National Institute for Health Research academic clinical fellow and honorary specialist registrar in Orthodontics, Department of Orthodontics, School of Dentistry, Manchester, United Kingdom.
Professor in Orthodontics, Department of Orthodontics, School of Dentistry, Manchester, United Kingdom.
Am J Orthod Dentofacial Orthop. 2014 Sep;146(3):279-85. doi: 10.1016/j.ajodo.2014.05.022.
The selection of appropriate outcomes is a fundamental part of the design of clinical trials. Orthodontic treatment aims to improve a person's dentofacial appearance, and research outcomes should therefore reflect the perspectives of both clinicians and patients. In this study, we aimed to identify which outcomes were measured in recent orthodontic trials and to explore whether any relevant outcome domains were underrepresented.
Five electronic databases were searched to identify all randomized controlled trials of orthodontic treatment interventions in children published in the last 5 years. Abstracts and eligible full-text articles were screened independently and in duplicate by 2 reviewers. Outcome measures were identified and categorized into 6 predetermined outcome domains.
The search identified 650 abstracts, of which 244 eligible articles were retrieved in full. One hundred thirty-three studies met the inclusion criteria and were included. Morphologic features of malocclusion were measured in 84 studies (63%); health resource utilization in 43 (32%); adverse effects of orthodontic treatment in 43 (32%); quality of life in 12 (9%); functional status in 10 (8%); and physical consequences of malocclusion in 3 (2%). There was no consistency in the outcomes selected among the trials to measure these domains.
Most of the outcomes used in orthodontic research are concerned with measuring morphologic changes of treatment and do not reflect patient perspectives. Five of the 6 domains were infrequently evaluated, and outcomes were heterogenous. A core set of outcomes for clinical trials of orthodontic treatment interventions would help to overcome these issues.
选择合适的结局是临床试验设计的基础部分。正畸治疗的目的是改善一个人的牙颌面外观，因此研究结果应反映临床医生和患者的观点。本研究旨在确定最近的正畸试验中测量了哪些结局，并探讨是否存在任何相关结局领域被低估。
搜索了五个电子数据库，以确定过去 5 年内发表的所有针对儿童正畸治疗干预的随机对照试验。由两名评审员独立和重复筛选摘要和合格的全文文章。确定了结局测量并将其分为 6 个预定的结局领域。
搜索共确定了 650 篇摘要，其中有 244 篇符合条件的全文文章被检索到。133 项研究符合纳入标准并被纳入。84 项研究（63%）测量了错颌畸形的形态特征；43 项（32%）研究测量了卫生资源利用；43 项（32%）研究测量了正畸治疗的不良反应；12 项（9%）研究测量了生活质量；10 项（8%）研究测量了功能状态；3 项（2%）研究测量了错颌的身体后果。这些研究中用于测量这些领域的结局选择并不一致。
正畸研究中使用的大多数结局都与测量治疗的形态变化有关，并未反映患者的观点。6 个领域中有 5 个评估频率较低，结局也具有异质性。正畸治疗干预临床试验的核心结局集将有助于解决这些问题。
