A novel population data-driven approach to quantifying feasibility of recruitment during the study planning stage: lessons learnt from an e-cigarette pilot study

Long-term effects of e-cigarette use remain insufficiently characterised to inform regulatory decisions.1 To contribute to this evidence gap, we conducted a pilot e-cigarette study nested within the Miami Heart study, a prospective cohort of English-speaking adults, aged 40–65 and free of known cardiovascular disease. A total of 2459 participants were enrolled in the parent cohort between 2015 and 2018.2 Using this cohort infrastructure, we aimed to recruit 30 sole e-cigarette users using diverse strategies including vape shops, employer networks, existing cohort members and digital outreach.

However, the pilot revealed significant feasibility challenges. Despite exhaustive efforts, recruitment remained extremely low. Out of 14 contacted vape shops, only 4 agreed to participate and only 3 participants were successfully enrolled using this channel. Many potential participants were dual users or did not meet the age or language eligibility criteria. We present a simple population data-driven probability tool as a worked…

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