives that might reduce health disparities in rural and underserved communities.
Performance Measures
Telemedicine is a relatively new yet rapidly growing field of research. The NEI will support the highest quality research on telemedicine identified through the peer-review process. Through its small business research program, the NEI will promote the development of necessary technological components. NEI will use multi-center clinical studies to test the comparative effectiveness of telemedical approaches versus traditional in-person care. The NEI telemedicine portfolio will continue to be evaluated periodically through the strategic planning process to determine whether the needs and opportunities for health services research are being adequately addressed. When necessary to stimulate research areas not adequately addressed in the portfolio, research solicitations in the form of program announcements, requests for proposals, or requests for applications will be issued.
Outcome Measures
The NEI will support telemedicine research that will build on the knowledge gained from its investment in the highest quality science and will translate the findings of this research program to improve health services. The outcome of this research will be to determine which uses of telemedicine are most safe, feasible, cost effective and reliable. The wide-spread use of telemedicine will improve health care quality and access to individuals in rural settings where geography is a traditional barrier, thereby reducing health disparities. Telemedicine may also save time and money for both patients and providers.
Area of Emphasis Three: Diabetic Retinopathy
Diabetes mellitus is one of the leading causes of death in this country and throughout the world and is also a major cause of blindness. One of the ocular complications of diabetes is diabetic retinopathy. Diabetic retinopathy causes excessive vascular permeability and is typically accompanied by neovascularization with ballooning of the retinal capillaries to form microaneurysms. The blood-retinal barrier may break down within these microaneurysms, causing leakage of blood proteins with subsequent hemorrhage into the retina and visual loss. Newly formed blood vessels tend to break through the retinal surface, which may result in hemorrhage into the vitreous and in traction retinal detachment, where the retina is pulled away from the underlying choroid. Because of the prevalence of diabetes, diabetic retinopathy is a major cause of blindness.
Rationale and Priority
The CDC estimated that there were 23.6 million Americans with diabetes in the year 2007, but that only 17.9 million have been diagnosed. Almost 1.6 million new cases are diagnosed annually.33 The CDC reports that African-Americans, Hispanic/Latino Americans, American Indians, and some native Hawaiians and other Pacific Islanders are at particularly high risk for type 2 diabetes.34 Although the prevalence of insulin-dependent diabetes mellitus (type 1) in Whites is nearly twice the incidence in Blacks, the prevalence of non-insulin-dependent diabetes mellitus (type 2) is between 1.4 and 2.3 times higher in Blacks than in Whites. Similarly the prevalence of type 2 diabetes is two to three times higher in Hispanics than in non-Hispanic Whites. The prevalence of the disease in U.S. Hispanics varies by geographic location and education.35, 36
A meta-analysis of data from eight population-based surveys indicated that there are 4.1 million adults in the U.S. with diabetic retinopathy, or 1 person for every 12 with diabetes. This study, along with a vision component of the Multi-Ethnic Study of Atherosclerosis, found that diabetic retinopathy was more prevalent in Hispanics and Blacks compared to Whites and that vision threatening diabetic retinopathy was likewise more prevalent in these groups compared to Whites.37, 38
With the increased prevalence of type 2 diabetes in Mexican-Americans, studies have shown that there is also a significantly increased risk of severe retinopathy.39 While the risk of progressing to retinopathy increases with the duration of diabetes and the level of glycemic control, recent data has also shown that high calorie diets and high dietary sodium levels significantly increase the risk of diabetic retinopathy in African-Americans with type 1 diabetes.40 Diabetic retinopathy has been shown to occur more often in Blacks than in whites, but this difference was not explained by differences in risk factors alone. Rather, the results suggested that the differences may be due to a greater susceptibility to the adverse effects of hyperglycemia and/or blood pressure.41 A recent study suggested that a high percentage of Blacks with type 1 diabetes do not receive adequate care and improvements in screening and access to eye care professionals is needed.42 Another study found that being eligible both for Medicare and Medicaid was associated with not receiving routine diabetes care.43
Although these associations may help explain the increased prevalence and severity of diabetic retinopathy in Blacks, it does not explain the excess prevalence and disease severity in Mexican-Americans with type 2 diabetes.44 Previous studies have demonstrated that disease duration, increased hyperglycemia, diagnosis at an earlier age, and the need for insulin treatment is associated with increased prevalence of diabetic retinopathy in both Mexican-Americans and Caucasians. Interestingly, no association was found with socioeconomic status.45 The finding that a high percentage of Blacks and Hispanics have severe diabetic retinopathy at initial presentation for treatment, strongly illustrates the need for earlier referral from primary care physicians and increased public education efforts.46 Although currently recommended treatments are over 95 percent effective in preventing further vision loss, only about half of those who could benefit from treatment are being treated.
