american journal of kidney disease
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DESCRIPTIONJournal of Kidney Disease
K/DOQITM DisclaimerThese guidelines are based on the best information available at the time of publication. They are designed
to provide information and assist in decision making. They are not intended to define a standard of care, andshould not be construed as one. Neither should they be interpreted as prescribing an exclusive course ofmanagement. Variations in practice will inevitably and appropriately occur when clinicians take into accountthe needs of individual patients, available resources, and limitations unique to an institution or type ofpractice. Every healthcare professional making use of these guidelines is responsible for evaluating theappropriateness of applying them in the setting of any particular clinical situation.
K/DOQI is a trademark of the National Kidney Foundation.
FROM ITS RUDIMENTARY beginnings inthe 1960s, renal replacement therapy hasbecome a lifesaving treatment that can provideend-stage renal disease (ESRD) patients with agood quality of life. As a result, the number ofESRD patients who receive renal replacementtherapy has risen, and their survival has in-creased, but considerable geographic variabilityexists in practice patterns and patient outcomes.It was this realization, and the belief that substan-tial improvements in the quality and outcomes ofrenal replacement therapy were achievable withcurrent technology, that prompted several organi-zations to seek to reduce variations in ESRDtreatment with the goal of a more uniform deliv-ery of the highest possible quality of care todialysis patients. Notable among these effortswere the report on Measuring, Managing andImproving Quality in the ESRD Treatment Set-ting issued by the Institute of Medicine inSeptember 1993; the Morbidity and Mortalityof Dialysis report issued by the National Insti-tute of Diabetes, Digestive and Kidney Diseases(NIDDK) in November 1993; the Core IndicatorProject initiated by the ESRD Networks and theHealth Care Financing Administration (HCFA)in 1993; the Clinical Practice Guidelines on theAdequacy of Hemodialysis issued by the RenalPhysicians Association in December 1993; andthe Dialysis Outcomes Quality Initiative (DOQI)initiated by the National Kidney Foundation(NKF) in 1995.
In keeping with its longstanding commitmentto the quality of care delivered to all patientswith kidney and urologic diseases, the NKFconvened a Consensus Conference on Controver-sies in the Quality of Dialysis Care in March
1994. Following a series of nationwide town hallmeetings held to obtain input into the recommen-dations made at the Consensus Conference, theNKF issued an Evolving Plan for the Contin-ued Improvement of the Quality of DialysisCare in November 1994. A central tenet of theplan was recognition of an essential need forrigorously developed clinical practice guidelinesfor the care of ESRD patients that would beviewed as an accurate and authoritative reflec-tion of current scientific evidence. It was to thisend that the NKF launched the Dialysis Out-comes Quality Initiative (DOQI) in March 1995,supported by an unrestricted grant from Amgen,Inc.
The objectives of DOQI were ambitious: toimprove patient survival, reduce patient morbid-ity, improve the quality of life of dialysis pa-tients, and increase efficiency of care. To achievethese objectives, it was decided to adhere toseveral guiding principles that were consideredto be critical to that initiatives success. The firstof these principles was that the process used todevelop the DOQI guidelines should be scientifi-cally rigorous and based on a critical appraisal ofall available evidence. Such an approach was feltto be essential to the credibility of the guidelines.Second, it was decided that participants involvedin the development of the DOQI guidelines shouldbe multidisciplinary. A multidisciplinary guide-line development process was considered to becrucial, not only to the clinical and scientificvalidity of the guidelines, but also to the need formultidisciplinary adoption of the guidelines fol-lowing their dissemination, in order for them tohave maximum effectiveness. Third, a decisionwas made to give the DOQI guideline develop-
American Journal of Kidney Diseases, Vol 35, No 6, Suppl 2 (June), 2000: pp S1-S3 S1
The Official Journal of the
National Kidney FoundationVOL 35, NO 6, SUPPL 2, JUNE 2000
AJKD American Journal ofKidney Diseases
ment Work Groups final authority over the con-tent of the guidelines, subject to the requirementthat guidelines be evidence-based whenever pos-sible. By vesting decision-making authority in agroup of individuals, from multiple disciplinesand with diverse viewpoints, all of whom areexperts with highly regarded professional reputa-tions, the likelihood of developing sound guide-lines was increased. Moreover, by insisting thatthe rationale and evidentiary basis of each DOQIguideline be made explicit, Work Group partici-pants were forced to be clear and rigorous informulating their recommendations. The finalprinciple was that the guideline development pro-cess would be open to general review. Thus, thechain of reasoning underlying each guideline wassubject to peer review and available for debate.
