PASSReviewer 1· 95% conf
The trial is rigorously designed with adequate randomization, blinding, sample size calculation, and pre-specified inclusion/exclusion criteria.
Evidence
direct quote[Methods, Randomisation and masking]
“An independent biostatistician generated random treatment assignments in a 1:1 ratio, stratified by trial site, with a block size of four using the PROC PLAN procedure of SAS 9.2 software (SAS Institute, Cary, NC).”direct quote[Methods, Randomisation and masking]
“All participants, healthcare team members, and outcome assessors were therefore fully blinded to treatment.”direct quote[Methods, Statistical analysis, Sample size estimation]
“With a two sided significance level set at 0.05 and power at 80%, we determined that 328 participants would be required to detect such a difference.”PASSReviewer 2· 95% conf
The trial design is rigorous: randomization method, allocation concealment, blinding, sample size calculation, and pre-specified inclusion/exclusion criteria are all adequately reported.
Evidence
direct quote[Methods, Randomisation and masking]
“An independent biostatistician generated random treatment assignments in a 1:1 ratio, stratified by trial site, with a block size of four using the PROC PLAN procedure of SAS 9.2 software (SAS Institute, Cary, NC). Allocations were sealed in sequentially numbered opaque envelopes controlled by investigators who were otherwise not involved in data acquisition or the participants’ care.”direct quote[Methods, Randomisation and masking]
“All participants, healthcare team members, and outcome assessors were therefore fully blinded to treatment.”direct quote[Methods, Statistical analysis, Sample size estimation]
“With a two sided significance level set at 0.05 and power at 80%, we determined that 328 participants would be required to detect such a difference. We expected a dropout rate of about 10% and thus planned to enrol a total of 364 participants.”