- Email: [email protected]
Renal rehabilitation: Obstacles, progress, and prospects for the future
Renal Rehabilitation: Obstacles, Progress, and Prospects for the Future Edith T. Oberley, MA, John H. Sadler, MD, and Paula Stec Alt, MBA ● The definition of rehabilitation for end-stage renal disease (ESRD) patients has changed significantly over the past 40 years. Initially, the concept focused on return to employment. In the early days, most members of the small, select group of patients chosen for dialysis met this criterion and were considered successfully rehabilitated. However, this ‘‘success’’ could not be replicated in the broader ESRD population when Medicare coverage was expanded to include older and more debilitated patients. This raised serious questions about the feasibility of renal rehabilitation efforts. Government policy makers and the nephrology community responded by (1) gathering data to enable the measurement and improvement of health-related quality of care, and (2) redefining rehabilitation and its goals. Today, renal rehabilitation is defined broadly, in terms of optimal functioning for individual patients and restoration to productive activities—not simply employment. To foster renal rehabilitation and guide program development, the Life Options Rehabilitation Advisory Council (LORAC) identified five core principles, called the ‘‘5 E’s’’—Encouragement, Education, Exercise, Employment, and Evaluation. Considerable progress has been made in measuring outcomes of care and in establishing a connection between rehabilitation interventions and improved outcomes. Increasingly, research is focused on the relationship between patient self-reports and health status outcomes. In the years ahead, clinicians and researchers will see growing evidence of relationships between specific rehabilitation interventions, improved outcomes (including health-related quality of life), and cost-effective delivery of care. 娀 2000 by the National Kidney Foundation, Inc. INDEX WORDS: Renal rehabilitation; end-stage renal disease; patient self-reports; health status outcomes; health-related quality of life.
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N THE 40 YEARS since Dr. Belding Scribner developed a permanent method of vascular access, making maintenance hemodialysis an option for the treatment of end-stage renal disease (ESRD), both clinicians and policy makers have increasingly focused on renal rehabilitation. Professional opinions about the feasibility and potential for renal rehabilitation have run the gamut from optimism to resignation, and even despair. Over time, the definition of renal rehabilitation evolved from one with a primary emphasis on return to employment, to a more comprehensive definition of restoration to productive activities and an independent lifestyle for people on dialysis.1 The clarification of a realistic definition of renal rehabilitation has provided focus for interventions and outcomes assessment. Efforts to measure and improve quality of care are allowing quantitation and comparison of clinical outcomes. Research demonstrates that some rehabilitation outcomes can also be measured and improved. The future holds great promise for even better understanding of how to design, deliver, and monitor successful renal rehabilitation programs. LEGISLATION FUELED BY OPTIMISM
The ability to return to productive activity was one of the primary criteria used by early selec-
tion committees to choose candidates who would gain access to a critically scarce resource— dialysis. In June 1972, there were only 5,786 dialysis patients in the United States.2 Among these patients, return to productivity, such as employment, school, or other functional roles, was common. Such excellent results were directly related to the fact that committees charged with selecting patients used age, income, educational background, occupation, and future potential as selection criteria.2 To expand access to treatment, on October 30, 1972, President Nixon signed Public Law 92603, with Section 2991 extending Medicare benefits to all ESRD patients. Support for this landmark legislative decision was based on optimistic expectations for the recipients of treatment. Senator Hartke, for example, argued that the cost of medical care would be offset by the fact that ‘‘60% of those on dialysis can return to work
From the Life Options Rehabilitation Program, Medical Media Associates, Madison, WI. Supported by Amgen Inc, Thousand Oaks, CA. Address reprint requests to Edith T. Oberley, MA, Life Options Rehabilitation Program, c/o Medical Media Associates, Inc, University Research Park, 603 Science Dr, Madison, WI 53711-1074. E-mail: [email protected]
娀 2000 by the National Kidney Foundation, Inc. 0272-6386/00/3504-0108$3.00/0
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[with] retraining, and most of the remaining 40% require no training whatsoever.’’3 He emphasized the potential for these people to be active and productive, if they received access to lifesaving dialysis treatment. Looking back, the expectation of 100% employment for dialysis patients seems, at best, naive. However, it must be remembered that this assumption was based on the experience of a small, select group of patients. UNFULFILLED EXPECTATIONS
Near-universal entitlement to dialysis changed the rehabilitation picture dramatically. The ESRD patient population grew in size and changed in demographics. This new population of dialysis recipients differed from the original population with regard to characteristics such as age, sex, race, and primary diagnosis. For example, patients 65 years and older represented 5% of the total Medicare ESRD population in 1973. By 1988, they represented 27% of patients, and accounted for 38% of all new patients in that year. Similarly, ‘‘the proportion of ESRD patients with a primary diagnosis of diabetes mellitus increased from about 13% in 1980 to 24% in 1988; this diagnosis accounted for 31% of all new patients in 1988.’’4 There was no question that the population of 10,000 ESRD beneficiaries when the entitlement began in 1973 was quite different from the nearly 150,000 beneficiaries in 1988. These same trends, toward older patients with significant comorbidities, continued into the 1990s. In 1996, patients aged 65 and older made up 33.5% of the ESRD population, and 46% of new dialysis patients that year were elderly. In the same year (1996), 32.5% of all dialysis patients had a diagnosis of diabetes mellitus, while 42.3% of new dialysis patients had the disease.5 This broader population of dialysis patients was then not generally able to return to work. Many were past retirement age, and others had previously accepted disability coverage. Advocates of rehabilitation fell silent. It was clear that most ESRD patients would not return to paid employment and become active taxpayers. There would not be a direct financial return for federal coverage for the cost of dialysis and transplantation. If paid employment was the definition of rehabilitation, the renal community of clinicians
and patients could not produce that result for a large percentage of this new, broad population of ESRD patients. A 1981 report by Gutman et al on 2,481 patients from 18 dialysis centers concluded that, based on the Karnofsky Activity Scale, 40% of nondiabetic dialysis patients and 77% of diabetic dialysis patients were incapable of engaging in any level of physical activity more strenuous than caring for themselves.6 The capacity for activity in 20% of the nondiabetics and 51% of the diabetics was so low that they could not even take care of themselves.6 Clinicians and policy makers were dismayed. Privately and publicly,7 the potential of renal rehabilitation was seriously questioned. ‘‘It [renal replacement therapy] represents effective lifesaving treatment for many patients which is transmuted into merely life-prolonging treatment for others with serious complications and low quality of life,’’ charged critics.3 The combined effect of discouraging reports, higher-than-expected costs, and lack of data about ESRD cast a pall over rehabilitation efforts. The period between 1976 and 1986 was, indeed, a ‘‘Dark Age’’ in terms of understanding rehabilitation potential. MEASURING QUALITY OF CARE
