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补偿效应对阿片类药物依赖的年轻成年人临床试验数据收集的影响。

Compensation effects on clinical trial data collection in opioid-dependent young adults.

机构信息

Department of Psychiatry, University of New Mexico, Albuquerque, 87131, USA.

出版信息

Am J Drug Alcohol Abuse. 2012 Jan;38(1):81-6. doi: 10.3109/00952990.2011.600393. Epub 2011 Sep 22.

Abstract

BACKGROUND

Attrition in studies of substance use disorder treatment is problematic, potentially introducing bias into data analysis.

OBJECTIVES

This study aimed to determine the effect of participant compensation amounts on rates of missing data and observed rates of drug use.

METHODS

We performed a secondary analysis of a clinical trial of buprenorphine/naloxone among 152 treatment-seeking opioid-dependent subjects aged 15-21 during participation in a randomized trial. Subjects were randomized to a 2-week detoxification with buprenorphine/naloxone (DETOX; N = 78) or 12 weeks buprenorphine/naloxone (BUP; N = 74). Participants were compensated $5 for weekly urine drug screens and self-reported drug use information and $75 for more extensive assessments at weeks 4, 8, and 12.

RESULTS

Though BUP assignment decreased the likelihood of missing data, there were significantly less missing data at 4, 8, and 12 weeks than other weeks, and the effect of compensation on the probability of urine screens being positive was more pronounced in DETOX subjects.

CONCLUSION

These findings suggest that variations in the amount of compensation for completing assessments can differentially affect outcome measurements, depending on treatment group assignment.

SCIENTIFIC SIGNIFICANCE

Adequate financial compensation may minimize bias when treatment condition is associated with differential dropout and may be a cost-effective way to reduce attrition. Moreover, active users may be more likely than non-active users to drop out if compensation is inadequate, especially in control groups or in groups who are not receiving active treatment.

摘要

背景

在物质使用障碍治疗研究中,人员流失是一个问题,这可能会给数据分析带来偏差。

目的

本研究旨在确定参与者补偿金额对缺失数据率和观察到的药物使用率的影响。

方法

我们对一项为期 15-21 岁的阿片类药物依赖者接受丁丙诺啡/纳洛酮治疗的临床试验进行了二次分析,这些参与者参加了一项随机试验。参与者被随机分配到丁丙诺啡/纳洛酮 2 周脱毒(DETOX;N=78)或丁丙诺啡/纳洛酮 12 周(BUP;N=74)。参与者每周进行尿液药物筛查和自我报告的药物使用信息,可获得 5 美元的报酬,在第 4、8 和 12 周进行更广泛的评估时,可获得 75 美元的报酬。

结果

尽管 BUP 组减少了缺失数据的可能性,但在第 4、8 和 12 周时,缺失数据明显较少,而补偿对 DETOX 组尿液筛查阳性概率的影响更为显著。

结论

这些发现表明,完成评估的补偿金额的变化可能会根据治疗组的分配,对结果测量产生不同的影响。

科学意义

充足的经济补偿可能会最大限度地减少因治疗条件不同而导致的偏差,并且可能是一种降低人员流失率的具有成本效益的方法。此外,如果补偿不足,积极使用者比非积极使用者更有可能退出,尤其是在对照组或未接受积极治疗的组中。

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