In the United States, more than 80% of all patients with end-stage renal disease (ESRD) initiate dialysis with hemodialysis, and current reports indicate that this trend has changed little over the past 2 decades.1 Hemodialysis is a life-saving procedure that requires the efficient removal and return of blood to the patient’s body.2 However, despite being a life-sustaining process, hemodialysis is associated with excessive morbidity, mortality, and high societal costs.1,2 The cornerstone of efficient hemodialysis is a well-functioning vascular access that allows for simultaneously efficient blood flow and cannulation. However, finding the optimum vascular access continues to be a challenge for nephrologists, vascular surgeons, and other healthcare providers.3-5
A significant part of the costs and societal impact for patients can be attributed to vascular access dysfunction. By itself, vascular access dysfunction is associated with approximately 25% of all hospital stays among prevalent hemodialysis patients and is the leading cause of dialysis-related hospitalizations.4 Morbidity associated with vascular access is estimated to exceed $1 billion annually, a large portion of which results from the management of vascular access complications.4 Nevertheless, much of the resources and research in this regard have been invested in the development and management of vascular access technologies for hemodialysis. In recent decades, clinical practice guideline developers have devoted much attention to vascular access design and implementation in an effort to improve dialysis outcomes.1-7 Despite these efforts, vascular access outcomes continue to be suboptimal.1-7
In the United States, 4 types of vascular access are available for hemodialysis, including tunneled central venous catheters, arteriovenous grafts, arteriovenous fistulae, and most recently, the hemodialysis reliable outflow graft, which has been growing in popularity.1,2,8-13
Vascular access creation has become a common surgical operation in the United States, with more than 500,000 procedures performed during the past decade.10 Vascular access creation is such a critical aspect of hemodialysis that for the first time in its history, the United States Renal Data System, one of the major entities for publishing ESRD data and information, dedicated an entire chapter to this important topic in its 2016 annual report.1
Much of the debate within the nephrology community surrounding hemodialysis vascular access focuses on the ostensible inability of healthcare systems to achieve the optimum vascular access for the right patient. It has been largely agreed that the use of tunneled central venous catheters should be discontinued, because prolonged use of these catheters can result in bloodstream infections, mechanical injury, and patient discomfort, which can lead to costly hospitalizations.1,3,6-8,10,14 However, fistulae and grafts can also have their own inherent problems, including high failure rates that result in loss of primary assisted patency.1,6,13
Despite being designated as the preferred type of access for hemodialysis as a consequence of its lower risk for malfunction and infection compared with other vascular access technologies, the arteriovenous fistula is limited by long maturity times and high failure rates.1,10,11,15 Furthermore, the arterial and venous systems of many patients make them poor candidates for a fistula.1,6,10,12,13,15 When patients are deemed unsuitable for a fistula, a graft is the second best choice.1,11,13,15,16 However, grafts are prone to frequent stenosis and thrombosis,10-14,16 and their long-term primary and assisted primary patency are not as good as with fistulae.1,10,14-16 Furthermore, compared with fistulae, grafts are associated with a higher rate of postsurgery complications that can significantly affect mortality, morbidity, and treatment costs.1,11,14,16-18 Therefore, despite being a fundamental aspect of hemodialysis therapy, the provision of quality vascular access for hemodialysis remains difficult to achieve.2-6,11-14,16-18
The major barrier to successful dialysis therapy has always been, and continues to be, the inability to establish a reliable vascular access management program that can optimize cost and clinical outcomes simultaneously.14,17 This has caused many experts in the ESRD community to shift their focus toward a more patient-specific approach to vascular access management, which challenges the quality of existing treatment recommendations for hemodialysis. Many experts also believe that the current treatment recommendations for hemodialysis vascular access do not sufficiently address patient perspectives, nor do they consider patient-specific characteristics, such as age, arterial and venous anatomy, body mass index, race, sex, life expectancy, concomitant conditions, and functional status at the initiation of dialysis.17,18
In an effort to improve arteriovenous fistulae patency rates, the 2006 edition of the National Kidney Foundation’s Kidney Disease Outcomes Quality Initiative provided recommendations for vessel mapping, as well as access management in pediatric patients.14 Today, the fastest growing segment of the US population with ESRD involves people aged ≥65 years, many of whom have deteriorated arterial and venous anatomies.19 This raises moral, ethical, financial, social, legal, and quality-of-life concerns with respect to how vascular access is made available to this particular segment of the population of people undergoing dialysis.19
It is important for nephrologists, vascular surgeons, registered nurses, and other clinicians who provide day-to-day care for dialysis patients to have a thorough understanding of patients’ needs and the relative appropriateness of vascular access devices for specific conditions19,20; however, this type of information is not easily attainable.
