| Bias | Author's judgement | Support for judgement |
| Randomization |
Some concerns |
Quote:"Randomization process: Concerns about (i) the fixed block size within centres (which it might have been easy to deduce, despite the blinding) and (ii) the rather informal use of text messages to implement
allocations."
Comment: Allocation sequence random. Unclear allocation concealment |
| Deviations from intervention |
Some concerns |
Quote: "Open Label"
Comment: Unblinded study. No participant cross-over. Information on administration of co-interventions of interest : biologics were not reported. Data were analyzed using intention-to-treat analysis |
| Missing outcome data |
Low |
Comment: 47 patients randomized; 47 patients analyzed.
Risk assessed to be low for the outcomes: Mortality. |
| Measurement of the outcome |
Low |
Comment: Unblinded study.
Mortality is an observer-reported outcome not involving judgement. Risk assessed to be low for the outcomes: Mortality. |
| Selection of the reported results |
Low |
Comment: The protocol and statistical analysis plan were not available. 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 outcomes: Mortality. |
| Overall risk of bias |
Some concerns |