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Evaluation of the quality of randomized controlled trials on exercise for cervical radiculopathy
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作者 Long Liang Jie Yu +8 位作者 Min-Shan Feng Shuai-Qi Zhou He Yin Gong-Bo Yang Xun-LuYin Kai-Ming Li Rong Xie Xu Wei Li-Guo Zhu 《Journal of Hainan Medical University》 2019年第13期65-71,共7页
Objective:To review and evaluate the quality of the randomized controlled trials of exercise for the treatment of cervical radiculopathy with the present internationally recognized CONSORT statement, which provides re... Objective:To review and evaluate the quality of the randomized controlled trials of exercise for the treatment of cervical radiculopathy with the present internationally recognized CONSORT statement, which provides reference and basis for the improvement of clinical research on exercise for intervening cervical radiculopathy in the future.Methods: A computer-based search of large domestic databases, including CNKI, Wanfang database and VIP database screened out literature that meet the requirements and used CONSORT statement for quality assessment.Results: According to the prescribed inclusion and exclusion criteria, 30 articles were retrieved in accordance with the standard. No literature was referred to the randomized controlled trial, 2 documents clearly defined the type of test design, 1 documents carried out the calculation of sample size, 13 documents clearly randomly assigned, 1 literature implemented the blind method, in the 7 literature, baseline information was shown in tabular form, and no reference was made to trial registration, trial protocol and funding.Conclusion:There are some aspects of randomized controlled trials on exercise for the treatment of cervical radiculopathy. However, there are some aspects that need to be improved. In the future randomized controlled trial report, the CONSORT statement should be highly valued and carefully considered to improve the accuracy and credibility of the research. 展开更多
关键词 CERVICAL RADICULOPATHY EXERCISE Randomized controlled trials quality evaluation CONSORT statement
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Novel method for the evaluation of data quality based on fuzzy control 被引量:1
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作者 Ban Xiaojuan Ning Shurong +1 位作者 Xu Zhaolin Cheng Peng 《Journal of Systems Engineering and Electronics》 SCIE EI CSCD 2008年第3期606-610,共5页
One of the goals of data collection is preparing for decision-making, so high quality requirement must be satisfied. Rational evaluation of data quality is an effective way to identify data problem in time, and the qu... One of the goals of data collection is preparing for decision-making, so high quality requirement must be satisfied. Rational evaluation of data quality is an effective way to identify data problem in time, and the quality of data after this evaluation is satisfactory with the requirement of decision maker. A fuzzy neural network based research method of data quality evaluation is proposed. First, the criteria for the evaluation of data quality are selected to construct the fuzzy sets of evaluating grades, and then by using the learning ability of NN, the objective evaluation of membership is carried out, which can be used for the effective evaluation of data quality. This research has been used in the platform of 'data report of national compulsory education outlay guarantee' from the Chinese Ministry of Education. This method can be used for the effective evaluation of data quality worldwide, and the data quality situation can be found out more completely, objectively, and in better time by using the method. 展开更多
