PASSReviewer 1· 95% conf
The trial design is rigorous with clear randomisation, allocation concealment, pre-specified analysis, and appropriate handling of blinding limitations.
Evidence
direct quote[Methods, Randomisation]
“Allocation concealment was maintained by an independent randomisation team at Warwick Clinical Trials Unit who were responsible for generation of the sequence and had no role in participant recruitment.”direct quote[Methods, Statistical analysis]
“As such, 478 participants were required to show a 4 point target difference (ie, a small, standardised mean difference of 0.3) at the 5% significance level, with 90% power, allowing a margin of 20% loss during follow-up.”direct quote[Methods, Randomisation]
“Following randomisation, masking participants or treating clinicians to treatment allocation was not possible. However, the treating clinician and the participant were masked to treatment allocation during the initial advice session.”PASSReviewer 2· 95% conf
The trial design is rigorous with clear randomisation, allocation concealment, pre-specified analysis, and a power calculation.
Evidence
direct quote[Methods, Randomisation]
“Allocation concealment was maintained by an independent randomisation team at Warwick Clinical Trials Unit who were responsible for generation of the sequence and had no role in participant recruitment.”direct quote[Methods, Randomisation]
“Following randomisation, masking participants or treating clinicians to treatment allocation was not possible.”direct quote[Methods, Statistical analysis]
“As such, 478 participants were required to show a 4 point target difference (ie, a small, standardised mean difference of 0.3) at the 5% significance level, with 90% power, allowing a margin of 20% loss during follow-up.”