PASSReviewer 1· 95% conf
The trial design is rigorous: randomised, stratified, with a prespecified analysis plan, sample size calculation, and clear inclusion/exclusion criteria. Blinding of the statistician is described, and the open-label nature is acknowledged.
Evidence
direct quote[Methods, Randomisation and masking]
“We used a computerised web based randomisation service and random number generator, stratified by clinic site, predominant compartmental distribution of knee osteoarthritis (based on a combination of clinical assessment and radiographic presentation), and the presence of instability (buckling), with a 1:1 allocation with random permuted blocks of sizes 2, 4, and 6.”direct quote[Methods, Randomisation and masking]
“Although masking participants or physiotherapists to treatment allocation was not possible, the trial statistician was masked to treatment allocation.”direct quote[Methods, Sample size]
“The trial was powered to detect an effect size between groups of 0.35 (small-to-medium effect) in KOOS-5 at six months with two sided 5% significance and 90% power.”PASSReviewer 2· 95% conf
The trial design is rigorous with adequate randomization, blinding, sample size calculation, and pre-specified inclusion/exclusion criteria.
Evidence
direct quote[Methods, Randomisation and masking]
“We used a computerised web based randomisation service and random number generator, stratified by clinic site, predominant compartmental distribution of knee osteoarthritis (based on a combination of clinical assessment and radiographic presentation), and the presence of instability (buckling), with a 1:1 allocation with random permuted blocks of sizes 2, 4, and 6.”direct quote[Methods, Randomisation and masking]
“Although masking participants or physiotherapists to treatment allocation was not possible, the trial statistician was masked to treatment allocation.”direct quote[Methods, Sample size]
“The trial was powered to detect an effect size between groups of 0.35 (small-to-medium effect) in KOOS-5 at six months with two sided 5% significance and 90% power.”