中国循证医学杂志

中国循证医学杂志

真实世界理念下观察性与实验性临床研究协同应用

查看全文

与传统临床试验相比,真实世界临床研究对所得证据的真实性(现实性)、适用性及时效性提出了更高要求。为满足这一需求,我们提出发挥观察性与实验性临床研究各自优势,将二者协同应用的思路。通过比较观察性与实验性临床研究的特点,提出二者至少可在提供证据、设计实施和数据分析三方面开展协同应用,为决策者提供更及时、高效、稳健和全面的证据。此外,在中医药疗效评价领域,传统以 RCT 为主的实验性研究设计并不完全适用,而与观察性研究的协同或可为中医药临床研究提供一些启示。

Compared with traditional clinical trials, the real-world studies set higher requirements on the authenticity (reality), applicability, and timeliness of the evidence obtained. In this paper, we brought up a hypothesis that creating synergies between observational and experimental studies may meet these requirements. And then it was discussed in three aspects including providing evidence, research design and execution. In addition, data analysis facilitated generating efficient and robust evidence which was in support of decision making. Finally, some enlightenment may be offered for Traditional Chinese Medicine evaluation methods based on the synergies of both study types.

关键词: 真实世界; 观察性研究; 实验性研究; 协同; 中医药

Key words: Real world; Observational study; Experimental study; Synergy; Traditional Chinese Medicine

引用本文: 张晓雨, 陈静, 赵晨, 商洪才. 真实世界理念下观察性与实验性临床研究协同应用. 中国循证医学杂志, 2018, 18(4): 284-288. doi: 10.7507/1672-2531.201710034 复制

登录后 ,请手动点击刷新查看全文内容。 没有账号,
登录后 ,请手动点击刷新查看图表内容。 没有账号,
1. 孙鑫, 谭婧, 唐立, 等. 重新认识真实世界研究. 中国循证医学杂志, 2017, 17(2): 126-130.
2. Sherman RE, Anderson SA, Dal Pan GJ, et al. Real-world evidence-what is it and what can it tell us?? N Engl J Med, 2016, 375(23): 2293-2297.
3. Fletcher RH, Fletcher SW, Fletcher GS. Clinical epidemiology: the essentials. Lippincott Williams & Wilkins, 2014: 134.
4. Fletcher RH, Fletcher SW, Fletcher GS. Clinical epidemiology: the essentials. Lippincott Williams & Wilkins, 2014: 62.
5. 唐金陵, 杨祖耀. 观察与实验效力与效果. 中华流行病学杂志, 2014, 35(3): 221-227.
6. Scott IA, Attia J. Cautionary tales in the interpretation of observational studies of effects of clinical interventions. Intern Med J, 2017, 47(2): 144-157.
7. 李立明. 流行病学(第 3 版). 北京: 人民卫生出版社, 2015: 113-115.
8. Anglemyer A, Horvath HT, Bero L. Healthcare outcomes assessed with observational study designs compared with those assessed in randomized trials. Cochrane Database Syst Rev, 2014, (4): MR000034.
9. Murad MH, Asi N, Alsawas M, et al. New evidence pyramid. Evid Based Med, 2016, 21(4): 125-127.
10. Newman AB, Avilés-Santa ML, Anderson G, et al. Embedding clinical interventions into observational studies. Contemp Clin Trials, 2016, 46: 100-105.
11. Relton C, Torgerson D, O'Cathain A, et al. Rethinking pragmatic randomised controlled trials: introducing the "cohort multiple randomised controlled trial" design. BMJ, 2010, 340: c1066.
12. Campbell R, Peters T, Grant C, et al. Adapting the randomized consent (Zelen) design for trials of behavioural interventions for chronic disease: feasibility study. J Health Serv Res Policy, 2005, 10(4): 220-225.
13. Kaizar EE. Incorporating both randomized and observational data into a single analysis. Ann Rev Stat Appl, 2015, 2(1): 49-72.
14. Klersy C, Ferlini M, Raisaro A, et al. Use of IVUS guided coronary stenting with drug eluting stent: a systematic review and meta-analysis of randomized controlled clinical trials and high quality observational studies. Int J Cardiol, 2013, 170(1): 54-63.
15. US GAO. Cross design synthesis: a new strategy for medical effectiveness research. Washington, DC: GAO, 1992: PEMD-92-18. Available at: www.gao.gov/assets/160/151472.pdf.
16. Verde PE, Ohmann C. Combining randomized and non-randomized evidence in clinical research: a review of methods and applications. Res Synth Methods, 2015, 6(1): 45-62.
17. Cole SR, Stuart EA. Generalizing evidence from randomized clinical trials to target populations: the ACTG 320 trial. Am J Epidemiol, 2010, 172(1): 107-115.
18. Zhao C, Liu Z, Lin J, et al. Standardizing individualized efficacy evaluation to optimize evidence-using pattern in traditional Chinese medicine-preliminarily establishing traditional Chinese medicine evidence-based case reporting system. World J Tradit Chin Med, 2016, 2(4): 49-54.