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INTRODUCTION: The aim of this work is to design a selection algorithm for total allowable error (TEa) source using a graphic tool that, by integrating internal (IQC) and external (EQC) quality control performances, enables the laboratory to evaluate which TEa source better fits the test analytical performance. MATERIALS AND METHODS: Two analytical performance indicators (bias and Sigma metrics) were estimated for 23 biochemistry tests during 2016. Bias was estimated on the EQC, and Sigma metrics was calculated through the results obtained in the IQC. The Sigma metrics was charted as a function of the bias (TEa%). Following the proposed algorithm (considering the hierarchy in the Milan 2014 consensus), the TEa was evaluated depending on two areas. One area in the chart was defined as the objective area in which the used TEa is the appropriate one for the analytical performance of the test under evaluation. For any test located outside this area, a performance re-evaluation was required using another source of TEa. RESULTS: In 19 out of 23 evaluated tests, the resulting analytical performance allowed for the selection of biologic variability as TEa source. In the four remaining cases, TEa sources of lesser hierarchy were selected. CONCLUSION: The graphic tool designed together with the proposed algorithm enabled the laboratory to standardize the selection procedure of the most appropriate TEa for the test analytical performance.
Assuntos
Técnicas de Laboratório Clínico , Gestão da Qualidade Total/métodos , HumanosRESUMO
BACKGROUND: Diarrhoea is the second leading cause of childhood mortality, with an estimated 1.3 million deaths per year. Promotion of Solar Water Disinfection (SODIS) has been suggested as a strategy for reducing the global burden of diarrhoea by improving the microbiological quality of drinking water. Despite increasing support for the large-scale dissemination of SODIS, there are few reports describing the effectiveness of its implementation. It is, therefore, important to identify and understand the mechanisms that lead to adoption and regular use of SODIS. METHODS: We investigated the behaviours associated with SODIS adoption among households assigned to receive SODIS promotion during a cluster-randomized trial in rural Bolivia. Distinct groups of SODIS-users were identified on the basis of six compliance indicators using principal components and cluster analysis. The probability of adopting SODIS as a function of campaign exposure and household characteristics was evaluated using ordinal logistic regression models. RESULTS: Standardised, community-level SODIS-implementation in a rural Bolivian setting was associated with a median SODIS use of 32% (IQR: 17-50). Households that were more likely to use SODIS were those that participated more frequently in SODIS promotional events (OR=1.07, 95%CI: 1.01-1.13), included women (OR=1.18, 95%CI: 1.07-1.30), owned latrines (OR=3.38, 95%CI: 1.07-10.70), and had severely wasted children living in the home (OR=2.17, 95%CI: 1.34-3.49). CONCLUSIONS: Most of the observed household characteristics showed limited potential to predict compliance with a comprehensive, year-long SODIS-promotion campaign; this finding reflects the complexity of behaviour change in the context of household water treatment. However, our findings also suggest that the motivation to adopt new water treatment habits and to acquire new knowledge about drinking water treatment is associated with prior engagements in sanitary hygiene and with the experience of contemporary family health concerns.Household-level factors like the ownership of a latrine, a large proportion of females and the presence of a malnourished child living in a home are easily assessable indicators that SODIS-programme managers could use to identify early adopters in SODIS promotion campaigns. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00731497.
Assuntos
Difusão de Inovações , Desinfecção/métodos , Fidelidade a Diretrizes , População Rural , Purificação da Água/métodos , Adolescente , Adulto , Idoso , Bolívia , Criança , Pré-Escolar , Diarreia/epidemiologia , Diarreia/prevenção & controle , Feminino , Gastroenteropatias/epidemiologia , Promoção da Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Microbiologia da Água , Abastecimento de Água , Adulto JovemRESUMO
Field studies often use caregiver-reported diarrhoea and related symptoms to measure child morbidity. There are various vernacular terms to define diarrhoea that vary across the local cultural contexts. The relationship between vernacular definitions of diarrhoea and symptoms-based definitions is not well-documented. This paper describes the association of the vernacular Quechua term k'echalera with the symptoms-based standard definition of diarrhoea in rural Bolivian settings. During a cluster randomized trial in rural Bolivia, both signs and symptoms of diarrhoea and reports of k'echalera were collected for children aged less than five years. Reported k'echalera were found to be associated with important changes in stool frequency, consistency, and presence of blood and mucus. Reported k'echalera were highly related to three of four recorded categories of watery stool. The intermediate (milk-rice) stool consistency, which fits into the definition of watery stool, was not strongly related to k'echalera. Mucus in the stool was also associated with k'echalera; however, its presence in k'echalera-free days accounted for at least 50% of the possible false negatives. The sensitivity and specificity of the term k'echalera were estimated by Bayesian methods, allowing for both symptoms of diarrhoea and reports of k'echalera to be subject to diagnosis error. An average specificity of at least 97% and the sensitivity of at least 50% were obtained. The findings suggest that the use of k'echalera would identify fewer cases of diarrhoea than a symptom-based definition in rural Bolivia.
