Zambonin Mazzoleni Gabriele, Bergna Andrea, Buffone Francesca, Sacchi Andrea, Misseroni Serena, Tramontano Marco, Dal Farra Fulvio
SOMA-Istituto Osteopatia Milano, Viale Sarca 336 F, 20126 Milan, Italy.
Physiotherapy Degree Course, Department of Medicine and Technology Innovation, Università degli Studi dell'Insubria, 21100 Varese, Italy.
J Clin Med. 2024 Aug 31;13(17):5181. doi: 10.3390/jcm13175181.
: In osteopathy, it becomes necessary to produce high-quality evidence to demonstrate its effectiveness. The aim of this meta-research study is to assess the reporting quality of RCTs published in the osteopathic field. : The protocol was preliminarily registered on the "Open Science Framework (OSF)" website. For reporting, we considered the PRISMA 2020 checklist. We included all the RCTs, published between 2011 and 2023, investigating the effectiveness of Osteopathic Manipulative Treatment (OMT) in any possible condition. The search process was conducted on four major biomedical databases including PubMed, Central, Scopus and Embase. A data extraction form was implemented to collect all relevant information. The completeness of reporting was calculated as the percentage of adherence to the CONSORT checklist; the Cochrane ROB 2 tool was considered to assess the risk of bias (RoB) in the following five major domains: randomization (D1), interventions (D2), missing data (D3), outcome measurement (D4), selective reporting (D5). : A total of 131 studies were included and the overall adherence was 57%, with the worst section being "other information" (42%). Studies with a lower RoB showed higher adherence to the CONSORT. The "results" section presented the highest differences as follows: D1 (-36.7%), D2 (-27.2%), D3 (-21.5%) and D5 (-25.5%). Significant correlations were also found between the preliminary protocol registration, higher journal quartile, publication in hybrid journals and the completeness of reporting (β: 19.22, CI: 14.45-24.00, < 0.001; β: 5.41; CI: 2.80-8.02, ≤ 0.001; β: 5.64, CI: 1.06-10.23, = 0.016, respectively). : The adherence to the CONSORT checklist in osteopathic RCTs is lacking. An association was found between a lower completeness of reporting and a higher RoB, a good journal ranking, publication in hybrid journals and a prospective protocol registration. Journals and authors should adopt all the strategies to adhere to reporting guidelines to guarantee generalization of the results arising from RCTs.
在整骨疗法中，有必要提供高质量的证据来证明其有效性。这项元研究的目的是评估整骨疗法领域发表的随机对照试验（RCT）的报告质量。该方案已在“开放科学框架（OSF）”网站上进行了初步注册。在报告方面，我们参考了PRISMA 2020清单。我们纳入了2011年至2023年间发表的所有研究整骨手法治疗（OMT）在任何可能病症中的有效性的随机对照试验。检索过程在四个主要生物医学数据库中进行，包括PubMed、Central、Scopus和Embase。实施了数据提取表以收集所有相关信息。报告的完整性以符合CONSORT清单的百分比来计算；采用Cochrane ROB 2工具在以下五个主要领域评估偏倚风险（RoB）：随机化（D1）、干预措施（D2）、缺失数据（D3）、结果测量（D4）、选择性报告（D5）。共纳入131项研究，总体符合率为57%，最差的部分是“其他信息”（42%）。偏倚风险较低的研究对CONSORT的符合度更高。“结果”部分呈现出最大差异如下：D1（-36.7%）、D2（-27.2%）、D3（-21.5%）和D5（-25.5%）。在初步方案注册、较高的期刊四分位数、在混合型期刊上发表与报告完整性之间也发现了显著相关性（β：19.22，CI：14.45 - 24.00，<0.001；β：5.41；CI：2.80 - 8.02，≤0.001；β：5.64，CI：1.06 - 10.23，=0.016，分别）。整骨疗法随机对照试验对CONSORT清单的符合度不足。发现报告完整性较低与较高的偏倚风险、良好的期刊排名、在混合型期刊上发表以及前瞻性方案注册之间存在关联。期刊和作者应采取所有策略以遵守报告指南，以确保随机对照试验结果的普遍性。
