Foreword

Abstract

From its rudimentary beginnings in the 1960s, renal replacement therapy has become a lifesaving treatment that can provide end-stage renal disease (ESRD) patients with a good quality of life. As a result, the number of ESRD patients who receive renal replacement therapy has risen, and their survival has increased, but considerable geographic variability exists in practice patterns and patient outcomes. It was this realization, and the belief that substantial improvements in the quality and outcomes of renal replacement therapy were achievable with current technology, that prompted several organizations to seek to reduce variations in ESRD treatment with the goal of a more uniform delivery of the highest possible quality of care to dialysis patients. Notable among these efforts were the report on “Measuring, Managing and Improving Quality in the ESRD Treatment Setting” issued by the Institute of Medicine in September 1993; the “Morbidity and Mortality of Dialysis” report issued by the National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK) in November 1993; the Core Indicator Project initiated by the ESRD Networks and the Health Care Financing Administration (HCFA) in 1993; the “Clinical Practice Guidelines on the Adequacy of Hemodialysis” issued by the Renal Physicians Association in December 1993; and the Dialysis Outcomes Quality Initiative (DOQI) initiated by the National Kidney Foundation (NKF) in 1995.In keeping with its longstanding commitment to the quality of care delivered to all patients with kidney and urologic diseases, the NKF convened a Consensus Conference on Controversies in the Quality of Dialysis Care in March 1994. Following a series of nationwide town hall meetings held to obtain input into the recommendations made at the Consensus Conference, the NKF issued an “Evolving Plan for the Continued Improvement of the Quality of Dialysis Care” in November 1994. A central tenet of the plan was recognition of an essential need for rigorously developed clinical practice guidelines for the care of ESRD patients that would be viewed as an accurate and authoritative reflection of current scientific evidence. It was to this end that the NKF launched the “Dialysis Outcomes Quality Initiative” (DOQI) in March 1995, supported by an unrestricted grant from Amgen, Inc.The objectives of DOQI were ambitious: to improve patient survival, reduce patient morbidity, improve the quality of life of dialysis patients, and increase efficiency of care. To achieve these objectives, it was decided to adhere to several guiding principles that were considered to be critical to that initiative's success. The first of these principles was that the process used to develop the DOQI guidelines should be scientifically rigorous and based on a critical appraisal of all available evidence. Such an approach was felt to be essential to the credibility of the guidelines. Second, it was decided that participants involved in the development of the DOQI guidelines should be multidisciplinary. A multidisciplinary guideline development process was considered to be crucial, not only to the clinical and scientific validity of the guidelines, but also to the need for multidisciplinary adoption of the guidelines following their dissemination, in order for them to have maximum effectiveness. Third, a decision was made to give the DOQI guideline development Work Groups final authority over the content of the guidelines, subject to the requirement that guidelines be evidence-based whenever possible. By vesting decision-making authority in a group of individuals, from multiple disciplines and with diverse viewpoints, all of whom are experts with highly regarded professional reputations, the likelihood of developing sound guidelines was increased. Moreover, by insisting that the rationale and evidentiary basis of each DOQI guideline be made explicit, Work Group participants were forced to be clear and rigorous in formulating their recommendations. The final principle was that the guideline development process would be open to general review. Thus, the chain of reasoning underlying each guideline was subject to peer review and available for debate.Based on the “NKF Evolving Plan for the Continued Improvement of the Quality of Dialysis Care” and criteria recommended by the Agency for Health Care Research and Quality (AHCRQ; formerly known as the Agency for Health Care Policy and Research [AHCPR]), four areas were selected for the initial set of clinical practice guidelines: hemodialysis adequacy, peritoneal dialysis adequacy, vascular access, and anemia. Each Work Group selected