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Vascular access outcomes reported in maintenance hemodialysis trials : a systematic review

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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.
Keywords
ARTERIOVENOUS-FISTULA, INCREASING VALUE, REDUCING WASTE, ACHILLES-HEEL, COMPLICATIONS, METAANALYSIS, GUIDELINES, DIALYSIS, FAILURE, PATIENT

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Chicago
Viecelli, Andrea K, Emma O’Lone, Benedicte Sautenet, Jonathan C Craig, Allison Tong, Eric Chemla, Lai-Seong Hooi, et al. 2018. “Vascular Access Outcomes Reported in Maintenance Hemodialysis Trials : a Systematic Review.” American Journal of Kidney Diseases 71 (3): 382–391.
APA
Viecelli, A. K., O’Lone, E., Sautenet, B., Craig, J. C., Tong, A., Chemla, E., Hooi, L.-S., et al. (2018). Vascular access outcomes reported in maintenance hemodialysis trials : a systematic review. AMERICAN JOURNAL OF KIDNEY DISEASES, 71(3), 382–391.
Vancouver
1.
Viecelli AK, O’Lone E, Sautenet B, Craig JC, Tong A, Chemla E, et al. Vascular access outcomes reported in maintenance hemodialysis trials : a systematic review. AMERICAN JOURNAL OF KIDNEY DISEASES. 2018;71(3):382–91.
MLA
Viecelli, Andrea K, Emma O’Lone, Benedicte Sautenet, et al. “Vascular Access Outcomes Reported in Maintenance Hemodialysis Trials : a Systematic Review.” AMERICAN JOURNAL OF KIDNEY DISEASES 71.3 (2018): 382–391. Print.
@article{8569360,
  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 {\textacutedbl}mean access blood flow (mL/min){\textacutedbl} (37 [27\%] trials) and {\textacutedbl}number of thromboses{\textacutedbl} (30 [22\%]). Infection was assessed in 136 different ways, with {\textacutedbl}number of access-related infections{\textacutedbl} 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.},
  author       = {Viecelli, Andrea K and O'Lone, Emma and Sautenet, Benedicte and Craig, Jonathan C and Tong, Allison and Chemla, Eric and Hooi, Lai-Seong and Lee, Timmy and Lok, Charmaine and Polkinghorne, Kevan R and Quinn, Robert R and Vachharajani, Tushar and Vanholder, Raymond and Zuo, Li and Irish, Ashley B and Mori, Trevor A and Pascoe, Elaine M and Johnson, David W and Hawley, Carmel M},
  issn         = {0272-6386},
  journal      = {AMERICAN JOURNAL OF KIDNEY DISEASES},
  keyword      = {ARTERIOVENOUS-FISTULA,INCREASING VALUE,REDUCING WASTE,ACHILLES-HEEL,COMPLICATIONS,METAANALYSIS,GUIDELINES,DIALYSIS,FAILURE,PATIENT},
  language     = {eng},
  number       = {3},
  pages        = {382--391},
  title        = {Vascular access outcomes reported in maintenance hemodialysis trials : a systematic review},
  url          = {http://dx.doi.org/10.1053/j.ajkd.2017.09.018},
  volume       = {71},
  year         = {2018},
}

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