K/DOQITM Disclaimer These 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, and should not be construed as one. Neither should they be interpreted as prescribing an exclusive course of management. Variations in practice will inevitably and appropriately occur when clinicians take into account the needs of individual patients, available resources, and limitations unique to an institution or type of practice. Every healthcare professional making use of these guidelines is responsible for evaluating the appropriateness of applying them in the setting of any particular clinical situation. K/DOQI is a trademark of the National Kidney Foundation. The Official Journal of the National Kidney Foundation VOL 35, NO 6, SUPPL 2, JUNE 2000 American Journal of AJKD Kidney Diseases FOREWORD ROM ITS RUDIMENTARY beginnings in 1994. Following a series of nationwide town hall Fthe 1960s, renal replacement therapy has meetings held to obtain input into the recommen- become a lifesaving treatment that can provide dations made at the Consensus Conference, the end-stage renal disease (ESRD) patients with a NKF issued an ‘‘Evolving Plan for the Contin- good quality of life. As a result, the number of ued Improvement of the Quality of Dialysis ESRD patients who receive renal replacement Care’’ in November 1994. A central tenet of the therapy has risen, and their survival has in- plan was recognition of an essential need for creased, but considerable geographic variability rigorously developed clinical practice guidelines exists in practice patterns and patient outcomes. for the care of ESRD patients that would be It was this realization, and the belief that substan- viewed as an accurate and authoritative reflec- tial improvements in the quality and outcomes of tion of current scientific evidence. It was to this renal replacement therapy were achievable with end that the NKF launched the ‘‘Dialysis Out- current technology, that prompted several organi- comes Quality Initiative’’(DOQI) in March 1995, zations to seek to reduce variations in ESRD supported by an unrestricted grant from Amgen, treatment with the goal of a more uniform deliv- Inc. ery of the highest possible quality of care to The objectives of DOQI were ambitious: to dialysis patients. Notable among these efforts improve patient survival, reduce patient morbid- were the report on ‘‘Measuring, Managing and ity, improve the quality of life of dialysis pa- Improving Quality in the ESRD Treatment Set- tients, and increase efficiency of care. To achieve ting’’ issued by the Institute of Medicine in these objectives, it was decided to adhere to September 1993; the ‘‘Morbidity and Mortality several guiding principles that were considered of Dialysis’’ report issued by the National Insti- to be critical to that initiative’s success. The first tute of Diabetes, Digestive and Kidney Diseases of these principles was that the process used to (NIDDK) in November 1993; the Core Indicator develop the DOQI guidelines should be scientifi- Project initiated by the ESRD Networks and the cally rigorous and based on a critical appraisal of Health Care Financing Administration (HCFA) all available evidence. Such an approach was felt in 1993; the ‘‘Clinical Practice Guidelines on the to be essential to the credibility of the guidelines. Adequacy of Hemodialysis’’ issued by the Renal Second, it was decided that participants involved Physicians Association in December 1993; and in the development of the DOQI guidelines should the Dialysis Outcomes Quality Initiative (DOQI) be multidisciplinary. A multidisciplinary guide- initiated by the National Kidney Foundation line development process was considered to be (NKF) in 1995. crucial, not only to the clinical and scientific In keeping with its longstanding commitment validity of the guidelines, but also to the need for to the quality of care delivered to all patients multidisciplinary adoption of the guidelines fol- with kidney and urologic diseases, the NKF lowing their dissemination, in order for them to convened a Consensus Conference on Controver- have maximum effectiveness. Third, a decision sies in the Quality of Dialysis Care in March was made to give the DOQI guideline develop- American Journal of Kidney Diseases, Vol 35, No 6, Suppl 2 (June), 2000: pp S1-S3 S1 S2 FOREWORD ment Work Groups final authority over the con- review and comment on a revised draft of the tent of the guidelines, subject to the requirement guidelines. After considering these comments that guidelines be evidence-based whenever pos- and suggestions, the Work Groups produced a sible. By vesting decision-making authority in a third draft of the Guidelines. In the final stage, group of individuals, from