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

Andrea K. Viecelli , Emma O'Lone , Benedicte Sautenet (1) , Jonathan C. Craig , Allison Tong , Eric Chemla , Lai-Seong Hooi , Timmy Lee , Charmaine Lok , Kevan R. Polkinghorne , Robert R. Quinn , Tushar Vachharajani , Raymond Vanholder , Li Zuo , Ashley B. Irish , Trevor A. Mori , Elaine M. Pascoe , David W. Johnson , Carmel M. Hawley

1 SPHERE - MethodS in Patients-centered outcomes and HEalth ResEarch

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.

Mots clés: function; Female; evidence-based practice; ESKD; Equipment Failure; end-stage renal disease (ESRD); central venous catheter (CVC); arteriovenous graft (AVG); arteriovenous fistula (AVG); Age Factors; Adult; Renal Dialysis; Review; Risk Assessment; Sex Factors; standardized outcomes; Survival Rate; systematic review; Time Factors; trials; Vascular access; Vascular Access Devices; Randomized Controlled Trials as Topic; patency; outcomes; outcome reporting; outcome measures; Health Care; Outcome Assessment; Middle Aged; maturation; Male; Maintenance; Chronic; Kidney Failure; Internationality; infection; Incidence; Humans; hemodialysis

Domaines: Sciences du Vivant [q-bio]

Andrea K. Viecelli, Emma O'Lone, Benedicte Sautenet, Jonathan C. Craig, Allison Tong, et al.. Vascular Access Outcomes Reported in Maintenance Hemodialysis Trials: A Systematic Review. American Journal of Kidney Diseases, 2018, 71 (3), pp.382-391. ⟨10.1053/j.ajkd.2017.09.018⟩. ⟨hal-03158644⟩