Purpose
To evaluate the impact of the Diabetes 2000 program, an initiative launched by the American Academy of Ophthalmology in 1990 to improve nationwide screening of diabetic retinopathy (DR) and to reduce the prevalence and severity of the condition.
Design
Retrospective, observational case study of Diabetes 2000 program.
Methods
This is a perspective piece with a review of literature and personal opinions.
Results
Patients with diabetes are likely to see an increase in the disease burdens associated with DR unless effective programs for early detection and control of DR are implemented.
Conclusions
Despite recent efforts to educate both patients and physicians alike about the importance of routine DR screening, the lessons learned from the Diabetes 2000 program illustrate the need for new strategies capable of improving accessibility to high-quality eye care, increasing involvement of primary care physicians in DR screening and encouraging at-risk individuals to seek testing.
Approximately 23% of Americans older than 60 years and 23.5 million older than 20 years are affected by diabetes mellitus. Minorities are affected disproportionately by diabetes, with the prevalence among Latino Americans (13.7%) and African Americans (12.5%) significantly greater than that among non-Hispanic white Americans (7.2%). Results of a study by the Eye Diseases Prevalence Research Group revealed that 40% of diabetes patients have some degree of diabetic retinopathy (DR) and that as many as 8% have severe, vision-threatening forms of DR. Given current age structures and improved survival among diabetes patients, the Centers for Disease Control and Prevention project a surge in DR from 5.5 million in 2005 to 16 million in 2050. Diabetes remains the leading cause of new cases of blindness among adults 20 to 74 years of age and causes 12 000 to 24 000 new cases of blindness each year. Despite several initiatives to improve early detection and treatment, the rates of eye examination have remained well below prescribed levels. As the prevalence of diabetes increases, effective strategies must be adopted for the prevention, early detection, and early treatment of diabetes and associated retinopathy. This article explores 1 initiative, Diabetes 2000, and the reasons for its failure and postulates strategies to improve early DR detection.
Background
DR progresses in stages, with mild, nonproliferative DR being the mildest form and proliferative diabetic retinopathy (PDR) being the most advanced. Chronic hyperglycemia causes capillary dropout and progressive retinal ischemia with compensatory intraretinal neovascularization. Without treatment, extraretinal neovascularization develops, signaling the development of PDR. Extraretinal neovascularization may lead to vitreous hemorrhage, whereas chronic extraretinal neovascularization may lead to the development of fibrovascular proliferation and tractional retinal detachment. Additionally, chronic hyperglycemia contributes to capillary pericyte loss and increased vascular permeability, contributing to diabetic macular edema and vision loss. Pregnancy, puberty, hypertension, and ocular surgery in patients with diabetes may accelerate the development of DR or may exacerbate pre-existing disease. The duration of diabetes and level of glycemic control both play a central role in determining the risk of developing DR. In fact, a strong link exists between hemoglobin A1c levels and the risk of developing DR and blindness resulting from DR. In individuals with a history of diabetes of 20 years or more, more than 60% of type 2 patients with diabetes and approximately 100% of type 1 patients with diabetes will have some degree of DR. In the Wisconsin Epidemiologic Study of Diabetic Retinopathy, 3.6% of patients with type 1 diabetes and 1.6% of patients with type 2 diabetes were legally blind, with 86% of blindness in the former group attributed to DR. The American Academy of Ophthalmology’s (the Academy) Preferred Practice Pattern for DR emphasizes the important role disease duration plays in determining the progression of the condition.
Randomized controlled trials, including the Diabetes Control and Complications Trial, have demonstrated that tight glycemic control is critical to reduce systemic and ocular complications of diabetes. The Diabetes Control and Complications Trial study found that after 6.5 years of follow-up, strict glycemic control (median hemoglobin A1c, 7.2%) resulted in a 76% decrease in the incidence of DR (95% confidence interval, 62% to 85%) and a 54% decrease in the progression of DR (95% confidence interval, 39% to 66%) compared with patients with normal glycemic control (median hemoglobin A1c, 9.1%). These findings were corroborated by a number of subsequent studies. Given that the prevalence of DR is correlated strongly with the duration of diabetes, maintaining healthy blood sugar levels remains essential for reducing vision loss associated with DR.