multiple disciplines this draft was made available for public review and with diverse viewpoints, all of whom are and comment by all interested individuals or experts with highly regarded professional reputa- parties. Following consideration of the com- tions, the likelihood of developing sound guide- ments submitted during this open review period, lines was increased. Moreover, by insisting that the guidelines were revised again and then pub- the rationale and evidentiary basis of each DOQI lished as supplements to the September and guideline be made explicit, Work Group partici- October 1997 issues of the American Journal of pants were forced to be clear and rigorous in Kidney Diseases was made available on the formulating their recommendations. The final Internet and widely distributed. principle was that the guideline development pro- The four sets of DOQI guidelines published in cess would be open to general review. Thus, the 1997 addressed only part of the ‘‘Evolving Plan chain of reasoning underlying each guideline was for the Continued Improvement of the Quality of subject to peer review and available for debate. Dialysis Care’’ adopted by the NKF in 1994. In Based on the ‘‘NKF Evolving Plan for the that plan, as well as in the early DOQI prioritiza- Continued Improvement of the Quality of Dialy- tion process, nutrition was considered to be an sis Care’’ and criteria recommended by the important determinant of ESRD patient out- Agency for Health Care Research and Quality come. Consequently, a Nutrition Work Group (AHCRQ; formerly known as the Agency for was convened in 1997 to review the key clinical Health Care Policy and Research [AHCPR]), nutrition literature and to define topics for which four areas were selected for the initial set of guidelines related to the nutritional management clinical practice guidelines: hemodialysis ad- of patients should be developed. Supported pri- equacy, peritoneal dialysis adequacy, vascular marily by a grant from Sigma Tau Pharmaceuti- access, and anemia. Each Work Group selected cals, Inc, the Nutrition Work Group began to which topics were considered for guideline cre- work intensively on those topics in January 1998, ation. During the DOQI guideline development and the Nutrition Guidelines that they have devel- process, nearly 11,000 potentially relevant pub- oped constitute this fifth set of the original DOQI lished articles were subjected to evaluation, and guidelines. both the content and methods of approximately NKF-DOQI achieved many, but not all of its 1,500 articles underwent formal, structured re- goals. The guidelines have been well received view. Although labor-intensive and costly, the and are considered by many to reflect the ‘‘state process resulted in an intensive, disciplined, and of the art’’ of medical practice in their fields. The credible analysis of all available peer-reviewed frequency with which the DOQI guidelines have information. When no evidence existed, or the been cited in the literature and have served as the evidence was inadequate, guidelines were based focus of local, national, and international scien- on the considered opinion of the Work Group tific and educational symposia is one measure of experts. In all cases the rationale and the eviden- their influence. The guidelines also have been tiary basis of each recommendation was stated translated into more than 10 languages and have explicitly. been adopted in countries across the globe. In Draft guidelines were then subjected to a three- addition, DOQI has spawned numerous educa- stage review process. In the first stage, an Advi- tional and quality improvement projects in virtu- sory Council, consisting of 25 experts and lead- ally all relevant disciplines, as well as in dialysis ers in the field, provided comments on the initial treatment corporations and individual dialysis draft of the guidelines. In the second stage, a centers. Furthermore, the Health Care Financing variety of organizations (ESRD Networks, profes- Administration has responded to a Congres- sional and patient associations, dialysis provid- sional mandate to develop a system for evalua- ers, government agencies, product manufactur- tion of the quality of care delivered in dialysis ers, and managed care groups) were invited to centers by developing a series of Clinical Perfor- FOREWORD S3 mance Measures (CPMs) based on selected DOQI DOQI have been adapted and expanded to reflect guidelines. the new mission of K/DOQI and its multidisci- It is encouraging that two of the ESRD Net- plinary focus. Relevant material from the Nutri- works have developed a guideline prioritization tion Guidelines and future K/DOQI Guidelines tool and embarked on a Prioritization