Dexamethasone 12 mg versus 6 mg for patients with COVID-19 and severe hypoxaemia: a pre-planned, secondary Bayesian analysis of the COVID STEROID 2 trial
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SciScore for 10.1101/2021.07.22.21260755: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: The trial protocol was approved by the Ethics Committee of the Capital Region of Denmark and institutionally at each trial site.
Consent: Consent procedure: We obtained informed consent from the patients or their legal surrogates according to national regulations.Sex as a biological variable We excluded patients who used systemic corticosteroids for other indications than COVID-19 in doses higher than 6 mg dexamethasone equivalents or had used systemic corticosteroids for COVID-19 for 5 days or more, those with invasive fungal infection or active tuberculosis, those with known hypersensitivity to dexamethasone and those who were pregnant. Randomization Trial design and oversight: The … SciScore for 10.1101/2021.07.22.21260755: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: The trial protocol was approved by the Ethics Committee of the Capital Region of Denmark and institutionally at each trial site.
Consent: Consent procedure: We obtained informed consent from the patients or their legal surrogates according to national regulations.Sex as a biological variable We excluded patients who used systemic corticosteroids for other indications than COVID-19 in doses higher than 6 mg dexamethasone equivalents or had used systemic corticosteroids for COVID-19 for 5 days or more, those with invasive fungal infection or active tuberculosis, those with known hypersensitivity to dexamethasone and those who were pregnant. Randomization Trial design and oversight: The COVID STEROID 2 trial was an investigator-initiated, international, parallel-grouped, stratified, blinded randomized clinical trial. Blinding Trial design and oversight: The COVID STEROID 2 trial was an investigator-initiated, international, parallel-grouped, stratified, blinded randomized clinical trial. Power Analysis 14 Statistical analysis: We estimated that 1000 patients were required for the trial to have 85% power to show a relative reduction of 15% in 28-day mortality combined with a 10% reduction in time on life support at a 2-sided alpha-level of 5%, assuming that 30% would die and 10% still be on life support at day 28 in the control group. 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:Limitations: We had limited power to detect differences in some of the outcomes and in the subgroup analyses. Some baseline variables may have differed between the groups, e.g. diabetes, but a pre-defined secondary analysis adjusting for diabetes and other important risk factors supported the primary result. As expected, the distribution of the primary outcome data was not normal, but it was unexpected that day 28 would have 41.4% of the counts. To mitigate this, we used a newly developed statistical test that accounts for excess zeroes and post hoc used bootstrapping to challenge the results further.18 The sample size estimation for the primary outcome was based on expected relative differences in 28-day mortality and time on life support of 15% and 10%, respectively, that may be considered large. Changes in the treatment of COVID-19 during trial (e.g. increased use of IL-6-RAs) may have influenced the results.
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04509973 Active, not recruiting Higher vs. Lower Doses of Dexamethasone for COVID-19 and Sev… 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.
Results from scite Reference Check: We found no unreliable references.
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