which topics were considered for guideline creation. During the DOQI guideline development process, nearly 11,000 potentially relevant published articles were subjected to evaluation, and both the content and methods of approximately 1,500 articles underwent formal, structured review. Although labor-intensive and costly, the process resulted in an intensive, disciplined, and credible analysis of all available peer-reviewed information. When no evidence existed, or the evidence was inadequate, guidelines were based on the considered opinion of the Work Group experts. In all cases the rationale and the evidentiary basis of each recommendation was stated explicitly.Draft guidelines were then subjected to a three-stage review process. In the first stage, an Advisory Council, consisting of 25 experts and leaders in the field, provided comments on the initial draft of the guidelines. In the second stage, a variety of organizations (ESRD Networks, professional and patient associations, dialysis providers, government agencies, product manufacturers, and managed care groups) were invited to review and comment on a revised draft of the guidelines. After considering these comments and suggestions, the Work Groups produced a third draft of the Guidelines. In the final stage, this draft was made available for public review and comment by all interested individuals or parties. Following consideration of the comments submitted during this open review period, the guidelines were revised again and then published as supplements to the September and October 1997 issues of the American Journal of Kidney Diseases was made available on the Internet and widely distributed.The four sets of DOQI guidelines published in 1997 addressed only part of the “Evolving Plan for the Continued Improvement of the Quality of Dialysis Care” adopted by the NKF in 1994. In that plan, as well as in the early DOQI prioritization process, nutrition was considered to be an important determinant of ESRD patient outcome. Consequently, a Nutrition Work Group was convened in 1997 to review the key clinical nutrition literature and to define topics for which guidelines related to the nutritional management of patients should be developed. Supported primarily by a grant from Sigma Tau Pharmaceuticals, Inc, the Nutrition Work Group began to work intensively on those topics in January 1998, and the Nutrition Guidelines that they have developed constitute this fifth set of the original DOQI guidelines.NKF-DOQI achieved many, but not all of its goals. The guidelines have been well received and are considered by many to reflect the “state of the art” of medical practice in their fields. The frequency with which the DOQI guidelines have been cited in the literature and have served as the focus of local, national, and international scientific and educational symposia is one measure of their influence. The guidelines also have been translated into more than 10 languages and have been adopted in countries across the globe. In addition, DOQI has spawned numerous educational and quality improvement projects in virtually all relevant disciplines, as well as in dialysis treatment corporations and individual dialysis centers. Furthermore, the Health Care Financing Administration has responded to a Congressional mandate to develop a system for evaluation of the quality of care delivered in dialysis centers by developing a series of Clinical Performance Measures (CPMs) based on selected DOQI guidelines.It is encouraging that two of the ESRD Networks have developed a guideline prioritization tool and embarked on a Prioritization and Implementation Project that would link selected DOQI guidelines into the Health Care Quality Improvement Project proposed by HCFA in the ESRD Networks' most recent Scope of Work. This project would involve a collaborative effort of professional organizations, local practitioners, and patients. In fact, it is this collaborative spirit and total commitment to patient care that accounts for the success that DOQI has achieved heretofore.As we begin the new millennium, the DOQI clinical practice guideline initiative will move forward into a completely new phase, in which its scope will be enlarged to encompass the spectrum of chronic kidney disease well before the need for dialysis, when early intervention and prevention measures can delay or prevent the need for dialysis and improve its outcomes. This enlarged scope increases the potential impact of improving outcomes of care from hundreds of thousands to millions of individuals with kidney disease. To reflect this expansion, the reference to “Dialysis” in DOQI