患者登记数据库构建技术规范
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摘要
患者登记数据库作为一种重要的真实世界数据来源,在药械评价和疾病管理等领域应用广泛。本文作为系列技术规范的第二篇,从患者登记的概念、适用范围、患者登记数据库的策划、构建流程、与基于既有健康医疗数据的研究型数据库的比较等维度提出了构建患者登记数据库的基本要求,并同时提出了患者登记数据库质量评价关键指标,以期规范和指导同类研究的开展。
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.
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.
引文
1Bouvy JC, Blake K, Slattery J, et al. Registries in European postmarketing 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.
3Zhang 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_NSvjlMbO2TiRDw9L mp63ypS7ArUC4tv2Zulat5pUc3zy0dg.
5Resnic 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.
7Goodney 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.
9Arts 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.
13Han Y, Jing Q, Li Y, et al. Sustained clinical safety and efficacy of a biodegradable-polymer coated sirolimus-eluting stent in"realworld"practice:three-year outcomes of the CREATE(MultiCenter 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.
15Langan 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.
2 Jonker CJ, van den Berg HM, Kwa MSG, et al. Registries supporting new drug applications. Pharmacoepidemiol Drug Saf,2017, 26(12):1451-1457.
3Zhang 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_NSvjlMbO2TiRDw9L mp63ypS7ArUC4tv2Zulat5pUc3zy0dg.
5Resnic 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.
7Goodney 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.
9Arts 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.
13Han Y, Jing Q, Li Y, et al. Sustained clinical safety and efficacy of a biodegradable-polymer coated sirolimus-eluting stent in"realworld"practice:three-year outcomes of the CREATE(MultiCenter 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.
15Langan 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.