NKF K/DOQI GUIDELINES 2000
 
 
   

 

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.

 

FOREWORD

From its rudimentary beginnings in the 1960s, renal replacement therapy has become a lifesaving treatment that can provide end-stage renal disease (ESRD) patients with a good quality of life. As a result, the number of ESRD patients who receive renal replacement therapy has risen, and their survival has increased, but considerable geographic variability exists in practice patterns and patient outcomes. It was this realization, and the belief that substantial improvements in the quality and outcomes of renal replacement therapy were achievable with current technology, that prompted several organizations to seek to reduce variations in ESRD treatment with the goal of a more uniform delivery of the highest possible quality of care to dialysis patients. Notable among these efforts were the report on "Measuring, Managing and Improving Quality in the ESRD Treatment Setting" issued by the Institute of Medicine in September 1993; the "Morbidity and Mortality of Dialysis" report issued by the National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK) in November 1993; the Core Indicator Project initiated by the ESRD Networks and the Health Care Financing Administration (HCFA) in 1993; the "Clinical Practice Guidelines on the Adequacy of Hemodialysis" issued by the Renal Physicians Association in December 1993; and the Dialysis Outcomes Quality Initiative (DOQI) initiated by the National Kidney Foundation (NKF) in 1995.

In keeping with its longstanding commitment to the quality of care delivered to all patients with kidney and urologic diseases, the NKF convened a Consensus Conference on Controversies in the Quality of Dialysis Care in March 1994. Following a series of nationwide town hall meetings held to obtain input into the recommendations made at the Consensus Conference, the NKF issued an "Evolving Plan for the Continued Improvement of the Quality of Dialysis Care" in November 1994. A central tenet of the plan was recognition of an essential need for rigorously developed clinical practice guidelines for the care of ESRD patients that would be viewed as an accurate and authoritative reflection of current scientific evidence. It was to this end that the NKF launched the "Dialysis Outcomes Quality Initiative" (DOQI) in March 1995, supported by an unrestricted grant from Amgen, Inc.

The objectives of DOQI were ambitious: to improve patient survival, reduce patient morbidity, improve the quality of life of dialysis patients, and increase efficiency of care. To achieve these objectives, it was decided to adhere to several guiding principles that were considered to be critical to that initiative's success. The first of these principles was that the process used to develop the DOQI guidelines should be scientifically rigorous and based on a critical appraisal of all available evidence. Such an approach was felt to be essential to the credibility of the guidelines. Second, it was decided that participants involved in the development of the DOQI guidelines should be multidisciplinary. A multidisciplinary guideline development process was considered to be crucial, not only to the clinical and scientific validity of the guidelines, but also to the need for multidisciplinary adoption of the guidelines following their dissemination, in order for them to have maximum effectiveness. Third, a decision was made to give the DOQI guideline development Work Groups final authority over the content of the guidelines, subject to the requirement that guidelines be evidence-based whenever possible. By vesting decision-making authority in a group of individuals, from multiple disciplines and with diverse viewpoints, all of whom are experts with highly regarded professional reputations, the likelihood of developing sound guidelines was increased. Moreover, by insisting that the rationale and evidentiary basis of each DOQI guideline be made explicit, Work Group participants were forced to be clear and rigorous in formulating their recommendations. The final principle was that the guideline development process would be open to general review. Thus, the chain of reasoning underlying each guideline was subject to peer review and available for debate.

Based on the "NKF Evolving Plan for the Continued Improvement of the Quality of Dialysis Care" and criteria recommended by the Agency for Health Care Research and Quality (AHCRQ; formerly known as the Agency for Health Care Policy and Research [AHCPR]), four areas were selected for the initial set of clinical practice guidelines: hemodialysis adequacy, peritoneal dialysis adequacy, vascular access, and anemia. Each Work Group selected which topics were considered for guideline creation. During the DOQI guideline development process, nearly 11,000 potentially relevant published articles were subjected to evaluation, and both the content and methods of approximately 1,500 articles underwent formal, structured review. Although labor-intensive and costly, the process resulted in an intensive, disciplined, and credible analysis of all available peer-reviewed information. When no evidence existed, or the evidence was inadequate, guidelines were based on the considered opinion of the Work Group experts. In all cases the rationale and the evidentiary basis of each recommendation was stated explicitly.

