PASSReviewer 1· 90% conf
The study design is rigorous: it is a prespecified secondary analysis of a randomized, double-blind, placebo-controlled trial with clear inclusion/exclusion criteria and appropriate statistical methods.
Evidence
direct quote[Methods, Study design and patients]
“The current work reports a prespecified analysis of SELECT, a randomized, double-blind, placebo-controlled, event-driven CV outcome trial”paraphrase[Methods, Study design and patients]
“Eligible patients were aged ≥45 years with a BMI of ≥27 kg m−2 and established ASCVD... Exclusion criteria included prior MI or stroke, hospitalization for unstable angina pectoris or a transient ischemic attack, all within 60 days of screening; glycated hemoglobin ≥6.5%...”direct quote[Methods, Statistical analysis]
“Missing data at week 104 were imputed using a multiple imputation model, conducted separately for each treatment arm and including baseline value as a covariate”PASSReviewer 2· 90% conf
The parent trial was a randomized, double-blind, placebo-controlled trial with appropriate methods; this prespecified analysis uses the same rigorous design.
Evidence
direct quote[Methods, Study design and patients]
“The current work reports a prespecified analysis of SELECT, a randomized, double-blind, placebo-controlled, event-driven CV outcome trial”paraphrase[Methods, Study design and patients]
“Eligible patients were aged ≥45 years with a BMI of ≥27 kg m−2 and established ASCVD, defined as at least one of the following: prior MI, prior ischemic or hemorrhagic stroke, or symptomatic peripheral artery disease).”direct quote[Methods, Statistical analysis]
“Missing data at week 104 were imputed using a multiple imputation model, conducted separately for each treatment arm and including baseline value as a covariate”