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酒精治疗研究评估暴露对象反应性效应:第一部分。酒精使用及相关后果。

Alcohol treatment research assessment exposure subject reactivity effects: part I. Alcohol use and related consequences.

作者信息

Clifford Patrick R, Maisto Stephen A, Davis Christine M

机构信息

School of Public Health, University of Medicine and Dentistry of New Jersey, 683 Hoes Lane West, 3rd Floor, Piscataway, New Jersey 08854, USA.

出版信息

J Stud Alcohol Drugs. 2007 Jul;68(4):519-28. doi: 10.15288/jsad.2007.68.519.

Abstract

OBJECTIVE

There has been increasing recognition among alcohol treatment researchers that research assessment exposure subject reactivity effects can contribute to clinical outcomes, decrease study design sensitivity, and confound research findings. The present study is an experimental investigation of two of the more salient components of the research assessment interview (i.e., frequency and comprehensiveness) and their effects on clinical outcomes (Part I: Alcohol Use and Related Consequences) and treatment participation (Part II: Treatment Engagement and Involvement).

METHOD

The study design was a 2 (Frequency of Assessment) x 2 (Comprehensiveness of Assessment) completely randomized factorial, and study participants were randomly assigned, using an urn randomization procedure, to one of the resulting four experimental research assessment exposure conditions: (1) frequent-comprehensive, (2) frequent-brief, (3) infrequent-comprehensive, and (4) infrequent-brief. Study participants were recruited from one of two hospital-based outpatient alcohol- and other substance-abuse clinics. Two hundred thirty-five subjects were randomly assigned to one of the four research assessment exposure conditions.

RESULTS

Research assessment exposure subject reactivity effects were related significantly to alcohol use and related negative consequences, such that subjects assigned to the infrequent-brief research assessment exposure condition reported the poorest outcomes.

CONCLUSIONS

The research protocols used to study alcohol treatments have clinical efficacy and can alter the outcomes (e.g., alcohol use) under investigation. It is important for researchers to control/account for subject reactivity effects when conducting alcohol treatment outcome trials. Accurate interpretation of data derived from clinical trials of alcohol treatments necessitates taking research assessment exposure subject reactivity effects into consideration.

摘要

目的

酒精治疗研究人员越来越认识到,研究评估中的暴露对象反应性效应会对临床结果产生影响,降低研究设计的敏感性,并混淆研究结果。本研究是一项实验性调查,旨在探究研究评估访谈中两个较为突出的组成部分(即频率和全面性)及其对临床结果(第一部分:酒精使用及相关后果)和治疗参与度(第二部分:治疗投入和参与)的影响。

方法

研究设计为2(评估频率)×2(评估全面性)完全随机析因设计,研究参与者通过瓮随机化程序被随机分配到由此产生的四种实验性研究评估暴露条件之一:(1)频繁-全面,(2)频繁-简要,(3)不频繁-全面,(4)不频繁-简要。研究参与者从两家医院门诊酒精及其他物质滥用诊所中的一家招募。235名受试者被随机分配到四种研究评估暴露条件之一。

结果

研究评估暴露对象反应性效应与酒精使用及相关负面后果显著相关,即被分配到不频繁-简要研究评估暴露条件的受试者报告的结果最差。

结论

用于研究酒精治疗的研究方案具有临床疗效,并且可以改变所研究的结果(例如酒精使用情况)。研究人员在进行酒精治疗结果试验时控制/考虑对象反应性效应非常重要。准确解释酒精治疗临床试验得出的数据需要考虑研究评估暴露对象反应性效应。

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