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. 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 comorbidity 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 patients and health care providers. Since their publication in 1997, the DOQI guidelines have had a significant and measurable impact on the care and outcomes of dialysis patients. 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 for clinical performance measures developed and put into effect by the Health Care Financing Administration (recently renamed the Center for Medicare and Medicaid Services) in the United States.
In the course of development of DOQI it became evident that in order to further improve dialysis outcomes, it is necessary to improve the health status of those who reach ESRD and that therein exists an even greater opportunity to improve outcomes for all individuals with kidney disease, from earliest kidney damage 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, when early intervention and appropriate measures can prevent the loss of kidney function in some, slow the progression of the disease in many others, and ameliorate organ dysfunction and comorbid conditions in those who progress to kidney failure and ESRD. 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 Kidney Disease Outcomes Quality Initiative (KDOQITM).
The objectives of KDOQI are ambitious and the challenges are considerable. As a first and essential step it was decided to adhere to the guiding principles that were instrumental in 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. The second principle was that 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. The third principle was that 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 would 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 recipients.
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 chronic kidney disease (CKD). This initial set of guidelines will provide 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 chronic kidney disease. Eventually, KDOQI will include interventional guidelines. Some of these are currently under development, based on the staging and classification developed by these initial CKD guidelines.
We are proud to present this first set and centerpiece of KDOQI guidelines. The Work Group appointed to develop the guidelines screened over 18,000 potentially relevant articles; over 1,100 were subjected to preliminary review and over 350 were then selected for formal structured review of content and methodology. While considerable effort has gone into the development of the guidelines during the past 24 months, and great attention has been paid to detail and scientific rigor, it is only their incorporation into clinical practice that will assure their applicability and practical utility.
We ask for your support in the implementation of these guidelines. It is hoped that implementation plans developed by the Advisory Board will assure the same acceptance of KDOQI 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 and Evidence Review Team charged with developing the guidelines, without whose tireless effort and commitment this first set of KDOQI 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 24 months 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 this initiative and provide the unrestricted funds necessary for its development; 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 near impossible deadlines.
A special debt of gratitude goes to Andrew S. Levey, MD, Chair of the Work Group, for his leadership, intellectual rigor, innumerable hours of dedication, and invaluable expertise in synthesizing the guidelines; and to Joseph Lau, MD, Director of the Evidence Review Team, 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, numerous 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
Nathan W. Levin, MD