In the belief that better quality of care would improve outcomes, government policy makers and the nephrology community responded to disappointing reports about the ESRD Medicare program by making a concerted effort to gather data that would enable the measurement, and improvement, of quality of care. In 1983, the Health Care Financing Administration (HCFA; Baltimore, MD) established a data system for collecting and maintaining statistics on ESRD patients in response to chronic complaints that unclear, incomplete data prevented analysis and accountability. While helpful for analysis, this system placed a spotlight on the ESRD program operations and outcomes, leading to focused criticism not possible with other Medicare programs. In 1987, Congress asked the Institute of Medicine (IOM; Washington, DC) of the National Academy of Sciences to investigate the quality of care provided to ESRD beneficiaries. While this committee’s report (‘‘Kidney Failure and the Federal Government’’), published in
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1991, concluded that there were insufficient data to assess quality, it expanded the definition of outcomes to include clinical indicators and measures of functional and health status.8 The 1991 IOM report also stimulated two follow-up activities: a 1993 conference on ‘‘Measuring, Managing, and Improving Quality in the End-Stage Renal Disease Treatment Setting,’’ and a 1994 workshop entitled ‘‘Assessing Health and Quality of Life Outcomes in Dialysis.’’ According to Richard Rettig, who directed these efforts, these IOM events progressively narrowed the focus on quality from general principles of quality assurance, to measurements of outcomes (functional and health status, and health-related quality of life) and processes of care, to the use of scientifically validated instruments in clinical settings for patient assessment and management.8 In 1993, the IOM committee concluded that ‘‘the measurement task can be approached effectively, albeit with appropriate caution.’’9 Moreover, in recent years, standards have been established for the measurement of clinical outcomes such as adequacy of dialysis, anemia management, and other measures.10 At the same time, Meyer,11 Kutner,12 and others have demonstrated the validity and value of measuring and monitoring functional status and health status outcomes of ESRD patients. Growing recognition of the importance of outcomes reawakened research and clinical interests in defining and focusing on rehabilitation. REDEFINING REHABILITATION
Efforts to measure and monitor quality marked just one aspect of the response to early events in the ESRD Medicare program. A second response involved redefinition of renal rehabilitation and its goals. Clearly, the original definition of rehabilitation as the return to productive employment was not realistic for an older, sicker ESRD population. There have been many attempts to develop definitions of renal rehabilitation that encompass more than employment. In 1985, Kutner and Brogan13 broadly defined rehabilitation as ‘‘restoring chronically ill patients as closely as possible to the level of activity they held before the onset of the disabling condition.’’ More recently, Harada et al14 have defined rehabilitation as
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‘‘restoring the individual with disease or disability to optimal functioning in his or her own normal societal environment.’’ The proliferation of rehabilitation definitions and goals was recognized by the IOM committee in 1993. They noted that there was no universal agreement on the purpose of the ESRD program among payers, healthcare providers, and patients.15 To address the need for a more systematic approach to renal rehabilitation, a group of patients, providers, government representatives, researchers, and private business individuals joined together, with the sponsorship of Amgen Inc (Thousand Oaks, CA), in 1993. They formed the Life Options Rehabilitation Advisory Council (LORAC; administered by Medical Media Associates, Madison, WI) to explore ways to improve rehabilitation outcomes for ESRD patients and recommend effective changes. In a seminal publication entitled ‘‘Renal Rehabilitation: Bridging the Barriers,’’1 this group not only redefined rehabilitation, they described a rehabilitation process that included psychosocial, physical, and vocational dimensions. Barriers to rehabilitation were described, and a ‘‘national agenda’’ for improving renal rehabilitation was proposed. In the same publication, the LORAC also identified five core principles, now known as ‘‘the 5 E’s,’’ that can lead to improved rehabilitation outcomes. The 5 E’s—Encouragement, Education, Exercise, Employment, Evaluation—formed the basis of a new paradigm of renal rehabilitation as an essential element of treatment for ESRD. The LORAC’s concept of the 5 E’s redefined in a realistic way what rehabilitation can be and how it can be objectively measured and assessed. This approach provides ‘‘a pattern for pursuing health and life enhancement.’’16 Numerous publications from the LORAC, including ‘‘Building Quality of Life: A Practical Guide to Renal Rehabilitation,’’17 outline specific rehabilitation interventions associated with each of the 5 E’s. These suggested interventions can guide providers in establishing rehabilitation programs that include measurable accomplishments suited to each patient’s capabilities. MEASURABLE PROGRESS
The development of the 5 E’s approach to renal rehabilitation in 1993 was based on the
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limited research available at the time and the collective experience of the original LORAC members. While it has proved valuable as a blueprint for rehabilitation programming, new research in the field of rehabilitation has begun to demonstrate the importance of each of the E’s. This research provides a basis for applying these methods in routine clinical ESRD care. There has been measurable progress in documenting the impact of renal rehabilitation on various outcomes, including employment, self-care, physical functioning, and quality of life. Examples are indicated after the description of each ‘‘E’’ below. ● Encouragement: Promote positive attitudes and active participation in care to foster autonomy and better patient outcomes. Encouraging a positive attitude, high expectations, and a proactive approach can enrich the clinical environment, improve relationships with staff, and affect employment outcomes. A study of employed versus unemployed working-age patients showed that patients’ perceptions of their own abilities and the support they received from their families and the dialysis staff were significant correlates of employment status.18 ● Education: Teach patients about kidney disease, its treatment, and self-care procedures. Education, including self-care training for dialysis, is an intervention that can empower patients and improve quality of life. Meers et al reported that patients trained in self-care had significantly better quality of life than untrained patients matched for age and comorbidity.19 ● Exercise: Assess and recommend appropriate exercise activities to break the cycle of deconditioning and the serious consequences of inactivity. Regular physical activity can improve patients’ physical functioning, while deconditioning can have serious physical consequences.17,20 For the majority of ESRD patients, the consequences of not exercising outweigh the risk of exercise.21 Furthermore, ‘‘preliminary studies of exercise training in patients with ESRD have shown improvement in exercise capacity, and it is likely that improved exercise capacity will be accompanied by improved quality of life. . . .’’22
