Current situation and challenge of registry in China
Yang Zhang1, Yuji Feng2, Zhi Qu1, Yali Qi3, Siyan Zhan1()
1. Department of Epidemiology and Biostatistics, School of Public Health, Peking University Health Science Centre, Beijing 100191, China 2. Pfizer Investment Co., Ltd., Beijing 100010, China 3. Department of Epidemiology, School of Public Health, Beihua University, Jilin 132001, China
Increasing emphasis has been placed on registries for an organized system used in developing clinical research to improve health care. China has sufficient data that can be applied broadly, but the heterogeneity and irregularity of registries limit their applicability. This article aims to describe the status of registries in China and the related challenges. Patient registries for observational studies were retrieved from the International Clinical Trials Registry to quantitatively evaluate the number of comparatively high-quality registries in China. A literature search was also performed to provide support and updates. A total of 64 patient registries were retrieved from ClinicalTrials.gov using disease, product, and health service as criteria. The sample sizes ranged from 15 to 30 400, with only 12 registries marked as completed. This article describes and compares the detailed information in many aspects. The efficient use of registries has already made considerable progress in China; however, registries still require standardization, high-quality transition, and coordinated development.
Patients under CEA in the Peking Union Medical College Hospital (PUMCH)
PUMCH
NCT02105025
A novel clinically usable point score to prejudge the complexity of colonoscopy
Prospective
612
Oct. 2013
Jan. 2014
Patients with digestive diseases from the Endoscopy Center
Fourth Military Medical University
NCT01838629
The effect of universal salt iodization on thyroid diseases
Ecological or community
12 438
Jul. 2009
Jun. 2012
Patients with thyroid disease in Hangzhou
Weimin Xu
NCT01755351
Comparative study about the influence of diabetes distress and depression on treatment adherence in Chinese type 2 diabetes patients
Cohort
200
Dec. 2011
Dec. 2012
Patients with type 2 diabetes who visited two local hospitals between December 2011 and April 2012
Shandong Provincial Hospital
NCT01752452
Effect of ulnar styloid fracture on the outcome of distal radial fractures treated with external fixation
Case control
106
Jan. 2009
Oct. 2012
Unstable distal radial fracture patients: (1) the initial dorsal angulation>20°, (2) with dorsal or volar commination of the metaphysis, (3) shortening of radius>5 mm, and (4) with an associated ulnar fracture
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
NCT01867853
Volume responsiveness before spontaneous breath trial predicts the outcome of mechanical ventilation weaning in critically ill patients
Case only
82
Oct. 2012
Mar. 2013
Patients mechanically ventilated and ready to undergo spontaneous breathing trial with a T-piece
Southeast University, China
NCT01984970
Evaluation McGrath series 5 videolaryngoscope for double-lumen tube intubation
Prospective
43
Nov. 2013
Jan. 2014
Adult patients scheduled for thoracic surgery requiring double-lumen tube insertion for one-lung ventilation
Huazhong University of Science and Technology
NCT02011776
A randomized, parallel-group comparison study of topical corticosteroids in dry eye patients with Sjögren syndrome
Case control
35
Mar. 2013
Nov. 2013
People who suffered from dry eye disease caused by the Sjögren syndrome
Santen Pharmaceutical (China) Co., Ltd.
NCT02102581
Evaluation of short-term effects of tourniquet use in different ways during total knee arthroplasty (TKA)
Case control
60
Feb. 2011
Dec. 2011
Consecutive patients who underwent routine TKA
Peking Union Medical College Hospital
Tab.1
Scope
Registered cases (Total= 61)
10–200
201–1000
1001–5000
>5000
Disease or condition
12
12
4
6
Drug
9
2
5
3
Device
10
12
1
1
Tab.2
Disease
No. (%)
Endocrine, nutritional, and metabolic diseases
10 (43)
Diseases of the circulatory system
10 (43)
Neoplasms
4 (17)
Diseases of the nervous system
3 (13)
Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism
3 (13)
Diseases of the respiratory system
1 (4)
Diseases of the musculoskeletal system and connective tissue
1 (4)
Tab.3
Title
Study design
Enrollment
Time
Study sponsor
Publications on PubMed
QUEST
Prospective
6416 patients in 62 hospitals
Jul. 2007 to Nov. 2006
Multicenter
8
CNSR
Prospective
22 216 patients in 132 hospitals
Aug. 2007 to Jul. 2008
Hospital-based registry funded bythe Chinese government
18
TIT
Retrospective
5720 patients in 23 medical centers
Jan. 2008 to Dec. 2010
Multicenter
1
CABG
Cohort
9248 patients in 35 centers
Jan. 2004 to Dec. 2005
Fuwai Hospital; multicenter
4
Tab.4
1
CD Mack, NA Dreyer, A Nancy, J Bosco, A Fabre. Using real-world evidence to inform decision making. Chin J Pharmacoepidemiol (Yao Wu Liu Xing Bing Xue Za Zhi) 2014; 23(1): 17–28 (in Chinese)
2
EM Brooke. The current and future use of registers in health information systems. Geneva: World Health Organization, 1974. Publication No.8
3
JA Churchill, HW Berendes, J Nemore. Neuropsychological deficits in children of diabetic mothers. A report from the Collaborative Sdy of Cerebral Palsy. Am J Obstet Gynecol 1969; 105(2): 257–268
pmid: 4980345
4
National Committee on Vital and Health Statistics. Frequency Asked Questions about Medical and Public Health Registries. . Accessed July 3, 2009
5
A service of the U.S. National Institutes of Health. 2014.
