Abstract
BACKGROUND: Despite the crucial role that randomised controlled trials (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 surgery with the aim of exploring barriers and enablers to efficient recruitment and trial delivery. METHODS: A mixed-methods approach was adopted to evaluate the recruitment and implementation processes of The Anaesthesia Choice for Creation of artEriovenouS fiStulae (ACCess) study ( https://doi.org/10.1136/bmjopen-2021-052188 ) (Deloitte. Patient Recruitment is Often the Holy Grail for Clinical Research…Could Virtual Trials Improve our Chances of Reaching It? 2020). Recruitment figures demonstrating trial progression and site set-up are reported quantitatively. Contemporaneous data was collected on site-specific challenges, particularly 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". An embedded process evaluation study, supplemented by the researchers own reflections, qualitatively explored motivators and challenges in trial set-up, recruitment and delivery utilising thematic analysis of semi-structured interviews with patients and health care practitioners (HCPs). A rapid feedback evaluation approach permitted within trial feedback to the main trial team. RESULTS: Five hundred seventy-one patients with stage V CKD or on haemodialysis were successfully recruited from 20 UK-centres over a 2-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. A pragmatic trial protocol, which could easily be implemented within existing clinical practice, was considered essential for many centres. 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 predicted timelines. In depth knowledge of the patient population; early engagement of a broad multidisciplinary team; and a pragmatic protocol that could be effectively incorporated into routine clinical care proved fundamental to success. Consideration of these factors may be of benefit to other researchers designing clinical trials, especially within the renal population. TRIAL REGISTRATION: Both the ACCess study and process evaluation study are registered with the respective clinical trials databases: ISRCTN14153938 and MRC SWAT Repository 150.