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Report of the Health Services Research
Working Group
PROGRAM OVERVIEW AND GOALS
With the changing organization and financing of health care in the United States, an understanding of the delivery and use of vision services is important to develop strategies to best prevent, diagnose, and treat eye conditions and reduce the risk of visual impairment. As healthcare resources become more constrained, it is essential to determine the most appropriate use of diagnostic strategies and treatments scientifically demonstrated to improve vision and preserve sight. 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 visioncare services.
To advance understanding of these issues, the National Eye Institute (NEI) is, for the first time, devoting a section to health services research in its Vision Research National Plan. The NEI defines the field of health services research broadly to include such diverse topics as: increasing patient access to and utilization of visioncare services, improving the delivery of vision services by eyecare professionals, and measuring the visual health of patients receiving eyecare services. 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. The selection of design methodology should be scientifically justified as appropriate for the research objectives of a given study.
In Fiscal Year 1997, the NEI funded six extramural research projects that were related to health services research at a total cost of $2,467,000. Two of the broad goals of health services research at the NEI are to:
- Assess the impact of eye disease and visual impairment on the Nation's health.
- Determine the most appropriate use of diagnostic strategies and treatments scientifically demonstrated to improve vision and preserve sight.
ASSESSMENT OF PROGRESS
Although not highlighted in previous plans, the NEI has had a growing interest in health services research. Several important contributions have been made in this area over the past 5 years.
Recognizing that a patient's quality of life is an important facet to consider in assessing visual health, several NEI-funded epidemiologic studies and clinical trials have incorporated a quality-of-life assessment into the study protocol. These quality-of-life data are useful for assessing a patient's acceptance of a scientifically proven treatment regimen. To elucidate the impact of clinical interventions specifically on vision-related quality of life from a patient perspective, the NEI fostered the development and testing of the NEI-Visual Functioning Questionnaire (NEI-VFQ). Based on findings from small groups of patients with specific vision deficits who answered this Questionnaire, diminished visual acuity has been associated with decreased performance of routine daily activities, reduced cognitive ability, and poorer health-related quality of life.
Surgery to remove a cataract and to implant a synthetic lens, one of the most frequently performed procedures among Medicare beneficiaries, was the focus of three large studies. Together, these studies concluded that as a direct benefit of cataract surgery, 77 percent to 92 percent of patients reported substantial improvement in their ability to see and to perform common, necessary daily activities. In addition, preliminary data indicate that, using patient characteristics assessed prior to surgery, it is possible to reliably predict which patients are most likely to benefit from having their cataract removed. Preoperative visual acuity in the eye with the cataract was not one of these predictive factors. This finding has important policy implications, since some managed care organizations mandate the use of visual acuity criteria to justify the need for cataract surgery.
People with diabetes mellitus are at risk to develop retinopathy, a leading cause of blindness. Since early diagnosis and treatment has been shown to prevent vision loss in over 90 percent of patients, medical practice guidelines recommend an annual dilated eye examination for all people with diabetes. Recent studies indicate, however, that many people with diabetes do not get an annual dilated eye examination. Several studies have attempted to determine why diabetic patients do not get an annual dilated eye examination and identify the reasons why the medical system is failing to reach this population at increased risk of visual impairment. Other studies have tested specific interventions aimed at the patient or the eyecare provider to increase the rates of ophthalmic screening among people with diabetes.
PROGRAM OBJECTIVES
The following four objectives have been identified as key areas to advance a health services research agenda over the next 5 years. They are:
- 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.
- Develop effective strategies for screening for eye disease and visual impairment in children and adults.
- Educate eyecare providers and the general public on scientific advances in detecting, preventing, and treating eye diseases and in translating these advances into nationwide clinical practice.
- Identify the factors associated with the most effective delivery and use of visioncare services.
The needs and opportunities related to each of these objectives and the strategies for accomplishing them will now be considered.
Objective 1: 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.
Research Needs and Opportunities
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 eyecare 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 three 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 followup of these groups of Caucasians and African-Americans is providing additional information on the frequency of new cases of eye disease. Similar information is needed on children and minority populations of all ages, particularly Hispanics and East Asians.
Even with better estimates of the numbers of Americans with eye disease and visual impairment, complete estimates of the economic and social costs of these conditions are lacking. Previous economic analyses of the costs associated with eye conditions have generally been limited to consideration of direct medical costs to the patient or third-party payers, and to indirect costs to society in the form of tax deductions or disability payments. Given that the onset of visual loss can be gradual and can worsen over time, the true costs of visual impairment are difficult to estimate. The magnitude of direct and indirect medical costs, as well as the costs to society, depends on a number of factors, including: the nature and severity of the visual impairment; the nature and severity of other illnesses; a patient's age, socioeconomic status, and family setting; cultural expectations regarding self-reliance and independence; attitudes about health and health care; and the part of the country where the person lives. All of these factors need to be considered in subsequent research efforts. Also of importance are costs associated with changes required in the home or workplace that allow visually impaired persons to safely go about their daily activities and income lost by family members who may have to reduce their hours of gainful employment or quit their job to care for a family member who has a visual deficit.
