bluuebunny/crossref_metadata_2025 huggingface dataset:
Avaliação da qualidade da informação de sites sobre Covid-19: uma alternativa de combate às fake news
Authors: Pereira Neto André , Ferreira Eduardo de Castro , Domingos Raquel Luciana Angela Marques Tauro , Barbosa Leticia , Vilharba Bruna Luiza de Amorim , Dorneles Francine de Sales , Reis Vania Silva dos , Souza Zilda Alves de , Graeff Samara Vilas-Bôas
Published: February 2022

RESUMO As tecnologias de informação e comunicação têm-se disseminado globalmente. Elas estão cada vez mais presentes em quase todos os aspectos da vida humana, incluindo a saúde. Em meio à ampla disseminação de informações falsas, a questão da qualidade da informação tem assumido grande importância, especialmente em contexto de pandemia. Entre julho e agosto de 2020, foi realizada uma avaliação da qualidade da informação em sites sobre Covid-19 de quatro secretarias de saúde do estado de Mato Grosso do Sul. Essa avaliação participativa utilizou cinco critérios, acompanhando a literatura internacional, a saber: Técnico, Interatividade, Abrangência, Legibilidade e Acurácia, subdivididos em 46 indicadores. Os resultados apontam que os sites avaliados apresentaram baixo grau de conformidade com os indicadores e critérios utilizados e não divulgam as principais evidências científicas sobre o tema, disponíveis no site do Ministério da Saúde. A pandemia de Covid-19 tem sido marcada pela alta circulação de fake news. Nesse contexto, é imprescindível que páginas de secretarias de saúde apresentem informação sobre a doença com qualidade e legibilidade. Só assim, oferecerão um conteúdo informativo confiável e baseado em evidências científicas, contribuindo para o enfrentamento de notícias falsas e seus impactos negativos.
Mortalidade por violência contra mulheres antes e durante a pandemia de Covid-19. Ceará, 2014 a 2020
Authors: Chagas Elisângela Rodrigues , Oliveira Fernando Virgílio Albuquerque de , Macena Raimunda Hermelinda Maia
Published: February 2022

RESUMO Compreendendo a importância do monitoramento da violência contra mulheres, este estudo teve como objetivo analisar o comportamento da curva de crimes violentos, letais e intencionais contra mulheres, no estado do Ceará, nos últimos anos e discutir acerca dos aspectos que envolvem a curva epidemiológica dos crimes letais contra a mulher, principalmente com o início da pandemia de Covid-19. Trata-se de uma pesquisa ecológica, utilizando os dados secundários disponíveis na plataforma da Secretaria de Segurança Pública e Defesa Social do estado do Ceará entre os anos de 2014 a 2020. A coleta foi realizada no mês de janeiro de 2021, os dados foram analisados com auxílio do programa Excel. Constatou-se que a violência contra a mulher no estado do Ceará encontra-se em ascensão e que anos com eventos sanitários atípicos, como a pandemia da Covid-19, tendem a impactar negativamente a vida em sociedade e mais diretamente a vida das mulheres. Torna-se essencial que as autoridades, as instituições, organizações sociais, comunidade acadêmica, profissionais de todos os setores e serviços públicos e privados estejam sensibilizados e empenhados em cobrar a efetivação das políticas de enfrentamento alinhadas a rede de serviços, principalmente no momento de maior vulnerabilidade da pandemia.
O processo de trabalho na Estratégia Saúde da Família voltado às pessoas com sobrepeso e obesidade em São Paulo
Authors: Jesus Juliana Giaj Levra de , Campos Célia Maria Sivalli , Scagliusi Fernanda Baeza , Burlandy Luciene , Bógus Cláudia Maria
Published: February 2022

RESUMO O objetivo do artigo é analisar as características dos processos de trabalho na Estratégia Saúde da Família direcionados às pessoas com sobrepeso e obesidade no município de São Paulo. Ancorado no referencial teórico da saúde coletiva sobre processo de trabalho, foi desenvolvido um estudo exploratório com abordagem qualitativa. Foram realizadas onze entrevistas com profissionais de uma unidade básica de saúde, na zona leste da cidade de São Paulo, entre os meses de julho e agosto de 2019. A partir da análise temática, o artigo apresenta os resultados e a discussão em três categorias analíticas: objeto de trabalho, instrumentos de trabalho e organização do trabalho. O cuidado às pessoas com sobrepeso e obesidade é mediado pelo baixo investimento em qualificação dos profissionais de saúde sobre o tema, pela falta de materiais técnicos de suporte ao trabalho e pelo modelo de gestão pautado pela produtividade e cobrança de resultados quantitativos. Conclui-se que os profissionais de saúde apresentam pouco domínio sobre seu processo de trabalho, cuja finalidade acaba sendo a mudança de comportamento e a perda de peso corporal, em vez de considerar as necessidades de saúde dos usuários e profissionais, produzindo, por vezes, insatisfação e desgaste com o trabalho.
O acesso aos serviços de saúde pela População em Situação de Rua: uma revisão integrativa
Authors: Andrade Rebeca de , Costa Alane Andréa Souza , Sousa Elyana Teixeira , Rocon Pablo Cardozo
Published: February 2022