Assuntos
Diarreia/diagnóstico , Diarreia/epidemiologia , Idioma , População Rural/estatística & dados numéricos , Bolívia/epidemiologia , Pré-Escolar , Análise por Conglomerados , Cultura , Países em Desenvolvimento , Reações Falso-Negativas , Reações Falso-Positivas , Seguimentos , Humanos , Prevalência , Reprodutibilidade dos Testes , Saúde da População Rural/estatística & dados numéricos , Sensibilidade e EspecificidadeRESUMO
Many different methods have been proposed for the analysis of cluster randomized trials (CRTs) over the last 30 years. However, the evaluation of methods on overdispersed count data has been based mostly on the comparison of results using empiric data; i.e. when the true model parameters are not known. In this study, we assess via simulation the performance of five methods for the analysis of counts in situations similar to real community-intervention trials. We used the negative binomial distribution to simulate overdispersed counts of CRTs with two study arms, allowing the period of time under observation to vary among individuals. We assessed different sample sizes, degrees of clustering and degrees of cluster-size imbalance. The compared methods are: (i) the two-sample t-test of cluster-level rates, (ii) generalized estimating equations (GEE) with empirical covariance estimators, (iii) GEE with model-based covariance estimators, (iv) generalized linear mixed models (GLMM) and (v) Bayesian hierarchical models (Bayes-HM). Variation in sample size and clustering led to differences between the methods in terms of coverage, significance, power and random-effects estimation. GLMM and Bayes-HM performed better in general with Bayes-HM producing less dispersed results for random-effects estimates although upward biased when clustering was low. GEE showed higher power but anticonservative coverage and elevated type I error rates. Imbalance affected the overall performance of the cluster-level t-test and the GEE's coverage in small samples. Important effects arising from accounting for overdispersion are illustrated through the analysis of a community-intervention trial on Solar Water Disinfection in rural Bolivia.
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Bioestatística , Modelos Estatísticos , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Algoritmos , Análise de Variância , Teorema de Bayes , Viés , Distribuição Binomial , Bolívia/epidemiologia , Pré-Escolar , Simulação por Computador , Intervalos de Confiança , Diarreia/epidemiologia , Diarreia/prevenção & controle , Desinfecção , Feminino , Humanos , Funções Verossimilhança , Modelos Lineares , Masculino , Cadeias de Markov , Método de Monte Carlo , Distribuição de Poisson , Tamanho da Amostra , Energia Solar , Resultado do Tratamento , Purificação da ÁguaRESUMO
BACKGROUND: Solar drinking water disinfection (SODIS) is a low-cost, point-of-use water purification method that has been disseminated globally. Laboratory studies suggest that SODIS is highly efficacious in inactivating waterborne pathogens. Previous field studies provided limited evidence for its effectiveness in reducing diarrhoea. METHODS AND FINDINGS: We conducted a cluster-randomized controlled trial in 22 rural communities in Bolivia to evaluate the effect of SODIS in reducing diarrhoea among children under the age of 5 y. A local nongovernmental organisation conducted a standardised interactive SODIS-promotion campaign in 11 communities targeting households, communities, and primary schools. Mothers completed a daily child health diary for 1 y. Within the intervention arm 225 households (376 children) were trained to expose water-filled polyethyleneteraphtalate bottles to sunlight. Eleven communities (200 households, 349 children) served as a control. We recorded 166,971 person-days of observation during the trial representing 79.9% and 78.9% of the total possible person-days of child observation in intervention and control arms, respectively. Mean compliance with SODIS was 32.1%. The reported incidence rate of gastrointestinal illness in children in the intervention arm was 3.6 compared to 4.3 episodes/year at risk in the control arm. The relative rate of diarrhoea adjusted for intracluster correlation was 0.81 (95% confidence interval 0.59-1.12). The median length of diarrhoea was 3 d in both groups. CONCLUSIONS: Despite an extensive SODIS promotion campaign we found only moderate compliance with the intervention and no strong evidence for a substantive reduction in diarrhoea among children. These results suggest that there is a need for better evidence of how the well-established laboratory efficacy of this home-based water treatment method translates into field effectiveness under various cultural settings and intervention intensities. Further global promotion of SODIS for general use should be undertaken with care until such evidence is available. TRIAL REGISTRATION: www.ClinicalTrials.govNCT00731497 Please see later in the article for Editors' Summary.