Numerous studies have demonstrated that early stages of DR may cause visual symptoms or may be clinically recognizable, underscoring the need for annual dilated eye examinations in at-risk populations to detect and treat the earliest stages of disease. Screening remains a primary component of DR management and is essential for reducing the long-term consequences of the disease. The Academy currently recommends ongoing management with annual retinal examinations beginning at the time of diagnosis for type 2 patients with diabetes and retinal examination 3 to 5 years after diagnosis and yearly thereafter for type 1 diabetes patients.
The importance of routine eye examinations for patients with diabetes is aimed at optimizing the timing of laser photocoagulation in patients with PDR and diabetic macular edema. Early laser photocoagulation in high-risk PDR has been shown to decrease the relative risk of vision loss by as much as 52%. Similarly, early treatment of clinically significant diabetic macular edema has been shown to reduce the risk of severe visual loss by 50% at 5 years. The vision-preserving effects of laser photocoagulation can be documented in more than two thirds of patients more than 10 years after treatment. An epidemiologic study involving 1370 patients corroborated this by demonstrating that each laser photocoagulation treatment is associated with at least 10 years of preserved vision. Despite recent programs designed to enhance early recognition, DR remains a leading cause of acquired blindness in the United States. With more than 64% of United States adults and 1 in every 5 children either overweight or obese, the projected increases in national diabetes prevalence is likely to exacerbate the aforementioned societal, economic, and healthcare burdens associated with DR.
Although the retinal changes that occur in DR are irreversible, numerous studies have demonstrated that adherence to guideline-recommended care, including routine referrals, early recognition of DR changes, prompt treatment, and regular follow-up, can help to improve early recognition of DR and can reduce the risk of permanent blindness in at-risk individuals. Despite its benefits, physician compliance with such guidelines remains low.
In addition to improving quality of life and preventing blindness, early detection and treatment of DR also can be cost effective. Blindness resulting from diabetes represents more than $500 million in lost income per year in the United States and more than $174 billion in annual overall costs to society. In fact, a report by Javitt and associates concluded that early detection and prompt management of DR potentially can save more than $108 million of federal funds each year. Another study suggested that more than $16 million potentially can be saved each year for every 10% improvement in adherence to diabetes vision care guidelines. Providing patients with guideline-recommended eye care also seems to correlate with savings.
Given their focus on quality of care, the evidence-based guidelines created by medical specialty societies like the Academy seem to be more effective in improving medical care when compared with guidelines released by general medical societies. In a retrospective study involving patients with diabetes with no prior evidence of DR, Sloan and associates demonstrated that those who received guideline-recommended care experienced substantially lower rates of low vision and blindness when compared with those who did not receive care consistent with guidelines. Studies also have demonstrated how adherence to evidence-based guidelines can improve quality of life while reducing the cost of care in most chronic conditions. As such, the intent of the Diabetes 2000 program described below was to create a cross-specialty program aimed at improving glycemic control and routine ophthalmic care for patients with DR in accordance with evidence-based practice.
The Diabetes 2000 Program
The role of physicians in encouraging eye care and adherence to vision care guidelines has important public health benefits. In an effort to address this and to enhance cooperation between various specialists, the Academy launched Diabetes 2000 in 1990 to maximize the guideline-recommended care of diabetes patients. Diabetes 2000 was a national 10-year program aimed at eliminating preventable blindness from diabetes by the year 2000. Although nearly all physicians recognize the impact of DR, the major goal of Diabetes 2000 was to focus on improving early intervention, diagnosis, and evidence-based treatment of DR. To reach this goal, Diabetes 2000 promoted a combination of continuing education activities for physicians, provided evidence-based guidelines for the treatment of patients with diabetes, and emphasized the role of primary care physicians (PCP) as key players in the early treatment and referral of DR patients to eye care professionals. The program also stressed the need for counseling of patients by ophthalmologists and offered strategies to streamline the referral process to provide for early detection and treatment of all stages of DR.
Additionally, improved coordination and collaboration between ophthalmologists and primary care physicians with routine counseling of patients was viewed as the cornerstone for improved eye care in diabetes patients. Given that laser photocoagulation represented the main therapeutic approach for preserving vision and delaying progression of DR, Diabetes 2000 also sought to improve access to laser photocoagulation in at-risk patients. Despite the fact that the guidelines developed by Diabetes 2000 intended to promote quality eye care, the program’s message was slow to be adopted among PCPs and failed to reduce inconsistencies in practice among ophthalmologists. In a study relying on questionnaires distributed among all licensed ophthalmologists in New York, Florida, and Massachusetts, Khadem and associates found that those ophthalmologists who received information as part of Diabetes 2000 made noticeable changes in their practice patterns, but that ultimately, greater efforts were needed to reduce inconsistencies among individual practices. Despite the program’s promise and purported benefits, DR remains a serious problem in populations of diabetes patients. By highlighting the shortcomings of the Diabetes 2000 program, the following section offers insight into potential logistical challenges other future national prevention programs may face.
