El Hajj 2017.
Methods |
Country: Qatar Design: Prospective cluster‐ randomised controlled trial Study objective: To test the effect of a structured smoking cessation programme delivered by trained pharmacists on smoking cessation rates in Qatar Method of analysis: Chi2 test, independent t‐test Clustering adjustments made: The main analysis did not change when adjusted for the possible clustering effect by the pharmacists |
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Participants |
Eligible for study: 361 Randomised: Intervention n = 167; Control n = 147 Completed: Intervention n = 68; Control n = 68 Age: Intervention 32.5% aged 30 to 39; Control 38.7% aged 30 to 39 Gender: Men n = 307; Women n = 54 Inclusion criteria: Smokers 18 years and older who smoked one or more cigarettes daily, were able to communicate in Arabic or English, and who were motivated to quit Exclusion criteria: use of NRT in the last 30 days, pregnancy, major medical or psychiatric conditions |
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Interventions |
Setting: 8 public and private pharmacies in Qatar Intervention description: Smokers assigned to the intervention group participated in a face‐to‐face 4‐session programme at the pharmacy by the study pharmacist at 2‐ to 4‐week intervals over 8 weeks. NRT was provided Control description: Participants in the control group received 5 to 10 minutes of unstructured one‐to‐one brief smoking cessation counselling by the pharmacist emulating current practice. NRT was offered Duration of intervention: 4 sessions over 8 weeks |
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Outcomes |
Prespecified outcomes: Self‐reported 7‐day point prevalence abstinence, self‐reported 30‐day point prevalence abstinence, self‐reported continuous abstinence defined as having smoked no cigarettes since quit day – validated by exhaled CO levels Follow‐up period: 3, 6 and 12 months |
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Notes | Funding: "This publication was made possible by a grant from the Qatar National Research Fund under its National Priorities Research Program (NPRP 4–716 ‐ 3–203). Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the Qatar National Research Fund." Declarations of interest: "The authors declare that 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 [randomization] sequences were generated by the study statistician using a computer program from the website randomization.com” |
Allocation concealment (selection bias) | Low risk | Quote: “Serially numbered, opaque, sealed randomization envelopes were then provided to each study pharmacist.” |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Follow‐up rates less than 50% overall and similar between groups (68/167 of intervention, 68/147 of control participants completed all 3 follow‐ups) |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: “at 12 months, participants who self‐reported not smoking were invited to come to their study clinic to measure their exhaled CO level by the clinic nurse who was blinded to the participants’ group.” Comment: Only 8/35 participants self‐reporting abstinence attended and the amount of face‐to‐face contact differed between groups |
Selective reporting (reporting bias) | Low risk | Protocol available. All outcomes of interest to this review reported as planned. All outcomes planned in the Methods section reported on in the Results |
Other bias | Unclear risk | Authors report that it is plausible that the pharmacists, who were overall extremely motivated and enthusiastic, might have inadvertently contaminated the usual‐care group with extra care. This may have increased the smoking cessation rates in this group. It was unclear whether the NRT offered in study arms was matched. The wording suggested that the NRT may have been provided in the intervention arm and only offered in the control arm. However, this uncertainty could just be the result of the terms used rather than an actual difference in practice |