American Journal of Kidney Diseases

Vascular Access Outcomes Reported in Maintenance Hemodialysis Trials: A Systematic Review

Published:December 01, 2017DOI:


      Many randomized controlled trials have been performed with the goal of improving outcomes related to hemodialysis vascular access. If the reported outcomes are relevant and measured consistently to allow comparison of interventions across trials, such trials can inform decision making. This study aimed to assess the scope and consistency of vascular access outcomes reported in contemporary hemodialysis trials.

      Study Design

      Systematic review.

      Setting & Population

      Adults requiring maintenance hemodialysis.

      Selection Criteria

      All randomized controlled trials and trial protocols reporting vascular access outcomes identified from, Embase, MEDLINE, and the Cochrane Kidney and Transplant Specialized Register from January 2011 to June 2016.


      Any hemodialysis-related intervention.


      The frequency and characteristics of vascular access outcome measures were analyzed and classified.


      From 168 relevant trials, 1,426 access-related outcome measures were extracted and classified into 23 different outcomes. The 3 most common outcomes were function (136 [81%] trials), infection (63 [38%]), and maturation (31 [18%]). Function was measured in 489 different ways, but most frequently reported as “mean access blood flow (mL/min)” (37 [27%] trials) and “number of thromboses” (30 [22%]). Infection was assessed in 136 different ways, with “number of access-related infections” being the most common measure. Maturation was assessed in 44 different ways at 15 different time points and most commonly characterized by vein diameter and blood flow. Patient-reported outcomes, including pain (19 [11%]) and quality of life (5 [3%]), were reported infrequently. Only a minority of trials used previously standardized outcome definitions.


      Restricted sampling frame for feasibility and focus on contemporary trials.


      The reporting of access outcomes in hemodialysis trials is very heterogeneous, with limited patient-reported outcomes and infrequent use of standardized outcome measures. Efforts to standardize outcome reporting for vascular access are critical to optimizing the comparability, reliability, and value of trial evidence to improve outcomes for patients requiring hemodialysis.

