897 resultados para Validation studies


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ERA-40 is a re-analysis of meteorological observations from September 1957 to August 2002 produced by the European Centre for Medium-Range Weather Forecasts (ECMWF) in collaboration with many institutions. The observing system changed considerably over this re-analysis period, with assimilable data provided by a succession of satellite-borne instruments from the 1970s onwards, supplemented by increasing numbers of observations from aircraft, ocean-buoys and other surface platforms, but with a declining number of radiosonde ascents since the late 1980s. The observations used in ERA-40 were accumulated from many sources. The first part of this paper describes the data acquisition and the principal changes in data type and coverage over the period. It also describes the data assimilation system used for ERA-40. This benefited from many of the changes introduced into operational forecasting since the mid-1990s, when the systems used for the 15-year ECMWF re-analysis (ERA-15) and the National Centers for Environmental Prediction/National Center for Atmospheric Research (NCEP/NCAR) re-analysis were implemented. Several of the improvements are discussed. General aspects of the production of the analyses are also summarized. A number of results indicative of the overall performance of the data assimilation system, and implicitly of the observing system, are presented and discussed. The comparison of background (short-range) forecasts and analyses with observations, the consistency of the global mass budget, the magnitude of differences between analysis and background fields and the accuracy of medium-range forecasts run from the ERA-40 analyses are illustrated. Several results demonstrate the marked improvement that was made to the observing system for the southern hemisphere in the 1970s, particularly towards the end of the decade. In contrast, the synoptic quality of the analysis for the northern hemisphere is sufficient to provide forecasts that remain skilful well into the medium range for all years. Two particular problems are also examined: excessive precipitation over tropical oceans and a too strong Brewer-Dobson circulation, both of which are pronounced in later years. Several other aspects of the quality of the re-analyses revealed by monitoring and validation studies are summarized. Expectations that the second-generation ERA-40 re-analysis would provide products that are better than those from the firstgeneration ERA-15 and NCEP/NCAR re-analyses are found to have been met in most cases. © Royal Meteorological Society, 2005. The contributions of N. A. Rayner and R. W. Saunders are Crown copyright.

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In order to validate the reported precision of space‐based atmospheric composition measurements, validation studies often focus on measurements in the tropical stratosphere, where natural variability is weak. The scatter in tropical measurements can then be used as an upper limit on single‐profile measurement precision. Here we introduce a method of quantifying the scatter of tropical measurements which aims to minimize the effects of short‐term atmospheric variability while maintaining large enough sample sizes that the results can be taken as representative of the full data set. We apply this technique to measurements of O3, HNO3, CO, H2O, NO, NO2, N2O, CH4, CCl2F2, and CCl3F produced by the Atmospheric Chemistry Experiment–Fourier Transform Spectrometer (ACE‐FTS). Tropical scatter in the ACE‐FTS retrievals is found to be consistent with the reported random errors (RREs) for H2O and CO at altitudes above 20 km, validating the RREs for these measurements. Tropical scatter in measurements of NO, NO2, CCl2F2, and CCl3F is roughly consistent with the RREs as long as the effect of outliers in the data set is reduced through the use of robust statistics. The scatter in measurements of O3, HNO3, CH4, and N2O in the stratosphere, while larger than the RREs, is shown to be consistent with the variability simulated in the Canadian Middle Atmosphere Model. This result implies that, for these species, stratospheric measurement scatter is dominated by natural variability, not random error, which provides added confidence in the scientific value of single‐profile measurements.

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Bioaccessibility studies have been widely used as a research tool to determine the potential human exposure to ingested contaminants. More recently they have been practically applied for soil borne toxic elements. This paper reviews the application of bioaccessibility tests across a range of organic pollutants and contaminated matrices. Important factors are reported to be: the physiological relevance of the test, the components in the gut media, the size fraction chosen for the test and whether it contains a sorptive sink. The bioaccessibility is also a function of the composition of the matrix (e.g. organic carbon content of soils) and the physico-chemical characteristics of the pollutant under test. Despite the widespread use of these tests, there are a large number of formats used and very few validation studies with animal models. We propose a unified format for a bioaccessibility test for organic pollutants. The robustness of this test should first be confirmed through inter laboratory comparison, then tested in-vivo.

