Department of Prosthodontics and Biomaterials, Faculty of Dentistry, University Hospital Münster, Waldeyerstraße 30, 48149 Münster, Münster, Germany.
Department of Orthodontics and Dentofacial Orthopedics, Dental School/Medical Faculty, University of Bern, Bern, Switzerland.
BMC Med Res Methodol. 2023 Apr 27;23(1):105. doi: 10.1186/s12874-023-01923-7.
Item 13 of the CONSORT guidelines recommends documentation of the participant flow in randomised clinical trials (RCTs) using a diagram. In the medical literature, the reporting of the flow of participants in RCTs has been assessed to be inadequate. The quality of reporting flow diagrams in periodontology and implantology remains unknown. The aim of this study was to assess the reporting of flow diagrams in RCTs published in periodontology and implantology journals.
RCTs published between 15 January 2018 and 15 January 2022 in twelve high-ranked periodontology and implantology journals were identified. Trial characteristics at the RCT level were extracted. The flow diagram included in each RCT was assessed for completeness of reporting in relation to published criteria and the CONSORT flow diagram template.
From the 544 eligible articles, 85% were single-centre, 82% of parallel-group design and 79% investigated surgical interventions. Three-hundred and fifteen (58%) articles were published in CONSORT endorsing journals. A flow diagram was reported in 317 (58%) trials and reporting was more common in periodontology (73.1%). Overall, 56% of publications with a flow diagram reported a complete CONSORT flow diagram, while in 44% of flow diagrams, at least one point from the CONSORT reporting template was missing. Reasons for loss to follow-up (69.7%) and exclusions from the RCT analysis (86.4%) were poorly reported.
The reporting of flow diagrams in periodontology and implantology RCTs was sub-optimal. Greater awareness of the importance of fully completing the participant CONSORT flow diagram is required.
CONSORT 指南的第 13 条建议使用图表记录随机临床试验(RCT)的参与者流程。在医学文献中,评估了 RCT 中参与者流程的报告不充分。牙周病学和种植学中报告流程图的质量仍不清楚。本研究的目的是评估发表在牙周病学和种植学杂志上的 RCT 中报告流程图的情况。
确定了 2018 年 1 月 15 日至 2022 年 1 月 15 日期间发表在 12 种高排名牙周病学和种植学杂志上的 RCT。从 RCT 层面提取试验特征。评估了纳入的每个 RCT 的流程图,以评估其与已发表标准和 CONSORT 流程图模板的报告完整性。
从 544 篇合格文章中,85%为单中心研究,82%为平行组设计,79%为手术干预。315 篇(58%)文章发表在支持 CONSORT 的期刊上。317 篇(58%)试验报告了流程图,牙周病学报告的更多(73.1%)。总体而言,56%有流程图的出版物报告了完整的 CONSORT 流程图,而在 44%的流程图中,至少有一个 CONSORT 报告模板的点缺失。失访的原因(69.7%)和从 RCT 分析中排除(86.4%)报告得很差。
牙周病学和种植学 RCT 中流程图的报告不够理想。需要提高对完整完成参与者 CONSORT 流程图的重要性的认识。