A randomised controlled trial comparing the outcomes of arteriovenous fistula for dialysis created under local vs regional anaesthesia: reflections on recruitment and process evaluation study

A randomised controlled trial comparing the outcomes of arteriovenous fistula for dialysis created under local vs regional anaesthesia: reflections on recruitment and process evaluation study | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article A randomised controlled trial comparing the outcomes of arteriovenous fistula for dialysis created under local vs regional anaesthesia: reflections on recruitment and process evaluation study Emma Louise Aitken, Cecilia Vindrola- Padros, Nicolas Hall This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-5427404/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 04 Aug, 2025 Read the published version in Trials → Version 1 posted 5 You are reading this latest preprint version Abstract Background: Despite the crucial role that RCTs play in establishing the efficacy of new treatments, many are terminated early due to difficulty with subject recruitment. Trials of complex perioperative interventions are notoriously difficult to deliver. We describe our experiences of successful recruitment into an RCT of anaesthetic technique in vascular access (VA) surgery and explore barriers and enablers for efficient site set-up and recruitment. Methods: The Anaesthesia Choice for Creation of artEriovenouS fiStulae (ACCess) study is a RCT comparing the outcome of de novo arteriovenous fistulae created under local vs regional anaesthesia with an embedded pilot and qualitative process evaluation study. The process evaluation study involved thematic analysis of semi-structured interviews with patients and health care practitioners (HCPs) exploring motivators and challenges in trial set-up, recruitment and delivery. A rapid feedback evaluation approach permitted within trial feedback to the main trial team. Additionally contemporaneous data was collected on site-specific difficulties in relation to the COVID-19 pandemic. The Scottish Vascular Access Appraisal Service Evaluation Tool was utilised to summarise the pre-existing vascular access infrastructure at each site and inferences made about service ‘resilience’. Results: 571 patients with stage V CKD or on haemodialysis were successfully recruited from 20 UK-centres over a two-year period making this the largest RCT of vascular access in Europe to date. A ‘desire to improve care for patients with kidney disease’ was the main motivator for participation amongst both patients and HCPs. Good communication, strong leadership and simple trial documentation were viewed as important enablers; whilst staffing shortages and reduced access to theatre were considered the principal barriers. Sites that reported well-established MDT-working appeared best-able to mitigate against these difficulties. The anxiety and uncertainty associated with dialysis initiation was evident in reasons for non-participation with 32% declining participation due to an unwillingness for randomisation. Furthermore, the workload associated with travel to study visits and completion of ‘tiresome’ HR-QOL questionnaires were considered additional barriers in a patient group with significant pre-existing treatment burden. Conclusions: Despite anticipated challenges, target recruitment was achieved on schedule with timelines. In depth knowledge of the patient population; early engagement of a broad multidisciplinary team and a pragmatic protocol mimicking standard clinical care proved fundamental to success. Results from the main trial are anticipated December 2024. Trial Registration: Both the ACCess study and process evaluation study are registered with the respective clinical trials databases: ISRCTN14153938 and MRC SWAT Repository 150. Full Text Supplementary Files CONSORTchecklistACCESSrecruitmentpaper.doc Cite Share Download PDF Status: Published Journal Publication published 04 Aug, 2025 Read the published version in Trials → Version 1 posted Editorial decision: Major revision 30 May, 2025 Reviewers agreed at journal 09 May, 2025 Reviewers invited by journal 28 Apr, 2025 Editor assigned by journal 28 Apr, 2025 First submitted to journal 17 Feb, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-5427404","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":449379494,"identity":"5f7459f5-5637-4fc4-9a21-1118ebb7d690","order_by":0,"name":"Emma Louise Aitken","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA9klEQVRIiWNgGAWjYPACCSBkYDiQUMGQQLQWCaAWxgMfzsC0EKETpIX54Mw2IrTwi51O/MBQY1En2d574DDvvDt58g3sDz98/IFbi+Ts3M0SDMckJKR5ziUc5t32rNjgAI+x5Aw8thjczt0gwcAmISEnkWMA1HI4cQMDDxszDx4t9rdzN/9g+AfUIv8GqGXO4cT5DezP8GoxkM7dJsHYBnSYBI/BwZkNhxMbDjCY4dUicTt3m0Vin4TkzJ4cgwMfjgEddhjklzTcWviB3r/x4Vsdv8TxM8YfEmqADmtvf/jhgw1uLWCA6gpmAqpHwSgYBaNgFBAGAGWEUkdnESQNAAAAAElFTkSuQmCC","orcid":"https://orcid.org/0000-0001-8939-7478","institution":"Queen Elizabeth University Hospital Campus: Queen Elizabeth University Hospital","correspondingAuthor":true,"prefix":"","firstName":"Emma","middleName":"Louise","lastName":"Aitken","suffix":""},{"id":449379495,"identity":"c42489a6-5b88-47fe-96eb-d13482a87c06","order_by":1,"name":"Cecilia Vindrola- Padros","email":"","orcid":"","institution":"University College London Division of