Effects of Photobiomodulation Therapy Combined with Static Magnetic Field in Severe COVID-19 Patients Requiring Intubation: A Pragmatic Randomized Placebo-Controlled Trial

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Abstract

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  1. SciScore for 10.1101/2020.12.02.20237974: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    Institutional Review Board StatementIRB: Ethics: This study was submitted and approved by the Research Ethics Committee of Associação Dr.
    Consent: All patients eligible for the study or patient’s legal representative (if the patient was too unwell to provide consent) were informed by study assessors of the objective and all signed the written informed consent before enrollment in the study.
    RandomizationTrial design: A prospectively registered (NCT04386694), pragmatic, two-arms, parallel randomized, triple-blinded (patients, therapists and outcome assessors), placebo-controlled trial was conducted.
    BlindingRandomization and blinding: Prior to initiation of the treatment, patients were randomized into their respective intervention groups: active PBMT-sMF or placebo PBMT-sMF.
    Power Analysisnot detected.
    Sex as a biological variableMoreover, cancer patients and pregnant women were also excluded.

    Table 2: Resources

    No key resources detected.


    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).


    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    However, although we have included several features in order to minimize bias, this study has some limitations. There were two deviation from the registered protocol. The first one was that we estimated that the endpoint assessment would be up to 20 days after randomization, however, as the endpoint assessment directly depended on the length of stay in the ICU, in some cases this assessment took more than 20 days. The second deviation was not having assessing IgG, IgM and D-dimmer because the third part laboratory in charge to carry out the blood analysis was not able to implement the necessary routines before the beginning of our trial. In addition, we might considerer as a limitation did not following up the patients after hospital discharge. Finally, another limitation to be considered is the small sample size. This trial is the first one assessing the effects of PBMT-sMF in patients with severe COVID-19, therefore was unknown a priori the adequate sample size to detect precise differences in the primary outcome of the study. However, this study was important to estimate the adequate sample size for further studies considering length of stay in the ICU as a primary outcome. Based in our results we estimated that further studies will require n= 68 patients per group to detect clinically important difference between groups. Therefore, further studies with rigorous methodological quality and adequate sample size are needed to investigate whether PBMT-sMF is able to decrease t...

    Results from TrialIdentifier: We found the following clinical trial numbers in your paper:

    IdentifierStatusTitle
    NCT04386694CompletedPhotobiomodulation Therapy Combined With Static Magnetic Fie…


    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.


    Results from JetFighter: We did not find any issues relating to colormaps.


    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • No protocol registration statement was detected.

    About SciScore

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.