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

Viecelli AK, Tong A, O'Lone E, Ju A, Hanson CS, Sautenet B, et al.

Am J Kidney Dis, 2018 05;71(5):690-700.
PMID: 29478866 DOI: 10.1053/j.ajkd.2017.12.003

Vascular access outcomes in hemodialysis are critically important for patients and clinicians, but frequently are neither patient relevant nor measured consistently in randomized trials. A Standardized Outcomes in Nephrology-Hemodialysis (SONG-HD) consensus workshop was convened to discuss the development of a core outcome measure for vascular access. 13 patients/caregivers and 46 professionals (clinicians, policy makers, industry representatives, and researchers) attended. Participants advocated for vascular access function to be a core outcome based on the broad applicability of function regardless of access type, involvement of a multidisciplinary team in achieving a functioning access, and the impact of access function on quality of life, survival, and other access-related outcomes. A core outcome measure for vascular access required demonstrable feasibility for implementation across different clinical and trial settings. Participants advocated for a practical and flexible outcome measure with a simple actionable definition. Integrating patients' values and preferences was warranted to enhance the relevance of the measure. Proposed outcome measures for function included "uninterrupted use of the access without the need for interventions" and "ability to receive prescribed dialysis," but not "access blood flow," which was deemed too expensive and unreliable. These recommendations will inform the definition and implementation of a core outcome measure for vascular access function in hemodialysis trials.

Matched MeSH terms: Vascular Access Devices/standards*
Identifying critically important vascular access outcomes for trials in haemodialysis: an international survey with patients, caregivers and health professionals

Viecelli AK, Howell M, Tong A, Teixeira-Pinto A, O'Lone E, Ju A, et al.

Nephrol Dial Transplant, 2020 04 01;35(4):657-668.
PMID: 31369099 DOI: 10.1093/ndt/gfz148

BACKGROUND: Vascular access outcomes reported across haemodialysis (HD) trials are numerous, heterogeneous and not always relevant to patients and clinicians. This study aimed to identify critically important vascular access outcomes.
METHOD: Outcomes derived from a systematic review, multi-disciplinary expert panel and patient input were included in a multilanguage online survey. Participants rated the absolute importance of outcomes using a 9-point Likert scale (7-9 being critically important). The relative importance was determined by a best-worst scale using multinomial logistic regression. Open text responses were analysed thematically.
RESULTS: The survey was completed by 873 participants [224 (26%) patients/caregivers and 649 (74%) health professionals] from 58 countries. Vascular access function was considered the most important outcome (mean score 7.8 for patients and caregivers/8.5 for health professionals, with 85%/95% rating it critically important, and top ranked on best-worst scale), followed by infection (mean 7.4/8.2, 79%/92% rating it critically important, second rank on best-worst scale). Health professionals rated all outcomes of equal or higher importance than patients/caregivers, except for aneurysms. We identified six themes: necessity for HD, applicability across vascular access types, frequency and severity of debilitation, minimizing the risk of hospitalization and death, optimizing technical competence and adherence to best practice and direct impact on appearance and lifestyle.
CONCLUSIONS: Vascular access function was the most critically important outcome among patients/caregivers and health professionals. Consistent reporting of this outcome across trials in HD will strengthen their value in supporting vascular access practice and shared decision making in patients requiring HD.

Matched MeSH terms: Vascular Access Devices/standards*
Six-year study on peripheral venous catheter-associated BSI rates in 262 ICUs in eight countries of South-East Asia: International Nosocomial Infection Control Consortium findings

Rosenthal VD, Bat-Erdene I, Gupta D, Rajhans P, Myatra SN, Muralidharan S, et al.