Draft guidelines were then subjected to a three-stage review process. In the first stage, an Advisory Council, consisting of 25 experts and leaders in the field, provided comments on the initial draft of the guidelines. In the second stage, a variety of organizations (ESRD Networks, professional and patient associations, dialysis providers, government agencies, product manufacturers, and managed care groups) were invited to review and comment on a revised draft of the guidelines. After considering these comments and suggestions, the Work Groups produced a third draft of the Guidelines. In the final stage, this draft was made available for public review and comment by all interested individuals or parties. Following consideration of the comments submitted during this open review period, the guidelines were revised again and then published as supplements to the September and October 1997 issues of the American Journal of Kidney Diseases was made available on the Internet and widely distributed.

The four sets of DOQI guidelines published in 1997 addressed only part of the "Evolving Plan for the Continued Improvement of the Quality of Dialysis Care" adopted by the NKF in 1994. In that plan, as well as in the early DOQI prioritization process, nutrition was considered to be an important determinant of ESRD patient outcome. Consequently, a Nutrition Work Group was convened in 1997 to review the key clinical nutrition literature and to define topics for which guidelines related to the nutritional management of patients should be developed. Supported primarily by a grant from Sigma Tau Pharmaceuticals, Inc, the Nutrition Work Group began to work intensively on those topics in January 1998, and the Nutrition Guidelines that they have developed constitute this fifth set of the original DOQI guidelines.

NKF-DOQI achieved many, but not all of its goals. The guidelines have been well received and are considered by many to reflect the "state of the art" of medical practice in their fields. The frequency with which the DOQI guidelines have been cited in the literature and have served as the focus of local, national, and international scientific and educational symposia is one measure of their influence. The guidelines also have been translated into more than 10 languages and have been adopted in countries across the globe. In addition, DOQI has spawned numerous educational and quality improvement projects in virtually all relevant disciplines, as well as in dialysis treatment corporations and individual dialysis centers. Furthermore, the Health Care Financing Administration has responded to a Congressional mandate to develop a system for evaluation of the quality of care delivered in dialysis centers by developing a series of Clinical Performance Measures (CPMs) based on selected DOQI guidelines.

It is encouraging that two of the ESRD Networks have developed a guideline prioritization tool and embarked on a Prioritization and Implementation Project that would link selected DOQI guidelines into the Health Care Quality Improvement Project proposed by HCFA in the ESRD Networks' most recent Scope of Work. This project would involve a collaborative effort of professional organizations, local practitioners, and patients. In fact, it is this collaborative spirit and total commitment to patient care that accounts for the success that DOQI has achieved heretofore.

As we begin the new millennium, the DOQI clinical practice guideline initiative will move forward into a completely new phase, in which its scope will be enlarged to encompass the spectrum of chronic kidney disease well before the need for dialysis, when early intervention and prevention measures can delay or prevent the need for dialysis and improve its outcomes. This enlarged scope increases the potential impact of improving outcomes of care from hundreds of thousands to millions of individuals with kidney disease. To reflect this expansion, the reference to "Dialysis" in DOQI will be changed to "Disease" and the new initiative will become known as Kidney Disease Outcomes Quality Initiative (K/DOQI).

The dissemination and implementation strategies that have proven so effective for NKF-DOQI have been adapted and expanded to reflect the new mission of K/DOQI and its multidisciplinary focus. Relevant material from the Nutrition Guidelines and future K/DOQI Guidelines will be developed into implementation tools appropriate not just for nephrology, but also the specialties most likely to encounter those at risk for chronic kidney disease early in the course of their illness, including cardiology, hypertension, diabetes, family practice, pediatrics, and internal medicine.

