Real world study using observational designs: plan for patient registry study and development of registry database_Chinese Journal of Evidence-Based Medicine

Authors：

TAN Jing , CHENG Liangliang , WANG Wen , LIU Yanmei , ZHANG Guiting ,  SUN Xin

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

Corresponding author：

SUN Xin, Email: sunx79@hotmail.com

Keywords：

DOI：

10.7507/1672-2531.201711112

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Abstract Full text Figures/Tables Video References Cited by

Real world data (RWD) and real world evidence (RWE) have increasingly received wide attention. Patient registry study is an important part of real-world studies using observational design. In this paper, we introduce the concept, classification and application of patient registries, and discuss the planning for a patient registry study and development of registry database, and provide methodological guidance for developing high-quality patient registry studies.

Citation： TAN Jing, CHENG Liangliang, WANG Wen, LIU Yanmei, ZHANG Guiting, SUN Xin. Real world study using observational designs: plan for patient registry study and development of registry database. Chinese Journal of Evidence-Based Medicine, 2017, 17(12): 1365-1372. doi: 10.7507/1672-2531.201711112 Copy

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2.	孙鑫, 谭婧, 唐力, 等. 重新认识真实世界研究. 中国循证医学杂志, 2017, 17(2): 126-30.
3.	唐立, 康德英, 喻佳洁, 等. 实效性随机对照试验: 真实世界研究的重要设计. 中国循证医学杂志, 2017, 2017(17): 999-1004.
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7.	中国器官移植注册登记. Available at: http://www.cotr.cn/.
8.	中国妇幼卫生监测.
9.	中国疾病预防控制中心. Available at: http://www.chinacdc.cn/.
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11.	Yang X, Li Z, Zhao X, et al. Use of warfarin at discharge among acute ischemic stroke patients with nonvalvular atrial fibrillation in China. Stroke, 2016, 47(2): 464-470.
12.	Zheng Z, Zhang L, Li X, et al. SinoSCORE: a logistically derived additive prediction model for post-coronary artery bypass grafting in-hospital mortality in a Chinese population. Front Med, 2013, 7(4): 477-485.
13.	Zheng Z, Zhang L, Hu S, et al. Risk factors and in-hospital mortality in Chinese patients undergoing coronary artery bypass grafting: analysis of a large multi-institutional Chinese database. J Thorac Cardiovasc Surg, 2012, 144(2): 355-359.
14.	Wandling MW, Ko CY, Bankey PE, et al. Expanding the scope of quality measurement in surgery to include nonoperative care: Results from the American College of Surgeons National Surgical Quality Improvement Program emergency general surgery pilot. J Trauma Acute Care Surg, 2017, 83(5): 837-845.
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16.	Zhao H, Yang L, Long C, et al. Hemophilia care in China: review of care for 417 hemophilia patients from 11 treatment centers in Shanxi Province. Expert Rev Hematol, 2015, 8(4): 543-550.
17.	Gao YT, McLaughlin JK, Blot WJ, et al. Reduced risk of esophageal cancer associated with green tea consumption. J Natl Cancer Inst, 1994, 86(11): 855-858.
18.	Xu WH, Zheng W, Xiang YB, et al. Soya food intake and risk of endometrial cancer among Chinese women in Shanghai: population based case-control study. BMJ, 2004, 328(7451): 1285.
19.	Berger ML, Mamdani M, Atkins D, et al. Good research practices for comparative effectiveness research: defining, reporting and interpreting nonrandomized studies of treatment effects using secondary data sources: the ISPOR Good Research Practices for Retrospective Database Analysis Task Force Report--Part I. Value Health, 2009, 12(8): 1044-1052.
20.	Gu Y, Wang C, Zheng Y, et al. Cancer incidence and mortality in patients with type 2 diabetes treated with human insulin: a cohort study in Shanghai. PLoS One, 2013, 8(1): e53411.
21.	Eggink FA, Mom CH, Boll D, et al. Compliance with adjuvant treatment guidelines in endometrial cancer: room for improvement in high risk patients. Gynecol Oncol, 2017, 146(2): 380-385.
