Report of the Standardized Outcomes in Nephrology–Hemodialysis (SONG-HD) Consensus Workshop on Establishing a Core Outcome Measure for Hemodialysis Vascular Access

Sautenet, Bénédicte; Craig, Jonathan C.; Johnson, David W.; Polkinghorne, Kevan R.; Levin, Adeera; Tong, Allison; Viecelli, Andrea K.; Ju, Angela; Wang, Angela Yee-Moon; Porter, Anna; Sautenent, Benedicte; Reddy, Bharathi; Manns, Braden; Hemmelgarn, Brenda R.; Schiller, Brigitte; Hanson, Camilla S.; Hawley, Carmel; Lok, Charmaine E.; Wheeler, David C.; Harris, David C.H.; Johnson, David W.; Schatell, Dori; Lacson, Eduardo; Bavlovlenkov, Elena; O’Lone, Emma; Chemla, Eric S.; Caskey, Fergus; Strippoli, Giovanni; Feldman, Harold I.; Apata, Ibironke W.; Tordoir, Jan H.M.; Flythe, Jennifer E.; Gill, John S.; Kusek, John W.; Craig, Jonathan C.; Polkinghorne, Kevan R; Abbott, Kevin C.; Hooi, Lai‐Seong; Dember, Laura M.; Zuo, Li; Cervantes, Lilia; Moist, Louise; Poole, Lynn; Tonelli, Marcello; Howell, Martin; Gallieni, Maurizio; Elliot, Meghan; Klusmeyer, M E; Josephson, Michelle A.; Robbin, Michelle L.; Riella, Miguel C.; Evangelidis, Nicole; Tugwell, Peter; Kerr, Peter G.; Ravani, Pietro; Roy‐Chaudhury, Prabir; Mehrotra, Rajnish; Vanholder, Raymond; Quinn, Robert R.; Pécoits-Filho, Roberto; Crowe, Sally; Evered, Sharrilyn; Segerer, Stephan; Fadem, Stephen Z.; McDonald, S.; Sprague, Stuart M.; Palmer, Suetonia C.; Poma, Tammy; Lee, Timmy; Vachharajani, Tushar J.; Sikirica, Vanja; Jha, Vivekanand; Biesen, Wim Van; Winkelmayer, Wolfgang C.; Mayers, Alison; Bell, Barry; Carter, Jane; Hardy, Kimberly; Ennis, Mary; Johnson, M.D.; Rouse, Noah; Wright, Sarita; Harris, Tess; Muhammad, Uthman; McNorton, Vanessa; Mayers, David; Ennis, David

doi:10.1053/j.ajkd.2017.12.003

Cited by 68 publications

(72 citation statements)

References 36 publications

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“…In addition to use in clinical trials, HRQOL measures have utility in monitoring patients in dialysis practice, evaluating real-world effectiveness of new treatments, quality measurement programs, and as a factor in choice of VA placement [1,7,8]. However, the impact of VA on patients' health is not fully represented by existing assessment tools [4,9].…”

Section: Introductionmentioning

confidence: 99%

“…Citing the limited availability of VA-specific HRQOL measures and lack of use in clinical trials, SONG-HD investigators advocated for access function to be a "core measure" in hemodialysis studies due in part to the impact of patient quality of life [9]. To date, the impact of hemodialysis on HRQOL has been based largely on the Kidney Dialysis Quality of Life (KDQOL™) instruments [12], including the KDQOL-36™ [13].…”

Section: Introductionmentioning

confidence: 99%

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Vascular access-specific health-related quality of life impacts among hemodialysis patients: qualitative development of the hemodialysis access-related quality of life (HARQ) instrument

Nordyke¹,

Nicholson²,

Gage

et al. 2020

BMC Nephrol

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Background: End stage kidney disease and hemodialysis dependence are associated with impairments in healthrelated quality of life (HRQOL), which may be related to vascular access (VA). Few HRQOL measures are VA-specific and none differentiate HRQOL impact by VA type. We developed a VA-targeted HRQOL measure to distinguish the impact of fistulas, grafts and catheters. Methods:We created an initial item pool based on literature review and then conducted focus groups at 4 US sites with 37 adults and interviews with nine dialysis clinicians about VA's impact on HRQOL. We then drafted the Hemodialysis Access-Related Quality of Life (HARQ) measure and cognitively tested it with 17 hemodialysis patients. Focus group and cognitive interview participants were diverse in age, gender, years on dialysis, and VA. Results:We identified six domains for the HARQ: symptoms, physical functioning, emotional impacts, social and role functioning, sleep, and care-related burdens. Cognitive interviews indicated that items were easily understood and supported content validity. Attributing HRQOL impact to VA as opposed to other hemodialysis burden was challenging for some items. Some items were dropped that were considered redundant by patients, limitations while dressing was added, and reference to VA-specific impact was included for each item. The average Flesch-Kincaid reading grade level for the revised 47-item HARQ was 5.3. Conclusions: The HARQ features VA-specific content not addressed in other HRQOL measures, making it ideal for comparisons of different VA types and new VA technologies. The psychometric properties of the HARQ will be evaluated in future research.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Vascular access-specific health-related quality of life impacts among hemodialysis patients: qualitative development of the hemodialysis access-related quality of life (HARQ) instrument

Nordyke¹,

Nicholson²,

Gage

et al. 2020

BMC Nephrol

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“…Patients/caregivers rated the importance of aneurysms/pseudoaneurysms third and significantly higher compared to health professionals. The responses from patients in our survey and the SONG-HD vascular access consensus workshop 181 suggest that fear of a catastrophic haemorrhage was a key reason for the high importance of this outcome. Other reasons may include pain associated with this vascular access outcome, appearance and having to restrict physical activity to reduce the risk of complications such as rupture 8,227 .…”

Section: Discussionmentioning

confidence: 89%

“…This is a more patient-centred goal of finding the optimal vascular access requiring the least number of procedures to provide adequate dialysis 238,239 . Incentivising a reduction in interventions is anticipated to reduce healthcare costs and hospitalisations while simultaneously reducing the burden of invasive, often painful and anxiety-provoking procedures that are disruptive to the patients' lives 8,181 .…”

Section: Discussionmentioning

confidence: 99%

“…A Centres for Disease Control and Prevention (CDC) evidence-based quality improvement project across 17 HD facilities confirmed that staff training and competence assessment, aseptic technique, chlorhexidine use for CVC exit site care, and feedback of performance to staff can reduce access-related bloodstream infections by 54% 243 . For these reasons, infection was deemed less suitable as a core outcome to be reported across all trials in HD compared to function 181 .…”

Section: Discussionmentioning

confidence: 99%

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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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