SWAT study design
PAD
PAD, RECRUITMENT
The purpose of the SWAT was to determine the effect of same-day vs delayed consent on recruitment, retention/attrition, and adherence of the participants in the host trial. The study was designed as a prospective cohort study. We followed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement guidelines for reporting on observational studies [After explaining the host trial and SWAT study to the invited patients with PAD, the patients who agreed to participate in the trial were given the option to sign the informed consent form on the same day or to delay signing their consent prior to alter date. Following the consent, the participants were assigned one of two groups (same-day consent vs. delayed consent) based on the participant’s choice of signing the consent form. After the participants consented to join the host trial, they were then randomized to either the control arm or the intervention arm of the host trial. This randomization within the host trial was independent on the fact that the participants had given a same-day or a delayed consent.