The NEI has established a clinical research network of core centers and participating clinics that will help satisfy the need to evaluate promising new approaches to treat diabetes induced retinal disorders and to investigate other approaches as they become available. This network approach is providing a framework for rapid initiation of important studies, efficient use of pooled clinical expertise in idea generation and protocol development, and efficient use of central resources for data management, quality control, and endpoint evaluation.
Objective One: Preventing and Treating Diabetic Retinopathy
Understand the pathogenesis of diabetic retinopathy and other vascular diseases of the retina and develop strategies for primary prevention and improved treatment.
Action Plan
Evaluate the comparative effectiveness of therapies for diabetic retinopathy in the real world setting through the Diabetic Retinopathy Clinical Research Network (DRCR.net). The DRCR.net is a collaborative network that supports the identification, design, and implementation of multicenter clinical research on diabetic retinopathy. It standardizes multiple study procedures, utilization of novel technology, extensive integration of information technology, and the ability to leverage its resources to bring promising new therapies to evaluation that might not otherwise exist. Its priorities include involvement of community-based practices as well as university-based centers. As of November 2009, there have been 222 participating clinical sites, with 770 total physicians and 2,217 additional personnel in 38 states. Approximately two-thirds were community-based practices, representing about one third of the U.S. retina specialists.
To date, 15 protocols (listed in the table) have enrolled patients. These protocols address multiple stages of diabetic eye disease and compare different treatment strategies:
| Protocol | |
|---|---|
| A | A Pilot Study of Laser Photocoagulation for Diabetic Macular Edema |
| B | A Randomized Trial Comparing Intravitreal Triamcinolone Acetonide and Laser Photocoagulation for Diabetic Macular Edema |
| C | Temporal Variation in Optical Coherence Tomography Measurements of Retinal Thickening in Diabetic Macular Edema |
| D | Evaluation of Vitrectomy for Diabetic Macular Edema Study |
| E | A Pilot Study of Peribulbar Triamcinolone Acetonide for Diabetic Macular Edema |
| F | An Observational Study of the Development of Diabetic Macular Edema Following Scatter Laser Photocoagulation |
| G | Subclinical Diabetic Macular Edema Study |
| H | A Phase 2 Evaluation of Anti-VEGF Therapy for Diabetic Macular Edema: Bevacizumab (Avastin) |
| I | Intravitreal Ranibizumab or Triamcinolone Acetonide in Combination with Laser Photocoagulation for Diabetic Macular Edema |
| J | Intravitreal Ranibizumab or Triamcinolone Acetonide as Adjunctive Treatment to Panretinal Photocoagulation for Proliferative Diabetic Retinopathy |
| K | The Course of Response to Focal Photocoagulation for Diabetic Macular Edema |
| L | Evaluation of Visual Acuity Measurements in Eyes with Diabetic Macular Edema |
| O | Comparison of Time Domain OCT and Spectral Domain OCT Retinal Thickness Measurement in Diabetic Macular Edema |
| P | A Pilot Study in Individuals with Center-Involved DME Undergoing Cataract Surgery |
| Q | An Observational Study in Individuals with Diabetic Retinopathy without Center-Involved DME Undergoing Cataract Surgery |
Three additional protocols are in the planning stages. A trial expected to start in the fall of 2010, will address health disparities by examining the effect of diabetes education during retina examination on diabetes control. Another trial will evaluate injections of the drug, Lucentis, to block hemorrhaging due to proliferative diabetic retinopathy. Lucentis is FDA-approved to treat age-related macular degeneration. The third planned protocol, also starting in 2010, will evaluate topical non-steroidal anti-inflammatory drugs on the progression of non-center involved Diabetic Macular Edema (DME).