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Diarreia/prevenção & controle , Desinfecção/métodos , Gastroenteropatias/epidemiologia , Luz Solar , Microbiologia da Água , Purificação da Água/métodos , Abastecimento de Água , Bolívia/epidemiologia , Pré-Escolar , Análise por Conglomerados , Países em Desenvolvimento , Diarreia/epidemiologia , Feminino , Promoção da Saúde , Inquéritos Epidemiológicos , Humanos , Incidência , Lactente , Cooperação do Paciente , Saúde da População RuralRESUMO
Previous studies on the effect of the oral administration of bacterial immunomodulators (IM-104 and RN-301) during the protein free diet period, have shown an increase on B and T cell gut repopulation, accompanied by IgA antibody production. The usefulness of oral administration of the immunomodulator thymomodulin (TmB) during the protein refeeding period was investigated. TmB allowed the recovery of a normal repopulation of gut lamina propria with IgA B and CD5 T cells and decreases to control values the number of activated intraepithelial lymphocytes (CD25+T cell subset). Therefore, the oral administration of TmB may be useful as a therapeutic agent as it seems to improve the repopulation of intestinal villi with immunocompetent cells. Also, it seems to regulate the immunosurveillance at the epithelium level as it increases the CD5+T cells but decreases the activated ones.
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Ratos , Feminino , Animais , Adjuvantes Imunológicos/uso terapêutico , Linfócitos B/efeitos dos fármacos , Imunoglobulina A/efeitos dos fármacos , Intestinos/efeitos dos fármacos , Deficiência de Proteína/tratamento farmacológico , Linfócitos T/efeitos dos fármacos , Extratos do Timo/uso terapêutico , Adjuvantes Imunológicos , Análise de Variância , Linfócitos B/metabolismo , Caseínas , Imunoglobulina A/metabolismo , Intestinos/citologia , Deficiência de Proteína/metabolismo , Ratos Wistar , Linfócitos T/metabolismo , Extratos do TimoRESUMO
Previous studies on the effect of the oral administration of bacterial immunomodulators (IM-104 and RN-301) during the protein free diet period, have shown an increase on B and T cell gut repopulation, accompanied by IgA antibody production. The usefulness of oral administration of the immunomodulator thymomodulin (TmB) during the protein refeeding period was investigated. TmB allowed the recovery of a normal repopulation of gut lamina propria with IgA B and CD5 T cells and decreases to control values the number of activated intraepithelial lymphocytes (CD25+T cell subset). Therefore, the oral administration of TmB may be useful as a therapeutic agent as it seems to improve the repopulation of intestinal villi with immunocompetent cells. Also, it seems to regulate the immunosurveillance at the epithelium level as it increases the CD5+T cells but decreases the activated ones. (AU)
Assuntos
Ratos , Feminino , Animais , RESEARCH SUPPORT, NON-U.S. GOVT , Adjuvantes Imunológicos/uso terapêutico , Deficiência de Proteína/tratamento farmacológico , Intestinos/efeitos dos fármacos , Imunoglobulina A/efeitos dos fármacos , Linfócitos B/efeitos dos fármacos , Linfócitos T/efeitos dos fármacos , Extratos do Timo/uso terapêutico , Adjuvantes Imunológicos/administração & dosagem , Intestinos/citologia , Imunoglobulina A/metabolismo , Linfócitos B/metabolismo , Ratos Wistar , Análise de Variância , Caseínas , Linfócitos T/metabolismo , Extratos do Timo/administração & dosagem , Deficiência de Proteína/metabolismoRESUMO
Un uso inadecuado e indiscriminado en forma topica y con menor frecuencia en forma sistemica de esteroides, puede levar la presion intraocular en personas, con predisposicion genetica o con factores de riesgo, simulando un Glaucoma Primario de Angulo abierto, que se presenta con mayor facilidad enpacientes con antecedentes anormales de Humor Acuoso. Diagnosticado el Glaucoma o la elevacion de la Presion Intraocular, debera suspenderse de inmediato la administracion o aplicacion de esteroides y recurir a un tratamiento medico, caso contrario a uno quirurgico. Es por eso que es de vital importancia tomar medidas preventivas para el uso adecuado y racional de estos farmacos