Survey of total error of precipitation and homogeneous HDL-cholesterol methods and simultaneous evaluation of lyophilized saccharose-containing candidate reference materials for HDL-cholesterol

BACKGROUND: Standardization of HDL-cholesterol is needed for risk assessment. We assessed for the first time the accuracy of HDL-cholesterol testing in The Netherlands and evaluated 11 candidate reference materials (CRMs). METHODS: The total error (TE) of HDL-cholesterol measurements was assessed in native human sera by 25 Dutch clinical chemistry laboratories. Concomitantly, the suitability of lyophilized, saccharose-containing CRMs (n = 11) for HDL-cholesterol was evaluated. RESULTS: In the precipitation method group, which included 25 laboratories and four methods, the mean (minimum-maximum) TE was 11.5% (2.7-25.2%), signifying that 18 of 25 laboratories satisfied the TE goal of </=13% issued by the National Cholesterol Education Program (NCEP). In the homogeneous HDL-cholesterol method group, which included five laboratories, each performing two different methods, the mean (minimum-maximum) TE was 9.5% (6.0-17.3%) for the Boehringer assay and 15.7% (3.3-30.7%) for the Genzyme assay. For the Boehringer homogeneous assay, one of five laboratories did not meet the TE criterion, whereas for the Genzyme homogeneous assay, three of five laboratories exceeded the 13% criterion. The biases on the HDL-cholesterol values found by various precipitation methods were highly variable in all CRMs, irrespective of the quality, whereas the biases found by the homogeneous method from Boehringer were far less than +/-5% for the highest-quality CRMs (CRMs 4-6). CONCLUSIONS: The NCEP goal was met by 24 of 35 laboratories assessed by use of native human sera. Selectively pooled, lyophilized CRMs that are cryoprotected with 200 g/L saccharose have ample potential for use in the standardization of homogeneous HDL-cholesterol methods

The global impact of the International Federation of Clinical Chemistry and Laboratory Medicine, Education and Management Division: engaging stakeholders and assessing HbA1c quality in a multicentre study across China

Background: Diabetes mellitus is a major global issue and high quality testing is essential for the diagnosis and treatment of the disease. The IFCC Committee for the Education in the Utility of Biomarkers in Diabetes (C-EUBD) plays a global role in improving knowledge and understanding around diabetes testing. This paper describes a multi-stakeholder approach, to improving diagnostic and therapeutic testing for diabetes, using a multicentre study in China as an example of the global impact of the group. Methods: Educational workshops were developed to support the scientific aims of the study in which 30 centres around China received identical, fresh frozen whole blood samples with values assigned using IFCC secondary reference methods and undertook precision (EP-5) and trueness studies. Performance was assessed using sigma metrics. Results: A successful multi-stakeholder group was developed and sustained throughout the study through several educational workshops, which enabled the formation of a long-term collaboration with key opinion leaders and policy makers in China. All 30 centres showed good performance with within and between laboratory coefficient of variations (CVs) below 3% in SI units at both low and high haemoglobin A1c (HbA1c) levels. All individual laboratories met the criteria of a sigma of two or more at a total allowable error (TAE) of 5 mmol/mol (0.46% NGSP). Conclusions: The study led to a successful multi-partner approach to improving diabetes testing in China. All centres involved in the study meeting the published IFCC quality criteria, paving the way for future clinical trials and an expanded role for HbA1c testing across the country

Relationship between HbA(1c) and cancer in people with or without diabetes: a systematic review

Aim: To identify the relationship between HbA1c and cancers in people with or without diabetes. Background: Cancer is a major public health problem, accounting for 8.2 million deaths worldwide in 2012. HbA1c level has been associated with the risk of developing certain cancers, although the existing evidence is conflicting. Methods: EMBASE, MEDLINE, CINAHL and the Cochrane Library were searched. Eligible articles included randomized controlled trials, cohort studies, case–control studies, systematic reviews and meta-analyses. Participants of either sex, with or without Type 1 or 2 diabetes, were included. The studies were assessed using the Scottish Intercollegiate Guidelines Network (SIGN) criteria by two independent assessors. No meta-analysis was performed because of the heterogeneity of results. Results: A total of 19 studies from 1006 met the inclusion criteria, of which 14 were cohort studies and five were nested case–control studies. Eight studies investigated outcomes for all cancer sites. Four of these studies reported that higher HbA1c levels were associated with higher incidence and/or mortality risk for all cancers. One study observed a U-shaped relationship between HbA1c and cancer incidence and mortality. Increasing HbA1c levels were associated with increasing risk of developing colorectal, pancreatic, respiratory and female genital tract cancers. No increased risk was observed for breast cancer, gastrointestinal or urological malignancies. Conclusion: HbA1c appears to be associated with cancer incidence and/or cancer mortality, but further studies are needed to fully understand the complex relationship between HbA1c and cancer

