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 |
Clemency 2021 |
Low risk of bias |
We judged this domain low as the randomisation process was adequate because it is done remotely and moreover consider concealment adequate. Slight baseline differences were most likely due to chance. |
Low risk of bias |
Deviations were balanced and most likely not due to the trial context in this double‐blinded trial. |
Low risk of bias |
Although there were around 5% of participants lost to follow‐up, it seems not probable that the outcome has been affected relevantly by those dropouts. |
Low risk of bias |
We judged low risk of bias, as the combination of structured contacts and eDiary provided a high probability that the outcome would be detected. |
High risk of bias |
We judged this domain high due to a subsequent addition of this outcome to the trial protocol month after having completed the trial. |
High risk of bias |
Overall, we judged high risk of bias due to subsequent addition of this outcome (probably during the analysis process). |
Yu 2021 |
Low risk of bias |
Participants were randomised via web‐based Sortition and the allocation sequence was intimated to GP and patient via email/letter. There are no baseline differences that would suggest a problem with randomisation |
Low risk of bias |
We judged risk of bias low because there were no reported deviations from intended interventions. |
Low risk of bias |
We judged this domain low because it is not likely that missingness in the outcome depended on its true value. There were about 5% of the participants without a diary entry. |
High risk of bias |
We judged this domain high because it is likely that the knowledge of the intervention has influenced the subjective self‐assessment of this outcome. Missing placebo control could introduce relevant confounding to subjective self‐assessment of this endpoint. |
Low risk of bias |
The data were in accordance with the protocol, so that we assessed domain 5 low. |
High risk of bias |
Overall judged high risk of bias due to measurement of the outcome. This introduces potential high risk of bias towards the experimental. |