关键词 data quality evaluation system fuzzy control theory neural network.
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Standardization and Quality control parameters of Kayam Churna
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作者 Prajwal Gupta Ashwini Kendle +4 位作者 Diksha Bhagat Mahera Khan Prabuddha Wakode Shruti Shah Sonali Patil 《TMR Modern Herbal Medicine》 CAS 2022年第3期39-47,共9页
Kayam Churna is proprietary ayurvedic formulation which is blend of seven ingredients which are Senna leaves(Cassia angustifolia),Black Salt,Mulethi(Glycyrrhiza glabra),Nishoth(Operculina turpethum),Ajwain(Trachysperm... Kayam Churna is proprietary ayurvedic formulation which is blend of seven ingredients which are Senna leaves(Cassia angustifolia),Black Salt,Mulethi(Glycyrrhiza glabra),Nishoth(Operculina turpethum),Ajwain(Trachyspermum ammi),Haritaki(Terminalia chebula)and Svarjikshara(Sodium bicarbonate)with Senna as a major ingredient.Standardization and stability studies play a vital role for each herbal formulation,so the research was carried out to prepare the formulation in the laboratory and to standardize the Churna,by means of its physicochemical properties,phytochemical analysis and microbiology study.The organoleptic and powdered characteristics were studied and compared with monographs.Various physicochemical analysis was carried out like bulk density,tapped density,percent compressibility,loss on drying,ash value and heavy metal determination.Phytochemical analysis was carried out to find the presence of tannins,alkaloids,glycosides,flavonoids and steroids.Microbiological analysis was evaluated using the Total Viable Count method.HPTLC Chromatographic technique was used for fingerprinting.Microscopic analysis of Formulation showed the presence of Vessels,Fibre,Calcium oxalate crystals,etc.Tannins,Alkaloids,flavonoids were found to be present in the formulation.Microbial count and all physicochemical parameters were found to be within the limits as per the WHO guidelines.Further studies can be carried out for finding out its efficacy and potency. 展开更多
关键词 Herbal formulation STandARDIZATION evaluation quality control tests Fingerprinting
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Reliable evaluation method of quality control for compressive strength of concrete
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作者 CHEN Kuen-suan SUNG Wen-pei SHIH Ming-hsiang 《Journal of Zhejiang University-Science A(Applied Physics & Engineering)》 SCIE EI CAS CSCD 2005年第8期836-843,共8页