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Propolis, a natural product of plant resins, is used by the bees to seal holes in their honeycombs and protect the hive entrance. However, propolis has also been used in folk medicine for centuries. Here, we apply the power of Saccharomyces cerevisiae as a model organism for studies of genetics, cell biology, and genomics to determine how propolis affects fungi at the cellular level. Propolis is able to induce an apoptosis cell death response. However, increased exposure to propolis provides a corresponding increase in the necrosis response. We showed that cytochrome c but not endonuclease G (Nuc1p) is involved in propolis-mediated cell death in S. cerevisiae. We also observed that the metacaspase YCA1 gene is important for propolis-mediated cell death. To elucidate the gene functions that may be required for propolis sensitivity in eukaryotes, the full collection of about 4,800 haploid S. cerevisiae deletion strains was screened for propolis sensitivity. We were able to identify 138 deletion strains that have different degrees of propolis sensitivity compared to the corresponding wild-type strains. Systems biology revealed enrichment for genes involved in the mitochondrial electron transport chain, vacuolar acidification, negative regulation of transcription from RNA polymerase II promoter, regulation of macroautophagy associated with protein targeting to vacuoles, and cellular response to starvation. Validation studies indicated that propolis sensitivity is dependent on the mitochondrial function and that vacuolar acidification and autophagy are important for yeast cell death caused by propolis.

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Introdução O espelho de Glatzel (EG) é correntemente utilizado em consultórios fonoaudiológicos para a avaliação rápida da permeabilidade nasal. O mesmo foi descrito inicialmente em 1898 por Zwaardemaker. Porém, estudos de validação inexistem na literatura. Este estudo teve por objetivos verificar a reprodutibilidade do EG e a correlação intra-sujeito entre área de condensação e percepção subjetiva de permeabilidade nasal. Material e Métodos Vinte e cinco sujeitos foram avaliados com o EG por cinco minutos consecutivos (475 medidas por sujeito); cada meia hora por quatro horas; cada dia no início da tarde, por cinco dias e toda a quinta-feira por cinco semanas consecutivas. Utilizou-se uma escala análoga visual para avaliar a percepção de respiração nos períodos de horas, dias e semanas. Resultados O coeficiente de correlação total (área direita mais esquerda) encontrado entre área de condensação e percepção subjetiva foi de r=0,04 (p=0,3761). No lado esquerdo foi de r=0,08 (p=0,0984) e no lado direito de r=0,05 (p=0,2862). Os coeficientes de variação unilaterais medianos foram menores que 15% e os totais menores que 12%, independente do intervalo de tempo entre teste e re-teste. Conclusão Não se evidenciou correlação significativa entre a percepção subjetiva e a área de condensação nasal. A variabilidade unilateral foi maior do que quando considerados os valores totais (direito mais esquerdo) e não houve diferença na variabilidade das medidas de área de condensação nasal nos diferentes momentos do tempo.

