Core Outcome Set for Clinical Trials of COVID-19 Based on Traditional Chinese and Western Medicine

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Abstract

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  1. SciScore for 10.1101/2020.03.23.20041533: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIRB: After the Delphi survey had been completed, a consensus meeting was conducted to determine the final COS. 2.5 Ethics and consent: The entire project is part of a clinical trial of COVID-19, which was approved by the Ethics Committee of Dongzhimen Hospital (DZMEC-KY-2020-09).
    Consent: Because of the special circumstances of the COVID-19 pandemic, participants who completed the questionnaire were assumed to have provided consent for their data to be used.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    2.1 Registry: This COS has been registered on the Core Outcome Measures in Effectiveness Trials (COMET) database [7].
    COMET
    suggested: (CoMet, RRID:SCR_011925)

    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:
    Our study had four main limitations. First, due to the highly infectious nature of SARS-CoV-2, patients and the public did not participate in the design or development of the preliminary list of outcomes. Second, the preliminary list of outcomes was developed from protocols of clinical trials when there were knowledge gaps in the prevalence, therapy, prognosis, clinical characteristics of COVID-19. Hence, the COS must be updated in the future. Third, the number of patients was small and all of them were from Hubei Province, so their perspectives may not reflect those of other regions in China or overseas. Fourth, almost all stakeholders were from China. Though one participant in round 1 of the Delphi survey was from Canada, his/her opinion reflected a Chinese perspective because the questionnaire was written in Chinese.

    Results from TrialIdentifier: No clinical trial numbers were referenced.


    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.