1.Data quality in clinical trials: the role of blind review.
Acta Pharmaceutica Sinica 2015;50(11):1498-1501
Blind review is one of the most important milestones in clinical trials, which connects data management process to statistical analysis. During blind review, data quality should be reviewed and assessed on both data management and statistical aspects. The primary work of data managers in blind review is to ensure the accuracy of data before it is handed over to biostatistics group. Database auditing, listing data reviewing and reconciliation should become a good clinical data management practice. Statisticians, on the other hand, will focus on quality findings related to protocol deviations or protocol violations. To investigate the protocol deviations and/or violations and relevant impacts on data outcomes, it is important to provide the essential basis of data quality through the blind review, and to assess the reliability of study outcomes.
Biostatistics
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Clinical Trials as Topic
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Data Accuracy
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Databases, Factual
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Reproducibility of Results
2.Factorial structure of connor-davidson resilience scale in Chinese college students
Yu CHEN ; Tao PEI ; Ning ZHANG
Chinese Journal of Behavioral Medicine and Brain Science 2012;21(10):945-947
ObjectiveTo explore the factorial structure of Chinese revision of connor-davidson resilience scale (CD-RISC) in Chinese college students.MethodsA total of 1534 college students were recruited for this study.After item analysis,half of the sample was used for exploratory factor analysis and the other for confirmatory factor analysis.ResultsThe Chinese revision of CD-RISC contained 19 items.Exploratory factor analysis showed that three factors were better:adaptability,tenacity and autonomy.And the results of confirmatory factor analysis ( x2/df =3.83,RMSEA =0.06,GFI =0.92,AGFI =0.90,CFI =0.92,NFI =0.89) indicated that this model provided a reasonable good fit for Chinese college students.ConclusionThis study indicate that the three-factor model of CD-RISC is adaptable to Chinese college students.
3.The Construction and Development of Ethics Committee in Hospitals——From New Drug Research to the Ethical Management of Medical Treatment
Chinese Medical Ethics 1996;0(01):-
Ethics committee in hospitals aims to protect the rights of human subjects and patients,and provide ethical evaluation and justification for guaranteeing the quality of medical research and treatment.Based on experiences in recent years,this paper suggests the following methods in order to manage the activities of ethics committees and push its further development,such as to draft the ethics system,establish the criteria of ethics,implement the process administration and provide ethics training.
4.Advances in Study on Relationship Between LncRNA and Inflammatory Diseases
Xinyu PEI ; Zonghao CHEN ; Yu ZHOU
Chinese Journal of Gastroenterology 2017;22(9):565-568
Long non-coding RNA (lncRNA)is a non-coding RNA which lacks a complete open reading frame (ORF)and plays an important role in biological processes such as cell proliferation,differentiation and apoptosis. At present,expression of lncRNA has been found to be abnormal in inflammatory reaction and inflammatory diseases. It might be involved in the development and progression of inflammatory diseases via regulating the expression of multiple genes and activation of signaling pathways. This article reviewed the progress in study on relationship between lncRNA and inflammatory diseases.
6.Insulin promotes rhesus retinal vascular endothelial cells angiogenesis via VEGF-A/VEGFR2 pathway
Saijun ZHOU ; Song CHEN ; Pei YU ; Demin YU
Chinese Journal of Endocrinology and Metabolism 2010;26(10):891-893
Rhesus retinal vascular endothelial cell line RF/6A cells were treated with human insulin. Cell proliferation, migration, and lumen formation, as well as the expressions of vascular endothelial growth factor-A ( VEGF-A ), VEGF-A receptors, and phosphorylated receptors were measured. Insulin promoted RF/6A cell proliferation, migration, and lumen formation ( all P<0. 01 ). Insulin increased the expression of VEGF-A mRNA and improved its protein activity ( all P<0. 05 ), and promoted the expression of VEGFR2 mRNA and its phosphorylation ( both P<0. 01 ). There was no significant difference in the expression of VEGFR1 mRNA among the groups ( P>0. 05 ).
7.Reliability and validity of Connor-Davidson resilience scale in Chinese college students
Yu CHEN ; Yueyi SUN ; Tao PEI ; Ning ZHANG
Chinese Journal of Behavioral Medicine and Brain Science 2013;22(11):1040-1043
Objective To examine the reliability and validity of Chinese revision of connor-davidson resilience scale(CD-RISC) in Chinese college students.Methods 1610 college students were tested with CD-RISC.783 of them took a more test by BFI and SCL-90 at the same time.After three weeks,83 students were retested by CD-RISC.Results (1) The results of confirmatory factor analysis (x2/df =6.632,RMSEA =0.059,GFI =0.934,AGFI =0.915,CFI =0.927,NFI =0.915) indicated that the three-factor model reasonably fitted Chinese college students.(2) The Cronabach α coefficients of the CD-RISC and three factors called adaptability,tenacity and autonomy were 0.914,0.865,0.784,0.767 respectively; the mean inter-item correlation coefficients of them were 0.364,0.417,0.425,0.398 respectively; the Guttman split-half coefficients were 0.888,0.843,0.707,0.650 respectively; the retest-reliability coefficients were 0.856,0.742,0.777,0.747.(3) The scores of the total scale of CDRISC and three factors were significantly correlated to BFI and SCL-90(P<0.01).There were significant differences between the low-resilient group and the high-resilient group in every index of BFI and SCL-90.(4) There were significant differences between male and female students in CD-RISC and factor tenacity and autonomy(male:2.77±0.60,2.70-±0.74,2.65±0.68;female:Z70±0.53,2.62±0.67,2.54±0.62; P<0.05).Conclusion The Chinese version of CD-RISC is a reliable and valid method for assessing resilience in Chinese college students.
