PASSReviewer 1· 90% conf
The study design is rigorous with adequate randomization, blinding, power analysis, and inclusion/exclusion criteria.
Evidence
direct quote[Methods, Study design]
“A web based central randomisation system incorporated in the registration system was used for allocation ( https://ccsr.cvs-china.com/ ). The randomisation code with fixed block size was generated by SAS.”direct quote[Methods, Outcomes]
“CT angiography results and clinical outcomes were centrally adjudicated by research personnel who were unaware of the treatment assignments.”direct quote[Methods, Statistical analysis]
“Using a two sided significance level of 0.05 and aiming for 90% power, the initial calculation indicated that 2000 patients would be required to achieve sufficient statistical power.”PASSReviewer 2· 90% conf
The trial design is rigorous: randomised, stratified, with a pre-specified sample size, ITT/mITT analyses, and central adjudication.
Evidence
paraphrase[Methods, Study design]
“A web based central randomisation system incorporated in the registration system was used for allocation... The randomisation code with fixed block size was generated by SAS. Randomisation was stratified by investigation centre.”direct quote[Methods, Outcomes]
“CT angiography results and clinical outcomes were centrally adjudicated by research personnel who were unaware of the treatment assignments.”paraphrase[Methods, Statistical analysis]
“We calculated the original sample size for the study based on an assumed effect size of a 43% relative risk reduction for the primary endpoint (from 8.4% to 4.8%). Using a two sided significance level of 0.05 and aiming for 90% power, the initial calculation indicated that 2000 patients would be required.”