Summary of findings 3. Nicotine EC compared to behavioural support only/no support for smoking cessation.
| Nicotine EC compared to behavioural support only/no support for smoking cessation | ||||||
| Patient or population: People who smoke Setting: Canada, Italy, UK, USA Intervention: Nicotine EC Comparison: Behavioural support only/no support | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with behavioural support only/no support | Risk with Nicotine EC | |||||
| Smoking cessation at 6 to 12 months Assessed using biochemical validation |
Study population | RR 2.50 (1.24 to 5.04) | 2312 (4 RCTs) | ⊕⊝⊝⊝ VERY LOWa,b | ‐ | |
| 4 per 100 | 10 per 100 (5 to 20) | |||||
| Adverse events at 12 weeks to 6 months Assessed via self‐report |
Study population | RR 1.17 (1.04 to 1.31) | 516 (3 RCTs) | ⊕⊝⊝⊝ VERY LOWa,c | ‐ | |
| 60 per 100 | 70 per 100 (62 to 78) | |||||
| Serious adverse events at 4 weeks to 6 months Assessed via self‐report and medical records |
Study population | RR 1.33 (0.25 to 6.96) | 842 (5 RCTs) | ⊕⊝⊝⊝ VERY LOWd,e | ‐ | |
| 1 per 100 | 1 per 100 (0 to 5) | |||||
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). For cessation, the assumed risk in the control group is based on receipt of limited stop‐smoking support. The assumed risk for adverse events and serious adverse events is a weighted mean average of quit rates across control groups in contributing studies. CI: Confidence interval; RCT: randomised controlled trial; RR: Risk ratio | ||||||
| GRADE Working Group grades of evidence High certainty: We are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect | ||||||
aDowngraded two levels due to risk of bias. All included studies judged to be at high risk of bias. bDowngraded one level due to imprecision; although confidence intervals are consistent with clinically‐ important difference, event count is very low (< 100). cDowngraded one level due to imprecision; confidence intervals incorporate no clinically‐significant difference. dDowngraded two levels due to risk of bias; 4 out of 5 studies considered at high risk. eDowngraded two levels due to imprecision; confidence intervals incorporate clinically‐significant benefit and clinically‐significant harm.