One of the most important DRCR.net priorities is to have a portfolio of ongoing clinical trials that not only encompasses a broad diversity of promising new therapeutic approaches, but also addresses the full spectrum of patients with diabetic eye disease. The Network is actively pursuing identification and design of important clinical trials that complement each other in terms of patient eligibility and therapeutic approach. This approach prevents competition between studies for similar patients and expands the opportunities for patients to participate in these investigations. One goal of the Network is to eventually provide opportunities for all patients with diabetes to enroll in a DRCR.net study protocol.
Performance Measures
The DRCR.net Data and Safety Monitoring Committee (DSMC) has a dual role of external monitoring of the Network's protocols and of advising the NEI on the merits of the protocols proposed by the Network as well as the Network's progress. The Committee meets in person at least twice a year and convenes by conference call as needed several times a year. The Network provides monthly data reports for the DSMC to review.
Within DRCR.net, there is an Executive Committee that is involved in policy decisions. In addition, a Protocol Concept Review Committee reviews ideas for protocols and advises the Executive Committee on whether an idea should be accepted for protocol development. If an idea is accepted, a Protocol Development Committee is created that is responsible for developing the protocol and has representatives from various aspects of DRCR.net. If the protocol involves a large randomized trial, it is presented to an External Protocol Review Committee whose members are assigned by the NEI to be advisory to the Institute regarding the protocol. These members have a standing meeting every 3 months in order to be prepared throughout the year to review protocols in a timely, efficient manner. Additional committees created by the Executive Committee include a Data Collection Committee whose members advise the Network regarding development of efficient data collection procedures, and a Quality Assurance Committee whose members review detailed information prepared by the Coordinating Center regarding quality of enrollment, follow-up, adherence to protocol, timeliness of response to data queries, and other issues judged critical to maintaining excellent quality of Network clinical center activities. Summary reports are provided twice a year to the sites to strive for continued improvement in quality.
In addition to the clinical trials supported through DRCR.net, the NEI will continue to support the highest quality basic and clinical diabetic retinopathy research identified through the peer-review process.
Outcome Measures
The NEI will support research that will build on the knowledge gained from its investment in the highest quality science on diabetic retinopathy and translate the findings of this research program to improved treatments and prevention strategies for the ocular complications associated with diabetes. The outcome of this line of research will be to understand the pathogenesis of vascular diseases of the retina and choroid, including diabetic retinopathy; and develop better methods of prevention and therapy to improve the visual health of those with diabetic retinopathy.
Areas of Emphasis in Research Capacity
Area of Emphasis One: Training of Minority Scientists
The strategies of developing a well-trained pool of laboratory and clinical scientists for the future must include the achievement of scientific literacy through innovative science education programs from elementary school through high school for all students regardless of age or gender or cultural, racial, or ethnic background. The NEI must take full advantage of the changes in the demographic patterns of the workforce and make special efforts to foster the scientific careers of women and minority groups. Programs of support for specific training in visual sciences at graduate and postgraduate levels must convince students that their educational endeavors will be rewarded with opportunities for productive careers and research support. Therefore, the NEI's emphasis on individual investigator-initiated research project grants will continue to be given high priority.
Objective One: Career Development
Ensure the proper resource requirements through Training/Career Development.
