Methods | Randomised controlled trial evaluating provision of videotaped vignettes for promoting smoking cessation and relapse prevention during pregnancy Study conducted in a community-based university setting, Texas, USA. Data collection dates not reported |
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Participants |
Inclusion criteria: Volunteers who were willing to quit within 2 weeks. Exclusion criteria: Women smoking < 3 cigarettes per day; < 18 years; > 30 weeks’ pregnant; do not have a working video recorder (approximately 12% Americans); depressed Recruitment: Through local media, such as newspaper, radio, subscriber letters, community business flyers, waiting room posters 146 women screened and 82 women who met inclusion criteria were randomised (C = 40, I = 42) Baseline characteristics: Mean cigarettes/day at first visit: C = 14.5, I = 17.3. Progress+ coding: None. |
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Interventions |
Control: Received a quit calendar and tip guide. Intervention: As for control plus were mailed a video with 6 × 25-30 minute vignettes covering a range of topics and strategies from initial quitting to relapse prevention Main intervention strategy: Counselling (single intervention) compared to a less intensive intervention Intensity: Frequency (C = 2, I = 2), Duration (C = 1, I = 4). Intervention provided by study staff: efficacy study. |
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Outcomes | Biochemically validated point prevalence abstinence obtained within 2-3 days of quit date, 4-5 weeks after the quit date (late pregnancy)* and 1 month postpartum (0-5 months postpartum*). Participant evaluation of intervention materials. Associated references report association of quitting and depressive disorders. CES-D scores at baseline only |
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Notes | Authors say women in this study tend to be heavier smokers than described in previous studies | |
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not stated. |
Allocation concealment (selection bias) | Unclear risk | Not stated. |
Incomplete outcome data (attrition bias) All outcomes |
Low risk | Only 61% of participants completed all assessments. All those with missing data were treated as continuing smokers in this review |
Selective reporting (reporting bias) | Low risk | Pre-specified outcomes reported. |
Other bias | Low risk | No other bias detected. |
Biochemical validation of smoking abstinence (detection bias) | Low risk | All reports of abstinence were validated by measurement of salivary cotinine |
Blinding of participants and personnel (performance bias) All outcomes |
Unclear risk | Video mailed to participants. Not clear if UC givers were aware of group allocation |
Blinding of outcome assessment (detection bias) All outcomes |
Unclear risk | Not reported. |
Incomplete implementation | High risk | Process evaluation showed only 53% of the intervention group viewed 1-3 of the 6 videos. 47% did not view them |
Equal baseline characteristics in study arms | Low risk | No significant difference in socioeconomic variables between groups |
Contamination of control group | Low risk | Video mailed out to participants only. |