TY - JOUR
T1 - Study protocol for Vascular Access outcome measure for function
T2 - 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
AU - Viecelli, Andrea K.
AU - Teixeira-Pinto, Armando
AU - Valks, Andrea
AU - Baer, Richard
AU - Cherian, Roy
AU - Cippà, Pietro E.
AU - Craig, Jonathan C.
AU - DeSilva, Ranil
AU - Jaure, Allison
AU - Johnson, David W.
AU - Kiriwandeniya, Charani
AU - Kopperschmidt, Pascal
AU - Liu, Wen J.
AU - Lee, Timmy
AU - Lok, Charmaine
AU - Madhan, Krishan
AU - Mallard, Alistair R.
AU - Oliver, Veronica
AU - Polkinghorne, Kevan R.
AU - Quinn, Rob R.
AU - Reidlinger, Donna
AU - Roberts, Matthew
AU - Sautenet, Bénédicte
AU - Hooi, Lai Seong
AU - Smith, Rob
AU - Snoeijs, Maarten
AU - Tordoir, Jan
AU - Vachharajani, Tushar J.
AU - Vanholder, Raymond
AU - Vergara, Liza A.
AU - Wilkie, Martin
AU - Yang, Bing
AU - Yuo, Theodore H.
AU - Zou, Li
AU - Hawley, Carmel M.
AU - on behalf of the VALID Investigator Team
AU - Robison, Laura
AU - Welch, Alyssa
AU - Badve, Sunil V.
AU - Boudville, Neil
AU - Campbell, Katrina
AU - Cho, Yeoungjee
AU - Collins, Michael
AU - Fahim, Magid A.
AU - Jardine, Meg
AU - Pascoe, Elaine M.
AU - Du Toit, Dianne
AU - Mayne, Michelle
AU - Stevenson, Kim
AU - James, Rachel
AU - Vu, Quynh
AU - Allen, Karyn
AU - Glancy, Leanne
AU - Kumbikkal, Jijo
AU - Burton, Sharan
AU - Gordon, Lisa
AU - McCarthy, Kylee
AU - Forrester, Cathy
AU - Lima, Sally
AU - Bourgault, Olivier
AU - Drouault, Claire
AU - Teasdale, Fanny
AU - Jiun, Liu Wen
AU - Abidin, Jamian
AU - Kiang, Cheng Jin
AU - Leng, Lee Soon
AU - Yusoff, Yuana Mohd
AU - Ciochina, Adriana
AU - van Loon, Magda
AU - Ophelders, Ronald
AU - Vleugels, Marie Jose
AU - Ferrari, Paolo
AU - Brodeur, Marie Ève
AU - Giunzioni, Davide
AU - Molfese, Christine Bressan
AU - Blackwell, Christopher
AU - Dunn, Louese
AU - Gillis, Laura
AU - Gray, Barry
AU - Jenkins, Sarah
PY - 2022/11/19
Y1 - 2022/11/19
N2 - 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.
AB - 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.
KW - Arteriovenous fistula
KW - Arteriovenous graft
KW - Central venous catheter
KW - Core outcome
KW - Feasibility
KW - Hemodialysis
KW - Implementation
KW - Patient engagement
KW - Validation
KW - Vascular access
UR - https://www.scopus.com/pages/publications/85142221068
UR - http://purl.org/au-research/grants/NHMRC/1092957
UR - http://purl.org/au-research/grants/NHMRC/1196033
U2 - 10.1186/s12882-022-02987-1
DO - 10.1186/s12882-022-02987-1
M3 - Article
C2 - 36402958
AN - SCOPUS:85142221068
SN - 1471-2369
VL - 23
JO - BMC NEPHROLOGY
JF - BMC NEPHROLOGY
IS - 1
M1 - 372
ER -