Modalidades de atendimento à domicilio do Sistema Único de Saúde (SUS) articuladas às Redes de Atenção à saúde

  The objective is to know the scientific literature published from 2008 to 2014 about the health care networks and the procedures for compliance with the domicile of the Unified Health System. It is an integrative review conducted online via the Virtual Library Health in the Latin American database and Caribbean Health Sciences (LILACS), Bank of Nursing data (BDEnf) and Medical Literature Analysis and Retrieval System Online (MEDLINE), respecting the ethical aspects regarding the authorship of articles. The sample consisted of 06 full scientific papers selected by observing the inclusion and exclusion criteria. It was observed that despite the Networks of Health Care and terms of service to the domicile of the Unified Health System are acquiring major in health, there are few published articles related to the topic. It is concluded that the services involved in health activities should form an interdependent network, interrelated using as basic point the complexity of user needs being met. It recommends a deepening of this issue so that there is a collective awareness on the subject. You must understand the real importance of the domicile to the service in conjunction with the health care network is able to provide for people's lives, however, it is necessary that those responsible directly or indirectly for coordination of health services able to implement them in interconnected networksEl objetivo es conocer la literatura científica publicada desde 2008 hasta 2014 sobre las redes de atención a la salud y los procedimientos de atención a domicilio del Sistema Único de Salud. Se trata de una revisión integradora realizada vía on line a través de la Biblioteca Virtual en Salud en la base de datos de la Literatura Latino.Americana y del Caribe en Ciencias de la Salud (LILACS), el Banco de Datos de Enfermería (BDEnf) y Medical Literature Analysis and Retrieval System Online (MEDLINE), respetando los aspectos éticos en cuanto a la autoría de artículos. La muestra consistió en 06 artículos científicos completos seleccionados mediante la observación de los criterios de inclusión y exclusión. Se observó que a pesar de que las Redes de Atención Médica y las modalidades de atención a domicilio del Sistema Único de Salud están adquiriendo gran importancia en el ámbito de la salud, existen pocos artículos publicados relacionados con esta temática. Se concluye que los servicios implicados en las actividades de salud deben formar una red interdependiente, interrelacionada, utilizando como punto básico la complejidad de las necesidades del usuario a ser atendido. Se recomienda una profundización en este asunto para lograr una conciencia colectiva sobre el tema. Es preciso comprender la importancia real que la atención a domicilio en conjunción con las redes de atención a la salud es capaz de proporcionar para la vida de las personas, sin embargo, es necesario que los responsables, directa o indirectamente, de la coordinación de los servicios de salud consigan implementarlas en las redes interconectadasObjetiva-se conhecer a produção científica publicada no período de 2008 à 2014, a respeito das Redes de atenção à saúde e as modalidades de atendimento à domicilio do Sistema Único de Saúde. Trata-se de uma revisão integrativa realizada via online na Biblioteca Virtual em Saúde na base de dados da Literatura Latino-Americana e do Caribe em Ciências da Saúde (LILACS), Banco de dados da Enfermagem (BDEnf) e Medical Literature Analysis and Retrieval System Online (MEDLINE), respeitando os aspectos éticos em relação as autorias dos artigos.  A amostra constituiu-se de 06 artigos científicos completos selecionados observando critérios de inclusão e exclusão. Observou-se que apesar das Redes de Atenção à Saúde e as modalidades de atendimento à domicilio do Sistema Único de Saúde estarem adquirindo grandes proporções no âmbito da saúde existe um número reduzido de artigos publicados relacionados à temática. Conclui-se que os serviços que integram as atividades de saúde deveriam constituir uma rede interdependente, inter-relacionada utilizando como ponto básico a complexidade das necessidades do usuário a ser atendido. Recomenda-se um aprofundamento desta temática para que haja uma sensibilização coletiva sobre o assunto. É preciso compreender a real importância que o atendimento à domicílio em articulação com às redes de atenção à saúde é capaz de proporcionar para a vida da população. Entretanto, é necessário que os responsáveis, direta ou indiretamente pela articulação dos serviços de saúde consigam implementá-los em redes inter-relacionadas

