Methods
PERIPHERAL ARTERIAL DISEASE, RECRUITMENT
The protocol design for this study within a trial (SWAT) was previously published in Wiley Online Library and registered at the Northern Ireland Network for Trials Methodology Research SWAT Store (SWAT84; 1/SEP/2018). Ethical approval has been obtained from the Merlin Park Hospital, Clinical Research Ethics Committee (approval number: C.A. 1912) [A SWAT is a self-contained research study design that has been embedded into a larger host trial for the purpose of assessing or investigating alternative ways to carry out and improve evidence base concerning trial processes [This SWAT was a part of a study evaluating the effectiveness of an intensive lifestyle modification programme in patients with peripheral arterial disease, from here on referred to as ‘the host trial’. The host trial was a two-armed randomized controlled trial of a risk factor modification intervention programme versus standard healthcare in a tertiary vascular care centre.The SWAT itself was designed as a prospective cohort design, non-randomized, parallel study to evaluate the effect of same-day consent compared with delayed consent on recruitment and retention of host trial participants.