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People with venous ulcers constitute as an important public health problem, its treatment is onerous and require assistance provided by trained professionals, systematized through protocols, however what lies in the assistance is that the management of this group of people differs from that preconized in the scientific literature, interfering with wound healing and quality of life of affected. In this sense, the construction of a assistance protocol specific to people with venous ulcers (VU) can help professionals of the Family Health Strategy both in patient assessment as and in establishment of quality assistance. Thus, this study aimed to analyse the validity of a multiprofessional assistance protocol for people with venous ulcers in primary care by health professionals using Delphi technique. This is a quantitative study, the methodological type conducted in two steps: first step related to integrative literature review to subsidize the development of the protocol, then these aspects were organized and proposed to the judges of the study through the Delphi technique. The study was initiated after approval by the Research Ethics Committee. The first step was performed between August and September 2012, in the virtual library of health, in the page of the Coordination of Improvement of Higher Education Personnel, of Municipal Health Secretariat and international guidelines of associations and in the subsequent step carried out between September 2012 to January 2013, was performed search by Lattes platform of the National Council of Technological and Scientific Development, in order to identify health professionals in Brazil who act as judges of the instrument and then, via online, the form was submitted to them.The sample for the second step was 51 judges in the first round and 35 for the second round Delphi. The analysis was done by adopting Kappa index ≥ 0.81 and Content Validity Index (CVI)> 0.80. In the first submission for the judges, items that did not reach Kappa and CVI established were: request / realization / test results, demographic data, medical history, risk factors, verification of pain / vital signs / pulse / infection signs / lesion location/ edema and pain treatment. After removal of items which have not obtained Kappa or CVI index established, it was found achieving optimal levels of these index for the categories. In the next step was the ressubmissão of protocol to judges through the Delphi technique in it was found that, of the 15 categories of the protocol, 12 presented higher scores in Delphi 2 phase and the other three categories remained the same Kappa and IVC of the previous phase. As for the average of evaluation requirements of the protocol was found that the scores assigned by the judges were higher in the second phase in nine of the 10 items, remaining the same in only one of the items indicating validity of the instrument before the consensus of the judges. Thus, we accepted the alternative hypothesis in this study, as they were obtained in the second Delphi phase the validity index greater than or equal to the Delphi 1 phase. The formulation of this assistance protocol valid and reproducible will enable a reorganization and redesign of assistance, with standardization of actions and continuity of care for persons with venous ulcers in primary health care

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This study aimed to validate the contents of an Instrument for Nursing Consultation in the Home Visit of people with Spinal Cord Injury (INCEVDOP-LM), based on the Self-Care Deficit Theory. The methodological development study was conducted with spinal cord injured (SCI) people ascribed in the Family Health Units the city of Natal/RN/Brazil, and with the nurses of these institutions. The study was conducted from Januray 2012 to January 2013 in two phases: the first aimed to identify the need for self-care of persons with SCI, and the second to develop and validate the INCEVDOP-LM. The first phase consisted of a census study of people with SCI living in Natal/RN. In the second phase, a non-probabilistic convencience sample of subjects was selected to form two groups: First stage - Group 1 of the first stage was comprised by 73 adults with SCI diagnosed with paraplegia or tetraplegia, with cognitive function preserved and that were registered to some family health unit; Group 2 of the Second phase was composed of six experts that were nurses with doctoral formation, scientific experience in the area of technology development or assistance to persons with SCI, and with publications in periodicals Qualis A2. Data collection of the first phase was conducted through home visits of people with SCI that responded three instruments: Questionnaire I (comprised of demographic and socioeconomic variables), The Competency Rating Scale for Self-care (ASA) and the Barthel Index (an instrument for evaluation of functional capacity). The research for the second phase was conducted in two stages: I-construction of the INCEVDOP LM; II-validation of the INCEVDOP-LM. The instrument and an evaluation form were forwarded to the experts for the validation. The correlations between the responses were analyzed by the Kappa test, with accepting values of>0.75. The evaluation criteria were: organization, clarity, simplicity, readability, appropriateness of vocabulary, objectivity, accuracy, reliability and suitability and the positive responses with frequency values of≥90% were considered excellent. The chi-square test was used to investigate the differences between proportions. The study attended to the principles of Human Rights CNS Resolution 196/96. Results were reported by means of four articles derived from the study. The findings indicate that the items that showed disagreement among experts (k=0.02) were diagnoses, interventions and evaluation of the nursing features pertaining to the domains of Nutrition, Hygiene, Elimination, Physical, Social and Psychological, and of the Ability to perform work activities feature. Agreement among the experts were reported for the other items, with kappa ranging from 0.72 to 1. After removing items with disagreement, all criteria achieved excellent rates and no significant differences were observed between the proportions of responses of evaluation of experts (p>0.05). We conclude that the instrument shows validity to serve as a guide for nurses to conduct a systematic consultation during the home visit to people with spinal cord injury, with emphasis on self-care. The instrument must go through other levels of validation when applied in the clinical setting

