Background

Historically, individuals managing serious mental illness (SMI) have often been excluded from research, typically because of concern that these individuals may not be able to understand and provide truly informed consent. As treatment has improved, the assumption that individuals managing SMI may not be capable of consent needs to be re-examined. Systematic exclusion from research may limit empirically tested treatments available for people managing SMI, and may contribute to the health care disparities seen in this population.

Objectives

This article examines this issue by documenting current rates of research exclusion for high disease burden conditions, based on empirical review of studies in ClinicalTrials.gov.

Research design

Current rates of exclusion from studies for psychiatric conditions were assessed through systematic review of relevant clinical trials on ClinicalTrials.gov.

Subjects

Subjects in this inquiry are either articles accessed in the literature reviews, or descriptions of studies in public data on ClinicalTrials.gov.

Measures

The primary measure was a previously published coding system to document the extent and types of research exclusion related to psychiatric status.

Results

Among studies of interventions for substance use disorders and chronic pain, individuals managing SMI were more likely to be excluded than those with other psychiatric disorders at statistically significant levels. This was not the case among studies of interventions for ischemic heart disease. In studies of substance use disorders, 9% explicitly excluded SMI and 83% could exclude people with SMI based on broader exclusion criteria. In studies of chronic pain these two categories of exclusion were 16% and 55%, and in studies of ischemic heart disease, these two categories of exclusion were 1% and 20%.

Conclusions

Evidence indicates that it is ethically and scientifically more appropriate to exclude based on capacity to consent than membership in the group of individuals managing SMI. The discussion outlines techniques researchers can use for more equitable and generalizable sampling.

中文翻译：

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重新考虑严重精神疾病的研究排除：伦理原则、现状和建议

背景

从历史上看，管理严重精神疾病 (SMI) 的个人经常被排除在研究之外，通常是因为担心这些人可能无法理解并提供真正的知情同意。随着治疗的改进，需要重新审查管理 SMI 的个人可能无法获得同意的假设。系统地排除研究可能会限制可用于管理 SMI 的人的经验测试治疗，并可能导致该人群中出现的医疗保健差异。

目标

本文基于对 ClinicalTrials.gov 研究的实证审查，通过记录当前高疾病负担条件的研究排除率来研究这个问题。

研究设计

通过对 ClinicalTrials.gov 上的相关临床试验进行系统审查，评估了当前被排除在精神疾病研究之外的比率。

科目

本次调查的主题要么是文献综述中访问的文章，要么是 ClinicalTrials.gov 上公共数据中的研究描述。

措施

主要措施是先前发布的编码系统，用于记录与精神病状态相关的研究排除的程度和类型。

结果

在对物质使用障碍和慢性疼痛的干预研究中，在统计显着水平上，管理 SMI 的个体比患有其他精神障碍的个体更有可能被排除在外。在缺血性心脏病干预研究中，情况并非如此。在物质使用障碍的研究中，9% 明确排除了 SMI，83% 可以根据更广泛的排除标准排除 SMI 患者。在慢性疼痛的研究中，这两种排除类别分别为 16% 和 55%，而在缺血性心脏病研究中，这两种排除类别分别为 1% 和 20%。

结论

证据表明，根据同意能力进行排除比加入管理 SMI 的个人群体在道德和科学上更合适。讨论概述了研究人员可以用于更公平和可推广的抽样的技术。