基于能力指数的临床实验室质量控制数据室间比对系统的建立与探讨

目的建立基于能力指数的实验室质量控制数据室间比对系统。 方法室内质控系统配置比对项目和规则,录入质控数据后系统自动计算能力指数,每隔10天各实验室同一项目最小能力指数传输至室间比对系统,分别与绝对标准、相对标准及历史结果的比较,得到各实验室比对结果,帮助实验室进行质量控制改善。 结果建立室内质控数据室间比对系统,根据WS/T403-2012标准,97%比对批次显示精密度处于良好及以上,总胆固醇和血糖共计5个批次提示精密度一般,需个别改善;95.8%比对批次显示准确度良好及以上,系统误差是导致酶类项目性能降低的主要因素。 结论基于能力指数的临床实验室室内质量控制数据室间比对系统,可从精密度和正确度两个方面帮助管理者发现质控隐患,并依据当前技术水平提供各项目的性能改进建议,确保患者结果安全。     

全国新生儿遗传代谢病筛查室内质量控制结果分析

目的 通过对2011全年新生儿疾病筛查实验室苯丙氨酸(phenylalanine, Phe)和促甲状腺素(thyrotropin-stimulating hormone, TSH)室内质量控制(internal quality control, IQC)数据的统计分析, 了解目前我国筛查实验室开展IQC工作的情况。方法 利用室间质量评价活动中收集IQC数据, 上报信息包括Phe和TSH室内质控的原始数据、质控物生产厂家、质控规则、质控物批号、质控结果的个数, 在控数据变异系数、累积在控数据的变异系数、方法学原理、仪器厂家和型号, 所用试剂等相关数据。通过对2011年Phe和TSH每个月份和长期累积的室内质控数据变异系数的监测和数据统计分析, 与室内允许不精密度<1/3TEa(10%)、<1/4TEa (7.5%)进行比较, 以评价各检测项目是否满足规定的质量要求。结果 2011年1-12月份筛查实验室室内质控数据总体回报率为61.78%~91.62%, 全年平均回报率为84.86%。在质控规则选择上, 其中有80家实验室(49%)选择了1_2S或1_3S质控规则;86家实验室(51%)选择了Westgard多规则质控方法。全年12个月Phe和TSH(批号1和批号2)当月在控数据变异系数满足<1/3TEa的实验室平均百分比分别为54.63%和64.54%(Phe), 58.25%和62.35%(TSH);满足<1/4TEa的分别为29.14%和34.48%, 27.70%和28.08%。其累积在控数据变异系数满足<1/3TEa的实验室平均百分比分别为53.20%和59.12%(Phe), 57.47%和56.21%(TSH);满足<1/4TEa的分别为26.46%和28.12%, 25.64%和25.87%。大多数实验室对于满足允许不精密度要求的所占的比例较低, 实验室应在精密度性能上需进一步提高。结论 以允许不精密度(<1/3TEa、<1/4TEa)的质量规范作为新生儿筛查遗传代谢病(Phe、TSH)室内质控不精密度的评判准则, 能客观的了解筛查实验室的检测水平。通过不断提高实验室工作质量, 推动质量改进工作。     

沙门菌常规检测方法分段控制技术在网络实验室构建中基础作用的评估

目的评估沙门菌常规检测方法分段控制技术在网络实验室建设中的基础性作用。方法建立经过关键点技术控制评价的沙门菌检测方法,评估上海市参加世界卫生组织一全球沙门菌监测项目(WHO-GSS)、中美新发和再发传染病项目(GFN)网络实验室的实施,培训云南省玉溪市疾病预防控制中心腹泻标本沙门菌常规检测能力,收集2006-2012年省级GSS-GFN监测点年度沙门菌监测阳性率。结果基于分段控制技术设计的沙门菌分离、鉴定和种属鉴定、血清分群方法,能同时满足网络实验室对伤寒、非伤寒沙门菌检测敏感性需求;上海市网络实验室建设从2006年的5个公共卫生实验室和8个临床实验室发展到2011年的9和22个,伤寒、非伤寒沙门菌临床分离菌株从2006年的196株增加到2011年1442株;2012年云南省玉溪市临床腹泻病例沙门菌阳性率为2.4%;除上海外还有3个省级监测点将亚硒酸盐磺绿增菌液(SBG)作为沙门菌选择性增菌液,以上海市沙门菌监测基线最稳定。结论常规沙门菌检测分段优化的方法是构建区域网络实验室的基础,由此可上升为具有精确表型鉴定和分子分型能力的国家网络实验室。     

