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, 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, 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, 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

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.

Conflict of interest statement

RRQ holds a patent for DMAR, a data collection platform for Q1 in dialysis and consultancy / research support Baxter Corporation. KM has consultancy fees from Otsuka Australia Pharmaceutical Pty Ltd., Support for professional meeting attendance from Amgen Australia and Roche Australia. DWJ has received consultancy fees, research grants, speaker’s honoraria and travel sponsorships from Baxter Healthcare and Fresenius Medical Care, consultancy fees from Astra Zeneca, Bayer, and AWAK, speaker’s honoraria from ONO and BI & Lilly, and travel sponsorships from Ono and Amgen. He is a current recipient of an Australian National Health and Medical Research Council Leadership Investigator Grant.

All other authors have no competing interests to declare.

© 2022. Crown.

Figures

Fig. 1
Fig. 1
Study Schema. Abbreviations: HD – Hemodialysis; VA – Vascular Access. The study design aligns with the STARD 2015 guidelines: An Updated List of Essential Items for Reporting Diagnostic Accuracy Studies [29]
Fig. 2
Fig. 2
Study Governance Structure. Abbreviations: AKTN – Australasian Kidney Trials Network; UQ – University of Queensland, Australia

References

    1. Liyanage T, Ninomiya T, Jha V, Neal B, Patrice HM, Okpechi I, et al. Worldwide access to treatment for end-stage kidney disease: a systematic review. Lancet. 2015;385(9981):1975–1982. doi: 10.1016/S0140-6736(14)61601-9.
    1. Hakim R, Himmelfarb J. Hemodialysis access failure: a call to action. Kidney Int. 1998;54(4):1029–1040. doi: 10.1046/j.1523-1755.1998.00122.x.
    1. Arora P, Kausz AT, Obrador GT, Ruthazer R, Khan S, Jenuleson CS, et al. Hospital utilization among chronic dialysis patients. J Am Soc Nephrol. 2000;11(4):740–746. doi: 10.1681/ASN.V114740.
    1. Manns B, Tonelli M, Yilmaz S, Lee H, Laupland K, Klarenbach S, et al. Establishment and maintenance of vascular access in incident hemodialysis patients: a prospective cost analysis. J Am Soc Nephrol. 2005;16(1):201–209. doi: 10.1681/ASN.2004050355.
    1. Taylor MJ, Hanson CS, Casey JR, Craig JC, Harris D, Tong A. "You know your own fistula, it becomes a part of you"-Patient perspectives on vascular access: A semistructured interview study. Hemodial Int. 2015;20(1):5–14. doi: 10.1111/hdi.12340.
    1. Tong A, Manns B, Hemmelgarn B, Wheeler DC, Tugwell P, Winkelmayer WC, et al. Standardised outcomes in nephrology - Haemodialysis (SONG-HD): study protocol for establishing a core outcome set in haemodialysis. Trials. 2015;16:364. doi: 10.1186/s13063-015-0895-7.
    1. Manns B, Hemmelgarn B, Lillie E, Dip SC, Cyr A, Gladish M, et al. Setting research priorities for patients on or nearing dialysis. Clin J Am Soc Nephrol. 2014;9(10):1813–1821. doi: 10.2215/CJN.01610214.
    1. Tong A, Manns B, Hemmelgarn B, Wheeler DC, Evangelidis N, Tugwell P, et al. Establishing core outcome domains in hemodialysis: report of the Standardised Outcomes in Nephrology – Hemodialysis (SONG-HD) consensus workshops. Am J Kidney Dis. 2017;69(1):11. doi: 10.1053/j.ajkd.2016.05.022.
    1. Al-Jaishi AA, Liu AR, Lok CE, Zhang JC, Moist LM. Complications of the arteriovenous fistula: a systematic review. J Am Soc Nephrol. 2017;28(6):1839–1850. doi: 10.1681/ASN.2016040412.
    1. Viecelli AK, O'Lone E, Sautenet B, Craig JC, Tong A, Chemla E, et al. Vascular access outcomes reported in maintenance hemodialysis trials: a systematic review. Am J Kidney Dis. 2018;71(3):382–391. doi: 10.1053/j.ajkd.2017.09.018.
    1. Lee T, Mokrzycki M, Moist L, Maya I, Vazquez M, Lok CE, et al. Standardized definitions for hemodialysis vascular access. Semin Dial. 2011;24(5):515–524. doi: 10.1111/j.1525-139X.2011.00969.x.
    1. Sidawy AN, Gray R, Besarab A, Henry M, Ascher E, Silva M, Jr, et al. Recommended standards for reports dealing with arteriovenous hemodialysis accesses. J Vasc Surg. 2002;35(3):603–610. doi: 10.1067/mva.2002.122025.
    1. Gray RJ, Sacks D, Martin LG, Trerotola SO. Society of interventional radiology technology assessment C. Reporting standards for percutaneous interventions in dialysis access. J Vasc Interv Radiol. 2003;14(9 Pt 2):S433–S442. doi: 10.1097/01.RVI.0000094618.61428.58.
    1. Vascular Access Working Group Clinical practice guidelines for vascular access. Am J Kidney Dis. 2006;48(Suppl 1):S248–S273.
    1. Standardised Outcomes in Nephrology (SONG) Initiative. Available from: . Accessed 12 Apr 2022.
    1. Shenoy S, Allon M, Beathard G, Brouwer-Maier D, Dember LM, Glickman M, et al. Clinical trial end points for hemodialysis vascular access: background, rationale, and definitions. Clin J Am Soc Nephrol. 2018;13(3):490–494. doi: 10.2215/CJN.13321216.