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● Employment: Use a systematic intervention to help patients maintain or resume employment or other productive activities. An early comprehensive assessment by the renal team allows intervention for health and functional status issues, education, and counseling. It also provides the opportunity for evaluation of prior employment, as well as employer contact and reassurance. Early intervention and accommodation, such as providing evening dialysis appointments, can help patients maintain or resume their jobs or other productive activities. Dialysis patients who believe their family and renal team support their decision to work are more likely to be employed.18 Cross-sectional research has associated gainful employment with higher scores on measures of dialysis patients’ physical, role, social, and mental health functioning.18 ● Evaluation: Provide individualized planning and conduct periodic assessment of outcomes on both the patient and program level. On the individual level, Meyer reports that ‘‘formal health status assessment elicits information from patients that they do not offer in the course of their clinical interaction with physicians and nurses.’’11 One of the merits of health status questionnaires is that patients can report on their own health status and response to therapy, resulting in a more comprehensive evaluation. Assessment on the program level is crucial as well, and is now made easier with tools such as the Life Options ‘‘Unit Self-Assessment Tool for Renal Rehabilitation.’’23 The studies noted above, and many others, are beginning to elucidate the impact of rehabilitation interventions on outcomes. To more fully understand the complex relationships between interventions and outcomes, Life Options has developed a working model (Fig 1) that expands on the traditional quality measurement triad of structure, process, and outcomes to recognize both short- and long-term outcomes. This model can serve as a guide for researchers who want to demonstrate links between specific rehabilitation interventions and outcomes. REHABILITATION AND OUTCOMES
The question of outcomes, and how to measure them, has been a central concern in renal
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Fig 1. This working model,17 adapted from a version by Nancy G. Kutner, PhD, has been adopted by Life Options to conceptualize the complex relationships between patient inputs, interventions, and outcomes. The model can serve as a guide for researchers who seek to demonstrate links between rehabilitation interventions and outcomes.
rehabilitation. What outcomes best correlate with successful rehabilitation? For years, clinical end points such as mortality and laboratory values (eg, Kt/V, URR, hematocrit) have received the most attention.11 These are, of course, fundamental to improving outcomes. More recently, however, efforts have focused on obtaining reliable assessment of ESRD patients’ health-related quality of life (HRQOL), which includes functional status, psychological and social functioning, and satisfaction with health.24 Although widely used in general internal medicine, measurement of HRQOL is a new, promising area of study in renal rehabilitation. Like most new areas of research, the use of questionnaires, including patient self-report instruments, to assess HRQOL has generated considerable interest and controversy. In December 1994, the IOM convened a workshop to examine the routine use of HRQOL measures in the clinical setting as a means of evaluating and monitoring the care of dialysis patients.25 This IOM committee recognized that a number of instruments in use at the time were valid, but did not select one as clearly best. The committee did reinforce the
rationale for use of these instruments in the ESRD clinical setting, however, by concluding that ‘‘functional status, health status, and healthrelated quality of life outcomes are those of greatest importance to the patient.’’25 In a comprehensive overview published in 1995, Meyer examined the arguments for and against the measurement of patient experience.11 He concluded that use of a questionnaire to formally assess a patient’s health status may elicit information previously unreported, and enhance the review of systems. However, he did acknowledge that ‘‘practical challenges’’ with the use of such instruments remained. Overcoming those practical challenges was the goal of the ESRD Health Status Outcomes (HSO) Group. Formed in late 1995 to follow up on work done by the IOM committee, the HSO group met quarterly (through July 1997) to educate the renal community about health status outcomes and encourage their use for monitoring patient condition and treatment response.26 Just 2 years later, the group reported that the body of literature specific to dialysis health status outcomes was growing.27 They continue to encourage use
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of HRQOL instruments to aid clinicians in assessing outcomes and communicating with patients. Today, a number of practical, validated patient self-report instruments are used to assess functional status and HRQOL.25 Generic instruments, which allow comparison with other disease populations, include the Medical Outcomes Study 36-Item Short Form (MOS SF-36; available from QualityMetric, Inc), the DUKE Health Profile (Duke University Medical Center), and the Dartmouth COOP Charts (Dartmouth Primary Care Cooperative Practice Network). Disease-specific instruments, which permit data gathering about ESRD topics, include the Kidney Disease Quality of Life (KDQOL), developed by a Working Group (Amin, Carter, Coons, Hays, Kamberg, Kallich, and Mapes) with the support of the RAND Corporation,28 and a revised version of the Dartmouth COOP Charts (currently in testing). More recently, the Choices for Health Outcomes in Caring for ESRD (CHOICE) study, sponsored by the Agency for Health Care Policy and Research (Washington, DC), developed an instrument called the CHOICE Health Experience Questionnaire (CHEQ).25 The average time for completion of these instruments varies, ranging from 5 to 30 minutes.25 Several investigators have demonstrated correlation of health status scores with clinical outcomes. For example, Hays et al29 correlated KDQOL scores with number of days in the hospital. DeOreo linked scores from the MOSSF-36 with mortality and morbidity (measured as hospitalization).30 Curtin et al point out that renal patients’ self-reports of functioning correlate with the results of a number of commonly performed laboratory tests. They emphasize that there is ‘‘convincing evidence that self-report of physical functioning is a potentially powerful predictor of dialysis patients’ mortality and morbidity.’’31
