Recommending Randomized Trials for Pediatric Leukemia: Observer and Physician Report of Recommendations

Abstract

Physicians' presentation of treatment options in a non-coercive manner is critical for informed consent for participation in randomized clinical trials (RCTs). This study examined discrepancies between observer and physician report of treatment recommendations for pediatric leukemia RCTs. This study also assessed relationships between recommendations and decisions to participate in RCTs. Participants were 104 parents of children with leukemia and the treating physicians. Measures included observations of informed consent conferences (ICCs), physician report of treatment recommendations, and parent report of trial participation. Observation revealed that physicians recommended RCTs in 38% of ICCs, while physicians reported recommending RCTs in 73% of ICCs. Treatment recommendations were unrelated to decisions to participate in RCTs. Results highlight the importance of enhancing parent-physician communication regarding RCT participation.