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

Andrea K Viecelli; Armando Teixeira-Pinto; Andrea Valks; Richard Baer; Roy Cherian; Pietro E Cippà; Jonathan C Craig; Ranil DeSilva; Allison Jaure; David W Johnson; Charani Kiriwandeniya; Pascal Kopperschmidt; Wen-J Liu; Timmy Lee; Charmaine Lok; Krishan Madhan; Alistair R Mallard; Veronica Oliver; Kevan R Polkinghorne; Rob R Quinn; Donna Reidlinger; Matthew Roberts; Bénédicte Sautenet; Lai Seong Hooi; Rob Smith; Maarten Snoeijs; Jan Tordoir; Tushar J Vachharajani; Raymond Vanholder; Liza A Vergara; Martin Wilkie; Bing Yang; Theodore H Yuo; Li Zou; Carmel M Hawley; VALID Investigator Team

doi:10.1186/s12882-022-02987-1

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

BMC Nephrol. 2022 Nov 19;23(1):372. doi: 10.1186/s12882-022-02987-1.

Authors

Andrea K Viecelli^{1

2

3}, Armando Teixeira-Pinto⁴, Andrea Valks⁵, Richard Baer⁶, Roy Cherian⁷, Pietro E Cippà⁸, Jonathan C Craig⁹, Ranil DeSilva¹⁰, Allison Jaure¹¹, David W Johnson^{12

13

5}, Charani Kiriwandeniya⁵, Pascal Kopperschmidt¹⁴, Wen-J Liu¹⁵, Timmy Lee¹⁶, Charmaine Lok¹⁷, Krishan Madhan¹⁸, Alistair R Mallard⁵, Veronica Oliver¹², Kevan R Polkinghorne^{19

20

21}, Rob R Quinn²², Donna Reidlinger⁵, Matthew Roberts²³, Bénédicte Sautenet²⁴, Lai Seong Hooi¹⁵, Rob Smith²⁵, Maarten Snoeijs²⁶, Jan Tordoir²⁶, Tushar J Vachharajani^{27

28}, Raymond Vanholder²⁹, Liza A Vergara⁵, Martin Wilkie³⁰, Bing Yang³¹, Theodore H Yuo¹⁰, Li Zou³¹, Carmel M Hawley^{12

13

5}; VALID Investigator Team

Collaborators

VALID Investigator Team:
Laura Robison, Alyssa Welch, Sunil V Badve, Neil Boudville, Katrina Campbell, Yeoungjee Cho, Michael Collins, Magid A Fahim, Meg Jardine, Dianne Du Toit, Michelle Mayne, Kim Stevenson, Rachel James, Quynh Vu, Karyn Allen, Leanne Glancy, Jijo Kumbikkal, Sharan Burton, Lisa Gordon, Kylee McCarthy, Cathy Forrester, Sally Lima, Olivier Bourgault, Claire Drouault, Fanny Teasdale, Liu Wen Jiun, Jamian Abidin, Cheng Jin Kiang, Lee Soon Leng, Yuana Mohd Yusoff, Adriana Ciochina, Magda van Loon, Ronald Ophelders, Marie-Jose Vleugels, Paolo Ferrari, Marie-Ève Brodeur, Davide Giunzioni, Christine Bressan Molfese, Christopher Blackwell, Louese Dunn, Laura Gillis, Barry Gray, Sarah Jenkins

Affiliations

¹ Department of Nephrology, Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba, QLD, 4102, Australia. andrea.viecelli@health.qld.gov.au.
² The Translational Research Institute, Brisbane, Australia. andrea.viecelli@health.qld.gov.au.
³ Australasian Kidney Trials Network, The University of Queensland, Brisbane, Australia. andrea.viecelli@health.qld.gov.au.
⁴ Centre for Kidney Research, School of Public Health, The University of Sydney, Sydney, Australia.
⁵ Australasian Kidney Trials Network, The University of Queensland, Brisbane, Australia.
⁶ Mater Hospital Brisbane, Brisbane, Queensland, Australia.
⁷ Mackay Base Hospital, Mackay, Australia.
⁸ Division of Nephrology, Ente Ospedaliero Cantonale, Bellinzona, Switzerland.
⁹ Flinders University, Adelaide, Australia.
¹⁰ University of Pittsburgh, Pittsburgh, PA, USA.
¹¹ The University of Sydney, Sydney, Australia.
¹² Department of Nephrology, Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba, QLD, 4102, Australia.
¹³ The Translational Research Institute, Brisbane, Australia.
¹⁴ Patient Partner, Fresenius Medical Care, Schweinfurt, Germany.
¹⁵ Sultanah Aminah, Johor Bahru, Malaysia.
¹⁶ Veterans Affairs Medical Center, Birmingham, AL, USA.
¹⁷ University of Toronto, Toronto, Ontario, Canada.
¹⁸ Hervey Bay Hospital, Urraween, Queensland, Australia.
¹⁹ Department of Nephrology, Monash Medical Centre, Monash Health, Clayton, VIC, Australia.
²⁰ Department of Medicine, Monash University, Clayton, VIC, Australia.
²¹ Department of Epidemiology & Preventive Medicine, Monash University, Clayton, VIC, Australia.
²² Departments of Medicine and Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Canada.
²³ Eastern Health Clinical School, Monash University, Melbourne, Australia.
²⁴ Tours University, Tours, France.
²⁵ Patient Partner, Royal Darwin Hospital, Darwin, Australia.
²⁶ Maastricht University Medical Center, Maastricht, Netherlands.
²⁷ Department of Kidney Medicine, Glickman Urological & Kidney Institute, Cleveland Clinic, Cleveland, USA.
²⁸ Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland, USA.
²⁹ Ghent University, Ghent, Belgium.
³⁰ Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.
³¹ Peking University People's Hospital, Beijing, China.

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.

Keywords: Arteriovenous fistula; Arteriovenous graft; Central venous catheter; Core outcome; Feasibility; Hemodialysis; Implementation; Patient engagement; Validation; Vascular access.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Feasibility Studies
Humans
Multicenter Studies as Topic
Outcome Assessment, Health Care*
Prospective Studies
Renal Dialysis* / methods
Surveys and Questionnaires

Associated data

ClinicalTrials.gov/NCT03969225