PASSReviewer 1· 95% conf
The trial design is rigorous with adequate randomization, blinding of outcome assessors, sample size calculation, and pre-specified inclusion/exclusion criteria.
Evidence
direct quote[Methods, Randomisation and masking]
“Randomisation was conducted using an online random generator ( https://www.sealedenvelope.com/ ) with block sizes of four to six. The computer generated randomised allocation sequence was securely placed in sealed opaque envelopes and kept by an independent researcher who did not interact with the participants during recruitment or during the interventions.”direct quote[Methods, Sample size]
“The sample size estimation was based on a primary comparison of perceived insomnia severity measured by ISI between the two groups using a 95% power and 0.05/2=0.025 maximum chance of committing false type I errors to account for multiplicity.”direct quote[Methods, Randomisation and masking]
“Outcome assessors were blinded to the group allocation and participants were instructed not to disclose their group allocation to the outcome assessors during the outcome assessments.”PASSReviewer 2· 95% conf
The trial design is rigorous: randomised, assessor-blinded, with pre-specified sample size, inclusion/exclusion criteria, and per-protocol and ITT analyses.
Evidence
direct quote[Methods, Randomisation and masking]
“Randomisation was conducted using an online random generator ( https://www.sealedenvelope.com/ ) with block sizes of four to six. The computer generated randomised allocation sequence was securely placed in sealed opaque envelopes and kept by an independent researcher who did not interact with the participants during recruitment or during the interventions.”direct quote[Methods, Statistical analysis, Sample size]
“The sample size estimation was based on a primary comparison of perceived insomnia severity measured by ISI between the two groups using a 95% power and 0.05/2=0.025 maximum chance of committing false type I errors to account for multiplicity.”direct quote[Methods, Randomisation and masking]
“Outcome assessors were blinded to the group allocation and participants were instructed not to disclose their group allocation to the outcome assessors during the outcome assessments.”