Definitions and End Points for Interventional Studies for Arteriovenous Dialysis Access

Beathard, Gerald A.; Lok, Charmaine E.; Glickman, Marc H.; Al-Jaishi, Ahmed A.; Bednarski, Donna; Cull, David L.; Lawson, Jeffery H.; Lee, Timmy C.; Niyyar, Vandana Dua; Syracuse, Donna; Trerotola, Scott O.; Roy‐Chaudhury, Prabir; Shenoy, Surendra; Underwood, Margo; Wasse, Haimanot; Woo, Karen; Yuo, Theodore H.; Huber, Thomas S.

doi:10.2215/cjn.11531116

Cited by 95 publications

(92 citation statements)

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“…A recent project from the Kidney Health Initiative, a partnership between the American Society of Nephrology and the US Food and Drug Administration, aimed to develop clinical trial end points for hemodialysis vascular access [17]. Although one of the end points included a period of reliable, consistent use of an access for hemodialysis [18], there is yet to be a definition of or consensus on an objective time period for clinically sustained use of an access.…”

Section: Doi: 101159/000495355mentioning

confidence: 99%

Clinical Outcomes of Arteriovenous Access in Incident Hemodialysis Patients with Medicare Coverage, 2012–2014

et al. 2019

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Background: Chronic hemodialysis requires a mode of vascular access through an arteriovenous fistula (AVF), a prosthetic arteriovenous graft (AVG), or a central venous catheter (CVC). AVF is recommended over AVG or CVC due to increased patency and decreased intervention rates for those that mature. AVG are preferred over CVC due to decreased infection and mortality risk. The aims of this study were to evaluate the lifespan of AVF and AVG in maturation, sustained access use, and abandonment. Methods: The United States Renal Data System (USRDS), Medicare claims, and CROWNWeb were used to identify access placements. Patients with a first end-stage renal disease (ESRD) service from January 1, 2012 to June 30, 2014 with continuous coverage with Medicare as primary payer and ≥1 AVF or AVG placed after ESRD onset were included. Maturation was defined as the first use of the access for hemodialysis recorded in CROWNWeb. Sustained access use was defined as 3 consecutive months of use without catheter placement or replacement. Accesses that were never used at any time post-placement were considered abandoned. Results: The cohort included 38,035 AVF placements and 12,789 AVG placements. Sixty-nine percent of AVF and 72% of AVG matured. Fifty-two percent of AVF and 51% of AVG achieved sustained access use. One quarter of AVF and 14% of AVG were abandoned without use as recorded in CROWNWeb. Conclusion: Although considered the gold standard for vascular access, only half of AVF and AVG placements achieved sustained access use. The USRDS database has inherent limitations but provides useful clinical insight into maturation, sustained use, and abandonment.

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Section: Doi: 101159/000495355mentioning

confidence: 99%

Clinical Outcomes of Arteriovenous Access in Incident Hemodialysis Patients with Medicare Coverage, 2012–2014

et al. 2019

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“…In March 2018, the Kidney Health Initiative (KHI), a public-private partnership between the American Society of Nephrology and the US Food and Drug Administration (FDA), published a four-paper series on clinical trial endpoints for HD vascular access 126,[131][132][133] . The KHI Clinical Trial Endpoints for Dialysis Vascular Access project aimed to improve the consistency of trial endpoints and outcome definitions related to HD vascular access.…”

Section: The Kidney Health Initiativementioning

confidence: 99%

“…The ability to assess the comparative effects of interventions on vascular access complications has been limited by inconsistent outcome reporting 28,64,68,186 . The need to standardise reporting of critically important outcomes has been widely advocated 127,[131][132][133] and there is a growing number of initiatives to establish core outcome sets, defined as an agreed minimum set of standardised outcomes that should be measured and reported in all trials for a specific clinical area 136,211,229,246 .…”

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confidence: 99%

“…To improve the relevance and consistency of vascular access outcome measures used in clinical trials and day-to-day clinical practice, we recommend implementation of trial endpoints tailored to the different types of vascular access and time points of their life cycle. These were recently published by the Dialysis VascularAccess group of the American Society of Nephrology KHI126,[131][132][133] . Complementing the KHI, the international SONG Initiative has established a core outcome set for HD that includes vascular access as one of four core outcome domains based on the shared priorities of patients and health professionals9,11 .…”

