| 'Risk of bias' assessment of Duan 2020 | |||
| Domain | Assessed outcomes | Authors' judgement | Support for judgement |
| Bias due to confounding | Mortality Clinical improvement |
Serious | Quote: "Historic control group was formed by random selection of 10 patients from the cohort treated in the same hospitals and matched by age, gender, and severity of the diseases to the 10 cases in our trial." Not adjusted for co‐morbidities, previous treatments, time of disease onset, etc. |
| Adverse events | Not applicable | Paper only reports transfusion‐related adverse events for intervention group | |
| Bias in selection of participants into the study | Mortality Clinical improvement |
Critical | Small sample size, unclear how participants were selected into intervention group, unclear how long participants of historical control group were followed |
| Adverse events | Not applicable | Paper only reports transfusion‐related adverse events for intervention group | |
| Bias in classification of interventions | Mortality Clinical improvement |
Critical | Assignment to control group was done retrospectively. Treatment details of control group are not provided, and it is unclear whether patients were treated during the same period or at a time when less was known about the disease and the treatment options. Knowledge of patients' outcomes at the time of assignment to the control group could have had a major impact on the selection. |
| Adverse events | Not applicable | Paper only reports transfusion‐related adverse events for intervention group | |
| Bias due to deviations from intended interventions | Mortality Clinical improvement Adverse events |
Low | All participants received the intended intervention. |
| Bias due to missing data | Mortality | Serious | Mortality is reported for participants in intervention group until day 3 of follow‐up. Unclear how long control group was followed and how clinical status was assessed |
| Clinical improvement | Critical | Unclear how long control group was followed and clinical status in terms of respiratory support was not assessed | |
| Adverse events | Critical | No safety data for control group reported | |
| Bias in measurement of outcomes | Mortality | Critical | Unclear whether follow‐up was comparable between groups |
| Clinical improvement | Critical | Clinical course is reported for participants in intervention group until day 3 of follow‐up | |
| Adverse events | Critical | Only transfusion‐related adverse events reported | |
| Bias in selection of the reported results | Mortality Clinical improvement |
Critical | Study was registered as single‐arm trial and control group was retrospectively selected |
| Adverse events | Critical | Observation period unclear; only transfusion‐related adverse events assessed and reported | |
| Overall bias | Mortality | Critical | The study is too problematic to provide any useful evidence, however better evidence is yet insufficient. |
| Clinical improvement | Critical | The study is too problematic to provide any useful evidence, however better evidence is yet insufficient. | |
| Adverse events | Critical | The study is too problematic to provide any useful evidence, however better evidence is yet insufficient. | |