PDF(Pubmed)
Abstract：
Preventing dropout (attrition) from clinical trials is vital for improving study validity. Dropout is particularly important in justice-involved populations as they can be very challenging to engage and recruit in the first instance. This study identifies factors associated with dropout in a double-blind, placebo-controlled randomised control trial of a selective serotonin reuptake inhibitor (SSRI) aimed at reducing reoffending in highly impulsive men with histories of violent offending. Age, education, social support, psychiatric history, and length of previous incarceration were identified as factors that predict attrition. These findings are consistent with previous research examining variables associated with attrition in clinical trials for community and offender populations. We also explored referral source and treatment allocation as attrition predictors. Although neither significantly predicted attrition, we identified that there are discernible differences in the median time to attrition among the referral source subgroups. Understanding factors that predict treatment completion and attrition will allow researchers to identify participants for whom additional provisions may optimise retention and inform development of targeted interventions.
摘要：
防止临床试验中的辍学（减员）对于提高研究的有效性至关重要。辍学在涉及司法的人群中尤为重要，因为他们首先参与和招募可能非常具有挑战性。这项研究确定了与双盲辍学相关的因素，一项选择性5-羟色胺再摄取抑制剂（SSRI）的安慰剂对照随机对照试验，旨在减少有暴力犯罪史的高冲动性男性的再犯罪。年龄,教育,社会支持,精神病史,和以前的监禁时间被确定为预测减员的因素。这些发现与先前研究社区和罪犯人群的临床试验中与自然减员相关的变量一致。我们还探讨了转诊来源和治疗分配作为自然减员预测因素。尽管两者都没有显著预测减员，我们发现,转诊来源亚组的减员中位时间存在明显差异.了解预测治疗完成和减员的因素将使研究人员能够确定参与者的额外规定可以优化保留并告知有针对性的干预措施的发展。