6
RE Gliklich, NA Dreyer. Registries for Evaluating Patient Outcomes: A User’s Guide. 2nd ed. (Prepared by Outcome DEcIDE Center [Outcome Sciences, Inc. d/b/a Outcome] under Contract No. HHSA29020050035I TO3.) AHRQ Publication No. 10–EHC049. Rockville, MD: Agency for Healthcare Research and Quality. September 2010
7
JL Chen, YJ Yang, JH Huang, XW Qin, SB Qiao, M Yao, HB Liu, B Xu, YJ Wu, JQ Yuan, J Chen, SJ You, J Dai, JJ Li, RL Gao. The incidence of thrombosis after implantation of drug-eluting stents in patients with coronary artery disease in the real world: a single center registry study. Chin J Cardiol (Zhonghua Xin Xue Guan Bing Za Zhi) 2007; 35(12): 1133–1135 (in Chinese)
pmid: 18341817
8
YM Xie, X Liao, YB Zhao, MB Li, YL Zhang, R Ma, SX Xian, J Liu, SY Li, ZH Wen, ZQ Yang, JD Zou, HS Sun, Y He, XL Li, JJ Jiang, ZF Wang, YY Li, LX Wang, YP Chang, W Yang, W Zhang. Technical specifications for intensive hospital safety monitoring of post-marketing Chinese medicine (draft version for comments). China J Chin Mater Med (Zhongguo Zhong Yao Za Zhi) 2013; 38: 2919–2924 (in Chinese)
9
E von Elm, DG Altman, M Egger, SJ Pocock, PC Gøtzsche, JP Vandenbroucke; STROBE-Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting of observational studies. Internist (Berl) 2008; 49(6): 688–693 https://doi.org/10.1007/s00108-008-2138-4
pmid: 18511988
10
D Taruscio, S Gainotti, E Mollo, L Vittozzi, F Bianchi, M Ensini, M Posada. The current situation and needs of rare disease registries in Europe. Public Health Genomics 2013; 16: 288–298
11
ML Berger, BC Martin, D Husereau, K Worley, JD Allen, W Yang, NC Quon, CD Mullins, KH Kahler. W Crown. A questionnaire to assess the relevance and credibility of observational studies to inform health care decision making: an ISPOR-AMCP-NPC Good Practice Task Force report. Value Health 2014; 17: 143–156
12
WQ Chen, RS Zheng, HM Zeng, SW Zhang, P Zhao, J He. Trend analysis and projection of cancer incidence in China between 1989 and 2008. Chin J Oncol (Zhonghua Zhong Liu Za Zhi) 2012; 34(7): 517–524 (in Chinese)
pmid: 22967471
13
Z Dai, RS Zheng, XN Zou, SW Zhang, HM Zeng, N Li, WQ Chen. Analysis and prediction of colorectal cancer incidence trend in China. Chin J Prev Med (Zhonghua Yu Fang Yi Xue Za Zhi) 2012; 46: 598–603 (in Chinese)
14
N Li, RS Zheng, SW Zhang, XN Zou, HM Zeng, Z Dai, WQ Chen. Analysis and prediction of breast cancer incidence trend in China. Chin J Prev Med (Zhonghua Yu Fang Yi Xue Za Zhi) 2012; 46: 703–707 (in Chinese)
15
ST Liu, JF Wu, RS Zheng, SW Zhang, XB Sun, WQ Chen. Incidence and mortality of oralcavity and pharyngeal cancer in China, 2009. Chin J Prev Med (Zhonghua Yu Fang Yi Xue Za Zhi) 2013; 47: 586–591 (in Chinese)
HM Zeng, RS Zheng, SW Zhang, P Zhao, J He, WQ Chen. Trend analysis of cancer mortality in China between 1989 and 2008.Chin J Oncol (Zhonghua Zhong Liu Za Zhi) 2012; 34(7): 525–531 (in Chinese)
pmid: 22967472
18
HM Zeng, RS Zheng, SW Zhang, XN Zou, N Li, Z Dai, WQ Chen. Analysis and prediction of esophageal cancer incidence trend in China. Chin J Prev Med (Zhonghua Yu Fang Yi Xue Za Zhi) 2012; 46: 593–597 (in Chinese)
