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

Author:

Zambonin Mazzoleni Gabriele12,Bergna Andrea13ORCID,Buffone Francesca14ORCID,Sacchi Andrea1,Misseroni Serena1,Tramontano Marco56ORCID,Dal Farra Fulvio17ORCID

Affiliation:

1. SOMA—Istituto Osteopatia Milano, Viale Sarca 336 F, 20126 Milan, Italy

2. Physiotherapy Degree Course, Department of Medicine and Technology Innovation, Università degli Studi dell’Insubria, 21100 Varese, Italy

3. AISO—Associazione Italiana Scuole di Osteopatia, 65125 Pescara, Italy

4. PPCR, Harvard T.H. Chan School of Public Health—ECPE, Boston, MA 02115-6096, USA

5. Department of Biomedical and Neuromotor Sciences, University of Bologna, 40126 Bologna, Italy

6. Unit of Occupational Medicine, IRCCS Azienda Ospedaliero-Universitaria di Bologna, 40138 Bologna, Italy

7. Department Information Engineering, University of Brescia, Via Branze 38, 25123 Brescia, Italy

Abstract

Background/Objectives: 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. Methods: 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). Results: 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, p < 0.001; β: 5.41; CI: 2.80–8.02, p ≤ 0.001; β: 5.64, CI: 1.06–10.23, p = 0.016, respectively). Conclusions: 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.

Publisher

MDPI AG

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