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Frontiers of Medicine

ISSN 2095-0217

ISSN 2095-0225(Online)

CN 11-5983/R

Postal Subscription Code 80-967

2018 Impact Factor: 1.847

Front. Med.    2014, Vol. 8 Issue (3) : 294-299     DOI: 10.1007/s11684-014-0355-x
REVIEW |
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
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Abstract  

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.

Keywords observational study      Chinese      registry study      patient registries     
Corresponding Authors: Siyan Zhan   
Online First Date: 02 September 2014    Issue Date: 09 October 2014
URL:  
http://academic.hep.com.cn/fmd/EN/10.1007/s11684-014-0355-x     OR     http://academic.hep.com.cn/fmd/EN/Y2014/V8/I3/294
Fig.1  The variation in the number of registries in China from January 2009 to April 2014.
NCT numberTitleStudy designEstimated enrollmentStart dateCompletion datePopulationSponsor
NCT01779310Clinical pathway for Alzheimer’s disease in China Case only1024Nov. 2012Apr. 2013Outpatients with clinically significant cognitive impairment per judgment of the participating physiciansPeking University
NCT02093156A predictive score identifies patients with inadequate bowel preparation for colonoscopyProspective605Sep. 2013Dec. 2013Patients with digestive diseases from the Endoscopy CenterFourth Military Medical University
NCT01939613Colloid improves organs function in resuscitation of extensive burn patientsCase control47Jul. 2010Jul. 2013Extensive burn patients admitted within four hours after injuryTang-Du Hospital
NCT02109120MMP-9 monitoring particulate cerebral embolizationCohort48Feb. 2012Nov. 2013Patients under CEA in the Peking Union Medical College Hospital (PUMCH)PUMCH
NCT02105025A novel clinically usable point score to prejudge the complexity of colonoscopyProspective612Oct. 2013Jan. 2014Patients with digestive diseases from the Endoscopy CenterFourth Military Medical University
NCT01838629The effect of universal salt iodization on thyroid diseasesEcological or community12 438Jul. 2009Jun. 2012Patients with thyroid disease in HangzhouWeimin Xu
NCT01755351Comparative study about the influence of diabetes distress and depression on treatment adherence in Chinese type 2 diabetes patientsCohort200Dec. 2011Dec. 2012Patients with type 2 diabetes who visited two local hospitals between December 2011 and April 2012Shandong Provincial Hospital
NCT01752452Effect of ulnar styloid fracture on the outcome of distal radial fractures treated with external fixationCase control106Jan. 2009Oct. 2012Unstable 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 fractureThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
NCT01867853Volume responsiveness before spontaneous breath trial predicts the outcome of mechanical ventilation weaning in critically ill patientsCase only82Oct. 2012Mar. 2013Patients mechanically ventilated and ready to undergo spontaneous breathing trial with a T-pieceSoutheast University, China
NCT01984970Evaluation McGrath series 5 videolaryngoscope for double-lumen tube intubationProspective43Nov. 2013Jan. 2014Adult patients scheduled for thoracic surgery requiring double-lumen tube insertion for one-lung ventilationHuazhong University of Science and Technology
NCT02011776A randomized, parallel-group comparison study of topical corticosteroids in dry eye patients with Sj?gren syndromeCase control35Mar. 2013Nov. 2013People who suffered from dry eye disease caused by the Sj?gren syndromeSanten Pharmaceutical (China) Co., Ltd.
NCT02102581Evaluation of short-term effects of tourniquet use in different ways during total knee arthroplasty (TKA)Case control60Feb. 2011Dec. 2011Consecutive patients who underwent routine TKAPeking Union Medical College Hospital
Tab.1  Characteristics of the 12 completed registries in China
ScopeRegistered cases (Total= 61)
10–200201–10001001–5000>5000
Disease or condition121246
Drug9253
Device101211
Tab.2  Registries in China stratified by disease, drug, device, and cases
DiseaseNo. (%)
Endocrine, nutritional, and metabolic diseases10 (43)
Diseases of the circulatory system10 (43)
Neoplasms4 (17)
Diseases of the nervous system3 (13)
Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism3 (13)
Diseases of the respiratory system1 (4)
Diseases of the musculoskeletal system and connective tissue1 (4)
Tab.3  Number of registries according to disease
TitleStudy designEnrollmentTimeStudy sponsorPublications on PubMed
QUESTProspective6416 patients in 62 hospitalsJul. 2007 to Nov. 2006Multicenter8
CNSRProspective22 216 patients in 132 hospitalsAug. 2007 to Jul. 2008Hospital-based registry funded bythe Chinese government18
TITRetrospective5720 patients in 23 medical centersJan. 2008 to Dec. 2010Multicenter1
CABGCohort9248 patients in 35 centersJan. 2004 to Dec. 2005Fuwai Hospital; multicenter4
Tab.4  Characteristics of QUEST, CNSR, TIT, and CABG registries
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