Multivariate risk and clinical signs evaluations for early-onset sepsis on late preterm and term newborns and their economic impact.

There is an increasing evidence that strict evaluation of clinical signs is effective in detecting newborns at risk of early-onset sepsis (EOS) that require antibiotic therapy. In a retrospective case control design, we compared EOS antibiotic indication by clinical signs surveillance with multivariate risk analysis (EOSCalc), and estimate their costs. Newborns ≥ 34 weeks who received EOS antibiotics from June 2014 to December 2016 were studied. Were considered symptomatic those with three clinical signs within first 24 h or two signs and one risk factor present. Cost estimative was done using bottom-up hospital's perspective. Eight thousand three hundred twenty-one were born, 384 were included. Two hundred nineteen (57%) would receive antibiotics by EOSCalc and 64 (16.7%) by clinical signs (p < 0.001). All patients with blood cultures were detected and false-negatives were absent. Total cost was US$ 574,121, estimate US$ 415,576 by EOSCalc, and US$ 314,353 by clinical signs (p < 0.001).Conclusions: The use of EOSCalc and clinical signs surveillance seem to be safe and accurate methods in EOS management. Additionally, the two approaches have shown an economic advantage when compared with the hospital's current practice. What is Known: • EOSCalc is a useful method for screening of EOS in late preterm and term infants. • Presence of clinical signs and/or maternal risk factors are present newborns with EOS. What is New: • Rigorous observation of clinical signs is a more accurate method than EOSCalc to screen for EOS in late preterm and term newborns. • Rigorous observation of clinical signs is more economic than EOSCalc in managing EOS in late preterm and term neonates.

Estimating the direct costs of ischemic heart disease: evidence from a teaching hospital in BRAZIL, a retrospective cohort study.

BACKGROUND: Coronary artery disease is the most prevalent cardiovascular disease. In the United States, 7% of adults over 20 years of age are estimated to have coronary artery disease. In Brazil, a prevalence of 5 to 8% has been estimated in adults over 40 years of age, with an increased number of hospitalizations associated with both stable and acute clinical manifestations; and health care costs have quadrupled in the last decade. To estimate the direct costs of managing ischemic heart disease patient care in a teaching hospital in Brazil from the perspective of the service payer, the Brazilian Unified Health System. METHODS: This study was a retrospective cohort study for the identification and valuation of resources used at both the outpatient and in-hospital levels in a sample of 330 patients selected from the hospital's ischemic heart disease clinic. Data were collected from computerized hospital records and patients' hospital bills from January 2000 to October 2015. A bivariate analysis and binary logistic regression were performed with p < 0.05 considered statistically significant. RESULTS: The study population consisted of 330 patients with a mean age 61 ± 10 years and a follow-up period of 107 ± 2.6 months; of the patients, 55% were male, 89% had hypertension, 48% had diabetes, and 65% had acute myocardial infarction. The mean annual cost of outpatient management was US $1,521 per patient. The mean cost per hospitalization was US $1,976, and the expenses were higher in the first and last years of follow-up. Unstable angina, revascularization procedures, diabetes, hypertension and obesity were predictors of higher hospitalization costs (p <0.05). CONCLUSION: The cost estimates in this study indicate a high proportion of drug treatment costs in the treatment of ischemic heart disease. Treatment costs are higher in the first year and at the end of treatment, and some clinical factors are associated with greater hospital care costs. These results may serve as a basis for the evaluation of existing public policies and inputs for cost-effectiveness studies in coronary artery disease. TRIAL REGISTRATION: CEP HCPA 11-0460 . Ethics Committee of Hospital de Clínicas de Porto Alegre.

Comparison of multiple genotyping methods for the identification of the cancer predisposing founder mutation p.R337H in TP53.