On behalf of the National Kidney Foundation, we would like to acknowledge the tremendous contributions of all the volunteers who gave so much of their time and effort to the success of DOQI in order to improve the quality of life and outcomes of dialysis patients. The Nutrition Guidelines extend the DOQI objectives even further into the new and broader K/DOQI goals. Since the effort that went into preparing the Nutrition Guidelines was under the aegis of the original DOQI Advisory Council and Steering Committee, these two bodies are acknowledged. The new K/DOQI Advisory Board now will assume the charge of disseminating and implementing the Nutrition Guidelines.

Garabed Eknoyan, MD
K/DOQI Co-Chair

Nathan W. Levin, MD
K/DOQI Co-Chair

K/DOQI Advisory Board Members

George Bailie, PharmD, PhD

Ramon G. Hannah, MD, MS

Rosa A. Rivera-Mizzoni, MSW, LCSW

Gavin Becker, MD, MBBS

Jaime Herrera Acosta, MD

Joseph V. Nally, MD

Jerrilynn Burrowes, MSN, RD, CDN

Ronald Hogg, MD

John M. Newmann, PhD, MPH

David N. Churchill, MD, FACP

Laurence Hunsicker, MD

Allen Nissenson, MD

Allan Collins, MD, FACP

Cynda Ann Johnson, MD

Keith Norris, MD

William Couser, MD

Michael Klag, MD, MPH

William Owen, Jr, MD

Dick DeZeeuw, MD

Saulo Klahr, MD

Glenda Payne, RN

Garabed Eknoyan, MD

Nathan W. Levin, MD, FACP

David Smith

Alan Garber, MD, PhD

Caya Lewis, MPH

Robert Star, MD

Thomas Golper, MD

Edmund Lowrie, MD

Michael Steffes, MD, PhD

Frank A. Gotch, MD

Arthur Mattas, MD

Theodore Steinman, MD

Antonio Gotto, MD

Sally McCulloch, MSN, RN, CNN

Professor John Walls

Joel W. Greer, PhD

Maureen Michael, BSN, MBA

Nanette Wenger, MD

Richard Grimm, Jr, MD

   

 

Introduction

Protein-energy malnutrition (PEM) is very common among patients with advanced chronic renal failure (CRF) and those undergoing maintenance dialysis (MD) therapy worldwide. Different reports suggest that the prevalence of this condition varies from roughly 18% to 70% of adult MD patients. In adults, the presence of PEM is one of the strongest predictors of morbidity and mortality. However, in the poorly nourished pediatric patient, mortality is less common, and growth retardation is an additional and greater concern. Impaired linear growth persists despite ongoing renal replacement therapy with either hemodialysis (HD) or peritoneal dialysis, and improvements in linear growth after successful renal transplantation usually fail to fully correct pre-existing growth retardation unless growth hormone (GH) is administered. Although several factors contribute to the impaired skeletal growth in pediatric patients with chronic renal disease, protein and energy malnutrition play a critical role, particularly during the first few years of life. Additional factors that contribute to impaired growth in pediatric patients include anemia, acidemia, calcitriol deficiency, renal osteodystrophy, and tissue resistance to the actions of GH and insulin-like growth factor-I (IGF-I).

There are many causes of PEM in patients with advanced CRF. These include:

(a) inadequate food intake secondary to:
  • anorexia caused by the uremic state
  • altered taste sensation
  • intercurrent illness
  • emotional distress or illness
  • impaired ability to procure, prepare, or mechanically ingest foods
  • unpalatable prescribed diets
(b) the catabolic response to superimposed illnesses
(c) the dialysis procedure itself, which may promote wasting by removing such nutrients as amino acids, peptides, protein, glucose, water-soluble vitamins, and other bioactive compounds, and may promote protein catabolism, due to bioincompatibility
(d) conditions associated with chronic renal failure that may induce a chronic inflammatory state and may promote hypercatabolism and anorexia
(e) loss of blood due to:
  • gastrointestinal bleeding
  • frequent blood sampling
  • blood sequestered in the hemodialyzer and tubing
(f) endocrine disorders of uremia (resistance to the actions of insulin and IGF-I, hyperglucagonemia, and hyperparathyroidism)
(g) possibly the accumulation of endogenously formed uremic toxins or the ingestion of exogenous toxins.

