PASSReviewer 1· 95% conf
The trial design is rigorous: computer-generated randomization with concealment, stratification by site, pre-specified inclusion/exclusion criteria, a priori power analysis, and a pre-specified analysis plan.
Evidence
direct quote[Methods, Enrolment and randomisation]
“The Medinsight database hosted by the clinical trial unit at Oslo University Hospital allowed for the computer generated random assignment of the eligible participants in a 1:1 ratio to undergo either decompression alone or decompression with instrumented fusion. The sequence was concealed from the investigators and stratified according to site using random block sizes of four and six participants.”direct quote[Methods, Statistical analysis]
“To reject H 0 , 116 participants were required in each group to be 80% certain (power) that the lower limit of a 95% confidence interval (CI) of the difference (decompression alone minus decompression with instrumented fusion) in the percentage of participants with a successful outcome on Oswestry disability index was above −15 percentage points.”direct quote[Methods, Enrolment and randomisation]
“Individual participants and their surgeons were not masked to the treatment assignment.”PASSReviewer 2· 95% conf
The trial design is rigorous with adequate randomization, blinding (open-label with rationale), power analysis, and pre-specified analysis populations.
Evidence
direct quote[Methods, Enrolment and randomisation]
“The Medinsight database hosted by the clinical trial unit at Oslo University Hospital allowed for the computer generated random assignment of the eligible participants in a 1:1 ratio to undergo either decompression alone or decompression with instrumented fusion. The sequence was concealed from the investigators and stratified according to site using random block sizes of four and six participants.”direct quote[Methods, Enrolment and randomisation]
“Individual participants and their surgeons were not masked to the treatment assignment.”direct quote[Methods, Statistical analysis]
“To reject H 0 , 116 participants were required in each group to be 80% certain (power) that the lower limit of a 95% confidence interval (CI) of the difference (decompression alone minus decompression with instrumented fusion) in the percentage of participants with a successful outcome on Oswestry disability index was above −15 percentage points. Considering a possible dropout of 10%, 128 participants were required in each group.”