strated relationship between improved health status outcomes and cost control. Researchers have begun the process of establishing these links. A brief review of the literature by Kutner et al suggests that ‘‘ESRD patients’ physical functioning, as well as their mental/emotional well-being, can be significantly improved as a result of rehabilitation efforts.’’32 They further suggest that improved mental and physical functioning are likely to produce cost savings in the form of ‘‘lowered patient morbidity and mortality, lower need for patients’ institutionalization and custodial care, and higher rates of patients’ gainful employment/ productive activity.’’32 Similar inferences can be made from the research (cited above) that links improved HRQOL scores with reduced hospitalization, morbidity, and mortality. In many ways, the evolutionary process of understanding renal rehabilitation is as yet rudimentary. The reality that an older, sicker group of patients is not going to return in droves to the workplace is universally understood. While many other ESRD patients have the potential for rehabilitation, the concept that functional status is an important predictor of long-term outcomes such as morbidity and mortality31 is still a well-kept secret. At the onset of dialysis, the patient is at a crossroads. Research in the last 10 years has shown that the environment in which a patient begins his course in dialysis will be a crucial determinant for success in the future. Groups like the IOM, the HSO Group, the LORAC, and individual researchers have made important forays into the frontier of establishing relationships between specific interventions and improved outcomes. In the century to come, we can hope that economic imperatives will align with good clinical practice to help clinicians design the optimal setting for the delivery of dialysis. REFERENCES
THE CHALLENGE AHEAD
The value of renal rehabilitation lies in its ability to affect outcomes. The value of improved outcomes to patients is obvious; by their own assessment, their lives are better. However, for healthcare providers and policy makers, value is inextricably linked with cost. To have value in these arenas, therefore, there must be a demon-
1. The Life Options Rehabilitation Advisory Council: Renal Rehabilitation: Bridging the Barriers. Madison, WI, Medical Education Institute, 1994 2. Rettig RA: The policy debate on patient care financing for victims of end-stage renal disease. Law Contemp Probl 40:239-273, 1976 3. Rettig RA: Origins of the Medicare Kidney Disease Entitlement: The Social Security Amendments of 1972. Washington, DC, Institute of Medicine, National Academy of Sciences, 1990
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4. Rettig RA, Levinsky NG, eds: Kidney Failure and the Federal Government. Washington, DC, Institute of Medicine, National Academy Press, 1991 5. US Renal Data System: USRDS Annual Data Report. Bethesda, MD, The National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, 1998 6. Gutman RA, Stead WW, Robinson RR: Physical activity and employment status of patients on maintenance dialysis. N Engl J Med 304:309-313, 1981 7. Rennie D: Renal rehabilitation—Where are the data? N Engl J Med 304:351-352, 1981 8. Rettig RA: Measuring functional and health status and health-related quality of life in end-stage renal disease patients: The Institute of Medicine’s efforts in perspective. Semin Dial 8:198-200, 1995 9. Schrier RW, Burrows-Hudson S, Diamond L, Lundin AP, Michael M, Patrick DL, Peters TG, Powe NR, Roberts JS, Sadler JH, Siu AL, Lohr KN, Rettig RA: Measuring, managing, and improving quality in the end-stage renal disease treatment setting: Committee statement. Am J Kidney Dis 24:383-388, 1994 10. National Kidney Foundation DOQI Dialysis Outcomes Quality Initiative: Executive Summaries of the NKFDOQI Clinical Practice Guidelines. New York, NY, National Kidney Foundation, 1997 11. Meyer K: The outcomes of ESRD and its treatment. Adv Ren Replace Ther 2:101-111, 1995 12. Kutner NG: Assessing end-stage renal disease patients’ functioning and well-being: Measurement approaches and implications for clinical practice. Am J Kidney Dis 24:321-333, 1994 13. Kutner NG, Brogan DJ: Disability labeling versus rehabilitation rhetoric for the chronically ill: A case study in policy contradictions. J Appl Behav Sci 21:169-183, 1985 14. Harada N, Sofaer S, Kominski G: Functional status outcomes in rehabilitation: Implications for prospective payment. Med Care 31:345-357, 1993 15. Rettig RA, Lohr KN: Measuring, managing, and improving quality in the end-stage renal disease treatment setting: Conference overview. Am J Kidney Dis 24:228-234, 1994 16. Sadler J: Health promotion for end-stage renal disease patients. Adv Ren Replace Ther 5:275-285, 1998 17. The Life Options Rehabilitation Advisory Council: Building Quality of Life: A Practical Guide to Renal Rehabilitation. Madison, WI, Medical Education Institute, 1997
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18. Curtin RB, Oberley ET, Sacksteder P, Friedman A: Differences between employed and nonemployed dialysis patients. Am J Kidney Dis 27:533-540, 1996 19. Meers C, Singer MA, Toffelmire EB, Hopman W, McMurray M, Morton AR, MacKenzie TA: Self-delivery of hemodialysis care: A therapy in itself. Am J Kidney Dis 27:844-847, 1996 20. Painter P: The importance of exercise training in rehabilitation of patients with end-stage renal disease. Am J Kidney Dis 24:S2-S9, 1994 (suppl 1) 21. Copley JB, Lindberg JS: The risks of exercise. Adv Ren Replace Ther 6:165-171, 1999 22. Painter P, Johansen K: Introduction: A call to activity. Adv Ren Replace Ther 6:107-109, 1999 23. The Life Options Rehabilitation Advisory Council, Unit Self-Assessment Manual for Renal Rehabilitation. Madison, WI, Medical Media Associates, 1998 24. Patrick DL: Assessing health-related quality of life outcomes, in Heithoff KA, Lohr KN (eds): Effectiveness and Outcomes in Health Care. Washington, DC, National Academy Press, 1990, pp 137-151 25. Rettig RA, Sadler JH, Meyer KB, Wasson JH, Parkerson GR, Kantz B, Hays RD, Patrick DL: Assessing health and quality of life outcomes in dialysis: A report on an Institute of Medicine Workshop. Am J Kidney Dis 30:140155, 1997 26. Sadler JH: Measuring quality: IOM work continues. Nephrol News Issues 9:38, 1995 27. Sadler JH, Rettig RA: A review of worldwide use of patient questionnaires in dialysis. Nephrol News Issues 11:25, 27, 1997 28. Sadler JH: Health promotion for end-stage renal disease patients. Adv Ren Replace Ther 5:275-285, 1998 29. Hays RD, Kallich JD, Mapes DL, Coons SJ, Carter WB: Development of the Kidney Disease Quality of Life (KDQOL) Instrument. Qual Life Res 3:329-338, 1994 30. DeOreo PB: Hemodialysis patient-assessed functional health status predicts continued survival, hospitalization, and dialysis-attendance compliance. Am J Kidney Dis 30:204-207, 1997 31. Curtin RB, Lowrie EG, DeOreo PB: Self-reported functional status: An important predictor of health outcomes among end-stage renal disease patients. Adv Ren Replace Ther 6:133-140, 1999 32. Kutner NG, Curtin RB, Oberley ET, Sacksteder P: Fulfilling the promise: Linking rehabilitation interventions with ESRD patient outcomes. Dial Transplant 26:282-292, 1997
I
N THE 40 YEARS since Dr. Belding Scribner developed a permanent method of vascular access, making maintenance hemodialysis an option for the treatment of end-stage renal disease (ESRD), both clinicians and policy makers have increasingly focused on renal rehabilitation. Professional opinions about the feasibility and potential for renal rehabilitation have run the gamut from optimism to resignation, and even despair. Over time, the definition of renal rehabilitation evolved from one with a primary emphasis on return to employment, to a more comprehensive definition of restoration to productive activities and an independent lifestyle for people on dialysis.1 The clarification of a realistic definition of renal rehabilitation has provided focus for interventions and outcomes assessment. Efforts to measure and improve quality of care are allowing quantitation and comparison of clinical outcomes. Research demonstrates that some rehabilitation outcomes can also be measured and improved. The future holds great promise for even better understanding of how to design, deliver, and monitor successful renal rehabilitation programs. LEGISLATION FUELED BY OPTIMISM
