Apriori feasibility testing of randomized clinical trial design in patients with cleft deformities and Class III malocclusion

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.

Canine retraction: A systematic review of different methods used

“…However, randomization is not always possible, and good quality observational studies may be another option. [ 38 ] Two RCT studies[ 22 23 ] were identified in this systematic review, and both of them were judged to have high quality. In the future, there is a need for additional, well-controlled RCTs concerning the effectiveness of different canine retraction techniques including implant systems and for assessing costs and side effects of the interventions.…”

Clinical effectiveness of late maxillary protraction in cleft lip and palate: A methods paper

“…The cephalometric analyses are performed with imaging software and are based on the University of Southern California (USC) analysis (American Board of Orthodontics [ABO], Steiner, Tweed, soft‐tissue facial thirds, Wits, Harvold triangle) and the Arnett surgical analysis (hard‐ and soft‐tissue analysis, facial angle and facial convexity) . The final outcomes are compared using z‐scores to record how many standards of deviation the treatment averages differ from the norm values …”

“…Two cohorts of adolescents with cleft lip and palate and Class III malocclusion are being recruited to study the impact of LF1 maxillary advancement surgery vs late maxillary protraction. Feasibility studies conducted by the principal investigator found that a randomized clinical trial (RCT) was not feasible or ethical for several reasons . Teenagers at ages 11‐13 randomized to the surgical arm would need to wait 4‐6 years for surgery; furthermore, orthognathic surgery requires informed consent.…”

A disease diagnosis and treatment recommendation system based on big data mining and cloud computing

“…A wearable assistant for gait training for Parkinson's disease was introduced in [24], which works with the freezing of gait in out-of-the-laboratory environments. In addition, large-scale medical data were analyzed in [25] to identify frequent diseases using the Apriori algorithm. The frequencies of diseases were identified for patients living in various geographical locations during different periods.…”