PASSReviewer 1· 95% conf
The study design is rigorous with adequate randomization, blinding, power analysis, and inclusion/exclusion criteria. Applicable sub-criteria are well-reported.
Evidence
paraphrase[Methods, Randomization and masking]
“Block randomization was performed with randomly selected block sizes of 4, 6 or 8 by a researcher uninvolved with participants using the Sealed Envelope Ltd online tool.”direct quote[Methods, Randomization and masking]
“Participants, investigators and other research personnel were blinded to allocation.”paraphrase[Methods, Statistical analysis]
“Assuming an s.d. of 10% in the difference... 23 participants would provide 80% power to detect this difference at a 5% significance level. To account for a 20% dropout rate, 28 participants were recruited.”PASSReviewer 2· 95% conf
The trial design is rigorous: randomized, double-blind, crossover, with block randomization, a priori power analysis, and pre-specified inclusion/exclusion criteria.
Evidence
paraphrase[Methods, Randomization and masking]
“Block randomization was performed with randomly selected block sizes of 4, 6 or 8 by a researcher uninvolved with participants using the Sealed Envelope Ltd online tool.”direct quote[Methods, Randomization and masking]
“Participants, investigators and other research personnel were blinded to allocation.”paraphrase[Methods, Statistical analysis]
“Assuming an s.d. of 10% in the difference, 23 participants would provide 80% power to detect this difference at a 5% significance level.”