FROM ITS rudimentary beginnings in the 1960s, through its widespread and increasing availability to the present, dialysis has provided lifesaving replacement therapy for millions of individuals with end-stage renal disease (ESRD). Parallel advances in understanding the course of progressive kidney disease and its complications have resulted in the development of interventions that can slow the progression and ameliorate the complications of chronic kidney disease (CKD). Thus, while dialysis has made it possible to prolong the lives of patients with ESRD, today it is also possible to retard the course of progression of kidney disease, to treat accompanying comorbidities earlier, and to improve the outcomes and quality of life of all individuals afflicted with kidney disease, well before replacement therapy becomes necessary. Yet, the application of these advances remains inconsistent, resulting in variations in clinical practice and, sadly, in avoidable differences in patient outcomes.
In keeping with its longstanding commitment to improving the quality of care delivered to all patients with kidney disease and the firm conviction that substantial improvements in the quality and outcomes of their care are achievable, the National Kidney Foundation (NKF) launched in 1995 the Dialysis Outcomes Quality Initiative (DOQI), supported by an educational grant from Amgen, Inc., to develop clinical practice guidelines for dialysis. Since their publication in 1997, the DOQI Guidelines have had a significant and measurable impact on the care and outcomes of dialysis patients.1,2 The frequency with which they continue to be cited in the literature and serve as the focus of national and international symposia is but a partial measure of their impact. The DOQI Guidelines have also been translated into more than a dozen languages; selected components of the Guidelines have been adopted in various countries across the world; and they have provided the basis of clinical performance measures developed and put into effect by the Health Care Financing Administration (now renamed the Center for Medicare and Medicaid Services [CMS] in the United States).
In the course of development of DOQI it became evident that, in order to further improve dialysis outcomes, it was necessary to improve the health status of those who reach ESRD, and that therein existed an even greater opportunity to improve outcomes for all individuals with kidney disease, from earliest kidney injury through the various stages of progression to kidney failure, when replacement therapy becomes necessary. It was on this basis that in the fall of 1999, the Board of Directors of the NKF approved a proposal to move the clinical practice guideline initiative into a new phase, in which its scope would be enlarged to encompass the entire spectrum of kidney disease. This enlarged scope increases the potential impact of improving outcomes of care from the hundreds of thousands on dialysis to the millions of individuals with kidney disease who may never require dialysis. To reflect these expanded goals, the reference to “dialysis” in DOQI was changed to “disease,” and the new initiative was termed the Kidney Disease Outcomes Quality Initiative (KDOQI).
The objectives of KDOQI are ambitious and its challenges considerable. As a first and essential step it was decided to adhere to the guiding principles that were instrumental to the success of DOQI. The first of these principles was that the development of guidelines would be scientifically rigorous and based on a critical appraisal of the available evidence. Secondly, the participants involved in developing the guidelines would be multidisciplinary. This was especially crucial because the broader nature of the new guidelines will require their adoption across several specialties and disciplines. Thirdly, the Work Groups charged with developing the guidelines would be the final authority on their content, subject to the requirements that they be evidence-based whenever possible, and that the rationale and evidentiary basis of each guideline be explicit. By vesting decision-making authority in highly regarded experts from multiple disciplines, the likelihood of developing clinically applicable and sound guidelines is increased. Finally, the guideline development process would be open to general review, in order to allow the chain of reasoning underlying each guideline to undergo peer review and debate prior to publishing. It was believed that such a broad-based review process would promote a wide consensus and support of the guidelines among health-care professionals, providers, managers, organizations, and patients.
To provide a unifying focus to KDOQI, it was decided that its centerpiece would be a set of clinical practice guidelines on the evaluation, classification, and stratification of CKD. This initial set of guidelines provided a standardized terminology for the evaluation and classification of kidney disease; the proper monitoring of kidney function from initial injury to end stage; a logical approach to stratification of kidney disease by risk factors and comorbid conditions; and consequently a basis for continuous care and therapy throughout the course of CKD. The Chronic Kidney Disease: Evaluation, Classification, and Stratification Guidelines were published in February 2002.3
KDOQI also includes interventional, disease-specific guidelines, based on the staging and classification developed by the CKD: Evaluation, Classification, and Stratification Guidelines. Work on 2 of these interventional Guidelines was begun in 2000. We are proud to present one of these interventional Guidelines for your review and comments. The Work Group appointed to develop the Guidelines screened over 22,300 potentially relevant articles; over 4,100 were subjected to preliminary review; about 470 were then selected for formal structured review of content and methodology. While considerable effort has gone into the development of the Guidelines and every attention has been paid to detail and scientific rigor, it is only the ongoing review and ratification that assures their clinical applicability and practical utility. The current Guidelines have been through three extensive reviews and represented herein is the product with incorporation of these comments.
Ultimately, we also ask for your suggestions for implementation of these Guidelines. It is hoped that implementation plans, currently being developed, will ensure the same acceptance of KDOQI by nephrologists as well as by the broader spectrum of professionals who provide primary care for kidney disease as that which DOQI received from those who provide dialysis care.
On behalf of the NKF, we would like to acknowledge the immense effort and contributions of those who have made these Guidelines possible. In particular, we wish to acknowledge the following: the members of the Work Group charged with developing the Guidelines, without whose tireless effort and commitment these Guidelines would not have been possible; the members of the Support Group, whose input at monthly conference calls was instrumental in resolving the problems encountered over the time it has taken to reach this stage; the members of the KDOQI Advisory Board, whose insights and guidance were essential in broadening the applicability of the Guidelines; Amgen, Inc., which had the vision and foresight to appreciate the merits of the KDOQI initiative and to provide the unrestricted funds necessary for its launching in 2000; Abbott Renal Care, which shared the KDOQI objective to improve the care of patients with CKD and as Primary Sponsor of the present set of Guidelines provided an unrestricted grant for their development; Genzyme Therapeutics, which as Associate Sponsor provided an unrestricted grant to support the completion of these Guidelines; and the NKF staff assigned to KDOQI who worked so diligently in attending to the innumerable details that needed attention at every stage of Guideline development and in meeting our nearly impossible deadlines.
A special debt of gratitude goes to Shaul G. Massry, MD, Chair of the Work Group, whose seminal contributions to the understanding of parathyroid gland, bone disease, and phosphate metabolism in CKD and personal commitment to KDOQI provided the leadership, intellectual rigor, and invaluable expertise in synthesizing these Guidelines; and to ECRI, for providing crucial methodological rigor and staff support in developing the evidentiary basis of the Guidelines.
In a voluntary and multidisciplinary undertaking of such magnitude, many others have made valuable contributions to these Guidelines but cannot be individually acknowledged here. To each and every one of them we extend our sincerest appreciation.
Garabed Eknoyan, MD
Adeera Levin, MD
Nathan W. Levin, MD
NKF–KDOQI Co-Chair Emeritus