Strategic Research Questions
How many Americans are visually impaired or have eye disease? Estimates of the number of visually impaired Americans and those with one of the major eye diseases are critical to plan future vision research efforts and evaluate the nationwide success of new prevention and treatment interventions. Since there are both genetic and environmental determinants of eye disease, it is particularly important to study ethnically diverse populations. Additional epidemiologic studies on Hispanic, East Asian, and Native American 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.
How many American children have eye disease or vision loss? National estimates of the number of children with vision disorders and their age at onset are critical to design age-appropriate screening programs for the pediatric population and to make adequate followup care available for children at increased risk of an eye disorder. Of particular interest are studies on anisometropia, strabismus, amblyopia, and refractive error. The impact of these disorders on normal child development should be explored in estimating the costs of these conditions in a pediatric population.
What are the direct and indirect medical and social costs associated with visual impairment (< 20/40 to > 20/200 in the better eye) and blindness (< or = 20/200 in the better eye)? Due to differences in the manifestations and age at onset of the major causes of vision loss—glaucoma, age-related macular degeneration and other diseases of the central retina, diabetic retinopathy and maculopathy, unoperated cataract, and CMV retinitis—separate studies may be necessary to accurately estimate the costs associated with each condition. Computerized administrative databases of expenditure and survey data maintained by governmental agencies and third-party payers often do not have information on the vision status of the participants and, as a result, may only provide a rough estimate of cost. On the other hand, these databases may allow investigators to identify a specific group of patients who can be contacted for further detailed study. The collection of data on the direct and indirect medical costs and social costs may also be obtained in the context of a randomized clinical trial.
Objective 2: Develop effective strategies for screening for eye disease and visual impairment in children and adults.
Research Needs and Opportunities
In an era of limited healthcare resources, it is important to develop cost-effective methods that identify disease in people who may be at increased risk of visual loss for those conditions amenable to treatment. Individuals who are identified by routine screening methods as having possible disease can then be referred to specialists for a more detailed examination and for treatment, should the diagnosis be confirmed. Screening strategies to detect eye disease and visual impairment could be very useful in identifying individuals most in need of comprehensive eyecare services to prevent vision loss and preserve vision-related quality of life.
To advance this objective in a scientific manner, proposed screening strategies directed at assessing visual impairment or eye disease need to be compared to results obtained from a thorough clinical examination. This will determine how well the screening method correctly identifies both people who have the condition and people who do not. Once they have been shown to measure disease or vision loss accurately, screening strategies must then be evaluated to determine whether they can be implemented in practice. In addition, cost-effective screening strategies should be publicly acceptable, relatively inexpensive to implement, targeted to high-risk groups, and able to identify disease at an early stage, when costs associated with treatment might be lower than costs for treating a more advanced stage of the disease.
As a greater number of individuals receive healthcare services in a managed care setting, where preapproval is required before patients can visit eyecare providers, it will become increasingly important to develop and evaluate screening strategies appropriate for implementation in primary care settings and in the community. The goal should be to identify people most in need of specialized care and then to target resources to provide high-quality vision care only to those who need it.
Strategic Research Questions
What screening methods are effective in identifying children most likely to have eye disease or vision loss? Since visual impairment may impact on normal development, it is important to develop screening programs for children to detect and treat eye diseases like strabismus, amblyopia, and significant refractive error. There are a number of issues to consider in designing screening strategies for children. What diseases can be identified using screening methods? At what age is screening optimal? What are age-appropriate considerations in designing the content of screening examinations for use in children? Are there specific settings in which widespread screening is most feasible and practical? Can lay examiners perform the screening? Does screening and subsequent treatment result in improved school performance?
Should there be routine screening for eye disease and visual impairment in adults? Given that the major eye diseases usually affect older Americans, routine screening of young and middle-aged adults for these conditions may not be cost-effective. On the other hand, uncorrected refractive error is an important source of visual impairment in these age groups. Screening methods to identify refractive errors have obvious, important implications for driver and public safety. Several issues deserve scientific investigation. How often should adults have their eyes examined? Should examinations become more frequent with advancing age? What tests should be included as part of these examinations? How often is a dilated eye examination necessary?
