Challenges and potential solutions to enrollment in a clinical trial of arteriovenous fistula vs arteriovenous graft vascular access strategy

Abstract

This article presents the rationale, challenges, and adaptive strategies employed during the initiation and execution of the arteriovenous (AV) access trial-a multicenter randomized controlled trial (RCT) comparing AV fistulas and AV grafts for hemodialysis in older adults with major comorbidities. Motivated by shifts in epidemiologic landscapes and evolving guidelines moving away from a fistula-first approach and to more patient-centric approaches, the objective of this randomized controlled trial was to fill critical knowledge gaps in determining the optimal vascular access for this complex patient population. We outline the challenges encountered in patient recruitment along with measures employed to overcome these obstacles in recruitment. We emphasize the pivotal role of continuous research in overcoming these challenges, underscoring its necessity to achieve a thorough comprehension of optimal vascular access strategies for this complex patient population.

Keywords: Arteriovenous fistula; Arteriovenous graft; Hemodialysis vascular access; Randomized controlled trial.

Fig 1.

Approach to recruitment in the arteriovenous (AV) access trial. The study team at each recruitment site reviews prospectively the vascular access surgery clinic appointments to identify patients scheduled for evaluation of AV Access surgery. Patients are prescreened for clinical eligibility criteria (inclusion criteria 1–7 and exclusion criteria 1–5) through review of health care system electronic medical records (EMRs). Patients who pass prescreening are screened for anatomical vascular eligibility (inclusion criteria 8 and 9 and exclusion criterion 6) at the time of clinic appointment with the vascular access surgery team. Patients who pass screening are approached for study participation and evaluation of inclusion criterion 10. AVF, arteriovenous fistular; AVG, arteriovenous graft; ESKD, end-stage kidney disease; HD, hemodialysis.

Fig 2.

Observed and expected accrual in the initial 13.5 months of recruitment in the arteriovenous AV Access trial. The first accrual occurred on August 18, 2022. Expected accrual occurred through October 2, 2023 and observed accrual through October 2, 2023. The percent accrual of expected was 30.5%.