will be changed to “Disease” and the new initiative will become known as Kidney Disease Outcomes Quality Initiative (K⧸DOQI).The dissemination and implementation strategies that have proven so effective for NKF-DOQI have been adapted and expanded to reflect the new mission of K⧸DOQI and its multidisciplinary focus. Relevant material from the Nutrition Guidelines and future K⧸DOQI Guidelines will be developed into implementation tools appropriate not just for nephrology, but also the specialties most likely to encounter those at risk for chronic kidney disease early in the course of their illness, including cardiology, hypertension, diabetes, family practice, pediatrics, and internal medicine.On behalf of the National Kidney Foundation, we would like to acknowledge the tremendous contributions of all the volunteers who gave so much of their time and effort to the success of DOQI in order to improve the quality of life and outcomes of dialysis patients. The Nutrition Guidelines extend the DOQI objectives even further into the new and broader K⧸DOQI goals. Since the effort that went into preparing the Nutrition Guidelines was under the aegis of the original DOQI Advisory Council and Steering Committee, these two bodies are acknowledged. The new K⧸DOQI Advisory Board now will assume the charge of disseminating and implementing the Nutrition Guidelines.K⧸DOQI Advisory Board Members1.George Bailie, PharmD, PhD2.Gavin Becker, MD, MBBS3.Jerrilynn Burrowes, MSN, RD, CDN4.David N. Churchill, MD, FACP5.Allan Collins, MD, FACP6.William Couser, MD7.Dick DeZeeuw, MD8.Garabed Eknoyan, MD9.Alan Garber, MD, PhD10.Thomas Golper, MD11.Frank A. Gotch, MD12.Antonio Gotto, MD13.Joel W. Greer, PhD14.Richard Grimm, Jr, MD15.Ramon G. Hannah, MD, MS16.Jaime Herrera Acosta, MD17.Ronald Hogg, MD18.Laurence Hunsicker, MD19.Cynda Ann Johnson, MD20.Michael Klag, MD, MPH21.Saulo Klahr, MD22.Nathan W. Levin, MD, FACP23.Caya Lewis, MPH24.Edmund Lowrie, MD25.Arthur Mattas, MD26.Sally McCulloch, MSN, RN, CNN27.Maureen Michael, BSN, MBA28.Rosa A. Rivera-Mizzoni, MSW, LCSW29.Joseph V. Nally, MD30.John M. Newmann, PhD, MPH31.Allen Nissenson, MD32.Keith Norris, MD33.William Owen, Jr, MD34.Glenda Payne, RN35.David Smith36.Robert Star, MD37.Michael Steffes, MD, PhD38.Theodore Steinman, MD39.Professor John Walls40.Nanette Wenger, MD From its rudimentary beginnings in the 1960s, renal replacement therapy has become a lifesaving treatment that can provide end-stage renal disease (ESRD) patients with a good quality of life. As a result, the number of ESRD patients who receive renal replacement therapy has risen, and their survival has increased, but considerable geographic variability exists in practice patterns and patient outcomes. It was this realization, and the belief that substantial improvements in the quality and outcomes of renal replacement therapy were achievable with current technology, that prompted several organizations to seek to reduce variations in ESRD treatment with the goal of a more uniform delivery of the highest possible quality of care to dialysis patients. Notable among these efforts were the report on “Measuring, Managing and Improving Quality in the ESRD Treatment Setting” issued by the Institute of Medicine in September 1993; the “Morbidity and Mortality of Dialysis” report issued by the National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK) in November 1993; the Core Indicator Project initiated by the ESRD Networks and the Health Care Financing Administration (HCFA) in 1993; the “Clinical Practice Guidelines on the Adequacy of Hemodialysis” issued by the Renal Physicians Association in December 1993; and the Dialysis Outcomes Quality Initiative (DOQI) initiated by the National Kidney Foundation (NKF) in 1995. In keeping with its longstanding commitment to the quality of care delivered to all patients with kidney and urologic diseases, the NKF convened a Consensus Conference on Controversies in the Quality of Dialysis Care in March 1994. Following a series of nationwide town hall meetings held to obtain input into the recommendations made at the Consensus Conference, the NKF issued an “Evolving Plan for the Continued Improvement of the Quality of Dialysis Care” in November 1994. A central tenet of the plan was recognition of an essential need for rigorously developed clinical practice guidelines for the care of ESRD patients that would be viewed as an accurate and authoritative reflection of current scientific evidence. It was to this end that the NKF launched the “Dialysis Outcomes Quality Initiative” (DOQI) in March 1995, supported by an unrestricted grant from Amgen, Inc. The