19
YJ Fan, X Song, JL Li, XM Li, B Liu, R Wang, ZM Fan, LD Wang. Esophageal and gastric cardia cancers on 4238 Chinese patients residing in municipal and rural regions: a histopathological comparison during 24-year period. World J Surg 2008; 32(9): 1980–1988 https://doi.org/10.1007/s00268-008-9674-x
pmid: 18566857
20
Q Gao, X Fu, JW Wei, X Chen, Y Huang, J Wang, CS Anderson, KS Wong. Use of oral anticoagulation among stroke patients with atrial fibrillation in China: the ChinaQUEST (QUality Evaluation of Stroke Care and Treatment) registry study. Int J Stroke 2013; 8: 150–154
21
JW Wei, EL Heeley, JG Wang, Y Huang, LK Wong, Z Li, S Heritier, H Arima, CS Anderson. Comparison of recovery patterns and prognostic indicators for ischemic and hemorrhagic stroke in China: the ChinaQUEST (QUality Evaluation of Stroke Care and Treatment) registry study. Stroke 2010; 41(9): 1877–1883 https://doi.org/10.1161/STROKEAHA.110.586909
pmid: 20651267
22
JJ Li, ZW Zhang, MY Qian, YF Li, SS Wang; China Transcatheter Interventional Therapy of Congenital Heart Disease Study Group. Transcatheter interventional therapy of congenital heart disease: the results of Chinese TIT registry. Chin J Cardiol (Zhonghua Xin Xue Guan Bing Za Zhi) 2012; 40(4): 283–288 (in Chinese)
pmid: 22801304
23
PL Wang, XQ Zhao, YL Wang, ZH Yang, AX Wang, YJ Wang; China National Stroke Registry (CNSR) investigators. The impact of in-hospital pneumonia on the risk of in-hospital and long-term mortality in patients with acute ischemic stroke. Chin J Intern Med (Zhonghua Nei Ke Za Zhi) 2013; 52(7): 554–557 (in Chinese)
pmid: 24266994
24
Y Li, Z Zheng, S Hu; Chinese Coronary Artery Bypass Grafting Registry Study. The Chinese coronary artery bypass grafting registry study: analysis of the national multicentre database of 9248 patients. Heart 2009; 95(14): 1140–1144 https://doi.org/10.1136/hrt.2008.146563
pmid: 18632834
25
LJ Zhang, YD Chen, XT Song, FH Zhao, SZ Lü. Antithrombotic and antiplatelet therapies in relation to risk stratification in patients with non-ST elevation acute coronary syndrome: insights from the Sino-Global Registry of Acute Coronary Events. Chin Med J (Engl) 2009; 122(5): 502–508
pmid: 19323898
RR German, LM Lee, JM Horan, RL Milstein, CA Pertowski, MN Waller; Guidelines Working Group Centers for Disease Control and Prevention (CDC). Updated guidelines for evaluating public health surveillance systems: recommendations from the Guidelines Working Group. MMWR Recomm Rep 2001; 50(RR-13): 1–35, quiz CE1–CE7
pmid: 18634202
28
D Moher, KF Schulz, D Altman; CONSORT Group. The CONSORT Statement: revised recommendations for improving the quality of reports of parallel-group randomized trials 2001. Explore (NY) 2005; 1(1): 40–45 https://doi.org/10.1016/j.explore.2004.11.001
pmid: 16791967
29
LP Garrison, Jr., PJ Neumann, P Erickson, D Marshall, CD Mullins. Using real-world data for coverage and payment decisions: the ISPOR Real-World Data Task Force report. Value Health 2007;10: 326–335
