PASSReviewer 1· 90% conf
For a human RCT, all applicable design elements are adequately reported: online randomisation with block sizes, individual-level allocation, assessor blinding with a stated open-label rationale, a pre-specified power calculation, detailed inclusion/exclusion criteria, and defined analysis populations/missing-data handling.
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.”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.”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.”PASSReviewer 2· 90% conf
The trial design is rigorous for a human RCT: randomisation method and unit stated, assessor blinding described, a priori power analysis performed, and detailed inclusion/exclusion criteria and missing-data strategy provided.
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.”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.”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.”