PASSReviewer 1· 85% conf
The trial design is rigorous with adequate randomization, blinding of outcome assessors, sample size estimation, and pre-specified inclusion/exclusion criteria.
Evidence
direct quote[Methods, Randomization and masking]
“Before the study was launched, a randomization list was generated by the IARC data manager using the random function in Excel to allocate a treatment to each participant’s ID.”paraphrase[Methods, Study design]
“The prospective, randomized, three-arm, partially blind, noninferiority trial... was launched in August 2017”paraphrase[Methods, Sample size estimation]
“We used the following assumptions: the treatment success rate in the cryotherapy (comparator) arm to be 55%... a noninferiority margin of 4%; an annual follow-up default rate of 30%; an 80% power; and a 2.5% significance level.”PASSReviewer 2· 90% conf
The trial design is rigorous with adequate randomization, blinding of outcome assessors, sample size estimation, and prespecified inclusion/exclusion criteria.
Evidence
direct quote[Methods, Randomization and masking]
“a randomization list was generated by the IARC data manager using the random function in Excel to allocate a treatment to each participant’s ID.”direct quote[Main, paragraph 3]
“We initiated a prospective, randomized, outcome assessor-blind, noninferiority trial”direct quote[Methods, Sample size estimation]
“We estimated that a total sample size of 3,123 women who were VIA screen-positive would be required”