Testing of hypothesis was affected by statistical analysis set division which was an important data management work before data base lock-in. Objective division of statistical analysis set under blinding was the guarantee of scientific trial conclusion. All the subjects having accepted at least once trial treatment after randomization should be concluded in safety set. Full analysis set should be close to the intention-to-treat as far as possible. Per protocol set division was the most difficult to control in blinded examination because of more subjectivity than the other two. The objectivity of statistical analysis set division must be guaranteed by the accurate raw data, the comprehensive data check and the scientific discussion, all of which were the strict requirement of data management. Proper division of statistical analysis set objectively and scientifically is an important approach to improve the data management quality.
Clinical Trials as Topic ; standards ; Databases, Factual ; Research Design ; standards ; Statistics as Topic

Missing data is a common but unavoidable issue in clinical trials. It not only lowers the trial power, but brings the bias to the trial results. Therefore, on one hand, the missing data handling methods are employed in data analysis. On the other hand, it is vital to prevent the missing data in the trials. Prevention of missing data should take the first place. From the perspective of data, firstly, some measures should be taken at the stages of protocol design, data collection and data check to enhance the patients' compliance and reduce the unnecessary missing data. Secondly, the causes of confirmed missing data in the trials should be notified and recorded in detail, which are very important to determine the mechanism of missing data and choose the suitable missing data handling methods, e.g., last observation carried forward (LOCF); multiple imputation (MI); mixed-effect model repeated measure (MMRM), etc.
Clinical Trials as Topic ; Data Collection ; methods ; standards ; Humans ; Models, Theoretical ; Research Design

Objective To investigate the relationship between the expression of ING4 and clinical primary breast cancer.Methods Tissue and peripheral blood samples of primary breast cancer patients were collected and the expression levels of ING4 and NF-κB in tissue samples were detected with immunohistochemistry.The expression of ING4 in the peripheral blood was detected with ELISA.Results The positive rates of expression of ING4 and NF-κB in breast cancer tissues were 100.00 ％ (30/30),which were significantly higher than that in the adjacent tissues 12.50 ％ (3/24) and 93.75 ％ (45/48) compared to 6.67 ％ (1/15) respectively.Compared with the preoperative,the ING4 level in peripheral blood from the postoperative breast cancer patients was significantly reduced (P =0.044).Conclusions The expression of ING4 does not decrease in the primary breast cancer patients.The increasing is perhaps due to the body's stress response against tumor development in early stage by secreting more ING4 protein.

R2) of the two models were 0.801,0.872 respectively. The fitting efficacy of the ARIMA-GRNN combination model was better than the single ARIMA, which had practical value in the research on time series data such as the incidence of scarlet fever.

Objective To investigate the expression of macrophage migration inhibition factor (MIF) and cell cycle regulating factor Cyclin D1 in hepatocellular carcinoma tissue and the interaction between MIF and Cyclin D1 in hepatocellular carcinoma cell cycle controlling. Methods Using quantitative real-time PCR and Western blotting to detect mRNA and protein expression of MIF and Cyelin DI in HCC tissues and tumor adjacent tissues. Specific small interfering RNA(siRNA) targeting MIF gene was transfccted at doses of 50 nmol/L and 100 nmoL/L into HCC cell lines of PLC and HepG2 with lipofeetamine 2000 methods to knockdown the expression of M1F gene and to investigare the the interaction between M1F and Cyclin D1. Results MIF and Cyclin D1 protein and mRNA were overexpressed in HCC tumor tissues. The relative expression of MIF,Cyclin D1 protein and mRNA were 0.825±0.13,0.843± 0.104 and 7.31±1.85 folds、4.27±1.05 folds, compared with the tumor adjacent tissues (FMIF= 15.5, P<0.01;FCyclin D1=87.5,P <0.01). In MIF siRNA treated PLC and HepG2 cells, MIF mRNA down regulation 71.2%±7.2%, 87.4%±2.9% ,74.3%±8.9% and 88.4%±4.6% respectively (FPLC = 315.5 ,P < 0.01 ; FHepG2= 201.2 P < 0.01). While MIF protein expression were significandy reduced to 0.33±0.03,0.11±0.02, 0.81±0.08 and 0.36±0.02 in a dose-dependent manner (FPLC= 43.9, P <0.01 ;FHepG2 = 133.4 P <0.01). Cyclin D1 mRNA was significantly down-regnlated in MIF siRNA treated PLC and HepG2 cell lines when compared with control group(P <0.01). In 50 nmol/L and 100 nmol/L groups, Cyclin DI mRNA levels were respectively decreased by 68.2%±3% and 78.1%±1.4% in PLC cell, 65.8%±4.7% and 77.3%±2.6% in HepG2 cell (FPLC= 1569, P < 0.01 ; FHepG2= 480.4, P <0.01). Compared with control groups, Cyclin D1 protein levels significantly reduced to 0.28±0.06、0.15±0.03 and 0.44 ±0.04、0.13±0.02 in the PLC and HepG2 after M IF siRNA treatment(FPLC= 35.5, P < 0.01 ; FHepG2 = 114.7, P < 0.01). Conclusions MIF and Cyclin D1 mRNA and protein were overexpressed in HCC tumor tissues and participated in tumor cell cycle regulation. MIF may up-regnlate the expression of Cyclin DI via ERK signalling and precipitate in carcinogenesis of hepatocellular carcinoma.