实验室间室内质量控制数据比对研究

目的 从实验室间室内质量控制数据比对报告中探求实验室检测中存在的问题,最终达到持续提高检测水平、持续提高检测质量的目的.方法 建立一个科学合理的实验室间室内质量控制数据比对方法,定期评价实验室间室内质控数据.结果 根据得出实验室检测的不准确度(标准差指数SDI)、不精密度(变异系数指数CVI)和总误差(TE),可以正确...     

广东省计划生育系统临床生化室内质控数据室间比对分析

目的:评价广东省计划生育系统各级计划生育服务机构临床生化检测的室内质控,了解质量现状,并分析提出改进措施。方法:比对分析19家计划生育机构实验室使用相同批号质控品的部分临床生化检测结果,以变异系数指数(CVI)和标准差指数(SDI)分别作为精密度和准确度评价指标。结果:丙氨酸氨基转移酶(ALT)的SDI和CVI合格率分别为100.00%和95.60%,肌酐(Cr)的SDI和CVI合格率分别为97.70%和97.70%,血糖(Glu)的SDI和CVI合格率分别为97.80%和93.30%。结论:在各级计划生育机构实验室之间开展室内质控数据室间比对,有利于监测及提高实验室临床生化检测质量。     

河南省2012-2016年乙型肝炎监测试点数据分析

目的 规范河南省乙型肝炎（乙肝）病例报告方法,提高乙肝病例监测工作质量。方法 选取郑州市新郑市、安阳市林州市、焦作市山阳区、漯河市召陵区、商丘市永城市和信阳市平桥区6个乙肝监测试点（监测点）,通过国家法定传染病报告系统,2012-2016年河南省报告的乙肝病例作为研究对象,2011年数据作为对照数据,分别对不同年份报告法定传染病报告系统的乙肝病例分类情况、HBsAg阳性时间、ALT值报告情况等进行描述性统计分析,对疑似急性乙肝病例进行抗-HBc IgM检测。以2016年监测点数据为基础,估算河南省2016年急性乙肝报告发病率。结果 河南省6个监测点乙肝报告病例从2011年的17 436例下降到2016年2 632例,下降了84.90%（14 804/17 436）;乙肝未分类病例从36.87%（6 370/17 275）下降至0.08%（2/2 632）。2012-2016年,河南省CDC共收到初筛抗-HBc IgM阳性血清777份,经过复核,29.34%（228/777）的疑似急性乙肝病例血样抗-HBc IgM阳性。依据2016年6个监测点急性乙肝报告发病率,估算河南省急性乙肝报告发病率为1.13/10万（95% CI：0.81/10万~1.45/10万）。结论 2012-2016年河南省监测点乙肝病例报告质量和临床诊断病例的准确性均不断提高。监测点应该进一步提高急性乙肝报告病例的血样采集率,改进检测方法。     

临床生化室内质量控制的实践体会

临床检验的室内质量控制工作,旨在监测样本测定中的精密度,并检测其准确度的改变,提高常规工作中测定结果的一致性;室间质控是通过实验室间的比对,观察实验室间结果的准确性、一致性,确保实验室维持较高的检测水平。为了保证出具准确检验报告,就要实行全面质量管理,做好生化室内质量控制,参加卫生部室间质控,提高检验质量,为临床提供准确、精密、具有完全可信性的实验结果。     

ELISA法检测项目室内质控框架建立的常用方法

目的阐述ELISA法检测项目室内质控建立的方法,使实验室以最短时间进入受控状态,增强检验结果的可信度,确保检验结果的有效性,提高准确率.方法利用实验室ELISA法检测的质控品数据,按照质控要求和检验项目的检测频度,采用多种模式设定靶值和控制限,建立室内质控框架.结果几种模式建立的室内质控框架,均符合ELISA法检测的室内质量控制要求,达到了质控目的.结论ELISA法检测室内质控建立与实施,是评价实验室检测结果可信度的重要手段之一,本文例举常用几种建立室内质控的方法,可满足大部分临床实验室的需求,同时解决了某些检验频度低的项目开展质控的难题.     