8.Clinical evaluation of two different -incision phacoemulsifications
Chen, ZHAO ; Yu-Qun, ZHANG ; Jie, CEN ; Pei-Yan, HUA
International Eye Science 2016;16(11):2019-2021
AIM:To study and compare the outcomes of coaxial 2. 2 mm phacoemulsiflcation with conventional coaxial 3 mm small-incision cataract surgery.
METHODS: A randomized prospective study was conducted on 100 patients with age - related cataract:coaxial 2. 2 mm micro - incision cataract surgery was performed in 50 cases (50 eyes), and coaxial 3 mm small incision cataract surgery was performed in 50 cases ( 50 eyes) . Statistical analysis was takenwith the data of the two groups. Visual acuity, VF and QOL were compared at intervals of 1wk and 3mo after surgery. In addition, surgically induced astigmatism ( SIA ) was analyzed. Statistic analysis was taken by Student's t-test and Chi-square test.
RESULTS:There was no significant difference on BCVA (t=-1. 366, -1. 688; P=0. 148, 0. 107) between these two groups. One week and 3mo after the surgery, SIA was (0. 46±0.29)D, (0. 43±0. 26)D in the 2. 2 group; and (1. 55±0. 59) D, (0. 89±0. 28) D, in 3. 0 group. The differences between these two groups were statistically significant ( t=-7. 348, -3. 788; P = 0. 000, 0. 000 ) There were no statistically significant differences on VF scores between two group, while it's got a better score in 2. 2 groups on vision adaptation. (t=-3. 348, P<0. 05).
CONCLUSION:Coaxial 2. 2mm micro-incision cataract surgery could significantly reduce SIA and obtain morestable status of VF and QOL. This suggests that the coaxial 2. 2 phacoemulsification surgery implanted AkreosMI60 intraocular lens could get earliervisual rehabilitation postoperation.
9.Effectiveness of electroacupuncture combined with rehabilitation exercises on swallowing function of dysphagic stroke patients
Zhen HUANG ; Hai-Xia YAN ; Yu MIN ; Pei-Shun CHEN ;
Chinese Journal of Physical Medicine and Rehabilitation 2003;0(07):-
Objective To observe the therapeutic effect of electroacupuncture combined with rehabilitation exercises on swallowing function and cerebral perfusion in dysphagic stroke patients.Methods Sixty-two stroke pa- tients with dysphagia were randomly divided into a treatment group(n=32)and a control group(n=30).The treat- ment group received electroacupunture,rehabilitation exercise and conventional medical treatment,while the control group received only rehabilitation exercise and conventional medical treatment.They were treated once a day,6 times a week for 4 weeks.Water drinking test,stethocatharsis scores and swallowing fluorography were used to assess the swallowing function before and after treatment.Single photon emission computed tomography(SPECT)was also em- ployed to observe the status of cerebral perfusion before and after treatment.Results It was shown that the swallo- wing function and cerebral perfusion in the treatment group were significantly better than the control group after treat- ment.The effective rate in the treatment group was 96.88% while that of the control group was 66.67%.Conclu- sion Electroacupuncture combined with rehabilitation exercises is effective in treating the dysphagic stroke patients, and can significantly improve the brain perfusion of these patients.
10.HBV Contaminated Blood Worktable Surface: Investigation and Analysis
Meizhen CHEN ; Jun YU ; Shangwang YANG ; Pei SUN ; Wei XIAO
Chinese Journal of Nosocomiology 2006;0(08):-
OBJECTIVE To discuss the possibility of HBV contaminating environment and transmission through the polluted surroundings. METHODS On the basis of that ascertain the contaminated environment by HBV marker(HBVM) and the relationship between HBVM and HBV infectivity in the blood,to discuss the probability of HBV contaminating and be spreading through the circumstance. RESULTS The positive rate of HBsAg and HBeAg was 26.39% and 11.11%,respectively in these specimens.While all of samples in control group were negative.The HBV DNA positive rate was 73.72% and 100.00%,respectively in the positive blood specimens of HBsAg and HBeAg.The infectivity was 0-10~9 and 10~2-10~9 ID/ml,respectively. CONCLUSIONS The blood worktable surface is contaminated by HBVM.The pollution is from patients′ blood.So the probability exists that HBV is transmitted through environment pollution.