Germline mutations in the TP53 gene are associated with Li-Fraumeni and Li-Fraumeni-Like Syndromes, characterized by increased predisposition to early-onset cancers. In Brazil, the prevalence of the TP53-p.R337H germline mutation is exceedingly high in the general population and in cancer-affected patients, probably as result of a founder effect. Several genotyping methods are used for the molecular diagnosis of LFS/LFL, however Sanger sequencing is still considered the gold standard. We compared performance, cost and turnaround time of Sanger sequencing, PCR-RFLP, TaqMan-PCR and HRM in the p.R337H genotyping. The performance was determined by analysis of 95 genomic DNA samples and results were 100% concordant for all methods. Sequencing was the most expensive method followed by TaqMan-PCR, PCR-RFLP and HRM. The overall cost of HRM increased with the prevalence of positive samples, since confirmatory sequencing must be performed when a sample shows an abnormal melting profile, but remained lower than all other methods when the mutation prevalence was less than 2.5%. Sequencing had the highest throughput and the longest turnaround time, while TaqMan-PCR showed the lowest turnaround and hands-on times. All methodologies studied are suitable for the detection of p.R337H and the choice will depend on the application and clinical scenario.

Costs of genetic testing: Supporting Brazilian Public Policies for the incorporating of molecular diagnostic technologies.

This study identifies and describes the operating costs associated with the molecular diagnosis of diseases, such as hereditary cancer. To approximate the costs associated with these tests, data informed by Standard Operating Procedures for various techniques was collected from hospital software and a survey of market prices. Costs were established for four scenarios of capacity utilization to represent the possibility of suboptimal use in research laboratories. Cost description was based on a single site. The results show that only one technique was not impacted by rising costs due to underutilized capacity. Several common techniques were considerably more expensive at 30% capacity, including polymerase chain reaction (180%), microsatellite instability analysis (181%), gene rearrangement analysis by multiplex ligation probe amplification (412%), non-labeled sequencing (173%), and quantitation of nucleic acids (169%). These findings should be relevant for the definition of public policies and suggest that investment of public funds in the establishment of centralized diagnostic research centers would reduce costs to the Public Health System.

Quality management of the periodic medical examination at a university hospital, from the workers' perspective.

Introduction: Implementation of quality assessment methodologies at healthcare services enables the results achieved to be monitored in terms of established objectives and standards of care delivery. Objectives: To assess the quality of the processes involved in provision of periodic medical examinations at a University Hospital, from the workers' perspective. Methods: This is a cross-sectional study using questionnaires to conduct quality assessment of the periodic medical examination processes, including Net Promoter Score satisfaction questions. Statistical analysis of the results was performed using SPSS version 18. Data on categorical variables are expressed as absolute frequencies and data on continuous variables as means and standard deviations. Chi-square tests and analysis of variance were used to identify associations. A significance level of 0.05 was adopted to determine the statistical relevance of findings. Results: A total of 381 respondents with a mean age of 45.25 years were included, 66% of whom were female. There was a statistically significant (p < 0.001) association between duration of consultations and the number of items assessed in the periodic medical examination. In general, the findings from application of the Net Promoter Score for self-scheduling (45%) and service at reception (42%) indicate a need for process improvement, whereas clinical care (50%) rated as a quality process. Conclusions: This study identified a set of information that can be used to describe, analyze, and improve the care delivered by the institution's occupational health service and to identify opportunities for improvement of periodic medical examination processes.

An 8-step framework for implementing time-driven activity-based costing in healthcare studies.

Micro-costing studies still deserving for methods orientation that contribute to achieve a patient-specific resource use level of analysis. Time-driven activity-based costing (TDABC) is often employed by health organizations in micro-costing studies with that objective. However, the literature shows many deviations in the implementation of TDABC, which might compromise the accuracy of the results obtained. One reason for that can be attributed to the non-existence of a step-by-step orientation to conduct cost analytics with the TDABC specific for micro-costing studies in healthcare. This article aimed at exploring the literature and practical cases to propose an eight-step framework to apply TDABC in micro-costing studies for health care organizations. The 8-step TDABC framework is presented and detailed exploring online spreadsheets already coded to demonstrate data structure and math formula building. A list of analyses that can be performed is suggested, including an explanation about the information that each analysis can provide to increase the organization capability to orient decision making. The case study developed show that actual micro-costing of health care processes can be achieved with the 8-step TDABC framework and its use in future researches can contribute to increase the number of studies that achieve high-quality level in cost information, and consequently, in health resource evaluation.

