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Table 2 Research questions and associated trial outcome measures

From: Promoting smoking cessation in Bangladeshi and Pakistani male adults: design of a pilot cluster randomised controlled trial of trained community smoking cessation workers

Research question

Outcome measure

Data source

LSSS Dataset

1. What is the rate at which the population of Pakistani and Bangladeshi male smokers will set a quit day with the stop smoking services in the intervention and control areas.

Recruitment rate is defined as the number of relevant population setting a quit day with the services as a fraction of all those estimated to have attempted to stop.

LSSS routine database

2. What proportions of those setting a quit day in the intervention and control areas achieve prolonged abstinence from smoking at a) 4 weeks, b) 3 months and c) 6 months after the agreed quit day?

a) Number of quits (measured by self assessment questionnaire & CO monitoring)

Total number of smokers* accessing LSSS

b) & c) number of quits (measured by self assessment questionnaire & CO monitoring)

a) LSSS routine database

b) & c) LSSS data collected specifically for the trial

3. What is the likely degree of contamination of the intervention and control areas and the design effect that need to be considered when conducting sample size calculations for a definitive cluster randomised controlled trial?

The design effect from cluster randomisation will be calculated from the multilevel analysis. Contamination cannot be easily measured; however, we have external controls which will help indicate whether it is occurring.

 

4. What are the key components of the intervention as it develops and how do these components relate to the outcome measured by the rates of setting quit dates and abstinence among those setting quit dates?

Qualitative data

Focus groups with outreach workers

Observation of management meetings

Shadowing

Analysis of outreach worker diaries

End of project interviews with outreach workers

5. What proportion of Pakistani and Bangladeshi male smokers that book an appointment with the stop smoking service attend the initial appointment and set a quit day in the intervention and control areas?

To be estimated from a sample of service providers records

SSA records

LSSS Routine database

Extended Dataset

6. What smoking cessation treatments do Pakistani and Bangladeshi men use in the intervention areas, facilitated by outreach workers, and in the control areas, without such workers?

Numbers of clients choosing each available treatment option (e.g. NRT, Zyban etc)

LSSS Routine database Patient satisfaction questionnaire administered by LSSS 'Call to Quit' team

7. What are the experiences of the services of the relevant groups in each of the trial arms and how satisfied are they?

Patient satisfaction

Patient satisfaction questionnaire administered by LSSS 'Call 2 Quit' team

8. What proportions of those enrolled adhere to the interventions chosen?

Numbers using oral tobacco during quit attempt (self report)

Number of people adhering to each medication used in each arm of the trial (self report)

Attendance at clinic in each arm of the trial

Adherence rating week by week then averaged, collected by SSA on extended data monitoring form

9. What impact, if any, are these interventions likely to have on smokeless (oral) tobacco use in these smokers?

Numbers using oral tobacco during quit attempt (self report)

Frequency rating week by week, collected by SSA on extended data monitoring form

Frequency of use of oral tobacco during this quit attempt rating on Patient satisfaction questionnaire administered by LSSS 'Call to Quit' team

10. What are the costs, from a health service perspective, of delivering these interventions?

Estimated benefits of the intervention in terms of QALYs or LYGs.

Additional costs to NHS of

(i) Employment, training, management of outreach workers-

(ii) Extra resources used by LSSS – e.g. medication, behavioural support

(Calculated from estimates of extra time used)