RESUMO Objetivamos analisar o acesso da População em Situação de Rua (PSR) à atenção básica, ambulatorial e hospitalar. O estudo foi realizado por meio de uma revisão integrativa (2009 a 2020) com dados retirados da Biblioteca Virtual em Saúde (BVS), nos idiomas português, espanhol e inglês, originados no Brasil e disponíveis em texto completo. Os descritores foram: PSR; morador de rua; acesso aos serviços de saúde; e os termos livres consultório na rua e consultório de rua. Os resultados indicam como barreiras para o acesso à atenção básica os preconceitos e estigmas produzidos sobre a PSR. Na atenção ambulatorial e hospitalar, os artigos revelam que não há acolhimento de pacientes PSR que possuem Transtorno Mental Grave (TMG). A exigência de documentos de identificação para o atendimento, somada à ausência de produção de vínculo e acolhimento, são barreiras presentes da atenção básica à hospitalar. Os estudos indicam o Consultório na Rua e a articulação com as Redes de Assistência Social e Atenção Psicossocial como potencializadores do acesso da PSR aos serviços de saúde. Conclui-se que a PSR requer um processo de trabalho em saúde pautado na equidade como princípio de atuação no Sistema Único de Saúde.
Comunidade Ampliada de Pesquisa em ambiente virtual (CAP on-line) sobre trabalho e saúde docente
Authors: Santos Gideon Borges dos , Souza Kátia Reis de , Rodrigues Andréa Maria dos Santos , Gomes Luciana , Félix Eliana Guimarães , Araujo Luísa Maiola de , Costa Jordânia Lira da
Published: February 2022

RESUMO A pandemia do novo coronavírus afetou a dinâmica do cotidiano escolar, obrigando os(as) professores(as) a um movimento de adaptação para dar conta das demandas impostas pelo distanciamento social. Esse cenário também atingiu as pesquisas, cujas técnicas de coletas de dados se davam de maneira presencial e tiveram que ser realizadas remotamente. O objetivo deste texto é descrever a trajetória da Comunidade Ampliada de Pesquisa, adaptada para o ambiente virtual (CAP on-line), como parte da pesquisa que buscou examinar as novas exigências do ensino remoto e suas implicações para a saúde dos(as) professores(as). Foram realizadas três oficinas com a participação de professores(as) do Ensino Fundamental e Médio. Observou-se que o processo de pesquisa tem correlações com os próprios resultados do estudo, especialmente no que se refere aos novos aprendizados trazidos pelo ensino remoto. Conclui-se que o compartilhamento de experiências de trabalho por meio da CAP on-line é uma possibilidade. No entanto, o aperfeiçoamento nos modos de interação virtual, o domínio do aparato tecnológico e o acesso a equipamentos de qualidade são elementos a serem observados para o aperfeiçoamento dessa abordagem coletiva de investigação.
NATURAL DISTRIBUTION OF Myracrodruon urundeuva FR. ALL. IN BRAZIL AT CURRENT AND FUTURE CLIMATE SCENARIOS DUE TO GLOBAL CLIMATE CHANGE
Authors: Capo Lorena Frigini Moro , Moraes Mario Luiz Teixeira de , Zulian Daniele Fernanda , Wrege Marcos Silveira , Portela Renan Marcelo , Cambuim José , Silva Alexandre Marques Da , Soares Márcia Toffani Simão , Sousa Valderês Aparecida de , Aguiar Ananda Virginia de
Published: February 2022

