Lead author Charmaine E. Lok, MD, MSc, FRCP(C) discusses trends in the field, the guideline-writing process, essential elements to a comprehensive care plan, and KDOQI in the COVID 19 era.
First, congratulations on completing the updated KDOQI guidance, the first since 2006. Looking back, what have been some of the biggest trends or paradigm shifts in the field since then?
Thank you—the congratulations goes out to the entire multidisciplinary work group that worked so tirelessly with me to complete this important project. A wave of changes has occurred in over a decade since the last version of the Kidney Disease Outcomes Quality Initiative (KDOQI) vascular access guidelines were published in 2006. Those guidelines were highly influential in promoting a “fistula first” approach to access choice and encouraging the use of arteriovenous access (fistula and graft) surveillance. Indeed, the impact of those guidelines was seen in the first wave of changes, with a positive trend in increasing fistula creation and the uptake of surveillance. Concurrently or shortly thereafter, there was a wave of reporting of new, more rigorous studies to inform practice. These studies, along with the realization that successful fistula maturation and use were more variable than anticipated after its creation, brought a trend of increasing intervention (particularly endovascular) to improve outcomes, an initial increase in catheter use, and stimulus to innovate to improve all vascular access types.
How does the KDOQI process of evidence review and guideline writing work
The process is very comprehensive. There are two separate groups—the KDOQI work group and an independent evidence review team (ERT). The work group comprises multidisciplinary experts in vascular access. The ERT is a seasoned team from the Minneapolis VA Center for Chronic Disease Outcomes Research. The work group develops a “scope of work” document that contains important topics and questions to be addressed in the guidelines. These are structured using a series of PICOTs–whereby the Population, Intervention, Comparator, Outcomes, and Time frames of each question or topic are given to the ERT to search. The ERT provides the work group with the evidence and quality of the evidence to use to write the guideline statements (previously known as guideline recommendations) using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Evidence to Decision frameworks.1 The work group determines the strength of the recommendations based on a matrix that includes not only the quality of the evidence but also the clinical importance, pros, cons, implications, and other factors. Work group members worked in teams, and individual members developed the statements. All statements were reviewed in a transparent and iterative process whereby the entire work group was involved in finalizing each statement. The frequencies of meetings ranged from weekly to monthly until the guidelines were completed.
The 2019 guideline emphasizes individualized plans for each patient. Can you tell us more about how the committee arrived at this as a central theme? What variable elements are essential to a comprehensive care plan?
The work group considered the end-stage kidney disease (ESKD) and dialysis “landscape” and realized that population metrics may not necessarily be the most fitting for an individual patient who would benefit from individualized care of their vascular access. For example, although fistulas are preferred and catheters should be avoided in the majority of people, this is not the case for all and not the intent of previous guidelines. Thus, the work group developed an overarching goal that would focus on the patient yet achieve outcomes desirable on a population basis. The overarching goal of these guidelines is to help patients achieve reliable, functioning, complication-free dialysis access to provide prescribed dialysis while preserving future dialysis access site options as required by the individual patient’s ESKD life plan.2 This goal first requires knowledge and understanding of the patient’s medical conditions, their personal goals and preferences for kidney replacement therapy (hemodialysis, peritoneal dialysis, transplant, or optimal nondialytic care), and the corresponding dialysis access based on these factors. This requires a coordinated multidisciplinary approach to plan for the most imminent and subsequent accesses for the patient’s life plan. For each access, there must be a creation plan, contingency plan, and succession plan, with an underlying vessel preservation plan.2
How did the writing committee mitigate the paradox of formalizing generalizable guidance based on the need for developing individualized care?
