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.

Humans Feasibility Studies Multicenter Studies as Topic Outcome Assessment, Health Care Prospective Studies Renal Dialysis / methods Surveys and Questionnaires
Arteriovenous fistula Arteriovenous graft Central venous catheter Core outcome Feasibility Hemodialysis Implementation Patient engagement Validation Vascular access

Journal

BMC nephrology
ISSN: 1471-2369
Titre abrégé: BMC Nephrol
Pays: England
ID NLM: 100967793

Informations de publication

Date de publication:
19 11 2022
Historique:
received: 06 05 2022
accepted: 24 10 2022
entrez: 19 11 2022
pubmed: 20 11 2022
medline: 23 11 2022
Statut: epublish

Résumé

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

Sections du résumé

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.

Identifiants

DOI: 10.1186/s12882-022-02987-1 PMID: 36402958 PMC: PMC9675211
pubmed: 36402958
doi: 10.1186/s12882-022-02987-1
pii: 10.1186/s12882-022-02987-1
pmc: PMC9675211
doi:

Banques de données

ClinicalTrials.gov
['NCT03969225']

Types de publication

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

Langues

eng

Sous-ensembles de citation

IM

Pagination

372

Investigateurs

Laura Robison (L)
Alyssa Welch (A)
Sunil V Badve (SV)
Neil Boudville (N)
Katrina Campbell (K)
Yeoungjee Cho (Y)
Michael Collins (M)
Magid A Fahim (MA)
Meg Jardine (M)
Dianne Du Toit (D)
Michelle Mayne (M)
Kim Stevenson (K)
Rachel James (R)
Quynh Vu (Q)
Karyn Allen (K)
Leanne Glancy (L)
Jijo Kumbikkal (J)
Sharan Burton (S)
Lisa Gordon (L)
Kylee McCarthy (K)
Cathy Forrester (C)
Sally Lima (S)
Olivier Bourgault (O)
Claire Drouault (C)
Fanny Teasdale (F)
Liu Wen Jiun (LW)
Jamian Abidin (J)
Cheng Jin Kiang (CJ)
Lee Soon Leng (LS)
Yuana Mohd Yusoff (YM)
Adriana Ciochina (A)
Magda van Loon (M)
Ronald Ophelders (R)
Marie-Jose Vleugels (MJ)
Paolo Ferrari (P)
Marie-Ève Brodeur (MÈ)
Davide Giunzioni (D)
Christine Bressan Molfese (CB)
Christopher Blackwell (C)
Louese Dunn (L)
Laura Gillis (L)
Barry Gray (B)
Sarah Jenkins (S)

Informations de copyright

© 2022. Crown.

Références

Nephrol Dial Transplant. 2020 Apr 1;35(4):657-668
pubmed: 31369099
J Am Soc Nephrol. 2000 Apr;11(4):740-746
pubmed: 10752533
Semin Dial. 2011 Sep-Oct;24(5):515-24
pubmed: 21906166
Am J Kidney Dis. 2017 Jan;69(1):97-107
pubmed: 27497527
Trials. 2016 Sep 13;17(1):449
pubmed: 27618914
Am J Kidney Dis. 2018 Jul;72(1):62-74
pubmed: 29475768
JAMA. 2012 May 2;307(17):1809-16
pubmed: 22550196
Clin J Am Soc Nephrol. 2014 Oct 7;9(10):1813-21
pubmed: 24832095
Trials. 2015 Aug 19;16:364
pubmed: 26285819
J Am Soc Nephrol. 2017 Jun;28(6):1839-1850
pubmed: 28031406
Am J Kidney Dis. 2018 Mar;71(3):382-391
pubmed: 29203125
Clin J Am Soc Nephrol. 2018 Mar 7;13(3):490-494
pubmed: 29487092
Am J Kidney Dis. 2017 Oct;70(4):464-475
pubmed: 28238554
Hemodial Int. 2016 Jan;20(1):5-14
pubmed: 26201992
Lancet. 2015 May 16;385(9981):1975-82
pubmed: 25777665
J Biomed Inform. 2009 Apr;42(2):377-81
pubmed: 18929686
Am J Kidney Dis. 2006 Jul;48 Suppl 1:S248-73
pubmed: 16813991
Kidney Int. 1998 Oct;54(4):1029-40
pubmed: 9767519
J Vasc Surg. 2002 Mar;35(3):603-10
pubmed: 11877717
J Vasc Interv Radiol. 2003 Sep;14(9 Pt 2):S433-42
pubmed: 14514859
Nephrol Dial Transplant. 2012 Feb;27(2):810-6
pubmed: 21693682
Clin J Am Soc Nephrol. 2013 May;8(5):810-8
pubmed: 23371955
J Am Soc Nephrol. 2005 Jan;16(1):201-9
pubmed: 15563567
Kidney Int. 2018 Dec;94(6):1053-1068
pubmed: 30360959
Kidney Int. 2020 Sep;98(3):553-565
pubmed: 32628942
J Vasc Surg. 2008 Nov;48(5 Suppl):26S-30S
pubmed: 19000590
BMC Nephrol. 2015 Jun 27;16:89
pubmed: 26116581
Am J Kidney Dis. 2016 Sep;68(3):444-54
pubmed: 26968042
Perit Dial Int. 2017 Nov-Dec;37(6):639-647
pubmed: 28765167
Am J Kidney Dis. 2018 May;71(5):690-700
pubmed: 29478866

Auteurs

Andrea K Viecelli (AK)

Department of Nephrology, Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba, QLD, 4102, Australia. andrea.viecelli@health.qld.gov.au.
The Translational Research Institute, Brisbane, Australia. andrea.viecelli@health.qld.gov.au.
Australasian Kidney Trials Network, The University of Queensland, Brisbane, Australia. andrea.viecelli@health.qld.gov.au.
ORCID: 0000-0003-2314-6654

Armando Teixeira-Pinto (A)

Centre for Kidney Research, School of Public Health, The University of Sydney, Sydney, Australia.