Concrete in reinforced concrete structure (RC) is generally under significant compressive stress load. To guarantee required quality and ductility, various tests have to be conducted to measure the concrete’s compres... Concrete in reinforced concrete structure (RC) is generally under significant compressive stress load. To guarantee required quality and ductility, various tests have to be conducted to measure the concrete’s compressive strength based on ACI (American Concrete Institute) code. Investigations of recent devastating collapses of structures around the world showed that some of the collapses directly resulted from the poor quality of the concrete. The lesson learned from these tragedies is that guaranteeing high quality of concrete is one of the most important factors ensuring the safety of the reinforced concrete structure. In order to ensure high quality of concrete, a new method for analyzing and evaluating the concrete production process is called for. In this paper, the indices of fit and stable degree are proposed as basis to evaluate the fitness and stability of concrete’s compressive strength. These two indices are combined to define and evaluate the quality index of the compressive strength of concrete. Prin-ciples of statistics are used to derive the best estimators of these indices. Based on the outcome of the study, a concrete compres-sive strength quality control chart is proposed as a tool to help the evaluation process. Finally, a new evaluation procedure to assess the quality control capability of the individual concrete manufacturer is also proposed. 展开更多
关键词 混凝土 质量控制 评估标准 可靠性分析 应力分析
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Evaluation of reanalysis surface wind products with quality-assured buoy wind measurements along the north coast of the South China Sea
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作者 Jing Cha Xinyu Lin +2 位作者 Xiaogang Guo Xiaofang Wan Dawei You 《Acta Oceanologica Sinica》 SCIE CAS CSCD 2021年第3期58-69,共12页
Three archived reanalysis wind vectors at 10 m height in the wind speed range of 2-15 m/s,namely,the second version of the National Centres for Environmental Prediction(NCEP)Climate Forecast System Reanalysis(CFSv2),E... Three archived reanalysis wind vectors at 10 m height in the wind speed range of 2-15 m/s,namely,the second version of the National Centres for Environmental Prediction(NCEP)Climate Forecast System Reanalysis(CFSv2),European Centre for Medium-Range Weather Forecasting Interim Reanalysis(ERA-I)and NCEPDepartment of Energy(DOE)Reanalysis 2(NCEP-2)products,are evaluated by a comparison with the winds measured by moored buoys in coastal regions of the South China Sea(SCS).The buoy data are first quality controlled by extensive techniques that help eliminate degraded measurements.The evaluation results reveal that the CFSv2 wind vectors are most consistent with the buoy winds(with average biases of 0.01 m/s and 1.76°).The ERA-I winds significantly underestimate the buoy wind speed(with an average bias of-1.57 m/s),while the statistical errors in the NCEP-2 wind direction have the largest magnitude.The diagnosis of the reanalysis wind errors shows the residuals of all three reanalysis wind speeds(reanalysis-buoy)decrease with increasing buoy wind speed,suggesting a narrower wind speed range than that of the observations.Moreover,wind direction errors are examined to depend on the magnitude of the wind speed and the wind speed biases.In general,the evaluation of three reanalysis wind products demonstrates that CFSv2 wind vectors are the closest to the winds along the north coast of the SCS and are sufficiently accurate to be used in numerical models. 展开更多
