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 |
BLAZE‐1 (phase 2, 0.7g) |
Low risk of bias |
Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation. |
Low risk of bias |
Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate. |
Low risk of bias |
Data for this outcome was available for 257 out of 265 participants randomised. |
Low risk of bias |
The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received. |
Low risk of bias |
The data that produced this result was analysed in accordance with the pre‐specified analysis plan and the outcome was reported as planned in the protocol. |
Low risk of bias |
For this outcome, there is a low risk of bias for all the domains. |
BLAZE‐1 (phase 2, 2.8g) |
Low risk of bias |
Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation. |
Low risk of bias |
Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate. |
Low risk of bias |
Data for this outcome was available for 263 out of 270 participants randomised. |
Low risk of bias |
The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received. |
Low risk of bias |
The data that produced this result was analysed in accordance with the pre‐specified analysis plan and the outcome was reported as planned in the protocol. |
Low risk of bias |
For this outcome, there is a low risk of bias for all the domains. |
BLAZE‐1 (phase 2, 7.0g) |
Low risk of bias |
Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation. |
Low risk of bias |
Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate. |
Low risk of bias |
Data for this outcome was available for 257 out of 265 participants randomised. |
Low risk of bias |
The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received. |
Low risk of bias |
The data that produced this result was analysed in accordance with the pre‐specified analysis plan and the outcome was reported as planned in the protocol. |
Low risk of bias |
For this outcome, there is a low risk of bias for all the domains. |