Estudos de Microcusteio aplicados a avaliações econômicas em saúde: uma proposta metodológica para o Brasil / Microcosting methods applied to health economic assessment: a Brazilian methods guideline

Objetivo: No cenário da avaliação de tecnologias em saúde (ATS), as estimativas de custos são um fator crítico no desenvolvimento das avaliações econômicas completas, especialmente pelo uso de diferentes metodologias de custeio. A fim de contribuir com a acurácia dos dados de custos usados nessas análises, este artigo sugere recomendações para apuração de custos em saúde no Brasil. Métodos: Reuniram-se pesquisadores de ATS de diferentes expertises e centros de pesquisa do Brasil, e ao longo de dois anos foram conduzidas revisões da literatura nacional e internacional e discussões sobre as formas de abordar a temática. Três simpósios foram realizados reunindo os pesquisadores com o propósito de alcançar o consenso entre os autores sobre as melhores recomendações para a realização de estudos de Microcusteio. Resultados: Consolidou-se em forma de uma recomendação este artigo que representa uma versão compacta da diretriz completa a ser publicada pela Rede Brasileira de Avaliação de Tecnologias em Saúde. A metodologia de Microcusteio é considerada como padrão-ouro para a identificação dos custos em saúde. Os métodos de definição do estudo, coleta e análise de dados apresentados são descritos de modo a permitir uma valoração dos custos validada e homogênea, principalmente para o uso dessa informação em avaliações econômicas de saúde. Conclusão: Essa recomendação tem o propósito de aumentar a acurácia das estimativas dos custos de saúde no nosso meio e homogeneizar a comunicação entre estudos conduzidos por diferentes grupos de pesquisa. Por fim, é esperado que a utilização dessas recomendações contribua para que as decisões baseadas em dados econômicos sejam mais acuradas e equânimes quando da incorporação de tecnologias no país.

Objective: In the context of health technology assessment (HTA), cost estimates are a critical factor in the development of economic evaluations, especially through the use of different costing methodologies. In order to contribute to the accuracy of the cost data used in these analyzes, this article suggests recommendations to develop health cost analysis in Brazil. Methods: HTA researchers with heterogeneous background and from different Brazilian research centers were engaged on the development of this health cost analysis recommendation over two years. Reviews of national and international literature and discussions on how to approach the theme were conducted. Three symposia were held bringing together the researchers with the purpose of reaching consensus among the authors on the best recommendations for micro-accounting studies. Results: This article was consolidated as a recommendation, which represents a compact version of the complete guideline that will be published by the Brazilian Health Technology Assessment Network (REBRATS). The Microcosting methodology is considered as a gold standard for the analysis of health costs. Methods to define the study, to perform data collection and analysis are described in order to allow a validated and homogeneous cost evaluation, mainly for the use of this information in economic health assessments. Conclusion: This recommendation is intended to increase the health cost estimated accuracy in our country and to homogenize the communication between studies conducted by different research groups. Finally, it is expected that the use of these recommendations will contribute to make decisions based on economic data more accurate and equitable when incorporating health technologies in the country.

A perspectiva estratégica na gestão de um laboratório de pesquisa na área da saúde