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confidence: 99%

“…These findings underpin the need for broader implementation of internationally agreed and standardized, patient-important outcome measures to enhance the consistency and relevance of outcome reporting in clinical trials and beyond. Recently, the KHI has published a series of papers on recommended trial endpoint definitions tailored to the different types of vascular access and time points of their life cycle to facilitate the development of effective interventions and products to improve vascular access outcomes126,[131][132][133] . Complementing this work by KHI, the inclusion of vascular access function as part of the core outcome set for HD established through the international SONG initiative will help to ensure more consistent reporting of outcomes in HD research that are considered important by all relevant stakeholders11,145 .Increasingly, clinical performance measures have been used for quality improvement for enhanced transparency through public reporting and calculating payment for services237 .…”

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Strategies to improve vascular access outcomes in haemodialysis patients

Viecelli¹

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It is estimated that over 3 million people worldwide are currently treated for end-stage kidney disease, with most receiving haemodialysis (HD). A functioning vascular access (VA) provides a lifeline for patients requiring HD but VA dysfunction remains one of the leading causes of excessive morbidity, mortality and healthcare costs in this group. Despite increasing numbers of VA trials, successful interventions to improve VA outcomes have been sparse and compromised by highly variable, often selectively reported outcomes of limited relevance to patients and health professionals.This thesis aimed to establish strategies to improve VA outcomes by 1) determining whether fish oil or aspirin is effective in improving outcomes of newly created arteriovenous fistulas (AVFs); and, 2) establishing a standardised core outcome measure for VA based on the shared priorities of patients and health professionals to improve the consistency, reliability and relevance of VA research in HD.Aim 1 was addressed with an international, double-blind, randomised, placebo-controlled trial entitled, "omega-3 fatty acids (Fish oils) and Aspirin in Vascular access OUtcomes in REnal Disease" (FAVOURED). It included 567 adult participants planned for AVF creation who were randomised to fish oil (4g/d) or placebo. Of these, 406 participants were also randomised to aspirin (100mg/d) or placebo. Treatment started 1 day pre-surgery and was continued for 12 weeks. The primary outcome was AVF failure (a composite of thrombosis and/or abandonment and/or cannulation failure) at 12 months. Secondary outcomes included the primary outcome components, AVF interventions, and central venous catheter (CVC) requirement. The FAVOURED study revealed that 12 weeks of fish oil did not reduce the proportion of AVF failure compared to placebo (47% versus 47%, relative risk [RR] adjusted for aspirin use 1.03, 95% confidence interval [CI] 0.86-1.23) or its outcome components. Low-dose aspirin was similarly ineffective. However, fish oil was effective in reducing AVF intervention rates (0.82 vs 1.14 interventions/1000 patient-days, incident rate ratio [IRR] 0.72, 95% CI 0.54-0.97), driven by a significant relative reduction in rescue interventions for thrombosis by 47%. Similarly, low-dose aspirin significantly reduced V Publications included in this thesis 1. Viecelli AK, Mori TA, Roy-Chaudhury P, Polkinghorne KR, Hawley CM, Johnson DW, Pascoe EM, Irish AB. The pathogenesis of hemodialysis vascular access failure and systemic XIII 9. Viecelli AK, Pascoe EM, Hawley CM, Polkinghorne KP, Mori TA, Johnson DW, Irish AB for the Omega-3 Fatty Acids (Fish Oils) and Aspirin in Vascular Access Outcomes in Renal Disease (FAVOURED) Study Collaborative Group. Effects of fish oil and aspirin use on arteriovenous fistula, patency, need for interventions and dialysis suitability in patients requiring haemodialysispost hoc analysis of the FAVOURED study. Nephrol Dial Transplant. 2017;32 (S3):iii65.

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Vascular Access for Hemodialysis

Polkinghorne

Viecelli

2022

Evidence‐Based Nephrology

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Definitions and End Points for Interventional Studies for Arteriovenous Dialysis Access

Cited by 95 publications

References 115 publications

Clinical Outcomes of Arteriovenous Access in Incident Hemodialysis Patients with Medicare Coverage, 2012–2014

Clinical Outcomes of Arteriovenous Access in Incident Hemodialysis Patients with Medicare Coverage, 2012–2014

Strategies to improve vascular access outcomes in haemodialysis patients

Vascular Access for Hemodialysis

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