Elizabeth McIlvaine1, Ali Borzabadi-Farahani2, Christianne J Lane1, Stanley P Azen1, Stephen L-K Yen3. 1. Statistical Consultation and Research Center, Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA. 2. Orthodontics, Warwick Dentistry, Warwick Medical School, University of Warwick, Coventry, UK; Formerly, Craniofacial Orthodontics, Children's Hospital Los Angeles, Los Angeles, CA, USA. 3. 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.
Abstract
OBJECTIVES: 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. MATERIALS AND 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. CONCLUSION: 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.
RCT Entities:
OBJECTIVES: 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. MATERIALS AND METHODS: Surveys about willingness to accept randomized treatment during adolescence were mailed to the parents of cleft lip and palatepatients 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. CONCLUSION: 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: Gordon H Guyatt; Andrew D Oxman; Gunn E Vist; Regina Kunz; Yngve Falck-Ytter; Pablo Alonso-Coello; Holger J Schünemann Journal: BMJ Date: 2008-04-26
Authors: Kevin O'Brien; Jean Wright; Frances Conboy; Priscilla Appelbe; Linda Davies; Ivan Connolly; Laura Mitchell; Simon Littlewood; Nicola Mandall; David Lewis; Jonathan Sandler; Mark Hammond; Stephen Chadwick; Julian O'Neill; Catherine McDade; Mojtaba Oskouei; Badri Thiruvenkatachari; Michael Read; Stephen Robinson; David Birnie; Alison Murray; Iain Shaw; Nigel Harradine; Helen Worthington Journal: Am J Orthod Dentofacial Orthop Date: 2009-05 Impact factor: 2.650