National Kidney Foundation Advisory on KDOQI Clinical Practice Guidelines
The National Kidney Foundation has published 22 Clinical Practice Guidelines through its KDOQI process. These include recently revised and updated guidelines for the care of dialysis patients and a new guideline on anemia at all stages of CKD. At times, KDOQI guidelines have been utilized in the development of government policy to improve outcomes for dialysis patients. Debate is a natural, and desirable, byproduct of the advancement of clinical science. Therefore, it is not surprising that KDOQI guidelines have stimulated controversy. This is especially true for the sensitive issue of anemia management. However, it is important to focus the guideline debate on scientific differences and to minimize confusion about public policy development, the guideline development process, and the relationship between the two.
Rationale for KDOQI Initiative
A decade ago there was marked variation in dialysis care around the country, and US dialysis patients experienced poorer outcomes than their counterparts in other industrialized nations. As a result, NKF undertook the responsibility for clinical practice guideline development because it believes that it was an opportunity to improve care and outcomes. For example, anemia in ESRD is associated with increased mortality and hospitalization, decreased mental acuity, cardiac enlargement, heart failure, reduced health-related quality of life and impaired rehabilitation. The need was so great and the opportunity so compelling, that KDOQI proceeded in the face of limited data from prospective randomized controlled trials, understanding that guideline development would have to include findings from observational studies and the judgment of experts.
Impact of KDOQI Guidelines
NKF’s KDOQI guidelines have clearly improved the clinical care of dialysis patients. In fact, the American Journal of Kidney Diseases reported considerable progress in all the clinical areas of KDOQI’s original dialysis guidelines. (AJ Collins, et al. “United States Renal Data System Assessment of the Impact of the National Kidney Foundation-Dialyis Outcomes Quality Initiative Guidelines,” American Journal of Kidney Diseases, Vol 39, no 4 April, 2002) Among others, examples are:
- The KDOQI Clinical Practice Guidelines for Vascular Access led to an increase in the prevalence of natural vascular accesses in hemodialysis patients to 41% and stimulated the development of the government sponsored “Fistula First National Vascular Access Improvement Initiative.”
- According to the USRDS 2005 Annual Data Report, survival rates for dialysis patients have improved – the latest data show a 6.5% increase in five year survival rates for hemodialysis patients and a 14% increase in five year survival rates for peritoneal dialysis patients.
- With regard to anemia therapy, the percentage of ESRD patients with hematocrit values less than 33% is approximately 20% today, compared to 84% in 1991.
Guiding principles for the KDOQI process:
In every KDOQI guideline, a rigorous scientific process was used. Elements of the process are:
- Independence of Work Groups to facilitate an unbiased approach to guideline development, without influence of organizations or industry
- Scientific and methodological rigor. To maintain the rigor and consistency of the KDOQI guideline development process, the NKF Center for Clinical Practice Guideline Development and Implementation was established in 2003 at Tufts-New England Medical Center (NKF Center). The NKF Center employs a team of methodologists (physicians with special expertise in statistical and epidemiologic analysis) who gather scientific evidence and assess that evidence for the Work Group members. This KDOQI evidence review team is centered around an AHRQ Evidence-Based Practice Center, one of 12 designated by the federal Agency for Healthcare Research and Quality (AHRQ) to produce systematic reviews of important clinical topics.
- Review of the Guidelines is an essential part of the KDOQI process. Guideline drafts are reviewed by the KDOQI leadership, the 45 member KDOQI Advisory Board and then by anyone interested in doing so. The recent KDOQI guideline on anemia management was reviewed by over 1,000 individuals, organizations, companies, government agencies and the public. All the reviewers’ comments were provided to the work group and all suggestions taken into account in the final revisions made by the work group.
- Separation of financing and content. To ensure that the competitive interests of sponsors do not influence work group deliberations or guideline content, sponsors are not informed or involved in any aspect of guideline development. Until the public review period, no sponsors are provided with copies of the draft guidelines or any details of the evidence or recommendations under consideration.
- Conflicts of Interest Monitoring. KDOQI Work Group members are required to complete detailed conflict of interest statements, which are reviewed by NKF’s scientific leadership, the Work Group chairs, the KDOQI guidelines development team and NKF’s Compliance Officer. Detailed biographies of all the work group members, including honoraria, grants or contracts with industry, are published along with the guidelines.
- Funding of Guidelines. To date, 12 corporate sponsors, including pharmaceutical companies and dialysis providers, have contributed to KDOQI guideline development; and more than 20 have supported dissemination and implementation of guidelines following their initial publication.
KDOQI Guidelines and Public Policy for Anemia Therapy
- The Medicare payment policy for EPO treatment for dialysis patients changed in January 1991 from a relatively fixed payment per treatment to a variable payment based on the amount of EPO administered with each treatment. The mean dose per treatment was low prior to the change in Medicare payment policy but increased almost 15% in the 6 months following the change in payment policy.
- In 1994, the Food and Drug Administration expanded the upper limit of the hematocrit target range to 36%. Medicare policy and KDOQI guidelines have also recognized the goal of maintaining dialysis patients between 33% and 36%.
- In 1997, the Health Care Financing Administration (now the Centers for Medicare and Medicare Services or CMS) introduced a “rolling hematocrit” policy to monitor the use of EPO for dialysis patients. Monitoring policy is distinct from coverage policy. This policy did not accommodate variability in the response of individual patients to anemia therapy. The result was a reduction in mean hematocrit and mean EPO dose. It was subsequently revised to trigger audits when hematocrits exceed 37.5%
- CMS policy for monitoring EPO usage was revised on November 9, 2005, and the implementation of that policy was revised on August 25, 2006, effective October 1, 2006. In order to avoid a reimbursement reduction, CMS requires a 25% cut in ESA dosage when the hematocrit level is above 39%. CMS explained that nutritional status, infection, and bleeding may cause the hematocrit to fluctuate, thus making it difficult to manage patients in the 33%-36% range.
What the 2006 Anemia Guidelines Say about Hemoglobin Targets
2006 Guideline 2.1.1 Lower Limit of Hb (hemoglobin):“In patients with CKD, Hb should be 11.0 g/dl or greater (MODERATELY STRONG RECOMMENDATION)” (Source)
2006 Guideline 2.1.2 HB Range -- Upper Limit of Hb
“In the opinion of the Work Group, there is insufficient evidence to recommend routinely maintaining Hb levels at 13.0 g/dL or greater in Erythropoiesis Stimulating Agent (ESA) - treated patients.” (Source)
Controversy regarding the KDOQI Process and the Anemia Guideline
Anemia management is a controversial and highly visible part of the care of dialysis patients and of the money expended by Medicare to cover it. Some of the controversy has been based on the fact that KDOQI guidelines have been supported by industry. NKF takes that issue very seriously and constantly reviews its policies and procedures to safeguard the work product of KDOQI and all NKF medical programs. NKF stands by the KDOQI process. No funds given to NKF have influenced the development of any KDOQI guideline’s content. Industry support has not been a factor in any work group’s deliberations.