Notwithstanding the many causes of PEM in patients with CRF, provision of adequate nutrition is a key component of the prevention and treatment of PEM in adults and children receiving MD. These K/DOQI Nutrition Clinical Practice Guidelines provide recommendations regarding the nutritional assessment of protein-energy nutritional status and the desirable dietary energy and protein intake for adults and children undergoing MD. Guidelines were developed for children treated with MD concerning their nutritional needs for vitamins, zinc, and copper and for their treatment with recombinant human GH. Guidelines are also provided regarding the nutritional intake of L-carnitine for adult MD patients, the nutritional management of the nondialyzed adult patient with advanced CRF, and the management of the acutely ill pediatric and adult patient. For logistical reasons, recommendations for the nutritional management of nondialyzed pediatric patients with advanced CRF were not developed. The decision was made to not address vitamin and mineral needs or the use of anabolic agents in the adult MD patient, because the scope of the subject matter and the volume of scientific literature was considered to be too large for inclusion in this set of guidelines.

The guidelines are based on a structured review of the medical literature and, where insufficient evidence exists, on the expert opinion of the Work Group members. In each case, the guidelines are intended to serve as starting points for clinical decision making, and it is emphasized that the clinical judgment of the health care practitioner must always be included in the decision making process and the application of these guidelines. The guidelines are not to be considered as rules or standards of clinical practice. At the end of each guideline, recommendations are made for research studies that may enhance the scientific evidence base concerning the subject matter of that guideline. In keeping with the K/DOQI objectives, it is hoped that the information provided in these guidelines and the research recommendations will improve the quality of care provided to children and adults who have chronic kidney disease or are receiving chronic dialysis therapy and will stimulate additional research that will augment and refine these guidelines in the future.

The K/DOQI Nutrition Work Group expresses its indebtedness and appreciation to Thomas Golper, MD, and John Burkhart, MD, for their contributions to Guideline 27; to Tom Greene, PhD, and Thomas Depner, MD, for their assistance with the development of Appendix V; to Paul Shekelle, MD, and Erin Stone, MD, for the structured review and guidance in the guideline development process; and to Donna Fingerhut, MSEd, for the innumerable hours she devoted to the overall administration of the project. The efforts and expertise of these individuals were invaluable.

© 2000 by the National Kidney Foundation, Inc.

 

 

METHODS

The Guideline Development Process

CLINICAL PRACTICE GUIDELINES DEFINED

 

The Institute of Medicine has defined practice guidelines as "systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances." The American Medical Association endorsed this definition by describing practice guidelines as "systematically developed statements, based on current professional knowledge, that assist practitioners and patients to make decisions about appropriate health care for specific clinical circumstances." Put simply, practice guidelines constitute an effort to advise health-care providers and patients as to what constitutes optimal clinical practice, based on the best information available. As a result, practice guidelines can not only improve both quality and cost-effectiveness of care, but can also facilitate continuous improvement in clinical practice as new information becomes available.

K/DOQI GUIDING PRINCIPLES

Four principles guided decision-making in the conduct of the NKF-DOQI and will be retained for the K/DOQI guidelines:

  1. K/DOQI practice guidelines will be developed using a scientifically rigorous process, and the rationale and evidentiary basis for each guideline will be clearly explained.
  2. K/DOQI guidelines will be developed by multidisciplinary Work Groups with expertise in the topic of interest.
  3. The Work Group members will work independently of any organizational affiliations and would have final responsibility for determining guideline content.
  4. K/DOQI guidelines will undergo widespread critical review before being finalized.

EVIDENTIARY BASIS FOR GUIDELINES

The guidelines were developed using an evidence-based approach similar to the one used by The Federal Agency for Health Care Research and Quality (AHCRQ). That is, before formulating recommendations, the Work Groups reviewed all published evidence pertinent to the topics being considered and critically appraised the quality and strength of that evidence. For many issues that the Work Groups chose to address, there either was no pertinent literature available or available evidence was flawed or weak. As a result, in many instances the Work Groups formulated their recommendations based on the opinions of the Work Group members and comments received from the peer reviewers. In all instances, the Work Groups have documented the rationale for their recommendations. That is, they have articulated each link in the chain of logic they used as the evidentiary or opinion-related basis for their recommendation. This approach helps readers of the guidelines determine the quantity and quality of evidence underlying each recommendation.

