Risk of bias for analysis 1.9 Quality of life up to 120 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 | |
| Jeronimo 2020 | Low risk of bias | An independent statistician prepared an electronically generated randomisation list with 14 blocks of 30 participants per block, generated via R software version 3.6.1 (blockrand package). The list was accessible only to non‐blinded pharmacists in the study. Participants were randomised by the study pharmacist to their designated treatment regimen at the time of inclusion and were subsequently identified throughout the study only by their allocated study number. There were no major differences in baseline characteristics between the intervention and placebo groups |
Some concerns | Intervention group: 14 excluded before starting treatment, 1 excluded after starting treatment; Control group: 5 excluded before starting treatment, 3 excluded after starting treatment As the study is meant to detect a positive effect of corticosteroids, participants in the control group receiving the experimental medication lead to expected bias towards null. Hence, we only see a slight tendency of under‐estimating the effect, but there is no increase in the risk to mistakenly introduce a medication for its beneficial effect. |
High risk of bias | Because of the issue of competing risk of death all data for this outcome might not be available. There was no adjustment in the analysis for competing risk of death. | Low risk of bias | We judged this domain low because the measurements were similar between groups. | Some concerns | The outcome was presented on a single scale and with one analysis only, but was not prespecified which leads to some concerns. | High risk of bias | Overall we see high risk bias due to missing adjustment for competing risks |