Use of exclusion criteria in selecting research subjects and its effect on the generalizability of alcohol treatment outcome studies
Use of exclusion criteria in selecting research subjects and its effect on the generalizability of alcohol treatment outcome studies
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DOI：
10.1176/appi.ajp.157.4.588
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发表时间：
2000-04-01
影响因子：
17.7
通讯作者：
Weisner, C
中科院分区：
文献类型：
--
作者：
Humphreys, K;Weisner, C
目的：研究者还没有系统地研究如何排除标准用于选择研究对象影响治疗结果研究的普遍性。本研究评估了酒精治疗结果研究中排除标准的使用及其对研究对象与寻求酒精治疗的现实个体可比性的影响。方法：酒精治疗研究文献中描述的八个最常见的排除标准被操作化，并应用于来自公共和私营部门的大型代表性临床患者样本，以确定假设的研究样本是否与真实世界的样本有很大差异。五百九十三个连续的个人寻求酒精治疗的八个治疗方案之一参加。一名训练有素的研究技术人员从参与者那里收集了有关人口统计学变量以及酒精、药物和精神问题的信息，这些信息由成瘾严重程度指数测量。结果：大部分潜在的研究对象被排除在大多数测试的标准。结果的总体模式表明，非裔美国人，低收入个人和有更严重的酒精，药物和精神问题的个人在大多数标准下被不成比例地排除在外。结论：排除标准可能导致酒精治疗结果研究样本中，与临床实践中观察到的物质滥用患者的真实世界样本相比，更多地由白色、经济稳定和功能更高的个体组成，这可能会损害结果的普遍性。出于科学和伦理原因，除了使用排除标准的研究外，还应进行不使用或使用最低限度排除标准的结果研究，以便酒精治疗结果研究可以更好地推广到弱势人群。
Objective: Researchers have not systematically examined how exclusion criteria used in selection of research subjects affect the generalizability of treatment outcome research. This study evaluated the use of exclusion criteria in alcohol treatment outcome research and its effects on the comparability of research subjects with real-world individuals seeking alcohol treatment. Method: Eight of the most common exclusion criteria described in the alcohol treatment research literature were operationalized and applied to large, representative clinical patient samples from the public and private sectors to determine whether the hypothetical research samples differed substantially from real-world samples. Five hundred ninety-three consecutive individuals seeking alcohol treatment at one of eight treatment programs participated. A trained research technician gathered information from participants on demographic variables and on alcohol, drug, and psychiatric problems as measured by the Addiction Severity Index. Results: Large proportions of potential research subjects were excluded under most of the criteria tested. The overall pattern of results showed that African Americans, low-income individuals, and individuals who had more severe alcohol, drug, and psychiatric problems were disproportionately excluded under most criteria. Conclusions: Exclusion criteria can result in alcohol treatment outcome research samples that are more heavily composed of white, economically stable, and higher-functioning individuals than are real-world samples of substance abuse patients seen in clinical practice, potentially compromising the generalizability of results. For both scientific and ethical reasons, in addition to studies that use exclusion criteria, outcome research that uses no or minimal exclusion criteria should be conducted so that alcohol treatment outcome research can be better generalized to vulnerable populations.