22.	Li Y, Li CX, Wang HC, et al. Efficacy and safety of firebird sirolimus-eluting stent in treatment of complex coronary lesions in Chinese patients: one-year clinical and eight-month angiographic outcomes from the FIREMAN registry. Chin Med J (Engl), 2011, 124(6): 817-824.
23.	Wang XZ, Xu K, Li Y, et al. Comparison of the efficacy of drug-eluting stents versus bare-metal stents for the treatment of left main coronary artery disease. Chin Med J (Engl), 2015, 128(6): 721-726.
24.	Chen SL, Ye F, Zhang JJ, et al. Comparison of a five-year clinical outcome between Chinese women and men with de novo coronary disease treated with implantation of a drug-eluting stent: a three-center, prospective, registry study. Chin Med J (Engl), 2012, 125(1): 7-11.
25.	Bu S, Zhang X, Zhu H, et al. Which patients will benefit from a switch in therapy from premixed insulin to insulin glargine plus oral antidiabetic drugs? further analysis of the lantus registry study. Diabetes Ther, 2017, 8(4): 887-898.
26.	Wang H, Pan Y, Meng X, et al. Validation of the mSOAR and SOAR scores to predict early mortality in Chinese acute stroke patients. PLoS One, 2017, 12(7): e0180444.
27.	Xu J, Tao Y, Xie X, et al. A comparison of mortality prognostic scores in ischemic stroke patients. J Stroke Cerebrovasc Dis, 2016, 25(2): 241-247.
28.	Luo JG, Yang M, Han L, et al. Validity of the global registry of acute coronary events risk score in prediction of acute myocardial infarction mortality in hospitalised chinese patients aged 80 and over. Australas J Ageing, 2014, 33(4): E1-5.
29.	Tan J, Liu X, Mao X, et al. HBsAg positivity during pregnancy and adverse maternal outcomes: a retrospective cohort analysis. J Viral Hepat, 2016, 23(10): 812-819.
30.	Tan J, Huang S, He G, et al. Maternal hepatitis B surface antigen carrier status and its impact on neonatal outcomes: a cohort study of 21 947 singleton newborns in China. J Matern Fetal Neonatal Med, 2017, 30(18): 2219-2224.
31.	Brown JB, Smith KJ, Gestring ML, et al. Comparing the air medical prehospital triage score with current practice for triage of injured patients to helicopter emergency medical services: a cost-effectiveness analysis. JAMA Surg, 2017, doi: 10.1001/jamasurg. 2017. 4485.
32.	Berrevoets MA, Ten Oever J, Sprong T, et al. Monitoring, documenting and reporting the quality of antibiotic use in the Netherlands: a pilot study to establish a national antimicrobial stewardship registry. BMC Infect Dis, 2017, 17(1): 565.
33.	Qiao S, Chen L, Chen S, et al. One-year outcomes from an all-comers chinese population of patients implanted with the resolute zotarolimus-eluting stent. Am J Cardiol, 2014, 113(4): 613-620.
34.	Uter W, Schnuch A, Wilkinson M, et al. Registries in Clinical Epidemiology: the European Surveillance System on Contact Allergies (ESSCA). Methods Inf Med, 2016, 55(2): 193-199.
35.	Wang P, Wang Y, Zhao X, et al. In-hospital medical complications associated with stroke recurrence after initial ischemic stroke: A prospective cohort study from the China National Stroke Registry. Medicine (Baltimore), 2016, 95(37): e4929.
36.	Xibib S, Meilan H, Moller H, et al. Risk factors for oesophageal cancer in Linzhou, China: a case-control study. Asian Pac J Cancer Prev, 2003, 4(2): 119-124.
37.	Helmuth IG, Poulsen A, Molbak K. A national register-based study of paediatric varicella hospitalizations in Denmark 2010-2016. Epidemiol Infect, 2017, 145(13): 2683-2693.
38.	Bebe A, Nielsen ABS, Willadsen TG, et al. Exploring the concurrent validity of the nationwide assessment of permanent nursing home residence in Denmark-A cross-sectional data analysis using two administrative registries. BMC Health Serv Res, 2017, 17(1): 607.
39.	Li G, Sajobi TT, Menon BK, et al. Registry-based randomized controlled trials- what are the advantages, challenges, and areas for future research? J Clin Epidemiol, 2016, 80: 16-24.

