增强创伤后应激障碍干预措施临床试验设计。
Enhancing clinical trial design of interventions for posttraumatic stress disorder.
机构信息
Department of Psychiatry, Weill Cornell Medical College, New York, NY 10065, USA.
出版信息
J Trauma Stress. 2009 Dec;22(6):603-11. doi: 10.1002/jts.20466.
Abstract
The 2008 Institute of Medicine review of interventions research for posttraumatic stress disorder (PTSD) concluded that new, well-designed studies are needed to evaluate the efficacy of treatments for PTSD. The Department of Veterans Affairs (VA), the Department of Defense, and the National Institute of Mental Health convened a meeting on research methodology and the VA issued recommendations for design and analysis of randomized controlled clinical trials (RCTs) for PTSD. The rationale that formed the basis for several of the components of the recommendations is discussed here. Fundamental goals of RCT design are described. Strategies in design and analysis that contribute to the goals of an RCT and thereby enhance the likelihood of signal detection are considered.
摘要
2008 年，医学研究院对创伤后应激障碍（PTSD）干预研究进行了审查，结论认为需要新的、精心设计的研究来评估 PTSD 治疗方法的疗效。美国退伍军人事务部（VA）、美国国防部和国家心理健康研究所召开了一次关于研究方法的会议，VA 发布了 PTSD 随机对照临床试验（RCT）的设计和分析建议。本文讨论了构成这些建议几个组成部分的基本原理。描述了 RCT 设计的基本目标。考虑了设计和分析中的策略，这些策略有助于实现 RCT 的目标，从而提高信号检测的可能性。
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本文引用的文献
1
A power primer.
Psychol Bull. 1992 Jul;112(1):155-9. doi: 10.1037//0033-2909.112.1.155.
2
Implications of clinical trial design on sample size requirements.
Schizophr Bull. 2008 Jul;34(4):664-9. doi: 10.1093/schbul/sbn035. Epub 2008 May 9.
3
Divalproex in the treatment of posttraumatic stress disorder: a randomized, double-blind, placebo-controlled trial in a veteran population.
J Clin Psychopharmacol. 2008 Feb;28(1):84-8. doi: 10.1097/JCP.0b013e318160f83b.
4
The rocks and hard places in psychotherapy outcome research.
J Trauma Stress. 2007 Oct;20(5):779-92. doi: 10.1002/jts.20292.
5
Bias reduction with an adjustment for participants' intent to dropout of a randomized controlled clinical trial.
Clin Trials. 2007;4(5):540-7. doi: 10.1177/1740774507083871.
6
Cognitive behavioral therapy for posttraumatic stress disorder in women: a randomized controlled trial.
JAMA. 2007 Feb 28;297(8):820-30. doi: 10.1001/jama.297.8.820.
7
Psychiatric diagnosis and clinical trial completion rates: analysis of the FDA SBA reports.
Neuropsychopharmacology. 2007 Nov;32(11):2422-30. doi: 10.1038/sj.npp.1301361. Epub 2007 Feb 21.
8
A randomized controlled clinical trial of psychoanalytic psychotherapy for panic disorder.
Am J Psychiatry. 2007 Feb;164(2):265-72. doi: 10.1176/ajp.2007.164.2.265.
9
Statistical power of multiplicity adjustment strategies for correlated binary endpoints.
Stat Med. 2007 Apr 15;26(8):1712-23. doi: 10.1002/sim.2795.
10
Maximizing follow-up in longitudinal studies of traumatized populations.
J Trauma Stress. 2006 Dec;19(6):757-69. doi: 10.1002/jts.20186.
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