Similar information on the frequency and content of eye examinations is necessary to develop screening strategies specifically for persons with systemic conditions or family history, both of which increase the risk of eye disease or visual impairment. For which disease(s) is screening possible? For which disease(s) is screening cost-effective? How can at-risk groups best be identified? How can screening programs be made culturally appropriate? As genetic markers to predict individuals at increased risk of eye disease or visual impairment become available, how will these influence the content and use of screening methods?
To preserve sight in the oldest group of Americans, it is necessary to develop cost-effective screening programs that can be implemented at in-patient facilities such as rehabilitation hospitals and community-based settings, including nursing homes and adult daycare facilities. Developing low cost, easy to operate, portable equipment would be an asset for such a screening effort.
Can screening for diabetic retinopathy be improved? There is strong evidence that dilated eye examinations are a cost-effective means for detecting treatable retinopathy in people with diabetes mellitus. Nevertheless, many people with diabetes do not get a regular dilated eye examination. It might be possible to develop screening strategies that will minimize the number of exams required and maximize the utility of those performed. What is the optimal interval for comprehensive eye examinations for individuals with diabetes mellitus? Can indicators of risk be identified to tailor the optimal interval for a given individual? Can effective screening with dilation be performed in a primary care setting or by having fundus photographs taken and sent to a reading center for interpretation? Can screening methods be made more culturally appropriate to increase their effectiveness?
Objective 3: Educate eyecare providers and the general public on scientific advances in detecting, preventing, and treating eye diseases and in translating these advances into nationwide clinical practice.
Research Needs and Opportunities
The investment of significant financial and human resources is required to develop new treatments for vision-related conditions and to evaluate their efficacy using randomized, controlled clinical trials. Once an efficacious treatment or prevention strategy is identified, it must be made readily available and utilized before it can be deemed successful. Implementing research findings into clinical practice is often a difficult task. For example, the benefit of detecting diabetic retinopathy to prevent blindness and the methods used to treat it are well established, yet many people with diabetes become blind. There are many possible reasons why this occurs, including poor access to health care, low prioritization of eye care by people who have diabetes along with many other competing health problems, and lack of coordination among providers who care for patients with diabetes.
With the increasing presence of managed care in America, many more patients are being cared for in primary care settings where there is growing pressure on healthcare providers to see a greater number of patients in less time, and to use fewer resources in caring for their patients. Providers also have limited opportunity to keep up with the fast pace of the scientific literature, especially across medical specialties. This presents a particular problem in educating not only eyecare specialists but also primary care providers on new scientific advances in vision research. On the other hand, managed care organizations may be more receptive to implementing new treatment guidelines if there are cost savings involved.
Research is needed to assess the barriers to translating medical knowledge into practice, and to develop innovative strategies that adapt scientifically proven interventions to the needs and constraints of "real world" settings. To the extent possible, the design of a clinical trial should lend itself to widespread application in the community and allow large numbers of patients with the opportunity to participate in a streamlined study plan.
Strategic Research Questions
How do the American public and the medical community become educated on medical advances related to eye disease and visual impairment? Educating the public and the medical community is one step in translating findings from randomized clinical trials into general clinical practice. Strategies for the effective communication of vision research advances may be different for different populations. A patient's receptivity depends on a number of factors, including native language, degree of literacy, and cultural expectations. How do patients become educated about their eye condition? How can people with diabetes be educated most effectively about the need to have a routine, dilated eye examination? How can patients in need of low-vision services be informed about devices that are available to improve their quality of life?
It is critical for healthcare providers to be receptive to new research findings for widespread implementation to be achieved. Their responsiveness may rely on several factors, including specialty training, exposure to scientific literature, experiences with their own patients, and general willingness to incorporate new knowledge into their clinical practice. In a managed care environment, primary care providers need to know how to identify and when to refer patients who need specialized eye care. How can vision research findings be communicated outside the eyecare profession? How can providers be educated on the use of genetic markers of eye disease?
How do patients and providers avail themselves of new treatment options? In designing clinical trials and implementing new interventions outside the research environment, it would be helpful to understand the criteria used by patients and providers in making healthcare decisions. Are there certain characteristics of patients, providers, and healthcare delivery settings that facilitate the incorporation of specific new knowledge into clinical practice? What factors are involved in clinical decisionmaking regarding patient management? What factors determine whether a treatment is acceptable to a given group of patients? How long after publication of study results do research findings become integrated into clinical practice?
Objective 4: Identify the factors associated with the most effective delivery and use of visioncare services.
Research Needs and Opportunities
Given the increasing number of Americans covered by managed care plans, research to examine the delivery and utilization of vision care takes on even greater importance. Little is known about the quantity and quality of eyecare services offered to different segments of the American population, or how the changing patterns of delivering visioncare services influence a person's access to and utilization of appropriate, high-quality vision care. With a characterization of the eyecare 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.
