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随机对照试验中不同招募策略导致的样本偏差对酒精依赖的影响。

Sample bias from different recruitment strategies in a randomised controlled trial for alcohol dependence.

机构信息

Central Clinical School of Medicine, The University of Sydney, Sydney, Australia.

出版信息

Drug Alcohol Rev. 2009 May;28(3):222-9. doi: 10.1111/j.1465-3362.2008.00022.x.

Abstract

INTRODUCTION AND AIMS

Participants may be recruited from diverse sources for randomised controlled trials (RCT) of treatments for alcohol dependence. A mixed recruitment strategy might facilitate recruitment and increase generalisability at the expense of introducing systematic selection bias. The current study aims to compare the effects of recruitment method on socio-demographics, baseline illness characteristics, treatment retention and treatment outcome measures.

DESIGN AND METHODS

A secondary analysis from a previous 12 week RCT of naltrexone, acamprosate and placebo for alcohol dependence was conducted. Participants (n = 169) were obtained via four channels of recruitment including in-patient and outpatient referral, live media and print media solicitation. Baseline parameters, retention in treatment and treatment outcomes were compared in these groups.

RESULTS

Relative to in-patient subjects, those recruited via live and print media had significantly lower scores on taking steps, less in-patient rehabilitation admissions and less previous abstinence before entering the trial. Subjects recruited via print media had significantly lower scores of alcohol dependence relative to all other modes recruitment. There were no differences between recruitment strategies on treatment retention or compliance. At outcome, no significant effect of recruitment method was detected.

DISCUSSION AND CONCLUSIONS

These results suggest that different recruitment methods may be sourcing subjects with different baseline characteristics of illness. Nonetheless, these differences did not significantly impact on treatment retention or outcome, suggesting that in this population it was appropriate to recruit subjects from mixed sources.

摘要

简介和目的

参与者可能来自不同的来源,以参加酒精依赖治疗的随机对照试验(RCT)。混合招募策略可能会促进招募并提高普遍性,但代价是引入系统选择偏差。本研究旨在比较招募方法对社会人口统计学、基线疾病特征、治疗保留和治疗结果测量的影响。

设计和方法

对以前进行的纳曲酮、安非他酮和安慰剂治疗酒精依赖的 12 周 RCT 进行二次分析。参与者(n=169)通过包括住院和门诊转诊、现场媒体和印刷媒体征集在内的四种招募渠道获得。在这些组中比较了基线参数、治疗保留和治疗结果。

结果

与住院患者相比,通过现场和印刷媒体招募的患者在采取措施、住院康复入院次数和进入试验前的先前戒酒次数方面得分明显较低。与其他所有招募模式相比,通过印刷媒体招募的患者的酒精依赖评分明显较低。在治疗保留或依从性方面,不同招募策略之间没有差异。在结果方面,未检测到招募方法的显著影响。

讨论和结论

这些结果表明,不同的招募方法可能会招募具有不同疾病基线特征的患者。尽管如此,这些差异并没有对治疗保留或结果产生重大影响,这表明在该人群中,从混合来源招募患者是合适的。

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