The cessation in pregnancy incentives trial (CPIT): study protocol for a randomized controlled trial.
The cessation in pregnancy incentives trial (CPIT): study protocol for a randomized controlled trial.
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DOI：
10.1186/1745-6215-13-113
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发表时间：
2012-07-20
期刊：
影响因子：
2.5
通讯作者：
Coleman T
中科院分区：
文献类型：
--
作者：
Tappin DM;Bauld L;Tannahill C;de Caestecker L;Radley A;McConnachie A;Boyd K;Briggs A;Grant L;Cameron A;Macaskill S;Sinclair L;Friel B;Coleman T
苏格兰70%的女性至少有一个孩子，这使得怀孕成为帮助大多数年轻女性在自己的健康受到不可挽回的损害之前戒烟的机会。通过在怀孕期间戒烟，她们的婴儿将免受流产和死产以及低出生体重、哮喘、注意力缺陷障碍和成人心血管疾病的影响。在英国，NICE指南：“如何在怀孕和分娩后戒烟”（2010年6月）强调，文献中几乎没有证据证实经济激励措施有助于怀孕吸烟者戒烟的有效性。它的第一个研究建议是确定：在英国的背景下，激励措施是否是一种可接受的，有效的和具有成本效益的方式来帮助吸烟的孕妇戒烟？这项研究是一项II期探索性个体随机对照试验，比较了标准护理与标准护理加额外提供的金融券激励措施，以参与专家戒烟服务和/或在怀孕期间戒烟。参与者（n = 600）将是在孕妇预约时确定的怀孕吸烟者，当专家戒烟服务联系时，他们同意将其详细信息传递到NHS无烟妊娠研究帮助热线以讨论试验。NHS无烟妊娠研究帮助热线将负责电话同意和妊娠后期的随访。主要结局将是通过可替宁测量验证的妊娠晚期自我报告的吸烟情况。经济评价将完善成本数据收集，评估潜在的成本效益，而与客户和保健专业人员的定性研究访谈将评估这种形式的奖励付款的接受程度。研究问题是：可能的治疗效果是什么？激励措施是否具有潜在的成本效益？个体随机化是否是一种有效的试验设计而不引入结果偏倚？能否以一种可行和可接受的方式引入激励措施？这项II期试验将建立一个可行的设计，以减少与未来确定的III期多中心随机对照试验相关的风险，并建立一个框架，以评估帮助怀孕吸烟者戒烟的经济激励的成本和效益。当前对照试验ISRCTN 87508788
Seventy percent of women in Scotland have at least one baby, making pregnancy an opportunity to help most young women quit smoking before their own health is irreparably compromised. By quitting during pregnancy their infants will be protected from miscarriage and still birth as well as low birth weight, asthma, attention deficit disorder and adult cardiovascular disease. In the UK, the NICE guidelines: ‘How to stop smoking in pregnancy and following childbirth’ (June 2010) highlighted that little evidence exists in the literature to confirm the efficacy of financial incentives to help pregnant smokers to quit. Its first research recommendation was to determine: Within a UK context, are incentives an acceptable, effective and cost-effective way to help pregnant women who smoke to quit? This study is a phase II exploratory individually randomized controlled trial comparing standard care for pregnant smokers with standard care plus the additional offer of financial voucher incentives to engage with specialist cessation services and/or to quit smoking during pregnancy. Participants (n = 600) will be pregnant smokers identified at maternity booking who, when contacted by specialist cessation services, agree to having their details passed to the NHS Smokefree Pregnancy Study Helpline to discuss the trial. The NHS Smokefree Pregnancy Study Helpline will be responsible for telephone consent and follow-up in late pregnancy. The primary outcome will be self reported smoking in late pregnancy verified by cotinine measurement. An economic evaluation will refine cost data collection and assess potential cost-effectiveness while qualitative research interviews with clients and health professionals will assess the level of acceptance of this form of incentive payment. The research questions are: What is the likely therapeutic efficacy? Are incentives potentially cost-effective? Is individual randomization an efficient trial design without introducing outcome bias? Can incentives be introduced in a way that is feasible and acceptable? This phase II trial will establish a workable design to reduce the risks associated with a future definitive phase III multicenter randomized controlled trial and establish a framework to assess the costs and benefits of financial incentives to help pregnant smokers to quit. Current Controlled Trials ISRCTN87508788
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