Foreword

Abstract

About 300,000 individuals in the United States receive some form of dialysis, which provides lifesaving renal replacement therapy for end-stage renal disease (ESRD). While there have been significant improvements in dialysis technology, there remain many more opportunities for further improvement. The publication of the NKF-Dialysis Outcomes Quality Initiative (DOQI) Clinical Practice guidelines in 1997 represented the first comprehensive effort to give evidence-based guidance to clinical care teams, thereby decreasing practice pattern variation in the over 3,100 dialysis facilities in the United States, and to develop concrete plans that could have a measurable impact on improving the quality of life for dialysis patients.The Guidelines, supported by an educational grant from Amgen, have been widely adopted in the United States and abroad and have been a stimulus for several national renal organizations to develop their own Guidelines. They have been translated into at least 10 languages, have been the focus of numerous quality improvement activities, and have served as the basis for ESRD clinical performance measures being developed by the Health Care Financing Administration.We are pleased to present now the revised and updated versions of the four DOQI guidelines originally published in 1997. In order to maintain the Guidelines as an evolving and live document, the four original Work Groups, covering adequacy of hemodialysis, adequacy of peritoneal dialysis, management of vascular access, and management of anemia, were reactivated to review the relevant literature published since 1997.The review process was prioritized to cover the following three end products: changes in guidelines, changes in rationales, and commentary expanding on existing line of logic. Selected articles were subjected to the established NKF-DOQI structured review process to evaluate both the content and methodology in each article. The methods used to evaluate the quality of evidence underlying the guidelines prior to their initial publication are reviewed in Steinberg et al.1Steinberg E Eknoyan G Levin N Eschbach J Golper T Owen W Schwab S Methods used to evaluate the quality of evidence underlying the National Kidney Foundation-Dialysis Outcomes Quality Initiative Clinical Practice Guidelines: Description, findings and implications.Am J Kidney Dis. 2000; 36: 1-11Abstract Full Text Full Text PDF PubMed Scopus (48) Google ScholarThe Work Groups appointed to examine the four areas covered by the guidelines initially reviewed more than 11,000 articles. Over 3,000 of these publications were subjected to preliminary review; and over half this number underwent formal, structured review.In contrast, the update process focused on a total of 85 articles published since 1997 that were considered to be potentially relevant by the Work Groups. Of these, 57 were subjected to structured review according to the published DOQI methods.1Steinberg E Eknoyan G Levin N Eschbach J Golper T Owen W Schwab S Methods used to evaluate the quality of evidence underlying the National Kidney Foundation-Dialysis Outcomes Quality Initiative Clinical Practice Guidelines: Description, findings and implications.Am J Kidney Dis. 2000; 36: 1-11Abstract Full Text Full Text PDF PubMed Scopus (48) Google ScholarAs before, the draft guidelines were subjected to a three-stage review process. They were presented first to the NKF-DOQI Steering Committee and revised in response to the comments received. In the second stage, the K/DOQI Advisory Board, along with other experts in the field, provided comments. After considering these, the Work Groups produced a third draft of the guidelines. In the final stage, this draft was made available for public review and comment to all interested parties, including ESRD Networks, professional and patient associations, dialysis providers, government agencies, product manufacturers, and managed care groups and individuals. The comments received were reviewed and, where appropriate, incorporated in the final version of the guidelines.While extensive effort has gone into the guideline development process and every attention has been paid to detail and scientific rigor, it is absolutely essential to emphasize unequivocally that these documents are guidelines, not standards or mandates. Each recommendation in the guidelines is accompanied by a rationale, enabling dialysis caregivers to make informed decisions about the proper care plan for each individual patient. Variations in practice are expected and appropriate. Please refer to the disclaimer statement that accompanies these guidelines for further details regarding their intended use.As the update process of the guidelines was underway, it was decided that with the beginning of the new millennium, the DOQI clinical practice guideline initiative would 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 in patients who develop end-stage disease. 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 was changed to “Disease” and the new initiative has become known as Kidney Disease Outcomes Quality Initiative (K/DOQI).The methodologic process 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 broadened multidisciplinary focus. Relevant material from 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 those who made the NKF-DOQI possible. A special debt of gratitude goes to the members of the Work Group, especially to the Work Group Chairs—Dr. Joseph Eschbach, Dr. Thomas Golper, Dr. William Owen, and Dr. Steve Schwab—for their innumerable hours of dedicated service and invaluable expertise in synthesizing the guidelines. Their enthusiasm, leadership, and tireless efforts to achieve a high level of quality made the NKF-DOQI Clinical Practice Guidelines what they are today—a trusted resource to provide guidance, direction, and vision on the issue of kidney disease with a single focused goal: making lives better by improving patient outcomes. In a cooperative undertaking of this magnitude and duration, numerous others have made essential contributions to the guidelines. To recognize them individually would be an impossible task. To every one of them, many