关键词 evaluation quality control buoy wind coastal regions of the South China Sea
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Evaluation of ICUs and weight of quality control indicators:an exploratory study based on Chinese ICU quality data from 2015 to 2020 被引量:2
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作者 Longxiang Su Xudong Ma +17 位作者 Sifa Gao Zhi Yin Yujie Chen Wenhu Wang Huaiwu He Wei Du Yaoda Hu Dandan Ma Feng Zhang Wen Zhu Xiaoyang Meng Guoqiang Sun Lian Ma Huizhen Jiang Guangliang Shan Dawei Liu Xiang Zhou China-NCCQC 《Frontiers of Medicine》 SCIE CSCD 2023年第4期675-684,共10页
This study aimed to explore key quality control factors that affected the prognosis of intensive care unit(ICU)patients in Chinese mainland over six years(2015–2020).The data for this study were from 31 provincial an... This study aimed to explore key quality control factors that affected the prognosis of intensive care unit(ICU)patients in Chinese mainland over six years(2015–2020).The data for this study were from 31 provincial and municipal hospitals(3425 hospital ICUs)and included 2110685 ICU patients,for a total of 27607376 ICU hospitalization days.We found that 15 initially established quality control indicators were good predictors of patient prognosis,including percentage of ICU patients out of all inpatients(%),percentage of ICU bed occupancy of total inpatient bed occupancy(%),percentage of all ICU inpatients with an APACHE II score≥15(%),three-hour(surviving sepsis campaign)SSC bundle compliance(%),six-hour SSC bundle compliance(%),rate of microbe detection before antibiotics(%),percentage of drug deep venous thrombosis(DVT)prophylaxis(%),percentage of unplanned endotracheal extubations(%),percentage of patients reintubated within 48 hours(%),unplanned transfers to the ICU(%),48-h ICU readmission rate(%),ventilator associated pneumonia(VAP)(per 1000 ventilator days),catheter related blood stream infection(CRBSI)(per 1000 catheter days),catheter-associated urinary tract infections(CAUTI)(per 1000 catheter days),in-hospital mortality(%).When exploratory factor analysis was applied,the 15 indicators were divided into 6 core elements that varied in weight regarding quality evaluation:nosocomial infection management(21.35%),compliance with the Surviving Sepsis Campaign guidelines(17.97%),ICU resources(17.46%),airway management(15.53%),prevention of deep-vein thrombosis(14.07%),and severity of patient condition(13.61%).Based on the different weights of the core elements associated with the 15 indicators,we developed an integrated quality scoring system defined as F score=21.35%xnosocomial infection management+17.97%xcompliance with SSC guidelines+17.46%×ICU resources+15.53%×airway management+14.07%×DVT prevention+13.61%×severity of patient condition.This evidence-based quality scoring system will help in assessing the key elements of quality management and establish a foundation for further optimization of the quality control indicator system. 展开更多
关键词 critical care medicine quality control evaluation exploratory factor analysis(EFA)model
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Improvement of Similarity Measure: Pearson Product-Moment Correlation Coefficient 被引量:5
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作者 LIUYong-suo MENGQing-hua CHENRong WANGJian-song JIANGShu-min HUYu-zhu 《Journal of Chinese Pharmaceutical Sciences》 CAS 2004年第3期180-186,共7页
