PASSReviewer 1· 85% conf
The trial design is rigorous with clear randomization, blinding, power analysis, and pre-specified inclusion/exclusion criteria.
Evidence
direct quote[Methods, Randomization and masking]
“Random allocation was performed, through a web portal requiring a login and password with access rights allocated to relevant Clinical Trials Unit staff, using a mixed minimization/randomization method, stratified within the study site using an a priori schedule for each site in blocks of 10.”direct quote[Methods, Randomization and masking]
“Masking was assured for two secondary outcome measures, TTPLS and PIRGAS, because data were collected (TTPLS) and rated (PIRGAS) by individuals with no contact with participants or other trial procedures.”paraphrase[Methods, Statistical analyses]
“Initially, the target sample size was 462 to achieve 90% power to detect an effect size of 0.35 s.d. on SDQ-TD with a loss to follow-up at 2.5 years of 25%.”PASSReviewer 2· 90% conf
The trial design is rigorous: cluster-randomized, single-blind, with a pre-specified statistical analysis plan, power calculation, and clear inclusion/exclusion criteria. Blinding and randomization methods are described.
Evidence
direct quote[Methods, Randomization and masking]
“Random allocation was performed, through a web portal requiring a login and password with access rights allocated to relevant Clinical Trials Unit staff, using a mixed minimization/randomization method, stratified within the study site using an a priori schedule for each site in blocks of 10.”direct quote[Methods, Randomization and masking]
“Masking was assured for two secondary outcome measures, TTPLS and PIRGAS, because data were collected (TTPLS) and rated (PIRGAS) by individuals with no contact with participants or other trial procedures. Participants were aware of the intervention to which they had been allocated; data collectors, researchers and statisticians were not.”paraphrase[Methods, Statistical analyses]
“Initially, the target sample size was 462 to achieve 90% power to detect an effect size of 0.35 s.d. on SDQ-TD with a loss to follow-up at 2.5 years of 25%.”