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Venous ulcers are lesions resulting from chronic venous insufficiency, venous valvular abnormalities and venous thrombosis. Its occurrence has been growing with the increase in life expectancy of the world population. Considered as fundamental aspects in the approach to the person with venous ulcer care with the interdisciplinary approach, adoption of protocol-specific knowledge, technical skill, coordination between levels of care complexity of the Health System and active participation of patients and their families, a holistic perspective. The construction of a clinical protocol for people with venous ulcers can help professionals of high complexity services in patient assessment and the establishment of quality care in a systematic way and focused on the factors that interfere with wound healing. Thus, this study aimed to analyze the evidence of validation of a clinical protocol for people with venous ulcers treated at high-complexity services. This is a methodological study with a quantitative approach, developed in three stages: literature review, evidence of content validity and evidence of validation in the clinical context. Approved by the Federal University of Rio Grande do Norte Research Ethics Committee (Opinion: 147.452 and CAAE: 07556312.0.0000.5537). The literature review was conducted in August and September 2012, becoming the basis for the construction of the protocol. Then the evidence of content validity, which included 53 judges (experts) selected by the Lattes platform to evaluate the protocol items was performed. The judges were contacted by e-mail and rated the protocol via Google Docs . After analyzing the ratios obtained in this step, which reported kappa between 0.75 and 0.96 and between 0.80 and 0.98 IVC, and the suggestions of the judges, the protocol was adjusted and subjected to empirical evidence to validate the clinical setting at the University Hospital Onofre Lopes in Natal / RN. Evidence of validation in the clinical setting involved 4 judges who acted in pairs (paired) evaluated 32 patients with venous ulcers in the clinical context of high complexity. In both stages, we used the Kappa Index and Content Validity Index to analyze the responses of the judges. The parameters set as acceptable for these indices were: Kappa ≥ 0.61 and Content Validity Index > 0.80. Any evidence of content validity, as evidence of validation in the clinical context, the protocol items that have not reached Kappa and Content Validity Index established indices were excluded and some items were modified or added after suggestions. The process of content validation evidence and evidence of validation in the clinical setting allowed the improvement of the protocol for the care of people with venous ulcers initially proposed. The initial version of the protocol, built from the literature, contained 15 categories and 108 items; after evidence of content validity, remained the reduction to 15 categories with 91 items; the final version, clinically validated, is composed of the same 15 categories, 76 items. The protocol was validated in its content and in the clinical aspect, so we accepted the alternative hypothesis in the study. This protocol may contribute to the care system, allowing tailor behaviors and promote greater resolution in the treatment of people with venous ulcers in health services of high complexity

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Conselho Nacional de Desenvolvimento Científico e Tecnológico

