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. 2021 Sep 23;16(9):e0257093.
doi: 10.1371/journal.pone.0257093. eCollection 2021.

Evaluation of reporting quality of randomized controlled trials in patients with COVID-19 using the CONSORT statement

Yuhuan Yin  1 , Fugui Shi  2 , Yiyin Zhang  1 , Xiaoli Zhang  1 , Jianying Ye  1 , Juxia Zhang  3
Affiliations

Evaluation of reporting quality of randomized controlled trials in patients with COVID-19 using the CONSORT statement

Yuhuan Yin et al. PLoS One. .

Abstract

Objective: To evaluate the reporting quality of randomized controlled trials (RCTs) regarding patients with COVID-19 and analyse the influence factors.

Methods: PubMed, Embase, Web of Science and the Cochrane Library databases were searched to collect RCTs regarding patients with COVID-19. The retrieval time was from the inception to December 1, 2020. The CONSORT 2010 statement was used to evaluate the overall reporting quality of these RCTs.

Results: 53 RCTs were included. The study showed that the average reporting rate for 37 items in CONSORT checklist was 53.85% with mean overall adherence score of 13.02±3.546 (ranged: 7 to 22). The multivariate linear regression analysis showed the overall adherence score to the CONSORT guideline was associated with journal impact factor (P = 0.006), and endorsement of CONSORT statement (P = 0.014).

Conclusion: Although many RCTs of COVID-19 have been published in different journals, the overall reporting quality of these articles was suboptimal, it can not provide valid evidence for clinical decision-making and systematic reviews. Therefore, more journals should endorse the CONSORT statement, authors should strictly follow the relevant provisions of the CONSORT guideline when reporting articles. Future RCTs should particularly focus on improvement of detailed reporting in allocation concealment, blinding and estimation of sample size.

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Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1
Fig 1. Literature screening process and results.
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References

    1. Hajibandeh S, Hajibandeh S, Antoniou GA, Green PA, Maden M, Torella F. Reporting and Methodological Quality of Randomised Controlled Trials in Vascular and Endovascular Surgery. European journal of vascular and endovascular surgery: the official journal of the European Society for Vascular Surgery. 2015;50(5):664–70. doi: 10.1016/j.ejvs.2015.06.114 - DOI - PubMed
    1. Butcher NJ, Mew EJ, Monsour A, Chan AW, Moher D, Offringa M. Outcome reporting recommendations for clinical trial protocols and reports: a scoping review. Trials. 2020;21(1):620. doi: 10.1186/s13063-020-04440-w - DOI - PMC - PubMed
    1. Karpouzis F, Bonello R, Pribicevic M, Kalamir A, Brown BT. Quality of reporting of randomised controlled trials in chiropractic using the CONSORT checklist. Chiropractic & manual therapies. 2016;24:19. doi: 10.1186/s12998-016-0099-6 - DOI - PMC - PubMed
    1. Ntala C, Birmpili P, Worth A, Anderson NH, Sheikh A. The quality of reporting of randomised controlled trials in asthma: a systematic review. Primary care respiratory journal: journal of the General Practice Airways Group. 2013;22(4):417–24. doi: 10.4104/pcrj.2013.00089 - DOI - PMC - PubMed
    1. Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, et al.. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. Jama. 1996;276(8):637–9. doi: 10.1001/jama.276.8.637 - DOI - PubMed

Publication types

Grants and funding

The study was funded by Horizontal project of School of Public Health of Lanzhou University “Research on the Thinking, difficulties and Countermeasures of High-quality Development of Lanzhou Hand and Foot Surgery Hospital” (071100278), Gansu Science and Technology Plan (Innovation Base and Talent Plan) project (21JR7RA607), and Health industry scientific research project of Gansu Province (GSWSKY-2019-50), received by Fugui Shi and Juxia Zhang.
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