海洛因成瘾者的随访研究（VEdeTTE2）：研究设计与方案

A follow-up study of heroin addicts (VEdeTTE2): study design and protocol.

作者信息

Vigna-Taglianti Federica D, Mathis Federica, Diecidue Roberto, Burroni Paola, Iannaccone Antonio, Lampis Fabio, Zuccaro Piergiorgio, Pacifici Roberta, Versino Elisabetta, Davoli Marina, Faggiano Fabrizio

机构信息

Piedmont Centre for Drug Addiction Epidemiology, ASL 5 - Grugliasco, Italy.

出版信息

Subst Abuse Treat Prev Policy. 2007 Mar 15;2:9. doi: 10.1186/1747-597X-2-9.

DOI:10.1186/1747-597X-2-9

PMID:17362515

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC1838901/

Abstract

BACKGROUND

In Italy, a large cohort study (VEdeTTE1) was conducted between 1998-2001 to evaluate the effectiveness of treatments in reducing mortality and increasing treatment retention among heroin addicts. The follow-up of this cohort (VEdeTTE2) was designed to evaluate the effectiveness of treatments on long-term outcomes, such as rehabilitation and social re-integration. The purpose of this paper is to describe the protocol of the VEdeTTE2 study, and to present the results of the pilot study carried out to assess the feasibility of the study and to improve study procedures.

METHODS

The source population for the VEdeTTE2 study was the VEdeTTE1 cohort, from which a sample of 2,200 patients, traced two or more years after enrollment in the cohort, were asked to participate. An interview investigates drug use; overdose; family and social re-integration. Illegal activity are investigated separately in a questionnaire completed by the patient. Patients are also asked to provide a hair sample to test for heroin and cocaine use. Information on treatments and HIV, HBV and HCV morbidity are obtained from clinical records. A pilot phase was planned and carried out on 60 patients.

RESULTS

The results of the pilot phase pointed out the validity of the procedures designed to limit attrition: the number of traced subjects was satisfactory (88%). Moreover, the pilot phase was very useful in identifying possible causes of delays and attrition, and flaws in the instruments. Improvements to the procedures and the instruments were subsequently implemented. Sensitivity of the biological test was quite good for heroin (78%) but lower for cocaine (42.3%), highlighting the need to obtain a hair sample from all patients.

CONCLUSION

In drug addiction research, studies investigating health status and social re-integration of subjects at long-term follow-up are lacking. The VEdeTTE2 study aims to investigate these outcomes at long-term follow-up. Results of the pilot phase underline the importance of the pilot phase when planning a follow-up study.

摘要

背景

在意大利，1998年至2001年间开展了一项大型队列研究（VEdeTTE1），以评估治疗在降低海洛因成瘾者死亡率及提高治疗依从性方面的有效性。该队列的随访研究（VEdeTTE2）旨在评估治疗对长期结果的有效性，如康复和社会重新融入。本文的目的是描述VEdeTTE2研究的方案，并展示为评估该研究的可行性及改进研究程序而进行的预试验结果。

方法

VEdeTTE2研究的源人群为VEdeTTE1队列，从中抽取了2200名患者作为样本，这些患者在队列入组后被追踪了两年或更长时间，并被邀请参与研究。通过访谈调查药物使用情况、过量用药情况、家庭和社会重新融入情况。非法活动则通过患者填写的问卷单独进行调查。患者还被要求提供一份头发样本，以检测海洛因和可卡因的使用情况。治疗信息以及艾滋病毒、乙肝和丙肝发病率信息均从临床记录中获取。计划并对60名患者进行了预试验阶段。

结果

预试验阶段的结果表明了旨在减少失访的程序的有效性：被追踪对象的数量令人满意（88%）。此外，预试验阶段对于识别延迟和失访的可能原因以及工具中的缺陷非常有用。随后对程序和工具进行了改进。生物检测对海洛因的敏感性相当高（78%），但对可卡因的敏感性较低（42.3%），这凸显了从所有患者获取头发样本的必要性。