The Diabetes 2000 Program
The role of physicians in encouraging eye care and adherence to vision care guidelines has important public health benefits. In an effort to address this and to enhance cooperation between various specialists, the Academy launched Diabetes 2000 in 1990 to maximize the guideline-recommended care of diabetes patients. Diabetes 2000 was a national 10-year program aimed at eliminating preventable blindness from diabetes by the year 2000. Although nearly all physicians recognize the impact of DR, the major goal of Diabetes 2000 was to focus on improving early intervention, diagnosis, and evidence-based treatment of DR. To reach this goal, Diabetes 2000 promoted a combination of continuing education activities for physicians, provided evidence-based guidelines for the treatment of patients with diabetes, and emphasized the role of primary care physicians (PCP) as key players in the early treatment and referral of DR patients to eye care professionals. The program also stressed the need for counseling of patients by ophthalmologists and offered strategies to streamline the referral process to provide for early detection and treatment of all stages of DR.
Additionally, improved coordination and collaboration between ophthalmologists and primary care physicians with routine counseling of patients was viewed as the cornerstone for improved eye care in diabetes patients. Given that laser photocoagulation represented the main therapeutic approach for preserving vision and delaying progression of DR, Diabetes 2000 also sought to improve access to laser photocoagulation in at-risk patients. Despite the fact that the guidelines developed by Diabetes 2000 intended to promote quality eye care, the program’s message was slow to be adopted among PCPs and failed to reduce inconsistencies in practice among ophthalmologists. In a study relying on questionnaires distributed among all licensed ophthalmologists in New York, Florida, and Massachusetts, Khadem and associates found that those ophthalmologists who received information as part of Diabetes 2000 made noticeable changes in their practice patterns, but that ultimately, greater efforts were needed to reduce inconsistencies among individual practices. Despite the program’s promise and purported benefits, DR remains a serious problem in populations of diabetes patients. By highlighting the shortcomings of the Diabetes 2000 program, the following section offers insight into potential logistical challenges other future national prevention programs may face.
Failure to Include Other Diabetic Retinopathy Risk Factors
Although Diabetes 2000 focused on tight glycemic control in at-risk individuals, the program failed to address other risk factors for the development of DR. Despite the existence of strong evidence linking DR with hypertension, hyperlipidemia, and renal disease, Diabetes 2000 remained singularly focused on effecting positive changes in glycemic control. This represented a shortcoming in Diabetes 2000 and signals the need for more comprehensive approaches in future national attempts to reduce the complications of DR.
Failure to Include Guidelines in Training Curricula
Another important issue with the Diabetes 2000 program was its failure to integrate its guidelines into residency curricula at Accreditation Council for Graduate Medical Education (ACGME)-accredited training sites. The ability of the Academy to integrate the program’s guidelines in ophthalmology, emergency medicine, and primary care graduate medical education (GME) curricula would have represented an opportunity to expose resident physicians to guideline-recommended care early in their careers. The integration of the program’s guidelines into training curricula also would have helped to reduce any variability or inconsistencies in management approaches among individual practitioners in a number of teaching hospitals nationwide. Rather than focus on the thousands of PCPs and ophthalmologists in private practices, an alternate approach would have been to initiate the program in GME programs, while gradually expanding into private practice settings. This approach would have encouraged guideline-based treatment from the earliest stages of young physicians’ careers. Instead, the Diabetes 2000 program focused on private physicians first, rather than GME programs. A recent study by Tseng and associates revealed trends in compliance with the Academy Preferred Practice Pattern in a GME setting. In their study involving 451 patient visits at resident ophthalmology clinics, Tseng and associates found that only 52% of visits were conducted in accordance with the Academy’s Preferred Practice Pattern for DR, with the most significant failures for ophthalmologists in the area of counseling and obtaining a thorough medical history. The failure to monitor compliance with guidelines undermines a program’s ability to achieve its goals. The lack of patient outreach, the absence of oversight mechanisms to ensure compliance among ophthalmologists, the minimal involvement of primary care physicians in the program, and the failure to incorporate GME programs into the framework of the Diabetes 2000 represent 3 critical components that likely contributed to the inability of the program to achieve its stated purpose.