Continuous quality improvement: DOQI becomes K/DOQI and is updated. National Kidney Foundation's Dialysis Outcomes Quality Initiative.
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Biomedical subjects
Publications and source records attributed to G Eknoyan.
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The beneficial effects of treating the anaemia of dialysis-dependent patients with erythropoietin on the improvement of cardiac status, exercise capacity, cognitive function and quality of life are well established. Equally, if not more important is the reduction in morbidity and mortality that accompanies the treatment of anaemia with epoietin. These documented improvements in outcomes of care notwithstanding, mortality and morbidity due to cardiovascular disease (CVD) remain high in dialysis patients. Recent epidemiological evidence indicates that: (i) the prevalence of CVD is very high in patients at the start of dialysis; (ii) pre-existing CVD is the major risk factor for mortality and morbidity on dialysis; (iii) CVD begins early in the course of kidney disease, shows an inverse relationship to kidney function and increases in prevalence and severity with progression of kidney disease; and (iv) corrective measures, which take 3-5 years to show a favourable effect, must be instituted well before the initiation of dialysis. Hypertension and anaemia, which develop in the course of progressive reduction in kidney function, are the principal risk factors for the prevalence of left ventricular hypertrophy (LVH) in those with chronic kidney disease, and their treatment has been shown to arrest or reverse LVH in these individuals. Whereas the treatment of hypertension early in the course of kidney disease has been incorporated into clinical practice, there has been reluctance in the treatment of anaemia because of the possibility of worsening kidney function with epoietin, as shown in rats. There is now convincing evidence that epoietin has no potential adverse effect on kidney function in humans. While the most compelling reason for the early treatment of the anaemia of kidney disease is its beneficial effect on cardiovascular function, other documented potential benefits are improvements in exercise capacity, cognitive function and quality of life.
The alarming increase in the incidence and mortality rate of end-stage renal disease (ESRD) over the past several years has prompted concerned physicians to ask why--and to ponder what can be done to ameliorate the situation. This article, the first in a seven-part series coordinated by the National Kidney Foundation, examines the factors surrounding the epidemic of chronic kidney disease and introduces readers to the organization's new clinical practice guidelines developed through its Kidney Disease Outcomes Quality Initiative. These recommendations emphasize early detection and treatment and offer a new avenue of communication between primary care physicians and nephrologists.
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The Hemodialysis Study is a multicenter clinical trial of hemodialysis prescriptions for patients with end stage renal disease. Participants from over 65 dialysis facilities associated with 15 clinical centers in the United States are randomized in a 2 x 2 factorial design to dialysis prescriptions targeted to a standard dose or a high dose, and to either low or high flux membranes. The primary outcome variable is mortality; major secondary outcomes are defined based on hospitalizations due to cardiovascular or infectious complications, and on the decline of serum albumin. The Outcome Committee, consisting of study investigators, uses a blinded review system to classify causes of death and hospitalizations related to the major secondary outcomes. The dialysis dose intervention is directed by the Data Coordinating Center using urea kinetic modeling programs that analyze results from dialysis treatments to monitor adherence to the study targets, adjust suggested dialysis prescriptions, and assist in trouble-shooting problems with the delivery of dialysis. The study design has adequate power to detect reductions in mortality rate equal to 25% of the projected baseline mortality rate for both of the interventions.
Rigorously developed clinical practice guidelines have the potential to improve patient outcomes. It is toward that end that the National Kidney Foundation (NKF) launched in March 1995 the Dialysis Outcome Quality Initiative (DOQI), an ambitious effort to develop evidence-based clinical practice guidelines for the care of patients with end-stage renal disease (ESRD). Independent, interdisciplinary work groups conducted a structured review of the content and methodologic rigor of all the published literature pertinent to four selected topics: hemodialysis adequacy, peritoneal dialysis adequacy, vascular access, and anemia. Following expert, organizational, and public review, the guidelines were issued in September and October 1997. An implementation plan that called for widespread dissemination of the guidelines and facilitation of adoption of them has resulted in their broad acceptance and Integration into quality improvement efforts. Additional guidelines on nutrition have recently been completed, while others on bone disease, hypertension, and hyperlipidemia are in various stages of planning or development. A major determinant of poor outcome of maintenance dialysis patients is the debilitated state of many individuals with ESRD at the time that they commence dialysis therapy. The recognition of this problem has stimulated an interest in extending the guidelines to management of patients with less severe renal insufficiency, well before they need renal replacement therapy; and to the early detection of renal insufficiency by a proteinuria and albuminuria risk assessment, detection, and elimination (PARADE) program. What started as an initiative to improve the quality of care of dialysis patients has evolved into a considerably expanded effort to making lives better for all individuals with any level of renal insufficiency.
