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: “A custom application built into the electronic health record (EHR) linked local inventory to patient encounters and provided a random mAb allocation at the time of referral.” “The prescriber and/or patient could request a specific mAb if desired.” “The trial launched with equal allocation randomization and planned interim analyses for adaptive randomization where mAb performing better would be given higher randomization probabilities.”
Comment: Allocation sequence probably random. No information on allocation concealment. Imbalances in baseline characteristics appear to be compatible with chance. |
| Deviations from intervention |
Low |
Quote: “Open-label”
Comment: Unblinded study (participants and personnel/carers) Deviations from intended intervention arising because of the study context: No participant cross-over. In the outpatient setting, we consider no important cointerventions of interest. Hence, no deviation arose because of the trial context. Our analysis for the binary outcome is an intention-to-treat analysis. This method was considered appropriate to estimate the effect of assignment to intervention. Risk assessed to be low for the outcomes: Mortality (D28). Hospitalization or death. |
| Missing outcome data |
Some concerns |
Comment: 2,466 participants randomized; 1,935 participants analyzed.
Data not available for all or nearly all participants randomized. No evidence that the result is not biased. Reasons: 443 not infused (154 became clinically ineligible, 146 patients declined, 81 patients could not be contacted, 32 patients with travel/logistic problems, 19 had no confirmed infusion, 11 for other reasons) and 88 were infused but data were not available/analyzed (46 no access to data, 42 infused in inpatient settings). Missing patients not reported by study arms. Missingness could depend on the true value of the outcome. Not likely that missingness depended on the true value of the outcome. Risk assessed to be some concerns for the outcome: Mortality (D28). Hospitalization or death. |
| Measurement of the outcome |
Low |
Comment: Method of measuring the outcome probably appropriate.
Measurement or ascertainment of outcome probably does not differ between groups. Unblinded study (outcome assessor) MORTALITY Mortality is an observer-reported outcome not involving judgement. Risk assessed to be low for the outcome: Mortality (D28). HOSPITALIZATION OR DEATH For this outcome, we consider that the assessment cannot possibly be influenced by knowledge of intervention assignment. Risk assessed to be low for the outcomes: Hospitalization or death. |
| Selection of the reported results |
Low |
Comment: The protocol (2021-02-24), statistical analysis plan (2021-02-24) and registry (2021-03-10) were available
Outcomes pre-specified. 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). Hospitalization or death. |
| Overall risk of bias |
Some concerns |