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随机对照试验文献能否推广到非随机选择的患者?

Can the randomized controlled trial literature generalize to nonrandomized patients?

作者信息

Stirman Shannon Wiltsey, Derubeis Robert J, Crits-Christoph Paul, Rothman Allison

机构信息

Department of Psychology, University of Pennsylvania, Philadelphia, PA 19104-6196, USA.

出版信息

J Consult Clin Psychol. 2005 Feb;73(1):127-35. doi: 10.1037/0022-006X.73.1.127.

Abstract

To determine the extent to which published randomized controlled trials (RCTs) of psychotherapy can be generalized to a sample of outpatients, the authors matched information obtained from charts of patients who had been screened out of RCTs to inclusion and exclusion criteria from published RCT studies. Most of the patients in the sample who had primary diagnoses represented in the RCT literature were judged eligible for at least 1 RCT. However, many patients in the sample with substance use disorders or social anxiety disorder were not eligible for at least 2 RCTs. Common reasons that patients did not match with at least 2 published RCTs for psychotherapy included (a) patients were in partial remission, (b) patients failed to meet minimum severity or duration criteria, (c) patients were being treated with antidepressant medication, and (d) the disorder being studied was not primary (mostly for social anxiety patients). The implications of these findings for future research and clinical practice are discussed.

摘要

为了确定已发表的心理治疗随机对照试验(RCT)能在多大程度上推广至门诊患者样本,作者将从被排除在RCT之外的患者病历中获取的信息与已发表的RCT研究中的纳入和排除标准进行了匹配。样本中大多数具有RCT文献中所代表的主要诊断的患者被判定至少符合一项RCT的条件。然而,样本中许多患有物质使用障碍或社交焦虑障碍的患者不符合至少两项RCT的条件。患者不符合至少两项已发表的心理治疗RCT的常见原因包括:(a)患者处于部分缓解期;(b)患者未达到最低严重程度或病程标准;(c)患者正在接受抗抑郁药物治疗;(d)所研究的障碍并非主要障碍(主要针对社交焦虑患者)。本文讨论了这些发现对未来研究和临床实践的意义。

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