Thinking and exploration for grading real-world evidence_Chinese Journal of Evidence-Based Medicine

Authors：

 FEI Yutong ^1,2,3 , CHAI Qianyun ^1,2,3 , XIA Ruyu ^1,2,3 , JIN Xuejing ^1,2,3

1. Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing 100029, P. R. China;
2. Institute for Excellence in Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing 100029, P. R. China;
3. Beijing GRADE Center, Beijing University of Chinese Medicine, Beijing 100029, P. R. China;

Corresponding author：

FEI Yutong, Email: feiyt@bucm.edu.cn

Keywords：

Real-world; Level of evidence; GRADE; Grading suggestion

DOI：

10.7507/1672-2531.202205141

Video：

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Abstract Full text Figures/Tables Video References Cited by

The formation, evaluation and grade division of real-world evidence (RWE) are bottlenecks restricting the in-depth development and scientific application of real-world study methods. This paper briefly reviewed the design grade and evidence grade of clinical medical research, and proposed the key points of evidence grade of real-world clinical research, including emphasizing the comprehensive evaluation of internal authenticity and external authenticity, determining the "starting point" of real-world evidence, and using the real-world evidence quality evaluation method. Based on the internationally recognized "grading of recommendations assessment, development, and evaluation (GRADE)", combined with the classification and characteristics of real-world evidence, a preliminary grading scheme was formed. An example was given to illustrate the grading suggestion.

Citation： FEI Yutong, CHAI Qianyun, XIA Ruyu, JIN Xuejing. Thinking and exploration for grading real-world evidence. Chinese Journal of Evidence-Based Medicine, 2022, 22(10): 1206-1211. doi: 10.7507/1672-2531.202205141 Copy

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16.	Gräsbeck H, Ekroos H, Halonen K, et al. Weak smoking cessation awareness in primary health care before surgery: a real-world, retrospective cohort study. Scand J Prim Health Care, 2020, 38(1): 42-46.
17.	Ricciardolo FLM, Levra S, Sprio AE, et al. Asthma in the real-world: the relevance of gender. Int Arch Allergy Immunol, 2020, 181(6): 462-466.
18.	Husson O, de Rooij BH, Kieffer J, et al. The EORTC QLQ-C30 summary score as prognostic factor for survival of patients with cancer in the "real-world": results from the population-based PROFILES registry. Oncologist, 2020, 25(4): e722-e732.
19.	Balshem H, Helfand M, Schünemann HJ, et al. GRADE guidelines: 3. Rating the quality of evidence. J Clin Epidemiol, 2011, 64(4): 401-406.
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22.	Guyatt GH, Oxman AD, Kunz R, et al. GRADE guidelines 6. Rating the quality of evidence-imprecision. J Clin Epidemiol, 2011, 64(12): 1283-1293.
23.	Guyatt GH, Oxman AD, Kunz R, et al. GRADE guidelines: 7. Rating the quality of evidence-inconsistency. J Clin Epidemiol, 2011, 64(12): 1294-1302.
24.	Guyatt GH, Oxman AD, Kunz R, et al. GRADE guidelines: 8. Rating the quality of evidence-indirectness. J Clin Epidemiol, 2011, 64(12): 1303-1310.
25.	Guyatt GH, Oxman AD, Sultan S, et al. GRADE guidelines: 9. Rating up the quality of evidence. J Clin Epidemiol, 2011, 64(12): 1311-1316.
26.	Proietti M, Romanazzi I, Romiti GF, et al. Real-World Use of Apixaban for Stroke Prevention in Atrial Fibrillation: A Systematic Review and Meta-Analysis. Stroke, 2018, 49(1): 98-106.
27.	李立明, 主编. 流行病学. 北京: 人民卫生出版社, 2008, 11: 71.

