| 'Risk of bias' assessment of Li 2020 | |||
| Domain | Assessed outcomes | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Mortality Clinical improvement Adverse events |
Low | Quote: "Patients were randomly assigned via computer‐generated random numbering (1:1) to receive standard treatment coupled with convalescent plasma transfusion or standard treatment alone (control group) (Figure 1). The randomization was stratified based on the severity of COVID‐19 (severe or life‐threatening) and a randomization schedule was generated using block randomization with block size of 4 for each type of COVID‐19 by SAS software." |
| Allocation concealment (selection bias) | Mortality Clinical improvement Adverse events |
Low | Quote: "This random number will connect the subject to the designated treatment group (experimental group or control group) for treatment. [...] Staff responsible for randomization will only be responsible for the assignment of random groups and will not be involved in any specific trial operations." |
| Blinding of participants and personnel (performance bias) | Mortality Clinical improvement Adverse events |
High | Quote: "open‐label" Co‐interventions not balanced across arms |
| Blinding of outcome assessment (detection bias) | Mortality | Low | Quote: "To avoid assessment bias, the evaluation of clinical outcomes was performed by an investigator who was blind to the study group allocation." |
| Clinical improvement Adverse events |
Low | Quote: "To avoid assessment bias, the evaluation of clinical outcomes was performed by an investigator who was blind to the study group allocation." | |
| Selective reporting (reporting bias) | Mortality | Low | Reported as determined at protocol stage |
| Clinical improvement | Unclear | Quote: "A post hoc analysis was added to compare rates of improvement at days 7, 14, and 28." | |
| Adverse events | High | Only transfusion‐related adverse events reported | |
| Incomplete outcome data (attrition bias) | Mortality | Low | ITT population reported |
| Clinical improvement | Low | ITT population reported | |
| Adverse events | High | No safety data for control group available | |
| Other bias | Mortality Clinical improvement Adverse events |
Unclear | Quote: "Due to the containment of the COVID‐19 epidemic in Wuhan, China, the numbers of patients with COVID‐19 decreased in late March 2020. [...] The trial was terminated early after 103 of a planned 200 patients were enrolled." The study expressed effect estimates as odds ratios. Therefore we recalculated relative effects as risk ratios. We noticed that our calculation arrived at the same numerical values, and therefore highlight that effect estimates, which are indicated as odds ratios in the primary study, are in fact risk ratios. |