Action Plan
Continue to attract strong minority scientists into vision research using the NIH-wide program for research supplements for underrepresented minorities. New vision researchers must come in greater measure from members of ethnic minority groups. Even if the research questions they address are not directly dealing with minority health, the unique perspectives of individuals in a diverse scientific workforce influences their approach to science. Seeing problems in different ways is critical for innovation and scientific breakthroughs.47 Members of minorities are markedly underrepresented in science in this country and, therefore, are an increasingly important source of talent for maintaining leadership in this area. The NEI has enthusiastically participated in NIH-wide special programs for underrepresented minorities. The National Advisory Eye Council (NAEC) reaffirms its recognition that progress in this area can come only if potential laboratory and clinical scientists seek and obtain sufficient grounding in fundamental levels of biological, physical, and mathematical sciences. This means that programs must begin at the elementary school and junior high school levels. The vision community must become involved in vision science programs at local schools, sharing the excitement and enthusiasm of science. Vision research organizations may be able to assist with these outreach programs nationwide. A school program called "Vision," for children in grades 4 through 8, was developed by the NEI in cooperation with The Association for Research in Vision and Ophthalmology. This program is a series of three lessons that was designed for vision researchers and eye care professionals for school classroom visits.
Performance Measures
The NEI will monitor the number of supplements that are awarded each year to support underrepresented minorities who are pursuing careers in eye and vision research.
Outcome Measures
The NEI will build on successful strategies that recruited underrepresented minorities into basic and clinical eye and vision research.
Area of Emphasis Two: Minority Representation in Clinical Trials
The NEI and NAEC fully endorse and support the NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research. Because the primary aim of research is to provide scientific evidence leading to a change in health policy or a standard of care, it is imperative to determine whether the intervention or therapy being studied affects women or men or members of minority groups and their subpopulations differently. To this end, the NIH guidelines are intended to ensure that all future NIH-supported biomedical and behavioral research involving human subjects will be carried out in a manner sufficient to elicit information about individuals of both genders and the diverse racial and ethnic groups and, in the case of clinical trials, to examine differential effects on such groups. Increased attention, therefore, must be given to gender, race, and ethnicity in earlier stages of research to allow for informed decisions at the Phase III clinical trial stage. The guidelines reaffirm NIH's commitment to the fundamental principles of inclusion of women and racial and ethnic minority groups and their subpopulations in research. This policy will continue to provide a variety of new research opportunities to address significant gaps in knowledge about health problems that affect women and racial/ethnic minorities and their subpopulations.
The guidelines require that when a Phase III clinical trial is proposed, evidence must be reviewed to show whether or not clinically important gender or race/ethnicity differences in the intervention effect are to be expected. This evidence may include, but is not limited to, data derived from prior animal studies, clinical observations, metabolic studies, genetic studies, pharmacology studies, and observational, natural history, epidemiology and other relevant studies.
Objective One: Inclusive Clinical Studies and Trials
Continue to ensure that all clinical trials that are funded by the NEI adhere to the NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research.
Action Plan
Ensure that all clinical trials funded by the NEI adhere to the NIH Guidelines on the inclusion of Women and Minorities as Subjects in Clinical Research. This will be an ongoing effort that will continue throughout the period of this plan and not incur any significant costs. In addition to ensuring recruitment in clinical trials, NEI encourages all clinical research to include adequate representation of minorities. However, certain studies, such as genomics studies need to carefully consider how to incorporate heterogeneous patient populations. When searching for rare genetic mutations, or combinations of genetic variants in complex diseases such as glaucoma, it is sometimes desirable to have a homogenous population. For example, a particularly high incidence of glaucoma in Barbados pointed to a strong genetic predisposition towards the disease; using this relatively homogenous Afro-Caribbean population, geneticists found a mutation that accounted for nearly one third of the genetic risk of the disease.48 The NEIGHBOR collaboration described in section 1.1 is using a primarily Caucasian population to find glaucoma genes, but will then follow up any gene discoveries by probing the genomes from other populations collected in other studies.
