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: "Using the Research Electronic Data Capture (REDCap) platform,18 patients were randomly assigned in a 1:1 ratio to receive either a standard prophylactic dose or an intermediate dose of enoxaparin."
Comment: Allocation sequence random. Allocation sequence concealed. |
| Deviations from intervention |
Low |
Quote: “This was an open-label trial without masking.”
Comment: Unblinded study (participants and personnel/carers). Deviations from intended intervention arising because of the study context: No participant cross-over. Co-interventions of interest: biologics, antivirals and corticosteroids, were reported and balanced between groups. Hence, deviations did not arise because of the trial context. MORTALITY 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 low for the outcome: Mortality (D28). TIME TO DEATH Participants were analyzed according to their randomized groups for the outcome. Of note, 1 vs 2 participants were excluded from the analysis post-randomization due to missing data which is accounted for in domain 3. This method was considered appropriate to estimate the effect of assignment to intervention for this outcome. Risk assessed to be low for the outcome: Time to death. |
| Missing outcome data |
Low |
Comment: 176 participants randomized; 173 participants analyzed.
Data available for all or nearly all participants randomized. Of note, 1 vs 2 participants were excluded due to withdrawal of consent. Risk assessed to be low for the outcomes: Mortality (D28). 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 Mortality is an observer-reported outcome not involving judgement. Risk assessed to be low for the outcomes: Mortality (D28). Time to death. |
| Selection of the reported results |
Low |
Comment: The prospective trial registry (dated April 24, 2020) and the protocol were available.
Outcomes pre-specified (mortality, risk of all-cause mortality). 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). Time to death. |
| Overall risk of bias |
Low |