ABSTRACT In this work, the prediction of the distribution of M. urundeuva Fr. All. was performed based on the region of natural occurrence of the species. Its geographic coordinates were obtained from online databases CRIA and SpecialLinks, from scientific articles and fieldwork carried out by Universidade Estadual Paulista (UNESP) in Ilha Solteira, São Paulo, Brazil. M. urundeuva is a native tree species with great potential for commercial use in Brazil. For this purpose, ecological niche modeling was used, with current layers of climate variables and layers prepared for future climate scenarios, according to the 4th Report of the Intergovernmental Panel on Climate Change (AR4/IPCC), using Worldclim data on Brazil. With the Open Modeller and ArcGIS programs, maps were generated to predict its occurrence for the current period and future climate scenarios, made according to the projections of global climate changes. With the projection of increases in temperature and precipitation in the area where the species occurs, it tends to migrate to areas of Brazil where the climate is currently milder, in the south and southeast regions. Due to climatic changes, the species tends to undergo changes in distribution and area size until 2080. It was projected for Caatinga and Pantanal, in both periods, an increase in area, while for the Cerrado, in the first period, the area increased, and, for the second, it decreased. Therefore, according to the results of the maps of future projections for the next decades, it is concluded that there will be changes in the distribution of M. urundeuva, with a significant reduction of the potential area of occurrence in the region.
O transbordamento do PIB do Agronegócio do Brasil: uma análise da importância setorial via Matrizes de Insumo-Produto
Authors: Luz Antônio da , Fochezatto Adelar
Published: February 2022

Resumo: A importância do agronegócio na economia é um tema bastante estudado no contexto brasileiro. O objetivo deste estudo é contribuir com este tema fazendo uma mensuração simultânea do agronegócio nacional e de todas as Unidades da Federação nos anos de 2000 e 2010. Os resultados do estudo permitem verificar como o agronegócio agregado e seus componentes se distribuem no território nacional e ao longo do tempo. Para isso foram utilizadas informações compatibilizadas das matrizes de insumo-produto e de empregos da RAIS. Considerando apenas o ano de 2010, os resultados obtidos mostram que o agronegócio representa 21% do Valor Adicionado da economia brasileira, que São Paulo é a Unidade da Federação com maior participação no agronegócio nacional (26%) e que Mato Grosso é a Unidade da Federação com maior participação do agronegócio na economia local (56%).
Potential risks of climate variability on rice cultivation regions in the Mekong Delta, Vietnam
Authors: Dinh T. K. H. , Dang T. A.
Published: February 2022

ABSTRACT In recent decades, the rice cultivation regions in the Mekong Delta have continuously suffered from unprecedented weather events due to a decline in rainfall as part of climate variability. The aim of this study was to perform a comprehensive exploration of the rainfall characteristics across the area, applying the Rainfall Anomaly Index (RAI), Spearman Rho test and Sen slope estimator to help track the weather as well as provide warnings on the potential risks caused by alterations in rainfall amounts. For this goal, the rainfall data sequences at 14 national observation stations across the Mekong Delta were collected for the 1984 - 2019 period. Results indicated that the dry weather seasons occurred more frequently during the normally wet weather seasons. Four typical dry weather seasons were identified for the 1997 - 1998, 2002 - 2004, 2014 - 2016, and 2018 - 2019 periods. Among these, the 2014 - 2016 period was the driest, with 9 out of 12 stations in the area being extremely dry and RAI risk peaks as high as -4.86 at the Moc Hoa station in the province of Long An. A weather trend of decreasing rainfall was evident, mainly in the coastal sub-regions. The discovery of changing rainfall trends is valuable for predicting future climate variability.
The applicability of the Visceral Adiposity Index (VAI) for predicting visceral fat
Authors: Silva Nadja Fernandes da , Pinho Cláudia Porto Sabino , Diniz Alcides da Silva , Arruda Ilma Kruze Grande de , Leão Ana Paula Dornelas , Rodrigues Isa Galvão
Published: February 2022

Abstract As obesity has reached epidemic proportions and given the current recognition of central adiposity as an important cardiometabolic risk factor, several researchers have focused on developing and validating predictive indexes and equations to evaluate Visceral Adipose Tissue (VAT). This study evaluates the applicability of the Visceral Adiposity Index (VAI) for predicting cardiometabolic risk in individuals treated in a hospital In the northeast region of Brazil. The VAT was evaluated by computed tomography (CT) and the VAI was calculated through specific equations for each gender. The sample involved adult and elderly patients of both genders followed up in a cardiology outpatient clinic. The following cardiometabolic parameters were collected: fasting glycemia, glycated hemoglobin, lipid profile, C-reactive protein (CRP) and uric acid. The simple linear regression was used to evaluate the explanatory power of the VAI in relation to the volume of VAT determined by CT. The predictive capacity of VAI in relation to the volume of VAT determined by CT was 25.8% (p=0.004) for males and 19.9% (p<0.001) for females. VAI correlated strongly with the triglyceride (TG) (p<0.001) and TG/high-density lipoprotein (HDL) ratio (p<0.001) and inversely correlated with HDL (p<0.001). Moreover, VAI showed low correlation with the following variables: abdominal circumference, total cholesterol, low density lipoprotein, fasting glycemia, and glycated hemoglobin (p<0.05). VAI was associated with variables considered as cardiometabolic risk factors, but exhibited a low predictive capacity regarding the volume of VAT determined by CT. Thus, caution is recommended in its use in Brazilian individuals.
Palliative care in medical education: the students’ perception
Authors: Castro Andrea Augusta , Taquette Stella Regina , Pereira Caio Assunção Rocha , Marques Natan Iório
Published: February 2022

