Adult ; Aged ; Cervical Intraepithelial Neoplasia ; pathology ; surgery ; Cervix Uteri ; pathology ; surgery ; Conization ; methods ; Female ; Follow-Up Studies ; Humans ; Hysterectomy ; methods ; Middle Aged ; Neoplasm Recurrence, Local ; Neoplasm, Residual ; pathology ; surgery ; Uterine Cervical Neoplasms ; pathology ; surgery

The tools used for the literature quality evaluation are introduced. The common evaluation tools that are publicly and extensively used for the evaluation of clinical trial literature quality in the world are analyzed, including Jadad scale, Consolidated Standards of Reporting Trials (CONSORT) statement and Grades of Recommendations Assessment, Development and Evaluation (GRADE) system and the others. Additionally, the present development, updates and applications of these tools are involved in analysis.
Biomedical Research ; standards ; Evaluation Studies as Topic ; Humans ; Publications ; standards ; Quality Control

Investigation of simvastatin and its related substances was carried out using a reversed phase ultra performance liquid chromatography/tandem mass spectrometry method. The identification of impurities in simvastatin was performed with a triple-quadrupole mass spectrometer, with an electrospray ionization (ESI) source in the negative/positive ion mode. A total of 12 compounds were characterized in commercial samples, among which 2 impurities had never been reported. All the impurities were deduced based on the MS fragment pathways of simvastatin and the biosynthetic pathway of lovastatin. This work provides very useful information for quality control of simvastatin.
Chromatography, High Pressure Liquid ; Chromatography, Reverse-Phase ; Drug Contamination ; Hypolipidemic Agents ; chemistry ; Quality Control ; Simvastatin ; chemistry ; Spectrometry, Mass, Electrospray Ionization ; Tablets ; Tandem Mass Spectrometry

Objective To quantify the validity and reliability of the Hong Kong version of the functional test for the Hemiplegic Upper Extremity (FTHUE-HK).Methods Forty-two stroke patients were studied.Patients were assessed twice within one week using the FTHUE-HK,the upper extremity component of Fugl-Meyer movement assessment (FMA) and the modified Barthel index (MBI).The test-retest reliability and inter-rater reliability of the FTHUE-HK were thus quantified.The FTHUE-HK's validity was evaluated according to the correlation between the FTHUE-HK,FMA and MBI results.Results Significant correlations between the three assessments were demonstrated(P≤0.01).The intra-and inter-class correlation coefficients were 0.983 and 0.985 respectively.Conclusion The FTHUE-HK is a simple and useful assessment of the upper extremity function of stroke patients with good validity and reliability.

Objective:To study the effect of electroacupuncture (EA) at the Pericardium Meridian on the heart function of volunteers with acute hypoxia, and to provide scientific evidence for the acupoints selection along the affected meridian in acupuncture-moxibustion therapy. Methods:Based on a self-control design, eighteen healthy volunteers were recruited in the study. Points from the Pericardium Meridian [Neiguan (PC 6), Ximen (PC 4), Quze (PC 3) and Tianquan (PC 2)], non-Pericardium Meridian point [Shousanli (LI 10)], non-meridian and non-acupoint points [1.0-1.5 cm lateral to Neiguan (PC 6) and Ximen (PC 4), respectively on both sides], and a blank control (only inhaling low-oxygen gas without EA stimulation) were selected to observe, once every week, 10 sessions in total, and only 1 acupoint was observed once. The volunteers inhaled low-oxygen gas mixture (10.8% O2 and 89.2% N2) for 30 min to imitate acute hypoxia. EA was conducted when the gas mixture was inhaled for 10 min and then lasted for 20 min; meanwhile, hemodynamic indexes such as cardiac output (CO), cardiac index (CI), systemic vascular resistance (SVR), systemic vascular resistance index (SVRI), left cardiac work (LCW), left cardiac work index (LCWI) and heart rate (HR) were recorded on a hemodynamic monitor. Results:EA at the acupoints of Pericardium Meridian significantly down-regulated the increased CO/CI, LCW/LCWI, and HR (P<0.05), and significantly up-regulated the decreased SVR/SVRI in hypoxia (P<0.05); EA at other meridian acupoints or at non-meridian and non-acupoint points didn't produce such effects. Conclusion: EA at the Pericardium Meridian can obviously improve the cardiac hyper-activation caused by acute hypoxia in healthy volunteers.