Aim To study the reason of the insensitiveness of Pearson preduct-moment correlation coefficient as a similarity measure and the method to improve its sensitivity. Methods Experimental and simulated data sets were use... Aim To study the reason of the insensitiveness of Pearson preduct-moment correlation coefficient as a similarity measure and the method to improve its sensitivity. Methods Experimental and simulated data sets were used. Results The distribution range of the data sets influences the sensitivity of Pearson product-moment correlation coefficient. Weighted Pearson product-moment correlation coefficient is more sensitive when the range of the data set is large. Conclusion Weighted Pearson product-moment correlation coefficient is necessary when the range of the data set is large. 展开更多
关键词 相似测度 皮尔逊 产品 瞬间相关系数 灵敏度
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An HPLC Fingerprint Identification of Dried Barks of Ilex rotunda and Ilex godajam
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作者 Yucui MA Chun WANG +5 位作者 Wei WANG Cui WU Ning DU Wen SUN Hui LI Zhimao CHAO 《Medicinal Plant》 CAS 2018年第3期33-36,39,共5页
[Objectives] A simple and reliable HPLC fingerprint method was developed for the identification of dried barks of Ilex rotunda and I. godajam. [Methods] Nine batches of dried barks of I. rotunda,and seven batches of d... [Objectives] A simple and reliable HPLC fingerprint method was developed for the identification of dried barks of Ilex rotunda and I. godajam. [Methods] Nine batches of dried barks of I. rotunda,and seven batches of dried barks of I. godajam collected from different pharmacies and arboretums in different regions of China were used to establish fingerprints. The software Similarity Evaluation System of Chromatographic Fingerprints of Traditional Chinese Medicine( 2004 A Edition) was used to evaluate the fingerprints. [Results]The fingerprints of dried barks of I. rotunda and I. godajam were established. Methodological study met the technical requirements of fingerprints. The similarities of the fingerprints of dried barks of I. rotunda and I. godajam were all more than 0. 8 and 0. 9 respectively. There were 31 and 28 common peaks in I. rotunda and I. godajam,which could be classified into two clusters by principal component analysis( PCA) and hierarchical cluster analysis. [Conclusions] The feasibility and advantages of used HPLC fingerprints were verified,and the results indicated that the HPLC fingerprint as a characteristic distinguishing method combining similarity evaluation,principal component analysis and hierarchical cluster analysis can be successfully used to identify the authenticity of dried barks of I. rotunda and I. godajam. 展开更多
关键词 Ilex rotunda Ilex godajam HPLC fingerprint Similarity evaluation Principal component analysis(PCA) Hierarchical cluster analysis quality control
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Method of effective evaluation for examination of chloride ion in concrete
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作者 SUNGWen-pei CHENKuen-suan LINHsue-chun 《Journal of Zhejiang University-Science A(Applied Physics & Engineering)》 SCIE EI CAS CSCD 2005年第3期159-165,共7页