Abstract: Introduction: Population aging, longer life expectancy and the increase in the prevalence of chronic diseases have brought new health demands, among them, palliative care (PC). Although present in the clinical routine, this topic has not yet been included in most medical schools in Brazil. Objective: To know the teaching-learning process in PC according to the perception of medical students from schools that have this subject. Method: Qualitative method through interviews with 35 medical students from 14 medical schools located in the Northeast, Southeast and South regions of the country. Results: The reports were classified into three categories: conception of PC, changes perceived after exposure to PC teaching, challenges and successful strategies identified in PC teaching. Students recognize the value of teaching in PC and have a greater understanding of PC approach and its early indication for people with complex chronic conditions. The inclusion of the topic contributed to the overcoming of fears and taboos related to death, providing greater comfort to deal with human suffering, adding emotional skills. The formal education in PC allowed understanding the person in their biopsychosocial and spiritual dimension. They stressed the importance of communication skills to communicate difficult news, symptom management, teamwork and an individualized approach to the person and their family. Although they identify little theoretical-practical integration in the teaching-learning scenario in PC, they report an interest in the topic, and indicated successive experiences as strategies throughout the training, in a humanist axis. Conclusion: PC teaching brings contributions to medical training that go beyond the learning of the subject and reinforces the development of empathy and compassion, recognized as essential in this profession, as well as the relevance of assertiveness in the management of suffering and the comprehensive care of people with advanced diseases.
Video Game Interaction Related to Increased Present Attention in College Students
Authors: Rodrigues Junior Radael Rezende , Rodrigues Lívia , Souza Mariane Lima de
Published: February 2022

Abstract Action video games require a high level of attention and almost automatic psychomotor reactions from the player. Therefore, this study aims to verify the relationship between the amount of hours of interaction with action video games and private self-awareness and attention to the present moment. In total, 1,315 college students were recruited (M = 21.6 years; SD = 2.7), who responded to the Digital Entertainment and Information Use Questionnaire, the Self-Reflection and Insight Scale, and the Full Attention and Awareness Scale. Statistical analysis (Kruskal-Wallis and Dunn’s Post-Hoc Tests) indicated a relationship between hours of video game interaction, attention to the present, and self-reflection. It is concluded that playing action video games regularly and for a certain period of time is related to a lower predisposition to turn attention to oneself and to lower impulsivity, but to a higher disposition to focus on everyday experiences (attention to the present).
Gestão do cuidado de Enfermagem para a qualidade da assistência pré-natal na Atenção Primária à Saúde
Authors: Amorim Tamiris Scoz , Backes Marli Terezinha Stein , Carvalho Karini Manhães de , Santos Evangelia Kotzias Atherino dos , Dorosz Paula Andreia Echer , Backes Dirce Stein
Published: February 2022

