Caponnetto 2017.
| Methods |
Country: Italy Design: Cluster‐randomised controlled trial Study objective: To evaluate the effect of the training on smoking cessation outcomes and to help participants (pharmacists) develop an understanding of the key principles of the stage‐of change model and MI approach Method of analysis: Descriptive statistics (i.e. frequencies/percentages, means/standard deviations) used to describe the intervention content (active vs control group); Smoking cessation rates reported and cessation rates analysed using the Fisher test; ITT analysis used in the context of analysis of variance (ANOVA) the Wilcoxon/Mann–Whitney test applied assuming that all those smokers who were lost to follow‐up were classified as failures Clustering adjustments made: No mention of correction for clustering |
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| Participants |
Eligible for study: n = 46 pharmacies Randomised: n = 42 pharmacies; n = 187 participants (Intervention n = 124; Control n = 63) Completed: n = 21 pharmacies; Participant numbers not reported; assume same numbers with lost‐to‐follow‐up reported as smoking Age: not reported Gender: not reported Inclusion criteria: all smokers who sought advice on smoking cessation or those who bought an OTC anti‐smoking product in preparation for a new attempt to stop smoking were eligible for inclusion Exclusion criteria: not reported |
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| Interventions |
Setting: Training conducted by Centro per la Prevenzione e Cura del Tabagismo at the University of Catania. During the recruitment period, all smokers who sought advice on smoking cessation or those who bought an OTC anti‐smoking product in preparation for a new attempt were recruited from the pharmacy Intervention description: Same as control, plus an additional 6‐hour training session; Smokers were informed that their pharmacists were trained in specific anti‐smoking counselling based on stage‐of‐change and MI theories; Intervention personnel offered their customers the professional anti‐smoking counselling; pharmacy staff maintained a confidential participant record which documented their progress in smoking cessation, any product supplied, points raised by the participant, and advice given. At each of the planned follow‐up visits, telephone call reminders were carried out to improve participation; Intervention pharmacotherapy was not provided as standard practice but could be provided if requested Control description: Control group pharmacists attended a 3‐hour conference training session based on the US Public Health Services 2008 Clinical Practice Guidelines for Treating Tobacco Use and Dependence, and aligned with the principles of MI and the stage‐of‐change model. Smokers were informed that their pharmacists recently attended a conference on “Clinical Practice Guidelines for Treating Tobacco Use and Dependence”; The control group asked customers to register and then continued to provide standard professional support; Pharmacy staff maintained a confidential participant record which documented their progress in smoking cessation, any product supplied, points raised by the participant, and advice given; at each of the planned follow‐up visits, telephone call reminders were carried out to improve participation Duration of intervention: Not specified |
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| Outcomes |
Prespecified outcomes: Number of treated smokers, smoking reduction at 24 weeks with validation through exhaled CO Follow‐up period: 24 weeks |
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| Notes | Funding: "The author(s) received no financial support for the research, authorship, and/or publication of this article." Declarations of interest: "The author(s) declared no potential conflicts of interest with respect to the research, authorship and/or publication of this article." |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote "Successively, pharmacies were randomly allocated, by sequential allocation, to the intervention or control group" |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Significant loss of study clusters: only 13/21 intervention pharmacies and 8/21 control pharmacies completed the study. Participant follow‐up rates not reported |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Abstinence biochemically validated |
| Selective reporting (reporting bias) | Unclear risk | No published protocol available; outcomes reported in the Methods were reported in analyses |