EurA1c: the European HbA1c Trial to Investigate the Performance of HbA1c Assays in 2166 Laboratories across 17 Countries and 24 Manufacturers by Use of the IFCC Model for Quality Targets

Background: A major objective of the IFCC Committee on Education and Use of Biomarkers in Diabetes is to generate awareness and improvement of HbA1c assays through evaluation of the performance by countries and manufacturers. Methods: Fresh whole blood and lyophilized hemolysate specimens manufactured from the same pool were used by 17 external quality assessment organizers to evaluate analytical performance of 2166 laboratories. Results were evaluated per country, per manufacturer, and per manufacturer and country combined according to criteria of the IFCC model for quality targets. Results: At the country level with fresh whole blood specimens, 6 countries met the IFCC criterion, 2 did not, and 2 were borderline. With lyophilized hemolysates, 5 countries met the criterion, 2 did not, and 3 were borderline. At the manufacturer level using fresh whole blood specimens, 13 manufacturers met the criterion, 8 did not, and 3 were borderline. Using lyophilized hemolysates, 7 manufacturers met the criterion, 6 did not, and 3 were borderline. In both country and manufacturer groups, the major contribution to total error derived from between-laboratory variation. There were no substantial differences in performance between groups using fresh whole blood or lyophilized hemolysate samples. Conclusions: The state of the art is that 1 of 20 laboratories does not meet the IFCC criterion, but there are substantial differences between country and between manufacturer groups. Efforts to further improve quality should focus on reducing between-laboratory variation. With some limitations, fresh whole blood and well-defined lyophilized specimens are suitable for purpose

Discordance in glycemic categories and regression to normality at baseline in 10,000 people in a Type 2 diabetes prevention trial

The world diabetes population quadrupled between 1980 and 2014 to 422 million and the enormous impact of Type 2 diabetes is recognised by the recent creation of national Type 2 diabetes prevention programmes. There is uncertainty about how to correctly risk stratify people for entry into prevention programmes, how combinations of multiple ‘at high risk’ glycemic categories predict outcome, and how the large recently defined ‘at risk’ population based on an elevated glycosylated haemoglobin (HbA1c) should be managed. We identified all 141,973 people at highest risk of diabetes in our population, and screened 10,000 of these with paired fasting plasma glucose and HbA1c for randomisation into a very large Type 2 diabetes prevention trial. Baseline discordance rate between highest risk categories was 45.6 %, and 21.3 - 37.0 % of highest risk glycaemic categories regressed to normality between paired baseline measurements (median 40 days apart). Accurate risk stratification using both fasting plasma glucose and HbA1c data, the use of paired baseline data, and awareness of diagnostic imprecision at diagnostic thresholds would avoid substantial overestimation of the true risk of Type 2 diabetes and the potential benefits (or otherwise) of intervention, in high risk subjects entering prevention trials and programmes

EQA-based evaluation of metrological traceability of clinical chemistry test results in Argentina

Equivalence of results among laboratories is a major mission for medical laboratories. In the Netherlands, medical laboratories only use homogenous, commercial for general chemistry analytes, whereas in Argentina heterogenous, home brew test applications are common. The effect of this practice difference on test accuracy is studied using key features of the accuracy-based EQA program of the Netherlands. Six frozen, human-based, commutable poolsera, covering the (patho) physiological measuring range for 17 general chemistry analytes, were assayed by similar to 75 Argentinian labs and similar to 200 Dutch laboratories in 2014. After removal of outliers, harmonization status among laboratories was evaluated by calculating overall mean interlaboratory coefficients of variation (CVs, %) per analyte and per country for all 6 levels. Evenso, standardization status was evaluated after removal of outliers by calculating overall mean recoveries (%) as compared to the assigned target values per analyte per country for all 6 levels. Absolute median biases were compared to (minimal/desirable) biases derived from biological variation criteria. For serum enzymes interlaboratory CVs in the Argentinian laboratories ranged between 10 and 22%, as compared to 3-6% in the Netherlands. For serum uric acid, creatinine, glucose and total protein, interlaboratory CVs varied between 4.3 and 13.1% in Argentinian labs, as compared to <3.5% in the Netherlands. For serum electrolytes, interlaboratory CVs ranged between 1.8 and 3.8% for Na+; 2.9-5.8% for CI ; 3.8-7.5% for K+; 9.4-10.4% for Ca2+ and 16.2-22.3% for Mg2+ as compared to <= 2% (Na+, K+, Cl-, Ca2+) and <= 3% (Mg2+) in the Netherlands. Mean recoveries in Argentinian laboratories for e.g. serum creatinine, glucose, CK, Ca2+ and Na+ were 95-119%; 95-104%; 98-102%; 98-102% and 96-100% respectively, whereas min-max recovery ranges were 65-155%; 58-126%; 47-132%; 66-132% and 85-115%. In the Netherlands, absolute mean recoveries were overall 98.9% with a SD of 2.0%. Median biases in Argentinian laboratories ranged from -2.9 to 18.2%; -3.1 - 2.6%; -3.3 - 0.5%; -1.1 - 3.8% and -4.3-0% for serum creatinine, glucose, CK, Ca2+ and Na+. In the Netherlands overall mean/median biases were 1.1% (SD=2.0%). Exchange of commutable, value-assigned EQA-materials was helpful for studying the harmonization and standardization status of medical tests in Argentina, and for revealing the future harmonization and standardization potential. The results clearly demonstrate that metrological traceability of test results in Argentina is on average in line with what is expected; yet, the spreading among laboratories is far too high and should be improved.Afdeling Klinische Chemie en Laboratoriumgeneeskunde (AKCL

