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|
|Quote: “A computer-generated randomisation scheme was used to assign each medical ward randomly in a 1:1 ratio to either the intervention or usual care. After April 14, 2020, most wards dedicated to the care of COVID-19 pneumonia gradually closed because of effective COVID-19 containment measures and a favourable evolution of the epidemic in our region. Four more patients were individually randomised by the computer-generated programme in the wards which remained open.”
Comment: Allocation sequence random. No information on allocation concealment.
|Deviations from intervention||
|Quote: “the intervention (incentive to self-prone) was not blinded”
Comment: Unblinded study (participants and personnel/carers)
Deviations from intended intervention arising because of the study context:
One participant randomized to the control group received the intervention (data retrieved from contact with authors).
No information on administration of co-interventions of interest: biologics and corticosteroids. Antivirals were reported.
Hence, no information on whether deviations arose because of the trial context.
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 outcomes: Mortality (D28). Clinical improvement (D28). WHO score 7 and above (D28). Adverse events. Serious adverse events.
|Missing outcome data||
|Comment: 6 wards randomized = 62 participants randomized; 27 participants analyzed.
Data not available for all or nearly all participants randomized.
No evidence that the result is not biased.
Reasons: refused to participate (19 vs 4), unable to self-prone (5 vs 0), were in end-of-life support care (3 vs 0), non-French speaker (0 vs 2), delirious when approached (0 vs 1), communication difficulties (0 vs 1).
Missingness could depend on the true value of the outcome.
Likely that missingness depended on the true value of the outcome (imbalanced proportion of and different reasons for missingness between arms).
Risk assessed to be high for the outcomes: Mortality (D28). Clinical improvement (D28). WHO score 7 and above (D28). Adverse events. Serious adverse events.
|Measurement of the outcome||
|Comment: Method of measuring the outcome probably appropriate.
Measurement or ascertainment of outcome probably does not differ between groups.
Unblinded study (outcome assessor)
Mortality is an observer-reported outcome not involving judgement.
Risk assessed to be low for the outcomes: Mortality (D28).
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).
Clinical improvement (defined as discharge) requires clinical judgement and could be affected by knowledge of intervention receipt, but it not considered likely to in the context of a pandemic.
Risk assessed to be some concerns for the outcomes: Clinical improvement (D28).
ADVERSE and SERIOUS ADVERSE EVENTS
The authors reported on adverse events and serious 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. Serious adverse events.
|Selection of the reported results||
|Comment: The protocol and statistical analysis plan were not available. The registry was available (dated June 16th 2020) however, there were no outcomes pre-specified.
No information on whether the result was selected from multiple outcome measurements or analyses of the data.
No information on whether the trial was analyzed as pre-specified.
Risk assessed to be some concerns for the outcome: Mortality (D28). Clinical improvement (D28). WHO score 7 and above (D28). Adverse events. Serious adverse events.
|Overall risk of bias||