PASSReviewer 1· 95% conf
The trial design is rigorous with adequate randomization, blinding of outcome assessment, sample size calculation, and pre-specified inclusion/exclusion criteria.
Evidence
direct quote[Methods, Randomisation and masking]
“participants were randomly allocated (1:1.03) to the REGAIN intervention or to usual care by a centralised computer generated randomisation sequence using a bespoke web based system, administered independently by Warwick Clinical Trials Unit.”direct quote[Methods, Randomisation and masking]
“Follow-up outcome assessments were completed by participants online, or, in a small number of cases, over the telephone by a member of the trial team, blind to treatment allocation.”direct quote[Methods, Sample size]
“Assuming an intracluster coefficient of 0.01, 90% power, and type I error rate of 5%, with a 10% loss to follow-up, we determined that 535 participants would be required.”PASSReviewer 2· 95% conf
The trial design is rigorous with adequate randomization, blinding of outcome assessment, sample size calculation, and pre-specified inclusion/exclusion criteria.
Evidence
direct quote[Methods, Randomisation and masking]
“participants were randomly allocated (1:1.03) to the REGAIN intervention or to usual care by a centralised computer generated randomisation sequence using a bespoke web based system, administered independently by Warwick Clinical Trials Unit.”direct quote[Methods, Randomisation and masking]
“Follow-up outcome assessments were completed by participants online, or, in a small number of cases, over the telephone by a member of the trial team, blind to treatment allocation.”direct quote[Methods, Sample size]
“Assuming an intracluster coefficient of 0.01, 90% power, and type I error rate of 5%, with a 10% loss to follow-up, we determined that 535 participants would be required.”