A Critical Appraisal of Reporting in Randomized Controlled Trials Investigating Osteopathic Manipulative Treatment: A Meta-Research Study

• Published in: Journal of clinical medicine Vol. 13; no. 17; p. 5181
• Main Authors: Zambonin Mazzoleni, Gabriele, Bergna, Andrea, Buffone, Francesca, Sacchi, Andrea, Misseroni, Serena, Tramontano, Marco, Dal Farra, Fulvio
• Format: Journal Article
• Language: English
• Published: Switzerland MDPI AG 31-08-2024
• Subjects: Bias; Clinical trials; Content analysis; Osteopathic medicine; Regression analysis; Reproducibility; research quality; meta-research; RCT; checklist; osteopathic manipulative treatment; reporting; osteopathy; randomized controlled trial
• DOI: 10.3390/jcm13175181
• EISSN: 2077-0383

: 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.