Evidence map›Paper›PMID 36402958›Full record

ArticleBMC nephrology2022

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 and 26 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC nephrology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03969225 (Vascular Access Outcome Measure for Function), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.8field-weighted citation impact, top 26% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03969225 completednot on this map

Vascular Access Outcome Measure for Function: a vaLidation Study In haemoDialysis (VALID)

TypeobservationalSponsorThe University of QueenslandRan2019 to 2023Enrolled702ConditionsVascular Access Complication, Hemodialysis Access Failure (Disorder)
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

36 authors at 20 institutions in 11 countries.

Andrea K ViecelliDepartment of Nephrology, Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba, QLD, 4102, Australia. andrea.viecelli@health.qld.gov.au.ORCID 0000-0003-2314-6654
Armando Teixeira-PintoCentre for Kidney Research, School of Public Health, The University of Sydney, Sydney, Australia.
Andrea ValksAustralasian Kidney Trials Network, The University of Queensland, Brisbane, Australia.
Richard BaerMater Hospital Brisbane, Brisbane, Queensland, Australia.
Roy CherianMackay Base Hospital, Mackay, Australia.
Pietro E CippàDivision of Nephrology, Ente Ospedaliero Cantonale, Bellinzona, Switzerland.
Jonathan C CraigFlinders University, Adelaide, Australia.
Ranil DeSilvaUniversity of Pittsburgh, Pittsburgh, PA, USA.
Allison JaureThe University of Sydney, Sydney, Australia.
David W JohnsonDepartment of Nephrology, Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba, QLD, 4102, Australia.
Charani KiriwandeniyaAustralasian Kidney Trials Network, The University of Queensland, Brisbane, Australia.
Pascal KopperschmidtPatient Partner, Fresenius Medical Care, Schweinfurt, Germany.
Wen-J LiuSultanah Aminah, Johor Bahru, Malaysia.
Timmy LeeVeterans Affairs Medical Center, Birmingham, AL, USA.
Charmaine LokUniversity of Toronto, Toronto, Ontario, Canada.
Krishan MadhanHervey Bay Hospital, Urraween, Queensland, Australia.
Alistair R MallardAustralasian Kidney Trials Network, The University of Queensland, Brisbane, Australia.
Veronica OliverDepartment of Nephrology, Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba, QLD, 4102, Australia.
Kevan R PolkinghorneDepartment of Nephrology, Monash Medical Centre, Monash Health, Clayton, VIC, Australia.
Rob R QuinnDepartments of Medicine and Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Canada.
Donna ReidlingerAustralasian Kidney Trials Network, The University of Queensland, Brisbane, Australia.
Matthew RobertsEastern Health Clinical School, Monash University, Melbourne, Australia.
Bénédicte SautenetTours University, Tours, France.
Lai Seong HooiSultanah Aminah, Johor Bahru, Malaysia.
Rob SmithPatient Partner, Royal Darwin Hospital, Darwin, Australia.
Maarten SnoeijsMaastricht University Medical Center, Maastricht, Netherlands.
Jan TordoirMaastricht University Medical Center, Maastricht, Netherlands.
Tushar J VachharajaniDepartment of Kidney Medicine, Glickman Urological & Kidney Institute, Cleveland Clinic, Cleveland, USA.
Raymond VanholderGhent University, Ghent, Belgium.
Liza A VergaraAustralasian Kidney Trials Network, The University of Queensland, Brisbane, Australia.
Martin WilkieSheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.
Bing YangPeking University People's Hospital, Beijing, China.
Theodore H YuoUniversity of Pittsburgh, Pittsburgh, PA, USA.
Li ZouPeking University People's Hospital, Beijing, China.
Carmel M HawleyDepartment of Nephrology, Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba, QLD, 4102, Australia.
VALID Investigator Team
The University of Queensland · AUTranslational Research Institute · AUMaastricht University · NLPeking University · CNSultanah Aminah Hospital · MYThe University of Sydney · AUUniversity of Pittsburgh · USBirmingham VA Medical Center · USCleveland Clinic · USEastern Health · AUEnte Ospedaliero Cantonale · CHFlinders University · AUFresenius Medical Care (Germany) · DEGhent University Hospital · BEMackay Base Hospital · AUMater Adult Hospital · AUMonash Medical Centre · AUPrincess Alexandra Hospital · AURoyal Darwin Hospital · AUSheffield Teaching Hospitals NHS Foundation Trust · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA 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.

methodsVALID 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 registrationClinicaltrials.gov: NCT03969225. Registered on 31st May 2019.

Indexed as

Outcome Assessment, Health CareRenal DialysisFeasibility StudiesHumansMulticenter Studies as TopicProspective StudiesSurveys and QuestionnairesArteriovenous fistulaArteriovenous graftCentral venous catheterCore outcomeFeasibilityHemodialysisImplementationPatient engagementValidationVascular access

Identifiers

PMID36402958
PMCPMC9675211
OpenAlexW4309662472

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.