2006－2012年全国伤害监测工作状况评估

目的 描述2006－2012年全国伤害监测工作现状,为监测数据的利用和解释及监测工作的发展和完善提供依据。方法 根据中国疾病预防控制中心慢性非传染性疾病预防控制中心(慢病中心)制定的全国伤害监测统一方案,通过回顾性自查收集2006－2012年全国各省级疾病预防控制中心和监测点伤害监测漏报率、错填率、漏录率、错录率、伤害监测产出数量以及2012年伤害监测专职工作人员数、伤害监测配套工作经费数及伤害监测数据共享情况指标,由慢病中心复核、录入及分析数据。结果 2006－2012年全国伤害监测病例增长1倍。各监测点漏报率和错填率持续降低:72.1%(31个)的监测点漏报率降低、53.5%(23个)的监测点错填率降低;2012年≤10%漏报率和错填率的监测点分别占76.7%(33个)和90.7%(39个)。全国伤害监测系统中省级和县(区)级疾病预防控制中心设置伤害监测专职人员分别占44.2%(19个)和76.2%(32个)。有27.9%的监测点(12个)未利用伤害监测数据发布过报告,有7.0%的监测点(3个)从未利用伤害监测数据;与其他部门实现数据共享的监测点仅占30.2%(13个)。结论 2006－2012年全国伤害监测工作质量显著提高且影响日益增加。     

数据上报质量对基于医疗机构的症状监测系统预警灵敏度影响的研究

目的 评价湖北省潜江地区基于医疗机构症状监测系统的数据上报质量对该系统预警灵敏度的影响。方法 计算医疗机构症状监测系统运行期间数据质量评估指标（迟报率、缺报率）;使用半合成模拟暴发数据及预测模型ROC曲线下面积（AUC）评估多种预警模型的预测能力,筛选最佳预警模型;采用时间序列的广义相加模型（GAM）对数据质量评估指标与系统灵敏度进行曲线拟合及阈值效应分析。结果 2012年4月1日至2014年1月31日潜江地区累计上报总症状179 905例,迟报8 744次,平均每月迟报416次,总迟报率为16.45%;缺报2 566次,缺报率为4.83%。与其他预警模型（累积和模型、休哈特模型、指数加权移动平均模型、早期异常报告系统模型）相比,移动平均法模型的预测效果最佳（AUC=0.93）;与其他模型相比,AUC差异有统计学意义（P<0.001）。症状监测系统运行期间,系统预警暴发的灵敏度介于84.89%～97.25%之间。缺报率对监测系统灵敏度有影响,即当缺报率>2.78%时,系统灵敏度迅速下降,未观察到迟报率对灵敏度有影响。结论 湖北省潜江地区医疗机构症状监测系统的数据报告质量影响该系统的预警灵敏度,在此次设定参数的前提下,主要是数据的缺报率对系统灵敏度有影响。     

Evaluation of the National Tuberculosis Surveillance System in Sana’a,Yemen, 2018: Observational Study

BackgroundTuberculosis remains a public problem that is considered one of the top causes of morbidity and mortality worldwide. The National Tuberculosis Control Program in Yemen was established in 1970 and included in the national health policy under the leadership of the Ministry of Public Health and Population to monitor tuberculosis control. The surveillance system must be evaluated periodically to produce recommendations for improving performance and usefulness.ObjectiveThis study aims to assess the usefulness and the performance of the tuberculosis surveillance system attributes and to identify the strengths and weaknesses of the system.MethodsA quantitative and qualitative evaluation of the national tuberculosis surveillance system was conducted using the Centers for Disease Control and Prevention’s updated guidelines. The study was carried out in 10 districts in Sana’a City. A total of 28 public health facilities providing tuberculosis services for the whole population in their assigned catchment areas were purposively selected. All participants were interviewed based on their involvement with key aspects of tuberculosis surveillance activities.ResultsThe tuberculosis surveillance system was found to have an average performance in usefulness (57/80, 71%), flexibility (30/40, 75%), acceptability (174/264, 66%), data quality (4/6, 67%), and positive predictive value (78/107, 73%), and poor performance in simplicity (863/1452, 59%) and stability (15%, 3/20). In addition, the system also had a good performance in sensitivity (78/81, 96%).ConclusionsThe tuberculosis surveillance system was found to be useful. The flexibility, positive predictive value, and data quality were average. Stability and simplicity were poor. The sensitivity was good. The main weaknesses in the tuberculosis surveillance system include a lack of governmental financial support, a paper-based system, and a lack of regular staff training. Developing an electronic system, securing governmental finances, and training the staff on tuberculosis surveillance are strongly recommended to improve the system performance.     

