Early safety indicators of COVID-19 convalescent plasma in 5000 patients
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SciScore for 10.1101/2020.05.12.20099879: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: The program was approved by the Mayo Clinic Institutional Review Board (IRB) on April 1st, 2020 which served as the central IRB for all participating facilities and empaneled an independent Data and Safety Monitoring Board to oversee the safety analysis.
Consent: Written informed consent was obtained from the participant or a legally-authorized representative prior to enrollment, except in jurisdictions allowing deferral of consent for emergency treatment, in which case, consent was obtained to continue participation.Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
… SciScore for 10.1101/2020.05.12.20099879: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: The program was approved by the Mayo Clinic Institutional Review Board (IRB) on April 1st, 2020 which served as the central IRB for all participating facilities and empaneled an independent Data and Safety Monitoring Board to oversee the safety analysis.
Consent: Written informed consent was obtained from the participant or a legally-authorized representative prior to enrollment, except in jurisdictions allowing deferral of consent for emergency treatment, in which case, consent was obtained to continue participation.Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Software and Algorithms Sentences Resources All serious adverse event reports will be independently adjudicated over the course of the study by the IND Sponsor and trained designee (AMK) using the National Healthcare Safety Network Biovigilance Component Hemovigilance Module Surveillance Protocol as a framework (12). National Healthcaresuggested: NoneRaw data were retrieved from REDCap via the application programming interface (API) and subjected to data consistency checks. REDCapsuggested: (REDCap, RRID:SCR_003445)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:Limitations: A key limitation of our observations includes the lack of detailed training of study personnel and monitoring in a highly diverse group of sites ranging from small community hospitals in rural areas to urban public hospitals to full-service academic medical centers. Given the speed at which the EAP was implemented and considering the stress on clinical staff at participating sites during this on-going pandemic, the web-based case reporting forms were designed to optimize convenience. Additionally, although the patient inclusion criteria were specific to hospitalized patients, these criteria were exceptionally broad. While these elements of the EAP may be suboptimal, they are perhaps understandable in a crisis of the magnitude of the COVID-19 pandemic. The efficacy of convalescent plasma for treatment of COVID-19 has not yet been determined, and this report, focused on safety signals, should not be misconstrued as evidence of effectiveness. To test the efficacy of this therapy, future analyses of EAP data will include exposure control cohorts of patients who did not receive COVID-19 convalescent plasma. However, randomized controlled trials— some of which are currently in progress— will ultimately be necessary to evaluate the potential efficacy of convalescent plasma treatment along the continuum of disease-severity (http://ccpp19.org). Importantly, evolving data from the EAP will continue to have high utility in understanding the real world safety of COVID-19 con...
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04338360 Approved for marketing Expanded Access to Convalescent Plasma for the Treatment of … 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.
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