PASSReviewer 1· 95% conf
The trial design is rigorous with clear randomization, pre-specified eligibility criteria, and a priori power calculations; blinding was not possible but is acknowledged.
Evidence
direct quote[Methods, Randomization and masking]
“a randomized block method was used to assign 201,000 individuals born 1954–1956 without prior CRC diagnosis to once-only primary colonoscopy, two rounds of FIT 2 years apart (FIT×2) or a usual care control arm”direct quote[Methods, Randomization and masking]
“Masking was not possible due to the nature of the trial.”direct quote[Methods, Power calculations]
“A priori, the study was powered to detect a 17.5% decrease in CRC mortality at 15 years in individuals invited to colonoscopy compared to the control arm and a 15% decrease in individuals invited to FIT compared to the control arm”PASSReviewer 2· 95% conf
The trial design is rigorous with clear randomization, pre-specified eligibility, and power calculations, though blinding was not possible.
Evidence
direct quote[Methods, Randomization and masking]
“a randomized block method was used to assign 201,000 individuals born 1954–1956 without prior CRC diagnosis to once-only primary colonoscopy, two rounds of FIT 2 years apart (FIT×2) or a usual care control arm”direct quote[Methods, Randomization and masking]
“Masking was not possible due to the nature of the trial.”direct quote[Methods, Power calculations]
“A priori, the study was powered to detect a 17.5% decrease in CRC mortality at 15 years in individuals invited to colonoscopy compared to the control arm and a 15% decrease in individuals invited to FIT compared to the control arm”