The ability to return to productive activity was one of the primary criteria used by early selec-
tion committees to choose candidates who would gain access to a critically scarce resource— dialysis. In June 1972, there were only 5,786 dialysis patients in the United States.2 Among these patients, return to productivity, such as employment, school, or other functional roles, was common. Such excellent results were directly related to the fact that committees charged with selecting patients used age, income, educational background, occupation, and future potential as selection criteria.2 To expand access to treatment, on October 30, 1972, President Nixon signed Public Law 92603, with Section 2991 extending Medicare benefits to all ESRD patients. Support for this landmark legislative decision was based on optimistic expectations for the recipients of treatment. Senator Hartke, for example, argued that the cost of medical care would be offset by the fact that ‘‘60% of those on dialysis can return to work
From the Life Options Rehabilitation Program, Medical Media Associates, Madison, WI. Supported by Amgen Inc, Thousand Oaks, CA. Address reprint requests to Edith T. Oberley, MA, Life Options Rehabilitation Program, c/o Medical Media Associates, Inc, University Research Park, 603 Science Dr, Madison, WI 53711-1074. E-mail: [email protected]
娀 2000 by the National Kidney Foundation, Inc. 0272-6386/00/3504-0108$3.00/0
American Journal of Kidney Diseases, Vol 35, No 4, Suppl 1 (April), 2000: pp S141-S147
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[with] retraining, and most of the remaining 40% require no training whatsoever.’’3 He emphasized the potential for these people to be active and productive, if they received access to lifesaving dialysis treatment. Looking back, the expectation of 100% employment for dialysis patients seems, at best, naive. However, it must be remembered that this assumption was based on the experience of a small, select group of patients. UNFULFILLED EXPECTATIONS
Near-universal entitlement to dialysis changed the rehabilitation picture dramatically. The ESRD patient population grew in size and changed in demographics. This new population of dialysis recipients differed from the original population with regard to characteristics such as age, sex, race, and primary diagnosis. For example, patients 65 years and older represented 5% of the total Medicare ESRD population in 1973. By 1988, they represented 27% of patients, and accounted for 38% of all new patients in that year. Similarly, ‘‘the proportion of ESRD patients with a primary diagnosis of diabetes mellitus increased from about 13% in 1980 to 24% in 1988; this diagnosis accounted for 31% of all new patients in 1988.’’4 There was no question that the population of 10,000 ESRD beneficiaries when the entitlement began in 1973 was quite different from the nearly 150,000 beneficiaries in 1988. These same trends, toward older patients with significant comorbidities, continued into the 1990s. In 1996, patients aged 65 and older made up 33.5% of the ESRD population, and 46% of new dialysis patients that year were elderly. In the same year (1996), 32.5% of all dialysis patients had a diagnosis of diabetes mellitus, while 42.3% of new dialysis patients had the disease.5 This broader population of dialysis patients was then not generally able to return to work. Many were past retirement age, and others had previously accepted disability coverage. Advocates of rehabilitation fell silent. It was clear that most ESRD patients would not return to paid employment and become active taxpayers. There would not be a direct financial return for federal coverage for the cost of dialysis and transplantation. If paid employment was the definition of rehabilitation, the renal community of clinicians
and patients could not produce that result for a large percentage of this new, broad population of ESRD patients. A 1981 report by Gutman et al on 2,481 patients from 18 dialysis centers concluded that, based on the Karnofsky Activity Scale, 40% of nondiabetic dialysis patients and 77% of diabetic dialysis patients were incapable of engaging in any level of physical activity more strenuous than caring for themselves.6 The capacity for activity in 20% of the nondiabetics and 51% of the diabetics was so low that they could not even take care of themselves.6 Clinicians and policy makers were dismayed. Privately and publicly,7 the potential of renal rehabilitation was seriously questioned. ‘‘It [renal replacement therapy] represents effective lifesaving treatment for many patients which is transmuted into merely life-prolonging treatment for others with serious complications and low quality of life,’’ charged critics.3 The combined effect of discouraging reports, higher-than-expected costs, and lack of data about ESRD cast a pall over rehabilitation efforts. The period between 1976 and 1986 was, indeed, a ‘‘Dark Age’’ in terms of understanding rehabilitation potential. MEASURING QUALITY OF CARE
In the belief that better quality of care would improve outcomes, government policy makers and the nephrology community responded to disappointing reports about the ESRD Medicare program by making a concerted effort to gather data that would enable the measurement, and improvement, of quality of care. In 1983, the Health Care Financing Administration (HCFA; Baltimore, MD) established a data system for collecting and maintaining statistics on ESRD patients in response to chronic complaints that unclear, incomplete data prevented analysis and accountability. While helpful for analysis, this system placed a spotlight on the ESRD program operations and outcomes, leading to focused criticism not possible with other Medicare programs. In 1987, Congress asked the Institute of Medicine (IOM; Washington, DC) of the National Academy of Sciences to investigate the quality of care provided to ESRD beneficiaries. While this committee’s report (‘‘Kidney Failure and the Federal Government’’), published in
RENAL REHABILITATION
1991, concluded that there were insufficient data to assess quality, it expanded the definition of outcomes to include clinical indicators and measures of functional and health status.8 The 1991 IOM report also stimulated two follow-up activities: a 1993 conference on ‘‘Measuring, Managing, and Improving Quality in the End-Stage Renal Disease Treatment Setting,’’ and a 1994 workshop entitled ‘‘Assessing Health and Quality of Life Outcomes in Dialysis.’’ According to Richard Rettig, who directed these efforts, these IOM events progressively narrowed the focus on quality from general principles of quality assurance, to measurements of outcomes (functional and health status, and health-related quality of life) and processes of care, to the use of scientifically validated instruments in clinical settings for patient assessment and management.8 In 1993, the IOM committee concluded that ‘‘the measurement task can be approached effectively, albeit with appropriate caution.’’9 Moreover, in recent years, standards have been established for the measurement of clinical outcomes such as adequacy of dialysis, anemia management, and other measures.10 At the same time, Meyer,11 Kutner,12 and others have demonstrated the validity and value of measuring and monitoring functional status and health status outcomes of ESRD patients. Growing recognition of the importance of outcomes reawakened research and clinical interests in defining and focusing on rehabilitation. REDEFINING REHABILITATION