The chloride ion contained in reinforced concrete seriously corrodes the steel surface and damages concrete, resulting in inferior reinforced concrete that strength seriously compromises the entire structure’s safety... The chloride ion contained in reinforced concrete seriously corrodes the steel surface and damages concrete, resulting in inferior reinforced concrete that strength seriously compromises the entire structure’s safety. Consequently, the examination of chloride ions contained in reinforced concrete becomes an important part of a complete quality control procedure. To effectively check the concentration of chloride ions in concrete, the evaluation process should be accurate and precise. Laboratory data ob- tained using existing evaluation methods for the examination of chloride ion are not sufficiently objective to yield reliable results with accuracy and consistency for each sample. An evaluation algorithm with capability to define indices of precision degree (Ep) and accuracy degree (Ea) is presented in this paper. The authors established a statistically reliable index of unbiased estimators and equations to critically examine the laboratory methods’ precision, accuracy degrees and application value for measuring chlorine ion concentration in reinforced concrete. 展开更多
关键词 氯化物离子 混凝土 精确度 评价标准 质量控制系统
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Top-down法评定EDTA络合滴定法测定海洋沉积物中碳酸钙含量的不确定度 被引量:1
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作者 李强 杨天邦 +3 位作者 黄雪华 雷知生 贺晓宇 陈宋英 《化学分析计量》 CAS 2024年第1期112-117,共6页
依据Top-down技术中的质控图法对EDTA络合滴定法测定海洋沉积物中碳酸钙含量的不确定度进行评定。利用2021年质控样标准物质GBW 07333、GBW 07314和GBW 07316中CaCO_(3)测定值的时序数据进行评定,3组时序数据正态统计量A^(2*)(s)和独立... 依据Top-down技术中的质控图法对EDTA络合滴定法测定海洋沉积物中碳酸钙含量的不确定度进行评定。利用2021年质控样标准物质GBW 07333、GBW 07314和GBW 07316中CaCO_(3)测定值的时序数据进行评定,3组时序数据正态统计量A^(2*)(s)和独立性统计量A^(2*)(RM)均小于1,CaCO_(3)测定值、A_(EWMi)和移动极差控制图没有失控点,3组时序数据处于受控状态。当CaCO_(3)质量分数分别为2.05%、6.20%和38.56%时,计算得其扩展不确定度分别为0.08%、0.07%和0.20%。将测量不确定度与对应含量值进行线性拟合建立了不确定度预测模型,GBW 07309和GBW 07334中CaCO_(3)的测量不确定度预测值分别为0.09%和0.18%,预测值与Top-down技术获取的评定结果较为吻合。 展开更多
关键词 海洋沉积物 碳酸钙 不确定度评定 质控图法 络合滴定法
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健康管理护理基本技术质量控制与评价指标体系的构建
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作者 秦春香 王颖 +7 位作者 李茜 朱小伶 彭洁 唐莉 贺雪 刘雪莲 王桂莲 邓玉玲 《中国护理管理》 CSCD 北大核心 2024年第4期495-500,共6页
目的:构建健康管理护理基本技术质量控制与评价指标体系,为健康管理护理基本技术规范化、同质化管理提供参考依据。方法:在三维质量结构理论基础上,采用文献检索法、研究小组讨论和德尔菲专家函询法,筛选指标并量化质量控制与评价的维... 目的:构建健康管理护理基本技术质量控制与评价指标体系,为健康管理护理基本技术规范化、同质化管理提供参考依据。方法:在三维质量结构理论基础上,采用文献检索法、研究小组讨论和德尔菲专家函询法,筛选指标并量化质量控制与评价的维度、条目及各级评价指标。结果:最终形成健康管理护理基本技术质量控制与评价指标体系,包括一级指标3项,二级指标10项,三级指标51项。2轮专家函询问卷有效应答率均为94.4%,函询专家的权威系数为0.879,第1、第2轮咨询的肯德尔和谐系数分别为0.210、0.199,均P<0.001。结论:本研究构建的健康管理护理基本技术质量控制与评价指标体系科学、有效、客观、可操作,对规范健康管理护理服务实践、培训和考核具有参考意义,也可为健康管理机构开展健康管理护理基本技术质量控制提供可借鉴的指标。 展开更多
关键词 健康管理护理 基本技术 质量控制与评价 指标体系 德尔菲技术 三维质量结构
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白蚁防治工程质量第三方评估体系初探
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作者 胡寅 宋晓钢 于保庭 《中华卫生杀虫药械》 CAS 2024年第1期91-93,共3页
白蚁防治工程质量控制是开展项目管理的核心目标和重要工作内容之一。基于行业管理现状和发展趋势,提出采用第三方评估的模式来加强白蚁防治职能部门的质控力度。初步构建了白蚁防治工程质量第三方评估的基本体系框架,确定了评估的目标... 白蚁防治工程质量控制是开展项目管理的核心目标和重要工作内容之一。基于行业管理现状和发展趋势,提出采用第三方评估的模式来加强白蚁防治职能部门的质控力度。初步构建了白蚁防治工程质量第三方评估的基本体系框架,确定了评估的目标、原则、流程与内容,认为第三方评估应坚持“公平、公正、公开”等原则,实现全流程控制和全过程管理,对白蚁防治工程项目的技术方案、防治用品、实施人员、施工操作、质量和效果等方面进行全面系统地评估,确保项目规范实施,提升白蚁防治公益服务效能。 展开更多
关键词 白蚁防治 工程质量 评估体系 第三方
