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14
Research Needs

Many questions remain unanswered regarding treatment of ESRD. The committee believes that a comprehensive research program related to renal disease is essential. This research program should include basic and applied medical research, epidemiologic research, and health services research.

There are near-term and long-term benefits of such an effort. In the near term, the effective management of a large and growing ESRD patient population requires that the scientific foundations of treatment be strengthened, that clinical practice be improved, that innovation be stimulated, that renal disease-specific measures and instruments be developed to assess and ensure quality, and that patient well-being be enhanced. In the long term, research is absolutely essential to the search for effective means of preventing ESRD.

Recently, the National Kidney and Urologic Diseases Advisory Board (NKUDAB, 1990) published a long-range plan for kidney and urologic diseases. The scope of its report includes nephrology, kidney transplantation, and urology and thus is broader than, but inclusive of, ESRD. The NKUDAB identified several objectives that are consistent with this IOM committee's effort. It identified improved access to and quality of care as important objectives, the subjects of Chapters 7, 8, and 12 of this report. It drew attention to the need for expanded data collection and analysis to facilitate the understanding of kidney and urologic diseases, consistent with the general concern of this committee expressed in Chapter 13. It highlighted the need for patient, professional, and public education about opportunities for prevention, early detection, and rehabilitation, themes reiterated throughout this report.

The NKUDAB made numerous recommendations regarding basic research, clinical research, and clinical trials, as well as epidemiology. These recommendations included the expansion of current NIH research grant programs



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Kidney Failure and the Federal Government 14 Research Needs Many questions remain unanswered regarding treatment of ESRD. The committee believes that a comprehensive research program related to renal disease is essential. This research program should include basic and applied medical research, epidemiologic research, and health services research. There are near-term and long-term benefits of such an effort. In the near term, the effective management of a large and growing ESRD patient population requires that the scientific foundations of treatment be strengthened, that clinical practice be improved, that innovation be stimulated, that renal disease-specific measures and instruments be developed to assess and ensure quality, and that patient well-being be enhanced. In the long term, research is absolutely essential to the search for effective means of preventing ESRD. Recently, the National Kidney and Urologic Diseases Advisory Board (NKUDAB, 1990) published a long-range plan for kidney and urologic diseases. The scope of its report includes nephrology, kidney transplantation, and urology and thus is broader than, but inclusive of, ESRD. The NKUDAB identified several objectives that are consistent with this IOM committee's effort. It identified improved access to and quality of care as important objectives, the subjects of Chapters 7, 8, and 12 of this report. It drew attention to the need for expanded data collection and analysis to facilitate the understanding of kidney and urologic diseases, consistent with the general concern of this committee expressed in Chapter 13. It highlighted the need for patient, professional, and public education about opportunities for prevention, early detection, and rehabilitation, themes reiterated throughout this report. The NKUDAB made numerous recommendations regarding basic research, clinical research, and clinical trials, as well as epidemiology. These recommendations included the expansion of current NIH research grant programs

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Kidney Failure and the Federal Government and the training of research investigators in several important fields of renal and urologic research. The Board also recommended a separate NIH institute for kidney and urologic diseases. Readers are referred to the NKUDAB report for additional discussion of its important recommendations. This committee has focused more sharply on the research issues that pertain to ESRD and, potentially, to its prevention. In the judgment of the committee, a serious need exists to reestablish a program of clinical studies on dialysis treatment. The termination of the Artificial Kidney/Chronic Disease research program of the National Institute of Arthritis and Metabolic Diseases (predecessor to NIDDK) left major gaps in clinical studies of dialysis. NIDDK, in the period from 1984 to 1989, supported basic research on transplantation and cellular and subcellular studies of the kidney, but made no awards for clinical dialysis studies (Levin et al., 1990). Other sources of support for clinical research in dialysis have declined. The Department of Veterans Affairs supports practically no clinical dialysis studies in its internally funded research programs (Levin et al., 1990). Baxter Healthcare recently launched an important research program (Baxter, 1990), but the private sector in general has funded little clinical research. Perhaps reflecting declining research support, the number of clinical dialysis papers presented at the annual meetings of the American Society of Artificial Internal Organs and the American Society of Nephrology has declined (Maher, 1989). Overall, the decline in dialysis research has two primary effects. First, it reduces the rate at which new clinical research is generated and thus restricts the flow of scientific information to dialysis clinicians. This may have been costly in the past decade during which the clinical community was placed under increasing financial stress by Medicare reimbursement reductions at a time when it was perhaps in greatest need of the benefits of clinical research. In particular, the discussion among clinicians of unresolved issues regarding the adequacy of dialysis, the effective delivery of the dialysis prescription, the effects of short treatment time on patient outcomes, and the relationship of nutrition to outcomes highlights the need for sustained clinical research. Second, without clinical studies, the reservoir of scientific ideas necessary to stimulate innovation in treatment technology is not replenished. Without public support for research on underlying issues, private commercialization of new products is dampened. Economic studies have shown that the societal benefits from research exceed the private return on research, thus resulting in underinvestment by the private sector in the socially optimal level of research and strongly arguing for public support (Mansfield et al., 1977). Research on the prevention of permanent kidney failure is essential to reduce the anticipated growth of the ESRD patient population. Recent laboratory investigations indicate that progression of established kidney disease can be slowed or possibly even prevented by various techniques. These include alterations in certain dietary constituents (protein, phosphate) and