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        • Malas M.B.
        • Canner J.K.
        • Hicks C.W.
        • et al.
        Trends in incident hemodialysis access and mortality.
        JAMA Surg. 2015; 150: 441-448
        • Al-Jaishi A.A.
        • Liu A.R.
        • Lok C.E.
        • Zhang J.C.
        • Moist L.M.
        Complications of the arteriovenous fistula: a systematic review.
        J Am Soc Nephrol. 2017; 28: 1839-1850
        • Al-Jaishi A.A.
        • Oliver M.J.
        • Thomas S.M.
        • et al.
        Patency rates of the arteriovenous fistula for hemodialysis: a systematic review and meta-analysis.
        Am J Kidney Dis. 2014; 63: 464-478
        • Manns B.
        • Tonelli M.
        • Yilmaz S.
        • et al.
        Establishment and maintenance of vascular access in incident hemodialysis patients: a prospective cost analysis.
        J Am Soc Nephrol. 2005; 16: 201-209
        • Ravani P.
        • Palmer S.C.
        • Oliver M.J.
        • et al.
        Associations between hemodialysis access type and clinical outcomes: a systematic review.
        J Am Soc Nephrol. 2013; 24: 465-473
        • Kjellstrand C.M.
        The Achilles' heel of the hemodialysis patient.
        Arch Intern Med. 1978; 138: 1063-1064
        • Taylor M.J.
        • Hanson C.S.
        • Casey J.R.
        • Craig J.C.
        • Harris D.
        • Tong A.
        “You know your own fistula, it becomes a part of you”-patient perspectives on vascular access: a semistructured interview study.
        Hemodial Int. 2015; 20: 5-14
        • Bay W.H.
        • Van Cleef S.
        • Owens M.
        The hemodialysis access: preferences and concerns of patients, dialysis nurses and technicians, and physicians.
        Am J Nephrol. 1998; 18: 379-383
        • Manns B.
        • Hemmelgarn B.
        • Lillie E.
        • et al.
        Setting research priorities for patients on or nearing dialysis.
        Clin J Am Soc Nephrol. 2014; 9: 1813-1821
        • Tong A.
        • Manns B.
        • Hemmelgarn B.
        • et al.
        Establishing core outcome domains in hemodialysis: report of the Standardised Outcomes in Nephrology – Hemodialysis (SONG-HD) consensus workshops.
        Am J Kidney Dis. 2017; 69: 97-107
        • Tanner N.C.
        • Da Silva A.
        Medical adjuvant treatment to increase patency of arteriovenous fistulae and grafts.
        Cochrane Database Syst Rev. 2015; 7: CD002786
        • Palmer S.C.
        • Di Micco L.
        • Razavian M.
        • et al.
        Antiplatelet therapy to prevent hemodialysis vascular access failure: systematic review and meta-analysis.
        Am J Kidney Dis. 2013; 61: 112-122
        • Riella M.C.
        • Roy-Chaudhury P.
        Vascular access in haemodialysis: strengthening the Achilles' heel.
        Nat Rev Nephrol. 2013; 9: 348-357
        • Kosa S.D.
        • Bhola C.
        • Lok C.E.
        Hemodialysis patients' satisfaction and perspectives on complications associated with vascular access related interventions: are we listening?.
        J Vasc Access. 2016; 17: 313-319
        • Kirkham J.J.
        • Gorst S.
        • Altman D.G.
        • et al.
        Core Outcome Set-STAndards for Reporting: the COS-STAR statement.
        PLoS Med. 2016; 13: e1002148
        • Dwan K.
        • Altman D.G.
        • Arnaiz J.A.
        • et al.
        Systematic review of the empirical evidence of study publication bias and outcome reporting bias.
        PLoS One. 2008; 3: e3081
        • Dwan K.
        • Gamble C.
        • Williamson P.R.
        • Kirkham J.J.
        • for the Reporting Bias Group and the Reporting Bias Group
        Systematic review of the empirical evidence of study publication bias and outcome reporting bias - an updated review.
        PLoS One. 2013; 8: e66844
        • Prinsen C.A.
        • Vohra S.
        • Rose M.R.
        • et al.
        How to select outcome measurement instruments for outcomes included in a “Core Outcome Set” - a practical guideline.
        Trials. 2016; 17: 449
        • Sautenet B.
        • Caille A.
        • Halimi J.M.
        • Goupille P.
        • Giraudeau B.
        Better reporting and greater homogeneity in outcome measures are seen in randomized trial protocols when guidelines exist.
        J Clin Epidemiol. 2013; 66: 838-846
        • Ioannidis J.P.
        • Greenland S.
        • Hlatky M.A.
        • et al.
        Increasing value and reducing waste in research design, conduct, and analysis.
        Lancet. 2014; 383: 166-175
        • Macleod M.R.
        • Michie S.
        • Roberts I.
        • et al.
        Biomedical research: increasing value, reducing waste.
        Lancet. 2014; 383: 101-104
        • Lee T.
        • Mokrzycki M.
        • Moist L.
        • et al.
        Standardized definitions for hemodialysis vascular access.
        Semin Dial. 2011; 24: 515-524
        • Sidawy A.N.
        • Gray R.
        • Besarab A.
        • et al.
        Recommended standards for reports dealing with arteriovenous hemodialysis accesses.
        J Vasc Surg. 2002; 35: 603-610
        • Gray R.J.
        • Sacks D.
        • Martin L.G.
        • Trerotola S.O.
        Society of Interventional Radiology Technology Assessment Committee. Reporting standards for percutaneous interventions in dialysis access.
        J Vasc Interv Radiol. 2003; 14: S433-S442
        • Vascular Access Working Group
        Clinical practice guidelines for vascular access.
        Am J Kidney Dis. 2006; 48: S248-S273
        • Zarin D.A.
        • Tse T.
        • Williams R.J.
        • Califf R.M.
        • Ide N.C.
        The results database–update and key issues.
        N Engl J Med. 2011; 364: 852-860
        • Black N.
        Patient reported outcome measures could help transform healthcare.
        BMJ. 2013; 346: f167
        • Fleming T.R.
        • DeMets D.L.
        Surrogate end points in clinical trials: are we being misled?.
        Ann Intern Med. 1996; 125: 605-613
      1. NKF-KDOQI Guidelines. Clinical practice guidelines and clinical practice recommendations 2006. Accessed January 22, 2017.