Develop Genome-Wide Association Techniques that Require Fewer Subjects. Genome-wide association studies (GWAS) has recently met with dramatic success in the analysis of complex diseases such as macular degeneration. These methods typically utilize hundreds of thousands of genetic markers to conduct case-control association tests on genes across the entire human genome. However, recruiting African-Americans for clinical studies has traditionally been a challenge; historical research abuse has made many potential African-Americans reluctant to participate. While NEI is committed to working with the African-American and other minority communities to educate them about the risks and benefits of participating in research studies, NEI is also employing a new genome-wide association methodology that takes into account the unique genetic structure of some populations, such as African-Americans, to conduct the analysis using fewer genetic markers. This technique, which has been successfully applied to map genes for multiple sclerosis and prostate cancer in African-Americans, does not require matching disease cases with healthy control subjects, so fewer individuals are needed for a high power genome scan. To complement the NEIGHBOR and GENEVA projects (see section 1.1), NEI plans to identify glaucoma susceptibility genes in African-Americans and to follow this up with a study of a West African population with high incidence of glaucoma.
Performance Measures
The NEI will closely monitor all clinical trials and applications to assure that appropriate numbers of women and minorities are included. NEI will continue to pay special attention to study section recommendations regarding strategies to recruit more minority subjects. Patient recruitment in clinical trials is monitored regularly. When recruitment of minorities is slower than expected, NEI will take a proactive approach to ensure adequate recruitment.
Outcome Measures
The NEI will strongly enforce the tenants of the NIH Guidelines on the inclusion of women and minorities, and the NEI will communicate to clinical research applicants the need to include women and minorities in their clinical protocols.
Areas of Emphasis in Community Outreach, Information Dissemination, and Public Health Education
Area of Emphasis One: National Eye Health Education Program
In 1991, NEI launched the National Eye Health Education Program (NEHEP), with the goal of increasing awareness among health care professionals and the public of scientifically based health information that can be applied to preserving sight and preventing blindness. Numerous organizations (more than 70 in all) from both the public and private sectors joined in partnership with the NEHEP. Working together, these partners endeavor to reach select target audiences, informing them of the importance of early detection and treatment of eye diseases, particularly glaucoma and diabetic retinopathy, and persuading them to make an appropriate change in behavior. The NEHEP currently has three major ongoing education/outreach programs and is in the process of developing a fourth program area on vision and aging.
Objective One: Outreach for Visual Health
Continue to increase awareness among health care professionals and the public of scientifically based health information that can be applied to preserving sight and preventing blindness.
Action Plan
Provide culturally specific and appropriate messages for all NEHEP content areas and materials; increase the representation of racial and ethnic populations and organizations in the NEHEP Partnership and continue to facilitate the national dialog among current and future NEHEP Partnership organizations.
The NEHEP Partnership initially identified two target audiences for the diabetes education program: people with diabetes, and health care professionals. Subsequent phases of the Program included groups in which diabetes is more prevalent than in the general population, including American Indians and Alaska Natives, Hispanics/Latinos, and African-Americans. The NEHEP has developed a Diabetes and Healthy Eyes Toolkit for community health workers, in English and Spanish, and, targeted to select audiences a Spanish-language booklet, ¡Ojo Con Su Visión! (Watch Out for Your Vision), designed to educate Hispanics/Latinos with diabetes about the ocular complications of the disease. Recently, print public service announcements on diabetic eye disease were developed in English and Spanish and distributed to magazines nationwide, and they will also appear as bus ads in five U.S. cities. The ¡Ojo Con Su Visión! Program, launched in 1995, has expanded to include culturally and linguistically appropriate outreach for all three of the NEHEP Program areas. Most recently, a Spanish-language general eye health brochure was developed to provide information to Hispanics/Latinos about eye health and eye diseases. This unique brochure covers information on comprehensive eye exams, four common diseases that can affect our vision, refractive errors, and myths and facts about eye care among other topics.
The NEHEP Partnership identified three target audiences for glaucoma education: glaucoma patients, the general public, and health care professionals. The current general primary target groups are African-Americans over age 40 and anyone over age 60. It also will be important to reach eye and other health care-related professionals to help motivate the higher risk populations to have regular eye exams. Educating the general public is a means to ensuring long-term success. The Glaucoma Public Education Program consists of a wide variety of English and Spanish language educational materials and resources that community agencies can use to conduct glaucoma awareness activities and comprehensive public service campaigns emphasizing early detection.
