KDOQI Disclosure and COI Policies
The National Kidney Foundation has a well-deserved reputation for developing and implementing medical programs which have had a significant positive impact on improving outcomes for patients. These include clinical practice guidelines published under NKF’s KDOQI brand. Since 1997, we have published 22 guidelines on topics ranging from vascular access for dialysis patients to chronic kidney disease itself. We are proud of those guidelines and the way they have helped the kidney community, in addition to individual patients and medical professionals, make better informed decisions about improving care. All these guidelines followed the rigorous KDOQI process, were developed by independent volunteer work groups and were funded by more than a dozen companies within the kidney disease field.
There have been three sets of guidelines dealing with anemia management. Our first, for dialysis patients, was published in 1997, and then it was updated in 2001. Finally, a new set for all stages of kidney disease was published in May of 2006. Since anemia management is a very visible and an expensive part of caring for our patients, there has been considerable attention paid to this last set of guidelines. Therefore, NKF has reviewed our KDOQI process and re-enforced the strict attention we always pay to transparency and management of conflicts of interest.
Some of the attention drawn to KDOQI’s latest anemia guideline has been based on two recently-published and high profile clinical trials examining the risks and benefits posed by higher hemoglobin levels in patients with chronic kidney disease. As we have always done, we will evaluate our guideline recommendations in light of new science and relevant publications. This has always strengthened our processes.
Therefore, at its recent regularly scheduled meeting, the NKF Board of Directors discussed these issues thoroughly and took several steps to improve operations. The two principal actions taken were votes that:
- The NKF Board of Directors reaffirmed its support for the KDOQI guideline development process.
- The NKF Board of Directors reaffirmed its support for the federal Food and Drug Administration as the agency responsible for patient safety and efficacy in treatment of disease
The Board also discussed and approved the following additional steps:
- NKF will strengthen and expand its Conflict of Interest policy and disclosure forms to provide an even higher level of transparency.
- Conflict of interest disclosure documents will be openly reviewed at each meeting of a KDOQI work group so that all in attendance are aware of every member’s disclosures.
- The KDOQI professional Evidence Review Team will be empowered to assure that all guideline recommendations are supported by the evidence. If a variance is perceived, the published guideline will reflect that fact.
- NKF’s Compliance Officer will oversee the internal processes used in developing all guidelines and medical programs and report directly to the Board of Directors on NKF’s actual practices related to potential conflicts of interest or industry influence.
- NKF will hold a meeting with other nephrology guideline development organizations from around the world that will include consensus understandings of the best ways to ensure independence of work groups and management of potential of conflicts of interest and industry influence.
- It shall be NKF’s policy that all guidelines and major medical programs will have multiple sponsors. Future funding of guidelines will be secured through a consortium of companies. There will be no single sponsor for any guideline.
- All new guidelines will note FDA’s labeling indications on specific drugs mentioned in the guidelines.
The Board also reaffirmed its support of KDOQI and other NKF medical programs and the value they have for patients. This record includes:
- NKF’s KDOQI guidelines have clearly improved the clinical care and outcomes of dialysis patients. Since 1997, the United States Renal Data System and the Centers for Medicare and Medicaid Services have documented considerable progress in all the clinical areas of KDOQI’s original dialysis guidelines -- hemodialysis, peritoneal dialysis, anemia management and vascular access.
- In every KDOQI guideline, a rigorous scientific process has been used that includes independence of work groups, comprised of volunteer nephrologists and other healthcare professionals, and total separation of financing and content.
- No attempt has ever been made by NKF officers or staff to communicate in any way with a work group regarding sponsor interests.
- To ensure that sponsors do not influence work group deliberations or guideline content, sponsors have never been informed or involved in any aspect of guideline development. They do not receive copies of the draft guidelines or any details of the evidence or recommendations under consideration until the guidelines are released for public review and comment.
- The KDOQI process has always included Conflict of Interest monitoring and management. Since the inception of KDOQI, work group members have been required to complete detailed disclosure statements. The contents of these disclosure statements and detailed biographies of all the work group members, including honoraria, grants or contracts with industry, are always published along with the guidelines.
- The KDOQI process has always included an extensive effort to secure community comment and feedback on proposed guidelines. All guidelines have been thoroughly vetted by the KDOQI Advisory Board and then by hundreds of interested individuals, companies, government officials and the public. All comments received are taken into account by the KDOQI leadership, guideline chairs and work groups. Only after this review process are guidelines published.
- KDOQI guidelines have always been updated when scientific advances or clinical developments warrant a new look at recommendations. New publications and evidence are reviewed as they relate to specific recommendations. If the new evidence indicates that a recommendation should be changed, KDOQI will publish and widely disseminate its new or clarified recommendation. If a substantial change is indicated, it will also be disseminated for review and comment by the KDOQI Advisory Board and the entire kidney community prior to publication.
NKF intends that its Conflict of Interest Policies and its safety and efficacy recommendations are consistent with the best medical practice and note FDA labeling recommendations such that the most rigorous standards are employed in healthcare and clearly define an ongoing commitment to continuously improving all of the foundation’s processes.
Elements of the updated NKF Conflict of Interest Policy:
- A detailed disclosure and attestation form will be completed annually by all NKF volunteers. Conflict of Interest disclosures will be reviewed and significant conflicts addressed and managed by the NKF Audit Committee and reported to the NKF Board of Directors.
- Disclosure will include specific dollar levels and types of support from industry:
- Financial relationship greater than $10,000 in any of the least three years
- $10, 000 to $ 20,000
- Over $20,000
- Disclosure statements of all work group members will be updated, distributed and reviewed during each meeting of the KDOQI workgroups and published with all guidelines.
Policy and Procedures Regarding Conflicts of Interest (PDF 27KB)
The National Kidney Foundation remains committed to developing, disseminating and implementing effective medical programs and clinical practice guidelines that benefit our patients. The processes by which those programs are developed are transparent and open to scrutiny by anyone. The KDOQI process has been well established and thoroughly described. NKF strongly endorses and implements the complete separation of industry support from the development of any guidelines, such that sources of industry support have no impact on the deliberations, decisions or recommendations of an independent KDOQI work group.
