Kidney Disease: Improving Global Outcomes (KDIGO) is an independently incorporated nonprofit foundation, governed by an international board of directors, that was established in 2003 with the stated mission to 'improve the care and outcomes of kidney disease patients worldwide through promoting coordination, collaboration, and integration of initiatives to develop and implement clinical practice guidelines.'
The rationale for focusing on guidelines was the increasing and convincing information that rigorously developed
evidence-based clinical practice guidelines, when implemented, improve patient outcomes and favorably affect the efficiency of
health-care delivery. The rationale for a global initiative was the mounting epidemiologic data that kidney disease is common
worldwide and its harmful complications are universal. Further, the science- and evidence-based care of these patients are
independent of geographical location and national borders. As such, international cooperation in the development of evidence-based guidelines can improve the efficiency and broaden the expertise base of guideline development, thereby saving regional resources for use in their implementation, rather than duplicating a review of essentially the same database. The rationale for focusing on patients with kidney disease is that it allows for the development of guidelines that are of maximum benefit to patients if resources were unlimited. In reality, that is never the case because available resources do vary, and-even in the wealthiest countries-there are always regional considerations that limit the adoption of ideal guidelines. Given that the KDIGO guidelines are meant to be global, trade-offs in applying individual interventions must be prioritized and determined regionally. KDIGO is committed to share the evidentiary basis of the guidelines and assist local Guideline Development Groups to determine and adopt the recommendations that are appropriate for regional implementation. This is the approach recommended by the World Health Organization (WHO) in its Guidelines on Guidelines, and the approach adopted by the KDIGO Board. Essentially, the objective is to globalize and share the evidence, but localize the decision for their adoption and implementation.
Now, we are proud to present the first product of what has been an unprecedented undertaking of the international renal community. It has been a rigorous process from the outset that took two years to launch. After much debate, the KDIGO Board decided to avoid duplication of existing guidelines in nephrology and selected the topic of infectious diseases as a heretofore orphan topic of worldwide interest. Five major infectious diseases were considered: human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B virus (HBV), tuberculosis, and malaria. Ultimately, HCV was selected because (i) of the larger number of available studies
on the subject; (ii) HCV is an infection that can detrimentally affect patients throughout the spectrum of chronic kidney disease (CKD) and can itself cause kidney disease; and (iii) HCV is a problem of worldwide clinical relevance in developed and developing countries.
At the same time as the board was deliberating the choice of a guideline topic, it commissioned a group of experts to develop a rigorous and consistent approach for the development and grading of the evidence and recommendations of nephrology guidelines, in general, and those of KDIGO, in particular. The recommendation of this expert group, based on the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) approach, is the process that was followed in developing the present guidelines. Essentially, the guideline development process was guided by (i) the level of scientific evidence and methodologic rigor of the available literature; (ii) the Work Group charged with developing the guidelines being interdisciplinary, international, and independent throughout the process; and (iii) ascertainment of openness of the entire development process, especially during its review phase.
The guidelines were subjected to a three-step review process. At every step of the review process, all comments received were carefully reviewed, considered, and discussed by the Work Group; where appropriate, they are integrated into the final version of the guidelines. As a first step, the Board reviewed an early draft of the questions to be addressed in December 2005. In the second phase, a first draft of the final guidelines was reviewed by the Board and representatives of Caring for Australians with Renal Impairment (CARI), United Kingdom Renal Association (UK-RA), Canadian Society of Nephrology (CSN), Kidney Disease Outcomes Quality Initiative (KDOQI), and European Best Practice Guidelines (EBPG) in December 2006.
In the third and final phase, the draft guidelines were submitted for public review and comment by any interested individual or party. All comments received were considered and discussed by theWork Group.Where appropriate, changes were made in this final document. This is an important step in the development of guidelines, as it increases the base of expertise that goes into their development. We owe a special debt of gratitude to all those who took time out of their busy schedules to share their comments with us. They have been instrumental in improving the final guidelines.
A major problem that plagues the development of guidelines, in general, and in nephrology, in particular, is the relatively small number of available high-level randomized clinical trials (RCTs) that address all the pertinent clinical issues needed for the care of patients. To convey the level of evidence for each guideline statement, the HCV Guideline Development Work Group elected to specify it in parentheses at the end of each statement and detail it in the rationale that follows. Guideline statements specified as 'Strong' refer to those where the quality of the evidence is high and assumes that most wellinformed individuals will make the same choice. Statements specified as 'Moderate' refer to those where the quality of the evidence is moderate or low, but additional considerations
support a recommendation to consider the specific intervention, with the assumption that a majority of well-informed individuals will consider its use. Statements specified as 'Weak' refer to consensus-based recommendations where the evidence is low, very low, or absent, with the expectation that consideration would be given to follow the suggested judgment-based recommendation on an individual basis. The table below summarizes the interpretation of the three levels of recommendations. To assist the reader, this table is repeated with each set of statements. In the final analysis, it is absolutely essential to keep in mind the definition of guidelines: 'Guidelines are systematically developed statements to assist practitioner and patient decisions about appropriate health care for special conditions.' As such, these are merely guidelines and not standards or mandates. In clinical practice, the decision to follow any guideline statement, independent of the level of its supporting evidence, must be made individually for each patient.
On behalf of KDIGO, we acknowledge the immense effort and contributions of those who made it all possible. In particular, we acknowledge the following: the members of the Guideline Development Work Group and the Evidence Review Team, without whose tireless effort and dedication this first set of KDIGO guidelines would not have been possible; the KDIGO Board, whose leadership, vision, and
guidance were instrumental at every step of preparing the guidelines; and the exceptional support of the National Kidney Foundation staff assigned to KDIGO who worked so diligently in resolving logistic problems, arranging activities, and attending the innumerable conference calls and meetings that went into bringing the process to fruition. Specifically, we acknowledge Donna Fingerhut, Michael Cheung, and Dekeya Slaughter-Larkem who were instrumental in coordinating the whole project.
A very special debt of gratitude is owed to Michel Jadoul and David Roth, Co-Chairs of the Guideline Development
Work Group, for their leadership, countless hours of work, dedicated commitment, invaluable expertise, and intellectual
rigor; and to Ethan Balk, Craig Gordon, and Amy Earley for their relentless vigilance in providing methodologic rigor and
guidance in developing the evidentiary basis and grading the final guideline statements.
In a voluntary and multidisciplinary undertaking of this magnitude, numerous others have made valuable contributions to these guidelines, but cannot be acknowledged individually. To each and every one of them, we express our sincerest appreciation and thanks.
| Garabed Eknoyan |
Norbert Lameire |
| Co-Chair, KDIGO |
Co-Chair, KDIGO |
