1.Electronic data quality control strategy in clinical research
Jianping HU ; Gaoqiang XIE ; Chen YAO
Chinese Journal of Medical Science Research Management 2015;28(1):40-43
Objective To establish a method for data quality control of clinical research data based on electronic data capture (EDC) system.Methods After analyzed the specific characteristics of EDC's workflow process,and also referred to international data management guideline,we established the data quality control strategy by summarizing actual data quality control experience of data management department in Peking University Clinical Research Institute.Results Application of EDC has changed traditional clinical research process,therefore EDC data quality control strategy should be built according to its own process flow,namely,selecting the appropriate EDC system,reasonable design and build electronic case report form (eCRF),standardization research center / user management processes,timely and accurate on line eCRF filling up,accurately capturing/docking ex ternal electronic data,planned data monitor and auditing,timely and efficient query management,strictly data locking and unlocking operation process,and strict electronic record life cycle monitoring.Conclusions At present time,clinical research in China is still in the earlier stage of the transition from traditional paper-based data collection (PDC) to EDC.Establishing and applying particular quality control strategy will optimize the process and results of data quality control.
2.Clinical Characteristics of Patients with Cerebral Infarction Complicated with Metabolic Syndrome
Honghui LIU ; Zhihong WANG ; Shuangliang SHONG ; Gaoqiang XIE
Chinese Journal of Hypertension 2007;0(04):-
Objective To explore clinical characteristics of patients with cerebral infarction(CI) complicated with metabolic syndrome(MS) and their correlation with severity of cerebrovascular stenosis. Methods A total of 585 cases with CI were retrospectively studied. The patients were catogorized in to groups with and without MS according to NCEP-ATPⅢ diagnostic criteria. Severity of cerebrovascular were evaluated by CT. ResultsTwo hundred ninty cases(49.6%) complicated with MS showed higher body mass index (BMI), waist circumference, blood pressure, serum total cholesterol(TC), triglyceride (TG), uric acid (UA), fasting blood glucose (FBG), two hours postprandial blood glucose (2 h PBG), glucosylated hemoglobin A1c(HbA1c), and lower high-densitylipoprotein-cholesterol(HDL-C) than those without MS. Larger size and multiple infarcts and more serious score of neurological deficit were shown in patients complicated with MS. Severity of cerebrovascular disease disclosed by CT was positively related to levels of waist circumferene, blood pressure, TC, TG, HbA1c, FBG and 2 h PBG while in versely related to the levels of HDL-C (r=-1.23, P
3.Side effects of glucocorticosteroids in the management of 1 291 patients of SARS
Nan LI ; Guangfa WANG ; Yangfeng WU ; Gaoqiang XIE ; Feng XIAO ; Bowen CHEN ; Yuexiang WANG ; Demi HAN
Journal of Peking University(Health Sciences) 2003;0(05):-
Objective: To analysis the relationship between glucocorticosteroids (GCS) usage and side effects in the treatment of severe acute respiratory syndrome (SARS). Methods: All clinical records of probable SARS patients in Beijing were collected and input into an Epi6 database, in which 1 291 patients had entire information and met the clinical criteria of SARS. The usage of GCS and GCS associated side effects were analyzed retrospectively. Results: Patients accepted GCS therapy were 83.96% (n= 1 084), whereas 16.04%(n=207) did not take GCS. The average dosage of GCS was 160 mg/d in the first week, and then reduced to 80 mg/d and 40 mg/d in the second and the third weeks, respectively. Initial blood glucose, systolic pressure (SBP), and diastolic pressure (DBP) were no significant difference between GCS group and non-GCS group. The highest blood glucose during the treatment in GCS group was markedly higher than that in non-GCS group [(8.68? 4.80 ) mmol/L vs (6.39?3.71) mmol/L, P05). After GCS administration, SBP and DBP were increased gradually, and reached their peaks in the fourth week [SBP (117.2?14.0) mm Hg and DBP (72.5?9.1) mm Hg vs SBP (120.0?12.5) mm Hg and DBP (74.5?8.7) mm Hg, P
4.Relationship Between the Progression Rate of Corotid Maximal Plaque Area and the Risk of New Ischemic Cardiovascular Disease
Meng WANG ; Gaoqiang XIE ; Hao WANG ; Fuxiu REN ; Lirong LIANG ; Liancheng ZHAO ; Ying YANG ; Wuxiang XIE ; Ping SHI ; Yangfeng WU
Chinese Circulation Journal 2014;(7):532-536
Objective: To explore the progression rate of cortid maximal plaque area and the risk of new ischemic cardiovascular disease (ICVD) in a rural cohort in Beijing.
