Farley 2017.
Methods |
Country: United Kingdom Design: Randomised controlled trial Study objective: To investigate the feasibility of implementing a smoking reduction programme in community pharmacies, when compared to self‐help methods Method of analysis: Relative risks and risk differences, generalised linear mixed model. t‐test to compare continuous outcomes Clustering adjustments made: Not applicable |
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Participants |
Eligible for study: 70 Randomised: Intervention n = 36; Control n = 32 Age: Intervention 44; Control 44 Gender: Men n = 34; Women n = 34 Inclusion criteria: Smokers aged 18 and over who were not planning to quit within the next 4 weeks but wanted to reduce consumption Exclusion criteria: currently using pharmacological, behavioural or alternative therapies for smoking cessation, pregnancy, severe medical or psychiatric conditions |
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Interventions |
Setting: Community pharmacies across the United Kingdom 2 x 2 factorial trial in which participants received either behavioural support or self‐help, and were encouraged to reduce their smoking either over 4 weeks or over 16 weeks. We consider only the support/self‐help comparison, and include both reduction times in each study arm Intervention description: Pharmacists provided behavioural support to promote smoking cessation; suggesting that learning a new pattern of smoking would prevent consumption increasing again by disrupting learnt associations between cues and smoking behaviour. They encouraged participants to use NRT and choose 1 of 3 methods of reduction Control description: In the control arm, the smoking reduction methods were exactly the same as above, but they were explained in a written booklet. We asked pharmacists to hand out the booklets without further advice or interaction Duration of intervention: 8 visits Pharmacotherapy: Participants in both study arms were prescribed NRT, and encouraged to take it for 9 months, regardless of intention to reduce or stop, or failure of either reduction or cessation. |
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Outcomes |
Prespecified outcomes: Biochemically confirmed prolonged abstinence measured at 6 months Follow‐up period: 6 months |
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Notes | Funding: "The trial was funded by the National Prevention Research Initiative of the UK, administered by the MRC. The funding partners are Alzheimer's Research UK, Alzheimer's Society, Biotechnology and Biological Sciences Research Council, British Heart Foundation, Cancer Research UK, Chief Scientist Office, Scottish Government Health Directorate, Department of Health, Diabetes UK, Economic and Social Research Council, Engineering and Physical Sciences Research Council, Health and Social Care Research Division, Public Health Agency, Northern Ireland, Medical Research Council, Stroke Association, Wellcome Trust, Welsh Government, and World Cancer Research Fund." Declarations of interest: "The authors declare that they have no competing interests." |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: “The research team generated the randomisation sequence using a computer algorithm at http://www.randomization.com” |
Allocation concealment (selection bias) | Unclear risk | Allocations given to pharmacists in numbered, sealed envelopes, but unclear if sequentially numbered and opaque |
Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: “The percentage of participants successfully contacted each month fell steadily in all trial arms, with 18, 24, 26 and 13% being followed up at 12 months in the behavioural/standard, self‐help/ standard, behavioural/short and self‐help/short groups respectively” Comment: Dropout differed across study arms |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | 6‐month abstinence biochemically verified |
Selective reporting (reporting bias) | Low risk | All outcomes planned in the protocol and Methods section reported on in the Results |
Other bias | High risk | Authors report that there was evidence that pharmacists did not follow randomisation protocols, as they strongly believed that their support was essential to participants in the control arm. Quote: “Participants randomised to the self‐help conditions should not have received behavioural support when returning to collect further NRT prescriptions. However, there was evidence that pharmacists were routinely recording reduction targets, setting new reduction targets, and less commonly recording reduction methods used in the self‐help participants, suggesting that they were in fact providing support” Quote: “There was evidence that pharmacists did not follow randomisation protocols… In both cases of duplicate enrolment, pharmacists opened a second envelope in order to offer behavioural support.” |