    1. Urquhart-Secord R, Craig JC, Hemmelgarn B, Tam-Tham H, Manns B, Howell M, et al. patient and caregiver priorities for outcomes in hemodialysis: an International nominal group technique study. Am J Kidney Dis. 2016;68(3):444–454. doi: 10.1053/j.ajkd.2016.02.037.
    1. Sautenet B, Tong A, Williams G, Hemmelgarn BR, Manns B, Wheeler DC, et al. Scope and consistency of outcomes reported in randomized trials conducted in adults receiving hemodialysis: a systematic review. Am J Kidney Dis. 2018;72(1):62–74. doi: 10.1053/j.ajkd.2017.11.010.
    1. Evangelidis N, Tong A, Manns B, Hemmelgarn B, Wheeler DC, Tugwell P, et al. Developing a set of core outcomes for trials in hemodialysis: an International Delphi survey. Am J Kidney Dis. 2017;70(4):464–475. doi: 10.1053/j.ajkd.2016.11.029.
    1. Viecelli AK, Tong A, O'Lone E, Ju A, Hanson CS, Sautenet B, et al. Report of the Standardized Outcomes in Nephrology-Hemodialysis (SONG-HD) consensus workshop on establishing a core outcome measure for hemodialysis vascular access. Am J Kidney Dis. 2018;71(5):690–700. doi: 10.1053/j.ajkd.2017.12.003.
    1. Tong A, Manns B, Wang AYM, Hemmelgarn B, Wheeler DC, Gill J, et al. Implementing core outcomes in kidney disease: report of the Standardized Outcomes in Nephrology (SONG) implementation workshop. Kidney Int. 2018;94(6):1053–1068. doi: 10.1016/j.kint.2018.08.018.
    1. Manera KE, Tong A, Craig JC, Brown EA, Brunier G, Dong J, et al. Standardized Outcomes in Nephrology-Peritoneal Dialysis (SONG-PD): study protocol for establishing a core outcome set in PD. Perit Dial Int. 2017;37(6):639–647. doi: 10.3747/pdi.2017.00022.
    1. Viecelli AK, Pascoe E, Polkinghorne KR, Hawley C, Paul-Brent PA, Badve SV, et al. The Omega-3 fatty acids (Fish Oils) and Aspirin in Vascular access OUtcomes in REnal Disease (FAVOURED) study: the updated final trial protocol and rationale of post-initiation trial modifications. BMC Nephrol. 2015;16:89. doi: 10.1186/s12882-015-0089-2.
    1. Lok CE, Sontrop JM, Tomlinson G, Rajan D, Cattral M, Oreopoulos G, et al. Cumulative patency of contemporary fistulas versus grafts (2000-2010) Clin J Am Soc Nephrol. 2013;8(5):810–818. doi: 10.2215/CJN.00730112.
    1. Lok CE, Moist L, Hemmelgarn BR, Tonelli M, Vazquez MA, Dorval M, et al. Effect of fish oil supplementation on graft patency and cardiovascular events among patients with new synthetic arteriovenous hemodialysis grafts: a randomized controlled trial. JAMA. 2012;307(17):1809–1816. doi: 10.1001/jama.2012.3473.
    1. Standardised Outcomes in Nephrology (SONG) Initiative. SONG Handbook (Version 1, 1st June 2017) for establishing and implementing core outcomes in chronic kidney disease. Available from: . Accessed 12 Apr 2022.
    1. Oliver MJ, Verrelli M, Zacharias JM, Blake PG, Garg AX, Johnson JF, et al. Choosing peritoneal dialysis reduces the risk of invasive access interventions. Nephrol Dial Transplant. 2012;27(2):810–816. doi: 10.1093/ndt/gfr289.
    1. Murad MH, Swiglo BA, Sidawy AN, Ascher E, Montori VM. Methodology for clinical practice guidelines for the management of arteriovenous access. J Vasc Surg. 2008;48(5 Suppl):26S–30S. doi: 10.1016/j.jvs.2008.08.045.
    1. Enhancing the QUAlity and Transparency Of health Research (EQUATOR network). STARD 2015: An Updated List of Essential Items for Reporting Diagnostic Accuracy Studies Available from: . Accessed 12 Apr 2022.
    1. Hanson CS, Craig JC, Logeman C, Sinha A, Dart A, Eddy AA, et al. Establishing core outcome domains in pediatric kidney disease: report of the Standardized Outcomes in Nephrology-Children and Adolescents (SONG-KIDS) consensus workshops. Kidney Int. 2020;98(3):553–565. doi: 10.1016/j.kint.2020.05.054.
    1. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377–381. doi: 10.1016/j.jbi.2008.08.010.
    1. Standardised Outcomes in Nephrology (SONG) Initiative. SONG-Haemodialysis Vascular Access Expert Working Group Available from: . Accessed 12 Apr 2022.
    1. Prinsen CA, Vohra S, Rose MR, Boers M, Tugwell P, Clarke M, et al. How to select outcome measurement instruments for outcomes included in a "Core Outcome Set" - a practical guideline. Trials. 2016;17(1):449. doi: 10.1186/s13063-016-1555-2.
    1. Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. 2006;3:77–101. doi: 10.1191/1478088706qp063oa.
    1. Viecelli AK, Howell M, Tong A, Teixeira-Pinto A, O'Lone E, Ju A, et al. Identifying critically important vascular access outcomes for trials in haemodialysis: an international survey with patients, caregivers and health professionals. Nephrol Dial Transplant. 2020;35(4):657–668. doi: 10.1093/ndt/gfz148.

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