Methods: The PRC-USA collaborative study had been regularly conducted in Shijingshan area in Beijing. The carotid ultrasound examination, ICVD risk factor and acute cardiovascular events follow-up were conducted in those participants. A total of 1479 subjects who received at least 2 carotid ultrasound examinations and had no cardiovascular disease before the second ultrasound were studied. They were divided into 5 groups:①Control group, the participants had no plaque detected by 2 ultrasounds; ② New plaque group, new plaque was found at the second ultrasound examination; ③ Plaque regression group; ④ Plaque stabilized group and ⑤ Plaque progression group. The hazard ratio (HR) between the progression rate of corotid maximal plaque area and new ICVD events was estimated by Cox proportional hazard regression analysis .
Results: Compared with Control group, the HR for new ICVD events were higher in groups②,③,④and⑤at 3.5, 5.7, 6.2 and 7.3 respectively, all P<0.05. The increasing trend of HRs remained signiifcant with the adjusted age and gender, P<0.001.
Conclusion: The progression rate of maximal corot id plaque area rate could predict the risk of new ICVD events in clinical practice.
5.Gender Disparity and Influencing Factors for In-hospital Mortality in Patients With ST-segment Elevation Myocardial Infarction at Secondary Hospitals in China
Ningbo MA ; Yangfeng WU ; Shenshen LI ; Min LI ; Tao WU ; Xin DU ; Yihong SUN ; Gaoqiang XIE ; Lingzhi KONG ; Wei GAO ; Yong HUO ; Dayi HU ; Runlin GAO
Chinese Circulation Journal 2016;31(10):957-961
Objective: To understand the gender disparity and influencing factors for in-hospital mortality in patients with ST-segment elevation myocardial infarction (STEMI) at secondary hospitals in China. Methods: A total of 5525 in-hospital STEMI patients from 99 secondary hospitals of 15 provinces or autonomous regions between 2011-09 to 2014-06 were recruited including 1649 female and 3876 male. The in-hospital mortalities were compared between 2 genders and the relevant inlfuencing factors were studied by multiple Logistic regression analysis. Results: There were about 29.8% female and 70.2% male STEMI patients were studied. The in-hospital mortalities in female and male were 13.2% and 5.9%,P<0.01; gender disparity was obviously existing regardless of age, history of MI, hypertension and diabetes mellitus. The mortality in female was higher than male even without diseases history and cardiovascular risk factors. Compared with male gender, female patients were usually having elder age and likely complicated with cardiovascular risk factors; they were with lower incidence to receive ECG, drug therapy and thrombolysis within 10 minutes of admission. With adjusted confounding factors, multiple regression analysis presented that female STEMI patients had the higher mortality than male (OR:1.7, 95% CI:1.4-2.0). Conclusion: The in-hospital mortality for STEMI patients was higher in female than male at secondary hospitals in China. Female patients were usually having elder age, complicated with more cardiovascular risk factors, while with less chances to receive ECG, drug therapy and thrombolysis within 10 minutes of admission.
6.Prevalence of overweight and obesity in Chinese middle-aged populations: Current status and trend of development.
Yangfeng WU ; Beifan ZHOU ; Shouqi TAO ; Xigui WU ; Jun YANG ; Ying LI ; Liancheng ZHAO ; Gaoqiang XIE
Chinese Journal of Epidemiology 2002;23(1):11-15
OBJECTIVETo understand the current status on prevalence of overweight and obesity in Chinese middle-aged population, and to quantify the magnitude of the trends of development in the past two decades.
