PASSReviewer 1· 90% conf
Core design elements for a human RCT are well specified: computer-generated stratified randomisation, a priori power calculation, explicit eligibility criteria, and a justified open-label design.
Evidence
direct quote[Methods, Sample size, randomisation, and masking]
“The newborn babies were randomised using a specially written computer program that checked eligibility, allocated treatment, and recorded baseline and outcome data. Randomisation was 1:1 and stratified by NICU, sex, and birth weight (<1000 g, 1000-1499 g, 1500-1999 g), and with a block size that varied randomly from 2-8 newborn babies.”direct quote[Methods, Sample size, randomisation, and masking]
“1998 infants would be required in each group to have 95% power to detect a 30% reduction in mortality using BCG and OPV with an α <0.01”direct quote[Methods, Sample size, randomisation, and masking]
“The BCG vaccine causes an obvious skin lesion, so it was not possible to mask staff to group assignment because it would have been unethical to cover the upper arm of these high risk babies for their entire stay in intensive care”PASSReviewer 2· 90% conf
A well-designed randomised trial with a stated computer-based randomisation method, stratified blocking, a priori sample-size calculation, pre-specified eligibility criteria, and a clear handling of protocol violations and missing data.
Evidence
direct quote[Methods, Sample size, randomisation, and masking]
“The newborn babies were randomised using a specially written computer program that checked eligibility, allocated treatment, and recorded baseline and outcome data. Randomisation was 1:1 and stratified by NICU, sex, and birth weight (<1000 g, 1000-1499 g, 1500-1999 g), and with a block size that varied randomly from 2-8 newborn babies.”direct quote[Methods, Sample size, randomisation, and masking]
“with a mortality rate of 15% in the control group, 1998 infants would be required in each group to have 95% power to detect a 30% reduction in mortality using BCG and OPV with an α <0.01”direct quote[Methods (masking) and Results]
“The BCG vaccine causes an obvious skin lesion, so it was not possible to mask staff to group assignment because it would have been unethical to cover the upper arm of these high risk babies for their entire stay in intensive care”