Table 2

Data collection components on behavioural support implementation and cytisine trial

Cytisine (efficacy)BS (implementation)
Quantitative data collection from routine trial data
  • Patient characteristics (age, gender, employment, tobacco use and nicotine dependency) from screening forms

  • Patients’ reasons for non-participation in trial from screening forms

  • Patients’ reasons for non-participation in tobacco cessation counselling as recorded by health workers

  • Medication and behavioural support delivered

  • Reach of the intervention

Qualitative data collection using SSIs with patients and health workers*:
  • Behavioural support delivered

  • Behavioural support received

  • Contextual factors

  • Mechanisms of impact

  • Satisfaction with the programme

  • Recommendations

Linking fidelity data to quit ratesAudio recordings of BS sessions for intervention fidelity coded using a predefined coding fidelity index
Qualitative questions about cytisine and the trial as part of the interviews with patients and health workers*
Site selection:
  • Observation checklist on site access and site characteristics

  • Assessment of site selection criteria fulfilment based on reporting by local partners

Updates from research assistants on changes at sites
  • *Only at two case study sites per country.

  • BS, behavioural support; SSIs, semi-structured interviews.