目的探讨直接节段多频生物电阻抗分析(DSM-BIA)技术在血液透析(MHD)患者干体质量评估中的应用价值。方法选取行规律MHD治疗3个月以上的非住院患者88例,应用Kraemer评分表观察患者症状体征,根据血容量减少症状、容量状态及有无负荷过重...目的探讨直接节段多频生物电阻抗分析(DSM-BIA)技术在血液透析(MHD)患者干体质量评估中的应用价值。方法选取行规律MHD治疗3个月以上的非住院患者88例,应用Kraemer评分表观察患者症状体征,根据血容量减少症状、容量状态及有无负荷过重等情况进行严格的临床干体质量调整管控,直至Kraemer评分为0分且持续1周,并将此时的透后体质量作为临床评估干体质量(DWclin)。采用直接节段多频生物电阻抗分析仪测量MHD患者透析前后相关参数,并通过包含年龄、透析后上肢在50 k Hz时的电阻抗数值(R50)、身高以及透后BMI等参数的CB公式计算干体质量(DWDSM-BIA–CB)。观察MHD患者透析前后不同部位的DWDSM-BIA–CB值差异,并绘制Bland-Altman图对2种干体质量评估方法评估值进行一致性分析。结果 MHD患者血液透析前后躯干部R50水平均显著低于内瘘对侧上肢R50、下肢R50(P<0.01);血液透析后内瘘对侧上肢R50、躯干R50、下肢R50分别较透析前显著升高(P<0.05);本组DWclin平均(66.3±13.2)kg,Bland-Altman图形分析显示DWclin和男/女性MHD的DWDSM-BIA–CB值一致性均较好。本组血透中仅有2例老年终末期肾病患者出现感染症状。结论 DSM-BIA技术能较好反映血透患者的容量负荷,结合严格的临床管控结果可进行准确的干体质量评估,对指导临床血透方案、降低并发症等具有显著应用价值。展开更多
AIM: To create and apply a framework for quality assessment and improvement in care for inflammatory bowel disease (IBD) patients. METHODS A framework for quality assessment and improvement was created for IBD based o...AIM: To create and apply a framework for quality assessment and improvement in care for inflammatory bowel disease (IBD) patients. METHODS A framework for quality assessment and improvement was created for IBD based on two generally acknowledged quality models. The model of Donabedian (Df) offers a logistical and productive perspective and the Clinical Value Compass (CVC) model adds a management and service perspective. The framework creates a pedagogical tool to understand the balance between the dimensions of clinical care (CVC) and the components of clinical outcome (Df). The merged models create a framework of the care process dimensions as a whole, reflecting important parts of the IBD care delivery system in a local setting. Clinical and organizational quality measures were adopted from clinical experience and the literature and were integrated into the framework. Data were collected at the yearly check-up for 481 IBD patients during 2008. The application of the quality assessment framework was tested and evaluated in a local clinical IBD care setting in Jnkping County, Sweden. RESULTS: The main outcome was the presentation of how locally-selected clinical quality measures, integrated into two complementary models to develop a frame-work, could be instrumental in assessing the quality of care delivered to patients with IBD. The selected quality measures of the framework noted less anemia in the population than previously reported, provided information about hospitalization rates and the few surgical procedures reported, and noted good access to the clinic. CONCLUSION: The applied local quality framework was feasible and useful for assessing the quality of care delivered to IBD patients in a local setting.展开更多
OBJECTIVE:To investigate the safety profiles of Motherwort injection(MI).METHODS:A multi-center,prospective and drugderived hospital intensive monitoring method was conducted to assess the safety of MI in real world a...OBJECTIVE:To investigate the safety profiles of Motherwort injection(MI).METHODS:A multi-center,prospective and drugderived hospital intensive monitoring method was conducted to assess the safety of MI in real world applications.This study was based on a very large population after the injection was approved and marketed in China.All patients using the injection in participating hospitals were monitored to determine the incidence,pattern,severity and outcome of associated adverse events.RESULTS:The post-marketing surveillance was performed in 10 094 female patients from April to December,2015.The incidence of adverse drug reactions(ADRs) was 0.79‰(8/10 094).Among the 8 patients,the reported adverse events mainly included systemic abnormalities,such as fever,chills and eyelid edema;skin and appendages disorders,such as pruritus and rash;gastrointestinal disorders,such as nausea,abdominal distension and pain;heart rate and rhythm disorders,such as palpitation and increased heart rate.All of these ADRs were mild in severity.CONCLUSION:In this study the ADRs incidence rate of MI is very low,which supports that it is generally safe for use in obstetric and gynecological diseases.However,the total number of 8 ADRs recorded over a relatively short time span seems limited,and the low number of reports could not represent an absolute guarantee of safety.展开更多
In this paper, for time-to-event data, we propose a new statistical framework for casual inference in evaluating clinical utility of predictive biomarkers and in selecting an optimal treatment for a particular patient...In this paper, for time-to-event data, we propose a new statistical framework for casual inference in evaluating clinical utility of predictive biomarkers and in selecting an optimal treatment for a particular patient. This new casual framework is based on a new concept, called Biomarker Adjusted Treatment Effect （BATE） curve. The BATE curve can be used for assessing clinical utility of a predictive biomarker, for designing a subsequent confirmation trial, and for guiding clinical practice. We then propose semi-p^rametric methods for estimating the BATE curves of biomarkers and establish asymptotic results of the proposed estimators for the BATE curves. We also conduct extensive simulation studies to evaluate finite-sample properties of the proposed estimation methods. Finally, we illustrate the application of the proposed method in a real-world data set.展开更多