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Kidney Failure and the Federal Government reduction in blood pressure, especially in the glomeruli (blood filtering elements) of the kidney. Early clinical studies suggest that these techniques may be effective in patients. This area of investigation holds great promise as a means to reduce both the human and the economic cost of ESRD. The effects of pre-ESRD interventions such as blood pressure control and glycemic control on the incidence and progression of renal disease must be evaluated. Effective prevention may require substantial behavioral change in activities as fundamental as diet, exercise, and smoking. Thus, research on behavioral change should be part of the program. Epidemiologic research on kidney disease has been greatly strengthened by the NIDDK support of USRDS. Epidemiology needs to become a more integral part of kidney disease research, as it has been in heart disease, cancer, and aging research. In particular, there is a need to identify and measure with greater specificity the major risk factors causing chronic kidney failure, for prevention as well as patient management purposes. Special attention should be given to racial and ethnic differences in the incidence and causes of renal failure and in strategies for prevention. The Transplant Amendments Act of 1990 expands the authority of the Health Resources and Services Administration to make grants related to organ procurement to entities other than organ procurement organizations. This opportunity should be seized to support well-designed research and demonstration projects that are promising with respect to increasing organ donation. Factors affecting access, outcomes, and organ donation for renal transplantation for minorities, females, and lower-income groups should be addressed. Hypotheses-generating medical anthropology studies may be appropriate ways to probe the social, cultural, and religious values that influence organ donation. The issues surrounding equitable access to organ transplantation require clarification and, where equity is not achieved, efforts should be made to identify remedies. The range and magnitude of the economic effects of kidney failure on the patients and their families, although known to be substantial, have not been adequately addressed. Data are needed on the extent of insurance coverage for ESRD patients by Medicare, private health insurance, and Medicaid. This concern about insurance reflects the growing awareness that private insurance correlates positively with health and functional status and may affect access to transplantation and other therapies. The effects of the Medicare-as-secondary-payer provision on patients' ability to obtain health insurance should be carefully examined. Studies of the economic effects of kidney failure should be designed to illuminate issues related to other chronic disease patients. A variety of methods are used for analyzing mortality, and these have led to some confusion and misinterpretation. A methodological working group, whether internal to HCFA or an external advisory body, is needed to deal

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Kidney Failure and the Federal Government with methodological problems on a continuing basis. A standard protocol for calculating mortality should be developed for use by HCFA, USRDS, UNOS, treatment facilities, and ESRD networks. Health services research, which deals with the organization, financing, and delivery of health care, has laid the foundation for linking clinical and expenditure data, nurtured the development of functional-and health-status assessment, promoted the concern for outcomes and effectiveness research and quality assessment, and been responsible for advances in measurement, methodology, and data-base development. Kidney disease research should embrace health services research as an integral part of a larger research strategy. Research should be supported to determine which components of medical care lead to better outcomes and to identify and validate quality measures for structure, process, and outcomes. Measuring the severity of illness of ESRD patients, including primary diagnosis, comorbid conditions, and functional status, and determining the relationship of these measures to treatment processes and patient outcomes should be central concerns of such research. Research related to functional-and health-status assessment should be directed to the adaptation of these tools for patient management. Research on the relationships of reimbursement (to physicians and facilities), patient characteristics, and treatment modalities to patient outcomes is sorely needed. During its work, the committee received numerous analyses that documented these interactions and indicated that a potential exists among nephrologists to generate a literature on these issues that would be useful to clinicians and policy makers alike. REFERENCES Baxter Renal Division. 1990. Extramural Grant Program. Deerfield, Illinois. Levin NW, Keshaviah P, Gotch FA. 1990. Effect of reimbursement on innovation in the ESRD program. Paper prepared for ESRD Study Committee, Institute of Medicine. New York: Beth Israel Hospital. Maher JF. 1989. The decline in dialysis research in the United States. Semin Dialysis 2:203–206. Mansfield E, Rapoport J, Romeo A, Wagner S, Beardsley G. 1977. Social and private rate of return from industrial innovations. Quarterly J Econ 91(May):221–240. NKUDAB (National Kidney and Urologic Diseases Advisory Board). 1990. 1990 Long-Range Plan: Window on the 21st Century. NIH Publ. No. 90-583. Washington, D.C.: U.S. Department of Health and Human Services.

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Kidney Failure and the Federal Government APPENDIXES

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