Brief intervention to reduce risky drinking in pregnancy: study protocol for a randomized controlled trial
Brief intervention to reduce risky drinking in pregnancy: study protocol for a randomized controlled trial
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减少怀孕期间危险饮酒的简短干预：随机对照试验的研究方案
作者：
Graeme B. Wilson;R. McGovern;G. Antony;P. Cassidy;M. Deverill;Erin Graybill;E. Gilvarry;M. Hodgson;E. Kaner;Kirsty Laing;E. McColl;D. Newbury;J. Rankin
背景英国女性怀孕期间的危险饮酒可能会导致许多怀孕期间接触酒精。美国的研究表明，短暂的干预有望降低产前护理中的酒精风险。然而，还需要进一步研究来确定来自美国的证据是否适用于英国。 这项试点研究旨在调查是否可以招募和保留孕妇参加一项随机对照试验，该试验旨在减少接受产前护理的妇女的危险饮酒。方法该试验将演练后续最终试验的平行组、非盲设计和程序。在超过 8 个月的时间里，在英格兰东北部与社区助产士 (n = 31) 进行预约的 18 岁及以上女性（目标人数 2,742 名）将使用酒精使用障碍识别测试 (AUDIT-C) 的消费问题进行酒精消费筛查。那些筛查呈阳性、无物质使用或酒精依赖史、无妊娠并发症、并且能够给予知情同意的人将被邀请参加试验（目标人数120）。助产士将以 1:1 的比例随机分配，以提供照常治疗（对照）或结构化简短建议，并转介与酒精保健工作者进行 20 分钟的动机访谈（干预）。除了人口和健康信息外，基线测量还包括两份 7 天时间线随访调查问卷和 EuroQoL EQ-5D-3 L 调查问卷。妊娠晚期和产后 6 个月将通过电话随访重复这些措施，届时还将完成有关国民医疗服务和社会护理资源使用情况的调查问卷。有关妊娠结局和死产的信息将在随访前从中央卫生服务记录中获取。主要结果将是研究人群的资格率、招募率、干预实施率和保留率，以便为最终试验的功效计算提供信息。卫生经济学部分将确定如何评估成本效益，并检查在主要试验中应收集哪些卫生服务资源使用数据。将征求参与者对仪器和程序的看法，以确认其可接受性。讨论该研究将制定完整的试验方案，并进行稳健的样本量计算，以扩展筛选和简短干预有效性的证据。试验注册当前对照试验 ISRCTN43218782
BackgroundRisky drinking in pregnancy by UK women is likely to result in many alcohol-exposed pregnancies. Studies from the USA suggest that brief intervention has promise for alcohol risk reduction in antenatal care. However, further research is needed to establish whether this evidence from the USA is applicable to the UK. This pilot study aims to investigate whether pregnant women can be recruited and retained in a randomized controlled trial of brief intervention aimed at reducing risky drinking in women receiving antenatal care.MethodsThe trial will rehearse the parallel-group, non-blinded design and procedures of a subsequent definitive trial. Over 8 months, women aged 18 years and over (target number 2,742) attending their booking appointment with a community midwife (n = 31) in north-east England will be screened for alcohol consumption using the consumption questions of the Alcohol Use Disorders Identification Test (AUDIT-C). Those screening positive, without a history of substance use or alcohol dependence, with no pregnancy complication, and able to give informed consent, will be invited to participate in the trial (target number 120). Midwives will be randomized in a 1:1 ratio to deliver either treatment as usual (control) or structured brief advice and referral for a 20-minute motivational interviewing session with an alcohol health worker (intervention). As well as demographic and health information, baseline measures will include two 7-day time line follow-back questionnaires and the EuroQoL EQ-5D-3 L questionnaire. Measures will be repeated in telephone follow-ups in the third trimester and at 6 months post-partum, when a questionnaire on use of National Health Service and social care resources will also be completed. Information on pregnancy outcomes and stillbirths will be accessed from central health service records before the follow-ups. Primary outcomes will be rates of eligibility, recruitment, intervention delivery, and retention in the study population, to inform power calculations for a definitive trial. The health-economics component will establish how cost-effectiveness will be assessed, and examine which data on health service resource use should be collected in a main trial. Participants’ views on instruments and procedures will be sought to confirm their acceptability.DiscussionThe study will produce a full trial protocol with robust sample-size calculations to extend evidence on effectiveness of screening and brief intervention.Trial RegistrationCurrent Controlled Trials ISRCTN43218782
用于戒烟临床试验的 7 天饮酒量简短估计。
影响因子：
4.4
作者：
Toll,BenjaminA;Leeman,RobertF;McKee,SherryA;O'Malley,StephanieS
通讯作者：
O'Malley,StephanieS
一项随机 I 期试验，对怀孕期间饮酒进行简短的计算机干预。
DOI：
10.1089/jwh.2011.2732
发表时间：
2011
期刊：
Journal of women's health (2002)
影响因子：
--
作者：
Tzilos,GolfoK;Sokol,RobertJ;Ondersma,StevenJ
通讯作者：
Ondersma,StevenJ