修正“酒精使用障碍患者的酒精特异性抑制训练:一项多中心、双盲随机临床试验,检查饮酒结果和工作机制”。

IF 5.3 1区 医学 Q1 PSYCHIATRY
Addiction Pub Date : 2025-07-02 DOI:10.1111/add.70124
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引用次数: 0

摘要

Stein, M, Soravia, LM, Tschuemperlin, RM, Batschelet, HM, Jaeger, J, Roesner, S,等。酒精使用障碍患者的酒精特异性抑制训练:一项多中心、双盲随机临床试验,研究饮酒结果和作用机制上瘾。2023;118(4): 646 - 657。https://doi.org/10.1111/add.16104In在对本研究数据进行二次分析[1]的背景下,与原始出版物[2]中提出的统计数据相关的信息引起了我们的注意。首先,回归分析中原始出版物中使用的多重imputation是扭曲的,不能与较新版本的R和小鼠包[3]复制。使用新版本产生的估算重新计算回归分析并没有复制原始出版物中报告的效果;虽然在描述水平上相似[估计改进的酒精特异性抑制训练(Alc-IT)优于标准的Alc-IT和对照组],但没有指标表明改进的Alc-IT (β = 8.06, SE = 5.49, P = 0.145, 95% CI = - 2.84至19.00)或标准的Alc-IT (β = - 2.22, SE = 5.66, P = 0.695, CI = - 13.5至9.05)有显著效果。因此,我们必须纠正我们的说法,即改进的Alc-IT可以通过基于多重imputations的线性回归观察到显著的效果。重要的是,层次线性模型(HLM)的结果不是基于多次插值,因此不受这些修正的影响,仍然产生了改进的Alc-IT的显着效果,如原始出版物中所述。在这种情况下,最大似然方法,如支持信息第2.3节中介绍的HLM分析,更合适[7,8,10 -12]。我们很遗憾没有在最初出版之前更彻底地解决这些问题,因为这将使我们更顽强地坚持高级别管理文件。这些hms——最初是我们的主要分析——在审查过程中从正文移到了干预的支持信息中,目的是增强与早期研究的可比性。然而,鉴于上述原因,用最合适的方法分析数据似乎更为重要,这种方法由hlm表示。其次,在敏感性分析中,条件标签出现错误,导致对照和改进的Alc-IT与标准Alc-IT作为基线进行比较。因此,表2中的正确标记应如下:表2(a):在MCAR和MNAR假设下3个月随访时PDA的分析(将对照和改进的Alc-IT与标准Alc-IT进行比较)。因此,该分析表明,改进的Alc-IT的表现明显优于标准Alc-IT。如果将改进后的Alc-IT和标准Alc-IT与基线进行比较计算分析,则改进后的Alc-IT的影响不显著,如下表2(b)所示:在MCAR和MNAR假设下3个月随访时PDA的分析(比较标准和改进的Alc-IT与对照组)因此,我们必须纠正我们最初的说法,即敏感性分析也产生了接受改进的Alc-IT和对照组训练的组之间的显着差异。在敏感性分析中,只有将改进的Alc-IT直接与标准Alc-IT进行比较,这些差异才显着。由于这些观点,我们为此道歉,我们得出结论,改进的Alc-IT对禁欲天数百分比的影响不如原始出版物中所述的那么强大,因为它只有在考虑数据的嵌套结构时才具有统计意义,就像HLMs中的情况一样。考虑到上面列出的统计论据,这些论据支持我们用HLM分析数据的原始计划,我们建议读者考虑HLM结果(在支持信息的2.3节中列出),同时当然承认基于新估算的回归的不显著影响限制了这些影响的稳健性和泛化性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Correction to “Alcohol-specific inhibition training in patients with alcohol use disorder: A multi-centre, double-blind randomized clinical trial examining drinking outcome and working mechanisms”

Stein, M, Soravia, LM, Tschuemperlin, RM, Batschelet, HM, Jaeger, J, Roesner, S, et al. Alcohol-specific inhibition training in patients with alcohol use disorder: A multi-centre, double-blind randomized clinical trial examining drinking outcome and working mechanisms. Addiction. 2023; 118(4): 646657. https://doi.org/10.1111/add.16104

In the context of secondary analyses [1] of this study's data, information relevant to the statistics presented in the original publication [2] came to our attention.