In 1999, NEHEP launched a new program for the purpose of addressing the impact of low vision on those who have it and to bring the message to them, their families, and the health and service professionals who care for them that information and help are available. The two primary audiences are (1) people age 65 and older who have decreased visual function that interferes with their activities of daily living and (2) people under age 65 who are particularly at risk for low vision--i.e., Hispanic/Latino and African-American populations. This Program continues to promote rehabilitation and services to people with low vision.
Performance Measures
The NEHEP Partnership will pretest the materials that it plans to distribute with focus groups to determine the effectiveness of the materials used to communicate NEHEP's message to its target populations. An analysis of public queries to the NEI Office of Health Education, Communication, and Public Liaison will also be conducted to determine if NEHEP products are having a positive impact on the public's knowledge of eye health.
Outcome Measures
The NEHEP Partnership will make changes based on the results of its evaluation of the Program to ensure that it continues to be effective in communicating to the public information about eye health and eye disease.
Area of Emphasis Two: Healthy People 2020: Vision and Hearing Chapter
Healthy People 2020 represents the ideas and expertise of a diverse range of individuals and organizations concerned about the Nation's health. The Healthy People Consortium-an alliance of more than 350 national organizations and 250 State public health, mental health, substance abuse, and environmental agencies-conducted four national meetings on the development of Healthy People 2020. Members of the voluntary, scientific, and professional organizations that comprise the vision research community joined forces to recommend the inclusion of a section on the visual health needs of the Nation. The NEI serves as the lead agency for vision.
As a means of stimulating collaborative community health education initiatives related to vision, the NEI established the Healthy Vision Community Awards Program. This program was designed to strengthen the capacity of community-based organizations by providing "seed money" to begin or continue vision-related health education projects. These awards provide NEI with opportunities to establish partnerships that extend the reach and effectiveness of its work. The following are examples of awards made in FY 2009:
- Prevent Blindness America-Illinois Program Area, Chicago, IL
The Diabetic Eye Disease Educator Certification Program teaches lay outreach personnel and allied health professionals about the visual system and the signs, symptoms, and complications of secondary diseases of diabetes, diabetic retinopathy and glaucoma. The program focuses on reaching populations at higher risk for developing diabetes-African-Americans and Hispanics/Latinos. - Prairie Band Potawatomi Health Center, Mayetta, KS
The Prairie Band Potawatomi Health Center (PBPHC) is a tribally operated primary care clinic that sees American Indians and Alaska Natives of all ages.
The Prairie Band Potawatomi Healthy Oshkishkwen (eyes) Project provides an educational program on diabetic retinopathy for PBPHC patients on their diabetic registry and those identified as pre-diabetic or insulin resistant. The project also raises community awareness of diabetic retinopathy and increases the number of patients with diabetes receiving dilated eye exams. - Codman Square Health Center, Dorchester, MA
The Patient Education about Glaucoma through the Eyes of the Haitian Patient project focuses on gaining insight and understanding on the perspectives of the Haitian community on glaucoma. The culturally sensitive information gained during the project will be used to produce educational materials for educating patients and the eye clinic staff, including clinicians, students, and support staff. - Emmanuel Baptist Church, Macon, MS
The Bright Sight Vision Program focuses on the eye health of children and adolescents residing in a high-risk area in rural Macon, Mississippi. The program addresses several barriers to obtaining proper eye care including lack of knowledge, lack of access, lack of transportation, and limited budgets. - N.A.T.I.V.E. Project, Spokane, WA
N.A.T.I.V.E. Project operates N.A.T.I.V.E. Health of Spokane, a non-profit urban Indian community health clinic that focuses efforts of the American Indian/Alaska Native people who are an underserved population of Spokane County.
N.A.T.I.V.E. Health's Vision Across the Generations project targets efforts in two areas-(1) vision screening for children and (2) vision impairment due to diabetic retinopathy. The project provides culturally appropriate information that focuses on the need for vision screening and offers incentives to persuade people to get their vision screened.
Objective One: Increasing Quality of Life
Increase quality and years of healthy life and eliminate health disparities.
