Avaliação da qualidade dos dados clínicos de dois protocolos cooperativos de tratamento a pacientes portadores de sarcoma de Ewing

Introdução: O câncer infantil é uma doença infrequente em relação à incidência na população adulta, contudo representa um importante problema de saúde coletiva sendo a principal causa de morte por doença nesta faixa etária. Todavia, pesquisadores se interessam em entender melhor as características clínicas e epidemiológicas dessa doença com a finalidade de assegurar a qualidade no tratamento e de planejar políticas de atendimento. A condução de um estudo clínico deve garantir a qualidade dos dados de acordo com as Boas Práticas Clínicas. Nos estudos clínicos podem haver limitações que prejudiquem a qualidade dos dados coletados. Esta pesquisa avaliou a experiência de dois ensaios clínicos cooperativos de iniciativa do investigador quanto à qualidade dos dados na América Latina. Objetivos: 1. avaliar e comparar a qualidade dos dados clínicos (completude e consistência) de dois protocolos cooperativos para tratamento de pacientes com sarcoma de Ewing; 2. identificar desvios e violações nos estudos; 3. avaliar o impacto dos treinamentos contínuos na qualidade dos dados clínicos. Materiais e Métodos: Trata-se de um estudo observacional transversal retrospectivo incluindo fichas clínicas em papel de 178 e eletrônicas de 294 participantes de pesquisa de dois ensaios clínicos denominados Ewing 1 e Ewing 2, respectivamente. Foram selecionadas as sete fichas clínicas consideradas mais relevantes pelo investigador em fases diferentes do protocolo (baseline, avaliação pré-quimioterapia, quimioterapia, avaliação pós-quimioterapia, radioterapia e cirurgia do tumor primário) utilizando as variáveis, foi verificado, as dimensões de qualidade dos dados entre os dois estudos. Adicionalmente, foram analisadas as mesmas variáveis em três momentos distintos dentro do protocolo Ewing 2 (anos de 2013, 2014 e 2016). As medidas de intervenção têm como o objetivo melhorar a qualidade dos dados coletados e são realizadas de forma constante durante a condução do estudo. Resultados: A taxa média geral de completude total (100%) de todas as fichas clínicas foi de 35% no Ewing 1 e de 27% no Ewing 2. Individualmente, os dados de completude do Ewing 1 se comportaram melhor em quatro das sete fichas analisadas (p = 90%) was found in baseline and radiotherapy records of the primary tumor, poor concordance (<70%) in chemotherapies, and for the overall data was also weak. In Ewing 2, we found "good agreement" for baseline and primary tumor radiotherapy, "reasonable concordance" for chemotherapies and general data. The comparison between the percentages of deviations and violations were smaller in Ewing 2 with statistical significance for: 'No diagnostic exams',' No post-induction assessment ',' No post-consolidation evaluation ',' Moment of radiotherapy and surgery primary tumors other than the preconized ',' Start of study without consent form 'and' Disobedience of eligibility criteria '. In the Ewing 2 study, we found a positive evolution in the reduction of missing data during the three years analyzed. The completeness of the data in the electronic system for both new cases and the same patient presented better results (p <0.001). Conclusion: A well-crafted and functioning data collection system, trained researchers and research assistants, and a clinical trial support team provide reliable results regardless of the collection model. The training and optimization in the electronic collection system helped to improve the conduction process of the Ewing 2 clinical trial, both in the completeness and in the consistency of the information collected throughout the study

Bovine grafting : an effective alternative after curettage of benign bone tumors

We retrospectively reviewed 28 patients (15 women and 13 men) with benign bone tumors or pseudotumors treated with curettage and filling with freeze-dried bovine bone graft Orthogen (Baumer S/A, São Paulo, Brazil). The aim of the study was to evaluate the rate of incorporation of Orthogen into the host bone, as well as to describe the outcomes of bone healing (quality, time, and complications). General characteristics, tumor volume, size, site, complications, percent filled, and healing quality at 6 and 12 months were assessed through radiographs. Mean patient age was 20.5 (range 4.7-75.1) years. The most common lesion type was simple bone cyst (12/28), and the most common sites were the tibia (7/28) and humerus (7/28). There were no postoperative pathologic fractures. Two cases (7.1%) of serous fluid leakage through the wound occurred. Mean cavity volume was 20.1 (range 2.7-101.4) cm3. At 6 and 12 months, 75% and 77.8% of cavities, respectively, showed complete bone healing. At 12 months, 81% of cavities filled >90% with graft showed complete bone healing vs. only 19% of those filled <90%. Filling with bovine bone graft resulted in few complications and excellent healing after curettage of benign bone tumors or pseudotumors. Complete healing occurred in most cases by 12 months. Cavities with a higher percentage of filling had a higher rate of complete radiographic incorporation

What is the impact of local control in Ewing sarcoma : analysis of the first Brazilian collaborative study group – EWING1

