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 randomized in blocks of four using a computerized random number generator. Allocation was concealed using sealed opaque envelopes."
Comment: Allocation sequence random. Allocation sequence concealed. |
Deviations from intervention |
Some concerns |
Quote: "neither the participants nor the treating clinicians were blinded."
Comment: Unblinded study (participants and personnel/carers). Deviations from intended intervention arising because of the study context: Administration of co-interventions of interest antivirals (22 vs 23), corticosteroids (received by all), and biologics (6 vs 5) were reported and were balanced between groups. Adherence to ≥6 hours prone only per day only achieved by 43% of the intervention group, while 53% of the standard care group lay prone for some of the day. This deviation could affect the outcome. Nevertheless, this domain was rated as some concern as it is impossible to distinguish deviation because of trial context and deviation because of intervention effect. 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 outcome: Mortality (D28).Adverse events |
Missing outcome data |
Low |
Comment: 60 participants randomized; 60 participants analyzed.
Data available for all participants randomized. Risk assessed to be low for the outcome: Mortality (D28).Adverse events. |
Measurement of the outcome |
Some concerns |
Comment: Method of measuring the outcome probably appropriate.
Measurement or ascertainment of outcome probably does not differ between groups. Unblinded study (outcome assessor). MORTALITY Mortality is an observer-reported outcome not involving judgement. Risk assessed to be low for the outcome: Mortality (D28). ADVERSE EVENTS The authors reported on adverse events that may contain both clinically- and laboratory-detected events, which can be influenced by knowledge of the intervention assignment, but is not likely in the context of the pandemic. Risk assessed to be some concerns for the outcomes: Adverse events. |
Selection of the reported results |
Some concerns |
Comment: The trial registry (prospective; dated 10th of December 2020) was available.
Mortality 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 outcome: Mortality (D28). Adverse events not pre-specified 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: Adverse events. |
Overall risk of bias |
Some concerns |