Sometimes results are expressed by repeated measure data in the field of medical research. Inappropriate statistical methods were widely used in the national medical literature. For instance, two way ANOVA or single effect analysis were usually used to analyze this kind of data. This paper introduces the repeated measure ANOVA. For repeated measure data, how to apply the SPSS 10.0 to conduct data analysis and how to report the statistically analyzed results correctly in the medical literature are also answered here.

This paper is prepared to discuss the common issues in data management, such as building and training of data management team, standard operation procedure, document management, execution and communication, strategies to correct and prevent mistakes, and measures to improve the quality and efficiency of clinical trials and data management.

Objective To develop electronic touch-screen inpatient satisfaction questionnaires so as to improve the real-fimeness and accuracy of data processing in patient satisfaction surveys and evaluations. Methods 266 inpatients from 20 clinical departments of a certain hospital in Zhangjiakou were asked to make satisfaction evaluations via a touch screen and the reliability and validity of the questionnaires were assessed by statistical and psychological means. Results The item response rate was 98.72％, the effective rate was 98.1％, and the a reliability coefficient for internal consistency was 0.9474; the composition of the questionnaires, which matched the reality of management, supported contents validity; a factor analysis showed that the factor load and structure, which matched the structure of the questionnaires, supported structure validity; intra-factor correlations, which were stronger than interfactor correlations, supported aggregation and discrimination validity. Conclusion The questionnaires, reliable andvalid, interface friendly and easy to operate, facilitate their use by patients with different backgrounds. The real-time occurrence and antomatic pooling of survey data render possible the automation of data collection in patient satisfaction surveys and evaluations.

Objective To evaluate the diagnostic value of one-stop cardiac CT (stress dynamic CT-MPI combining with CTA) in CAD. Methods Thirty patients underwent CCTA combined with stress dynamic CT-MPI and stress SPECT-MPI including 16 patients underwent ICA were retrospectively enrolled. All procedures were performed within 2 weeks without related treatment. CT-MPI and SPECT-MPI were evaluated visually and MBF was quantified according to dynamic CT-MPI which was compared through paired t test. The diagnostic value of CT-MPI for myocardial ischemia was evaluated with SPECT-MPI as the reference standard. The consistency between the two techniques was determined by Kappa test. With SPECT combined with ICA as the reference standard, we evaluated the value of CT-MPI and its combination with CCTA in the diagnosis of CAD with hemodynamic stenosis. Results On stress CT-MPI, 19 of 30 patients and 52 segments were evaluated with myocardial perfusion defects. There was a significant difference in MBF values between normal[(117.61±29.82)ml·100 ml-1·min-1] and hypoperfused [(80.60±22.15)ml·100 ml - 1 · min - 1] segments (t=15.764,P<0.001). With SPECT as reference standard, the sensitivity, specificity were 94.12% (32/34), 95.80% (456/476) on the vessel basis. The Kappa value of the two examinations was 0.772(P<0.001). As for the 16 patients who also underwent ICA, 15 patients with 22 vessel-areas had hemodynamic stenosis on CT-MPI. Compared with SPECT combined with ICA, the sensitivity, specificity for detecting hemodynamic stenosis were 92.31% (12/13), 71.43% (25/35) for CT-MPI;100%(13/13), 51.43%(18/35) for CTA and 92.31%(12/13), 82.86%(29/35) for CT-MPI combined with CTA, respectively. Moderate correlation was observed between the combination of CT-MPI and CCTA and reference standard (r=0.690,P<0.001). Conclusion Stress dynamic CT-MPI can detect myocardial perfusion defects and hemodynamic changes and improves the diagnostic ability of functional stenosis of CAD combined with CTA, which can finally achieve the one-stop mode of cardiac CT in CAD.