Evaluation of a Reference Material for Glycated Haemoglobin

Peer Reviewe

Care practices in normal birth: the experience of primiparous women

Objective: To know the care practices developed by nursing professionals during the birth process from the perspective of primiparous women. Method: A descriptive and exploratory study with a qualitative approach, developed with ten primiparous women in the months of February to April 2014. Data were collected through semi-structured interviews and analyzed using Minayo's operative proposal. This study was approved by the Ethics Committee of the Federal University of Santa Maria, under CAEE 26452313.8.0000.5346. Results: Were structured into three categories from the World Health Organization Practical Guide with recommendations for safe practices in normal birth. Conclusion: It is considered the need to rethink and reformulate institutional care practices that are in disuse and investment in continued education and in the practice of care that contributes to the physiological evolution of childbirth.Fed Univ Rio Grande PPGEnf FURG, Grad Program Nursing, Rio Grande, RS, BrazilFed Univ Sao Paulo UNIFESP, Nursing Prenatal Care, Sao Paulo, BrazilGEES CNPq, Study & Res Grp Ecosyst Management Nursing Hlth, Rio Grande, RS, BrazilUniv Fed Santa Maria, Nursing & Grad Program Nursing, Santa Maria, RS, BrazilFundacao Univ Fed Rio Grande, Grad Program Nursing, Rio Grande, RS, BrazilGEES CNPq Study & Res Grp, Rio Grande, RS, BrazilFed Univ Sao Paulo UNIFESP, Nursing Prenatal Care, Sao Paulo, BrazilWeb of Scienc

One in Five Laboratories Using Various Hemoglobin A(1c) Methods Do Not Meet the Criteria for Optimal Diabetes Care Management

Background: We assessed the reference change value (RCV) of currently available hemoglobin A(1c) (HbA(1c)) laboratory assays, which is defined as the critical difference between two consecutive HbA(1c) measurements representing a significant change in health status. Methods: We examined the individual laboratory coefficients of variation (CVs) in the Dutch/Belgian quality scheme based on 24 lyophilized samples and calculated the RCV per laboratory (n-220) and per assay method. In addition, two pooled whole blood samples were sent to the participating laboratories. The individual laboratory results were compared to the assigned value +/- an allowable total error (TEa) of 6%. Results: At HbA(1c) values of 41.0 mmol/mol (5.9%-Diabetes Control and Complications Trial [DCCT]) and 61.8 mmol/mol (7.8%-DCCT), 99% and 98%, respectively, of the laboratories reported a value within a TEa limit of 6%. The analytical CV of the HbA(1c) method used in 78% of the laboratories is Conclusions: The analytical performance of the majority of laboratory HbA(1c) methods is within the clinical requirements. However, based on the calculated RCV, 21.8% of the laboratories using different HbA(1c) methods are not able to distinguish an HbA(1c) result of 59 mmol/mol (7.5%-DCCT) from a previous HbA(1c) result of 53 mmol/mol (7.0%-DCCT). It can be presumed that differences in HbA(1c) results of 5 mmol/mol (0.5%-DCCT) do influence treatment decisions