Synergy between observational and experimental studies in the real-world research_Chinese Journal of Evidence-Based Medicine

Authors：

ZHANG Xiaoyu ¹ ,  CHEN Jing ² , ZHAO Chen ³ ,  SHANG Hongcai ¹

1. Key Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, 100700, P.R.China;
2. Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, P.R.China;
3. School of Chinese Medicine, Hong Kong Baptist University, HongKong, 999077, P.R.China;

Corresponding author：

CHEN Jing, Email: cjshcsyc@126.com; SHANG Hongcai, Email: shanghongcai@foxmail.com

Keywords：

Real world; Observational study; Experimental study; Synergy; Traditional Chinese Medicine

DOI：

10.7507/1672-2531.201710034

Video：

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Abstract Full text Figures/Tables Video References Cited by

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.

Citation： ZHANG Xiaoyu, CHEN Jing, ZHAO Chen, SHANG Hongcai. Synergy between observational and experimental studies in the real-world research. Chinese Journal of Evidence-Based Medicine, 2018, 18(4): 284-288. doi: 10.7507/1672-2531.201710034 Copy

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.

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.

Chinese Journal of Evidence-Based Medicine

Synergy between observational and experimental studies in the real-world research

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