Objective To explore the feasibility and safety of the posterior approach of robotassisted laparoscopic radical prostatectomy and to the approach.Methods From November 2001 to April 2017,32 patients underwent posterior approach of robot-assisted laparoscopic radical prostatectomy.Patients aged 53 to 81 years,with mean of 66.9 years old.Their prostate volumes were 12.0-73.7 ml with an average of 32.9 ml.All patients were diagnosed by prostate biopsy before surgery.The operation time,blood loss and length of hospital stay were recorded.Results All the operations were completed by robotic assisted laparoscopy with no transition to open surgery.The surgery time was 129-210 minutes with an average of 163.6 minutes.The estimated blood loss was 20-200 ml with an average of 59.3 ml.The hospital stay was 8-21 days with an average of 12.8 days.The postoperative hospital stay was 3-13 days with an average of 6.9 days.The time of postoperative catheter removal was 4-14 days with an average of 7.5 days.Postoperative follow-up was 1-6 months.Twenty-four (75％) patients had early recovery of continence,and all (100％) patients regained continence 3-month postoperatively.Conclusion The posterior approach of robotic assisted laparoscopic radical prostatectomy was a safe and effective surgical technique,which was beneficial in early continence recovery.

To evaluate the separation of T lymphocyte subsets by immunomagnetic beads and to find optimization of strategy for specific binding of antibody-coated beads to cells, two strategies to isolate enriched T lymphocyte subpopulation CD4+ T cells and CD8+ T cells from small volumes (< 5 ml) of peripheral blood by using immunomagnetic beads or complement cytotoxicity method were compared. The purity and activity of CD4+ T cells and CD8+ T cells were measured by using flow cytometry, trypan-blue dye exclusion test, etc. The results showed that the yields of CD4+ T lymphocytes and CD8+ T lymphocytes by using immunomagnetic beads were (94.2 +/- 1.4)% and (93.8 +/- 3.0)% respectively, higher than those of control group and the group of using completement cytotoxicity method (P < 0.05). At the same time, the yields of CD4+ T lymphocytes and CD8+ T lymphocytes by using complement cytotoxicity method were (76.0 +/- 2.8)% and (77.0 +/- 3.0)% respectively, higher than those of unenriched group (P < 0.05). The trypan-blue dye exclusion test confirmed that there were no influences on activity of CD4+ T cells and CD8+ T cells when immunomagnetic beads were used for separation of these cells from peripheral blood. It is concluded that the immunomagnetic bead method has a higher efficiency for separation of CD4+ T cells and CD8+ T cells from peripheral blood than complement cytotoxic method, especially for small sample. This method has no influence on activity and proliferation of T lymphocyte subpopulations, and would be expected to establish conditions for research of biological characteristics of CD4+ T cells and CD8+ T cells in future.
CD4-Positive T-Lymphocytes ; cytology ; CD8-Positive T-Lymphocytes ; cytology ; Flow Cytometry ; Humans ; Immunomagnetic Separation ; methods ; Leukocytes, Mononuclear ; cytology ; immunology

Models, Statistical ; Propensity Score

OBJECTIVETo explore several numerical methods of ordinal variable in one-way ordinal contingency table and their interrelationship, and to compare corresponding statistical analysis methods such as Ridit analysis and rank sum test.

METHODSFormula deduction was based on five simplified grading approaches including rank_r(i), ridit_r(i), ridit_r(ci), ridit_r(mi), and table scores. Practical data set was verified by SAS8.2 in clinical practice (to test the effect of Shiwei solution in treatment for chronic tracheitis).

RESULTSBecause of the linear relationship of rank_r(i) = N ridit_r(i) + 1/2 = N ridit_r(ci) = (N + 1) ridit_r(mi), the exact chi2 values in Ridit analysis based on ridit_r(i), ridit_r(ci), and ridit_r(mi), were completely the same, and they were equivalent to the Kruskal-Wallis H test. Traditional Ridit analysis was based on ridit_r(i), and its corresponding chi2 value calculated with an approximate variance (1/12) was conservative. The exact chi2 test of Ridit analysis should be used when comparing multiple groups in the clinical researches because of its special merits such as distribution of mean ridit value on (0,1) and clear graph expression. The exact chi2 test of Ridit analysis can be output directly by proc freq of SAS8.2 with ridit and modridit option (SCORES =).

CONCLUSIONThe exact chi2 test of Ridit analysis is equivalent to the Kruskal-Wallis H test, and should be used when comparing multiple groups in the clinical researches.

Biomedical Research ; methods ; Statistics as Topic ; Statistics, Nonparametric

OBJECTIVETo study the incidence of injuries among residents living in the communities in Zhejiang.

METHODSA household questionnaire survey was conducted to 16 899 residents in four communities.

RESULTSThe incidence of injuries was 16.11% in total, higher in urban area than in rural area and higher in men than in women. The leading causes of injuries were falls (4.80%), knife-cutting or by sharp articles (3.86%), traffic accident (2.07%), collision (1.99%), scalds (1.13%) and animal bites (1.06%). Peak incidence of age group was different in different injuries, such as traffic accident was high in 45 - 60 age group and falls was high in 5 and 60 age group. Direct economic loss for each case with injury would cost 324.21 RMB yuan.

CONCLUSIONInjury was common and frequently occurred among residents at the community level which seriously on danger their health and families.

Accidental Falls ; statistics & numerical data ; Accidents, Traffic ; statistics & numerical data ; Adolescent ; Adult ; Aged ; Animals ; Bites and Stings ; epidemiology ; Burns ; epidemiology ; Child ; China ; epidemiology ; Community Health Services ; Dogs ; Female ; Humans ; Male ; Middle Aged ; Prevalence ; Wounds and Injuries ; epidemiology ; mortality