Department of Anaesthesiology, Centre for Anaesthesiological Research, Zealand University Hospital, Lykkebækvej 1, 4600, Køge, Denmark.
Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
Trials. 2021 Apr 14;22(1):280. doi: 10.1186/s13063-021-05233-5.
The Consolidated Standards of Reporting Trials (CONSORT) statement aims to improve transparent reporting of randomised clinical trials. It comprises a participant flow diagram with the reporting of essential numbers for enrolment, allocation and analyses. We aimed to quantify the use of participant flow diagrams in randomised clinical trials on postoperative pain management after total hip and knee arthroplasty.
We searched PubMed, Embase and CENTRAL up till January 2020. The primary outcome was the proportion of trials with adequate reporting of participant flow diagrams, defined as reporting of number of participants screened for eligibility, randomised and included in the primary analysis. Secondary outcomes were recruitment (randomised:screened) and retention (analysed:randomised) rates, reporting of a statistical strategy, reasons for exclusion from the primary analysis and handling of missing outcome data. Trends over time were assessed with statistical process control.
Of the 570 included trials, we found adequate reporting in 240 (42%). Reporting with participant flow diagram increased significantly over time. Median recruitment was 73% (IQR 44-91%), and retention was 97% (IQR 93-100%). These rates did not change over time. Trials with adequate reporting of participant flow were more likely to report a statistical strategy (41% vs 8%), reasons for post-randomisation exclusions (100% vs 55%) and handling of missing outcome data (14% vs 6%).
Adherence to participant flow diagrams for RCTs has increased significantly over time. Still, there is room for improvement of adequate reporting of flow diagrams, to increase transparency of trials details.
《CONSORT 声明》旨在提高随机临床试验报告的透明度。它包含一个参与者流程图，报告了纳入、分配和分析的基本数量。我们旨在量化在全髋关节和膝关节置换术后疼痛管理的随机临床试验中使用参与者流程图的情况。
我们检索了 PubMed、Embase 和 CENTRAL，截至 2020 年 1 月。主要结果是充分报告参与者流程图的试验比例，定义为报告筛选出符合条件的参与者数量、随机分配和纳入主要分析的数量。次要结果是招募（随机分配：筛选）和保留（分析：随机分配）率、报告统计策略、从主要分析中排除的原因以及处理缺失结局数据的方法。使用统计过程控制评估随时间的趋势。
在 570 项纳入的试验中，我们发现有 240 项（42%）报告充分。随着时间的推移，报告中使用参与者流程图的比例显著增加。中位数招募率为 73%（IQR 44-91%），保留率为 97%（IQR 93-100%）。这些比率没有随时间变化。充分报告参与者流程图的试验更有可能报告统计策略（41% vs 8%）、随机化后排除的原因（100% vs 55%）以及处理缺失结局数据的方法（14% vs 6%）。
随着时间的推移，对 RCT 中参与者流程图的遵守程度显著增加。尽管如此，在充分报告流程图方面仍有改进的空间，以提高试验细节的透明度。