Andrea Valks (A)

Australasian Kidney Trials Network, The University of Queensland, Brisbane, Australia.

Richard Baer (R)

Mater Hospital Brisbane, Brisbane, Queensland, Australia.

Roy Cherian (R)

Mackay Base Hospital, Mackay, Australia.

Pietro E Cippà (PE)

Division of Nephrology, Ente Ospedaliero Cantonale, Bellinzona, Switzerland.

Jonathan C Craig (JC)

Flinders University, Adelaide, Australia.

Ranil DeSilva (R)

University of Pittsburgh, Pittsburgh, PA, USA.

Allison Jaure (A)

The University of Sydney, Sydney, Australia.

David W Johnson (DW)

Department of Nephrology, Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba, QLD, 4102, Australia.
The Translational Research Institute, Brisbane, Australia.
Australasian Kidney Trials Network, The University of Queensland, Brisbane, Australia.

Charani Kiriwandeniya (C)

Australasian Kidney Trials Network, The University of Queensland, Brisbane, Australia.

Pascal Kopperschmidt (P)

Patient Partner, Fresenius Medical Care, Schweinfurt, Germany.

Wen-J Liu (WJ)

Sultanah Aminah, Johor Bahru, Malaysia.

Timmy Lee (T)

Veterans Affairs Medical Center, Birmingham, AL, USA.

Charmaine Lok (C)

University of Toronto, Toronto, Ontario, Canada.

Krishan Madhan (K)

Hervey Bay Hospital, Urraween, Queensland, Australia.

Alistair R Mallard (AR)

Australasian Kidney Trials Network, The University of Queensland, Brisbane, Australia.

Veronica Oliver (V)

Department of Nephrology, Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba, QLD, 4102, Australia.

Kevan R Polkinghorne (KR)

Department of Nephrology, Monash Medical Centre, Monash Health, Clayton, VIC, Australia.
Department of Medicine, Monash University, Clayton, VIC, Australia.
Department of Epidemiology & Preventive Medicine, Monash University, Clayton, VIC, Australia.

Rob R Quinn (RR)

Departments of Medicine and Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Canada.

Donna Reidlinger (D)

Australasian Kidney Trials Network, The University of Queensland, Brisbane, Australia.

Matthew Roberts (M)

Eastern Health Clinical School, Monash University, Melbourne, Australia.

Bénédicte Sautenet (B)

Tours University, Tours, France.

Lai Seong Hooi (LS)

Sultanah Aminah, Johor Bahru, Malaysia.

Rob Smith (R)

Patient Partner, Royal Darwin Hospital, Darwin, Australia.

Maarten Snoeijs (M)

Maastricht University Medical Center, Maastricht, Netherlands.

Jan Tordoir (J)

Maastricht University Medical Center, Maastricht, Netherlands.

Tushar J Vachharajani (TJ)

Department of Kidney Medicine, Glickman Urological & Kidney Institute, Cleveland Clinic, Cleveland, USA.
Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland, USA.

Raymond Vanholder (R)

Ghent University, Ghent, Belgium.

Liza A Vergara (LA)

Australasian Kidney Trials Network, The University of Queensland, Brisbane, Australia.

Martin Wilkie (M)

Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.

Bing Yang (B)

Peking University People's Hospital, Beijing, China.

Theodore H Yuo (TH)

University of Pittsburgh, Pittsburgh, PA, USA.

Li Zou (L)

Peking University People's Hospital, Beijing, China.

Carmel M Hawley (CM)

Department of Nephrology, Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba, QLD, 4102, Australia.
The Translational Research Institute, Brisbane, Australia.
Australasian Kidney Trials Network, The University of Queensland, Brisbane, Australia.

Articles similaires

[Redispensing of expensive oral anticancer medicines: a practical application].

Lisanne N van Merendonk, Kübra Akgöl, Bastiaan Nuijen
1.00
Humans Antineoplastic Agents Administration, Oral Drug Costs Counterfeit Drugs

Smoking Cessation and Incident Cardiovascular Disease.

Jun Hwan Cho, Seung Yong Shin, Hoseob Kim et al.
1.00
Humans Male Smoking Cessation Cardiovascular Diseases Female

Evaluation of Low-Value Services Across Major Medicare Advantage Insurers and Traditional Medicare.

Ciara Duggan, Adam L Beckman, Ishani Ganguli et al.
1.00
Humans United States Aged Cross-Sectional Studies Medicare Part C

Effectiveness of Virtual Yoga for Chronic Low Back Pain: A Randomized Clinical Trial.

Hallie Tankha, Devyn Gaskins, Amanda Shallcross et al.
1.00
Humans Yoga Low Back Pain Female Male

Classifications MeSH

questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Study protocol for Vascular Access outcome...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études de faisabilité › Study protocol for Vascular Access outcome...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études multicentriques comme sujet › Study protocol for Vascular Access outcome...
questionsmedicales.fr › Qualité, accès, évaluation des soins de santé › Qualité des soins de santé › Mécanismes d'évaluation des soins de santé › Évaluation des résultats et des processus en soins de santé › Évaluation de résultat (soins) › Study protocol for Vascular Access outcome...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études épidémiologiques › Études de cohortes › Études prospectives › Study protocol for Vascular Access outcome...
questionsmedicales.fr › Thérapeutique › Détoxication par sorption › Dialyse rénale › Study protocol for Vascular Access outcome...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Collecte de données › Enquêtes et questionnaires › Study protocol for Vascular Access outcome...