Barriers to participation in surgical randomized controlled trials in pediatric urology: A qualitative study of key stakeholder perspectives

While some parents are open to participation in surgical RCTs, providers and parents of children with hydronephrosis feel discomfort with the element of chance in surgical randomized trials. Parents and providers are more likely to participate in observational studies where treatment decisions may be made jointly by the physician and the parent. These findings suggest that pragmatic trial strategies with the option for participation in an observational cohort may improve recruitment of pediatric patients into surgical clinical trials.Table. Perceived barriers to participation in surgical randomized controlled trials.ParentsPediatric urologistsPediatriciansCounseling and decision-makingLoss of control over treatment decisionChild's inability to participate in decisionDiscomfort with admission of uncertainty in treatmentTime and effort needed for education regarding RCTsEthics of randomization in young children/lack of patient input into decisionComplications and risksStigma of child being labeled as “sick”Concerns about cost and long term complicationsAdequacy of safeguards and justification of potential risksPotential risk of sham surgery/anesthesia exposureRisk of side effects, unnecessary tests, and unknown long term consequencesUnique attributes of surgeryIrreversibility of surgeryNo difference between medical and surgical RCTsLack of true equipoise between surgical and non-surgical treatment armsIrreversibility of surgery