Summary of findings 3. Nicotine EC compared to behavioral support only/no support for smoking cessation.
| Nicotine EC compared to behavioral support only/no support for smoking cessation | ||||||
| Patient or population: People who smoke Setting: Canada, Italy, UK, USA Intervention: Nicotine EC Comparison: Behavioral 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 behavioral support only/no support | Risk with Nicotine EC | |||||
| Smoking cessation at 6 to 12 months Assessed using biochemical validation |
Study population | RR 2.70 (1.39 to 5.26) | 2561 (5 RCTs) | ⊕⊝⊝⊝ VERY LOWa, b | ‐ | |
| 4 per 100 | 11 per 100 (6 to 21) | |||||
| Adverse events at 12 weeks to 6 months Assessed via self‐report |
Study population | RR 1.22 (1.12 to 1.32) | 765 (4 RCTs) | ⊕⊕⊝⊝ LOWa | ‐ | |
| 60 per 100 | 73 per 100 (67 to 79) | |||||
| Serious adverse events at 4 weeks to 6 months Assessed via self‐report and medical records |
Study population | RR 1.17 (0.33 to 4.09) | 1011 (6 RCTs) | ⊕⊝⊝⊝ VERY LOWa, c | 4 of the 6 studies reported no SAEs; MA is based on pooled results from 2 studies | |
| 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: randomized 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. Due to lack of blinding and differential support between arms, 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 two levels due to imprecision; confidence intervals incorporate clinically‐significant benefit and clinically‐significant harm.