J Vasc Access, 2021 Jan;22(1):34-41.
PMID: 32406328 DOI: 10.1177/1129729820917259

BACKGROUND: Short-term peripheral venous catheter-associated bloodstream infection rates have not been systematically studied in Asian countries, and data on peripheral venous catheter-associated bloodstream infections incidence by number of short-term peripheral venous catheter days are not available.
METHODS: Prospective, surveillance study on peripheral venous catheter-associated bloodstream infections conducted from 1 September 2013 to 31 May 2019 in 262 intensive care units, members of the International Nosocomial Infection Control Consortium, from 78 hospitals in 32 cities of 8 countries in the South-East Asia Region: China, India, Malaysia, Mongolia, Nepal, Philippines, Thailand, and Vietnam. For this research, we applied definition and criteria of the CDC NHSN, methodology of the INICC, and software named INICC Surveillance Online System.
RESULTS: We followed 83,295 intensive care unit patients for 369,371 bed-days and 376,492 peripheral venous catheter-days. We identified 999 peripheral venous catheter-associated bloodstream infections, amounting to a rate of 2.65/1000 peripheral venous catheter-days. Mortality in patients with peripheral venous catheter but without peripheral venous catheter-associated bloodstream infections was 4.53% and 12.21% in patients with peripheral venous catheter-associated bloodstream infections. The mean length of stay in patients with peripheral venous catheter but without peripheral venous catheter-associated bloodstream infections was 4.40 days and 7.11 days in patients with peripheral venous catheter and peripheral venous catheter-associated bloodstream infections. The microorganism profile showed 67.1% were Gram-negative bacteria: Escherichia coli (22.9%), Klebsiella spp (10.7%), Pseudomonas aeruginosa (5.3%), Enterobacter spp. (4.5%), and others (23.7%). The predominant Gram-positive bacteria were Staphylococcus aureus (11.4%).
CONCLUSIONS: Infection prevention programs must be implemented to reduce the incidence of peripheral venous catheter-associated bloodstream infections.

Matched MeSH terms: Vascular Access Devices/adverse effects*
Vascular Access Outcomes Reported in Maintenance Hemodialysis Trials: A Systematic Review

Viecelli AK, O'Lone E, Sautenet B, Craig JC, Tong A, Chemla E, et al.

Am J Kidney Dis, 2018 03;71(3):382-391.
PMID: 29203125 DOI: 10.1053/j.ajkd.2017.09.018

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.

Matched MeSH terms: Vascular Access Devices/adverse effects*
The Real-World CONSEQUENT ALL COMERS Study: Predictors for Target Lesion Revascularization and Mortality in an Unselected Patient Population

Langhoff R, Arjumand J, Waliszewski M, Reimer P, Härtel D, Hohl C, et al.

Angiology, 2021 Sep;72(8):724-732.
PMID: 33779291 DOI: 10.1177/0003319721997314

We evaluated the safety and efficacy of a resveratrol-paclitaxel-coated peripheral balloon catheter in an all-comer patient cohort undergoing endovascular treatment of above-the-knee and below-the-knee peripheral artery disease. CONSEQUENT ALL COMERS (Clinical Post-Market Clinical Follow-up [PMCF] on Peripheral Arteries treated with SeQuent Please OTW [Over-the Wire]) is a prospective, single-arm, multicenter observational study (ClinicalTrials Identifier: NCT02460042). The primary end point was the 12-month target lesion revascularization (TLR) rate. Secondary end points included vessel patency, target vessel revascularization, and all-cause mortality. A total of 879 lesions in 784 consecutive patients (71.3 ± 10.4 years old, 57.7% male) were analyzed; 53.3% had claudication, whereas the remaining 46.7% exhibited critical limb ischemia (CLI). Substantial comorbidities were present, including diabetes mellitus (41.2%), smoking (66.1%), and coronary artery disease (33.9%). Lesion length (879 lesions) was 12.0 ± 9.3 cm and 31.8% were Transatlantic Inter-Society Consensus II C/D lesions. The overall technical success rate of the 1269 drug-coated balloon (DCB)'s used was 99.6% (1.60 ± 0.79 DCB's/patient). At 12 months, the TLR rates were 6.3% in patients with CLI and 9.6% in claudicants, with a primary patency rate of 89.9% and 87.1%, respectively. All-cause mortality was 4.3% (28/658). The most important predictors for TLR were female gender, in-stent restenosis at baseline and lesion length.

Matched MeSH terms: Vascular Access Devices