| 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 |
| Bounfrate 2021 |
Low risk of bias |
Centralized web‐based randomization. There are no baseline differences that would suggest a problem with randomization. |
Low risk of bias |
Both participants and those delivering the intervention were not aware of the intervention received and the analysis was appropriate. |
Low risk of bias |
Data for this outcome were reported for all participants that were randomized and did not withdraw consent before the study start. |
Some concerns |
Outcome assessors were not aware of the intervention received. There was insufficient information on definition and measurement of the outcome. |
Some concerns |
The protocol was prospectively registered. The outcome any serious adverse events was not registered. Prespecification in the protocol could not be judged since the protocol itself was not published. |
Some concerns |
Due to insufficient information on outcome definition and measurement of the outcome as well as lack of prospectively registering the outcome. |
| 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 randomization. |
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. |
Some concerns |
Outcome assessors were not aware of the intervention received. There was insufficient information on definition and measurement of the outcome. |
Some concerns |
The protocol was prospectively registered. The outcome was not prespecified. |
Some concerns |
Due to lack of information on definition and measurement of the outcome. Due to lack of prospectively registering the outcome. |
| I‐TECH 2022 |
Low risk of bias |
Centralized web‐based randomization. There are no baseline differences that would suggest a problem with randomization. |
Low risk of bias |
Both participants and those delivering the intervention were aware of intervention received. The majority of the patients adhered to the assigned intervention. The analysis was appropriate (mITT). |
Low risk of bias |
Data for this outcome were reported for all participants that meet inclusion and exclusion criteria (miTT population). |
Some concerns |
Outcome assessors were aware of the intervention received. There was sufficient and clear information on definition and measurement of the outcome. Judgement of severity of symptoms could have been influenced by knowledge of the intervention, assuming a protocol was followed and regarding the results it seems not likely. |
Low risk of bias |
The protocol was prospectively registered and the outcome was not specifically registered, but only reported upon request. Therefore no bias was introduced. |
Some concerns |
Due to some risk of bias in measurement of the outcome caused by lack of blinding the outcome assessors. |
| López‐Medina 2021 |
Low risk of bias |
Random sequence was generated by an independent pharmacist using a computer‐based programme. Allocation assignment was concealed from investigators and patients. There was no baseline imbalance that would suggest a problem with randomization. |
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. The outcome of the journal publication was not registered. Due to relevance of this outcome data in this context of this trial we did not assume that the results have been selected. |
Some concerns |
Due to inappropriate analysis (per protocol analysis). |
| Vallejos 2021 |
Low risk of bias |
Randomization was performed by an team member who was not part of any other part of the study using a computer‐based programme. There was no baseline imbalance that would suggest a problem with randomization. |
Low risk of bias |
Both participants and those delivering the intervention were not aware of the intervention received 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 in the journal publication was reported as registered. |
Low risk of bias |
Due to low risk of bias in all domains. |
