Table 7.
Evidentiary Basis for Strong Recommendation Favoring Extended over Standard-Duration Treatment Regimens, with Moderate-Certainty Evidence
| Certainty Assessment |
Number (or Percent) |
Effect (95% CI) |
Certainty | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No. of Studies | Study Design | Risk of Bias | Inconsistency | Indirectness | Imprecision | Other Considerations | Extended Duration | Standard Duration | Relative | Absolute (per 1,000 Patients) | ||
|
Seven-day point-prevalence tobacco abstinence at 1 yr (follow-up: mean, 1 yr; assessed with self-report + exhaled carbon-monoxide concentration verification) | ||||||||||||
| 8 | RCT | Serious | Not serious | Not serious | Not serious | None | 751/1,935 (38.8%) | 24.2% | RR, 1.22 (1.07–1.39) | 53 more (↑17–↑94) | Moderate | Critical |
|
Quality of life (follow-up: 52 wk; assessed with SF-12; higher score indicates worse quality of life; scale of 12–47) | ||||||||||||
| 1 | RCT | Serious | Not serious | Serious | Serious | None | 47 | 51 | — | MD, 1.15 lower (↓3.75–↑1.45) | Very low | Important |
|
No. of cigarettes (follow-up: mean, 1 yr) | ||||||||||||
| 1 | RCT | Serious | Not serious | Not serious | Serious | None | 345 | 180 | — | MD, 0.6 lower (↓1.53–↑0.33) | Low | Important |
|
Serious adverse events | ||||||||||||
| 5 | RCT | Not serious | Not serious | Not serious | Serious | None | 30/1,304 (2.3%) | 0.8% | RR, 1.37 (0.79–2.36) | 3 more (↓2–↑11) | Moderate | Critical |
|
Relapse (follow-up: range, 12–18 mo) | ||||||||||||
| 2 | RCT | Not serious | Not serious | Not serious | Serious | None | 322 | 333 | HR, 0.43 (0.29–0.64) | 0 fewer (0–0) | Moderate | Important |
|
Time to relapse (follow-up: 1 yr) | ||||||||||||
| 2 | RCT | Serious | Serious | Not serious | Not serious | None | 948 | 787 | — | MD, 22.03 d more (↑10.81–↑33.24) | Low | Important |
|
Other substance use, not reported | ||||||||||||
| — | — | — | — | — | — | — | — | — | — | — | — | Important |
|
Withdrawal (follow-up: range, 13–14 wk; assessed with craving and urge to smoke; low score indicates better outcome) | ||||||||||||
| 2 | RCT | Serious | Serious | Not serious | Serious | None | 601 | 585 | — | MD, 1.54 lower (↓3.94–↑0.85) | Very low | Important |
|
Withdrawal (follow-up: 25 wk; assessed with MNWS urge to smoke; lower score indicates better outcome; scale of 0–4) | ||||||||||||
| 1 | RCT | Serious | Not serious | Not serious | Serious | None | 499 | 468 | — | MD, 0.27 lower (↓0.44–↓0.1) | Low | Important |
Definition of abbreviations: ↑ = increase of; ↓ = decrease of; CI = confidence interval; HR = hazard ratio; MD = mean difference; MNWS = Minnesota Nicotine Withdrawal Scale; RCT = randomized controlled trial; RR = relative risk; SF-12 = Short-Form Health Survey.
Treatment with more than 12 weeks of pharmacotherapy provides a larger benefit than treatment courses of fewer than 12 weeks and has a similar risk of serious adverse events. For complete evidence tables, together with references, explanations of certainty assessments, and results of the Evidence-to-Decision process, see online supplement.