1. 汪旻晖, 赵杨, 邓亚中, 等. 真实世界数据/真实世界证据应用的政策法规及指导原则的比较研究. 中国临床药理学与治疗学, 2020, 25(8): 878-889.
2. Food and Drug Administration. Use of real world evidence to support regulatory decision marking for medical devices. Available at: https://www.fda.gov/media/99447/download.
3. Heads of Medicines Agencies. Observational data (real world data) -subgroup report. Available at: https://www.ema.europa.eu/en/documents/report/observational-data-real-world-data-subgroup-report_en.pdf.
4. Association of the British Pharmaceutical Industry. The vision for real world data-Harnessing the opportunities in the UK. Available at: https://www.abpi.org.uk/publications/vision-for-real-world-data.
5. 国家药品监督管理局. 关于发布真实世界证据支持药物研发与审评的指导原则(试行)的通知. Available at: http://www.nmpa.gov.cn/WS04/CL2138/373175.html.
6. 中华中医药学会. 中医药真实世界研究技术规范—证据质量评价与报告. 中医杂志, 2022, 63(3): 293-300.
7. 黄新余, 王益威. “最佳证据"推动人性化医疗. 医学与哲学, 2019, 40(23): 1-4.
8. 陈薇, 方赛男, 刘建平, 等. 国际循证医学证据分级体系的发展与现状. 中国中西医结合杂志, 2017, 37(12): 1413-1419.
9. GRADE working group. What is GRADE? Available at: https://www.gradeworkinggroup.org/#pub.
10. The periodic health examination. Canadian task force on the periodic health examination. Can Med Assoc J, 1979, 121(9): 1193-1254.
11. Phillips B. GRADE: levels of evidence and grades of recommendation. Arch Dis Child, 2004, 89(5): 489.
12. SUNY downstate EBM Tutorial. Guide to research methods: the evidence pyramid. Available at: http://library.downstate.edu/EBM2/2100.htm.
13. Berkman ND, Lohr KN, Ansari MT, et al. Grading the strength of a body of evidence when assessing health care interventions: an EPC update. J Clin Epidemiol, 2015, 68(11): 1312-1324.
14. The Joanna Briggs Institute. The JBI approach: levels of evidence. Available at:http://joannabriggs.org/jbi-approach.html#tabbed-nav=Levels-of-Evidence.
15. 陈薇, 陈可冀, 刘建平. 中医药真实世界研究证据的构成及分级标准建议. 中国中西医结合杂志, 2021, 41(5): 608-611.
16. Gräsbeck H, Ekroos H, Halonen K, et al. Weak smoking cessation awareness in primary health care before surgery: a real-world, retrospective cohort study. Scand J Prim Health Care, 2020, 38(1): 42-46.
17. Ricciardolo FLM, Levra S, Sprio AE, et al. Asthma in the real-world: the relevance of gender. Int Arch Allergy Immunol, 2020, 181(6): 462-466.
18. Husson O, de Rooij BH, Kieffer J, et al. The EORTC QLQ-C30 summary score as prognostic factor for survival of patients with cancer in the "real-world": results from the population-based PROFILES registry. Oncologist, 2020, 25(4): e722-e732.
19. Balshem H, Helfand M, Schünemann HJ, et al. GRADE guidelines: 3. Rating the quality of evidence. J Clin Epidemiol, 2011, 64(4): 401-406.
20. Guyatt GH, Oxman AD, Vist G, et al. GRADE guidelines: 4. Rating the quality of evidence-study limitations (risk of bias). J Clin Epidemiol, 2011, 64(4): 407-415.
21. Guyatt GH, Oxman AD, Montori V, et al. GRADE guidelines: 5. Rating the quality of evidence-publication bias. J Clin Epidemiol, 2011, 64(12): 1277-1282.
22. Guyatt GH, Oxman AD, Kunz R, et al. GRADE guidelines 6. Rating the quality of evidence-imprecision. J Clin Epidemiol, 2011, 64(12): 1283-1293.
23. Guyatt GH, Oxman AD, Kunz R, et al. GRADE guidelines: 7. Rating the quality of evidence-inconsistency. J Clin Epidemiol, 2011, 64(12): 1294-1302.
24. Guyatt GH, Oxman AD, Kunz R, et al. GRADE guidelines: 8. Rating the quality of evidence-indirectness. J Clin Epidemiol, 2011, 64(12): 1303-1310.
25. Guyatt GH, Oxman AD, Sultan S, et al. GRADE guidelines: 9. Rating up the quality of evidence. J Clin Epidemiol, 2011, 64(12): 1311-1316.
26. Proietti M, Romanazzi I, Romiti GF, et al. Real-World Use of Apixaban for Stroke Prevention in Atrial Fibrillation: A Systematic Review and Meta-Analysis. Stroke, 2018, 49(1): 98-106.
27. 李立明, 主编. 流行病学. 北京: 人民卫生出版社, 2008, 11: 71.

Chinese Journal of Evidence-Based Medicine

Thinking and exploration for grading real-world evidence

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