title: Apriori feasibility testing of randomized clinical trial design in patients with cleft deformities and Class III malocclusion.
abstract: OBJECTIVE
  To assess the feasibility of randomizing treatment (surgical vs. non-surgical) for correction of a Class III malocclusion (underbite) resulting from an earlier repair of cleft lip and palate.
  
  
  METHODS
  Surveys about willingness to accept randomized treatment during adolescence were mailed to the parents of cleft lip and palate patients under the care of Children's Hospital Los Angeles between 2005 and 2010. The inclusion criteria were patients with cleft lip and palate, Class III malocclusion due to maxillary deficiency, and absence of medical and cognitive contraindications to treatment.
  
  
  RESULTS
  Out of 287 surveys, 82 (28%) were completed and returned; 47% of the subjects held a strong treatment preference (95% CI, 35-58%), while 30% were willing to accept randomization (95% CI, 20-41%). Seventy-eight percent would drop out of a randomized trial if dissatisfied with the assigned treatment (95% CI, 67-86%). The three most commonly cited reasons for being unwilling to accept random treatment assignment were 1) the desire for doctors to choose the best treatment, 2) the desire for parents to have input on treatment, and 3) the desire to correct the underbite as early as possible.
  
  
  CONCLUSIONS
  Based on this study, 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. This highlight the limitations associated with randomization trials involving surgical modalities and provide justification for other research models (e.g., cohort studies) to compare two treatment options when randomization is not feasible.
authors.affiliation: Statistical Consultation and Research Center, Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: McIlvaine
authors.affiliation: Orthodontics, Warwick Dentistry, Warwick Medical School, University of Warwick, Coventry, UK; Formerly, Craniofacial Orthodontics, Children's Hospital Los Angeles, Los Angeles, CA, USA.
authors.forename: Ali
authors.initials: A
authors.lastname: Borzabadi-Farahani
authors.affiliation: Statistical Consultation and Research Center, Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.
authors.forename: Christianne J
authors.initials: CJ
authors.lastname: Lane
authors.affiliation: Statistical Consultation and Research Center, Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.
authors.forename: Stanley P
authors.initials: SP
authors.lastname: Azen
authors.affiliation: Craniofacial Orthodontics, Children's Hospital Los Angeles, Los Angeles, CA, USA; Center for Craniofacial Molecular Biology, Ostrow School of Dentistry, University of Southern California, Los Angeles, CA, USA. Electronic address: syen@usc.edu.
authors.forename: Stephen L-K
authors.initials: SL
authors.lastname: Yen
mesh_terms: D000293:Adolescent; D001294:Attitude to Health; D002140:California; D016009:Chi-Square Distribution; D002648:Child; D002971:Cleft Lip / Q000175:diagnosis / Q000453:epidemiology / Q000628:therapy*; D002972:Cleft Palate / Q000175:diagnosis / Q000453:epidemiology / Q000628:therapy*; D015331:Cohort Studies; D016001:Confidence Intervals; D005240:Feasibility Studies; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006776:Hospitals, Pediatric; D006801:Humans; D008297:Male; D008310:Malocclusion / Q000175:diagnosis / Q000453:epidemiology / Q000628:therapy*; D057240:Patient Preference / Q000706:statistics & numerical data*; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic; D011795:Surveys and Questionnaires
keywords: Feasibility; Observational cohort study; Randomized trial