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.