Technical guidance for developing patient registry databases_Chinese Journal of Evidence-Based Medicine

Authors：

 TAN Jing ¹ ^# , PENG Xiaoxia ² ^# , SHU Xiaochen ³ ^# , WANG Li ⁴ , LI Guowei ⁵ , ZHANG Ling ⁶ , MAO Chen ⁷ , GUO Xinfeng ⁸ ,  SUN Xin ¹ , On behalf of China REal world data and studies ALliance (ChinaREAL)

1. Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu, 610041, P.R.China;
2. National Center for Children’s Health, China; Clinical Epidemiology and Evidence-based Medicine Center, Beijing Children’s Hospital, Capital Medical University, Beijing, 100045, P.R.China;
3. Department of Epidemiology and Biostatistics, School of Public Health, Medical College Soochow University, Suzhou, 215123, P.R.China;
4. Department of Epidemiology and Biostatistics, Institute of Basic Medical Sciences Chinese Academy of Medical Sciences, School of Basic Medicine Peking Union Medical College, Beijing, 100005, P.R.China;
5. Center for Clinical Epidemiology and Methodology (CCEM), Guangdong Second Provincial General Hospital, Guangzhou, 510317, P.R.China;
6. School of Public Health, Capital Medical University, Beijing, 100069, P.R.China;
7. Department of Epidemiology, School of Public Health, Southern Medical University, Guangzhou, 510515, P.R.China;
8. Guangdong Provincial Hospital of Chinese Medicine, Guangdong Provincial Academy of Chinese Medical Sciences & 2nd Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, 510120, P.R.China;

Corresponding author：

TAN Jing, Email: tanjing84@outlook.com; SUN Xin, Email: sunx79@hotmail.com

Keywords：

Patient registry; Real-world data; Research database; Technical guidance

DOI：

10.7507/1672-2531.201904161

Video：

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Abstract Full text Figures/Tables Video References Cited by

A patient registry database is an important source of real-world data, and has been widely used in the assessment of drug and medical devices, as well as disease management. As the second part of the serial technical guidance for real-world data and studies, this paper introduces the concept and scope of potential uses of patient registry databases, proposes recommendations for planning and developing a patient registry database, and compares existing health and medical databases. This paper further develops essential quality indicators for developing a patient registry database, in expect to guide future studies.

Citation： TAN Jing, PENG Xiaoxia, SHU Xiaochen, WANG Li, LI Guowei, ZHANG Ling, MAO Chen, GUO Xinfeng, SUN Xin, On behalf of China REal world data and studies ALliance (ChinaREAL). Technical guidance for developing patient registry databases. Chinese Journal of Evidence-Based Medicine, 2019, 19(7): 771-778. doi: 10.7507/1672-2531.201904161 Copy

1.	Bouvy JC, Blake K, Slattery J, et al. Registries in European post-marketing surveillance: a retrospective analysis of centrally approved products, 2005-2013. Pharmacoepidemiol Drug Saf, 2017, 26(12): 1442-1450.
2.	Jonker CJ, van den Berg HM, Kwa MSG, et al. Registries supporting new drug applications. Pharmacoepidemiol Drug Saf, 2017, 26(12): 1451-1457.
3.	Zhang S, Gaiser S, Kolominsky-Rabas PL. Cardiac implant registries 2006-2016: a systematic review and summary of global experiences. BMJ Open, 2018, 8(4): e019039.
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5.	Resnic FS, Majithia A, Marinac-Dabic D, et al. Registry-based prospective, active surveillance of medical-device safety. N Engl J Med, 2017, 376(6): 526-535.
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7.	Goodney PP. Improving the quality of data in surgical registries. JAMA Surg, 2015, 150(7): 636.
8.	Arts D, De Keizer NF, Scheffer GJ. Defining and improving data quality in medical registries: a literature review, case study, and generic framework. J Am Med Inform Assoc, 2002, 9(6): 600-611.
9.	Arts D, de Keizer N, Scheffer GJ, et al. Quality of data collected for severity of illness scores in the Dutch National Intensive Care Evaluation (NICE) registry. Intensive Care Med, 2002, 28(5): 656-659.
10.	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.
11.	谭婧, 程亮亮, 王雯, 等. 患者登记研究的策划与患者登记数据库构建: 基于观察性设计的真实世界研究. 中国循证医学杂志, 2017, 17(12): 1365-1371.
12.	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.
13.	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.
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.	Langan SM, Schmidt SA, Wing K, et al. The reporting of studies conducted using observational routinely collected health data statement for pharmacoepidemiology (RECORD-PE). BMJ, 2018, 363: k3532.
16.	Spitzer E, Cannon CP, Serruys PW. Should real-world evidence be incorporated into regulatory approvals? Expert Opin Drug Saf, 2018, 9: 1-5.
17.	李洪, 魏来, 郭晓蕙, 等. 真实世界研究伦理审查初探. 中国循证医学杂志, 2018, 18(11): 1198-1202.