objectives of DOQI were ambitious: to improve patient survival, reduce patient morbidity, improve the quality of life of dialysis patients, and increase efficiency of care. To achieve these objectives, it was decided to adhere to several guiding principles that were considered to be critical to that initiative's success. The first of these principles was that the process used to develop the DOQI guidelines should be scientifically rigorous and based on a critical appraisal of all available evidence. Such an approach was felt to be essential to the credibility of the guidelines. Second, it was decided that participants involved in the development of the DOQI guidelines should be multidisciplinary. A multidisciplinary guideline development process was considered to be crucial, not only to the clinical and scientific validity of the guidelines, but also to the need for multidisciplinary adoption of the guidelines following their dissemination, in order for them to have maximum effectiveness. Third, a decision was made to give the DOQI guideline development Work Groups final authority over the content of the guidelines, subject to the requirement that guidelines be evidence-based whenever possible. By vesting decision-making authority in a group of individuals, from multiple disciplines and with diverse viewpoints, all of whom are experts with highly regarded professional reputations, the likelihood of developing sound guidelines was increased. Moreover, by insisting that the rationale and evidentiary basis of each DOQI guideline be made explicit, Work Group participants were forced to be clear and rigorous in formulating their recommendations. The final principle was that the guideline development process would be open to general review. Thus, the chain of reasoning underlying each guideline was subject to peer review and available for debate. Based on the “NKF Evolving Plan for the Continued Improvement of the Quality of Dialysis Care” and criteria recommended by the Agency for Health Care Research and Quality (AHCRQ; formerly known as the Agency for Health Care Policy and Research [AHCPR]), four areas were selected for the initial set of clinical practice guidelines: hemodialysis adequacy, peritoneal dialysis adequacy, vascular access, and anemia. Each Work Group selected which topics were considered for guideline creation. During the DOQI guideline development process, nearly 11,000 potentially relevant published articles were subjected to evaluation, and both the content and methods of approximately 1,500 articles underwent formal, structured review. Although labor-intensive and costly, the process resulted in an intensive, disciplined, and credible analysis of all available peer-reviewed information. When no evidence existed, or the evidence was inadequate, guidelines were based on the considered opinion of the Work Group experts. In all cases the rationale and the evidentiary basis of each recommendation was stated explicitly. Draft guidelines were then subjected to a three-stage review process. In the first stage, an Advisory Council, consisting of 25 experts and leaders in the field, provided comments on the initial draft of the guidelines. In the second stage, a variety of organizations (ESRD Networks, professional and patient associations, dialysis providers, government agencies, product manufacturers, and managed care groups) were invited to review and comment on a revised draft of the guidelines. After considering these comments and suggestions, the Work Groups produced a third draft of the Guidelines. In the final stage, this draft was made available for public review and comment by all interested individuals or parties. Following consideration of the comments submitted during this open review period, the guidelines were revised again and then published as supplements to the September and October 1997 issues of the American Journal of Kidney Diseases was made available on the Internet and widely distributed. The four sets of DOQI guidelines published in 1997 addressed only part of the “Evolving Plan for the Continued Improvement of the Quality of Dialysis Care” adopted by the NKF in 1994. In that plan, as well as in the early DOQI prioritization process, nutrition was considered to be an important determinant of ESRD patient outcome. Consequently, a Nutrition Work Group was convened in 1997 to review the key clinical nutrition literature and to define topics for which guidelines related to the nutritional management of patients should be developed. Supported primarily by a grant from Sigma Tau Pharmaceuticals, Inc, the Nutrition Work Group began to work