Performance of the Severe Acute Respiratory Illness Sentinel Surveillance System in Yemen: Mixed Methods Evaluation Study

BackgroundThe national severe acute respiratory illness (SARI) surveillance system in Yemen was established in 2010 to monitor SARI occurrence in humans and provide a foundation for detecting SARI outbreaks.ObjectiveTo ensure that the objectives of national surveillance are being met, this study aimed to examine the level of usefulness and the performance of the SARI surveillance system in Yemen.MethodsThe updated Centers for Disease Control and Prevention guidelines were used for the purposes of our evaluation. Related documents and reports were reviewed. Data were collected from 4 central-level managers and stakeholders and from 10 focal points at 4 sentinel sites by using a semistructured questionnaire. For each attribute, percent scores were calculated and ranked as follows: very poor (≤20%), poor (20%-40%), average (40%-60%), good (60%-80%), and excellent (>80%).ResultsAs rated by the evaluators, the SARI surveillance system achieved its objectives. The system’s flexibility (percent score: 86%) and acceptability (percent score: 82%) were rated as “excellent,” and simplicity (percent score: 74%) and stability (percent score: 75%) were rated as “good.” The percent score for timeliness was 23% in 2018, which indicated poor timeliness. The overall data quality percent score of the SARI system was 98.5%. Despite its many strengths, the SARI system has some weaknesses. For example, it depends on irregular external financial support.ConclusionsThe SARI surveillance system was useful in estimating morbidity and mortality, monitoring the trends of the disease, and promoting research for informing prevention and control measures. The overall performance of the SARI surveillance system was good. We recommend expanding the system by promoting private health facilities’ (eg, private hospitals and private health centers) engagement in SARI surveillance, establishing an electronic database at central and peripheral sites, and providing the National Central Public Health Laboratory with the reagents needed for disease confirmation.     

Impact of a web-based personally tailored physical activity intervention on depression,anxiety, stress and quality of life: Secondary outcomes from a randomized controlled trial

BackgroundFew studies have investigated the impact of web-based physical activity interventions on mental health outcomes. Therefore, this study examined the impact of a web-based personally tailored physical activity intervention on depression, anxiety, stress and quality of life.Methods501 participants were randomised into either a control group or a pooled intervention condition who received a 3-month web-based personally tailored physical activity intervention. Previously, this intervention has demonstrated to improve self-reported physical activity, but not device-measured physical activity. At baseline, 3- and 9-months, depression, anxiety and stress were assessed using the DASS21, and quality of life was assessed using the SF-12V2. General linear mixed models examined differences between groups over time.ResultsMost participants (>80%) reported normal levels of depression, anxiety or stress. Relative to baseline levels, significant reductions of depression, anxiety, stress and the SF12 mental health component were observed in the pooled intervention group at 3 and 9 months. Relative to the control group, significant reductions were observed in the pooled intervention group for depression and stress (3-months only) and anxiety (3- and 9-months), but not quality of life.ConclusionA web-based physical activity intervention can result in positive mental health outcomes, even in the absence of device-measured physical activity improvements. However, these findings need to be confirmed in future studies.Trial registration numberACTRN12615000057583.     

Accesibilidad y utilización de la espirometría en los centros de atención primaria de Cataluña

ObjectiveExamine the accessibility and use of forced spirometry (FS) in public primary care facilities centers in Catalonia.DesignCross-sectional study using a survey.ParticipantsThree hundred sixty-six Primary Care Teams (PCT) in Catalonia. Third quarter of 2010.MeasurementsSurvey with information on spirometers, training, interpretation and quality control, and the priority that the quality of spirometry had for the team. Indicators FS/100 inhabitants/year, FS/month/PCT; FS/month/10,000 inhabitants.Main resultsResponse rate: 75%. 97.5% of PCT had spirometer and made an average of 2.01 spirometries/100 inhabitants (34.68 spirometry/PCT/month). 83% have trained professionals. > 50% centers perform formal training but no information is available on the quality. 70% performed some sort of calibration. Interpretation was made by the family physician in 87.3% of cases. In 68% of cases not performed any quality control of exploration. 2/3 typed data manually into the computerized medical record. > 50% recognized a high priority strategies for improving the quality.ConclusionDespite the accessibility of EF efforts should be made to standardize training, increasing the number of scans test and promote systematic quality control.     