Efforts to measure and monitor quality marked just one aspect of the response to early events in the ESRD Medicare program. A second response involved redefinition of renal rehabilitation and its goals. Clearly, the original definition of rehabilitation as the return to productive employment was not realistic for an older, sicker ESRD population. There have been many attempts to develop definitions of renal rehabilitation that encompass more than employment. In 1985, Kutner and Brogan13 broadly defined rehabilitation as ‘‘restoring chronically ill patients as closely as possible to the level of activity they held before the onset of the disabling condition.’’ More recently, Harada et al14 have defined rehabilitation as
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‘‘restoring the individual with disease or disability to optimal functioning in his or her own normal societal environment.’’ The proliferation of rehabilitation definitions and goals was recognized by the IOM committee in 1993. They noted that there was no universal agreement on the purpose of the ESRD program among payers, healthcare providers, and patients.15 To address the need for a more systematic approach to renal rehabilitation, a group of patients, providers, government representatives, researchers, and private business individuals joined together, with the sponsorship of Amgen Inc (Thousand Oaks, CA), in 1993. They formed the Life Options Rehabilitation Advisory Council (LORAC; administered by Medical Media Associates, Madison, WI) to explore ways to improve rehabilitation outcomes for ESRD patients and recommend effective changes. In a seminal publication entitled ‘‘Renal Rehabilitation: Bridging the Barriers,’’1 this group not only redefined rehabilitation, they described a rehabilitation process that included psychosocial, physical, and vocational dimensions. Barriers to rehabilitation were described, and a ‘‘national agenda’’ for improving renal rehabilitation was proposed. In the same publication, the LORAC also identified five core principles, now known as ‘‘the 5 E’s,’’ that can lead to improved rehabilitation outcomes. The 5 E’s—Encouragement, Education, Exercise, Employment, Evaluation—formed the basis of a new paradigm of renal rehabilitation as an essential element of treatment for ESRD. The LORAC’s concept of the 5 E’s redefined in a realistic way what rehabilitation can be and how it can be objectively measured and assessed. This approach provides ‘‘a pattern for pursuing health and life enhancement.’’16 Numerous publications from the LORAC, including ‘‘Building Quality of Life: A Practical Guide to Renal Rehabilitation,’’17 outline specific rehabilitation interventions associated with each of the 5 E’s. These suggested interventions can guide providers in establishing rehabilitation programs that include measurable accomplishments suited to each patient’s capabilities. MEASURABLE PROGRESS
The development of the 5 E’s approach to renal rehabilitation in 1993 was based on the
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limited research available at the time and the collective experience of the original LORAC members. While it has proved valuable as a blueprint for rehabilitation programming, new research in the field of rehabilitation has begun to demonstrate the importance of each of the E’s. This research provides a basis for applying these methods in routine clinical ESRD care. There has been measurable progress in documenting the impact of renal rehabilitation on various outcomes, including employment, self-care, physical functioning, and quality of life. Examples are indicated after the description of each ‘‘E’’ below. ● Encouragement: Promote positive attitudes and active participation in care to foster autonomy and better patient outcomes. Encouraging a positive attitude, high expectations, and a proactive approach can enrich the clinical environment, improve relationships with staff, and affect employment outcomes. A study of employed versus unemployed working-age patients showed that patients’ perceptions of their own abilities and the support they received from their families and the dialysis staff were significant correlates of employment status.18 ● Education: Teach patients about kidney disease, its treatment, and self-care procedures. Education, including self-care training for dialysis, is an intervention that can empower patients and improve quality of life. Meers et al reported that patients trained in self-care had significantly better quality of life than untrained patients matched for age and comorbidity.19 ● Exercise: Assess and recommend appropriate exercise activities to break the cycle of deconditioning and the serious consequences of inactivity. Regular physical activity can improve patients’ physical functioning, while deconditioning can have serious physical consequences.17,20 For the majority of ESRD patients, the consequences of not exercising outweigh the risk of exercise.21 Furthermore, ‘‘preliminary studies of exercise training in patients with ESRD have shown improvement in exercise capacity, and it is likely that improved exercise capacity will be accompanied by improved quality of life. . . .’’22
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● Employment: Use a systematic intervention to help patients maintain or resume employment or other productive activities. An early comprehensive assessment by the renal team allows intervention for health and functional status issues, education, and counseling. It also provides the opportunity for evaluation of prior employment, as well as employer contact and reassurance. Early intervention and accommodation, such as providing evening dialysis appointments, can help patients maintain or resume their jobs or other productive activities. Dialysis patients who believe their family and renal team support their decision to work are more likely to be employed.18 Cross-sectional research has associated gainful employment with higher scores on measures of dialysis patients’ physical, role, social, and mental health functioning.18 ● Evaluation: Provide individualized planning and conduct periodic assessment of outcomes on both the patient and program level. On the individual level, Meyer reports that ‘‘formal health status assessment elicits information from patients that they do not offer in the course of their clinical interaction with physicians and nurses.’’11 One of the merits of health status questionnaires is that patients can report on their own health status and response to therapy, resulting in a more comprehensive evaluation. Assessment on the program level is crucial as well, and is now made easier with tools such as the Life Options ‘‘Unit Self-Assessment Tool for Renal Rehabilitation.’’23 The studies noted above, and many others, are beginning to elucidate the impact of rehabilitation interventions on outcomes. To more fully understand the complex relationships between interventions and outcomes, Life Options has developed a working model (Fig 1) that expands on the traditional quality measurement triad of structure, process, and outcomes to recognize both short- and long-term outcomes. This model can serve as a guide for researchers who want to demonstrate links between specific rehabilitation interventions and outcomes. REHABILITATION AND OUTCOMES
The question of outcomes, and how to measure them, has been a central concern in renal
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Fig 1. This working model,17 adapted from a version by Nancy G. Kutner, PhD, has been adopted by Life Options to conceptualize the complex relationships between patient inputs, interventions, and outcomes. The model can serve as a guide for researchers who seek to demonstrate links between rehabilitation interventions and outcomes.
