PASSReviewer 1· 95% conf
The trial design is rigorous with adequate randomization, blinding, power analysis, and pre-specified criteria.
Evidence
direct quote[Methods, Randomisation and masking]
“We used an offsite, independent, and automated service (Clinical Trials Centre, University of Sydney) to generate the sequence with stratification and block randomisation, to conceal the schedule from the recruiter, and to reveal allocation to the trial coordinators.”direct quote[Methods, Randomisation and masking]
“Researchers masked to group allocation measured outcomes at baseline, at six months (end of intervention), and at 12 months in the home. Masking participants and therapists to group allocation was not possible. A statistician masked to group allocation did the statistical analysis.”direct quote[Methods, Statistical analysis]
“Assuming a 15% loss to follow-up, with a two sided level of significance of 5% and power of 80%, we needed a sample size of 185 per group to detect a 30% lower rate of falls in the experimental group than in the control group.”PASSReviewer 2· 95% conf
The trial design is rigorous with clear randomization, masking, sample size calculation, and pre-specified inclusion/exclusion criteria.
Evidence
direct quote[Methods, Randomisation and masking]
“We used an offsite, independent, and automated service (Clinical Trials Centre, University of Sydney) to generate the sequence with stratification and block randomisation, to conceal the schedule from the recruiter, and to reveal allocation to the trial coordinators.”direct quote[Methods, Randomisation and masking]
“Researchers masked to group allocation measured outcomes at baseline, at six months (end of intervention), and at 12 months in the home. Masking participants and therapists to group allocation was not possible. A statistician masked to group allocation did the statistical analysis.”direct quote[Methods, Statistical analysis]
“Assuming a 15% loss to follow-up, with a two sided level of significance of 5% and power of 80%, we needed a sample size of 185 per group to detect a 30% lower rate of falls in the experimental group than in the control group.”