Pragmatic randomized controlled trial: an important design for real-world study_Chinese Journal of Evidence-Based Medicine

Authors：

TANG Li , KANG Deying , YU Jiajie , LIU Jiali , JIA Pengli ,  SUN Xin

Chinese Evidence-based Medicine Center and CREAT Group, West China Hospital, Sichuan University, Chengdu, 610041, P.R.China;

Corresponding author：

SUN Xin, Email: sunx79@hotmail.com

Keywords：

DOI：

10.7507/1672-2531.201708037

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Citation： TANG Li, KANG Deying, YU Jiajie, LIU Jiali, JIA Pengli, SUN Xin. Pragmatic randomized controlled trial: an important design for real-world study. Chinese Journal of Evidence-Based Medicine, 2017, 17(9): 999-1004. doi: 10.7507/1672-2531.201708037 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.	Schwartz D, Lellouch J. Explanatory and pragmatic attitudes in therapeutical trials. J Chronic Dis, 1967, 20(8): 637-648.
3.	Roland M, Torgerson DJ. What are pragmatic trials? BMJ, 1998, 316(7127): 285.
4.	Zwarenstein M, Treweek S, Gagnier JJ, et al. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ, 2008, 337: a2390.
5.	Thorpe KE, Zwarenstein M, Oxman AD, et al. A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. CMAJ, 2009, 180(10): 47-57.
6.	Loudon K, Treweek S, Sullivan F, et al. The PRECIS-2 tool: designing trials that are fit for purpose. BMJ, 2015, 350: h2147.
7.	Califf RM, Sugarman J. Exploring the ethical and regulatory issues in pragmatic clinical trials. Clin Trials, 2015, 12(5): 436-441.
8.	Taylor D, Carlyle JA, McPherson S, et al. Tavistock Adult Depression Study (TADS): a randomised controlled trial of psychoanalytic psychotherapy for treatment-resistant/treatment-refractory forms of depression. BMC Psychiatry, 2012, 12: 60.
9.	Devereaux PJ, Bhandari M, Clarke M, et al. Need for expertise based randomised controlled trials. BMJ, 2005, 330(7482): 88.
10.	Westendorp WF, Vermeij JD, Zock E, et al. The Preventive Antibiotics in Stroke Study (PASS): a pragmatic randomised open-label masked endpoint clinical trial. Lancet, 2015, 385(9977): 1519-1526.
11.	Craig P, Dieppe P, Macintyre S, et al. Developing and evaluating complex interventions: the new medical research council guidance. Int J Nurs Stud, 2013, 50(5): 587-592.

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. Schwartz D, Lellouch J. Explanatory and pragmatic attitudes in therapeutical trials. J Chronic Dis, 1967, 20(8): 637-648.
3. Roland M, Torgerson DJ. What are pragmatic trials? BMJ, 1998, 316(7127): 285.
4. Zwarenstein M, Treweek S, Gagnier JJ, et al. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ, 2008, 337: a2390.
5. Thorpe KE, Zwarenstein M, Oxman AD, et al. A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. CMAJ, 2009, 180(10): 47-57.
6. Loudon K, Treweek S, Sullivan F, et al. The PRECIS-2 tool: designing trials that are fit for purpose. BMJ, 2015, 350: h2147.
7. Califf RM, Sugarman J. Exploring the ethical and regulatory issues in pragmatic clinical trials. Clin Trials, 2015, 12(5): 436-441.
8. Taylor D, Carlyle JA, McPherson S, et al. Tavistock Adult Depression Study (TADS): a randomised controlled trial of psychoanalytic psychotherapy for treatment-resistant/treatment-refractory forms of depression. BMC Psychiatry, 2012, 12: 60.
9. Devereaux PJ, Bhandari M, Clarke M, et al. Need for expertise based randomised controlled trials. BMJ, 2005, 330(7482): 88.
10. Westendorp WF, Vermeij JD, Zock E, et al. The Preventive Antibiotics in Stroke Study (PASS): a pragmatic randomised open-label masked endpoint clinical trial. Lancet, 2015, 385(9977): 1519-1526.
11. Craig P, Dieppe P, Macintyre S, et al. Developing and evaluating complex interventions: the new medical research council guidance. Int J Nurs Stud, 2013, 50(5): 587-592.

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