PASSReviewer 1· 90% conf
The trial design is rigorous: adequate randomisation method and unit, explicit open-label rationale with a blinded data-interpretation scheme, a detailed a priori power calculation, clearly pre-specified inclusion/exclusion criteria, and defined analysis populations (ITT, per-protocol, as-treated).
Evidence
direct quote[Methods, Randomisation]
“A statistician with no clinical involvement in the trial prepared sequentially numbered, opaque, sealed envelopes with random permuted blocks (block size known only by the statistician) and no stratifications using a computerised random number generator.”direct quote[Methods, Blinding]
“Blinding of participants and outcome assessors was not possible owing to the nature of the interventions. However, we interpreted the results of the trial according to a blinded data interpretation scheme”direct quote[Methods, Statistical analysis]
“Assuming α=0.05, power 80% (1−β=0.8), and accounting for a 20% dropout rate, the required sample size was calculated to be 63 participants in each group (total n=126).”PASSReviewer 2· 95% conf
The study design is rigorous, with adequate randomization, blinding of data interpretation, a priori power analysis, clear eligibility criteria, and handling of missing data and outliers.
Evidence
direct quote[Methods, Randomisation]
“A statistician with no clinical involvement in the trial prepared sequentially numbered, opaque, sealed envelopes with random permuted blocks (block size known only by the statistician) and no stratifications using a computerised random number generator.”paraphrase[Methods, Blinding]
“Blinding of participants and outcome assessors was not possible owing to the nature of the interventions. However, we interpreted the results of the trial according to a blinded data interpretation scheme...”direct quote[Methods, Statistical analysis]
“Assuming α=0.05, power 80% (1−β=0.8), and accounting for a 20% dropout rate, the required sample size was calculated to be 63 participants in each group (total n=126).”PASSReviewer 3· 95% conf
Randomisation, allocation concealment, power calculation, eligibility criteria, and analysis populations are clearly described; blinding is unfeasible but handled via a blinded data-interpretation scheme.
Evidence
direct quote[Methods, Randomisation]
“A statistician with no clinical involvement in the trial prepared sequentially numbered, opaque, sealed envelopes with random permuted blocks (block size known only by the statistician) and no stratifications using a computerised random number generator.”direct quote[Methods, Statistical analysis]
“Assuming α=0.05, power 80% (1−β=0.8), and accounting for a 20% dropout rate, the required sample size was calculated to be 63 participants in each group (total n=126).”direct quote[Methods, Blinding]
“Blinding of participants and outcome assessors was not possible owing to the nature of the interventions. However, we interpreted the results of the trial according to a blinded data interpretation scheme”