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: “Patients were assigned to either the intervention (awake prone positioning group) or standard care (control group) using a 1:1 computer-generated variable block size sequence. Allocation concealment at randomisation was ensured by an online randomisation system or with on-site opaque sealed envelopes, depending on the trial.”
Comment: Allocation sequence random. Allocation sequence concealed. Imbalances in baseline characteristics appear to be compatible with chance. |
| Deviations from intervention |
Some concerns |
Quote: “Open label. By the very nature of the intervention and design, trial participants, care providers, outcome assessors, and data analysts could not be blinded to the intervention.”
Comment: Unblinded study (participants and personnel/carers) Deviations from intended intervention arising because of the study context: 64 (11%) of 557 patients of the standard care group received at least one episode of awake prone positioning. No information on administration of co-interventions of interest: biologics and antivirals. Corticosteroids were reported and balanced between groups. Hence, insufficient information on whether deviations arose because of the trial context. MORTALITY, WHO SCORE 7 AND ABOVE 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 some concerns for the outcomes: Mortality (D28). WHO score 7 and above (D28). TIME TO DEATH, TIME TO WHO SCORE 7 AND ABOVE Participants were analyzed according to their randomized groups for the outcome. Of note, 3 vs 2 participants were excluded from the analysis post-randomization due to missing data which is accounted for in domain 2. This method was considered appropriate to estimate the effect of assignment to intervention for this outcome. Risk assessed to be some concerns for the outcomes: Time to death. Time to WHO score 7 and above. |
| Missing outcome data |
Low |
Comment: 1126 participants randomized; 1121 participants analyzed.
Data available for nearly all participants randomized. Risk assessed to be low for the outcomes: Mortality (D28). Time to death. WHO score 7 and above (D28). Time to WHO score 7 and above. |
| 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. (TIME TO) 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 (D28). Time to WHO score 7 and above. |
| Selection of the reported results |
Low |
Comment: The protocols, statistical analysis plans and registries were available.
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). Time to death. WHO score 7 and above (D28). Time to WHO score 7 and above. |
| Overall risk of bias |
Some concerns |