PASSReviewer 1· 85% conf
The study design is a post hoc analysis of two randomized, double-blind, placebo-controlled trials; randomization, blinding, and inclusion/exclusion criteria are described, and the analysis methods are detailed.
Evidence
direct quote[Methods, Study participants]
“These were randomized, double-blind, placebo-controlled trials”direct quote[Methods, Study participants]
“Key exclusion criteria included an eGFR lower than <30 ml min −1 1.73 m − 2 in DAPA-HF and an eGFR <25 ml min −1 1.73 m −2 in DELIVER.”direct quote[Methods, Statistical analyses]
“The sample size requirements and statistical power of the hierarchical composite endpoint (main model) were compared using bootstrap resampling of the pooled dataset”PASSReviewer 2· 85% conf
The study design is rigorous, leveraging two randomized, double-blind, placebo-controlled trials with pre-specified outcomes and sensitivity analyses; the post hoc nature is acknowledged.
Evidence
direct quote[Methods, Study participants]
“These were randomized, double-blind, placebo-controlled trials, and the trial designs and primary results have been published elsewhere”direct quote[Methods, Study participants]
“Key exclusion criteria included an eGFR lower than <30 ml min −1 1.73 m − 2 in DAPA-HF and an eGFR <25 ml min −1 1.73 m −2 in DELIVER.”direct quote[Results, Power analysis]
“When using a hierarchical composite endpoint, sample size requirements are smaller than the time-to-first composite endpoint evaluated using the Cox proportional hazards model (Extended Data Fig. ).”