Background: Relapse in localized Ewing sarcoma patients has been a matter of concern regarding poor prognosis. Therefore, we investigated the impact of local control modality (surgery, surgery plus radiotherapy, and radiotherapy) on clinical outcomes such as survival and recurrence in patients with non-metastatic Ewing sarcoma treated on the first Brazilian Collaborative Group Trial of the Ewing Family of Tumors (EWING1). Methods: Seventy-three patients with localized Ewing sarcoma of bone aged < 30 years were included. The treating physicians defined the modality of local control based on the recommendations of the coordinating center and the patient and tumor characteristics. Possible associations of local control modality with local failure (LF), disease-free survival (DFS), event-free survival (EFS), overall survival (OS), and clinical characteristics were analyzed. Results: Mean patient age was 12.8 years (range, 2 to 25 years) and median follow-up time was 4.5 years (range, 2. 3 to 6.7 years). Forty-seven patients underwent surgery, 13 received radiotherapy, and 13 received both. The 5-year EFS, OS, and DFS for all patients was 62.1%, 63.3%, and 73.1%, respectively. The 5-year cumulative incidence (CI) of LF was 7.6% for surgery, 11.1% for radiotherapy, and 0% for postoperative radiotherapy (PORT) (p = 0.61). The 5-year EFS was 71.7% for surgery, 30.8% for radiotherapy, and 64.1% for PORT (p = 0.009). Conclusions: There was a significant effect of local control modality on EFS and OS in the study. Surgery and PORT modalities yielded very close results. The group treated with radiotherapy alone had considerably worse outcomes. This may be confounded by greater risk factors in these patients. There was no significant effect of local control modality on the CI of LF and DFS

Avaliação da qualidade dos dados clínicos de dois protocolos cooperativos de tratamento a pacientes portadores de sarcoma de Ewing

Introdução: O câncer infantil é uma doença infrequente em relação à incidência na população adulta, contudo representa um importante problema de saúde coletiva sendo a principal causa de morte por doença nesta faixa etária. Todavia, pesquisadores se interessam em entender melhor as características clínicas e epidemiológicas dessa doença com a finalidade de assegurar a qualidade no tratamento e de planejar políticas de atendimento. A condução de um estudo clínico deve garantir a qualidade dos dados de acordo com as Boas Práticas Clínicas. Nos estudos clínicos podem haver limitações que prejudiquem a qualidade dos dados coletados. Esta pesquisa avaliou a experiência de dois ensaios clínicos cooperativos de iniciativa do investigador quanto à qualidade dos dados na América Latina. Objetivos: 1. avaliar e comparar a qualidade dos dados clínicos (completude e consistência) de dois protocolos cooperativos para tratamento de pacientes com sarcoma de Ewing; 2. identificar desvios e violações nos estudos; 3. avaliar o impacto dos treinamentos contínuos na qualidade dos dados clínicos. Materiais e Métodos: Trata-se de um estudo observacional transversal retrospectivo incluindo fichas clínicas em papel de 178 e eletrônicas de 294 participantes de pesquisa de dois ensaios clínicos denominados Ewing 1 e Ewing 2, respectivamente. Foram selecionadas as sete fichas clínicas consideradas mais relevantes pelo investigador em fases diferentes do protocolo (baseline, avaliação pré-quimioterapia, quimioterapia, avaliação pós-quimioterapia, radioterapia e cirurgia do tumor primário) utilizando as variáveis, foi verificado, as dimensões de qualidade dos dados entre os dois estudos. Adicionalmente, foram analisadas as mesmas variáveis em três momentos distintos dentro do protocolo Ewing 2 (anos de 2013, 2014 e 2016). As medidas de intervenção têm como o objetivo melhorar a qualidade dos dados coletados e são realizadas de forma constante durante a condução do estudo. Resultados: A taxa média geral de completude total (100%) de todas as fichas clínicas foi de 35% no Ewing 1 e de 27% no Ewing 2. Individualmente, os dados de completude do Ewing 1 se comportaram melhor em quatro das sete fichas analisadas (p = 90%) was found in baseline and radiotherapy records of the primary tumor, poor concordance (<70%) in chemotherapies, and for the overall data was also weak. In Ewing 2, we found "good agreement" for baseline and primary tumor radiotherapy, "reasonable concordance" for chemotherapies and general data. The comparison between the percentages of deviations and violations were smaller in Ewing 2 with statistical significance for: 'No diagnostic exams',' No post-induction assessment ',' No post-consolidation evaluation ',' Moment of radiotherapy and surgery primary tumors other than the preconized ',' Start of study without consent form 'and' Disobedience of eligibility criteria '. In the Ewing 2 study, we found a positive evolution in the reduction of missing data during the three years analyzed. The completeness of the data in the electronic system for both new cases and the same patient presented better results (p <0.001). Conclusion: A well-crafted and functioning data collection system, trained researchers and research assistants, and a clinical trial support team provide reliable results regardless of the collection model. The training and optimization in the electronic collection system helped to improve the conduction process of the Ewing 2 clinical trial, both in the completeness and in the consistency of the information collected throughout the study

Experiência de dois estudos clínicos cooperativos: avaliação da monitorização de dados clínicos

We investigate the estimation of illuminance flow using Histograms of Oriented Gradient features (HOGs). In a regression setting, we found for both ridge regression and support vector machines, that the optimal solution shows close resemblance to the gradient based structure tensor (also known as the second moment matrix). Theoretical results are presented showing in detail how the structure tensor and the HOGs are connected. This relation will benefit computer vision tasks such as affine invariant texture/object matching using HOGs. Several properties of HOGs are presented, among others, how many bins are required for a directionality measure, and how to estimate HOGs through spatial averaging that requires no binning.Industrial DesignIndustrial Design Engineerin