一项针对孕妇戒烟的整群随机对照试验，比较基于跨理论（行为改变阶段）模型的干预措施与标准护理。
A cluster randomised controlled trial of smoking cessation in pregnant women comparing interventions based on the transtheoretical (stages of change) model to standard care.
作者信息
Lawrence T, Aveyard P, Evans O, Cheng K K
机构信息
The Department of Public Health and Epidemiology, University of Birmingham, Birmingham, UK.
出版信息
Tob Control. 2003 Jun;12(2):168-77. doi: 10.1136/tc.12.2.168.
OBJECTIVES
To evaluate the effectiveness in helping pregnant women stop smoking of two interventions (Pro-Change for a healthy pregnancy) based on the transtheoretical model of behaviour change (TTM) compared to current standard care.
DESIGN
Cluster randomised trial.
SETTING
Antenatal clinics in West Midlands, UK general practices.
PARTICIPANTS
918 pregnant smokers
INTERVENTIONS
100 general practices were randomised into the three trial arms. Midwives in these practices delivered three interventions: A (standard care), B (TTM based self help manuals), and C (TTM based self help manuals plus sessions with an interactive computer program giving individualised smoking cessation advice).
MAIN OUTCOME MEASURES
Biochemically confirmed smoking cessation for 10 weeks previously, and point prevalence abstinence, both measured at 30 weeks of pregnancy and 10 days after delivery.
RESULTS
There were small differences between the TTM arms. Combining the two arms, the odds ratios at 30 weeks were 2.09 (95% confidence interval (CI) 0.90 to 4.85) for 10 week sustained abstinence and 2.92 (95% CI 1.42 to 6.03) for point prevalence abstinence relative to controls. At 10 days after delivery, the odds ratios were 2.81 (95% CI 1.11 to 7.13) and 1.85 (95% CI 1.00 to 3.41) for 10 week and point prevalence abstinence respectively.
CONCLUSIONS
While there is a small borderline significant increase in quitting in the combined intervention arms compared with the controls, the effect of the intervention is small. At 30 weeks gestation and at 10 days postnatal, only about 3% of the intervention groups achieved sustained cessation, with numbers needed to treat of 67 (30 weeks of gestation) and 53 (10 weeks postnatal) for one additional woman to achieve sustained confirmed cessation. Given also that the intervention was resource intensive, it is of doubtful benefit.
目的
与当前标准护理相比，评估基于行为改变跨理论模型（TTM）的两种干预措施（健康孕期的Pro-Change）帮助孕妇戒烟的效果。
设计
整群随机试验。
地点
英国西米德兰兹郡的产前诊所、全科医疗诊所。
参与者
918名吸烟孕妇
干预措施
100家全科医疗诊所被随机分为三个试验组。这些诊所的助产士实施了三种干预措施：A组（标准护理）、B组（基于TTM的自助手册）和C组（基于TTM的自助手册加与提供个性化戒烟建议的交互式计算机程序的课程）。
主要观察指标
生化确认在怀孕30周和分娩后10天前10周持续戒烟情况以及点患病率戒烟情况。
结果
基于TTM的两组之间存在微小差异。将这两组合并后，相对于对照组，怀孕30周时10周持续戒烟的优势比为2.09（95%置信区间（CI）0.90至4.85），点患病率戒烟的优势比为2.92（95%CI 1.42至6.03）。在分娩后10天，10周持续戒烟和点患病率戒烟的优势比分别为2.81（95%CI 1.11至7.13）和1.85（95%CI 1.00至3.41）。
结论
虽然与对照组相比，合并干预组的戒烟率有小幅临界显著提高，但干预效果较小。在妊娠30周和产后10天，只有约3%的干预组实现了持续戒烟，每多一名女性实现持续确认戒烟所需治疗人数为67（妊娠30周）和53（产后10周）。此外，鉴于该干预措施资源密集，其益处存疑。
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