rehabilitation. What outcomes best correlate with successful rehabilitation? For years, clinical end points such as mortality and laboratory values (eg, Kt/V, URR, hematocrit) have received the most attention.11 These are, of course, fundamental to improving outcomes. More recently, however, efforts have focused on obtaining reliable assessment of ESRD patients’ health-related quality of life (HRQOL), which includes functional status, psychological and social functioning, and satisfaction with health.24 Although widely used in general internal medicine, measurement of HRQOL is a new, promising area of study in renal rehabilitation. Like most new areas of research, the use of questionnaires, including patient self-report instruments, to assess HRQOL has generated considerable interest and controversy. In December 1994, the IOM convened a workshop to examine the routine use of HRQOL measures in the clinical setting as a means of evaluating and monitoring the care of dialysis patients.25 This IOM committee recognized that a number of instruments in use at the time were valid, but did not select one as clearly best. The committee did reinforce the
rationale for use of these instruments in the ESRD clinical setting, however, by concluding that ‘‘functional status, health status, and healthrelated quality of life outcomes are those of greatest importance to the patient.’’25 In a comprehensive overview published in 1995, Meyer examined the arguments for and against the measurement of patient experience.11 He concluded that use of a questionnaire to formally assess a patient’s health status may elicit information previously unreported, and enhance the review of systems. However, he did acknowledge that ‘‘practical challenges’’ with the use of such instruments remained. Overcoming those practical challenges was the goal of the ESRD Health Status Outcomes (HSO) Group. Formed in late 1995 to follow up on work done by the IOM committee, the HSO group met quarterly (through July 1997) to educate the renal community about health status outcomes and encourage their use for monitoring patient condition and treatment response.26 Just 2 years later, the group reported that the body of literature specific to dialysis health status outcomes was growing.27 They continue to encourage use
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of HRQOL instruments to aid clinicians in assessing outcomes and communicating with patients. Today, a number of practical, validated patient self-report instruments are used to assess functional status and HRQOL.25 Generic instruments, which allow comparison with other disease populations, include the Medical Outcomes Study 36-Item Short Form (MOS SF-36; available from QualityMetric, Inc), the DUKE Health Profile (Duke University Medical Center), and the Dartmouth COOP Charts (Dartmouth Primary Care Cooperative Practice Network). Disease-specific instruments, which permit data gathering about ESRD topics, include the Kidney Disease Quality of Life (KDQOL), developed by a Working Group (Amin, Carter, Coons, Hays, Kamberg, Kallich, and Mapes) with the support of the RAND Corporation,28 and a revised version of the Dartmouth COOP Charts (currently in testing). More recently, the Choices for Health Outcomes in Caring for ESRD (CHOICE) study, sponsored by the Agency for Health Care Policy and Research (Washington, DC), developed an instrument called the CHOICE Health Experience Questionnaire (CHEQ).25 The average time for completion of these instruments varies, ranging from 5 to 30 minutes.25 Several investigators have demonstrated correlation of health status scores with clinical outcomes. For example, Hays et al29 correlated KDQOL scores with number of days in the hospital. DeOreo linked scores from the MOSSF-36 with mortality and morbidity (measured as hospitalization).30 Curtin et al point out that renal patients’ self-reports of functioning correlate with the results of a number of commonly performed laboratory tests. They emphasize that there is ‘‘convincing evidence that self-report of physical functioning is a potentially powerful predictor of dialysis patients’ mortality and morbidity.’’31
strated relationship between improved health status outcomes and cost control. Researchers have begun the process of establishing these links. A brief review of the literature by Kutner et al suggests that ‘‘ESRD patients’ physical functioning, as well as their mental/emotional well-being, can be significantly improved as a result of rehabilitation efforts.’’32 They further suggest that improved mental and physical functioning are likely to produce cost savings in the form of ‘‘lowered patient morbidity and mortality, lower need for patients’ institutionalization and custodial care, and higher rates of patients’ gainful employment/ productive activity.’’32 Similar inferences can be made from the research (cited above) that links improved HRQOL scores with reduced hospitalization, morbidity, and mortality. In many ways, the evolutionary process of understanding renal rehabilitation is as yet rudimentary. The reality that an older, sicker group of patients is not going to return in droves to the workplace is universally understood. While many other ESRD patients have the potential for rehabilitation, the concept that functional status is an important predictor of long-term outcomes such as morbidity and mortality31 is still a well-kept secret. At the onset of dialysis, the patient is at a crossroads. Research in the last 10 years has shown that the environment in which a patient begins his course in dialysis will be a crucial determinant for success in the future. Groups like the IOM, the HSO Group, the LORAC, and individual researchers have made important forays into the frontier of establishing relationships between specific interventions and improved outcomes. In the century to come, we can hope that economic imperatives will align with good clinical practice to help clinicians design the optimal setting for the delivery of dialysis. REFERENCES