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This study aimed to validate tools for evaluating the ability and knowledge about blood pressure (BP) among nursing students. It is a cross-sectional, descriptive, quantitative and methodological study accomplished at the Universidade Federal do Rio Grande do Norte (UFRN), Universidade do Estado do Rio Grande do Norte (UERN) and a private university of the state. The sample consisted of 27 judges of research selected from the inclusion criteria: nursing, teachers of the semiology and/or semiotics discipline, with at least 1 year of experience, being from UFRN, EEN, UERN and private university of the state and and agree to participate voluntarily with the signing of the consent form. The research was development in three stages: construction of two instruments based on the scientific literature, resulting in a structured checklist consists of 28 items and a knowledge questionnaire with 12 questions; submission of the instruments to the judges, in the period from June to September 2012, which should evaluate each item in appropriate , appropriate with changes and inappropriate , addition to making an overall assessment of each instrument based on 10 requirements; validation and verification to the level of agreement among the judges, through the application of Kappa and Content Validity Index (CVI). Was used the consensus level greater than 0.61 (good) to the Kappa index and greater than 0.75 for CVI. Was approved by the Ethics in Research / HUOL. After being coded and tabulated, the data were analyzed using descriptive statistics. Of the 27 judges who evaluated the instrument, 77.8% are female, with a mean age of 36.6 (± 9.0) years, 63.0% worked in UFRN, 74.1% had academic master and 63.0% worked exclusively on teaching. Average length of teaching experience was 7.9 (± 8.0) years and in the semiology and/or semiotics discipline of 5.5 (± 6.7) years. In the judgment of structured checklist and questionnaire of knowledge about blood pressure mensurement any item/question was considered inappropriate since all obtained level of agreement within the indices established (CVI> 0,75 E Kappa> 0.61). In relation to structured checklist, of those 28 items present, 9 showed perfect concordance index (CVI = 1.00, Kappa = 1.00) and another 19 were considered appropriate with changes, especially with regard to clarity and vocabulary. In the questionnaire of knowledge, among the 12 questions that comprised, 7 had perfect concordance index and the others were considered appropriate with changes as requirements as clarity, vocabulary, and feasible sequence of instructional topics. In terms of a overall evaluating of instruments, the structured checklist got CVI of 0.94 and Kappa of 0.89 and the knowledge questionnaire, CVI of 0.97 and a kappa of 0.94. Both instruments proved to be valid as to their content, configuring it as clear and objective tools of assessment of knowledge and ability on blood pressure, being of nursing students as well as others students and health professionals, since the use of valid measures seeking to reduce the risk of distorting the results

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That study had the aim to validate an instrument to evaluate the knowledge about the Urinary Catheterization (UC) in males. Cross-sectional, descriptive, quantitative and methodological study, accomplished in Universidade Federal do Rio Grande do Norte (UFRN), Universidade do Estado do Rio Grande do Norte (UERN) and a private university from Rio Grande do Norte. Sample of 27 judges selected from the inclusion criteria: registered nurses, discipline of semiology and/or semiotics teachers, with at least 1 year of experience in the disciplines, to work at UFRN, UERN or in private university and agree to participate voluntarily with the signing of the Consent Form. Study developed in three stages: a) elaboration of twos instruments based on the scientific literature, resulting in a structured observation script type checklist consisting of 36 items and a knowledge questionnaire with 12 questions; b) submission of instruments to judges from June to September 2012, which should evaluate each item in "adequate," "adequate with changes" and "inappropriate", and make an overall evaluation of each instrument based on 10 requirements; c) and validation with a verification of the agreement level among the judges, through the application of Kappa Index (K) and Content Validity Index (CVI). It was used the consensus level higher than 0.60 (good) for Kappa Index and higher than 0.70 for CVI. The research project had favorable opinion from the Ethics in Research/HUOL (CAAE n. 0002.0.294.000-10). After being coded and tabulated, the data were analyzed using descriptive statistics. Of the 27 judges who evaluated the instrument, 77.8% are female, with a mean age of 36.6 (± 9.0) years, 63.0% worked in UFRN, 74.1% had master degree and 63.0% worked exclusively on teaching. The experience time mean in teaching was 7.9 (± 8.0) years and in the disciplines of semiology and/or semiotics in nursing was 5.5 (± 6.7) years. In judgment of the checklist and knowledge questionnaire, no step/question was considered inappropriate, since all achieved level of agreement within the established values. All the checklist steps obtained good to excellent K (between 0.60 and 1.00). Of the 36 items, 25 had excellent K (0.75 ≤ K <1.00) and excellent total K (K = 0.83). Regarding the IVC, all steps reached levels above 0.70 (between 0.74 and 1.00) and CVI total was 0.90. All questionnaire questions evaluated separately (K from 0.60 to 0.93 and CVI from 0.74 to 0.96) and generally (K from 0.79 to 1.00 and CVI from 0.89 to 1.00) had evaluation levels of content validity within the established values. The instruments were reformulated based on the agreement levels between judges and international guidelines, dissertations and scientific articles. Both instruments proved to be valid regarding to their content, allowing a clear and objective evaluation of knowledge and skills about UC, both nursing students as well as other students and health professionals, since the use of valid measures seeking the reduction of the risk of the results distorted

