Reflections under Evidence-Based Medicine on the Intervention Clinical Research Designs_Chinese Journal of Evidence-Based Medicine

Authors：

XU Weihua ,  LIANG Weixiong , WANG Qi , WEN Zehuai

DME Center, Guangzhou University of Chinese Medicine, Guangzhou 510405, China;

Corresponding author：

LIANG Weixiong, Email: liangwx@pub.guangzhou.gd.cn

Keywords：

Evidence-based medicine; Randomized controlled trial; Non-randomized controlled trial

DOI：

10.7507/1672-2531.20110105

Video：

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Although the evidence from randomized controlled trials (RCTs) is regarded as a golden standard, it often fails to be applied in clinical practice for lack of generalizability. Evidence from either RCTs or non-RCTs is mutually complementary and referred. Different designs are suitable for different stages and can resolve different issues. During evaluation of an intervention, the proper research design should be selected in accordance with the objective, feasibility, and merits and limitations of different design modes.

Citation： XU Weihua,LIANG Weixiong,WANG Qi,WEN Zehuai. Reflections under Evidence-Based Medicine on the Intervention Clinical Research Designs. Chinese Journal of Evidence-Based Medicine, 2011, 11(6): 597-599. doi: 10.7507/1672-2531.20110105 Copy

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13.	loannidis JPA, Haidich AB, Pappa M, et al. 随机与非随机研究治疗效果证据的比较. 美国医学会杂志中文版, 2002, 21(4): 205-208, 218.
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1. 1 de Almeida Neto AC, Chen TF. When pharmacotherapeutic recommendations may lead to the reverse effect on physician decision-making. Pharm World Sci , 2008, 30(1): 3-8.
2. 2 Black N. Why we need observational studies to evaluate the effectiveness of health care. BMJ , 1996, 312(7040): 1215-1218.
3. 3 Benson K, Hartz AJ. A comparison of observational and randomized controlled trials. N Engl J Med , 2000, 342: 1878-1886.
4. 4 Zimmerman M, Mattia JI, Posternak MA. Are subjects in pharmacological treatment trials of depression representative of patients in routine clinical practice? Am J Psychiatry , 2002, 159(3): 469-473.
5. 5 Yastrubetskaya O, Chiu EO&Connell S. Is good clinical research practice for clinical trials good for clinical practice? International Journal of Geriatric Psychiatry , 1997, 12(2): 227-231.
6. 6 Van Spall HG, Toren A, Kiss A, et al . Eligibility criteria of randomized controlled trials published in high-impact general medical journals: a systematic sampling review. JAMA , 2007, 297(11): 1233-1240.
7. 10 Concato J, Shah N, Horwitz RI. Randomized, controlled trials, observational studies and the hierarchy of research designs. N Engl J Med , 2000, 342(25): 1887-1892.
8. 11 Britton A, McKee M, Black N, et al . Choosing between randomized and non-randomised studies: A systematic review. Health Technology Assessment , 1998, 2(13): 1-124.
9. 13 Robins JM, Hernán MA, Brumback B. Marginal structural models and causal inference in epidemiology. Epidemiology , 2000, 11(5): 550-560.
10. 14 Horwitz RI, Viscoli CM, Clemens JD, et al . Developing improved observational methods for evaluating therapeutic effectiveness. Am J Med , 1990, 89(5): 630-638.
11. Xue CC, Yang AW. 中医临床研究的证据等级体系. 见: 刘建平, 主编. 循证中医药临床研究方法学. 第1版. 北京: 人民卫生出版社, 2006, 11.
12. 赖世隆, 主编. 中西医结合临床科研方法学. 第2版. 北京: 科学出版社, 2008: 97.
13. loannidis JPA, Haidich AB, Pappa M, et al. 随机与非随机研究治疗效果证据的比较. 美国医学会杂志中文版, 2002, 21(4): 205-208, 218.
14. 汪涛, 冯学山, 吴擢春. 非随机化医学研究中风险比的一种估计方法. 中国卫生统计, 2004, 21(5): 293-296.

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