Can COVID-19 impact the natural history of paracoccidioidomycosis? Insights from an atypical chronic form of the mycosis

ABSTRACT Paracoccidioidomycosis (PCM) is a systemic fungal infection caused by Paracoccidioides spp. It can occur as an acute/subacute form (A/SAF), a chronic form (CF) and rarely as a mixed form combining the features of the two aforementioned forms in an immunocompromised patient. Here, we report a 56-year-old male patient with CF-PCM who presented with atypical manifestations, including the development of an initial esophageal ulcer, followed by central nervous system (CNS) lesions and cervical and abdominal lymphatic involvement concomitant with severe SARS-CoV-2 infection. He was HIV-negative and had no other signs of previous immunodeficiency. Biopsy of the ulcer confirmed its mycotic etiology. He was hospitalized for treatment of COVID-19 and required supplemental oxygen in the intensive unit. The patient recovered without the need for invasive ventilatory support. Investigation of the extent of disease during hospitalization revealed severe lymphatic involvement typical of A/SAF, although the patient`s long history of high-risk exposure to PCM, and lung involvement typical of the CF. Esophageal involvement is rare in non-immunosuppressed PCM patients. CNS involvement is also rare. We suggest that the immunological imbalance caused by the severe COVID-19 infection may have contributed to the patient developing atypical severe CF, which resembles the PCM mixed form of immunosuppressed patients. Severe COVID-19 infection is known to impair the cell-mediated immune response, including the antiviral response, through T-lymphopenia, decreased NK cell counts and T-cell exhaustion. We hypothesize that these alterations would also impair antifungal defenses. Our case highlights the potential influence of COVID-19 on the course of PCM. Fortunately, the patient was timely treated for both diseases, evolving favorably.

Sistema para el manejo de datos de Ensayos Clínicos XAVIA SIDEC / Clinical Trials Data Management System XAVIA SIDEC

El ensayo clínico constituye el método empleado para evaluar un producto, sustancia, medicamento, técnica diagnóstica o terapéutica. La industria biotecnológica emplea sistemas de gestión de ensayos clínicos para lograr un manejo eficiente de los datos recopilados durante el proceso. El Centro de Inmunología Molecular (CIM) emplea el Sistema de Gestión de Ensayos Clínicos XAVIA Clínicas desarrollado por la UCI, para soportar el 100 por ciento de los ensayos clínicos desde el 2012. XAVIA Clínicas posee limitantes en sus funcionalidades; además, a partir de la experiencia obtenida por su uso, se identificaron mejoras y nuevas funcionalidades que constituyen el incentivo para desarrollar un nuevo sistema. El objetivo del presente artículo es presentar el Sistema para el manejo de datos de Ensayos Clínicos XAVIA SIDEC y su generalización en las instituciones de BioCubaFarma. Se estudió la bibliografía referente al manejo de datos de ensayos clínicos y cuadernos de recogida de datos electrónicos y se analizaron sistemas homólogos disponibles en el mercado internacional. La metodología de desarrollo empleada fue AUP-UCI. Se utilizó Eclipse como entorno integrado de desarrollo, Java como lenguaje de programación, JBoss como servidor de aplicaciones y PostgreSQL como sistema de gestión de bases de datos. El Sistema para el manejo de datos de Ensayos Clínicos XAVIA SIDEC facilita y flexibiliza el diseño y aprobación de los Cuadernos de recogida de información (CRD), estandariza la información manejada, valida los datos recopilados a través de reglas, mejora el flujo de información entre las entidades que conducen el ensayo y optimiza el proceso de monitoreo(AU)

Clinical trial is the method used to evaluate a product, substance, medicine, diagnostic or therapeutic technique. The biotechnology industry employs clinical trial management systems to achieve efficient management of data collected during clinical trials. CIM (Centro de Inmunología Molecular) uses the Clinical Trials Management System XAVIA Clínicas developed by UCI, to support 100 percent of clinical trials since 2012. This system has limitations in its functionalities; furthermore, based on the experience obtained, improvements and new functionalities were identified, so it was decided to develop a new version of the system. The objective of this article is to present the Clinical Trials Data Management System XAVIA SIDEC and its generalization in BioCubaFarma institutions. The bibliography referring to the clinical trial data management and electronic data collection notebooks was studied and homologous systems available in the international market were analyzed. The development methodology used was AUP-UCI. Eclipse was used as an integrated development environment, Java as a programming language, JBoss as an application server and PostgreSQL as a database management system. The Clinical Trials Data Management System XAVIA SIDEC facilitates and makes the Case Report Forms (CRF) design and approval more flexible, standardizes the information handled, validates the data collected through rules, improves the flow of information between the entities conducting the trial and optimizes the monitoring process(AU)

Construção e validação de uma ficha clínica para acompanhamento de pré-natal de risco habitual* / Construcción y validación de una ficha clínica para el monitoreo del riesgo prenatal habitual * / Construction and validation of a clinical form for usual-risk prenatal follow-up*

Objetivo: construir e validar uma ficha clínica para acompanhamento do pré-natal de risco habitual. Método: pesquisa metodológica com emprego de Técnica Delphi para validar o instrumento quanto a pertinência/representatividade, aplicando-se o cálculo do coeficiente de validade de conteúdo, cujo valor mínimo adotado foi ≥ 80 %. Os critérios de seleção dos participantes consistiram em ser enfermeiro, docente de instituição pública com título de Doutor e especialista em Obstetrícia. O primeiro painel foi constituído por 15 juízes e o segundo por 13. O estudo foi realizado entre fevereiro a junho de 2016. Resultados: o cálculo do Coeficiente de Validação de Conteúdo mensurou a Pertinência/Representatividade de cada item da ficha clínica mediante a análise de dois painéis, os quais alcançaram o coeficiente estabelecido. Conclusão: a ficha clínica validada está apta para aplicação em consultas de pré-natal de risco habitual.

