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: “Randomization sequence stratified by site and severity of illness was generated by an independent statistician. A permuted block randomization of block sizes 2 or 4 was used within each stratum. Eligible patients were randomized 1:1 to receive fostamatinib or placebo on day 1 in addition to standard of care.”
Comment: Allocation sequence random. Allocation sequence concealed. |
| Deviations from intervention |
Low |
Quote: “double-blind, placebo-controlled”
Comment: Blinded study (participants and personnel/carers) 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 outcomes: Mortality (D28). Mortality (D60 or more). Serious adverse events. |
| Missing outcome data |
Low |
Comment: 59 participants randomized; 59 participants analyzed.
Of note, one participant from the intervention arm withdrew consent. Data available for all or nearly all participants randomized. Risk assessed to be low for the outcomes: Mortality (D28). Mortality (D60 or more). Serious adverse events. |
| Measurement of the outcome |
Low |
Comment: Method of measuring the outcome probably appropriate.
Measurement or ascertainment of outcome probably does not differ between groups. Blinded study (outcome assessor). Risk assessed to be low for the outcomes: Mortality (D28). Mortality (D60 or more). Serious adverse events. |
| Selection of the reported results |
Low |
Comment: The prospective trial protocol and registry were available (dated 17th September 2020 and 6th October 2020, respectively).
Outcomes pre-specified. Results were not selected from multiple outcome measurements or analyses of the data. Trial analyzed as pre-specified. Risk assessed to be low for the outcomes: Mortality (D28). Mortality (D60 or more). Serious adverse events. |
| Overall risk of bias |
Low |