Therefore, the objective of this study was to assist in bridging this gap by reviewing the available clinical practice guidelines for hemodialysis vascular access to document how patient-specific treatment recommendations were addressed during the guideline development process. This information can help future guideline developers to determine the feasibility of incorporating patient-specific treatment recommendations into their practice guidelines.
Clinical Practice Guidelines
The Institute of Medicine defines clinical practice guidelines as “statements that include recommendations intended to optimize patient care that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options.”21 Clinical practice guidelines are usually found in published materials that summarize the directions or the principles to assist healthcare providers with patient-care decisions regarding the appropriate diagnostic, therapeutic, or other clinical procedures for specific clinical circumstances.22
Clinical practice guidelines are usually developed by government agencies, healthcare institutions, professional societies, governing boards, or expert panels. They are designed for assessing and evaluating the quality and effectiveness of healthcare delivery in terms of measuring improved health, reducing variation in services or procedures performed, and reducing variation in health outcomes.22 The guidelines are subject to continuous revision, as is warranted by the evolution of medical knowledge, technology, and practice.20
In healthcare management, clinical performance targets are designed to improve patient outcomes through quality improvement, but evidence linking target attainment and patient outcomes in clinical practice is often lacking.22 It is generally agreed within the healthcare community that clinical practice guidelines can improve the quality of healthcare by recommending evidence-based best practices for managing medical conditions.22-24 This can be achieved by systematically reviewing the evidence and through collaborative efforts that involve the perspectives of clinicians and patients. However, in most cases, the perspective of patients is missing from clinical practice guideline recommendations.25 It is important to note that the quality of care for patients undergoing hemodialysis is only as good as the guidelines developed to manage their health condition.
Evidence-based clinical practice guidelines can assist providers and patients in making decisions about appropriate healthcare for specific clinical conditions, as well as play an important role in the development of health policy.22 For example, those evidence-based clinical practice guidelines that were developed for vascular access management can optimize patient outcomes and use of healthcare resources.25 Modern-day clinical practice guidelines have evolved to cover a wide variety of topics in healthcare. However, their potential benefits are limited by their inherent quality, especially if appropriate methodologies and rigorous strategies are not applied during the guideline development process.22
Because clinical practice guidelines are critical for helping providers and patients make optimal choices among competing healthcare interventions, such guidelines should aim at formulating explicit and specific recommendations that can be adopted in clinical practice, produce better clinical outcomes, including better quality of life for patients, and promote cost-effectiveness.26 Several practice guidelines have been developed to improve vascular access outcomes and overall quality of life for patients undergoing dialysis. These guidelines were designed to provide guidance regarding the placement and management of vascular access devices, and for reducing infectious, mechanical, thrombotic, and other adverse events associated with the selection, placement, and maintenance of vascular access devices.22-30
There is considerable potential for including patient-specific treatment recommendations in future clinical practice guidelines for hemodialysis vascular access. A revised version of the Canadian Society of Nephrology’s guidelines for managing chronic kidney disease includes patient-specific clinical recommendations for diabetes, hypertension, dyslipidemia, and anemia, and even lifestyle management.31 Similar guidelines are also available in Australia, the United Kingdom, and the United States; however, it is not clear whether any of the patients for whom the guidelines were developed were receiving hemodialysis.
Methods
We systematically searched PubMed for full-text clinical practice guidelines published in peer-reviewed journals in the English language. We also searched websites of professional societies and healthcare organizations that specialize in dialysis care to find relevant clinical practice guidelines for evaluation. The search strings included “hemodialysis vascular access,” “clinical practice guidelines,” “clinical practice guidelines for hemodialysis vascular access,” and “patient-specific clinical practice guideline recommendations.” The search was limited to free full-text guidelines with recommendations for hemodialysis vascular access. Further eligibility criteria required the guidelines to be published between the years 2000 and 2016, be developed by a professional society or endorsed by a government organization within the United States, be published in the English language, meet the definition of a clinical practice guideline as suggested by the Institute of Medicine,21 and address at least 1 of the 4 modalities for hemodialysis vascular access.
All potentially relevant guidelines were screened to determine eligibility using the above criteria. A vascular surgeon was also consulted to determine relevant items for inclusion. A coding sheet was developed to document how many of the objective criteria were identified in the clinical practice guidelines. These included patient-specific treatment recommendations related to age category (particularly juveniles and octogenarians); arterial and venous structures; body mass index; race; sex; life expectancy; comorbid conditions (eg, diabetes and hypertension); and functional status at dialysis initiation.
The 3 researchers (authors) of this study independently reviewed the guidelines to ensure that they met the inclusion and exclusion criteria, and then they documented evidence of any patient-specific recommendations that were identified in the clinical practice guidelines on the coding sheets. Discrepancies were resolved through discussion among the reviewers when necessary.