1. Bouvy JC, Blake K, Slattery J, et al. Registries in European post-marketing surveillance: a retrospective analysis of centrally approved products, 2005-2013. Pharmacoepidemiol Drug Saf, 2017, 26(12): 1442-1450.
2. Jonker CJ, van den Berg HM, Kwa MSG, et al. Registries supporting new drug applications. Pharmacoepidemiol Drug Saf, 2017, 26(12): 1451-1457.
3. Zhang S, Gaiser S, Kolominsky-Rabas PL. Cardiac implant registries 2006-2016: a systematic review and summary of global experiences. BMJ Open, 2018, 8(4): e019039.
4. U.S. Food & Drug Administration. Use of real-world evidence to support regulatory decision-making for medical devices. Available at: https://www.sogou.com/link?url=hedJjaC291MKYTE9c75enrRl1lre67CaI2smYvubWPDFTrmuzC6_HxuOpabFoY9DDAtF2Uxnf_K7H6UfOzzMu_peCDdarnS0mCuc_NSvjlMbO2TiRDw9Lmp63ypS7ArUC4tv2Zulat5pUc3zy0dg.
5. Resnic FS, Majithia A, Marinac-Dabic D, et al. Registry-based prospective, active surveillance of medical-device safety. N Engl J Med, 2017, 376(6): 526-535.
6. Peterson ED, Shah BR, Parsons L, et al. Trends in quality of care for patients with acute myocardial infarction in the National Registry of Myocardial Infarction from 1990 to 2006. Am Heart J, 2008, 156(6): 1045-1055.
7. Goodney PP. Improving the quality of data in surgical registries. JAMA Surg, 2015, 150(7): 636.
8. Arts D, De Keizer NF, Scheffer GJ. Defining and improving data quality in medical registries: a literature review, case study, and generic framework. J Am Med Inform Assoc, 2002, 9(6): 600-611.
9. Arts D, de Keizer N, Scheffer GJ, et al. Quality of data collected for severity of illness scores in the Dutch National Intensive Care Evaluation (NICE) registry. Intensive Care Med, 2002, 28(5): 656-659.
10. 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.
11. 谭婧, 程亮亮, 王雯, 等. 患者登记研究的策划与患者登记数据库构建: 基于观察性设计的真实世界研究. 中国循证医学杂志, 2017, 17(12): 1365-1371.
12. 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.
13. 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.
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. Langan SM, Schmidt SA, Wing K, et al. The reporting of studies conducted using observational routinely collected health data statement for pharmacoepidemiology (RECORD-PE). BMJ, 2018, 363: k3532.
16. Spitzer E, Cannon CP, Serruys PW. Should real-world evidence be incorporated into regulatory approvals? Expert Opin Drug Saf, 2018, 9: 1-5.
17. 李洪, 魏来, 郭晓蕙, 等. 真实世界研究伦理审查初探. 中国循证医学杂志, 2018, 18(11): 1198-1202.

Chinese Journal of Evidence-Based Medicine

Technical guidance for developing patient registry databases

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