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The reports of adverse events date from 1990 up to the present day. Conceptually, these adverse events are unintentional injuries unrelated to the underlying disease, causing measurable lesions in patients, extending the period of hospitalization, or leading to death. These issues require discussions with regard to patient safety, improved quality of service, and preventing medical errors. In the Intensive Care Units, this concern is greater because these are sectors of intensive care to individuals with hemodynamic changes and imminent risk of death. Therefore, it is essential to conduct evaluation processes to investigate aspects of quality of nursing care and patient safety in these spaces. For that reason, we aimed to propose the Evaluation protocol of nursing care and patient safety in Intensive Care Units. For its achievement, we needed to: 1) analyze the evolution of the patient safety concept used in scientific productions, under Rodgers evolutionary concept; 2) identify the necessary items to build the evaluation protocol of nursing care and patient safety in the Intensive Care Unit, from the available evidence in literature; 3) construct an instrument for content validation of the evaluation protocol of nursing care and patient safety in the Intensive Care Unit; and 4) describe and evaluate the appropriateness of the content for an evaluation protocol of nursing care and patient safety in the Intensive Care Unit. This is a methodological study for the content validation of the abovementioned protocol. To meet the first three specific objectives, we used the integrative literature review in Theses Database of the Coordination for the Improvement of Higher Education Personnel and the portal of the Collaborating Centre for Quality of Care and Patient Safety. The fourth specific objective happened through the participation of judges, located from the Lattes curricula, in the content validation process developed in two stages: Delphi 1 and Delphi 2. As instrument, we used the electronic form of Google docs. We present in tables the answers from the evaluation instruments by Delphi consensus and Content Validity Index (CVI) of the entire protocol. We summarized the results in articles entitled Analysis of the patient safety concept: Rodgers evolutionary concept ; Scientific evidence regarding patient safety in the Intensive Care Unit ; Technological device for the content validation process: experience report ; and Evaluation protocol of nursing care and patient safety in Intensive Care Units. The Embodied Opinion of the Research Ethics Committee of the Universidade Federal do Rio Grande do Norte, No. 461,246, under CAAE 19586813.2.0000.5537, approved the study. Thus, we conclude the protocol valid in its content, constituting an important tool for evaluating the quality of nursing care and patient safety in Intensive Care Units

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Physical activity is one of the main components of a healthy lifestyle, responsible for many health benefits. Despite being considered important for both disease prevention and health promotion there is high prevalence of sedentary behavior in the elderly population. Questionnaires are practical and feasible instruments for assessing levels of physical activity. However, they may have limitations in older age ranges. Accelerometers, movement sensors that make physical activity data more objective, emerge as reliable measuring devices. Aim: Determine the validity of the International Physical Activity Questionnaire (IPAQ) adapted for elderly with accelerometry in elderly women. Methods: 57 elderly women, with mean age of 66.05 ± 5.98 years who took part in hypertension control and physical activity incentive programs were assessed in relation to objective and subjective measures of physical activity. The accelerometer was used for 07 consecutive days, 24 hours per day before the IPAQ was applied. Data were analyzed using measures of central tendency and dispersion to characterize the sample according to variables collected. To check the validity of the data we used the Spearman correlation test, considering a significance level of p <0.05. Results: With respect to the categories of physical activity obtained by IPAQ, 46.4% developed moderate physical activity, followed by a high (30.3%) and low level (23.2%). There was a negative correlation only between self-reported time spent sitting and time spent on light activities as measured by accelerometry (r = - 0.408; p = 0.003) and mean activity level (counts/min) with physical activity levels evaluated by IPAQ (r = 0.297; p = 0.036). Conclusion: The IPAQ used in elderly women shows moderate to low validity levels according to accelerometry measures. Assessment of sedentary activities exhibited acceptable levels compared to accelerometry; however, moderate (r = 0.096; p > 0.05) to vigorous (r = 0.098; p > 0.05) activities were not correlated, demonstrating the inability of IPAQ to evaluate this type of activity in elderly women