Objective To identify the outcome of pregnancy and the alteration of renal function in women with nephrotic syndrome. Methods From 2003 to 2007, 59 pregnant women with nephrotic syndrome in our hospital were enrolled in the study. Their clinical data were retrospectively analyzed, including the time of kidney disease onset, 24-hour proteinuria, serum albumin, serum creatinine, blood uric acid, blood pressure, fetal survival, fetal mortality, rate of premature delivery, birth weight of the newborn, and proteinuria, renal function, blood pressure of the patients during their postpartum follow-up. Logistic regression analysis was used to identify the risk factors influencing the outcome of the patients and the newborns. Results The average gestational week was (20.35±9.40) weeks when proteinuria was detected in these pregnant women. The 24-hour proteinuria ranged from 3.5 to 15 g/24 h (median 5.1 g/24 h). The serum albumin was between 10 and 28 g/L (median 22.5 g/L). The serum creatinine was between 32 and 825 μmol/L (median 84 μmol/L) and the serum uric acid ranged from 196 to 793 μmol/L (median 385.5 μmol/L). Pregnancy-induced hypertension syndrome occurred in 75% of the patients, among whom 55.5% suffered from preeclampsia. Forty-three (72.9%) newborns survived , among whom 76.7% (33/43) were premature births and 62.8% (27/43) were low birth weight infants. 50% of the pregnant women still had nephrotic syndrome after delivery. 75% of 24 patients with pre-existing chronic glomerulonephritis had increased proteinuria during pregnancy. Among the 38 patients with renal insufficiency, 36.8% had poorer renal function after delivery. 23.7% of the patients progressed into end stage renal failure after delivery, 80% of whom had serum creatinine ≥ 265 μmol/L. 89% of the patients had persistent hypertension after childbirth. The Logistic regression analysis indicated hyperuricemia during pregnancy (P=0.018, OR=1.012) and the increase of serum creatinine (P=0.039, OR=1.005) were risk factors of renal failure in pregnant women after delivery. Hyperuricemia (P=0.012, OR=1.006)was the risk factor of fetal death. Conclusions Pregnancy with nephrotic syndrome leads to a low fetal survival. Hyperuricemia is the most important risk factor of the poor outcome of pregnant women and newborn.

Objective To compare the efficacy between the two-cuff swan neck catheter and the Tenckhoff catheter in continuous ambulatory peritoneal dialysis (CAPD) patients prospectively. Methods One hundred and ten patients with end-stage renal disease (ESRD) were selected as candidates, who received catheter implantation and CAPD therapy for the first time. Patients were divided into group A (swan neck catheter group) and group B (Tenckhoff catheter group), 55 patients for each group. Catheters of beth groups had a straight end and were implanted by routine surgical procedure. One-year follow-up was performed and information was recorded such as complications, survival time, quit of dialysis, death, etc. Survival analysis was carried out by Kaplan-Meier method and Log-Rank tests. Results At the end of follow-up, 17 patients died, 3 received renal transplantation, 8 were transferred to hemodialysis, 3 went to other hospitals, and 79 patients (71.8%) remained in our department for CAPD. Twenty-six patients of both groups had peritonitis with a total of 35 occurrences. The total incidence of peritonitis was 0.32 times/patient year, with the detailed figure of 0.35 times/patient year for group A and 0.29 times/patient year for group B respectively (P0.05). The time interval between the catheter implanting and the onset of peritonitis was (30±29) weeks and (29±24) weeks for group A and group B respectively (P0.05). The risk of developing peritonitis in both groups was 26.97% within 1 year. Tunnel infection occurred in 2 patients and exit-site infections in 9 patients of two groups. The incidence of tunnel plus exit-site infections was 0.1 times/patient year. Incidence of tunnel infection and the exit-site infection for group A was lower than that of group B (0 vs 0.036 times/patient year and 0.06 times/patient year vs 0.11 times/patient year respectively). However, the difference was not significant (P0.05). Mechanical complications of catheter (catheter migration, omcntum wrapping, leakage of peritoneal dialysates, slip out of outer cuff), incidence of inguinal hernia and bellyache between two groups were not significantly different (P0.05). There were 4 cases of catheter drawing in each group. Both two groups had the same 12-month technical survival rate as 92.73%. Of 17 dead cases, 7 were in group A and 10 in group B (P0.05). The main death causes were cardiocerebral events (47.1%) and infections (23.5%). The 12-month survival rate was 86.34% for group A and 80.68% for group B (P0.05). Conclusions There are no significant differences of infection, mechanical complications, technical survival rate and patients' survival rate between two groups. The efficacy of swan-neck catheter is similar to Tenckhoff catheter in CAPD patients.

Establishment of quality management system (QMS) plays a critical role in the clinical data management (CDM). The objectives of CDM are to ensure the quality and integrity of the trial data. Thus, every stage or element that may impact the quality outcomes of clinical studies should be in the controlled manner, which is referred to the full life cycle of CDM associated with the data collection, handling and statistical analysis of trial data. Based on the QMS, this paper provides consensus on how to develop a compliant clinical data management plan (CDMP). According to the essential requirements of the CDM, the CDMP should encompass each process of data collection, data capture and cleaning, medical coding, data verification and reconciliation, database monitoring and management, external data transmission and integration, data documentation and data quality assurance and so on. Creating and following up data management plan in each designed data management steps, dynamically record systems used, actions taken, parties involved will build and confirm regulated data management processes, standard operational procedures and effective quality metrics in all data management activities. CDMP is one of most important data management documents that is the solid foundation for clinical data quality.