1. U.S. Department of Health and Human Services Food and Drug Administration. Use of real-world evidence to support regulatory decision-making for medical devices. 2017.
2. 孙鑫, 谭婧, 唐力, 等. 重新认识真实世界研究. 中国循证医学杂志, 2017, 17(2): 126-30.
3. 唐立, 康德英, 喻佳洁, 等. 实效性随机对照试验: 真实世界研究的重要设计. 中国循证医学杂志, 2017, 2017(17): 999-1004.
4. Agency for Healthcare Research and Quality. Registries for Evaluating Patient Outcomes: A User’s Guide. US Department of Health and Human Services, Agency for Healthcare Research and Quality (AHRQ), 2014: 1-356.
5. Clinical trials. Available at: http://Clinicaltrials.Gov/Ct2/Manage-Recs/How-Register.
6. 中国临床试验注册中心. Available at: http://www.chictr.org.cn/.
7. 中国器官移植注册登记. Available at: http://www.cotr.cn/.
8. 中国妇幼卫生监测.
9. 中国疾病预防控制中心. Available at: http://www.chinacdc.cn/.
10. Han Y, Jing Q, Li Y, et al. Sustained clinical safety and efficacy of a biodegradable-polymer coated sirolimus-eluting stent in "real-world" practice: three-year outcomes of the CREATE (Multi-Center Registry of EXCEL Biodegradable Polymer Drug Eluting Stents) study. Catheter Cardiovasc Interv, 2012, 79(2): 211-216.
11. Yang X, Li Z, Zhao X, et al. Use of warfarin at discharge among acute ischemic stroke patients with nonvalvular atrial fibrillation in China. Stroke, 2016, 47(2): 464-470.
12. Zheng Z, Zhang L, Li X, et al. SinoSCORE: a logistically derived additive prediction model for post-coronary artery bypass grafting in-hospital mortality in a Chinese population. Front Med, 2013, 7(4): 477-485.
13. Zheng Z, Zhang L, Hu S, et al. Risk factors and in-hospital mortality in Chinese patients undergoing coronary artery bypass grafting: analysis of a large multi-institutional Chinese database. J Thorac Cardiovasc Surg, 2012, 144(2): 355-359.
14. Wandling MW, Ko CY, Bankey PE, et al. Expanding the scope of quality measurement in surgery to include nonoperative care: Results from the American College of Surgeons National Surgical Quality Improvement Program emergency general surgery pilot. J Trauma Acute Care Surg, 2017, 83(5): 837-845.
15. 曾红梅, 郑荣寿, 张思维, 等. 1989-2008 年中国恶性肿瘤死亡趋势分析. 中华肿瘤杂志, 2012, 34(7): 525-531.
16. Zhao H, Yang L, Long C, et al. Hemophilia care in China: review of care for 417 hemophilia patients from 11 treatment centers in Shanxi Province. Expert Rev Hematol, 2015, 8(4): 543-550.
17. Gao YT, McLaughlin JK, Blot WJ, et al. Reduced risk of esophageal cancer associated with green tea consumption. J Natl Cancer Inst, 1994, 86(11): 855-858.
18. Xu WH, Zheng W, Xiang YB, et al. Soya food intake and risk of endometrial cancer among Chinese women in Shanghai: population based case-control study. BMJ, 2004, 328(7451): 1285.
19. Berger ML, Mamdani M, Atkins D, et al. Good research practices for comparative effectiveness research: defining, reporting and interpreting nonrandomized studies of treatment effects using secondary data sources: the ISPOR Good Research Practices for Retrospective Database Analysis Task Force Report--Part I. Value Health, 2009, 12(8): 1044-1052.
20. Gu Y, Wang C, Zheng Y, et al. Cancer incidence and mortality in patients with type 2 diabetes treated with human insulin: a cohort study in Shanghai. PLoS One, 2013, 8(1): e53411.
21. Eggink FA, Mom CH, Boll D, et al. Compliance with adjuvant treatment guidelines in endometrial cancer: room for improvement in high risk patients. Gynecol Oncol, 2017, 146(2): 380-385.
22. Li Y, Li CX, Wang HC, et al. Efficacy and safety of firebird sirolimus-eluting stent in treatment of complex coronary lesions in Chinese patients: one-year clinical and eight-month angiographic outcomes from the FIREMAN registry. Chin Med J (Engl), 2011, 124(6): 817-824.
