Potential barriers to randomized clinical trials in infants with brachial plexus birth palsy.

Abstract

Randomized clinical trials (RCTs) are the gold standard for comparing medical treatments. However, pediatric surgical RCTs are uncommon. We sought the opinions of parents whose children had undergone reconstructive nerve surgery on participating in research studies. Twenty-nine of 30 parents indicated that they would enroll their child in a research study, and 24 of them indicated that they would enroll their child in a surgical RCT. However, the most common reason for willingness to participate was a desire to help their child, demonstrating a fundamental misunderstanding of RCTs. The burden is on the researcher to ascertain the subject's level of understanding before consenting to randomization.