Action Plan
Increase the proportion of persons who have a dilated exam at appropriate intervals.
Increase the proportion of preschool children aged 5 years and under who receive vision screening.
Reduce uncorrected visual impairment due to refractive errors.
Reduce blindness and visual impairment in children aged 17 and under.
Reduce visual impairment due to diabetic retinopathy.
Reduce visual impairment due to glaucoma.
Reduce visual impairment due to cataract. Reduce occupational eye injury.
Increase the use of appropriate personal protective eyewear in recreational activities and hazardous situations around the home.
Increase the use of vision rehabilitation services and adaptive devices by people with visual impairments.
Healthy People 2020 is a ten-year plan to improve the health of the American people.
Performance Measures
Baseline data were established in 2008. The next data points will be in 2016. A mid-course evaluation will be done in 2015.
Outcome Measures
Based on the results of the mid-course review, strategies for achieving the goals of Healthy People 2020 will be adjusted to enhance the probability of achieving those goals by 2020.
Integration of Research, Research Capacity Building, and Community Outreach, Information Dissemination and Public Health Education
Area of Emphasis One: Translating Research into Clinical Practice
The NEI is committed to the improving the health of the entire population which necessarily involves reducing health disparities between individual groups. Translational research uses knowledge obtained from basic science discoveries to develop diagnostics and therapeutics to treat patients. Then, for therapies, clinical trials may be undertaken to examine safety and efficacy of a new treatment. Once an effective treatment is identified, widespread use in clinical practice must be achieved to have a significant affect on health. NEI conducts comparative effectiveness research to learn how different therapies work in a "real world" setting. This can be a community clinic where patients and their health care providers must make decisions about risks and benefits of various interventions, while factoring in issues such as financial costs of therapy, personal preferences, medical history, and patient compliance with medications. Other barriers exist in translating science into medical practice. These include educating health professionals and updating medical guidelines issued by professional societies, providing affordable access to the necessary health interventions, producing culturally sensitive outreach to communities, and educating vulnerable populations about preventive health strategies, such as glaucoma screenings in African-American and other at-risk communities.
There are many factors contributing to health disparities, including genetic differences, environmental factors (diet, exposure to toxins, infectious diseases, ultraviolet light), or behavioral and sociological differences (smoking, nutrition, exercise). Other factors in health disparities including access to health care, geography, poverty or other financial considerations, and health literacy can all be barriers for disadvantaged groups. This strategic plan seeks to understand and eliminate sources of health disparities in vision. To the extent that some diseases such as glaucoma and diabetic retinopathy disproportionally affect some minority populations, NEI is conducting research to understand the biology, to uncover biological underpinnings of health disparity, and to develop therapies to treat the diseases. NEI conducts epidemiological research to assess the burden of ocular diseases within certain populations and for the nation as a whole. Health services and health care delivery are an equally important component of the health research.
NIH, along with other federal agencies such as the Center for Disease Control and Prevention and the Agency for Healthcare Research and Quality, is conducting research into health services and their impact on health disparity. To increase the health disparities research capacity, NEI is working to attract and train minority scientists to vision research. Furthermore, NEI continues to ensure that clinical trials have adequate representation of minorities and will be proactive in cases where recruitment goals are not being met. Finally, NEI fosters a robust eye health education program. NEHEP, along with the vision component of Healthy People 2010, is educating the public about vision health and specifically targeting minority populations and at-risk communities. Each of these efforts is an important component to resolving health disparities in the U.S., and integrating research, capacity building, and outreach in specific initiatives may help accelerate all of these efforts.
Objective One: Developing Outreach Strategies for Diabetic Retinopathy
Develop innovative strategies for involving communities in diabetic retinopathy research, screening and prevention, education, and outreach.
