Risk of bias for analysis 3.3 Clinical improvement: discharged alive.
| 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 | |
| Subgroup 3.3.1 Dexamethasone | ||||||||||||
| Horby 2021 | Low risk of bias | Randomisation was performed with the use of a web‐based system with concealment of the trial‐group assignment. No baseline differences between the groups. | Some concerns | 8% of the participants in the control group received dexamethasone | Low risk of bias | Data for this outcome was available for all participants randomised. | Some concerns | Outcome assessors were aware of the treatment assignments. Knowledge of intervention received could have affected ascertainment only in patients who had not died. So the influence of the unblinded assessor is limited but existing ‐ therefore deviation between algorithm and judgement. | Low risk of bias | No issue with selective reporting. | Some concerns | Overall judged some concerns due to the randomisation process, protocol deviations and limited bias in measurement. |
| 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 | Data for this outcome was available for all participants randomised | Some concerns | Outcome assessors were aware of the treatment assignments. Knowledge of intervention received could have affected ascertainment only in patients who had not died. So the influence of the unblinded assessor is limited but existing ‐ therefore deviation between algorithm and judgement. | Low risk of bias | The protocol and statistical analysis plan were available. Outcomes reported as prespecified. | Some concerns | Overall rated some concerns due to protocol deviations and measurement of the outcome. |
| Subgroup 3.3.2 Methylprednisolone | ||||||||||||
| Edalatifard 2020 | Some concerns | No information about the allocation concealment. | Some concerns | In this study, patients did not know which group of them used medicine Physicians and clinicians team know about the medicine and intervention groups. 6 patients in the control group received the intervention drug and were excluded from the analyses Intention‐to‐treat |
Low risk of bias | Data for this outcome was available for all participants randomised | Some concerns | Outcome assessors were aware of the treatment assignments. Knowledge of intervention received could have affected ascertainment only in patients who had not died. So the influence of the unblinded assessor is limited but existing ‐ therefore deviation between algorithm and judgement.No protocol or SAP available. | Some concerns | Neither the protocol nor the SAP were available | Some concerns | Overall judged some concerns due to missing information about the allocation concealment, deviations from the intended interventions, measurement of the outcome and selection of the reported result |