Acceptance of Randomized Assignment in Adolescent Cleft Palate Trial

Objective: To assess the feasibility of randomizing treatment (surgical vs. non-surgical) correction of a Cl III malocclusion(underbite) resulting from earlier surgical correction of cleft lip and palate. Method: Surveys about willingness to accept randomized treatment during adolescence(13-17) were mailed to the parents of cleft lip and palate patients under the care of CHLA between 2005 and 2010 as identified by billing records. Inclusion criteria were cleft lip and palate, a Cl III malocclusion and absence of medical and cognitive contraindications to treatment. Out of 287 surveys 82 were completed and returned. Result: Forty-seven percent of subjects held a strong treatment preference (95% CI: 35% - 58%) while thirty percent were willing to accept randomization (CI: 20% - 41%). Seventy-eight percent would drop out of a randomized trial if dissatisfied with assigned treatment (CI: 67% - 86%). The three most commonly cited reasons for being unwilling to accept random treatment assignment were 1)the desire for doctors to have input on treatment, 2) the desire for parents to have input on treatment, and 3) the desire to correct the underbite as early as possible. Conclusion: There is sufficient evidence that parents and patients would be unwilling to accept a randomly assigned treatment and would not remain in an assigned group if treatment did not meet expectations. Possible contributing factors include the dissimilarities between the two treatments, the comparatively late age of the treatments, and the formation of strong treatment opinions by patients and their parents over the course of the child’s medical care. A randomized clinical trial may not be feasible for Cl III treatment in adolescent patients and a prospective cohort design may need to be considered.