Michelangelo (1475-1564) had a life-long interest in anatomy that began with his participation in public dissections in his early teens, when he joined the court of Lorenzo de' Medici and was exposed to its physician-philosopher members. By the age of 18, he began to perform his own dissections. His early anatomic interests were revived later in life when he aspired to publish a book on anatomy for artists and to collaborate in the illustration of a medical anatomy text that was being prepared by the Paduan anatomist Realdo Colombo (1516-1559). His relationship with Colombo likely began when Colombo diagnosed and treated him for nephrolithiasis in 1549. He seems to have developed gouty arthritis in 1555, making the possibility of uric acid stones a distinct probability. Recurrent urinary stones until the end of his life are well documented in his correspondence, and available documents imply that he may have suffered from nephrolithiasis earlier in life. His terminal illness with symptoms of fluid overload suggests that he may have sustained obstructive nephropathy. That this may account for his interest in kidney function is evident in his poetry and drawings. Most impressive in this regard is the mantle of the Creator in his painting of the Separation of Land and Water in the Sistine Ceiling, which is in the shape of a bisected right kidney. His use of the renal outline in a scene representing the separation of solids (Land) from liquid (Water) suggests that Michelangelo was likely familiar with the anatomy and function of the kidney as it was understood at the time.
This report describes the approach the National Kidney Foundation-Dialysis Outcomes Quality Initiative (NKF-DOQI) used to assess the strength of published evidence pertinent to individual NKF-DOQI Clinical Practice Guidelines, as well as the relationship between that approach and methods used by the US Preventive Services Task Force, the Cochrane Collaboration, and the Agency for Health Care Policy and Research to rate the quality and/or strength of evidence. We also present the results of an analysis of the strength of evidence underlying the NKF-DOQI Guidelines showing that one cannot infer the quality of evidence reported in a study (rated either on a 0-to-1 scale or categorically as excellent, very good, good, fair, or poor) simply by knowing the type of study design used (randomized trial, nonrandomized trial, natural experiment, cohort study, cross-sectional study, case-control study, case report). Issues related to assessment of the strength of evidence underlying a practice guideline opposed to that reported in an individual study are highlighted.
The Hemodialysis (HEMO) Study is a multicenter, prospective, randomized, 2 x 2 factorial clinical trial designed to evaluate the efficacy of the dose of dialysis delivered ("standard" v "high") and dialysis membrane flux ("low" v "high") in reducing the morbidity and mortality of patients. The study is nearly half complete. Although both patients and investigators are blinded to the overall findings, which will not be available for another 3 years, important data have been generated from which a more accurate expression has been derived for the dose of dialysis received by each patient in the trial. This new expression of the effectiveness of dialysis, eKt/V, is a two-pool approximation derived from the traditional single-pool Kt/V (spKt/V) and time on dialysis. The dialysis prescription for the HEMO Study subjects is individualized to achieve the target dose for each patient and is closely monitored by measuring the more accurate and validated expression of eKt/N. Comparisons of the HEMO Study dose of dialysis with other studies have been confused by this unique expression (eKt/V) of the dialysis dose and adequacy adopted for the HEMO Study. The target eKt/V dose in the "standard" arm of the Study is 1.05 and in the "high" arm is 1.45 per dialysis thrice weekly. Based on data available from 426 subjects randomized to each arm, the target of 1.05 in the "standard" dose of the HEMO Study is equivalent to an spKt/V of 1.32, and that of the "high" dose, 1.67. Thus, volunteers in the "standard" arm of the Study are receiving a tightly controlled and closely monitored dose, which is above the current national mean spKt/V, and above that of the accepted minimum standard spKt/N of 1.2. When completed, the HEMO Study will show whether there are merits of a tightly controlled hemodialysis dose that is consistently delivered over a prolonged period and whether a high dose is beneficial and safe to prescribe.
