Królikowska Aleksandra, Urban Natalia, Lech Marcin, Reichert Paweł, Ramadanov Nikolai, Kayaalp Mahmut Enes, Prill Robert
Physiotherapy Research Laboratory University Centre of Physiotherapy and Rehabilitation, Faculty of Physiotherapy, Wroclaw Medical University Wroclaw Poland.
Evidence-Based Healthcare in Wroclaw: A JBI Affiliated Group The University of Adelaide Adelaide South Australia Australia.
J Exp Orthop. 2025 Jan 7;12(1):e70117. doi: 10.1002/jeo2.70117. eCollection 2025 Jan.
The official medical journals of scientific societies advocate for high-quality standards. It's important to assess whether randomized controlled trials (RCTs) in influential journals, such as the hybrid journal of the European Society of , and (), adhere to reporting guidelines and best practices. Therefore, the present scoping review aimed to explore and map the reporting practices and methodological quality in recent RCTs published in the () journal, focusing on identifying gaps in adherence to reporting guidelines and transparency. The study was preregistered and followed the PRISMA-ScR checklist. RCTs published in between 2022 and 2023 were included. The search was conducted via PubMed. A two-stage selection process was employed, with two independent reviewers conducting study selection and data extraction. Data collected included study characteristics, intervention details, sample size calculation reporting, data transparency, and adherence to Consolidated Standards of Reporting Trials (CONSORT) guidelines. Critical appraisal was conducted using the JBI tool for RCTs. All included RCTs ( = 25) reported a predetermined minimum sample size. Study protocol preregistration was reported in 52% of the RCTs, while only 24% provided data availability statements. Most RCTs offering data availability indicated data would be shared upon request. Adherence to CONSORT guidelines was reported in 96% of studies, with only one RCT not adhering to recognized reporting standards. All the included studies adequately addressed statistical conclusion validity. However, internal validity was less consistently addressed across the studies.
While most recently published RCTs in adhered to CONSORT guidelines, there is potential for improvement in the reporting of protocol preregistration and data availability statements. Although all studies reported sample size calculations, transparency in data sharing remains limited.
Level I.
科学协会的官方医学期刊倡导高质量标准。评估诸如欧洲学会的混合型期刊以及《柳叶刀》等有影响力的期刊中的随机对照试验(RCT)是否遵循报告指南和最佳实践非常重要。因此,本范围综述旨在探索并梳理发表在《柳叶刀》期刊上的近期随机对照试验的报告实践和方法学质量,重点是找出在遵循报告指南和透明度方面的差距。该研究已预先注册,并遵循PRISMA - ScR清单。纳入了2022年至2023年在《柳叶刀》上发表的随机对照试验。通过PubMed进行检索。采用两阶段筛选过程,由两名独立评审员进行研究筛选和数据提取。收集的数据包括研究特征、干预细节、样本量计算报告、数据透明度以及对《报告试验的统一标准》(CONSORT)指南的遵循情况。使用JBI工具对随机对照试验进行批判性评价。所有纳入的随机对照试验(n = 25)均报告了预定的最小样本量。52%的随机对照试验报告了研究方案的预先注册情况,而只有24%提供了数据可用性声明。大多数表明有数据可用性的随机对照试验表示会应要求共享数据。96%的研究报告遵循了CONSORT指南,只有一项随机对照试验未遵循公认的报告标准。所有纳入的研究都充分解决了统计结论的有效性问题。然而,各项研究在内部有效性方面的处理不太一致。
虽然最近发表在《柳叶刀》上的大多数随机对照试验遵循了CONSORT指南,但在方案预先注册和数据可用性声明的报告方面仍有改进空间。尽管所有研究都报告了样本量计算,但数据共享的透明度仍然有限。
一级。