| Bias | Author's judgement | Support for judgement |
| Randomization |
Some concerns |
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 |
High |
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: Single-blind trial 6 patients in the control group (17% of the control group) received the intervention drug and were excluded from the analyses. Deviations imbalanced between arms. No information on administration of co-interventions of interest: antivirals, biologics. Data were analyzed using intention-to-treat analysis, however 6 patients were excluded from the analyses. |
| Missing outcome data |
High |
Comment: 68 randomized, 62 analyzed.
6 patients in the control group were not included in the analysis because of deviations from the protocol(8.82% of the sample). Missingness in data is likely to depend on its true value. Risk assessed to be high for the outcomes: Mortality. Time to death. Adverse Events. Serious adverse events. |
| Measurement of the outcome |
Some concerns |
Comment: Unblinded study (outcome assessor).
Mortality is an observer-reported outcome not involving judgement. Risk assessed to be low for outcomes: Mortality. Time to death. Adverse events and Serious adverse events may contain both clinically and laboratory-detected outcomes, therefore it can be influenced by knowledge of the intervention assignment. Risk assessed to be some concerns for outcomes: Adverse events. Serious adverse events. |
| Selection of the reported results |
Low |
Comment: Neither the protocol nor statistical analysis plan were available. The registry was available and utilized.
Mortality was registered and reported in the paper as such. Safety outcomes were neither registered nor reported as outcomes. Results were not selected from multiple outcome measurements. Trial analyzed as prespecified. Risk assessed to be low for the outcomes: Mortality. Time to death. Adverse events. Serious adverse events. |
| Overall risk of bias |
High |