Action Plan
Fortify community research capacity, public outreach, and clinical effectiveness research protocols by strengthening the Diabetes Retinopathy Clinical Research Network. In the 2006 Institute of Medicine (IOM) report Examining the Health Disparities Research Plan of the National Institutes of Health: Unfinished Business, the IOM recommended using community-based research partnerships to study health disparities. As introduced in section 1.3, the objective of the Diabetic Retinopathy Clinical Research Network (DRCR.net) is to maintain a collaborative network to facilitate multicenter clinical research on diabetic retinopathy, diabetic macular edema and associated conditions. Its priorities include involvement of community-based practices as well as university-based centers. As of November 2009, there have been 222 participating clinical sites, with 770 total physicians and 2,217 additional personnel in 38 states. Approximately two-thirds were community-based practices, representing about one third of the U.S. retina specialists. Another priority is to collaborate with industry to facilitate investigations and opportunities otherwise not possible. These collaborations are conducted in a manner consistent with NIH policies, the Network's commitment to academic integrity and optimal clinical trial performance, and within DRCR.net's Industry Collaboration guidelines. Since its inception in 2002, the Network has collaborated with the Juvenile Diabetes Research Foundation International, which has contributed $1.7 million dollars, and two industries (Allergan and Genentech), which have provided over $12 million dollars for support of clinical site costs, as well as drug supply and distribution costs.
One DRCR.net priority is to have a portfolio of ongoing clinical trials that not only encompasses a broad diversity of promising new therapeutic approaches, but also addresses the full spectrum of patients with diabetic eye disease. DRCR.net is actively pursuing identification and design of important clinical trials that complement each other in terms of patient eligibility and therapeutic approach. This approach prevents competition between studies for similar patients and expands the opportunities for patients to participate in these investigations. A goal of DRCR.net is to eventually provide all patients with diabetes opportunities to participate in a DRCR.net study protocol.
DRCR.net also contributes to the training and knowledge of the ophthalmologic community with regard to rigorous clinical trials. This is one of the reasons for including a large number of community-based sites, offering them an opportunity to participate and become experienced in these efforts. Such expansion of quality clinical centers helps not only the Network, but patients throughout the country and the overall education of the ophthalmologic community.
Stimulate private sector research and development for public outreach and education strategies. NEI has released a research funding opportunity announcement directed to small businesses to address specific needs in translating diabetic retinopathy (DR) science progress into medical practice. This initiative, entitled "Innovative Patient Outreach Programs and Ocular Screening Technologies to Improve Detection of Diabetic Retinopathy," integrates research, capacity building, and public outreach. One goal of the NIH Small Business Innovation Research program is to build the research capacity of small businesses by stimulating early phase research projects that might not be profitable in the private sector alone but have potential for large public health benefit. Research being solicited includes the following topics: development of educational tools and programs to increase awareness of the importance for early detection and therapy to prevent the blinding consequences of diabetes; development of inexpensive and compact ophthalmic instruments for DR detection that can be easily used by trained personnel who are not eye care specialists; development of methods for automated image analysis to speed screening; development of systems to enable telemedicine screening for DR; development of automated systems to aid evaluation and diagnosis; and development of ocular screening venues in public locales and retail stores.
Performance Measures
The DRCR.net is funded through 2013 to complete the 15 current protocols and three planned protocols. After that time, the NEI will accept a new application for continued funding and will require peer-review to evaluate the progress and productivity of the network. The Phase I Small Business Innovation Research proposals will be competitively reviewed through the two-level peer review process by May 2010. Successful projects may apply for Phase II funding following a peer review of the progress in Phase I.
Outcome Measures
The integration of research, research capacity building, and public outreach has many potentially synergistic outcomes. In addition to the research outcomes of providing an evidence base for the comparative effectiveness of therapeutic interventions for diabetic eye disease and developing innovative patient outreach programs and ocular screening technologies to improve detection of diabetic retinopathy, these initiatives will train and educate community physicians in clinical research and in the latest treatments for diabetic retinopathy. They will help patients with diabetes understand the risks of diabetic retinopathy and will diagnose certain complications at earlier stages where therapy will be more beneficial. The ideal outcome would not just translate research into practice, but for the translation to be bidirectional: observations in the clinic would stimulate the physicians to propose new research questions in the laboratory.
References
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