Although some of the DOQI guidelines are clearly based entirely on evidence or entirely on opinion, many are based in part on evidence and in part on opinion. Such "hybrid" guidelines arise when some (or even most) of the links in the chain of logic underlying a guideline are based on empirical evidence, but some (ie, at least one) are based on opinion. The opinion of the Work Group members can enter the chain of logic that supports a guideline either to fill in a gap in available evidence on some scientific or clinical issue, or in the form of a value judgment regarding what they feel is appropriate clinical practice based on available evidence. Thus, many opinion-based guidelines may have substantial empirical evidence underlying them. These guidelines were developed using a seven-stage process.

Phase I: Work Group Member Selection

The DOQI Steering Committee selected a Chair to lead the Adult and Pediatric Nutrition Work Group and suggested names of individuals with particular expertise to serve on the Work Group. Final decisions on the membership of the Work Group were made by the Work Group Chair. In recognition of the different bodies of literature and expertise for nutrition issues in adult and pediatric ESRD and MD patients, the Work Group Chairs appointed separate nutrition Work Groups for adult and pediatric patients. Two Vice Chairs, for protein-energy nutrition and for carnitine, were appointed for the Adult Work Group, and one Vice Chair was appointed for the Pediatric Work Group.

Support for the Work Groups in coordinating and performing the systematic literature review, synthesizing data abstracted from the literature into evidence tables, facilitation of the guideline development process, conducting meetings of the Work Groups, and analyzing results of the guideline development meetings was provided by personnel from the RAND Corporation and Cedars-Sinai Medical Center. Both of these institutions are associated with the Southern California Evidence-Based Practice Center.

Phase II: Targeting

The Work Groups defined the specific topics on which guidelines would focus and the specific questions on which the systematic literature would focus. The following clinical questions were formulated:

Question 1. Which of the following measures of nutritional status best predicts patient morbidity/mortality (and growth rate in children) in MD patients?

Serum albumin, serum prealbumin, anthropometric measures (height, weight, skinfold thickness, body mass index [BMI], percent of normal body weight, percent of desirable body weight, postdialysis body weight), bioelectrical impedance (BIA), urea nitrogen appearance, serum creatinine and creatinine index, subjective global nutritional assessment (SGA), dietary diaries and interviews, serum cholesterol, serum transferrin, serum IGF in pediatric patients, protein equivalent of total nitrogen appearance (PNA/PCR), prognostic nutrition index, serum acute-phase proteins (C-reactive protein), serum alpha-1 glycoprotein, dual energy x-ray absorptiometry (DXA), a combination of more than one of these measures.

Question 2. Which of the following measures is the best diagnostic test for protein/energy nutritional status in MD patients?

Serum albumin, serum prealbumin, anthropometric measures (height, weight, skinfold thickness, BMI, percent of normal body weight, percent of ideal body weight, postdialysis body weight), BIA, urea nitrogen appearance, serum creatinine and creatinine index, SGA, dietary diaries and interviews, serum cholesterol, serum transferrin, serum IGF, PNA, prognostic nutrition index, serum acute phase proteins (C-reactive protein), serum alpha-1 glycoprotein, DXA, a combination of more than one of these measures.

Question 3. What is the effect of acid/base status on nutritional measures in MD patients?

Question 4. Which levels of intake of protein and energy in MD patients produce the following:

The lowest morbidity/mortality, the most optimum changes in nutritional status using measures from Question 1 above, positive nitrogen balance, the most optimal growth in children?

Question 5. Which levels of protein and energy intake in predialysis patients produce the lowest morbidity at the initiation of dialysis? (This question was included because of evidence that nutritional status at the onset of MD therapy is a strong predictor of nutritional status and mortality during the course of MD therapy.)

Question 6. What is the energy expenditure of MD patients during resting and other activities, and how does it compare with energy expenditure in normal individuals?

