MP71-01 A TALE OF TWO SURGERIES: A NOVEL FAMILY DESIGNED RECRUITMENT STRATEGY FOR A BLINDED, RANDOMIZED SURGICAL TRIAL IN CHILDREN

Abstract

INTRODUCTION AND OBJECTIVE: There are few randomized controlled trial (RCTs) comparing techniques in pediatric surgery. We propose the use of novel patient-centered research methods to develop a recruitment approach acceptable to pediatric patients and their families and to evaluate enrollment using this approach to conduct a pilot trial comparing open pyeloplasty (OP) vs. roboticassisted pyeloplasty (RAP). METHOD(S): We performed a single-center qualitative study utilizing patient engagement methods to create a recruitment tool for a blinded, randomized controlled trial of two different surgical techniques. We enrolled a total of 28 parents to participate in three sessions focused on factors influencing the decision between RAP and OP, in order to identify barriers to randomization and blinding using established human-centered design techniques to generate multimedia tools (video and handouts) for use in recruitment. Patients planning OP or RAP as well as those who already had the procedure were recruited. RESULT(S): From the initial sessions of parents of children who had either OP or RAP we discovered that the concept of two operations being interchangeable was difficult for participants to grasp. We learned to refer to them, not as two "operations", but as two "surgical approaches". With this knowledge, we developed two videos to introduce parents of children with ureteropelvic junction obstruction (UPJO) to the concept of clinical equipoise between the two corrective surgical approaches their child could undergo. A subsequent session with parents of children ages 2-8 years and no history of surgery or UPJO watched the two videos, discussed their choice for either approach and whether the videos altered that choice. We learned that the videos improved the parents' understanding that two surgical approaches could be interchangeable. Using input from this last session, a final video was created to be used for a pilot prospective, blinded randomized controlled trial of RAP versus OP. To date, this video has been used with a successful enrollment rate of 92% (11 of 12 families approached over 16 months). CONCLUSION(S): Using generative qualitative human-centered design sessions, we found that the concept of clinical equipoise of two surgical approaches is a difficult concept to grasp for parents. Using concepts gleaned from this approach, we created a video focused on explaining this concept. Use of this video has resulted in over 90% patient enrollment in an ongoing randomized, blinded pilot study comparing two surgical approaches in children.