| Study |
Bias |
| Randomisation process |
Deviations from intended interventions |
Missing outcome data |
Measurement of the outcome |
Selection of the reported results |
Overall |
| Authors' judgement |
Support for judgement |
Authors' judgement |
Support for judgement |
Authors' judgement |
Support for judgement |
Authors' judgement |
Support for judgement |
Authors' judgement |
Support for judgement |
Authors' judgement |
Support for judgement |
| Chaccour 2021 |
Low risk of bias |
Randomization was performed by an independent trial statistician generating a list of random numbers. There was no baseline imbalance that would suggest a problem with randomisation. |
Low risk of bias |
Both participants and those delivering the intervention were not aware of the intervention received, there were no deviations from intended interventions and the analysis was appropriate. |
Low risk of bias |
Data for this outcome were available for all randomized participants. |
Low risk of bias |
Knowledge of intervention received could have affected outcome measurement. But outcome assessors were not aware of the intervention received. |
Low risk of bias |
The protocol was prospectively registered and the outcome drug‐related adverse events (7 days) in the journal publication was reported as registered. Any adverse events within 28 days was not registered but results were in full detail reported in the trial register. Due to relevance of this outcome data in this context of this trial we did not assume that the results have been selected. |
Low risk of bias |
Due to low risk of bias in all domains. |
| López‐Medina 2021 |
Low risk of bias |
Random sequence was generated by an independent pharmacist using a computer‐based program. Allocation assignment was concealed from investigators and patients. There was no baseline imbalance that would suggest a problem with randomisation. |
Some concerns |
Both participants and those delivering the intervention were not aware of intervention received. The primary analysis is a per‐protocol analysis. 76 (16%) participants receiving the wrong intervention due to a labelling error in the early study phase were excluded. The analysis was not appropriate, but an as‐treated sensitivity analysis was reported and results did not differ. |
Low risk of bias |
Data for this outcome were available for all participants included in the per protocol population. Reasons for missing outcome data are reported and are unrelated to the outcome (labelling error). |
Low risk of bias |
Knowledge of intervention received could have affected outcome measurement. But outcome assessors were not aware of the intervention received. |
Low risk of bias |
The protocol was prospectively registered and the outcome in the journal publication was reported as registered. |
Some concerns |
Due to inappropriate analysis (per protocol analysis). |
