Frequently Asked Questions: The KDOQI Process
KDOQI was founded on the principles of structured review with data abstraction of pertinent articles. All of the original guidelines were developed in this manner. Since that time, additional refinement and maturation of this process has occurred. This rigorous process of guideline development has been well received as a credible and transparent process. Therefore, it is imperative that this process continues, both in the selection of all new guidelines, and also for all updates to existing guidelines. The same rigor and transparency of guideline selection choice as well as timing of updates needs to be operative.
How does the NKF decide what new guidelines will be developed?
Recommendations for guidelines come from various sources – medical and healthcare professionals, NKF volunteers and patients, among others. In order for a guideline topic to be considered, it must meet at least three of the five criteria listed below:
- Important aspect of clinical care with demonstrable impact on patient outcomes
- Recognized variation or uncertainty, confusion or conflict in information available such that there is overt evidence that this variation leads to compromise in clinical outcomes
- Body of evidence exists which is of sufficient breadth and depth to enable the development of evidence based guidelines
- Standard definitions exist for the clinical outcomes to be measured or a process is developed by which those definitions can be developed
- Sufficient interest of the clinical public (including patients, care givers, policy makers) to generate interest in the results of the guideline development and implementation. This may be determined through systematic polls, surveys or by a multidisciplinary group (e.g., NKF Advisory Board), with appropriate background, and input.
After being vetted by the KDOQI Chair/Vice Chair, the proposal and rationale for the development of any new guideline are presented to the KDOQI Advisory Board for discussion and approval/disapproval in collaboration with the KDOQI Chair/Vice Chair. Ideally, a proposed timetable would also be presented, based on consultation from all entities in guideline development, including the Evidence Review Team and NKF staff.
After a guideline topic is approved by the KDOQI Advisory Board, Work Group Chair/Co-Chairs are selected based on proven expertise in the area, clear understanding of the guideline development process and ability to commit time to the project.
How can I submit a proposal for a guideline?
Proposals may be submitted to the KDOQI Chair or Vice Chair, or the President or CEO of the National Kidney Foundation. All proposals should include the criteria noted in the section above that justifies the development of this guideline. This proposal should be sent to the following address or e-mail:
National Kidney Foundation 30 E. 33rd Street New York, NY 10016
Attention: Emily Newell, KDOQI Information Director
emilyn@kidney.org
What is the purpose of a Scope of Work?
After the Work Group Chair and Co-Chair have been selected, their first task is to develop a Scope of Work that will serve as an initial outline to help uncover specific areas to be addressed, plan a timeline and identify potential Work Group. About three-to-five pages in length, this document describes the following:
- Need for the guideline at this point in time
- Background of the problem and specific issues which we expect to be helped by this guideline
- Population of interest (i.e. all CKD, dialysis only, etc.)
- Presumption as to sources of evidence which may exist
- Mock guideline statements
- Areas better suited to clinical recommendations (i.e. not enough evidence)
- Discussion/input of Evidence Review Team and KDOQI chair and vice-chair
- Revision of Scope of work documents
How are Work Group members selected?
All KDOQI work groups comprise myriad specialties and disciplines, including nephrology, pediatric nephrology, pharmacy, nutrition, social work, nursing, internal medicine, transplantation and where applicable, government officials or policy makers. They are selected based on their experience in the subject of the guideline being developed.
Members are required to attend at least 75% of the three-to-four in-person meetings, participate in conference calls, review articles, develop and revise guideline statements and assist in the development of educational materials that discuss various aspects of the guidelines. Work Group members sign conflict of interest statements, provide full disclosure and unbiased representation.
How long does it take to complete a guideline?
It takes between two-to-three years from conception to publication. After a guideline is published, implementation of the guideline is administered through the NKF’s Kidney Learning System.
What is included in a KDOQI guideline?
- KDOQI Chair/Vice Chair introduction
- Executive summary
- Introduction and rationale for guidelines
- Process/Methodology
- Guideline statements
- Rationale statements
- Evidence base for guidelines, literature review
- Evidence tables
- Limitations of current guideline statement, including implications for implementation (clinical and economic)
- Clinical considerations and background information
- Research recommendations section(s)
- Specific guidelines that could be considered for clinical performance measures
Is there a review process for the guidelines?
Yes, there is a multi-tiered review process for all KDOQI guidelines and guideline updates. After the guideline is close to completion, it is presented to the KDOQI Advisory Board for comment. Once that feedback is incorporated into the document and agreed upon by the Work Group, the guideline is distributed for organizational and peer review. Reviewers have about two months to read and critique the guideline. After this feedback is reviewed and incorporated into the guideline, it is voted on by the Work Group and is readied for publication.
How are the guidelines funded?
KDOQI clinical practice guidelines are funded through the generous support of corporate sponsors. Sponsors are not involved in any aspect of the actual guideline development process.
What are guideline updates?
KDOQI guidelines continue to evolve, even after initial publication. About three years after the publication of a guideline, the KDOQI co-chairs, guideline Work Group co-chairs and NKF staff review literature that has been published since the closing of the evidence of the guideline and evaluate if it would be appropriate to reconvene the work group to analyze this new literature to make any necessary updates to the guideline. All KDOQI guideline updates undergo the same rigorous development and review process as does a new guideline. It takes one-to-two years to publish an updated guideline.
What is the KDOQI Center?
The KDOQI Center for Clinical Practice Guideline Development and Implementation was established in July 2003 at Tufts-New England Medical Center. The mission of the KDOQI Center is to contribute to improvements in the quality of care in individuals with kidney disease within the framework of NKF’s KDOQI. The aims of the center are to:
- Provide service to the NKF in KDOQI guideline development
- Provide service to the NKF in KDOQI guideline implementation
- Conduct research in guideline development
- Conduct research in guideline implementation
- Train fellows in applications of evidence-based medicine in kidney diseases.
