肝纤维化知识是否会影响高危饮酒行为（KLIFAD）：一项开放标签实用可行性随机对照试验
Does knowledge of liver fibrosis affect high-risk drinking behaviour (KLIFAD): an open-label pragmatic feasibility randomised controlled trial.
作者信息
Subhani Mohsan, Enki Doyo G, Knight Holly, Jones Katy A, Sprange Kirsty, Rennick-Egglestone Stefan, Morling Joanne R, Wragg Andrew, Hutton Clare, Ryder Stephen D
机构信息
Nottingham Digestive Diseases Centre (NDDC), School of Medicine, University of Nottingham, Nottingham, UK.
NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and the University of Nottingham, Nottingham, UK.
出版信息
EClinicalMedicine. 2023 Jun 30;61:102069. doi: 10.1016/j.eclinm.2023.102069. eCollection 2023 Jul.
BACKGROUND
Early identification followed by effective behaviour interventions is pivotal to changing the natural history of alcohol-related liver disease. We examined the feasibility of using transient elastography based advice and alcohol recovery video stories (ARVS) to change drinking behaviour in community alcohol services.
METHODS
A feasibility randomised control trial (RCT) was conducted in three community alcohol services. Adults 18+ years presenting with a primary alcohol problem were randomised (1:1) to receive either usual care (control group) or usual care and the KLIFAD Intervention, consisting of advice tailored to liver stiffness measure and access to ARVS (intervention group). Data were collected at baseline and six months. To establish definitive trial feasibility, recruitment and retention rates, study procedure safety and extent of effectiveness were measured (Start date: 02.10.2019, End date: 30.11.2022, ISRCTN.com: 16922410).
FINDINGS
382 service users were screened, 184 were randomised (intervention: 93, control: 91), and baseline data were collected for 128 (intervention: 71, control: 59). Six months follow-up data were available in 87 (intervention: 53, control: 34). Intervention compared to the control group had a longer duration of engagement with services (mean difference 8.6 days SD = 18.4), was more likely to complete the allocated treatment program and reduced or stop drinking (54.9% vs 43.9%) and reduce AUDIT category (71.7% vs 61.8%). There were no reported serious adverse reactions, one intervention group participant reported an increase in AUDIT category.
INTERPRETATION
Integration of transient elastography in community alcohol services is feasible. It may improve engagement with services, retention in clinical trials and supplement the reduction in self-reported alcohol consumption. A definitive RCT is supported.
FUNDING
National Institute for Health and Care Research (NIHR201146).
背景
早期识别并随后采取有效的行为干预措施对于改变酒精性肝病的自然病程至关重要。我们研究了使用基于瞬时弹性成像的建议和酒精康复视频故事（ARVS）来改变社区酒精服务中饮酒行为的可行性。
方法
在三个社区酒精服务机构中进行了一项可行性随机对照试验（RCT）。18岁及以上有原发性酒精问题的成年人被随机分组（1:1），分别接受常规护理（对照组）或常规护理加KLIFAD干预，后者包括根据肝脏硬度测量结果量身定制的建议以及获取ARVS（干预组）。在基线和六个月时收集数据。为确定试验的可行性，测量了招募率和保留率、研究程序安全性以及有效性程度（开始日期：2019年10月2日，结束日期：2022年11月30日，ISRCTN.com：16922410）。
结果
筛查了382名服务使用者，184人被随机分组（干预组：93人，对照组：91人），并为128人收集了基线数据（干预组：71人，对照组：59人）。87人有六个月的随访数据（干预组：53人，对照组：34人）。与对照组相比，干预组与服务机构接触的时间更长（平均差异8.6天，标准差=18.4），更有可能完成分配的治疗方案并减少或停止饮酒（54.9%对43.9%）以及降低酒精使用障碍识别测试（AUDIT）类别（71.7%对61.8%）。未报告严重不良反应，一名干预组参与者报告AUDIT类别增加。
解读
在社区酒精服务中整合瞬时弹性成像技术是可行的。它可能会改善与服务机构的接触、提高临床试验中的保留率，并补充自我报告饮酒量的减少。支持进行确定性的随机对照试验。
资助
国家卫生与保健研究机构（NIHR201146）。
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