PASSReviewer 1· 98% conf
The study design is rigorous with adequate randomisation, blinding, power analysis, and 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, 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.”paraphrase[Methods, Participants]
“People with stroke were screened and invited to participate if they were ≥50 years old, within five years of a first stroke, community dwelling after being discharged from formal rehabilitation, able to walk 10 m across flat ground with or without an aid, and capable of providing consent... We excluded people who had moderate-to-severe receptive aphasia... or if they could walk >1.4 m/s and had not fallen in the previous year.”PASSReviewer 2· 95% conf
The study design is rigorous: randomisation, allocation concealment, masking of outcome assessors and statistician, a priori power analysis, clear inclusion/exclusion criteria, and intention-to-treat analysis are all reported and adequate.
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.”paraphrase[Methods, Randomisation and masking]
“Researchers masked to group allocation measured outcomes at baseline, at six months... and at 12 months... A statistician masked to group allocation did the statistical analysis.”direct quote[Methods, Statistical analysis]
“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.”