Question 7. Is interdialytic weight gain a good measure for dietary compliance or a good prognostic indicator?

Question 8. Does carnitine supplementation in adult MD patients improve morbidity or mortality?

Question 9. What are the toxic/adverse effects of L-carnitine, if any, in adult MD patients?

Question 10. Which nutritional interventions produce the lowest morbidity/mortality (and best growth in children) or the most optimum changes in nutritional status in MD patients using measures from Question 1 above?

Question 11. Does GH therapy improve growth or morbidity/mortality in pediatric MD patients?

Question 12. Does vitamin or mineral supplementation (exclusive of calcium, magnesium, and vitamin D) improve morbidity/mortality in pediatric MD patients?

Phase III: Literature Review, Selection, and Abstraction

A structured database search of two computerized bibliographic databases (MEDLINE and EMBASE) was performed with the following specifications: language: English and non-English articles; dates: 1966 through 1997; subjects: human; article types: letters, editorials, reviews, case reports, and abstracts of meeting proceedings were excluded. The literature search was performed in collaboration with a librarian experienced in searching computerized bibliographic databases and performing "evidence-based" systematic reviews. The Journal of Renal Nutrition was hand-searched, because, at the time, it was not indexed in the bibliographic databases listed above. Additionally, referrals from DOQI Work Group members through August 1999 were reviewed.

After loading articles from MEDLINE, EMBASE, Work Group referrals, and the Sigma Tau bibliography into an electronic database, one reviewer performed an initial title review of these articles. Two independent reviewers then reviewed the abstracts of articles whose titles were selected. Selection disagreements were resolved by consensus. English language articles for which the abstracts were selected were then obtained and categorized based on the clinical question the article addressed. Two independent reviewers then reviewed these articles. Information was abstracted from the articles (see below) by one abstracter and verified by a second. Disagreements were resolved by consensus. Articles that were rejected at this stage were coded using the following codes:

R1: Editorial, letter, review, case report, article published as abstracts
R2: Article does not answer clinical question of interest
R3: Article does not have study design of interest
R4: Pediatric article (if adult section)
R5: Not human
R6: Adult article (if pediatric section)

In order to increase precision and reduce systematic errors, the language of manuscripts was not limited to English.1,2 The English titles and English abstracts of foreign language articles, when available, were sent to all Work Group members for review. The abstracts of foreign language manuscripts were translated into English if any Work Group member thought that the paper might contribute positively to the evidence base. Selections were further based on study design. For prognostic articles, only those with prospective cohort or historical prospective cohort designs were included for further analysis. For assessment of nutritional status, only manuscripts in which a nutritional parameter was compared to a recognized standard nutritional measure or to a clinical outcome were included for further analysis. For manuscripts examining nutritional treatment, only those with a prospective design with concurrent controls were analyzed further. Because there were smaller numbers of these types of studies for carnitine treatment or pediatric renal nutrition, these requirements were not as rigidly applied for this literature.

After article abstraction (see below), evidence tables were produced from a subset of abstracted data elements and evaluated by the Work Group during meetings in Los Angeles in August 1998 (Adult Work Group), in October 1998 (Pediatric Work Group), and during a series of subsequent conference calls. The Work Group accepted or rejected articles based on the study design and methods and the adequacy with which it addressed the clinical questions. The final selected articles are indicated by an asterisk in the reference section. Other citations, that are not asterisked, were not used for guideline development, but were used to more fully explain the background or rationale for a guideline.

Critical Appraisal Method for Articles Concerning Prognosis.    For each prognostic article, the following characteristics were ascertained3: (1) the study type; (2) the three main co-morbid conditions; (3) whether there was a representative and well-defined sample of patients at a similar phase in the course of disease; (4) the characteristics of the study population and dialysis procedures that might have affected the study results; (5) the duration of the follow-up period; (6) whether the outcomes were objective and the interpretation of the outcomes was unbiased; (7) whether adjustment was made for important known prognostic factors; and (8) the results of the study.