intensively on those topics in January 1998, and the Nutrition Guidelines that they have developed constitute this fifth set of the original DOQI guidelines. NKF-DOQI achieved many, but not all of its goals. The guidelines have been well received and are considered by many to reflect the “state of the art” of medical practice in their fields. The frequency with which the DOQI guidelines have been cited in the literature and have served as the focus of local, national, and international scientific and educational symposia is one measure of their influence. The guidelines also have been translated into more than 10 languages and have been adopted in countries across the globe. In addition, DOQI has spawned numerous educational and quality improvement projects in virtually all relevant disciplines, as well as in dialysis treatment corporations and individual dialysis centers. Furthermore, the Health Care Financing Administration has responded to a Congressional mandate to develop a system for evaluation of the quality of care delivered in dialysis centers by developing a series of Clinical Performance Measures (CPMs) based on selected DOQI guidelines. It is encouraging that two of the ESRD Networks have developed a guideline prioritization tool and embarked on a Prioritization and Implementation Project that would link selected DOQI guidelines into the Health Care Quality Improvement Project proposed by HCFA in the ESRD Networks' most recent Scope of Work. This project would involve a collaborative effort of professional organizations, local practitioners, and patients. In fact, it is this collaborative spirit and total commitment to patient care that accounts for the success that DOQI has achieved heretofore. As we begin the new millennium, the DOQI clinical practice guideline initiative will move forward into a completely new phase, in which its scope will be enlarged to encompass the spectrum of chronic kidney disease well before the need for dialysis, when early intervention and prevention measures can delay or prevent the need for dialysis and improve its outcomes. This enlarged scope increases the potential impact of improving outcomes of care from hundreds of thousands to millions of individuals with kidney disease. To reflect this expansion, the reference to “Dialysis” in DOQI will be changed to “Disease” and the new initiative will become known as Kidney Disease Outcomes Quality Initiative (K⧸DOQI). The dissemination and implementation strategies that have proven so effective for NKF-DOQI have been adapted and expanded to reflect the new mission of K⧸DOQI and its multidisciplinary focus. Relevant material from the Nutrition Guidelines and future K⧸DOQI Guidelines will be developed into implementation tools appropriate not just for nephrology, but also the specialties most likely to encounter those at risk for chronic kidney disease early in the course of their illness, including cardiology, hypertension, diabetes, family practice, pediatrics, and internal medicine. On behalf of the National Kidney Foundation, we would like to acknowledge the tremendous contributions of all the volunteers who gave so much of their time and effort to the success of DOQI in order to improve the quality of life and outcomes of dialysis patients. The Nutrition Guidelines extend the DOQI objectives even further into the new and broader K⧸DOQI goals. Since the effort that went into preparing the Nutrition Guidelines was under the aegis of the original DOQI Advisory Council and Steering Committee, these two bodies are acknowledged. The new K⧸DOQI Advisory Board now will assume the charge of disseminating and implementing the Nutrition Guidelines. K⧸DOQI Advisory Board Members1.George Bailie, PharmD, PhD2.Gavin Becker, MD, MBBS3.Jerrilynn Burrowes, MSN, RD, CDN4.David N. Churchill, MD, FACP5.Allan Collins, MD, FACP6.William Couser, MD7.Dick DeZeeuw, MD8.Garabed Eknoyan, MD9.Alan Garber, MD, PhD10.Thomas Golper, MD11.Frank A. Gotch, MD12.Antonio Gotto, MD13.Joel W. Greer, PhD14.Richard Grimm, Jr, MD15.Ramon G. Hannah, MD, MS16.Jaime Herrera Acosta, MD17.Ronald Hogg, MD18.Laurence Hunsicker, MD19.Cynda Ann Johnson, MD20.Michael Klag, MD, MPH21.Saulo Klahr, MD22.Nathan W. Levin, MD, FACP23.Caya Lewis, MPH24.Edmund Lowrie, MD25.Arthur Mattas, MD26.Sally McCulloch, MSN, RN, CNN27.Maureen Michael, BSN, MBA28.Rosa A. Rivera-Mizzoni, MSW, LCSW29.Joseph V. Nally, MD30.John M. Newmann, PhD, MPH31.Allen Nissenson, MD32.Keith Norris, MD33.William Owen, Jr, MD34.Glenda Payne, RN35.David Smith36.Robert Star, MD37.Michael Steffes, MD, PhD38.Theodore Steinman, MD39.Professor John Walls40.Nanette Wenger, MD