Based on the NKF Evolving Plan for theContinued Improvement of the Quality of Dialy-sis Care and criteria recommended by theAgency for Health Care Research and Quality(AHCRQ; formerly known as the Agency forHealth Care Policy and Research [AHCPR]),four areas were selected for the initial set ofclinical practice guidelines: hemodialysis ad-equacy, peritoneal dialysis adequacy, vascularaccess, and anemia. Each Work Group selectedwhich topics were considered for guideline cre-ation. During the DOQI guideline developmentprocess, nearly 11,000 potentially relevant pub-lished articles were subjected to evaluation, andboth the content and methods of approximately1,500 articles underwent formal, structured re-view. Although labor-intensive and costly, theprocess resulted in an intensive, disciplined, andcredible analysis of all available peer-reviewedinformation. When no evidence existed, or theevidence was inadequate, guidelines were basedon the considered opinion of the Work Groupexperts. In all cases the rationale and the eviden-tiary basis of each recommendation was statedexplicitly.
Draft guidelines were then subjected to a three-stage review process. In the first stage, an Advi-sory Council, consisting of 25 experts and lead-ers in the field, provided comments on the initialdraft of the guidelines. In the second stage, avariety of organizations (ESRD Networks, profes-sional and patient associations, dialysis provid-ers, government agencies, product manufactur-ers, and managed care groups) were invited to
review and comment on a revised draft of theguidelines. After considering these commentsand suggestions, the Work Groups produced athird draft of the Guidelines. In the final stage,this draft was made available for public reviewand comment by all interested individuals orparties. Following consideration of the com-ments submitted during this open review period,the guidelines were revised again and then pub-lished as supplements to the September andOctober 1997 issues of the American Journal ofKidney Diseases was made available on theInternet and widely distributed.
The four sets of DOQI guidelines published in1997 addressed only part of the Evolving Planfor the Continued Improvement of the Quality ofDialysis Care adopted by the NKF in 1994. Inthat plan, as well as in the early DOQI prioritiza-tion process, nutrition was considered to be animportant determinant of ESRD patient out-come. Consequently, a Nutrition Work Groupwas convened in 1997 to review the key clinicalnutrition literature and to define topics for whichguidelines related to the nutritional managementof patients should be developed. Supported pri-marily by a grant from Sigma Tau Pharmaceuti-cals, Inc, the Nutrition Work Group began towork intensively on those topics in January 1998,and the Nutrition Guidelines that they have devel-oped constitute this fifth set of the original DOQIguidelines.
NKF-DOQI achieved many, but not all of itsgoals. The guidelines have been well receivedand are considered by many to reflect the stateof the art of medical practice in their fields. Thefrequency with which the DOQI guidelines havebeen cited in the literature and have served as thefocus of local, national, and international scien-tific and educational symposia is one measure oftheir influence. The guidelines also have beentranslated into more than 10 languages and havebeen adopted in countries across the globe. Inaddition, DOQI has spawned numerous educa-tional and quality improvement projects in virtu-ally all relevant disciplines, as well as in dialysistreatment corporations and individual dialysiscenters. Furthermore, the Health Care FinancingAdministration has responded to a Congres-sional mandate to develop a system for evalua-tion of the quality of care delivered in dialysiscenters by developing a series of Clinical Perfor-
mance Measures (CPMs) based on selected DOQIguidelines.
It is encouraging that two of the ESRD Net-works have developed a guideline prioritizationtool and embarked on a Prioritization and Imple-mentation Project that would link selected DOQIguidelines into the Health Care Quality Improve-ment Project proposed by HCFA in the ESRDNetworks most recent Scope of Work. Thisproject would involve a collaborative effort ofprofessional organizations, local practitioners,and patients. In fact, it is this collaborative spiritand total commitment to patient care that ac-counts for the success that DOQI has achievedheretofore.
As we begin the new millennium, the DOQIclinical practice guideline initiative will moveforward into a completely new phase, in whichits scope will be enlarged to encompass thespe