Critical Appraisal Methods for Articles Concerning Nutritional Assessment.    For each article concerning nutritional assessment, the following information was obtained4,5: (1) the type of study; (2) the three main co-morbid conditions; (3) whether there was an independent blinded comparison with a reference (gold) standard; (4) the characteristics of the study population and the dialysis procedures that might have affected the study results; (5) whether the results of the nutritional measure that was studied influenced the decision to measure the reference standard; (6) whether characteristics and variety of the patients' standard is similar to those found in dialysis centers; (7) whether the test methodology are described well enough to be reproducible; and (8) the results of the study.

Critical Appraisal Methods for Articles Concerning Nutritional Treatment.    For each treatment article, the following information was obtained6,7: (1) the type of study; (2) the three main co-morbid conditions; (3) the Jadad quality scores8; (4) the randomization score; (5) the double blind score; (6) the score for whether all patients were accounted for; (7) an intention-to-treat score; (8) whether the treatment groups were similar at baseline; (9) the characteristics of the study population, dialysis procedure, and other ancillary treatment that might have affected the study results; (10) whether the treatment groups were treated similarly except for the study intervention; and (11) the results of the study.

The Jadad quality scores address issues most important in demonstrating the validity of randomized clinical trials and have been demonstrated to reflect methodological quality. Empirical evidence demonstrates that when these quality features are not met in clinical trials, bias and an exaggeration of the effect sizes often result.8-12

Results of the Systematic Review.    The initial literature search identified 19,272 MEDLINE and 4,943 EMBASE articles. In addition, the Work Groups referred 134 articles for review, and the Sigma Tau Pharmaceutical Corporation submitted a bibliography that contained 138 additional references that were included in the analysis. Of these 24,487 references, 22,362 titles were rejected as not meeting the inclusion criteria, leaving 2,125 titles. Abstracts of these articles were reviewed and 1,021 were rejected as not meeting the inclusion criteria, thus leaving 1,104 articles. One hundred and seventy of these were foreign language articles whose titles and abstracts were sent to the Adult or Pediatric Work Groups. Of these, 102 were not selected for further evaluation. Two were selected but could not be translated, and 66 were further evaluated. Of the remaining 1,000 manuscripts (including the 66 mentioned above), 29 were unobtainable, leaving 971 to be abstracted. Of these, 640 were rejected because they were classified as an editorial, letter, review, case report, or abstract, did not answer a clinical question of relevance, did not have a valid study design, or did not involve humans. The remaining 331 articles were sent to the Adult or Pediatric Work Groups along with evidence tables for these articles created from the abstraction forms. The Work Groups rejected 81 additional articles for one or more of the same reasons indicated above, leaving 250 accepted articles.

Phase IV: Formulation of Guidelines

The group process used to develop the guidelines is a modification of the RAND/UCLA Appropriateness Method. This group process method has the following essential features: multidisciplinary, iterative, quantitative, and each panelist has equal weight in determining the final result.13

In conjunction with the Work Groups, RAND and Cedars-Sinai staff developed draft guidelines based on the results of the systematic review. The draft guidelines corresponded to the key questions developed by each Work Group. The draft guidelines included all possible topics articulated by the Work Groups during the targeting phase and at the Work Group meetings to discuss the evidence. These draft guidelines were then transmitted to the Work Group members, who used the evidence tables and their expert judgment to rate each guideline statement for validity on a 1-to-9 scale. The RAND staff then compiled summaries for the face-to-face meetings of the Work Groups. At these meetings, Work Group members were provided with the summaries of these first round ratings of validity. These summary ratings were used to key a point-by-point discussion of the evidence and opinion surrounding each potential guideline statement. After each discussion, the Work Group members privately re-rated each guideline statement for validity. These votes form the basis for the final guidelines. Statements were accepted as valid if the median panel rating on validity was 7 or greater on the 1-to-9 scale. "Complete agreement" was defined as occurring when all Work Group members rated a guideline statement within the same three-point range of the scale (for example, all members' ratings were in the range of 7, 8, or 9). After determining the final guideline statements, Work Group members went through a similar two-step rating process to assess the level of evidence. A rating of "Evidence" was defined as "mainly convincing scientific evidence, limited added opinion"; "Opinion" was defined as "mainly opinion, limited scientific evidence"; and "Evidence plus Opinion" was defined as "about equal mixtures of scientific evidence and opinion."

