Note: The risk of bias by domain corresponds to the highest risk of bias among outcomes by domain.
The overall risk of bias corresponds to the overall highest risk of bias assessed among outcomes.
|Bias||Author's judgement||Support for judgement|
|Quote: "The patients were randomly allocated in a 1:1 ratio by block randomization method."
Comment: Allocation sequence random.
No information on allocation concealment.
|Deviations from intervention||
|Quote: "In this study, patients did not know which group of them used medicine. Physicians and clinicians team know about the medicine and intervention groups. Due to the emergency
nature of this trial, placebos of methylprednisolone were not prepared."
Comment: Participants blinded. Personnel/carers not blinded.
Deviations from intended intervention arising because of the study context:
Cross-over: 6 patients in the control group (17% of the control group) received the intervention drug.
No information on administration of co-interventions of interest: antivirals, biologics.
This deviations were not balanced and could affect the outcome. Nevertheless, this domain was rated as some concern as it is impossible to distinguish deviation because of trial context and deviation because of intervention effect.
Data for the binary outcomes were analyzed using intention-to-treat analysis. This method was considered appropriate to estimate the effect of assignment to intervention.
Participants were analyzed according to their randomized groups for the time-to-event outcome.
Of note, 6 participants randomized to the control group received the intervention and were excluded from the analysis post-randomization. This method was considered inappropriate to estimate the effect of assignment to intervention for this time-to-event outcome. There was probably no substantial impact of failure to analyze participants according to their randomized groups.
Risk assessed to be some concerns for the outcome: Mortality (D60 or more). Time to death. Adverse events. Serious adverse events.
|Missing outcome data||
|Comment: 68 participants randomized, 62 participants analyzed.
Data not available for all or nearly all participants randomized.
No evidence that the result is not biased.
Reason: 6 patients in the control group were not included in the analysis because of deviations from the protocol(8.82% of the sample)[receipt of intervention].
Missingness could not depend on the true value of the outcome.
Risk assessed to be low for the outcomes: Mortality (D60 or more). Time to death. Adverse events. Serious adverse events.
|Measurement of the outcome||
|Comment: Method of measuring the outcome probably appropriate.
Measurement or ascertainment of outcome probably does not differ between groups.
Unblinded study (outcome assessor).
Mortality is an observer-reported outcome not involving judgement.
Risk assessed to be low for outcomes: Mortality (D60 or more). Time to death.
The authors reported on adverse events and serious adverse events that may contain both clinically- and laboratory-detected events. All these outcomes can be influenced by knowledge of the intervention assignment, but is not likely in the context of the pandemic.
Risk assessed to be some concerns for outcomes: Adverse events. Serious adverse events.
|Selection of the reported results||
|Comment: Neither the protocol nor statistical analysis plan were available. The registry was available and utilized.
Mortality was registered but there was no discernible timepoint. Time to death and safety outcomes were not registered.
No information on whether the result was selected from multiple outcome measurements or analyses of the data.
Trial probably not analyzed as pre-specified.
Risk assessed to be some concerns for the outcomes: Mortality (D60 or more). Time to death. Adverse events. Serious adverse events.
|Overall risk of bias||