ObjectiveTo establish a new method with low usage amount of arsenic trioxide for measuring 300 - 1200 μg/L high concentration iodine in urine by As3+-Ce4+ catalytic spectrophotometry using ammonium persulfate digestion, which would be convenient for monitoring urinary iodine in excessive iodine regions and to reduce environmental arsenic pollution. Methods Calibrators and urine samples(0.20 ml each) were digested according to the current standard detection method of urinary iodine(WS/T 107-2006). At the same time, improving the current standard method, the amount of arsenious acid solution was reduced from 0.100 moL/L H3AsO3 (containing NaCl 25 g/L) 2.5 ml to 0.025 mol/L H3AsO3(containing NaCl 40 g/L) 2.5 ml; amount of ceric ammonium sulfate solution was reduced from 0.076 mol/L 0.30 ml to 0.025 mol/L 0.50 ml; and photometric wavelength was changed from 420 nm to 380 nm. The new method was evaluated by standard curve linearity and linear range, sample detection precision, accuracy, and the results of urinary iodine were compared with those determined bycurrent standard method, and this new method was also tested of suitable combination of reaction temperature and reaction time of cerium arsenic in the temperature range of 20 - 30 ℃. Results The calibration relation of C =a + blgA (C: iodine concentration, A : measuring absorhance) in the new method existed when As3+- Ce4+ catalytic reaction was kept at a certain stable temperature range between 20 - 30 ℃ and in certain fixed reacting time. The linear range of the calibration curve was 300 - 1200 μg/L and the linear correlative coefficient was- 0.9999. The relative standard deviations(RSD) were 1.0％(3.2/330.3), 0.4％(2.0/517.3), 0.5％(3.9/712.6) and 0.9％(9.4/1042.3) when measuring urine samples with iodine concentration of 330.3, 517.3,712.6, and 1042.3 μg/L, respectively. The total average recovery was 98.3％ with a range of 93.4％ (186.8/200.0) - 101.5％ (202.9/200.0) when measuring 4 urine samples containing different concentration of high iodine, and average recovery was 99.1％ (148.6/150.0), 97.5％ (195.0/200.0), 98.8％ (395.3/400.0), and 98.2％ (392.7/400.0),respectively. The test results of four urinary iodine standard materials were all within the given value range and the relative deviations(RD) were all ＜ 2.0％ at different test temperature, respectively. No significant difference was found between the results of the 16 urine samples containing high concentration of iodine determined by the new method and the current standard method (|t| =0.727, P ＞ 0.05). The table of suitable combination of As3+-Ce4+ reaction temperature and reaction time for this method was obtained(such as 20 ℃ and 33 min, 25 ℃ and 25 min,30 ℃ and 19 min, etc). Conclusions This method greatly reduces the amount of arsenic in waste, reduces pollution, saves reagents, and this method is easier to be performed with better precision and accuracy, which is suitable for measuring high concentration of iodine in urine.

