Risk of bias for analysis 1.3 Clinical improvement: Ventilator‐free days.

Study

Bias

Randomisation process

Deviations from intended interventions

Missing outcome data

Measurement of the outcome

Selection of the reported results

Overall

Authors' judgement

Support for judgement

Authors' judgement

Support for judgement

Authors' judgement

Support for judgement

Authors' judgement

Support for judgement

Authors' judgement

Support for judgement

Authors' judgement

Support for judgement

Tomazini 2020

Low risk of bias

Randomisation was performed through an online web‐based system using computer‐generated random numbers and blocks of 2 and 4, unknown to the investigators, and was stratified by centre. The group treatment was disclosed to the investigator only after all information regarding patient enrolment was recorded in the online system. Baseline characteristics were well‐balanced between groups.

Some concerns

25 deviations from protocol in the intervention arm (16.55%); 1 patient received a corticosteroid other than dexamethasone. In the control arm, 52 patients received corticosteroids, of which 14 were protocol deviations (9.4%).

Low risk of bias

No data missing.

Low risk of bias

Individuals who assessed the outcomes were not blinded for the assigned treatment. Both groups measured at the same time. Specified definition (alive and free from mechanical ventilation).

Low risk of bias

The protocol and statistical analysis plan were available. Outcomes reported as prespecified.

Some concerns

Overall judged some concerns due to protocol deviations.