Diarrheal illness among infants and toddlers in day care centers: effects of active surveillance and staff training without subsequent monitoring

From October 1981 to September 1984, the authors conducted a three-year longitudinal study of diarrhea among infants and toddlers attending day care centers in Maricopa County, Arizona. In the third year of study, they evaluated the effects on diarrhea rates of staff training without external monitoring and of active surveillance conducted throughout the study. From 21 study day care centers, they randomly selected 10 ("intervention day care centers") to receive staff training in procedures to reduce transmission of infectious diarrhea. Continuing active surveillance in the 10 intervention and 11 control day care centers found no difference between diarrhea rates in intervention day care centers in the pre- and posttraining years and no difference between diarrhea rates in the two groups of centers either before or after the training intervention. Biweekly family-based surveys during the two months after training also demonstrated no difference between infant-toddler diarrhea rates in intervention and control day care centers. These surveys found the 21 study day care centers to have significantly higher diarrhea rates than did day care homes or households not using day care, but significantly lower rates than day care centers not included in the active surveillance. Continuous surveillance without training was associated with a significant decrease in diarrheal illness during the course of longitudinal study. One-time staff training without subsequent monitoring did not result in additional decreases and did not lower day care center diarrhea rates to the levels observed in day care homes and households not using day care.     

Research capacity training for surveillance and response in the Indo-Pacific: a case study of implementation

SETTING:Surveillance and response workforce in the Indo-Pacific region, including Papua New Guinea (PNG), Solomon Islands, Fiji, Eastern Indonesia and Timor-Leste.OBJECTIVE:To evaluate the implementation of a modified WHO SORT IT research training programme which included a workplace-based research project. The training was designed for surveillance and response frontline workforce in the Indo-Pacific region.DESIGN:This was a programme evaluation using mixed methods. Fifty-three health and biosecurity workers from Fiji, Indonesia, PNG, Solomon Islands and Timor-Leste participated in the research training programme.RESULTS:Implementation of the programme was modified to reflect the context of participant countries. Work-place research projects focused on priority issues identified by local policy makers and in-country stakeholders. Self-reported research skills showed a significant increase (P < 0.01) after the completion of training. Participants reported high scores for satisfaction with training.CONCLUSIONS:This case study provides lessons learnt for future research training, and demonstrates that the SORT IT model can be modified to reflect the context of implementation without compromising purpose or outcomes.     

Web-Based Apps for Responding to Acute Infectious Disease Outbreaks in the Community: Systematic Review

BackgroundWeb-based technology has dramatically improved our ability to detect communicable disease outbreaks, with the potential to reduce morbidity and mortality because of swift public health action. Apps accessible through the internet and on mobile devices create an opportunity to enhance our traditional indicator-based surveillance systems, which have high specificity but issues with timeliness.ObjectiveThe aim of this study is to describe the literature on web-based apps for indicator-based surveillance and response to acute communicable disease outbreaks in the community with regard to their design, implementation, and evaluation.MethodsWe conducted a systematic search of the published literature across four databases (MEDLINE via OVID, Web of Science Core Collection, ProQuest Science, and Google Scholar) for peer-reviewed journal papers from January 1998 to October 2019 using a keyword search. Papers with the full text available were extracted for review, and exclusion criteria were applied to identify eligible papers.ResultsOf the 6649 retrieved papers, 23 remained, describing 15 web-based apps. Apps were primarily designed to improve the early detection of disease outbreaks, targeted government settings, and comprised either complex algorithmic or statistical outbreak detection mechanisms or both. We identified a need for these apps to have more features to support secure information exchange and outbreak response actions, with a focus on outbreak verification processes and staff and resources to support app operations. Evaluation studies (6 out of 15 apps) were mostly cross-sectional, with some evidence of reduction in time to notification of outbreak; however, studies lacked user-based needs assessments and evaluation of implementation.ConclusionsPublic health officials designing new or improving existing disease outbreak web-based apps should ensure that outbreak detection is automatic and signals are verified by users, the app is easy to use, and staff and resources are available to support the operations of the app and conduct rigorous and holistic evaluations.