23. Wang XZ, Xu K, Li Y, et al. Comparison of the efficacy of drug-eluting stents versus bare-metal stents for the treatment of left main coronary artery disease. Chin Med J (Engl), 2015, 128(6): 721-726.
24. Chen SL, Ye F, Zhang JJ, et al. Comparison of a five-year clinical outcome between Chinese women and men with de novo coronary disease treated with implantation of a drug-eluting stent: a three-center, prospective, registry study. Chin Med J (Engl), 2012, 125(1): 7-11.
25. Bu S, Zhang X, Zhu H, et al. Which patients will benefit from a switch in therapy from premixed insulin to insulin glargine plus oral antidiabetic drugs? further analysis of the lantus registry study. Diabetes Ther, 2017, 8(4): 887-898.
26. Wang H, Pan Y, Meng X, et al. Validation of the mSOAR and SOAR scores to predict early mortality in Chinese acute stroke patients. PLoS One, 2017, 12(7): e0180444.
27. Xu J, Tao Y, Xie X, et al. A comparison of mortality prognostic scores in ischemic stroke patients. J Stroke Cerebrovasc Dis, 2016, 25(2): 241-247.
28. Luo JG, Yang M, Han L, et al. Validity of the global registry of acute coronary events risk score in prediction of acute myocardial infarction mortality in hospitalised chinese patients aged 80 and over. Australas J Ageing, 2014, 33(4): E1-5.
29. Tan J, Liu X, Mao X, et al. HBsAg positivity during pregnancy and adverse maternal outcomes: a retrospective cohort analysis. J Viral Hepat, 2016, 23(10): 812-819.
30. Tan J, Huang S, He G, et al. Maternal hepatitis B surface antigen carrier status and its impact on neonatal outcomes: a cohort study of 21 947 singleton newborns in China. J Matern Fetal Neonatal Med, 2017, 30(18): 2219-2224.
31. Brown JB, Smith KJ, Gestring ML, et al. Comparing the air medical prehospital triage score with current practice for triage of injured patients to helicopter emergency medical services: a cost-effectiveness analysis. JAMA Surg, 2017, doi: 10.1001/jamasurg. 2017. 4485.
32. Berrevoets MA, Ten Oever J, Sprong T, et al. Monitoring, documenting and reporting the quality of antibiotic use in the Netherlands: a pilot study to establish a national antimicrobial stewardship registry. BMC Infect Dis, 2017, 17(1): 565.
33. Qiao S, Chen L, Chen S, et al. One-year outcomes from an all-comers chinese population of patients implanted with the resolute zotarolimus-eluting stent. Am J Cardiol, 2014, 113(4): 613-620.
34. Uter W, Schnuch A, Wilkinson M, et al. Registries in Clinical Epidemiology: the European Surveillance System on Contact Allergies (ESSCA). Methods Inf Med, 2016, 55(2): 193-199.
35. Wang P, Wang Y, Zhao X, et al. In-hospital medical complications associated with stroke recurrence after initial ischemic stroke: A prospective cohort study from the China National Stroke Registry. Medicine (Baltimore), 2016, 95(37): e4929.
36. Xibib S, Meilan H, Moller H, et al. Risk factors for oesophageal cancer in Linzhou, China: a case-control study. Asian Pac J Cancer Prev, 2003, 4(2): 119-124.
37. Helmuth IG, Poulsen A, Molbak K. A national register-based study of paediatric varicella hospitalizations in Denmark 2010-2016. Epidemiol Infect, 2017, 145(13): 2683-2693.
38. Bebe A, Nielsen ABS, Willadsen TG, et al. Exploring the concurrent validity of the nationwide assessment of permanent nursing home residence in Denmark-A cross-sectional data analysis using two administrative registries. BMC Health Serv Res, 2017, 17(1): 607.
39. Li G, Sajobi TT, Menon BK, et al. Registry-based randomized controlled trials- what are the advantages, challenges, and areas for future research? J Clin Epidemiol, 2016, 80: 16-24.

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