Risk of bias for analysis 1.6 Adverse events.
| 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 | |
| Edalatifard 2020 | Some concerns | No information about the allocation concealment. | Some concerns | 6 patients in the control group received the intervention drug and were excluded from the analyses (17%) | High risk of bias | 6 patients in the control group were not included in the analysis because of deviations from the protocol (17%) Unknown amount of missing data because of competing risk, and no analysis to adjust for this was made. |
Low risk of bias | The measurements were similar between groups. | Some concerns | Neither the protocol nor statistical analysis plan were available | High risk of bias | Overall judged high because 6 patients in the control group received the intervention drug and were excluded from the analyses. Moreover, occurrence of non‐terminal events can be precluded by death as a competing risk. Without adjustment this leads to high risk of bias. |
| Tang 2021 | Low risk of bias | Randomisation was stratified by the statistician of the leading site, who produced computer‐generated block randomisation lists with a block size of 4 patients. | Low risk of bias | ITT presented. The participants were blinded, and the physicians were aware of the treatment assignment. No protocol deviations. | High risk of bias | Unknown amount of missing data because of competing risk, and no analysis to adjust for this was made. | Low risk of bias | The measurements were similar between groups. | Some concerns | Endpoint including its subitems were not named in NCT registration. | High risk of bias | Occurrence of non‐terminal events can be precluded by death as a competing risk. Without adjustment this leads to high risk of bias, so overall we judged high risk of bias. |
| 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%). | High risk of bias | We requested data from the authors. Unknown amount of missing data because of competing risk, and no analysis to adjust for this was made. | Low risk of bias | The measurements were similar between groups. | Low risk of bias | The protocol and statistical analysis plan were available. Outcomes reported as prespecified. | High risk of bias | Occurrence of non‐terminal events can be precluded by death as a competing risk. Without adjustment this leads to high risk of bias, so overall we judged high risk of bias. |