First, the multiple imputations used in the original publication in the regression analysis were distorted and do not replicate with newer versions of R and of the mice package [3]. Recomputing the regression analyses using imputations generated with the newer versions did not replicate the effects reported in the original publication; while similar on a descriptive level [with estimates for improved alcohol-specific inhibition training (Alc-IT) being superior to standard Alc-IT and control], no indicators for a significant effect of improved (β = 8.06, SE = 5.49, P = 0.145, 95% CI = −2.84 to 19.00) or standard Alc-IT (β = −2.22, SE = 5.66, P = 0.695, CI = −13.5 to 9.05) were yielded. We, therefore, must correct our statement that a significant effect of improved Alc-IT can be observed with a linear regression based on multiple imputations.

Importantly, the hierarchical linear model (HLM) results, which are not based on the multiple imputations and are, therefore, not affected by these corrections, still yield a significant effect of improved Alc-IT, as described in the original publication.

In such a case, maximum likelihood methods, like the HLM analyses, which are presented in section 2.3 of the Supporting information, are more appropriate [7, 8, 10-12]. We regret not addressing these issues more thoroughly before the original publication, as this would have led us to stick more tenaciously to the HLMs. These HLMs—originally presented as the main analyses by us—were moved from the main text to the Supporting information on intervention during the review process with the aim to enhance comparability with earlier studies. However, given the reasons above, it seems more important to analyze the data with the most appropriate approach, which is represented by the HLMs.

Second, in the sensitivity analyses, an error in the condition labels occurred, leading to control and improved Alc-IT being compared against standard Alc-IT as a baseline. Correct labels in eTable 2 would, therefore, have been as follows:

eTable 2(a): Analyses of PDA at 3-month follow-up under a MCAR and MNAR assumption (comparing control and improved Alc-IT against standard Alc-IT)

This analysis, therefore, indicates that improved Alc-IT performed significantly better than standard Alc-IT. If the analyses are computed comparing improved Alc-IT and standard Alc-IT against baseline, the effect of improved Alc-IT is insignificant, as can be seen in eTable 2 (b) below:

eTable 2(b): Analyses of PDA at 3-month follow-up under a MCAR and MNAR assumption (comparing standard and improved Alc-IT against control)

We, therefore, must correct our original statement that the sensitivity analyses also yielded significant differences between the groups receiving improved Alc-IT and control training. In the sensitivity analyses, these differences are only significant if improved Alc-IT is compared directly against standard Alc-IT.

As a consequence of these points, for which we apologize, we conclude that the effect of improved Alc-IT on percentage of days abstinent is less robust than stated in the original publication, because it only becomes statistically significant if the nested structure of the data is considered, as is the case in the HLMs. Given the statistical arguments listed above, which support our original plan to analyze the data with HLMs, we advise readers to consider the HLM results (that are listed in section 2.3 of the Supporting information), while of course acknowledging the fact that the insignificant effects of the regression based on the new imputations limit the robustness and generalizability of these effects.

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来源期刊
Addiction
Addiction 医学-精神病学
CiteScore
10.80
自引率
6.70%
发文量
319
审稿时长
3 months
期刊介绍: Addiction publishes peer-reviewed research reports on pharmacological and behavioural addictions, bringing together research conducted within many different disciplines. Its goal is to serve international and interdisciplinary scientific and clinical communication, to strengthen links between science and policy, and to stimulate and enhance the quality of debate. We seek submissions that are not only technically competent but are also original and contain information or ideas of fresh interest to our international readership. We seek to serve low- and middle-income (LAMI) countries as well as more economically developed countries. Addiction’s scope spans human experimental, epidemiological, social science, historical, clinical and policy research relating to addiction, primarily but not exclusively in the areas of psychoactive substance use and/or gambling. In addition to original research, the journal features editorials, commentaries, reviews, letters, and book reviews.
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