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

机译:对阿片类药物依赖的年轻成年人的临床试验数据收集的补偿影响

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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 buprenorphinealoxone 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 buprenorphinealoxone (DETOX; N = 78) or 12 weeks buprenorphinealoxone (BUP; N = 74). Participants were compensated5 for weekly urine drug screens and self-reported drug use information and75 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.
机译:背景:物质使用失调症治疗研究中的人员流失是有问题的,有可能在数据分析中引入偏见。目的:本研究旨在确定参与者补偿金额对数据丢失率和观察到的药物使用率的影响。方法:在一项随机试验中,我们对152名年龄在15-21岁的阿片类药物依赖患者中进行了丁丙诺啡/纳洛酮临床试验的二次分析。将受试者随机接受丁丙诺啡/纳洛酮(DETOX; N = 78)或12周丁丙诺啡/纳洛酮(BUP; N = 74)排毒2周。在每周的第4周,第8周和第12周,对参加者的每周尿液筛查和自我报告的药物使用信息进行补偿5,对更广泛的评估进行补偿75。在第8周和第12周时,补偿水平对DETOX受试者中尿液筛查呈阳性的可能性的影响更为明显。结论:这些发现表明,根据治疗组的分配,完成评估的补偿金额差异可能会不同程度地影响结果测量。科学意义:当治疗状况与差异性辍学有关时,充足的经济补偿可以最大程度地减少偏差,并且可能是降低损耗的经济有效方式。此外,如果补偿不足,活跃用户比非活跃用户更有可能退出,特别是在对照组或未接受活跃治疗的组中。

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