As pesquisas na área da saúde tem sido desenvolvidas com recursos governamentais obtidos junto às agências de fomento ou com recursos próprios das instituições, num esforço conjunto para a obtenção de parâmetros, em que se destacam os estudos epidemiológicos, voltados à melhoria na resolutividade dos problemas de saúde da população. A inserção da temática Gestão em Serviços de Saúde na área epidemiológica surge do enfoque multidisciplinar como uma forma de complementar os estudos trazendo conhecimentos oriundos da Administração para a abordagem das questões relativas à qualidade na atenção, eqüidade, identificação dos agravos de saúde, novas tecnologias e avaliação de custoefetividade das intervenções em saúde. A capacidade de auto-sustentabilidade de um laboratório de pesquisa de uma instituição pública de saúde em relação aos seus recursos financeiros e materiais e ao desenvolvimento do seu potencial humano de forma efetiva e eficaz é o foco deste trabalho que tem por objetivo desenvolver e aplicar o sistema gerencial Balanced Scorecard (BSC) no Centro de Terapia Gênica do Hospital de Clínicas de Porto Alegre. O desenvolvimento do Balanced Scorecard no Centro de Terapia Gênica foi realizado em duas etapas: a primeiro, voltada à construção do modelo conceitual através da elaboração do Mapa Estratégico e a segunda, à definição do Plano de Ação com a seleção das áreas de indicadores do laboratório. As referências usadas nessas fases foram a revisão da literatura sobre o BSC e seu desenvolvimento em outras organizações do setor público e privado, a análise exploratória dos indicadores de desempenho sugeridos pela Associação Brasileira das Instituições de Pesquisa Tecnológica (ABIPTI), o Planejamento Estratégico do Hospital de Clínicas e o levantamento dos dados do laboratório. Os resultados obtidos indicam a viabilidade da aplicação do BSC em um laboratório de pesquisa de um hospital público de ensino. Mostram, também, que a administração das atividades de pesquisa, vista sob uma perspectiva estratégica, torna a multidisciplinaridade de conhecimentos presentes em uma instituição como um fator importante para a busca das melhores práticas gerenciais que contribuam para agregar valor científico, tecnológico e econômico às atividades de pesquisa e desta forma, auxiliem a impulsionar as atividades de P e D na organização. (AU)

A perspectiva estratégica na gestão de um laboratório de pesquisa da área da saúde / The strategic perspective in the administration of a research laboratory in healthcare

O Centro de Terapia Gênica é um laboratório compartilhado, implantado em 2002, que atuana área de genética e localiza-se no Centro de Pesquisas do Hospital de Clínicas de Porto Alegre.Tem como característica principal ser um prestador de serviços de biologia molecular e celular para os projetos de pesquisa que se desenvolvem no hospital. Os resultados financeiros negativos ao final de cada período motivaram este estudo, que teve como objetivo desenvolver e aplicar o sistema de gestão balanced scorecard. Realizou-se a revisão da literatura, o levantamento de dados do laboratório e o desenvolvimento do planejamento estratégico. O trabalho foi implementado em novembro de 2004. Os resultados foram a construção do mapa estratégico, definição de metas para o período 2005-2008, crescimento da receita de faturamento em 21%, redução dos custos operacionais em 43%, estabelecimento dos custos de 39% das técnicas básicas do laboratório e aumento da captação de projetos em 47%. Este estudo mostra que a gestão das atividades de pesquisa, vista sob uma perspectiva estratégica, poderá agregar valor tanto científico como econômico à instituição, expresso sob a forma dos novos conhecimentos gerados,publicações realizadas, captação de recursos para a pesquisa e redução dos custos operacionais.

The Centro de Terapia Gênica (Gene Therapy Center), which was established in 2002, is a shared laboratory specialized in genetics. It is located at Research Center, Hospital de Clínicasde Porto Alegre. Its main characteristic is to provide services of molecular and cellular biologyfor research projects that are being developed at the hospital. This study was motivated by thenegative financial results at the end of each year. Therefore, it aims to develop and apply thebalanced scorecard, a strategic management system. We performed a literature review, laboratory data collection, and development of the strategic planning. This study was implemented on November 2004. Results were: elaboration of a strategic map, definition of goals for 2005-2008, increase in revenue by 21%, reduction in operational costs by 43%, establishment of the costs concerning 39% of basic laboratory techniques, and increase in submission of projects by 47%.This study shows that the strategic administration of research activities may add scientific and economic value to the institution. This value is expressed as increased knowledge, publications, generation of resources for research, and reduction in operational costs.