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在一项大规模聚类随机对照试验中对以往饮酒报告的撤回。

Recanting of Previous Reports of Alcohol Consumption within a Large-Scale Clustered Randomised Control Trial.

机构信息

Centre for Evidence and Social Innovation, School of Social Sciences, Education and Social Work, Queen's University Belfast, Belfast, UK.

Northern Ireland Clinical Trials Unit, Belfast, UK.

出版信息

Prev Sci. 2019 Aug;20(6):844-851. doi: 10.1007/s11121-019-0981-2.

Abstract

The aim of this study was to examine the extent of recanting (inconsistencies in reporting of lifetime alcohol use) and its impact on the assessment of primary outcomes within a large-scale alcohol prevention trial. One hundred and five post-primary schools in were randomised to receive either the intervention or education as normal. Participants (N = 12,738) were secondary school students in year 8/S1 (mean age 12.5) at baseline. Self-report questionnaires were administered at baseline (T0) and at T1 (+ 12 months post-baseline), T2 (+ 24 months) and T3 (+ 33 months). The primary outcomes were (i) heavy episodic drinking (consumption of ≥ 6 units in a single episode in the previous 30 days for males and ≥ 4.5 units for females) assessed at T3 and (ii) the number of alcohol-related harms experienced in the last 6 months assessed at T3. Recanting was defined as a negative report of lifetime alcohol consumption that contradicted a prior positive report. Between T1 and T3, 9.9% of students recanted earlier alcohol consumption. Recanting ranged from 4.5 to 5.3% across individual data sweeps. While recanting was significantly associated (negatively) with both primary outcomes, the difference in the rate of recanting across trial arms was small, and adjusting for recanting within the primary outcome models did not impact on the primary outcome effects. Males were observed to recant at a greater rate than females, with a borderline small-sized effect (V = .09). While differential rates of recanting have the potential to undermine the analysis of prevention trial outcomes, recanting is easy to identify and control for within trial primary outcome analyses. Adjusting for recanting should be considered as an additional sensitivity test within prevention trials.Trial Registration: ISRCTN47028486 ( http://www.isrctn.com/ISRCTN47028486 ). The date of trial registration was 23/09/2011, and school recruitment began 01/11/2011.

摘要

本研究旨在探讨在一项大规模酒精预防试验中,报告不一致(即报告终生饮酒情况的不一致)的程度及其对主要结局评估的影响。105 所中学被随机分为干预组或正常教育组。参与者(N=12738)为基线时八年级/一年级(平均年龄 12.5 岁)的中学生。基线(T0)时以及 T1(+基线后 12 个月)、T2(+24 个月)和 T3(+33 个月)时进行自我报告问卷调查。主要结局是(i)在 T3 时评估的重度发作性饮酒(男性在过去 30 天内单次发作中消耗≥6 单位,女性≥4.5 单位)和(ii)在 T3 时评估的过去 6 个月内经历的酒精相关危害数量。报告不一致定义为报告的终生饮酒量为阴性,与先前的阳性报告相矛盾。在 T1 和 T3 之间,9.9%的学生报告了早期饮酒的不一致情况。在个体数据扫掠中,报告不一致的范围从 4.5%到 5.3%。虽然报告不一致与两个主要结局均显著相关(呈负相关),但试验臂之间的报告不一致率差异较小,并且在主要结局模型中调整报告不一致对主要结局影响无影响。观察到男性的报告不一致率高于女性,具有边缘小效应(V=0.09)。虽然报告不一致的差异率有可能破坏预防试验结果的分析,但在试验主要结局分析中很容易识别和控制报告不一致。在预防试验中,应考虑调整报告不一致作为附加敏感性测试。试验注册:ISRCTN47028486(http://www.isrctn.com/ISRCTN47028486)。试验注册日期为 2011 年 9 月 23 日,学校招募于 2011 年 11 月 1 日开始。

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