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建筑智能化方案精准设计方法探索
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作者 陈杰甫 陈众励 +1 位作者 胡一峰 陈浩楠 《建筑电气》 2024年第3期29-32,3,共5页
以智能建筑的顶层设计为基础,在比较不同智能化系统优劣的基础上,提出基于约束条件的智能化设计方案的整体比较方法,为业主智能化设计的投资优化方案提供指导。同时,构建MATLAB模型以简化计算过程,实现设计方案的便捷比较和直观展示,助... 以智能建筑的顶层设计为基础,在比较不同智能化系统优劣的基础上,提出基于约束条件的智能化设计方案的整体比较方法,为业主智能化设计的投资优化方案提供指导。同时,构建MATLAB模型以简化计算过程,实现设计方案的便捷比较和直观展示,助力精准控制方法在实际应用中的优化。 展开更多
关键词 精准控制 顶层设计 建筑智能化 质量功能配置 效益评价 智能化设计方案 设计流程 MATLAB
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基于优化组合赋权的可拓学磷矿山岩体质量评价 被引量:1
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作者 凡奥奇 王万禄 +3 位作者 李树建 张斌 刘映辉 吴浩 《黄金科学技术》 CSCD 北大核心 2024年第1期132-143,共12页
为解决岩体质量评价相邻等级之间指标参数模糊不确定性问题,引入可拓学理论,提出基于优化组合赋权的可拓学岩体质量分级模型,对昆阳二矿磷矿山地下开采的岩石进行质量评价。首先,根据矿山地质特征选取岩石单轴饱和抗压强度(Rc)、岩石质... 为解决岩体质量评价相邻等级之间指标参数模糊不确定性问题,引入可拓学理论,提出基于优化组合赋权的可拓学岩体质量分级模型,对昆阳二矿磷矿山地下开采的岩石进行质量评价。首先,根据矿山地质特征选取岩石单轴饱和抗压强度(Rc)、岩石质量指标(RQD)、节理间距(Jd)、结构面条件(Jf)、地下水状态(W)和地应力影响系数(Z)6个影响指标,将每个指标划分为5个等级;然后通过改进的层次分析法和熵权法分别确定指标的主观和客观权重,引入矩估计法对主客观权重进行优化组合;最后应用修正的RMR法和Q系统法对岩体质量进行评价,将分级结果与基于优化组合赋权的可拓学岩体质量分级结果进行比较。研究表明:5个待评价岩体中,除上矿体N3的模型分级结果与修正RMR法存在差异之外,其余岩体的分级结果与修正RMR法相同,使用Q系统法的评价结果整体偏低。此外,该模型可得出岩体质量等级偏向于相邻等级的程度,分级结果符合昆阳二矿磷矿山生产勘探地质报告岩体质量范围,比修正RMR法和Q系统法更加准确,验证了本文方法的可靠性,为地下矿山开采提供了技术支撑。 展开更多
关键词 岩体质量评价 可拓学 物元模型 矩估计法 RMR法 改进层次分析法
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优化质量控制体系与评价指标对新生儿遗传代谢病筛查效率的影响分析
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作者 李强 陈迟 +3 位作者 周莹 毛华庆 徐益红 徐艳华 《临床儿科杂志》 CAS CSCD 北大核心 2024年第6期515-519,共5页
目的 分析优化质量控制体系与评价指标对新生儿遗传代谢病筛查(简称新筛)效率的影响。方法 采用管理质量、血片质量、诊治质量3个维度的13个评价指标,分析浙江省《质量控制监测与评价指标》(简称《指标》)建立前的2013年,建立后的2015... 目的 分析优化质量控制体系与评价指标对新生儿遗传代谢病筛查(简称新筛)效率的影响。方法 采用管理质量、血片质量、诊治质量3个维度的13个评价指标,分析浙江省《质量控制监测与评价指标》(简称《指标》)建立前的2013年,建立后的2015年、修订后的2020年和2023年新筛工作质量变化,了解考核与管理指标对新筛工作的实际影响。结果 2013、2015、2020和2023年之间浙江省新筛率和召回率经卡方检验差异有统计学意义(P<0.05),但经线性回归检验后差异无统计学意义(P>0.05)。不同年份之间浙江省新生儿遗传代谢病的血片不合格率、血片不合格数未补采率、血片迟递率和血片缺错项率经卡方检验差异均有统计学意义(P<0.05),2023年上述指标均达到最低值;并通过线性回归检验后显示血片不合格率、血片不合格数未补采率和血片缺错项率有下降趋势(P<0.05)。不同年份之间先天性甲状腺功能减低症(CH)和苯丙酮尿症(PKU/BH4D)生后2、3和4周的诊断率和治疗率经卡方检验差异均有统计学意义(P<0.05),经线性回归进行趋势检验后CH生后2、4周诊断率和治疗率及PKU/BH4D生后3周诊断率和治疗率有上升趋势(P<0.05)。结论 通过建立和优化可量化的《指标》能有效评价和提升浙江省新筛的工作效率,从而进一步加强对于出生缺陷的防治能力。 展开更多
关键词 遗传代谢病筛查 质量控制 评价指标 优化 新生儿
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质谱技术在兽用治疗性蛋白药物表征和定量分析上的应用
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作者 邱基程 杨宇欣 +3 位作者 张璐 温泽宇 陈苏蒙 曹兴元 《中国畜牧兽医》 CAS CSCD 北大核心 2024年第6期2319-2329,共11页
治疗性蛋白药物已成为药物开发的一个重要分支,由于其具有良好的临床获益和安全性,现已成为肿瘤、自身免疫等疾病治疗的重点研发药物。通过体外细胞表达的治疗性蛋白药物通常具有高度复杂性,因此,在开发或生产过程中建立一系列质量分析... 治疗性蛋白药物已成为药物开发的一个重要分支,由于其具有良好的临床获益和安全性,现已成为肿瘤、自身免疫等疾病治疗的重点研发药物。通过体外细胞表达的治疗性蛋白药物通常具有高度复杂性,因此,在开发或生产过程中建立一系列质量分析和评价标准来保证药物的一致性和安全性尤为重要。质谱技术已被广泛用于小分子药物开发,具有灵敏度高、选择性和特异性良好、高通量等优点,该技术已逐步成为治疗性蛋白药物质量分析研究的重要工具,用于治疗性蛋白药物结构表征、翻译后修饰分析、定量分析、杂质分析及相互作用等研究。笔者综述了常用于蛋白质分析的质谱组成,包括常见电离方式、解离方式和质量分析仪;在此基础上,对利用质谱技术进行治疗性蛋白药物定性、翻译后修饰(糖基化、二硫键)研究的一般样品处理方法和质谱方法进行分析,并对利用质谱技术进行蛋白质定量分析方法开发、样品前处理和常用分析程序进行分析阐述;同时,笔者也对抗体药物偶联物(antibody-drug conjugate, ADC)表征、定量分析和其他质谱分析表征应用的一般方法进行总结。通过对上述内容研究分析,旨在为利用质谱技术加快兽用治疗性蛋白药物开发和研究提供参考和借鉴。 展开更多
关键词 治疗性蛋白药物 质谱分析技术 质量控制分析 定量分析
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中医药治疗良性前列腺增生随机对照试验的方法学质量与文献报告质量评价
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作者 王任远 唐新越 +3 位作者 韩强 曾银 王和天 郭军 《中华男科学杂志》 CAS CSCD 2024年第2期167-173,共7页