Objective: to build and validate a clinical form record for usual-risk prenatal follow-up. Method: methodological research with employment of Delphi Technique to validate the instrument as the relevance/representativeness, by applying the calculation of the content validity coefficient, whose minimum value adopted was ≥ 80 %. The criteria for the selection of participants consisted of being a nurse, professor at government institution with the degree of PhD and specialist in Obstetrics. The first panel was composed of 15 judges and the second, of 13. The study was conducted between February and June 2016. Results: the calculation of the Content Validity Coefficient measured the Relevance/Representativeness of each item of the clinical form through the analysis of two panels, which reached the coefficient set. Conclusion: the validated clinical form is suitable for application in usual-risk prenatal consultations.

Objetivo: construir y validar una ficha clínica para el monitoreo del riesgo prenatal habitual. Método: investigación metodológica con el empleo de la Técnica Delphi para validar el instrumento de acuerdo con la pertinencia/representatividad, aplicando el cálculo del coeficiente de validación de contenido, cuyo valor mínimo aprobado era ≥ 80 %. Los criterios para la selección de los participantes consistían en ser un(a) enfermero(a), profesor(a) de institución pública con el título de Doctor(a) y especialista en Obstetricia. El primer panel estuvo integrado por 15 jueces y el segundo, por 13. El estudio se realizó entre febrero y junio de 2016. Resultados: el cálculo del Coeficiente de Validación de Contenido midió la pertinencia/representación de cada elemento de la forma clínica a través del análisis de dos paneles, que alcanzaron el coeficiente establecido. Conclusión: la ficha clínica validada es adecuada para su aplicación en las consultas prenatales de riesgo habitual.

Clinical profile and prognostic factors of mortality among adult tetanus patients in Cagayan Valley Medical Center: A crosssectional study

Introduction@#Tetanus remains a public health threat in developing countries and is associated with a high morbidity and mortality rate. There is paucity of published data regarding the management of tetanus in the Philippines, hence, the study was conducted to determine the demographic, clinical profile, and prognostic factors that are associated with mortality among adult tetanus patients admitted in Cagayan Valley Medical Center (CVMC).@*Methods@#This is a retrospective study of patients who presented with a clinical diagnosis of tetanus, above 19 years old at CVMC between September 1, 2012 to October 31, 2018.@*Results@#A total of 194 patients were studied. The male to female ratio was 11:1.Majority of patients were aged > 40 years (68.56%), rural dwellers (88.66%), farmers (84.02%) and males (91.75%). Only 3.09% of patients had prior tetanus immunization. Most common antecedent injury is trauma (84.53%), most commonly due to punctured wounds (63.40%). All patients had generalized tetanus, and majority were admitted in moderate grade (68.56%). Most common manifestations were trismus (92.78%), spasms (84.02%), dysphagia (80.93%) and rigidity (68.04%). Complication rate is 64.43%. Mortality rate is 38.66%. Most common cause of death is acute respiratory failure. Poor prognostic factors determined by univariate analysis were age more than 40 years (OR=2.24, p-value=0.0160), incubation period less than seven days (OR=2.65, p-value= 0.0027), period of onset less than three days (OR=2.52, p-value=0.0150) , severity of disease (OR=17.35, p-value=<0.0001), need for ventilatory support (OR=22.20, p-value=<0.0001) and presence of complications (OR=2.96, p-value= 0.0013). In multivariate analysis, only need for ventilatory support is associated with mortality (OR=31.57, p-value=0.000).@*Conclusion@#Mortality rate of adult tetanus in Cagayan Valley Medical Center is high. Therefore, health education is highly encouraged to promote awareness, specifically in immunization and basic wound management.

Manufacture and evaluation of health education form for spinal tuberculosis patients / 中国实用护理杂志

Objective To investigate the requirement of health education for patients with spinal tuberculosis,making clinical education form,and determine the evaluation system.Methods 134 cases of spinal tuberculosis patients were surveyed with self-designed questionnaires.The questionnaire included 5 aspects,using the Likert 4 scoring method.Delphi method was applied in 16 experts.Results The health demand of patients showed high positive correlation in domains of cognition and operation.There was a moderate positive correlation between affective domain and cognition,operation domain.Two rounds of expert consultation showed that the expert opinion coordination coefficient was 100％,the average of authority was above 0.8,the expert opinion coordination coefficients of all the indexes were between 0.2～0.6.Conclusions The health education form for spinal tuberculosis patients can help to understand the needs of patients,it is pertinent and get the recognition of experts.