Apriori feasibility testing of randomized clinical trial design in patients with cleft deformities and Class III malocclusion.
Apriori feasibility testing of randomized clinical trial design in patients with cleft deformities and Class III malocclusion.
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DOI：
10.1016/j.ijporl.2014.01.006
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发表时间：
2014-05
影响因子：
1.5
通讯作者：
Yen, Stephen L. -K.
中科院分区：
文献类型：
--
作者：
McIlvaine, Elizabeth;Borzabadi-Farahani, Ali;Lane, Christianne J.;Azen, Stanley P.;Yen, Stephen L. -K.
评估随机治疗（手术与非手术）矫正早期唇腭裂修复术所致III类错（反牙合）的可行性。2005年至2010年期间，洛杉矶儿童医院向唇腭裂患者的父母邮寄了关于青少年接受随机治疗意愿的调查。纳入标准为唇腭裂患者，由于上颌骨缺陷导致的III类错牙合，以及没有医疗和认知禁忌症的患者。在287项调查中，82项（28%）完成并返回; 47%的受试者持有强烈的治疗偏好（95% CI，35-58%），而30%的受试者愿意接受随机化（95% CI，20- 41%）。如果对分配的治疗不满意，78%的患者会退出随机试验（95% CI，67-86%）。不愿意接受随机治疗分配的三个最常见的原因是：1）希望医生选择最好的治疗方法，2）希望父母对治疗有意见，3）希望尽早纠正反牙合。根据这项研究，父母和患者将不愿意接受随机分配的治疗，如果治疗不符合预期，他们将不会留在分配的组中。这突出了与涉及手术方式的随机试验相关的局限性，并为其他研究模型（例如，队列研究），以在随机化不可行时比较两种治疗方案。
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. 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. 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. 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.
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