Maguire 2001.
Methods |
Country: United Kingdom Design: Randomised controlled trial Study objective: To evaluate whether a structured community pharmacy‐based smoking cessation programme (the PAS model) would produce a higher smoking cessation rate compared with ad hoc advice from pharmacists Method of analysis: Clustering of data from tape recordings were analysed through the Gestault method to focus on similar key themes and concepts and to examine how they were related to variables within the same population Clustering adjustments made: Not applicable |
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Participants |
Eligible for study: Smokers n = 484 (Pharmacies n = 51) Randomised: Intervention n = 265; Control n = 219 Completed: Intervention n = 38 (14.3%); Control n = 6 (2.7%) Age: Intervention 42; Control 38 Gender: Men n = 281; Women n = 203 Inclusion criteria: Smokers expressing a wish to stop smoking, > 18 years, not pregnant, no minimum cigarettes/day |
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Interventions |
Setting: One‐to‐one counselling interventions were carried out in community pharmacies in Northern Ireland and in London, England 3‐hour training workshop for pharmacists plus 1 support visit to each pharmacist. The workshop covered epidemiology, smoking statistics, NRT use, cycle of change model and Pharmacists' Action on Smoking (PAS) model Intervention description: The PAS intervention involved a structured counselling programme, information leaflet and record keeping. They were required to attend a weekly follow‐up for the first 4 weeks then monthly for 3 months as needed. NRT was offered if appropriate Control description: Unstructured brief advice. The normal pharmaceutical service was provided by the pharmacist (including an offer of NRT if appropriate). Participants were not counselled using the PAS resources, were not given the PAS information leaflet and were not asked to attend follow‐up interviews. Demographic details were collected from this group Duration of intervention: Pharmacy follow‐up advice weekly for 4 weeks, then monthly for 3 months |
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Outcomes |
Prespecified outcomes: Smoking status or self‐reported continuous abstinence at 3, 6 and 12 months and positive and negative aspects of experiences during smoking cessation study Follow‐up period: 12 months |
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Notes | Pharmacists paid GBP 15 per smoker enrolled and followed up for 12 months. No recruit attended for counselling after 4 weeks Funding: the Medical Research Council and the N. Ireland Department of Health and Social Services Declarations of interest: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: “Randomization was achieved using a sealed envelope technique (Altman & Gore, 1982). The randomization envelopes were provided to each site for the use of one pharmacist only” Comment: No further information provided |
Allocation concealment (selection bias) | Unclear risk | Quote: “Randomization was achieved using a sealed envelope technique (Altman & Gore, 1982). The randomization envelopes were provided to each site for the use of one pharmacist only” Comment: Not specified if opaque |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Loss to follow‐up reported for both groups at 3‐month follow‐up (10.2% (27/265) of the PAS group; 14.2% (31/219) of the non‐PAS group). Loss to follow‐up was reported to stay the same at 6‐ and 12‐month follow‐up |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Abstinence was biochemically verified using urinary cotinine |
Selective reporting (reporting bias) | Unclear risk | No published protocol available. All outcomes planned in the Methods section report on in the Results |