        • Division of Nosocomial and Occupational Infectious Diseases, Bureau of Infectious Diseases Laboratory Centre for Disease Control Health Canada
        Preventing infections associated with indwelling intravascular access devices.
        Can Commun Dis Rep. 1997; 23 (i-iii, 1-32, i-iv, 31-16)
        • Mermel L.A.
        • Farr B.M.
        • Sherertz R.J.
        • et al.
        Guidelines for the management of intravascular catheter-related infections.
        Clin Infect Dis. 2001; 32: 1249-1272
        • O'Grady N.P.
        • Alexander M.
        • Dellinger E.P.
        • et al.
        Guidelines for the prevention of intravascular catheter-related infections. Centers for Disease Control and Prevention.
        MMWR Recomm Rep. 2002; 51: 1-29
        • Robbin M.L.
        • Chamberlain N.E.
        • Lockhart M.E.
        • et al.
        Hemodialysis arteriovenous fistula maturity: US evaluation.
        Radiology. 2002; 225: 59-64
        • Silberzweig J.E.
        • Sacks D.
        • Khorsandi A.S.
        • Bakal C.W.
        Society of Interventional Radiology Technology Assessment C. Reporting standards for central venous access.
        J Vasc Interv Radiol. 2003; 14: S443-S452
        • Boers M.
        • Kirwan J.R.
        • Tugwell P.
        • et al.
        The OMERACT Handbook.
        OMERACT, Ottowa, ON, Canada2014
        • Tong A.
        • Manns B.
        • Hemmelgarn B.
        • et al.
        Standardised Outcomes in Nephrology - Haemodialysis (SONG-HD): study protocol for establishing a core outcome set in haemodialysis.
        Trials. 2015; 16: 364
        • Evangelidis N.
        • Tong A.
        • Manns B.
        • et al.
        Developing a set of core outcomes for trials in hemodialysis: an international Delphi survey.
        Am J Kidney Dis. 2017; 70: 464-475
      2. Standardised Outcomes in Nephrology - Haemodialysis (SONG-HD) Expert Working Groups. Accessed August 7, 2017.

        • Dember L.M.
        • Beck G.J.
        • Allon M.
        • et al.
        Effect of clopidogrel on early failure of arteriovenous fistulas for hemodialysis: a randomized controlled trial.
        JAMA. 2008; 299: 2164-2171
        • Quinn R.R.
        • Lamping D.L.
        • Lok C.E.
        • et al.
        The Vascular Access Questionnaire: assessing patient-reported views of vascular access.
        J Vasc Access. 2008; 9: 122-128
      3. Allon M, Brouwer-Maier DJ, Abreo K, et al. Recommended clinical trial end points for dialysis catheters [published online ahead of print July 20, 2017]. Clin J Am Soc Nephrol.

      4. Beathard GA, Lok CE, Glickman MH, et al. Definitions and end points for interventional studies for arteriovenous dialysis access [published online ahead of print July 20, 2017]. Clin J Am Soc Nephrol.

      5. Hurst FP, Lee RE, Thompson AM, Pullin BD, Silverstein DM. FDA regulatory perspectives for studies on hemodialysis vascular access [published online ahead of print July 24, 2017]. Clin J Am Soc Nephrol.

      6. Standardised Outcomes in Nephrology - Haemodialysis (SONG-HD) Initiative. 2016. Accessed August 7, 2017.

        • Campos R.P.
        • do Nascimento M.M.
        • Chula D.C.
        • Riella M.C.
        Minocycline-EDTA lock solution prevents catheter-related bacteremia in hemodialysis.
        J Am Soc Nephrol. 2011; 22: 1939-1945