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The clinical effectiveness and cost-effectiveness of brief intervention for excessive alcohol consumption among people attending sexual health clinics:a randomised controlled trial (SHEAR)

机译：参加性健康诊所的人过度饮酒的简短干预的临床效果和成本效益：一项随机对照试验（SHEAR）

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BackgroundExcessive use of alcohol is associated with poor sexual health, but the clinical effectiveness and cost-effectiveness of brief alcohol intervention in this setting has not been investigated.ObjectiveTo examine the effects and cost-effectiveness of brief intervention for excessive alcohol consumption among people who attend sexual health clinics.DesignA two-arm, parallel-group, single-blind, pragmatic, randomised controlled trial. Participants were randomised via an independent and remote telephone randomisation service using permuted blocks, stratified by clinic.SettingStudy participants were recruited from three sexual health clinics in central and west London.ParticipantsFor inclusion, potential participants had to be aged ≥ 19 years, drink excessive alcohol according to the Modified-Single Alcohol Screening Question, and be willing to provide written informed consent. We excluded those who were unable to communicate in English sufficiently well to complete the baseline assessment and those who could not provide contact details for the follow-up assessment.InterventionsBrief advice was delivered by the treating clinician and comprised feedback on the possible health consequences of excessive drinking, a discussion of whether the participant’s clinic attendance was linked to current alcohol use, written information on alcohol and health and an offer of an appointment with an alcohol health worker (AHW). Appointments with AHWs took place either in person or by telephone, lasted up to 30 minutes, and used the ‘FRAMES’ (Feedback about the adverse effects of alcohol, an emphasis on personal Responsibility for changing drinking behaviour, Advice about alcohol consumption, a Menu of options for further help and advice, an Empathic stance towards the patient and an emphasis on Self-efficacy) approach. Those in the control arm of the trial were offered a copy of a leaflet providing general information on health and lifestyle.Main outcome measuresOutcomes were assessed 6 months after randomisation. The primary outcome was mean weekly alcohol consumption during the previous 90 days. The main secondary outcome was unprotected sex during this period.ResultsEight hundred and two people were recruited to the study of whom 592 (74%) were followed up 6 months later. Among 402 participants who were randomised to brief intervention, 397 (99%) received brief advice from the treating clinician and 81 (20%) also received input from an AHW. The adjusted mean difference in alcohol consumption after 6 months was –2.33 units per week [95% confidence interval (CI) –4.69 to 0.03 units per week, p = 0.053] for those in the active arm compared with the control arm. Unprotected sex was reported by 154 (53%) of those who received brief intervention and by 178 (59%) of controls (adjusted odds ratio 0.89, 95% CI 0.63 to 1.25, p = 0.496). Participants randomised to brief intervention reported drinking a mean of 10.4 units of alcohol per drinking day compared with 9.3 units among control participants (difference 1.10, 95% CI 0.29 to 1.96, p = 0.009). We found no statistically significant differences in other outcomes. Brief intervention (brief advice and input from an AHW) cost on average £12.60 per person to deliver and did not appear to provide a cost-effective use of resources.ConclusionsIntroduction of universal screening and brief intervention for excessive alcohol use among people who attend sexual health clinics does not result in clinically important reductions in alcohol consumption or provide a cost-effective use of resources. While people attending sexual health clinics may want to achieve better sexual health, attempts to reduce alcohol consumption may not be seen by them as a necessary means of trying to achieve this aim.
机译：背景过量饮酒与性健康不良有关，但尚未研究这种情况下短暂酒精干预的临床效果和成本效益。目的探讨短暂干预对过量饮酒人群的影响和成本效益。性健康诊所设计一种两臂，平行组，单盲，实用，随机对照试验。参与者是通过独立的远程电话随机服务，通过按诊所分层的随机分组进行随机分组的。设置研究参与者来自伦敦中西部的三个性健康诊所。参与者包括在内，潜在参与者的年龄必须≥19岁，饮酒过量根据修改后的单一酒精筛查问题，并愿意提供书面知情同意书。我们排除了那些不能用英语进行充分交流以完成基线评估的人和不能提供后续评估联系方式的人。干预措施由主治医生提供了简短的建议，其中包括对过量使用可能对健康造成的影响的反馈饮酒，讨论参与者诊所的出勤是否与当前的酒精使用情况有关，有关酒精与健康的书面信息以及与酒精健康工作者（AHW）预约的提议。 AHW的任命可以亲自或通过电话进行，历时长达30分钟，并使用了“ FRAMES”（有关酒精不良影响的反馈，强调个人改变饮酒行为的责任，有关饮酒的建议，菜单提供更多帮助和建议的选择，对患者的同情态度和对自我效能的重视。为研究的对照组提供了一份传单，其中提供了有关健康和生活方式的一般信息。主要结局指标随机分组后6个月评估结局。主要结局是过去90天内每周平均饮酒量。结果在此期间主要的次要结果是未保护的性行为。结果招募了802人作为研究对象，其中592人（占74％）在6个月后得到了随访。在随机分为短期干预的402名参与者中，有397名（99％）从主治医生那里得到了简短的建议，还有81名（20％）从AHW中得到了建议。与对照组相比，活动组的六个月后酒精摄入量的调整后平均差异为–2.33单位[95％置信区间（CI）–4.69至0.03单位，p = 0.053]。接受短暂干预的患者中有154（53％）人和对照者中有178（59％）人受到无保护的性行为的报告（调整后的优势比0.89，95％CI为0.63至1.25，p = 0.496）。随机参加短期干预的参与者报告平均每天饮酒10.4单位，而对照组参与者则为9.3单位（差异1.10，95％CI为0.29至1.96，p = 0.009）。我们发现其他结局无统计学差异。简短的干预（来自AHW的简要建议和意见）平均每人交付费用为12.60英镑，似乎并未提供具有成本效益的资源使用。结论普遍筛查和对参加性行为者过度饮酒的简短干预卫生诊所不会导致临床上重要的饮酒量减少或提供经济有效的资源使用。虽然去性健康诊所就诊的人可能希望获得更好的性健康，但他们并不认为减少饮酒的尝试是实现该目标的必要手段。

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