The movement toward fully automated medical records 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 visioncare services. It is important to note, however, that persons in systems of care with automated records may be different from the general population.
Strategic Research Questions
In what ways do eyecare professionals differ in how they manage patients with a given eye disease or disorder? Although guidelines for providing medical care exist, the practice of medicine has traditionally been left to the judgment of physicians and their patients. While individual customization remains an important part of medical care, large variations in approaches are often associated with wide fluctuations in cost. If alternate clinical management strategies result in similar patient outcomes and with a similar degree of patient satisfaction, widespread application of the most cost-effective strategy could save significant eyecare resources. In this way, resources could be redirected toward other vision-related needs.
To date, cataract surgery has been the topic of most ophthalmic outcomes research because it occurs so frequently and is associated with significant financial expenditure. Outcomes research on the management of a variety of other prevalent ocular disorders is needed. What are the long-term outcomes and costs associated with initial surgery as compared to medical treatment for glaucoma? What are the long-term visual abilities and educational achievements among children whose amblyopia or strabismus was treated using different approaches?
Do variations in clinical practice among eyecare providers in the community result in different patient outcomes as compared to findings from randomized, controlled clinical trials? Variations in practice patterns exist among eyecare providers. Similarly, findings from randomized, controlled trials become incorporated into clinical practice in a variety of ways. Whether or not a treatment deemed efficacious in a research setting will result in similar patient outcomes in a "real world" setting is unknown. There are many possible reasons for this. Because of stringent eligibility criteria, patients who participate in clinical trials are often fundamentally different from average patients in the community with the same condition. Alternatively, healthcare providers in the community may elect to implement new clinical trial results in ways that are somewhat different from the rigid study protocol required for proper conduct of the clinical trial. Studies are needed on the visual outcomes and patient satisfaction associated with widespread implementation of clinical trial findings. This information may be used to identify subgroups for whom the trial results may not be applicable, to recognize ineffectual implementation of clinical trial findings related to protocol deviations or patient dissatisfaction, and to gather ideas on how to better design future clinical trials.
What are the variations in outcomes, cost, and patient satisfaction associated with various approaches to treat refractive error? Refractive error, a common eye condition, can be corrected by wearing spectacles or contact lenses or by undergoing laser surgery to reshape the cornea. How do persons choose among these corrective options? Given that younger patients have a significant likelihood of further myopic progression, are these corrective modalities associated with similar clinical outcomes and levels of patient satisfaction? Which methods are most cost-effective?
What interventions can be undertaken to increase access to and use of visioncare services among persons at increased risk of eye disease or visual impairment? Even if widespread delivery of eyecare services was available, some patients in need of eye care would not obtain it because of failure to access vision care or failure to comply with the recommendations of eyecare providers. Research is needed to understand how and why patients choose to access or fail to access visioncare services and their reasons for not complying with prescribed services or treatment. This information will provide the basis for designing specific interventions to improve access to and use of appropriate eyecare services.
Several topics are relevant to such research. What is the relationship between a patient's perspective of visual ability and actual clinical or psychophysical measures of vision functioning? How does a patient's knowledge of his or her eye disease or visual impairment influence the perceived need to seek out visioncare services? Why do patients who perceive a need for eye care choose not to make use of visioncare services? How do persons prioritize visual health among other medical conditions or quality-of-life considerations? What are the most appropriate methods for measuring quality of life among visually impaired persons with different eye conditions and from different socioeconomic and cultural backgrounds? Are currently available quality-of-life questionnaires sufficient to capture this information or are new questionnaires needed? How do patients decide whether or not they are satisfied with eyecare services? Particular attention should be paid to visually impaired children and their families, adolescents, nursing home residents, persons with a family history of eye disease, and other populations at increased risk of eye disease, visual impairment, or blindness.
HEALTH SERVICES RESEARCH WORKING GROUP
Roy Beck, M.D., Ph.D.
JAEB Center For Health Research, Inc.
Tampa, FL
Carol Mangione, M.D.
UCLA School of Medicine
Los Angeles, CA
PANEL MEMBERS
Charles Basch, Ph.D.
Columbia University
New York, NY
Maureen Maguire, Ph.D.
Scheie Eye Institute
Philadelphia, PA
Elinor Schoenfeld, Ph.D.
SUNY at Stony Brook
Stony Brook, NY
James Tielsch, Ph.D.
Johns Hopkins University School of Hygiene and Public Health
Baltimore, MD
NEI STAFF
Mary Frances Cotch, Ph.D.
National Eye Institute, NIH
Bethesda, MD
