Koufatzidou Marianna, Karveleas Ilias, Mitsika Ioanna, Patel Krishna, Seehra Jadbinder, Pandis Nikolaos
Private Practice, Piraeus, Greece.
Private Practice, Bern, Switzerland.
Eur J Orthod. 2025 Apr 8;47(3). doi: 10.1093/ejo/cjaf019.
BACKGROUND/OBJECTIVES: The inclusion of a participant flow diagram in randomized clinical trials (RCTs) is a requirement of the CONSORT guidelines. The aim of this study was to assess the reporting quality of flow diagrams of RCTs published in orthodontic journals in relation to the CONSORT Flow Diagram for Parallel Group RCTs.
MATERIALS/METHODS: RCTs published between January 2011 and December 2023 in five orthodontic journals were identified and trial characteristics were extracted. The reporting of the flow diagram (if included) was assessed for completeness in relation to the CONSORT flow diagram template. Descriptive statistics and cross tabulations between RCT characteristics and presence/no presence of a flow diagram were performed. On an exploratory basis, univariable associations between RCT characteristics and presence/no presence of a flow diagram were performed and univariable logistic regression to examine the effect of publication year on flow diagram reporting.
Three hundred and thirty-four RCTs met the inclusion criteria. The majority were published in 2021 (n = 39, 11.7%), and had 2 arms (n = 279, 83.5%). Three-hundred and seven (92.0%) RCTs were published in journals endorsing the CONSORT guidelines. Two hundred and thirty-three (69.8%) RCTs included a flow diagram and from these, 48.1% (n = 112) were fully compliant with flow diagram reporting. 121 (51.9%) omitted at least one item of the CONSORT reporting template. Significant associations between journal type, CONSORT endorsement by authors, ethical approval status, presence of a published protocol, significance of the primary outcome, involvement of a statistician, presence of conflict of interest, center type, type of analysis undertaken and the presence/ no presence of a flow diagram were present. Across the study timeframe, the odds of inclusion of RCT flow diagram increased per additional year (OR:1.47; 95%CI:1.34,1.61; p < .001).
Only five orthodontic journals.
CONCLUSIONS/IMPLICATIONS: Despite improvements over time, the inclusion and reporting of CONSORT flow diagram for parallel group RCTs in trials published in orthodontic journals requires improvement. To mitigate potential biased interpretation of trial results, journal editors should ensure a complete CONSORT flow diagram is submitted by researchers.
背景/目的：在随机临床试验（RCT）中纳入参与者流程图是CONSORT指南的一项要求。本研究的目的是评估正畸期刊上发表的RCT流程图的报告质量，参照平行组RCT的CONSORT流程图。
材料/方法：确定2011年1月至2023年12月期间在五本正畸期刊上发表的RCT，并提取试验特征。评估流程图（若有）的报告相对于CONSORT流程图模板的完整性。对RCT特征与是否存在流程图之间进行描述性统计和交叉制表。在探索性基础上，对RCT特征与是否存在流程图之间进行单变量关联分析，并进行单变量逻辑回归以检验发表年份对流程图报告的影响。
334项RCT符合纳入标准。大多数发表于2021年（n = 39，11.7%），且有2个组（n = 279，83.5%）。307项（92.0%）RCT发表于认可CONSORT指南的期刊。233项（69.8%）RCT纳入了流程图，其中48.1%（n = 112）完全符合流程图报告要求。121项（51.9%）至少遗漏了CONSORT报告模板中的一项内容。期刊类型、作者对CONSORT的认可、伦理批准状态、是否有已发表的方案、主要结局的显著性、统计学家的参与、利益冲突的存在、中心类型、所进行的分析类型与是否存在流程图之间存在显著关联。在整个研究时间段内，RCT流程图纳入的几率每增加一年就会增加（OR：1.47；95%CI：1.34，1.61；p <.001）。
仅涉及五本正畸期刊。
结论/启示：尽管随着时间推移有所改进，但正畸期刊发表的试验中平行组RCT的CONSORT流程图的纳入和报告仍需改进。为减轻对试验结果的潜在偏倚解释，期刊编辑应确保研究人员提交完整的CONSORT流程图。