We took an approach of “individualization of best care with standardized processes.” Perhaps the best way to describe this is with an everyday analogy. Most people need a motor vehicle to travel from point A to point B. That vehicle can be likened to the patient’s vascular access through their journey with ESKD. Although one person’s goals and preferences can be met by one type of car, it may not be suitable for another. For example, an adventurous youth may prefer and need a sports car (such as a radiocephalic fistula) to meet his or her needs, while a parent of three children may need a van (such as a graft). Grandpa may just need a rental car temporarily (such as a catheter). Regardless, standardized processes to prepare for and maintain that vehicle to keep the individual safe in their journey is required. Individuals need to be eligible for a car (vascular access) and prepare for and get their driver’s license (have the appropriate preoperative assessments). A good car (vascular access) should be bought from a reputable dealer (a skilled, knowledgeable, and committed surgeon/interventionalist in a qualified facility). Once purchased (created), processes are in place to keep the car working well and the patient safe (use of seat belts, oil changes, etc), with a regular maintenance schedule for longevity (regular access monitoring, careful cannulation is required, etc). If a car problem is detected (eg, flat tire or access stenosis), a plan to rectify it should be in place (access contingency plan such as angioplasty of stenosis). Care is taken to plan ahead (access succession plan). The next car (vascular access) is already in mind and plans are in place to obtain it, before the current one fails. For example, the pace of that youth’s life and work circumstance changes and as the sports car gains more mileage and wears down, a different car may be more appropriate. Rather than waiting until the sports car is nondrivable (access loss), the youth has put funds aside and shopped for that new car already, rather than needing a rental car (catheter). The work group recognizes that the best access for each individual patient and their access needs is best determined by the patient and their health care team (rather than a one-size-fits-all statement from the guidelines). However, the guidelines provide the standardized processes to help guide the individual patient and the team in the most optimal creation, maintenance, and salvage of the accesses that they choose.
Which changes or recommendations are most likely to affect interventional practices?
Guideline 1 discusses the ESKD life plan, which is a new concept worth reviewing and understanding for all clinicians involved with dialysis access. Table 1 outlines some select statements that may specifically impact interventional practices.
The last several years have seen considerable development in interventional options for creating and treating accesses. How does the guidance approach the use of newer technologies?
The guidelines are highly supportive of the use of newer technologies. Given the rigorous and high standards set by the ERT, the work group recognized that many newer technologies lack sufficient evidence for recommendation. However, the guidelines were very careful not to recommend against new technologies in this situation but encourage further study to inform the next set of guidelines. Thus, many statements have wording to the effect of “…based on the operator’s discretion and best clinical judgment, as there is insufficient evidence….” The work group was very mindful that the guidelines should encourage and not limit new technologies, their development, and rigorous study.
How do you recommend teams dedicated to dialysis access management approach absorbing and implementing the new guidance?
A good initial approach is to read the introduction section of the guidelines (pages S17-S24). The introduction is then followed by a summary of guidelines statements that start on page S25; this allows the reader to become familiar with the range of topics covered. A guideline statement or topic of interest can then be selected for further review. Each guideline section or topic can be read independently, as each is accompanied by a rationale/background, detailed justification, special discussions, implementation considerations, monitoring and evaluation, and future research subsections. Therefore, the reader will have a more thorough understanding of the statements and their implications. Such an approach will enable the reader to use the guidelines in a digestible but comprehensive way.
The updated KDOQI guidelines were in progress for years before the world knew of the COVID-19 pandemic. With chronic kidney disease and ESKD patients representing a particularly susceptible population that requires regular, frequent health care contact, how would you briefly summarize a KDOQI P-L-A-N–like approach to their care during this time
Each patient should have their P-L-A-N (Patient Life plan and Access Needs) established, since a patient with ESKD may far outlive the pandemic. Nevertheless, the P-L-A-N should consider the impact of the COVID-19 pandemic and what local services are practically available to the patient. Of note, on March 26, 2020, the Centers for Medicare & Medicaid Services stated, “We have received feedback that providers are experiencing difficulties scheduling for placement or repair of arteriovenous fistulas, arteriovenous grafts, peritoneal dialysis catheters, and intravenous catheters. We wish to clarify that these planned procedures are essential in that establishing vascular access is crucial for [ESKD] patients to receive their life-sustaining dialysis treatments.” Fortunately, the P-L-A-N is intended to be (and should be) regularly reviewed; consequently, it can be updated based on progress in overcoming the COVID-19 pandemic. The P-L-A-N was specifically designed to accommodate changes in the patient’s clinical and life circumstances, including the impact of the COVID-19 pandemic.