Andrea K Viecelli1, Emma O'Lone2, Benedicte Sautenet3, Jonathan C Craig2, Allison Tong2, Eric Chemla4, Lai-Seong Hooi5, Timmy Lee6, Charmaine Lok7, Kevan R Polkinghorne8, Robert R Quinn9, Tushar Vachharajani10, Raymond Vanholder11, Li Zuo12, Ashley B Irish13, Trevor A Mori14, Elaine M Pascoe15, David W Johnson16, Carmel M Hawley16. 1. Department of Nephrology, Princess Alexandra Hospital, Brisbane, Australia; Australasian Kidney Trials Network, School of Medicine, University of Queensland, Brisbane, Australia. Electronic address: andrea.viecelli@health.qld.gov.au. 2. Sydney School of Public Health, The University of Sydney, Sydney, Australia; Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia. 3. Sydney School of Public Health, The University of Sydney, Sydney, Australia; Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia; University Francois Rabelais, Tours, France; Department of Nephrology and Clinical Immunology, Tours Hospital, Tours, France. 4. St George's University Hospitals Foundation Trust, London, United Kingdom. 5. Department of Medicine and Haemodialysis Unit, Hospital Sultanah Aminah, Johor Bahru, Malaysia. 6. Division of Nephrology, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL; Section of Nephrology, Veterans Affairs Medical Center, Birmingham, AL. 7. Division of Nephrology, University Health Network, Toronto, Ontario, Canada; Department of Medicine, University of Toronto, Toronto, Ontario, Canada. 8. Department of Nephrology, Monash Medical Centre, Melbourne, Australia; Department of Medicine, Monash University, Melbourne, Australia; School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia. 9. Department of Medicine, University of Calgary, Calgary, Canada; Department of Community Health Sciences, University of Calgary, Calgary, Canada. 10. Division of Nephrology, W.G. (Bill) Hefner Veterans Affairs Medical Center, Salisbury, NC. 11. Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium; Department of Nephrology, Ghent University Hospital, Ghent, Belgium. 12. Peking University People's Hospital, Beijing, China. 13. Department of Nephrology, Fiona Stanley Hospital, Perth, Australia; School of Medicine and Pharmacology, University of Western Australia, Perth, Australia. 14. School of Medicine and Pharmacology, University of Western Australia, Perth, Australia. 15. Australasian Kidney Trials Network, School of Medicine, University of Queensland, Brisbane, Australia. 16. Department of Nephrology, Princess Alexandra Hospital, Brisbane, Australia; Australasian Kidney Trials Network, School of Medicine, University of Queensland, Brisbane, Australia; Translational Research Institute, Brisbane, Australia.
Abstract
BACKGROUND: 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 ClinicalTrials.gov, Embase, MEDLINE, and the Cochrane Kidney and Transplant Specialized Register from January 2011 to June 2016. INTERVENTIONS: Any hemodialysis-related intervention. OUTCOMES: The frequency and characteristics of vascular access outcome measures were analyzed and classified. RESULTS: 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. LIMITATIONS: Restricted sampling frame for feasibility and focus on contemporary trials. CONCLUSIONS: 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.
BACKGROUND: 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 ClinicalTrials.gov, Embase, MEDLINE, and the Cochrane Kidney and Transplant Specialized Register from January 2011 to June 2016. INTERVENTIONS: Any hemodialysis-related intervention. OUTCOMES: The frequency and characteristics of vascular access outcome measures were analyzed and classified. RESULTS: 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. LIMITATIONS: Restricted sampling frame for feasibility and focus on contemporary trials. CONCLUSIONS: 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.
Authors: Yong Pey See; Yeoungjee Cho; Elaine M Pascoe; Alan Cass; Ashley Irish; David Voss; Kevan R Polkinghorne; Lai Seong Hooi; Loke-Meng Ong; Peta-Anne Paul-Brent; Peter G Kerr; Trevor A Mori; Carmel M Hawley; David W Johnson; Andrea K Viecelli Journal: Kidney360 Date: 2020-09-14
Authors: Allison Tong; Braden Manns; Angela Yee Moon Wang; Brenda Hemmelgarn; David C Wheeler; John Gill; Peter Tugwell; Robert Pecoits-Filho; Sally Crowe; Tess Harris; Wim Van Biesen; Wolfgang C Winkelmayer; Adeera Levin; Aliza Thompson; Vlado Perkovic; Angela Ju; Talia Gutman; Amelie Bernier-Jean; Andrea K Viecelli; Emma O'Lone; Jenny Shen; Michelle A Josephson; Yeoungjee Cho; David W Johnson; Bénédicte Sautenet; Marcello Tonelli; Jonathan C Craig Journal: Kidney Int Date: 2018-10-22 Impact factor: 10.612
Authors: Andrea K Viecelli; Kevan R Polkinghorne; Elaine M Pascoe; Peta-Anne Paul-Brent; Carmel M Hawley; Sunil V Badve; Alan Cass; Lai-Seong Hooi; Peter G Kerr; Trevor A Mori; Loke-Meng Ong; David Voss; David W Johnson; Ashley B Irish Journal: PLoS One Date: 2019-03-26 Impact factor: 3.240
Authors: Robert J Nordyke; Gina Nicholson; Shawn M Gage; Ted Lithgow; Jonathan Himmelfarb; Matthew B Rivara; Ron D Hays; Karen Woo; John Devin Peipert Journal: BMC Nephrol Date: 2020-01-14 Impact factor: 2.388