Medicine","correspondingAuthor":false,"prefix":"","firstName":"Cecilia","middleName":"Vindrola-","lastName":"Padros","suffix":""},{"id":449379496,"identity":"ecbefaa2-b997-4009-bdca-aa45471b7890","order_by":2,"name":"Nicolas Hall","email":"","orcid":"","institution":"University College London Division of Medicine","correspondingAuthor":false,"prefix":"","firstName":"Nicolas","middleName":"","lastName":"Hall","suffix":""}],"badges":[],"createdAt":"2024-11-10 19:22:01","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-5427404/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-5427404/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s13063-025-08945-0","type":"published","date":"2025-08-04T15:57:47+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":88814182,"identity":"dd8a6961-0107-4980-8041-99792fe74485","added_by":"auto","created_at":"2025-08-11 16:08:05","extension":"pdf","order_by":1,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":662186,"visible":true,"origin":"","legend":"","description":"","filename":"ACCESSstudyrecruitmentpaper101124.pdf","url":"https://assets-eu.researchsquare.com/files/rs-5427404/v1_covered_87b67245-15f5-49b3-9bb1-033669ab2c87.pdf"},{"id":81946339,"identity":"134a92e6-e3a3-472b-87c2-80710001359a","added_by":"auto","created_at":"2025-05-05 08:16:49","extension":"doc","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":223744,"visible":true,"origin":"","legend":"","description":"","filename":"CONSORTchecklistACCESSrecruitmentpaper.doc","url":"https://assets-eu.researchsquare.com/files/rs-5427404/v1/fb9a6bce5cc200a664732ab1.doc"}],"financialInterests":"","formattedTitle":"A randomised controlled trial comparing the outcomes of arteriovenous fistula for dialysis created under local vs regional anaesthesia: reflections on recruitment and process evaluation study","fulltext":[],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":false,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":true,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":true,"isPdf":true,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"trials","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"trls","sideBox":"Learn more about [Trials](http://trialsjournal.biomedcentral.com/)","snPcode":"13063","submissionUrl":"https://www.editorialmanager.com/trls","title":"Trials","twitterHandle":"MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"","lastPublishedDoi":"10.21203/rs.3.rs-5427404/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-5427404/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003eBackground: Despite the crucial role that RCTs play in establishing the efficacy of new treatments, many are terminated early due to difficulty with subject recruitment. Trials of complex perioperative interventions are notoriously difficult to deliver. We describe our experiences of successful recruitment into an RCT of anaesthetic technique in vascular access (VA) surgery and explore barriers and enablers for efficient site set-up and recruitment.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eMethods: The Anaesthesia Choice for Creation of artEriovenouS fiStulae (ACCess) study is a RCT comparing the outcome of de novo arteriovenous fistulae created under local vs regional anaesthesia with an embedded pilot and qualitative process evaluation study. The process evaluation study involved thematic analysis of semi-structured interviews with patients and health care practitioners (HCPs) exploring motivators and challenges in trial set-up, recruitment and delivery. A rapid feedback evaluation approach permitted within trial feedback to the main trial team. Additionally contemporaneous data was collected on site-specific difficulties in relation to the COVID-19 pandemic. The Scottish Vascular Access Appraisal Service Evaluation Tool was utilised to summarise the pre-existing vascular access infrastructure at each site and inferences made about service ‘resilience’.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eResults: 571 patients with stage V CKD or on haemodialysis were successfully recruited from 20 UK-centres over a two-year period making this the largest RCT of vascular access in Europe to date. A ‘desire to improve care for patients with kidney disease’ was the main motivator for participation amongst both patients and HCPs. Good communication, strong leadership and\u0026nbsp; simple trial documentation were viewed as important enablers; whilst staffing shortages and reduced access to theatre were considered the principal barriers. Sites that reported well-established MDT-working appeared best-able to mitigate against these difficulties. The anxiety and uncertainty associated with dialysis initiation was evident in reasons for non-participation with 32% declining participation due to an unwillingness for randomisation. Furthermore, the workload associated with travel to study visits and completion of ‘tiresome’ HR-QOL questionnaires were considered additional barriers in a patient group with significant pre-existing treatment burden.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eConclusions: Despite anticipated challenges, target recruitment was achieved on schedule with timelines. \u0026nbsp;In depth knowledge of the patient population; early engagement of a broad multidisciplinary team and a pragmatic protocol mimicking standard clinical care proved fundamental to success. 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