文摘目的探讨直接节段多频生物电阻抗分析(DSM-BIA)技术在血液透析(MHD)患者干体质量评估中的应用价值。方法选取行规律MHD治疗3个月以上的非住院患者88例,应用Kraemer评分表观察患者症状体征,根据血容量减少症状、容量状态及有无负荷过重等情况进行严格的临床干体质量调整管控,直至Kraemer评分为0分且持续1周,并将此时的透后体质量作为临床评估干体质量(DWclin)。采用直接节段多频生物电阻抗分析仪测量MHD患者透析前后相关参数,并通过包含年龄、透析后上肢在50 k Hz时的电阻抗数值(R50)、身高以及透后BMI等参数的CB公式计算干体质量(DWDSM-BIA–CB)。观察MHD患者透析前后不同部位的DWDSM-BIA–CB值差异,并绘制Bland-Altman图对2种干体质量评估方法评估值进行一致性分析。结果 MHD患者血液透析前后躯干部R50水平均显著低于内瘘对侧上肢R50、下肢R50(P<0.01);血液透析后内瘘对侧上肢R50、躯干R50、下肢R50分别较透析前显著升高(P<0.05);本组DWclin平均(66.3±13.2)kg,Bland-Altman图形分析显示DWclin和男/女性MHD的DWDSM-BIA–CB值一致性均较好。本组血透中仅有2例老年终末期肾病患者出现感染症状。结论 DSM-BIA技术能较好反映血透患者的容量负荷,结合严格的临床管控结果可进行准确的干体质量评估,对指导临床血透方案、降低并发症等具有显著应用价值。
基金Supported by The Futurum Research Council, Jnkping County Council, the Foundation for Clinical Cancer Research in Jnkping CountyVINNVRD-research program for more effective and better health care
文摘AIM: To create and apply a framework for quality assessment and improvement in care for inflammatory bowel disease (IBD) patients. METHODS A framework for quality assessment and improvement was created for IBD based on two generally acknowledged quality models. The model of Donabedian (Df) offers a logistical and productive perspective and the Clinical Value Compass (CVC) model adds a management and service perspective. The framework creates a pedagogical tool to understand the balance between the dimensions of clinical care (CVC) and the components of clinical outcome (Df). The merged models create a framework of the care process dimensions as a whole, reflecting important parts of the IBD care delivery system in a local setting. Clinical and organizational quality measures were adopted from clinical experience and the literature and were integrated into the framework. Data were collected at the yearly check-up for 481 IBD patients during 2008. The application of the quality assessment framework was tested and evaluated in a local clinical IBD care setting in Jnkping County, Sweden. RESULTS: The main outcome was the presentation of how locally-selected clinical quality measures, integrated into two complementary models to develop a frame-work, could be instrumental in assessing the quality of care delivered to patients with IBD. The selected quality measures of the framework noted less anemia in the population than previously reported, provided information about hospitalization rates and the few surgical procedures reported, and noted good access to the clinic. CONCLUSION: The applied local quality framework was feasible and useful for assessing the quality of care delivered to IBD patients in a local setting.
基金Sichuan Science and Technology Support Project:the Nested Case-control Study on Adverse Reaction Centralized Monitoring and Risk Factors of Leonurus Japonicus Injection(No.2014ZS0139)the Major State Basic Research Grant(973-program+2 种基金2011CB505406)Ph.D.Programs Foundation of Ministry of Education of China(No.2013-1210110001)State Administration of Traditional Chinese Medicine "Twelve-Five" Focus on Cultivating Subjects of Chinese Preventive Medicine[(2012)170]
文摘OBJECTIVE:To investigate the safety profiles of Motherwort injection(MI).METHODS:A multi-center,prospective and drugderived hospital intensive monitoring method was conducted to assess the safety of MI in real world applications.This study was based on a very large population after the injection was approved and marketed in China.All patients using the injection in participating hospitals were monitored to determine the incidence,pattern,severity and outcome of associated adverse events.RESULTS:The post-marketing surveillance was performed in 10 094 female patients from April to December,2015.The incidence of adverse drug reactions(ADRs) was 0.79‰(8/10 094).Among the 8 patients,the reported adverse events mainly included systemic abnormalities,such as fever,chills and eyelid edema;skin and appendages disorders,such as pruritus and rash;gastrointestinal disorders,such as nausea,abdominal distension and pain;heart rate and rhythm disorders,such as palpitation and increased heart rate.All of these ADRs were mild in severity.CONCLUSION:In this study the ADRs incidence rate of MI is very low,which supports that it is generally safe for use in obstetric and gynecological diseases.However,the total number of 8 ADRs recorded over a relatively short time span seems limited,and the low number of reports could not represent an absolute guarantee of safety.
基金supported by a Core Investigator,Research Career Scientist(Grant No.RCS OS-196)Biostatistics Unit Director at the Northwest HSR&D Center of Excellence,Department of Veterans Affairs Medical Center,Seattle,WA and Department of Veterans Affairs,Veterans Health Administration,Health Services Research and Development Service,project(Grant No.XVA61-036)
文摘In this paper, for time-to-event data, we propose a new statistical framework for casual inference in evaluating clinical utility of predictive biomarkers and in selecting an optimal treatment for a particular patient. This new casual framework is based on a new concept, called Biomarker Adjusted Treatment Effect （BATE） curve. The BATE curve can be used for assessing clinical utility of a predictive biomarker, for designing a subsequent confirmation trial, and for guiding clinical practice. We then propose semi-p^rametric methods for estimating the BATE curves of biomarkers and establish asymptotic results of the proposed estimators for the BATE curves. We also conduct extensive simulation studies to evaluate finite-sample properties of the proposed estimation methods. Finally, we illustrate the application of the proposed method in a real-world data set.