Results
The initial search strings returned 73 items, including 64 from PubMed and 9 from websites of professional societies or government organizations. After further screening, only 5 clinical practice guidelines met the study criteria used in this study.14,27-30 An outline of the screening process and the reasons for exclusion of noneligible clinical practice guidelines are provided in the Figure.
The characteristics of the extracted clinical practice guidelines are outlined in the Table.14,27-30 Of the 5 clinical practice guidelines eligible for inclusion in this evaluation, only 2 included treatment recommendations for 3 (ie, arteriovenous fistulae, arteriovenous grafts, and central venous catheters) of the 4 vascular access options noted earlier.14,28
The other 3 clinical practice guidelines provided treatment recommendations only for central venous catheters.27,29,30 None of the 5 clinical practice guidelines provided treatment recommendations for the hemodialysis reliable outflow graft; however, considering the recent time frame (ie, 2008) during which the hemodialysis reliable outflow graft was endorsed by the US Food and Drug Administration as a reliable vascular access alternative, this finding is not surprising.
The 5 selected studies were characterized by considerable variation in their time of publication and by the number of treatment recommendation categories. Of the 5 eligible clinical practice guidelines, 4 were published after 2007.27-30 The number of treatment recommendations ranged from 4 to 13 (Table).14,27-30 For convenience and space considerations, only a summary of the treatment recommendations in each clinical practice guideline is provided in the Table.
The 2 clinical practice guidelines that address at least 3 vascular access alternatives include a treatment category for access selection.14,28 Although not shown in the Table, these clinical practice guidelines were unanimous in their promotion of arteriovenous fistulae as the access of first choice, followed by arteriovenous grafts. These 2 clinical practice guidelines were also unanimous in their nonadvocacy of central venous catheters for long-term dialysis.14,28
Only 1 clinical practice guideline included patient-specific recommendations.14 However, these recommendations were limited to juvenile patients and made no provisions for other age categories. It must be noted that this same guideline supports vessel mapping, which can assist with the accurate placement of vascular accesses, in its recommendations for future research.14 No other evidence of patient-specific treatment recommendations specifically for vascular access was identified in the clinical practice guidelines.
Discussion
During the study’s coding process, patient-specific treatment recommendations were identified for other aspects of hemodialysis therapy; however, because the study objective was to identify patient-specific treatment recommendations explicitly for vascular access, those treatment recommendations are not included in the results.
This review evaluated the level of patient-specific treatment recommendations in clinical practice guidelines for hemodialysis vascular access. This study revealed that clinical practice guidelines for hemodialysis vascular access lack patient-specific treatment recommendations.
However, patient-specific treatment recommendations for other aspects of hemodialysis therapy were unveiled during our study. This is an encouraging discovery, because there is great need for the inclusion of patient-specific treatment recommendations in future clinical practice guidelines for hemodialysis vascular access in the United States. At the very least, this assertion is supported by the National Kidney Foundation, whose treatment recommendations for hemodialysis vascular access14 are among the most widely used for dialysis therapy globally. Their clinical practice guidelines were among the 5 guidelines included in our study.
Limitations
This study sought to determine the level of patient-specific treatment recommendations in clinical practice guidelines for hemodialysis vascular access in the United States. Therefore, the study findings cannot be generalized to clinical practice guidelines developed by foreign healthcare organizations.
Furthermore, the emphasis was strictly on identifying patient-specific treatment recommendations for hemodialysis vascular access, hence patient-specific treatment recommendations for other aspects of dialysis therapy were not considered.
Finally, by focusing on the primary study objective, we did not critically appraise the overall quality of the included guidelines as purported by developers of guideline appraisal tools.22
Conclusion
It is difficult to find vascular access technologies that simultaneously improve clinical outcomes (including the patient’s health-related quality of life) and reduce treatment costs for patients undergoing hemodialysis. This has caused many experts in the nephrology community to question the quality of existing clinical practice guideline recommendations for hemodialysis vascular access. It is generally accepted among dialysis experts that greater attention should be given to patient-specific factors when developing clinical practice guideline recommendations. Considering the amount of discussion provided here regarding the quality of clinical practice guidelines and patient-centered approaches to healthcare, we hope that this study can be a catalyst for continued improvements in these important aspects of care for patients undergoing hemodialysis.
Acknowledgments
The authors thank Grace Ogot and Michael Piagentini of Robert Wood Johnson Barnabas Health for assistance in the chart review of this analysis, and Marjorie Schulman for assistance in the claims data analysis.
Author Disclosure Statement
Dr Queeley, Dr Campbell, and Dr Ali have no conflicts of interest to report.
Dr Queeley is Research Associate, Dr Campbell is Associate Professor, and Dr Ali is Assistant Professor, Division of Economic, Social, and Administrative Pharmacy, College of Pharmacy and Pharmaceutical Sciences, Florida A&M University Tallahassee.
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