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 |
| Randomization |
Low |
Quote: “Random sequence generation was performed by an external monitor who assigned a code to each patient who met the inclusion criteria. The staff who recruited the patients had no way of knowing which intervention each participant was assigned.”
Comment: Allocation sequence probably random. Allocation sequence probably concealed. |
| Deviations from intervention |
Some concerns |
Quote: “Double-blinded. The staff involved in the infusion of plasma and solutions and the patients and staff who treated them were blinded to the treatment received.”
MORTALITY Our analysis for the binary outcome is an intention-to-treat analysis. This method was considered appropriate to estimate the effect of assignment to intervention. Risk assessed to be low for the outcome: Mortality (D28). TIME TO DEATH Participants were analyzed according to their randomized groups for the outcome. Of note, 3/32 vs 1/11 participants were excluded from the analysis post-randomization because they were over the age requirement. This method was considered inappropriate to estimate the effect of assignment to intervention for this 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 outcomes: Time to death. |
| Missing outcome data |
Some concerns |
Comment: 43 participants randomized; 39 participants analyzed.
MORTALITY Data not available for all or nearly all participants randomized. No evidence that the result is not biased. Reasons:3/32, 1/11 patients excluded from analysis due to not meeting age criteria. Missingness could not depend on the true value of the outcome. Not likely that missingness depended on the true value of the outcome. Risk assessed to be some concerns for the outcomes: Mortality (D28). TIME TO DEATH Data not available for all or nearly all participants randomized. No evidence that the result is not biased. Reasons:3/32, 1/11 patients excluded from analysis due to not meeting age criteria. Howver, this has been assessed in ROB2. Risk assessed to be low for the outcome: Time to death. |
| Measurement of the outcome |
Low |
Comment: Method of measuring the outcome probably appropriate.
Measurement or ascertainment of outcome probably does not differ between groups. Unblinded study (outcome assessor) MORTALITY, TIME TO DEATH Observer-reported outcome not involving judgement. Risk assessed to be low for the outcomes: Mortality (D28). Time to death. |
| Selection of the reported results |
Some concerns |
Comment: The prospective registry was available (dated May 28, 2020).
Outcome not pre-specified: mortality time point different in the article compared to the registry. 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 outcome: Mortality (D28). Time to death. |
| Overall risk of bias |
Some concerns |