Objective To evaluate the academic status of 16 Chinese core orthopaedic journals from 2005 to 2007 in terms of general citation frequency, impact factors, allo-citation rate and specialty influence index. Methods On the basis of the normalized data published by Chinese S& T Journal Citation Reports (CJCR), the general citation frequency, impact factors, allo-citation rate and specialty influence index of the 16 Chinese core orthopaedic journals from 2005 to 2007 were ranked respectively and sta-tistically analyzed. Results In terms of the above 4 indicators, Chinese Journal of Orthopedics ranked the first, followed by Chinese Journal of Trauma and Chinese Journal of Reparative and Reconstructive Surgery. Considering its short history, our journal, Chinese Journal of Orthopedic Trauma, made a rapid progress in academic status. Conclusion Generally speaking, the 16 Chinese core orthopaedic journals enjoy a high academic quality and relatively significant impact.

Objective To evaluate the functional magnetic resonance (MR) imaging in the assessment of renal involvement and pathological changes in patients with lupus nephritis (LN).Methods Seventeen patients with LN and 10 healthy controls underwent coronal echo-planar diffusion-weighted (DW) MR imaging and blood oxygen level dependent (BOLD) MR imaging of the kidneys with a single breath-hold time of 16 s.The apparent diffusion coefficient (ADC) and R2* value of the kidneys were calculated with high b values (b=500 s/mm2).The correlation between the renal injury variables and the ADCs or R2* values was evaluated.Results The mean ADC value of kidneys in patients with LN was (2.43+0.24)×10-3 mm2/s,the mean R2* values of the renal cortex and medulla were (11.72+2.35)/s and (13.07+2.35)/s respectively,which were all significantly lower than those in volunteers (P=0.045,P=0.048and P=0.001,respectively).In the patients with LN,the mean ADC values were positively correlated with estimated glomerular filtration rate (eGFR) (r=0.558,P＜0.05).There was a negative correlation between the ADC values of the right kidneys and pathological chronic indexes (r=-0.493,P＜0.05).Moreover,the R2*values of the renal medulla were negatively correlated with 24 hours proteinuria,serum creatinine,pathological active indexes.The patients were assigned to group A (class Ⅲ,Ⅳ,Ⅴ,n=8) and group B class Ⅴ + Ⅲ and Ⅴ + Ⅳ,n=9).The tubulointerstitial lesions in group B were more severe than those in group A,while the mean ADC values and R2* values of the renal cortex in group B were lower as compared to group A.Conclusion DW MR imaging and BOLD MR imaging may be used to non-invasively monitor the disease activity and evaluate the efficacy in lupus nephritis.

Objective To analyze the causes and clinical features of 20 patients with hemolytic uremic syndrome (HUS) in order to improve the prognosis. Methods Twenty patients with HUS hospitalized in our department during July 1998 to December 2004 were enrolled in this study. The etiology, clinical features, individualized therapy and prognosis were retrospectively analyzed. Results These 20 HUS patients (18 HUS patients complicated with ARF) accounted for 2.48% of total patients with acute renal failure (ARF) in our hospital. There were 16 females and 4 males with mean age of (49.11±19.85) years. Five patients were idiopathic HUS and the other 15 were secondary HUS (10 SLE-associated HUS, 2 pregnancy-associated HUS, 1 APS-associated HUS, 1 renal arterioles sclerosis-associated HUS and 1 drug-associated HUS). Eighteen cases had ARF and 15 had nephrotic syndrome. Hypertension was found in 17 patients, among them 4 had malignant hypertension. Twelve patients had gross hematuria and the other 8 had microscopic hematuria. Diarrhea was found only in 1 patient. At onset, mean serum creatinine was (504.40±381.10) μmol/L and 24-h proteinuria was (5.0±2.6) g. Renal biopsy was pedormed in 16 patients. Fourteen patients received hemopurification therapy: 2 patients plasma exchange (PE); 8 patients PE combined with CVVHDF and /or HD; 4 patients CVVHDF and HD. Seven cases were treated with intravenous immunoglobulin (IVIg). Patients with SLE-associated HUS received the corticosteroids and immunosuppressants. Low or middle dosage of corticosteroids( 10-40 mg/d) was administered in patients with idiopathic HUS. For patients with APS, low molecular weight heparin was used. HUS patients were followed-up for average (46.0±32.8) months. During follow-up, 4 patients died, 11 recovered from renal insufficiency, 4 progressed to end stage renal failure of whom 2 depended on dialysis and 1 lost. The survival rates of SLE-associated HUS and none-SLE-associated HUS were 70% and 90%, and renal survival rates were 50% and 60% respectively, which were not significantly different between these two groups. Conclusions Most of the patients are secondary HUS. SLE-associated HUS is the main type of secondary HUS. The prognosis of SLE-associated HUS is poor. PE and IVIg are main therapy. Low dosage of corticosteroids can reduce relapse of HUS. Immunosuppressants can improve the prognosis.