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Study protocol for Vascular Access outcome measure for function: a vaLidation study In hemoDialysis (VALID) : A multi-center, multinational validation study to assess the accuracy and feasibility of measuring vascular access function in clinical practice

Viecelli AK 1 , Teixeira-Pinto A 2 , Valks A 3 , Baer R 4 , Cherian R 5 , Cippà PE 6 Show all authors , Craig JC 7 , DeSilva R 8 , Jaure A 9 , Johnson DW 10 , Kiriwandeniya C 3 , Kopperschmidt P 11 , Liu WJ 12 , Lee T 13 , Lok C 14 , Madhan K 15 , Mallard AR 3 , Oliver V 10 , Polkinghorne KR 16 , Quinn RR 17 , Reidlinger D 3 , Roberts M 18 , Sautenet B 19 , Hooi LS 12 , Smith R 20 , Snoeijs M 21 , Tordoir J 21 , Vachharajani TJ 22 , Vanholder R 23 , Vergara LA 3 , Wilkie M 24 , Yang B 25 , Yuo TH 8 , Zou L 25 , Hawley CM 10 , VALID Investigator Team

Affiliations 

  • 1 Department of Nephrology, Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba, QLD, 4102, Australia. andrea.viecelli@health.qld.gov.au
  • 2 Centre for Kidney Research, School of Public Health, The University of Sydney, Sydney, Australia
  • 3 Australasian Kidney Trials Network, The University of Queensland, Brisbane, Australia
  • 4 Mater Hospital Brisbane, Brisbane, Queensland, Australia
  • 5 Mackay Base Hospital, Mackay, Australia
  • 6 Division of Nephrology, Ente Ospedaliero Cantonale, Bellinzona, Switzerland
  • 7 Flinders University, Adelaide, Australia
  • 8 University of Pittsburgh, Pittsburgh, PA, USA
  • 9 The University of Sydney, Sydney, Australia
  • 10 Department of Nephrology, Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba, QLD, 4102, Australia
  • 11 Patient Partner, Fresenius Medical Care, Schweinfurt, Germany
  • 12 Sultanah Aminah, Johor Bahru, Malaysia
  • 13 Veterans Affairs Medical Center, Birmingham, AL, USA
  • 14 University of Toronto, Toronto, Ontario, Canada
  • 15 Hervey Bay Hospital, Urraween, Queensland, Australia
  • 16 Department of Nephrology, Monash Medical Centre, Monash Health, Clayton, VIC, Australia
  • 17 Departments of Medicine and Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Canada
  • 18 Eastern Health Clinical School, Monash University, Melbourne, Australia
  • 19 Tours University, Tours, France
  • 20 Patient Partner, Royal Darwin Hospital, Darwin, Australia
  • 21 Maastricht University Medical Center, Maastricht, Netherlands
  • 22 Department of Kidney Medicine, Glickman Urological & Kidney Institute, Cleveland Clinic, Cleveland, USA
  • 23 Ghent University, Ghent, Belgium
  • 24 Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK
  • 25 Peking University People's Hospital, Beijing, China
BMC Nephrol, 2022 Nov 19;23(1):372.
PMID: 36402958 DOI: 10.1186/s12882-022-02987-1

Abstract

BACKGROUND: A functioning vascular access (VA) is crucial to providing adequate hemodialysis (HD) and considered a critically important outcome by patients and healthcare professionals. A validated, patient-important outcome measure for VA function that can be easily measured in research and practice to harvest reliable and relevant evidence for informing patient-centered HD care is lacking. Vascular Access outcome measure for function: a vaLidation study In hemoDialysis (VALID) aims to assess the accuracy and feasibility of measuring a core outcome for VA function established by the international Standardized Outcomes in Nephrology (SONG) initiative.

METHODS: VALID is a prospective, multi-center, multinational validation study that will assess the accuracy and feasibility of measuring VA function, defined as the need for interventions to enable and maintain the use of a VA for HD. The primary objective is to determine whether VA function can be measured accurately by clinical staff as part of routine clinical practice (Assessor 1) compared to the reference standard of documented VA procedures collected by a VA expert (Assessor 2) during a 6-month follow-up period. Secondary outcomes include feasibility and acceptability of measuring VA function and the time to, rate of, and type of VA interventions. An estimated 612 participants will be recruited from approximately 10 dialysis units of different size, type (home-, in-center and satellite), governance (private versus public), and location (rural versus urban) across Australia, Canada, Europe, and Malaysia. Validity will be measured by the sensitivity and specificity of the data acquisition process. The sensitivity corresponds to the proportion of correctly identified interventions by Assessor 1, among the interventions identified by Assessor 2 (reference standard). The feasibility of measuring VA function will be assessed by the average data collection time, data completeness, feasibility questionnaires and semi-structured interviews on key feasibility aspects with the assessors.

DISCUSSION: Accuracy, acceptability, and feasibility of measuring VA function as part of routine clinical practice are required to facilitate global implementation of this core outcome across all HD trials. Global use of a standardized, patient-centered outcome measure for VA function in HD research will enhance the consistency and relevance of trial evidence to guide patient-centered care.

TRIAL REGISTRATION: Clinicaltrials.gov: NCT03969225. Registered on 31st May 2019.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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