Objective To analysis the quality of life of patients with active ankylosing spondylitis (AS).Methods The quality of life was assessed in 52 patients with active AS using SF-36 and was compared with the general population.The correlation between the quality of life and the clinical measures of disease,in- cluding the Bath AS disease activity index(BASDAI),Bath AS functional index(BASFI),Bath AS metrology index(BASMI),patient's global assessment(PGA),spinal inflammation,total back pain,nocturnal back pain, and enthesis index(EI),were determined.Results The patients with active AS reported significant decreased scores on all dimensions of SF-36.The score of physical health components was poorer than that of mental health components.BASFI was the strongest factor correlated with the score of SF-36,followed by BASDAI and PGA.BASMI and total back pain were correlated with three dimensions only.In multivariate regression analysis,BASFI showed relative closer relationship to the qulity of life with active AS than other clinical mea- sures of disease and it accounted for 50.3%,35.2% and 47.9% of the variance in the physical health compo- nents,the mental health components and the overall score of SF-36,respectively.Conclusion The quality of life in patients with active AS is significantly declined compared with general population.The physical aspects seem to be more severely affected.Functional status of the patients with active AS are correlated with the quality of life closely.

Objective To evaluate the follow-up results of patients with cervical intraepithelial neoplasia Ⅲ(CIN Ⅲ)after surgical treatment.Methods A retrospective analysis of consecutive patients with CIN Ⅲ after surgical treatment between Jan 1st,1999 and Jun 30 th,2004 was performed.The follow- ups of the patients after surgical treatment were assessed.Results In the follow-up of patients with CINⅢ after surgical treatment,the rate of abnormal cytology was 9.3%.The rate of follow-up was higher in patients with cervical conization than in patients with initial hysterectomy and in patients of the oncological group than of the non-oncological group.The rate of follow-up was lower in patients over 40 years old.There was no difference in the residential areas of the patients.Conclusions Cytological follow-up of patients with CINⅢ after operation is varied.The rate of follow-up is lower in patients over 40 years old,in patients having initial hysterectomy and in patients of the non-oncological group.The rate of follow-up is associated with the knowledge about CIN of both surgeons and patients.

Objective To evaluate the effect of comprehensive intervention on perioperative antimicrobial prophy-laxis in clean incision surgery in a hospital.Methods From 2011 ,clean incision surgery cases were performed com-prehensive intervention,antimicrobial use in 2011 -2013 were compared.Results A total of 5 945 cases of clean in-cision surgeries were investigated between 2011 and 2013,3 827 cases (64.37%)received prophylactic use of anti-microbial agents.Prophylactic antimicrobial usage rates in 2011 -2013 were 84.95%,69.99%,and 52.97% re-spectively(χ2 =380.94,P <0.001);the correct rates of medication time were 50.97%,79.99%,and 98.95% re-spectively(χ2 =827.02,P <0.001 );the percentages of prophylactic antimicrobial use ≤24 hours were 24.91 %, 39.96%,and 64.95% respectively(χ2 =422.55,P <0.001 );additional antimicrobial usage rates during surgery were 50.00%,60.00%,and 80.00% respectively(χ2 =59.47,P <0.001 ).Conclusion The implementation of comprehensive intervention measures can standardize antimicrobial use,reduce prophylactic antimicrobial usage rate,improve the correct rate of medication time,shorten the duration of antimicrobial use,and implement addition-al use of antimicrobial agents during surgery.

Data quality management system is essential to ensure accurate, complete, consistent, and reliable data collection in clinical research. This paper is devoted to various choices of data quality metrics. They are categorized by study status, e.g. study start up, conduct, and close-out. In each category, metrics for different purposes are listed according to ALCOA+ principles such us completeness, accuracy, timeliness, traceability, etc. Some general quality metrics frequently used are also introduced. This paper contains detail information as much as possible to each metric by providing definition, purpose, evaluation, referenced benchmark, and recommended targets in favor of real practice. It is important that sponsors and data management service providers establish a robust integrated clinical trial data quality management system to ensure sustainable high quality of clinical trial deliverables. It will also support enterprise level of data evaluation and bench marking the quality of data across projects, sponsors, data management service providers by using objective metrics from the real clinical trials. We hope this will be a significant input to accelerate the improvement of clinical trial data quality in the industry.
Benchmarking ; Clinical Trials as Topic ; Data Collection ; standards ; Information Storage and Retrieval ; standards ; Quality Control