PASSReviewer 1· 95% conf
The trial design is rigorous with adequate randomization, blinding rationale, power analysis, and pre-specified analysis plan.
Evidence
direct quote[Methods, Randomization and Blinding]
“Participants were randomized 1:1 to receive collagenase injection or limited fasciectomy, using randomly varying block sizes (Sizes 4 and 6) and stratification by the reference joint (metacarpophalangeal or proximal interphalangeal joint).”direct quote[Methods, Randomization and Blinding]
“Clinicians and participants could not be blinded due to the nature of trial interventions.”direct quote[Methods, Sample Size]
“Using these parameters, a sample size of 568 participants (284 per arm) was required to obtain 90% power to test H 0 : δ ≥ 6 vs H 1 : δ < 6 with one sided p < 0.025.”PASSReviewer 2· 95% conf
The trial design is rigorous with clear randomization, blinding rationale, power analysis, and pre-specified analysis plan.
Evidence
direct quote[Methods, Randomization and Blinding]
“Participants were randomized 1:1 to receive collagenase injection or limited fasciectomy, using randomly varying block sizes (Sizes 4 and 6) and stratification by the reference joint (metacarpophalangeal or proximal interphalangeal joint).”direct quote[Methods, Randomization and Blinding]
“Clinicians and participants could not be blinded due to the nature of trial interventions.”direct quote[Methods, Sample Size]
“a sample size of 568 participants (284 per arm) was required to obtain 90% power to test H 0 : δ ≥ 6 vs H 1 : δ < 6 with one sided p < 0.025.”