THE CHALLENGE AHEAD
The value of renal rehabilitation lies in its ability to affect outcomes. The value of improved outcomes to patients is obvious; by their own assessment, their lives are better. However, for healthcare providers and policy makers, value is inextricably linked with cost. To have value in these arenas, therefore, there must be a demon-
1. The Life Options Rehabilitation Advisory Council: Renal Rehabilitation: Bridging the Barriers. Madison, WI, Medical Education Institute, 1994 2. Rettig RA: The policy debate on patient care financing for victims of end-stage renal disease. Law Contemp Probl 40:239-273, 1976 3. Rettig RA: Origins of the Medicare Kidney Disease Entitlement: The Social Security Amendments of 1972. Washington, DC, Institute of Medicine, National Academy of Sciences, 1990
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4. Rettig RA, Levinsky NG, eds: Kidney Failure and the Federal Government. Washington, DC, Institute of Medicine, National Academy Press, 1991 5. US Renal Data System: USRDS Annual Data Report. Bethesda, MD, The National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, 1998 6. Gutman RA, Stead WW, Robinson RR: Physical activity and employment status of patients on maintenance dialysis. N Engl J Med 304:309-313, 1981 7. Rennie D: Renal rehabilitation—Where are the data? N Engl J Med 304:351-352, 1981 8. Rettig RA: Measuring functional and health status and health-related quality of life in end-stage renal disease patients: The Institute of Medicine’s efforts in perspective. Semin Dial 8:198-200, 1995 9. Schrier RW, Burrows-Hudson S, Diamond L, Lundin AP, Michael M, Patrick DL, Peters TG, Powe NR, Roberts JS, Sadler JH, Siu AL, Lohr KN, Rettig RA: Measuring, managing, and improving quality in the end-stage renal disease treatment setting: Committee statement. Am J Kidney Dis 24:383-388, 1994 10. National Kidney Foundation DOQI Dialysis Outcomes Quality Initiative: Executive Summaries of the NKFDOQI Clinical Practice Guidelines. New York, NY, National Kidney Foundation, 1997 11. Meyer K: The outcomes of ESRD and its treatment. Adv Ren Replace Ther 2:101-111, 1995 12. Kutner NG: Assessing end-stage renal disease patients’ functioning and well-being: Measurement approaches and implications for clinical practice. Am J Kidney Dis 24:321-333, 1994 13. Kutner NG, Brogan DJ: Disability labeling versus rehabilitation rhetoric for the chronically ill: A case study in policy contradictions. J Appl Behav Sci 21:169-183, 1985 14. Harada N, Sofaer S, Kominski G: Functional status outcomes in rehabilitation: Implications for prospective payment. Med Care 31:345-357, 1993 15. Rettig RA, Lohr KN: Measuring, managing, and improving quality in the end-stage renal disease treatment setting: Conference overview. Am J Kidney Dis 24:228-234, 1994 16. Sadler J: Health promotion for end-stage renal disease patients. Adv Ren Replace Ther 5:275-285, 1998 17. The Life Options Rehabilitation Advisory Council: Building Quality of Life: A Practical Guide to Renal Rehabilitation. Madison, WI, Medical Education Institute, 1997
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18. Curtin RB, Oberley ET, Sacksteder P, Friedman A: Differences between employed and nonemployed dialysis patients. Am J Kidney Dis 27:533-540, 1996 19. Meers C, Singer MA, Toffelmire EB, Hopman W, McMurray M, Morton AR, MacKenzie TA: Self-delivery of hemodialysis care: A therapy in itself. Am J Kidney Dis 27:844-847, 1996 20. Painter P: The importance of exercise training in rehabilitation of patients with end-stage renal disease. Am J Kidney Dis 24:S2-S9, 1994 (suppl 1) 21. Copley JB, Lindberg JS: The risks of exercise. Adv Ren Replace Ther 6:165-171, 1999 22. Painter P, Johansen K: Introduction: A call to activity. Adv Ren Replace Ther 6:107-109, 1999 23. The Life Options Rehabilitation Advisory Council, Unit Self-Assessment Manual for Renal Rehabilitation. Madison, WI, Medical Media Associates, 1998 24. Patrick DL: Assessing health-related quality of life outcomes, in Heithoff KA, Lohr KN (eds): Effectiveness and Outcomes in Health Care. Washington, DC, National Academy Press, 1990, pp 137-151 25. Rettig RA, Sadler JH, Meyer KB, Wasson JH, Parkerson GR, Kantz B, Hays RD, Patrick DL: Assessing health and quality of life outcomes in dialysis: A report on an Institute of Medicine Workshop. Am J Kidney Dis 30:140155, 1997 26. Sadler JH: Measuring quality: IOM work continues. Nephrol News Issues 9:38, 1995 27. Sadler JH, Rettig RA: A review of worldwide use of patient questionnaires in dialysis. Nephrol News Issues 11:25, 27, 1997 28. Sadler JH: Health promotion for end-stage renal disease patients. Adv Ren Replace Ther 5:275-285, 1998 29. Hays RD, Kallich JD, Mapes DL, Coons SJ, Carter WB: Development of the Kidney Disease Quality of Life (KDQOL) Instrument. Qual Life Res 3:329-338, 1994 30. DeOreo PB: Hemodialysis patient-assessed functional health status predicts continued survival, hospitalization, and dialysis-attendance compliance. Am J Kidney Dis 30:204-207, 1997 31. Curtin RB, Lowrie EG, DeOreo PB: Self-reported functional status: An important predictor of health outcomes among end-stage renal disease patients. Adv Ren Replace Ther 6:133-140, 1999 32. Kutner NG, Curtin RB, Oberley ET, Sacksteder P: Fulfilling the promise: Linking rehabilitation interventions with ESRD patient outcomes. Dial Transplant 26:282-292, 1997