PASSReviewer 1· 90% conf
The trial design is rigorous with clear randomization, blinding of the independent review committee, a pre-specified sample size calculation, and defined inclusion/exclusion criteria.
Evidence
direct quote[Methods, Randomisation and masking]
“A computer generated random number code was provided for randomisation of enrolled patients at the Sun Yat-sen University Cancer Center. Random distribution sequences were generated using a permuted block of flexible size (2, 4, 6, or 8), with no stratification factors.”direct quote[Methods, Randomisation and masking]
“The therapy assignment was not masked to investigators, patients, and other treating oncologists, but the central evaluation of the imaging data by an independent review committee was done in a masked manner.”direct quote[Methods, Statistical analysis]
“We calculated that we would need to randomise approximately 134 patients (67 patients per group), providing 80% power to detect the underlying hazard ratio of 0.42 for the primary analysis of progression-free at a two sided α level of 5% with one interim analysis.”PASSReviewer 2· 90% 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]
“A computer generated random number code was provided for randomisation of enrolled patients at the Sun Yat-sen University Cancer Center. Random distribution sequences were generated using a permuted block of flexible size (2, 4, 6, or 8), with no stratification factors.”direct quote[Methods, Randomisation and masking]
“The therapy assignment was not masked to investigators, patients, and other treating oncologists, but the central evaluation of the imaging data by an independent review committee was done in a masked manner.”direct quote[Methods, Statistical analysis]
“We calculated that we would need to randomise approximately 134 patients (67 patients per group), providing 80% power to detect the underlying hazard ratio of 0.42 for the primary analysis of progression-free at a two sided α level of 5% with one interim analysis.”