Note: The risk of bias by domain corresponds to the highest risk of bias among outcomes by domain.
The overall risk of bias corresponds to the overall highest risk of bias assessed among outcomes.
| Bias | Author's judgement | Support for judgement |
| Randomization |
Some concerns |
Quote: "Randomization was performed on the Castor EDC platform (Castor, Hoboken, NJ), using variable block sizes of 4, 6, and 8 patients. The 2 principal investigators (PIs) in the radiation oncology department, who carried out the randomization, and 1 medical physicist who was responsible for quality assurance were aware of the group allocation. All other investigators remained blinded for the duration of the study."
Comment: Allocation sequence random. Unclear allocation concealment. |
| Deviations from intervention |
Some concerns |
Quote: “The 2 principal investigators (PIs) in the radiation oncology department, who carried out the randomization, and 1 medical physicist who was responsible for quality assurance were aware of the group allocation. The medical physicist, aware of the group allocation, authorized treatment with multileaf collimator leaves fully open (whole-lung LDRT) or closed (sham-RT). All other investigators remained blinded for the duration of the study. This included the entire ICU treatment team.”
Comment: Unclear blinding (participants blinded, unclear if all personnel/carers blinded, i.e. the personnel giving the intervention). Deviations from intended intervention arising because of the study context: No participant cross-over. No information on administration of co-interventions of interest: Biologics. All patients recieved corticosteroids. Antivirals reported and not babalced between groups: More patients in the control arm (64%) received antivirals than in the treatment arm (36%). Three patients (1 treatment, 2 control) received experimental drugs (canakinumab, conestat alfa); not reported which arm. Hence, no information on whether deviations arose because of the trial context. Data for the outcome were analyzed using intention-to-treat analysis. This method was considered appropriate to estimate the effect of assignment to intervention. Risk assessed to be some concerns for the outcome: Mortality (D28). |
| Missing outcome data |
Low |
Comment: 22 participants randomized; 22 participants analyzed.
Data available for all participants randomized. Risk assessed to be low for the outcome: Mortality (D28). |
| Measurement of the outcome |
Low |
Comment: Method of measuring the outcome probably appropriate.
Measurement or ascertainment of outcome probably does not differ between groups. Unclear blinding (outcome assessor) MORTALITY Mortality is an observer-reported outcome not involving judgement. Risk assessed to be low for the outcome: Mortality (D28). |
| Selection of the reported results |
Low |
Comment: The prospective trial registry was available.
Results were not selected from multiple outcome measurements or analyses of the data. Trial analyzed as pre-specified. Risk assessed to be low for the outcome: Mortality (D28). |
| Overall risk of bias |
Some concerns |