Table 1 Outcome measure and collection time point
Assessment | Time point (months post randomisation) | ||
|---|---|---|---|
Baseline | 6 | 12 | |
Eligibility and consent | |||
Eligibility | X | ||
Consent | X | ||
Background and follow-up | |||
Personal details, general health | X | ||
Body Mass Index | X | X | X |
Mental health details | |||
Mental health history | X | ||
Current mental health status | X | X | X |
Current medications | X | X | X |
Referrals to mental health services | X | X | |
Admissions to hospital related to mental health | X | X | |
Smoking details | |||
Smoking history | X | ||
Current smoking status | X | X | X |
Use of electronic cigarettes | X | X | X |
Use of smoking-cessation services | X | X | X |
CO measurement | X | X | X |
Adverse event reporting | Ongoing collection | ||
Questionnaires | |||
Fagerström Test for Nicotine Dependence (FTND) [17] | X | X | X |
Motivation to Quit questionnaire (MTQ) | X | X | X |
Patient Health Questionnaire (PHQ-9) | X | X | X |
Generalised Anxiety Disorder Assessment (GAD-7) | X | X | X |
Health-related quality of life (SF-12) | X | X | X |
Health-state utility (EuroQol – EQ-5D-5L) | X | X | X |
Health Economics/Service Utilisation Questionnaire | X | X | X |