Phase V: Draft Report With Supporting Rationale

Following the development of the guidelines, the Work Group drafted a report that included the supporting rationale for each guideline. While writing the rationale for each guideline, Work Group members cited additional references that had either not been identified previously in the literature search efforts, or had been identified but rejected. These citations contained information that was felt to be important either as background material, or to further explain the rationales. However, these additional references were not part of the evidence base that was used to either formulate the guideline statements or the votes on the validity or the rating of evidence versus opinion for each guideline.

Phase VI: Peer Review

The purpose of the peer review process was to identify:

  • unclear wording in the draft guidlines
  • substantive concerns regarding the content of specific guidelines
  • important but uncited data relevant to specific draft guidelines
  • guidelines that may be difficult to implement or that would benefit from specific strategies to facilitate compliance such as educational programs, tools, etc.

The nutrition guidelines were subjected to a three-stage peer review process:

Stage One: Primary Review.    NKF-DOQI's multidisciplinary Steering Committee was assigned to review the draft report. Drafts were distributed to the committee in August 1999 and members had the opportunity to offer oral comments at a face-to-face meeting in mid-September. The draft report was also sent to the NKF-DOQI Advisory Council, the NKF Scientific Advisory Board, and selected experts in the field. Many substantive comments were received, and this resulted in substantive changes in the organization and content of some of the guidelines and rationales. Given the large volume of comments received, the Work Group vice-chairs reviewed the comments first and entered them into a computer database separating these according to whether they had a potential minor or substantive impact. Comments were sorted by guideline topic and then provided to the Work Groups for analysis and response.

Stage Two: Organizational Review.    Close to 200 individuals representing nearly 50 end-stage renal disease (ESRD)-related organizations reviewed the second draft of the guidelines in December 1999. Organizations that were invited to participate in the second round of peer review were selected by the Steering Committee based on suggestions from the Advisory Council and the Work Groups. Organizations included various nephrology professional societies (eg, Renal Physicians Association, American Society of Nephrology, American Nephrology Nurses Association, and American Renal Administrators Association), the American Association of Kidney Patients, the ESRD Networks, NKF Councils, dialysis chains, managed care organizations, and private industry organizations selected their own reviewers.

Stage Three: Open Review.    In the final round of review, in December 1999, approximately 400 individuals received copies of the revised draft guidelines. Within 3 weeks, 30% of these reviewers provided comments. The Work Group vice-chairs sorted and organized these comments and the Work Group analyzed the responses.

Phase VII: Issue Final Guidelines

The Work Group and staff performed several tasks to complete the guidelines. The guidelines were edited to ensure clarity and consistency. The Work Group carefully reviewed the final draft and made the indicated changes. Accuracy of the literature citations for each guideline document were also verified.

K/DOQI IMPLEMENTATION PLANNING

The NKF plans to undertake three types of activities to promote implementation of these recommendations.

  1. Translating recommendations into practice. K/DOQI will develop core patient and professional education programs and tools to facilitate the adoption of their recommendations.
  2. Building commitment to reducing practice variations. K/DOQI will work with providers and insurers to clarify the need for and the benefits of changes in practice patterns and to encourage the adoption of the guidelines.
  3. Evaluation. K/DOQI, in collaboration with other relevant organizations, will participate in the development of performance measures that can be used to assess compliance with the K/DOQI practice guidelines. In addition, the association between compliance with the K/DOQI guidelines and patient outcomes will be evaluated in an effort to validate and improve the guidelines over time.

The development of the K/DOQI practice guidelines is a cooperative, rewarding, and unifying effort for the participants and the community of health care workers who are involved in the care of the individual with kidney disease. We hope this spirit of cooperation and commitment to improvement of dialysis patient outcomes will help the K/DOQI in efforts to put its quality improvements into practice.

© 2000 by the National Kidney Foundation, Inc.

 

 


 

© 2000 National Kidney Foundation, Inc

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