Hubei-MOST KLOS & KLOBM, Wuhan University, China.
Department of Orthodontics, Wuhan University, China.
Eur J Orthod. 2021 Oct 4;43(5):557-566. doi: 10.1093/ejo/cjaa085.
To assess the reporting quality of split-mouth trials (SMTs) in orthodontic journals, and to identify factors associated with better reporting.
Seven leading orthodontic journals were hand searched for SMTs published during 2015-19. The CONSORT 2010 guideline and CONSORT for within-person trial (WPT) extension were used to assess the trial reporting quality (TRQ) and WPT-specific reporting quality (WRQ) of included SMTs, respectively. A binary score (0 or 1) was given to each item of the guidelines, and total scores were calculated for TRQ (score range, 0-32) and WRQ (score range, 0-15). Univariable and multivariable linear regression analyses were performed to identify factors associated with TRQ and WRQ.
A total of 42 SMTs were included. The mean overall scores for TRQ and WRQ were 16.8 [standard deviation (SD) 7.1] and 5.6 (SD 2.3), respectively. Only 11 SMTs (26.2%) presented the rationale for using a split-mouth design. Key methodological items including random sequence generation (22/42, 52.4%), allocation concealment (9/42, 21.4%), and blinding (20/42, 47.6%) were poorly reported. Only six SMTs (14.3%) used a paired method for sample size calculation, and half (21/42, 50.0%) considered the dependent nature of data in statistical analysis. In multivariable analyses, higher TRQ and WRQ were both significantly associated with journal, reported use of CONSORT and funding status.
The reporting quality of SMTs in orthodontics has much room for improvement. Joint efforts from relevant stakeholders are needed to improve the reporting quality of SMTs and reduce relevant avoidable research waste.
评估口腔正畸学杂志中裂口试验（split-mouth trials，SMTs）的报告质量，并确定与更好报告相关的因素。
手工检索了 2015 年至 2019 年期间发表的 7 种领先的口腔正畸学杂志中的 SMTs。使用 CONSORT 2010 指南和 CONSORT 用于个体内试验（within-person trial，WPT）扩展分别评估纳入的 SMTs 的试验报告质量（trial reporting quality，TRQ）和 WPT 特定报告质量（WPT-specific reporting quality，WRQ）。对指南的每个项目给予二进制评分（0 或 1），并计算 TRQ（评分范围 0-32）和 WRQ（评分范围 0-15）的总分。进行单变量和多变量线性回归分析，以确定与 TRQ 和 WRQ 相关的因素。
共纳入 42 项 SMTs。TRQ 和 WRQ 的平均总分为 16.8 [标准差（standard deviation，SD）7.1]和 5.6（SD 2.3）。仅有 11 项 SMTs（26.2%）提出了使用裂口设计的理由。关键的方法学项目，包括随机序列生成（22/42，52.4%）、分配隐藏（9/42，21.4%）和盲法（20/42，47.6%）报告较差。仅有 6 项 SMTs（14.3%）使用配对方法进行样本量计算，有一半（21/42，50.0%）在统计分析中考虑了数据的依赖性。在多变量分析中，较高的 TRQ 和 WRQ 均与杂志、报告使用 CONSORT 和资助状况显著相关。
口腔正畸学中 SMTs 的报告质量有很大的改进空间。需要相关利益相关者共同努力，提高 SMTs 的报告质量，减少相关的可避免的研究浪费。
