LADD Lab, Centro de Pesquisa Clínica, Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil.
Postgraduate Program in Health Sciences (Cardiology and Cardiovascular Sciences), Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.
PLoS One. 2024 Aug 30;19(8):e0309087. doi: 10.1371/journal.pone.0309087. eCollection 2024.
This study addresses the need for improved transparency and reproducibility in randomized clinical trials (RCTs) within the field of physical activity (PA) interventions. Despite efforts to promote these practices, there is limited evidence on the adherence to established reporting and methodological standards in published RCTs. The research, part of the Strengthening the Evidence in Exercise Sciences Initiative (SEES Initiative) in 2020, assessed the methodological standards and reporting quality of RCTs focusing on PA interventions.
RCTs of PA advice or exercise interventions published in 2020 were selected. Monthly searches were conducted on PubMed/MEDLINE targeting six top-tier exercise science journals. Assessments were conducted by two independent authors, based on 44 items originally from CONSORT and TIDieR reporting guidelines. These items were divided into seven domains: transparency, completeness, participants, intervention, rigor methodology, outcomes and critical analysis. Descriptive analysis was performed using absolute and relative frequencies, and exploratory analysis was done by comparing proportions using the χ2 test (α = 0.05).
Out of 1,766 RCTs evaluated for eligibility, 53 were included. The median adherence to recommended items across the studies was 30 (18-44) items in individual assessments. Notably, items demonstrating full adherence were related to intervention description, justification, outcome measurement, effect sizes, and statistical analysis. Conversely, the least reported item pertained to mentioning unplanned modifications during trials, appearing in only 11.3% of studies. Among the 53 RCTs, 67.9% reported having a registration, and these registered studies showed higher adherence to assessed items compared to non-registered ones.
In summary, while critical analysis aspects were more comprehensively described, aspects associated with transparency, such as protocol registrations/modifications and intervention descriptions, were reported suboptimally. The findings underscore the importance of promoting resources related to reporting quality and transparent research practices for investigators and editors in the exercise sciences discipline.
本研究旨在提高体育活动（PA）干预领域随机临床试验（RCT）的透明度和可重复性。尽管已经努力推广这些实践，但在已发表的 RCT 中，关于遵守既定报告和方法学标准的证据有限。这项研究是 2020 年加强运动科学倡议（SEES 倡议）的一部分，评估了专注于 PA 干预的 RCT 的方法学标准和报告质量。
选择了 2020 年发表的 PA 建议或运动干预 RCT。每月在 PubMed/MEDLINE 上进行搜索，针对六本顶级运动科学期刊。评估由两名独立作者进行，基于 CONSORT 和 TIDieR 报告指南的 44 项原始项目。这些项目分为七个领域：透明度、完整性、参与者、干预、严格的方法学、结果和批判性分析。使用绝对和相对频率进行描述性分析，并使用 χ2 检验（α = 0.05）比较比例进行探索性分析。
在评估的 1766 项 RCT 中，有 53 项符合纳入标准。在个体评估中，研究中建议项目的中位数依从率为 30（18-44）项。值得注意的是，完全依从的项目与干预描述、正当性、结果测量、效应大小和统计分析有关。相比之下，最少报告的项目与试验期间未计划的修改有关，仅出现在 11.3%的研究中。在这 53 项 RCT 中，有 67.9%报告了注册，与未注册的研究相比，这些注册研究对评估项目的依从性更高。
总之，虽然更全面地描述了批判性分析方面，但在透明度方面，如方案注册/修改和干预描述，报告不足。这些发现强调了为运动科学领域的研究人员和编辑推广报告质量和透明研究实践相关资源的重要性。
