Division of Orthopedic Surgery, McMaster University, Hamilton, Canada.
Centre for Evidence Based Orthopedics, Hamilton, Canada.
Bone Joint J. 2021 May;103-B(5):898-901. doi: 10.1302/0301-620X.103B5.BJJ-2020-2245.
This study reviews the past 30 years of research from the Canadian Orthopedic Trauma Society (COTS), to identify predictive factors that delay or accelerate the course of randomized controlled trials in orthopaedic trauma.
We conducted a methodological review of all papers published through the Canadian Orthopaedic Trauma Society or its affiliates. Data abstracted included: year of publication; journal of publication; study type; number of study sites; sample size; and achievement of sample size goals. Information about the study timelines was also collected, including: the date of study proposal to COTS; date recruitment began; date recruitment ended; and date of publication.
In total, 22 studies have been published through the COTS working group, 13 of which are randomized controlled trials (RCTs). In total, 1,423 individual patients have been involved in COTS studies, a mean of 110 patients per trial (22 to 424). Each study was conducted across a mean of approximately six centres (1 to 11) and took nearly ten years (mean 119.9 months (59 to 188)) from presentation of concept to publication. The mean length of enrolment was 63 months (26 to 113) and the mean time from cessation of enrolment to publication 51 months (19 to 78). Regardless of sample size, the only factor associated with a decreased length of enrolment was a higher number of clinical sites (p = 0.041). Neither study sample size nor length of enrolment were associated with total time to publication.
Over the last three decades, COTS has developed a multinational strategy to produce high-quality evidence in the field of orthopaedic trauma through 13 multicentre RCTs. Future efficiencies can be realized by recruitment of more clinical sites, improving connectivity between the sites, and the promotion of national streamlined ethics processes. Cite this article: 2021;103-B(5):898-901.
本研究回顾了加拿大骨科创伤学会（COTS）过去 30 年的研究，以确定影响骨科创伤随机对照试验进程的预测因素，包括延迟或加速试验进程的因素。
我们对加拿大骨科创伤学会或其分支机构发表的所有论文进行了方法学回顾。提取的数据包括：发表年份；发表期刊；研究类型；研究地点数量；样本量；以及是否达到样本量目标。还收集了有关研究时间线的信息，包括：向 COTS 提交研究提案的日期；开始招募的日期；招募结束的日期；以及发表的日期。
共有 22 项研究通过 COTS 工作组发表，其中 13 项为随机对照试验（RCT）。共有 1423 名患者参与了 COTS 研究，平均每个试验 110 名患者（22 至 424 名）。每个研究涉及的中心数量平均约为 6 个（1 至 11 个），从提出概念到发表需要近 10 年（平均 119.9 个月（59 至 188 个月）。登记的平均长度为 63 个月（26 至 113 个月），从登记结束到发表的平均时间为 51 个月（19 至 78 个月）。无论样本量大小如何，唯一与登记时间缩短相关的因素是临床中心数量较多（p = 0.041）。研究样本量和登记时间均与总发表时间无关。
在过去的三十年中，COTS 通过 13 项多中心 RCT 制定了一项多国家战略，以在骨科创伤领域产生高质量的证据。通过增加临床中心的数量、改善中心之间的连接以及促进国家简化的伦理流程，可以实现未来的效率提升。
