PASSReviewer 1· 85% conf
The trial design is rigorous with adequate randomization, blinding, sample size calculation, and pre-specified analysis population.
Evidence
direct quote[Methods, Sample size, randomisation, and blinding]
“Randomisation was done centrally at the main study centre by using permuted block randomisation (block size of six), implemented through a web based randomisation system”direct quote[Methods, Sample size, randomisation, and blinding]
“Ethics committee and institutional review board restrictions meant that a sham procedure was not permitted and patients could not be blinded to allocation. However, all researchers, clinicians, and staff members responsible for follow-up care, outcome adjudication, and data analysis remained blinded.”direct quote[Methods, Sample size, randomisation, and blinding]
“We initially calculated the sample size to include approximately 118 patients in the intervention arm and 220 patients in the control arm to detect a difference in heart failure incidence rate, assuming rates of 3.9% in the intervention group and 12% in the control group on the basis of the results from the BAMI trial.”PASSReviewer 2· 85% conf
The trial design is rigorous with adequate randomization, blinding, sample size calculation, and pre-specified inclusion/exclusion criteria.
Evidence
direct quote[Methods, Sample size, randomisation, and blinding]
“Randomisation was done centrally at the main study centre by using permuted block randomisation (block size of six), implemented through a web based randomisation system”direct quote[Methods, Sample size, randomisation, and blinding]
“Ethics committee and institutional review board restrictions meant that a sham procedure was not permitted and patients could not be blinded to allocation.”direct quote[Methods, Sample size, randomisation, and blinding]
“We initially calculated the sample size to include approximately 118 patients in the intervention arm and 220 patients in the control arm to detect a difference in heart failure incidence rate, assuming rates of 3.9% in the intervention group and 12% in the control group”