METHODSBody mass index (BMI) was measured on 15 389 middle-aged men and women from 15 natural populations all over China with different geographical, economical (urban/rural) and occupational status. Overweight was defined as BMI >/= 25 while obesity as BMI >/= 30.
RESULTS1) The rates of prevalence on overweight and obesity varied dramatically between populations. 2) In general, the prevalence rates were higher in the northern areas, in urban areas, and in women. 3) The current problem of obesity was related to 'pre-obese' stage, with less than 10% in most populations. 4) The prevalence of overweight and obesity started to show significantly increase from early 80's to early 90's but more prominant in the late 90's.
CONCLUSIONPrevention and intervention of overweight and obesity are in urgent need in the Chinese populations, especially in those economically fast developing areas.
Adult ; Body Height ; Body Mass Index ; Body Weight ; China ; epidemiology ; Female ; Humans ; Male ; Mass Screening ; statistics & numerical data ; trends ; Middle Aged ; Obesity ; epidemiology ; physiopathology ; Prevalence
7.Relationship between lipid metabolism molecules in plasma and carotid atheroscle-rotic plaques,traditional cardiovascular risk factors,and dietary factors
Jing HE ; Zhongze FANG ; Ying YANG ; Jing LIU ; Wenyao MA ; Yong HUO ; Wei GAO ; Yangfeng WU ; Gaoqiang XIE
Journal of Peking University(Health Sciences) 2024;56(4):722-728
Objective:To explore the relationship between lipid metabolism molecules in plasma and carotid atherosclerotic plaques,traditional cardiovascular risk factors and possible dietary related factors.Methods:Firstly,among 1 312 community people from those who participated in a 10-year follow-up study of subclinical atherosclerosis cohort in Shijingshan District,Beijing,85 individuals with 2 or more carotid soft plaques or mixed plaques and 89 healthy individuals without plaques were selected according to the inclusive and the exclusive criteria(<70 years,not having clinical cardiovascular disease and other diseases,etc.).Secondly,10 cases and 10 controls were randomly selected in the above 85 and 89 individuals respectively.Carotid plaques were detected using GE Vivid i Ultrasound Machine with 8L de-tector.Lipid metabolism molecules were detected by high performance liquid chromatography-mass spec-trometry.The detection indexes included 113 lipid metabolism molecules.Traditional cardiovascular risk factors were collected by unified standard questionnaires,and dietary related factors were collected by main dietary frequency and weight scale.The difference of lipid metabolism molecules between the case group and the control group was analyzed by Wilcoxin rank test.In the control group,the Spearman cor-relation method was used to analyze the correlation between statistically significant lipid metabolism molecules and traditional cardiovascular risk factors and dietary factors.Results:Among the 113 lipid metabolism molecules,53 lipid metabolism molecules were detected.C24∶0 sphingomyelin(SM),C22∶0/C24∶0 ceramide molecules,C18∶0 phosphoethanolamine(PE)molecules,and C18∶0/C18∶2(Cis)phosphatidylcholine(PC)were significantly higher in the carotid atherosclerotic plaque group than in the control group.The correlation analysis showed that C24∶0 SM was significantly positively correlated with low density lipoprotein cholesterol(LDL-C,r=0.636,P<0.05),C18∶2(Cis)PC(DLPC)was sig-nificantly positively correlated with systolic pressure(r=0.733,P<0.05),C18∶0 PE was significantly positively correlated with high sensitivity C-response protein(r=0.782,P<0.01),C22∶0,C24∶0 ce-ramide and C18∶0 PE were negatively correlated with vegetable intake(r=-0.679,P<0.05;r=-0.711,P<0.05;r=-0.808,P<0.01),C24∶0 ceramide was also negatively correlated with beans food intake(r=-0.736,P<0.05)in the control group.Conclusion:The increase of plasma C24∶0 SM,C22∶0,C24∶0 ceramide,C18∶0PE,C18∶2(Cis)PC(DLPC),C18∶0PC(DSPC)may be new risk factors for human atherosclerotic plaques.These molecules may be related to blood lipid,blood pres-sure or inflammatory level and the intake of vegetables and soy products,but the nature of the association needs to be verified in a larger sample population.