目的:系统评价中医药治疗BPH随机对照试验(RCT)的方法学质量与文献报告质量,以期为今后的临床实践和研究提供方法学参考。方法:检索中国知网(CNKI)、维普网(VIP)、万方数据(WF)、PubMed中自2013年1月以来至2023年11月公开发表的关于中... 目的:系统评价中医药治疗BPH随机对照试验(RCT)的方法学质量与文献报告质量,以期为今后的临床实践和研究提供方法学参考。方法:检索中国知网(CNKI)、维普网(VIP)、万方数据(WF)、PubMed中自2013年1月以来至2023年11月公开发表的关于中医药治疗BPH的RCT,2名研究者单独筛选文献,以Cochrane偏倚风险评估工具和CONSORT-中药复方为依据,评价纳入RCT的方法学质量和报告质量。结果:纳入88篇RCT,方法学质量方面,根据Cochrane偏倚风险评估工具评价:随机化过程中的偏倚27篇为低风险,61篇存在一定风险;偏离既定干预措施的偏倚(干预措施分配的效果)中76篇为低风险,10篇存在一定风险,2篇高风险;偏离既定干预措施的偏倚(干预措施依从的效果)中76篇为低风险,12篇存在一定风险;结局数据缺失的偏倚中86篇为低风险,2篇存在一定风险;结局测量的偏倚中全部文献为低风险;选择性报告结果的偏倚中65篇为低风险,2篇存在一定风险,21篇为高风险。报告质量方面,根据CONSORT-中药复方的评价标准:1篇(0.01%)采用了适当的关键词,27篇(30.68%)描述了随机分配序列方法,5篇(5.68%)对分配限定细节进行了描述,3篇(3.41%)提及分配隐藏,3篇(3.41%)实施了盲法及分配隐藏,10篇(11.36%)记录了脱落情况,38篇(43.18%)报道了不良事件,18篇(20.45%)分析了试验局限性;所有文献均无完整的干预措施、无受试者流程图、无临床试验注册及研究方案。结论:目前国内有关中医药治疗BPH的RCT的方法学质量与文献报告质量普遍偏低,问题集中在实验设计不完整,缺乏随机与盲法的详细描述,结局指标缺少中医症候评价等方面。在采纳和运用其结果时应谨慎;研究者应遵循CONSORT声明进行方案设计、注册、实施及报告,充分考虑中医药治疗BPH的临床特点,合理设计和报告评价指标。 展开更多
关键词 良性前列腺增生 中医药 随机对照试验 质量评价
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腹腔镜手术机器人应用质量与安全评价标准体系研究
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作者 程立瑞 朱志刚 +3 位作者 严浩 李树晗 张晓峰 路鹤晴 《生物医学工程学进展》 CAS 2024年第1期27-33,共7页
腹腔镜手术机器人能提高操作精度,缩短手术用时,患者出血少,恢复速度快。近年来,国产创新手术机器人的研发取得了显著成果,但目前国内外缺乏相关评价标准,增加了临床应用的风险。为科学评价腹腔镜手术机器人的应用质量与安全,急需研究... 腹腔镜手术机器人能提高操作精度,缩短手术用时,患者出血少,恢复速度快。近年来,国产创新手术机器人的研发取得了显著成果,但目前国内外缺乏相关评价标准,增加了临床应用的风险。为科学评价腹腔镜手术机器人的应用质量与安全,急需研究建立质量检测与评价标准。该研究从控制系统、图像质量、机械精度、电气安全4个维度优选评价指标。在控制系统方面选取软件功能检测规范指标;在图像质量方面选取图像质量检测规范指标;在机械精度方面选取机械臂检测规范指标;在电气安全方面选取设备外观检测规范和产品故障预防与维护控制规范两个指标。通过验证试验研究合理可行的检测与评价方法,为腹腔镜手术机器人的应用质量与安全评价提供依据,填补国内外腹腔镜手术机器人相关标准方面的空白。 展开更多
关键词 手术机器人 质量控制 检测与评价 卫生标准 腔镜手术
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针灸治疗良性前列腺增生随机对照试验报告文献质量评价
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作者 李安文 耿强 +5 位作者 孙远 郭孝伟 赵丰 赵玉 陈少峰 李重 《中国性科学》 2024年第5期118-121,共4页
目的基于国际标准,评价良性前列腺增生针灸随机对照试验报告文献质量,以期为临床诊疗应用提供循证证据。方法计算机检索中国知网、维普数据库、万方数据库、PubMed等数据库建库至2022年3月发表的良性前列腺增生针灸疗法的临床研究文献... 目的基于国际标准,评价良性前列腺增生针灸随机对照试验报告文献质量,以期为临床诊疗应用提供循证证据。方法计算机检索中国知网、维普数据库、万方数据库、PubMed等数据库建库至2022年3月发表的良性前列腺增生针灸疗法的临床研究文献。采用基于国际公认的临床试验报告统一标准及报告针刺临床试验中干预措施的国际标准(STRICTA)进行文献报道质量评估。根据Cochrane Handbook 5.2.0对文献进行方法学质量评价。结果共纳入文献42篇,方法学质量评价:20篇列明随机方法,21篇提及病例脱落,5篇提及隐藏,4篇提及盲法。对39篇与针刺相关的文献进行报道质量评估:7篇提到不同类型的针刺方法,2篇提及治疗的变动情况,30篇报道针刺的深度,32篇报告针刺反应,12篇提及治疗师的资历。结论良性前列腺增生针灸疗法的临床随机对照研究数量正在快速增长,但是文献水平和研究质量仍有待提高。 展开更多
关键词 良性前列腺增生 针灸 随机对照试验 文献质量评价
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国外地质勘查与资源调查评价中样品分析质量保证与质量控制的实践
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作者 李博文 郭冬发 +1 位作者 黄秋红 孙紫坚 《铀矿地质》 CAS CSCD 2024年第2期367-376,共10页
文章总结了质量保证与质量控制(Quality Assurance/Quality Control, QA/QC)在地质勘查和资源调查评价样品分析中的意义,根据最佳工业实践,推荐质控样品的插入率≥20%。对质控样品的选择与评价方法进行总结,标准样品应与待测样品基体匹... 文章总结了质量保证与质量控制(Quality Assurance/Quality Control, QA/QC)在地质勘查和资源调查评价样品分析中的意义,根据最佳工业实践,推荐质控样品的插入率≥20%。对质控样品的选择与评价方法进行总结,标准样品应与待测样品基体匹配且含量范围涵盖整个待测样品的含量水平,标准样品的测试结果使用控制图进行准确度判断;重复样品应在每一个重要的采样、制样阶段进行采集,并且应随机选取,重复样品的分析结果通过散点图判断精密度是否达到预期设定界限,通过相对偏差图可以获得不同因素对精密度的影响,国际上通用的量化重复样品精密度的方法是计算变异系数(Coefficient of Variation, CV);空白样品的目标元素含量应低于检出限,实验室空白样品一般为高纯度的石英砂,实际的资源勘查项目中也可采集野外空白样品进行污染监控,空白样品的控制限为3~5倍方法检出限;外检样品应送到级别相当或更高的实验室进行检测,判断两个实验室测量结果的差异,外检样品选择应随机,通过散点图判断外检样品结果的可靠性。文章通过国际上资源调查评价中质量控制与质量保证的实例进行总结,与国际标准对标,对于今后海外找矿,海外资源调查评价有重要作用。 展开更多
关键词 地质勘查 资源调查评价 质量保证与质量控制 最佳工业实践
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