PASSReviewer 1· 95% conf
The trial is rigorously designed with adequate randomization, allocation concealment, masking attempts, sample size calculation, and pre-specified analysis populations.
Evidence
direct quote[Methods, Randomisation and masking]
“we randomised participants in a 1:1 ratio based on permuted random blocks of variable sizes (2-6 in each block) generated before enrolment.”paraphrase[Methods, Randomisation and masking]
“Masking was maintained until the trial database was locked and all analyses ... had been done and interpreted.”direct quote[Methods, Sample size]
“180 participants providing 80.2% power to detect an 8 point mean difference in AUSCAN function scores.”PASSReviewer 2· 95% conf
The trial design is rigorous: randomization method, allocation concealment, masking attempts, sample size calculation, and pre-specified analysis populations are all described.
Evidence
direct quote[Methods, Randomisation and masking]
“we randomised participants in a 1:1 ratio based on permuted random blocks of variable sizes (2-6 in each block) generated before enrolment.”direct quote[Methods, Randomisation and masking]
“The mittens were coded A or B to conceal the allocation from participants, clinical and non-clinical staff, and outcome assessors.”direct quote[Methods, Sample size]
“180 participants providing 80.2% power to detect an 8 point mean difference in AUSCAN function scores.”