Objective To examine effectiveness, cost effectiveness, generalisability, and acceptability of financial incentives for smoking cessation during pregnancy in addition to variously organised UK stop smoking services. Design Pragmatic, multicentre, single blinded, phase 3, randomised controlled trial (Cessation in Pregnancy Incentives Trial phase 3 (CPIT III)). Setting Seven UK stop smoking services provided in primary and secondary care facilities in Scotland, Northern Ireland, and England. Participants 944 pregnant women (age ≥16 years) who self-reported as being smokers (at least one cigarette in the past week) when asked at first maternity visit, less than 24 weeks’ gestation, and notified to the trial team by routine stop smoking services. Interventions Participants in the control group were offered the standard stop smoking services, which includes the offer of counselling by specially trained workers using withdrawal orientated therapy and the offer of free nicotine replacement therapy. The intervention was the offer of usual support from the stop smoking services and the addition of up to £400 ($440; €455) of LoveToShop financial voucher incentives for engaging with current stop smoking services or to stop smoking, or both, during pregnancy. Main outcome measures Self-reported smoking cessation in late pregnancy (between 34 and 38 weeks’ gestation) corroborated by saliva cotinine (and anabasine if using nicotine replacement products). Results were adjusted for age, smoking years, index of multiple deprivation, Fagerström score, before or after covid, and recruitment site. Secondary outcomes included point and continuous abstinence six months after expected date of delivery, engagement with stop smoking services, biochemically validated abstinence from smoking at four weeks after stop smoking date, birth weight of baby, cost effectiveness, generalisability documenting formats of stop smoking services, and acceptability to pregnant women and their carers. Results From 9 January 2018 to 4 April 2020, of 4032 women screened by stop smoking services, 944 people were randomly assigned to the intervention group (n=471) or the control group (n=470). Three people asked for their data to be removed. 126 (27%) of 471 participants stopped smoking from the intervention group and 58 (12%) of 470 from the control group (adjusted odds ratio 2.78 (1.94 to 3.97) P<0.001). Serious adverse events were miscarriages and other expected pregnancy events requiring hospital admission; all serious adverse events were unrelated to the intervention. Most people who stopped smoking from both groups relapsed after their baby was born. Conclusions The offer of up to £400 of financial voucher incentives to stop smoking during pregnancy as an addition to current UK stop smoking services is highly effective. This bolt-on intervention supports new guidance from the UK National Institute for Health and Care Excellence, which includes the addition of financial incentives to support pregnant women to stop smoking. Continuing incentives to 12 months after birth is being examined to prevent relapse. Trial registration ISRCTN Registry [ISRCTN15236311][1]. Limited data will be made available on reasonable request to York Trials Unit alex.mitchell@york.ac.uk. [1]: /external-ref?link_type=ISRCTN&access_num=ISRCTN15236311

中文翻译：

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英国戒烟服务提供的经济券激励对孕妇戒烟的影响（CPIT III）：务实、多中心、单盲、3 期、随机对照试验


目的 除了英国组织的各种戒烟服务之外，还检验怀孕期间戒烟经济激励措施的有效性、成本效益、普遍性和可接受性。设计务实、多中心、单盲、3 期、随机对照试验（戒烟激励试验第 3 期 (CPIT III)）。设置 英国在苏格兰、北爱尔兰和英格兰的初级和二级保健机构提供七项戒烟服务。参与者 944 名孕妇（年龄≥16 岁），在第一次产检时被询问时自我报告吸烟（过去一周至少吸一支烟），怀孕时间不到 24 周，并通过例行停止通知试验团队吸烟服务。干预措施 对照组的参与者接受标准戒烟服务，其中包括由经过专门培训的工作人员使用戒断导向疗法提供咨询以及免费尼古丁替代疗法。干预措施是提供戒烟服务的常规支持，并增加高达 400 英镑（440 美元；455 欧元）的 LoveToShop 财务代金券奖励，用于在怀孕期间参与当前的戒烟服务或戒烟，或两者兼而有之。主要结果指标 怀孕后期（妊娠 34 至 38 周之间）自我报告的戒烟情况，并通过唾液可替宁（如果使用尼古丁替代产品，则为假烟碱）证实。结果根据年龄、吸烟年数、多重剥夺指数、Fagerström 评分、新冠病毒感染前后以及招募地点进行了调整。 次要结局包括预产期后六个月的点戒烟和持续戒烟、参与戒烟服务、戒烟日期后四个星期经生化验证的戒烟、婴儿出生体重、成本效益、戒烟服务的普遍性记录格式、以及孕妇及其护理人员的接受度。结果 2018年1月9日至2020年4月4日，在接受戒烟服务筛查的4032名女性中，944人被随机分配到干预组（n=471）或对照组（n=470）。三人要求删除他们的数据。干预组 471 名参与者中有 126 名 (27%) 戒烟，对照组 470 名参与者中有 58 名 (12%) 戒烟（调整后比值比 2.78（1.94 至 3.97）P<0.001）。严重不良事件是流产和其他需要住院的预期妊娠事件；所有严重不良事件均与干预无关。两组中大多数戒烟的人在孩子出生后都复吸了。结论 作为英国现有戒烟服务的补充，提供高达 400 英镑的怀孕期间戒烟经济券奖励非常有效。这项补充干预措施支持英国国家健康与护理卓越研究所的新指南，其中包括增加经济激励措施以支持孕妇戒烟。正在研究持续激励措施至出生后 12 个月，以防止复发。试用注册 ISRCTN 注册中心 [ISRCTN15236311][1]。有限的数据将根据合理要求向约克审判部门 alex.mitchell@york.ac.uk 提供。 [1]：/外部引用？link_type=ISRCTN&access_num=ISRCTN15236311