thanks. About 300,000 individuals in the United States receive some form of dialysis, which provides lifesaving renal replacement therapy for end-stage renal disease (ESRD). While there have been significant improvements in dialysis technology, there remain many more opportunities for further improvement. The publication of the NKF-Dialysis Outcomes Quality Initiative (DOQI) Clinical Practice guidelines in 1997 represented the first comprehensive effort to give evidence-based guidance to clinical care teams, thereby decreasing practice pattern variation in the over 3,100 dialysis facilities in the United States, and to develop concrete plans that could have a measurable impact on improving the quality of life for dialysis patients. The Guidelines, supported by an educational grant from Amgen, have been widely adopted in the United States and abroad and have been a stimulus for several national renal organizations to develop their own Guidelines. They have been translated into at least 10 languages, have been the focus of numerous quality improvement activities, and have served as the basis for ESRD clinical performance measures being developed by the Health Care Financing Administration. We are pleased to present now the revised and updated versions of the four DOQI guidelines originally published in 1997. In order to maintain the Guidelines as an evolving and live document, the four original Work Groups, covering adequacy of hemodialysis, adequacy of peritoneal dialysis, management of vascular access, and management of anemia, were reactivated to review the relevant literature published since 1997. The review process was prioritized to cover the following three end products: changes in guidelines, changes in rationales, and commentary expanding on existing line of logic. Selected articles were subjected to the established NKF-DOQI structured review process to evaluate both the content and methodology in each article. The methods used to evaluate the quality of evidence underlying the guidelines prior to their initial publication are reviewed in Steinberg et al.1Steinberg E Eknoyan G Levin N Eschbach J Golper T Owen W Schwab S Methods used to evaluate the quality of evidence underlying the National Kidney Foundation-Dialysis Outcomes Quality Initiative Clinical Practice Guidelines: Description, findings and implications.Am J Kidney Dis. 2000; 36: 1-11Abstract Full Text Full Text PDF PubMed Scopus (48) Google Scholar The Work Groups appointed to examine the four areas covered by the guidelines initially reviewed more than 11,000 articles. Over 3,000 of these publications were subjected to preliminary review; and over half this number underwent formal, structured review. In contrast, the update process focused on a total of 85 articles published since 1997 that were considered to be potentially relevant by the Work Groups. Of these, 57 were subjected to structured review according to the published DOQI methods.1Steinberg E Eknoyan G Levin N Eschbach J Golper T Owen W Schwab S Methods used to evaluate the quality of evidence underlying the National Kidney Foundation-Dialysis Outcomes Quality Initiative Clinical Practice Guidelines: Description, findings and implications.Am J Kidney Dis. 2000; 36: 1-11Abstract Full Text Full Text PDF PubMed Scopus (48) Google Scholar As before, the draft guidelines were subjected to a three-stage review process. They were presented first to the NKF-DOQI Steering Committee and revised in response to the comments received. In the second stage, the K/DOQI Advisory Board, along with other experts in the field, provided comments. After considering these, the Work Groups produced a third draft of the guidelines. In the final stage, this draft was made available for public review and comment to all interested parties, including ESRD Networks, professional and patient associations, dialysis providers, government agencies, product manufacturers, and managed care groups and individuals. The comments received were reviewed and, where appropriate, incorporated in the final version of the guidelines. While extensive effort has gone into the guideline development process and every attention has been paid to detail and scientific rigor, it is absolutely essential to emphasize unequivocally that these documents are guidelines, not standards or mandates. Each recommendation in the guidelines is accompanied by a rationale, enabling dialysis caregivers to make informed decisions about the proper care plan for each individual patient. Variations in practice are expected and appropriate. Please refer to the disclaimer statement that accompanies these guidelines for further details regarding their intended use. As the update process of the guidelines was underway, it was decided that with the beginning of the new millennium, the DOQI clinical practice guideline initiative would 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 in patients who develop end-stage disease. 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 was changed to “Disease” and the new initiative has become known as Kidney Disease Outcomes Quality Initiative (K/DOQI). The methodologic process 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 broadened multidisciplinary focus. Relevant material from 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 those who made the NKF-DOQI possible. A special debt of gratitude goes to the members of the Work Group, especially to the Work Group Chairs—Dr. Joseph Eschbach, Dr. Thomas Golper, Dr. William Owen, and Dr. Steve Schwab—for their innumerable hours of dedicated service and invaluable expertise in synthesizing the guidelines. Their enthusiasm, leadership, and tireless efforts to achieve a high level of quality made the NKF-DOQI Clinical Practice Guidelines what they are today—a trusted resource to provide guidance, direction, and vision on the issue of kidney disease with a single focused goal: making lives better by improving patient outcomes. In a cooperative undertaking of this magnitude and duration, numerous others have made essential contributions to the guidelines. To recognize them individually would be an impossible task. To every one of them, many thanks.