PASSReviewer 1· 95% conf
The trial design is rigorous with adequate randomization, blinding, power analysis, and pre-specified analysis populations.
Evidence
direct quote[Methods, Trial Design, Randomization, and Treatment]
“Participants were randomized 2:1: to pomalidomide 4 mg daily or matching placebo using permuted blocks with random sizes of 3 and 6, stratified by site and implemented within the electronic data management system.”direct quote[Methods, Trial Design, Randomization, and Treatment]
“Participants and study staff were blinded to treatment assignment except for one statistician (BAC) who provided emergency unblinding and interim analyses.”direct quote[Methods, Statistical Analysis]
“We planned to randomize 159 participants to obtain 90% power to identify a treatment difference in Epistaxis Severity Score change from baseline at 24 weeks of 1.0, assuming a standard deviation of 1.7 and discontinuation rate of 10%.”PASSReviewer 2· 95% conf
The trial design is rigorous: randomized, double-blind, placebo-controlled, with adequate power, pre-specified analysis populations, and appropriate statistical methods.
Evidence
direct quote[Methods, Trial Design, Randomization, and Treatment]
“Participants were randomized 2:1: to pomalidomide 4 mg daily or matching placebo using permuted blocks with random sizes of 3 and 6, stratified by site and implemented within the electronic data management system. Participants and study staff were blinded to treatment assignment except for one statistician (BAC) who provided emergency unblinding and interim analyses.”direct quote[Methods, Statistical Analysis]
“We planned to randomize 159 participants to obtain 90% power to identify a treatment difference in Epistaxis Severity Score change from baseline at 24 weeks of 1.0, assuming a standard deviation of 1.7 and discontinuation rate of 10%.”direct quote[Methods, Statistical Analysis]
“Efficacy outcomes were analyzed for all randomized and treated participants with post-baseline data (modified intent-to-treat mITT population). A supportive pre-specified per-protocol analysis excluded early discontinuations and participants with treatment compliance less than 80%.”