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非自愿门诊治疗随机对照试验的伦理挑战。

The ethical challenges of a randomized controlled trial of involuntary outpatient commitment.

作者信息

Swartz M S, Burns B J, George L K, Swanson J, Hiday V A, Borum R, Wagner H R

机构信息

Department of Psychiatry, Duke University Medical Center, Durham, NC 27710, USA.

出版信息

J Ment Health Adm. 1997 Winter;24(1):35-43. doi: 10.1007/BF02790478.

DOI:10.1007/BF02790478
PMID:9033154
Abstract

Involuntary outpatient commitment (OPC) is a civil justice procedure intended to enhance compliance with community mental health treatment, to improve functioning, and to reduce recurrent dangerousness and hospital recidivism. The research literature on OPC indicates that it appears to improve outcomes in rates of rehospitalization and length of stay. However, all studies to date have serious methodological limitations because of selection bias; lack of specification of target populations; unclear operationalization of OPC; unmeasured variability in type, frequency, and intensity of treatment; as well as other confounding factors. To address limitations in these studies, the authors designed a randomized controlled trial (RCT) of OPC, combined with community-based case management, which is now under way in North Carolina. This article describes ethical dilemmas in designing and implementing an RCT of a legally coercive intervention in community-based settings. These ethical dilemmas challenge the experimental validity of an RCT but can be successfully addressed with careful planning and negotiation.

摘要

非自愿门诊治疗承诺(OPC)是一种民事司法程序,旨在提高对社区心理健康治疗的依从性,改善功能状况,并减少反复出现的危险性和住院复发率。关于OPC的研究文献表明,它似乎能改善再住院率和住院时间等结果。然而,由于选择偏倚、目标人群未明确界定、OPC的操作定义不清晰、治疗类型、频率和强度方面存在未测量的变异性以及其他混杂因素,迄今为止所有研究都存在严重的方法学局限性。为解决这些研究中的局限性,作者设计了一项OPC随机对照试验(RCT),并结合基于社区的病例管理,该试验目前正在北卡罗来纳州进行。本文描述了在社区环境中设计和实施一项具有法律强制性干预措施的RCT时所面临的伦理困境。这些伦理困境对RCT的实验有效性构成挑战,但通过精心规划和协商可以成功解决。

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The ethical challenges of a randomized controlled trial of involuntary outpatient commitment.非自愿门诊治疗随机对照试验的伦理挑战。
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2
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本文引用的文献

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Loyola Los Angel Law Rev. 1987 Jun;20(4):1329-429.
2
New directions in research on involuntary outpatient commitment.非自愿门诊治疗承诺研究的新方向。
Psychiatr Serv. 1995 Apr;46(4):381-5. doi: 10.1176/ps.46.4.381.
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A national survey of the use of outpatient commitment.一项关于门诊治疗委托使用情况的全国性调查。
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Compulsory community and involuntary outpatient treatment for people with severe mental disorders.针对严重精神障碍患者的强制社区治疗和非自愿门诊治疗。
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Of mice but not men. Problems of the randomized clinical trial.只适用于小鼠而非人类。随机临床试验的问题。
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Clinical trials--are they ethical?
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