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临床随机对照试验的外部真实性及其评价的探讨 被引量：8

External validity and its evaluation used in clinical trials
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摘要 一、临床试验及其真实性 临床随机对照试验（RCT）严格遵循随机、对照、盲法等三大设计原则，并在试验过程中有效控制了潜在的混杂与偏倚，从而保证试验结果的真实可靠。现已成为验证临床药物或某项干预措施是否安全有效的重要研究手段。
作者 吴宇侠 康德英 洪旗 王家良
机构地区 四川大学华西医院循证医学与临床流行病学教研室
出处 《中华流行病学杂志》 CAS CSCD 北大核心 2011年第5期514-518,共5页 Chinese Journal of Epidemiology
基金 国际临床流行病学网（INCLEN）资助（20041NCLEN_1632）
关键词 随机对照试验 外部真实性 评价 Randomised controlled trial External validity Evaluation
分类号 R4 [医药卫生—临床医学]
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参考文献20

  • 1Glasgow RE,Green LW,Klesges LM,et al.External validity:we need to do more.Ann Behav Med,2006,31:105-108.
  • 2Rothwell PM.External validity of randomised controlled trials:'to whom do the results of this trial apply?' Lancet,2005,365:82-93.
  • 3Persaud N,Mamdani MM.External validity:the neglected dimension in evidence ranking.J Evaluat Clin Prac,2006,12(4):450-453.
  • 4David MK,Georgios K.Against pragmatism:on efficacy,effectiveness and the real world.Trials,2009,10:48.
  • 5Roland M,Torgerson DJ.Understanding controlled trials:what are pragmatic trials? BMJ,1998,316(7127):285.
  • 6Godwin M,Ruhland L,Casson I,et al.Pragmatic controlled clinical trials in primary care:the struggle between external and internal validity.BMC Med Res Methodol,2003,3:28.
  • 7Dekkers OM,vonElm E,AlgraA,et al.How to assess the external validity of therapeutic trials:a conceptual approach.Int J Epidemiol,2010,39:89-94.
  • 8Rothwell PM.Commentary:external validity of results of randomized trials:disentangling a complex concept.Int J Epidemiol,2010,39:94-96.
  • 9Rothwell PM,Eliasziw M,Gutnikov SA,et al.Analysis of pooled data from the randomised controlled trials of endarterectomy for symptomatic carotid stenosis.Lancet,2003,361:107-116.
  • 10Swanson GM,Wald AJ.Recruiting minorities into clinical trials:toward a participant-friendly system.J Natl Cancer Inst,1995,87:1747-1759.

二级参考文献11

  • 1卫生部心血管病防治研究中心．中国心血管病报告2005．北京：中国大百科全书出版社，2006：1-2．
  • 2Rothwell PM. External validity of randomised controlled trials: "to whom do the results of this trial apply?". Lancet, 2005, 365(9453): 82-93.
  • 3Gross CP, Mallory R, Heiat A, et al. Reporting the recruitment process in clinical trials: who are these patients and how did they get there? Ann Intern Med, 2002, 137( 1): 10-16.
  • 4Persaud N, Mamdani MM. External validity: the neglected dimension in evidence ranking. J Eval Clin Pract, 2006, 12(4): 450-453.
  • 5Steg PG, Lypez-Sendyn J, Lopez de Sa E, et al. External validity of clinical trials in acute myocardial infarction. Arch Intern Med, 2007, 167(1): 68-73.
  • 6Britton A, McKee M, Black N, et al. Threats to applicability of randomised trials: exclusions and selective participation. J Health Serv Res Policy, 1999, 4(2):112-121.
  • 7Roberts C. The implications of variation in outcome between health professionals for the design and analysis of randomized controlled trials. Stat Med, 1999, 18(19): 2605-2615.
  • 8Petersen MK, Andersen KV, Andersen NT, et al. "To whom do the results of this trial apply?" External validity of a randomized controlled trial involving 130 patients scheduled for primary total hi p replacement. Acta Orthop, 2007, 78 ( 1 ): 12-18.
  • 9Packer M, Bristow MR, Cohn JN, et al. The effect of carvedilol on morbidity and mortality in patients with chronic heart failure. U.S. Carvedilol Heart Failure Study Group. N Engl J Med, 1996, 334(21): 1349-1355.
  • 10Uijen AA, Bakx JC, Mokkink HG, et al. Hypertension patients participating in trials differ in many aspects from patients treated in general practices. J Clin Epidemiol, 2007, 60(4): 330-335.

同被引文献86

引证文献8

二级引证文献74

中华流行病学杂志
2011年 第5期

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