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: "This parallel-group, single-blind, and randomized controlled trial was designed by randomly assigning patients to the intervention and control groups using a 6-item randomized block method and an equal allocation ratio (1:1). To maintain single blinding, we used a “Simple Central randomization” in which the individual recruiting the patient (senior physician responsible for therapeutic intervention) contacted the center by phone after the patient is enrolled. The respondent in the center was the second researcher, who had designed a table of the 6-item randomized block by computer and added concealment codes without knowing the patients’ medical conditions."
Comment: Allocation sequence random. Unclear allocation concealment.
|Deviations from intervention||
|Quote: "The senior physician and patients were aware"
Comment: Unblinded study (participants and personnel/carers)
Deviations from intended intervention arising because of the study context:
No participant cross-over.
No information on the administration of co-interventions of interest: Biologics, antivirals and corticosteroids.
Hence, no information on whether deviations arose because of the trial context.
Data for the outcome were analyzed using intention-to-treat analysis. This method was considered appropriate to estimate the effect of assignment to intervention.
Risk assessed to be some concerns for the outcomes: Mortality (D60 or more). WHO score 7 and above (D60 or more)
|Missing outcome data||
|Comment: 62 participants randomized; 60 participants analyzed.
Data available for all or nearly all participants randomized.
Of note, 1 vs 1 participants lost to follow-up
Risk assessed to be low for the outcomes: Mortality (D60 or more). WHO score 7 and above (D60 or more).
|Measurement of the outcome||
|Comment: Method of measuring the outcome probably appropriate.
Measurement or ascertainment of outcome probably does not differ between groups.
Probably unblinded study (outcome assessor).
Mortality is an observer-reported outcome not involving judgement.
Risk assessed to be low for the outcomes: Mortality (D60 or more).
WHO SCORE 7 AND ABOVE
For WHO score 7 and above, we consider that the assessment cannot possibly be influenced by knowledge of intervention assignment.
Risk assessed to be low for the outcomes: WHO score 7 and above (D60 or more).
|Selection of the reported results||
|Comment: The trial registry was retrospective.
No information on whether the result was selected from multiple outcome measurements or analyses of the data.
No information on whether the trial was analyzed as pre-specified.
Risk assessed to be some concerns for the outcomes: Mortality (D60 or more). WHO score 7 and above (D60 ore more).
|Overall risk of bias||