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Rigorously developed clinical practice guidelines have the potential to improve outcomes and favorably alter practice patterns. Because of widespread community concerns over the quality of dialysis care, the National Kidney Foundation initiated a Dialysis Outcomes Quality Initiative (NKF-DOQI) in March 1995 in an effort to create evidence-based best-practice clinical guidelines. Independent interdisciplinary Work Groups reviewed the available body of scientific literature on four selected topics: hemodialysis adequacy, peritoneal dialysis adequacy, vascular access, and anemia. More than 11,000 publications were identified, of which 1,500 were considered relevant and were subjected to structured review. Draft guidelines, with supporting rationales of their evidentiary basis, were subjected to a three-stage public and organizational review process. The final guidelines were issued in the fall of 1997. Because the potential benefit of guidelines depends on their implementation, planning for the implementation of NKF-DOQI was begun simultaneously with its review process. A 3-year implementation plan, with specific priorities and estimated costs, was developed and set into action by the end of 1997. The main objectives of the rather diverse and multifaceted plan of action are translating the NKF-DOQI Guidelines into clinical practice, building on what has been accomplished, and continued evaluation and review of the Guidelines.
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Driven by their deep-seated desire for eternal life in a healthy body, ancient Egyptians were one of the first civilizations to begin collecting and recording medical lore and medicinals that were effective for a healthy body. With its religious origins, medical care was initially provided by priests, but evolved over time into an independent discipline practiced by the swnw (sounou) or physician. What has been preserved of their knowledge in extant medical papyri reflects the great capacity of Egyptians for practical achievement in treating symptoms, but lacks the abstract thought that was to come with the advent of the more rational Greek medicine. The number of prescriptions and incantations for the management of urinary disorders (hematuria, retention, frequency, infection) and dropsy that are mentioned in extant medical papyri likely reflect the frequency with which these problems were encountered. Urine was thought to be formed in the region of the bladder, by a process considered akin to purification. Available studies on preserved mummies indicate that kidney disease was not uncommon. Whether a functional role of the kidney was appreciated at all is highly doubtful. On the other hand, the available evidence suggests an awareness of the kidney (ggt) to which was ascribed a mythological role that may well account for why the kidneys and the heart were the only organs not removed during the process of mummification.
The intellectual renaissance of the closing decades of the sixteenth century provided the fertile ground in which the budding spirit of scientific inquiry emerged in the seventeenth century. Direct observation, soon augmented by instrumentation that allowed for quantification and, therefore, verification, became the revelatory medium for the progress of the sciences. In medicine, progress depended on the application of the exact sciences of chemistry, mathematics and physics to the study of function. One of the medical luminaries of this early scientific revolution was Santorio Sanctorius (1561- 1636), whose principal contributions were his studies on insensible perspiration and his instrumental inventions. To study insensible perspiration, he designed a movable platform attached to a steelyard scale that allowed for the quantification of changes in body weight of subjects who partook in their daily activities on the platform. After years of self-experimentation, he applied his device to the study of patients. Unfortunately, his records are lost. What survives is a summary of his observations in a series of aphorisms published under the title of Ars de statica medicina, in 1614; 3 years after he was appointed Ordinary Professor of Theoretical Medicine in Padua. To enhance the bedside evaluation of patients, he also designed instruments to quantify the pulse, temperature, and environmental humidity. For his pioneering and detailed balance studies, Sanctorius clearly deserves the title of founding father of metabolic balance studies.
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Hundreds of thousands of individuals are alive today because of the availability of dialysis for the treatment of patients with end-stage renal disease (ESRD). From the outset, it was evident that this was a costly therapy and would require specialized training. The federal government responded by providing financial support and medicine by establishing the discipline of nephrology to provide specialized training. As a result, the center stage that ESRD has come to occupy was dictated by a successful treatment in the purview of a new discipline by a model and well-intentioned, but restrictive, law that provided support only to the terminal stage of kidney disease. That this natural evolution was short-sighted has become a belated, but well-deserved, focus of attention. The care of chronic renal disease (CRD) patients cannot start after the onset of ESRD when renal replacement therapy is initiated but must be set into motion when renal failure first begins to exert its detrimental effects on the metabolic balance, function, and structure of the body. Attentive care is needed throughout the course of progressive renal failure, because once CRD begins to progress, there is an increasing number of detrimental consequences whose cumulative burden will exert its ravages on the body simultaneously with that of the ongoing loss of renal function. Consequently, the patient with CRD who presents in ESRD has already sustained considerable, often irreversible, loss of body function. Preventive measures to circumvent this eventuality are most effective, cost-efficient, and of greatest benefit when instituted early in the course of progressive CRD. This is probably truest of cardiovascular disease, which is the leading cause of mortality of patients on dialysis and following transplantation. The report of the National Kidney Foundation Task Force on Cardiovascular Disease in CRD is a first attempt to promulgate and provide evidence-based recommendations for this holistic approach to the care of patients with renal disease.