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The human buccal micronucleus cytome assay (BMCyt) is one of the most widely used techniques to measure genetic damage in human population studies. Reducing protocol variability, assessing the role of confounders, and estimating a range of reference values are research priorities that will be addressed by the HUMNXL, collaborative study. The HUMNXL, project evaluates the impact of host factors, occupation, life-style, disease status, and protocol features on the occurrence of MN in exfoliated buccal cells. In addition, the study will provide a range of reference values for all cytome endpoints. A database of 5424 subjects with buccal MN values obtained from 30 laboratories worldwide was compiled and analyzed to investigate the influence of several conditions affecting MN frequency. Random effects models were mostly used to investigate MN predictors. The estimated spontaneous MN frequency was 0.74 parts per thousand (95% CI 0.52-1.05). Only staining among technical features influenced MN frequency, with an abnormal increase for non-DNA-specific stains. No effect of gender was evident, while the trend for age was highly significant (p < 0.001). Most occupational exposures and a diagnosis of cancer significantly increased MN and other endpoints frequencies. MN frequency increased in heavy smoking (>= 40 cig/day. FR = 1.37:95% CI 1.03-.82) and decreased with daily fruit consumption (FR = 0.68; 95% CI 0.50-0.91). The results of the HUMNXL, project identified priorities for validation studies, increased the basic knowledge of the assay, and contributed to the creation of a laboratory network which in perspective may allow the evaluation of disease risk associated with MN frequency. (C) 2011 Elsevier B.V. All rights reserved.

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Objective. To develop widely acceptable preliminary criteria of global flare for childhood-onset systemic lupus erythematosus (cSLE).Methods. Pediatric rheumatologists (n = 138) rated a total of 358 unique patient profiles with information about the cSLE flare descriptors from 2 consecutive visits: patient global assessment of well-being, physician global assessment of disease activity (MD-global), health-related quality of life, anti-double-stranded DNA antibodies, disease activity index scores, protein: creatinine (P:C) ratio, complement levels, and erythrocyte sedimentation rate (ESR). Based on 2,996 rater responses about the course of cSLE (baseline versus followup), the accuracy (sensitivity, specificity, and area under the receiver operating characteristic curve) of candidate flare criteria was assessed. An international consensus conference was held to rank these candidate flare criteria as per the American College of Rheumatology recommendations for the development and validation of criteria sets.Results. The highest-ranked candidate criteria considered absolute changes (Delta) of the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) or British Isles Lupus Assessment Group (BILAG), MD-global, P:C ratio, and ESR; flare scores can be calculated (0.5 x Delta SLEDAI + 0.45 x Delta P:C ratio + 0.5 x Delta MD-global + 0.02 x Delta ESR), where values of >= 1.04 are reflective of a flare. Similarly, BILAG-based flare scores (0.4 x Delta BILAG + Delta 0.65 x Delta P:C ratio + 0.5 + Delta MD-global + 0.02 x Delta ESR) of >= 1.15 were diagnostic of a flare. Flare scores increased with flare severity.Conclusion. Consensus has been reached on preliminary criteria for global flares in cSLE. Further validation studies are needed to confirm the usefulness of the cSLE flare criteria in research and for clinical care.