Resumo Objetivo compreender o significado da gestão do cuidado de Enfermagem para a qualidade da assistência pré-natal na visão de enfermeiras da Atenção Primária à Saúde. Método pesquisa qualitativa desenvolvida com a Teoria Fundamentada nos Dados e o pensamento complexo de Edgar Morin. Realizaram-se observações participantes e entrevistas semiestruturadas individuais com 11 enfermeiras da atenção primária. Análise dos dados: codificação aberta, axial e seletiva/integração e organização pelo software NVIVO®. Resultados o fenômeno central “Promovendo a gestão do cuidado de Enfermagem na Atenção Primária à Saúde” evidenciou que a gestão do cuidado de Enfermagem realizada pelas enfermeiras contribui para promover a autonomia das gestantes, a qualidade dos cuidados, o protagonismo e o empoderamento maternos no processo de gestar, parir, nascer e amamentar, envolvendo a participação da família/rede de apoio nos cuidados. Considerações finais e implicações para a prática a gestão do cuidado realizada pelas enfermeiras busca acolher as singularidades das gestantes/famílias e promover o cuidado singular, multidimensional, contínuo, vigilante, sistematizado e integrado, valorizando a subjetividade e o protagonismo da mulher, pautado nos princípios da autonomia e empoderamento materno. Recomendam-se o dimensionamento de pessoal adequado, a realização das ações de saúde de forma integrada/em rede, a comunicação efetiva entre os diferentes níveis de atenção e a preparação intensificada para o parto fisiológico, o puerpério e a amamentação.
Study on the performance of thermal energy of a classroom built with natural materials
Authors: Benaddi Fatima Zahra , Boukhattem Lahcen , Benhamou Brahim , Tabares-Velasco Paulo Cesar , Ait Nouh Fatima
Published: February 2022

This study highlights the indoor thermal comfort in a classroom building mostly built with locally available construction materials combined with some passive techniques in the hot semi-arid climate of Marrakech, Morocco. The thermal assessment of this so-called Baterre building was analysed against a typical building (TB), which represents the structure most widely used in Moroccan rural classrooms and is constructed with conventional materials. A TRNSYS-based dynamic model was developed and validated using onsite monitoring measurements according to American Society of Heating, Refrigerating and Air-Conditioning Engineers (Ashrae) guideline 14. Simulation results show that the Baterre structure has a noticeable positive effect on indoor thermal comfort since its indoor air temperature remains stable while that of the TB classroom has higher oscillations. The hourly calculated indoor air temperature in Baterre is greater by 3.6°C during winter and lower by 9.54°C during summer than that in the TB. Moreover, indoor thermal comfort analysis based on the Ashrae Standard 55-2013 shows that Baterre provides good indoor thermal comfort 63% of the time all year round, while the corresponding indoor thermal comfort time value in the TB is 32%. Furthermore, the annual thermal load of Baterre is lower by 53% than that of the TB.
Clinical Investigations on Medical Devices, after the New European Regulation (2017/745)
Authors:   AKROS BioScience s.r.l., Piazza Aldo Moro 20/d, 00071 Pomezia (Rome), Italy, Bianco Salvatore , Nunziata Alfredo ,   AKROS BioScience s.r.l., Piazza Aldo Moro 20/d, 00071 Pomezia (Rome), Italy, Pozzoli Giacomo ,   Institute of Pharmacology, Catholic University School of Medicine, Largo F. Vito 1, 00168 Rome, Italy
Published: February 2022

Medical devices (MDs) include different products and their importance in the healthcare industry is truly remarkable. The recently issued Regulation 2017/745 (Reg. 2017/745) introduced several major changes concerning planning, conducting and reporting of clinical investigations (CIs). Manufacturers and independent researchers would have to adapt quickly to this complex regulation, as the transition period from the previous regulations to the new one would last only three years. The present study having analysed Reg. 2017/745, provides a reference guide for researchers willing to conduct a CI. In particular, this study focused on six aspects of practical interest: (1) significance of CIs in the clinical evaluation of MDs, (2) aims of a CI, (3) cases where a CI is mandatory and exceptions to this rule, (4) application procedure for a CI, (5) requirements for conducting CI, (6) serious adverse events (AE) reporting (7), CI results. The regulations governing CI are influenced by different international, national and regional laws and guidelines. The aim of the paper is to create awareness among the readers about complex regulations and provide the readers a reference to the EU regulations. In addition to that, the authors stress on some issues that they consider to be of particular importance. Even though this paper does not serve as a substitute or replacement of the regulation; it acts as a guide for the reference of the readers with respect to the EU, national and local regulations. The authors conclude that the design and conducting of CIs demands that the personnel in charge have the relevant training and expertise in the field of MDs.
Diversity and Recruitment of Minorities in Clinical Trials: An Unmet Need
Authors:   Founder, IntCom Trials and Research, Avenue Nouvelle 78, Brussels, Belgium, Vives Nathalie
Published: February 2022

Patient centricity has led to the idea that drugs should answer medical needs not only defined by the medical bodies but relevant for the patients themselves. This implies that the diversity of the patients should be represented in clinical trials. Disparities in representation of diverse populations in clinical trials have been well-documented for several pathologies like arterial hypertension, diabetes but also in oncology. Today, Caucasian patients included in clinical trials represent at least 75% of the clinical trials population even in pathologies where minorities are largely more affected than Caucasians. Filling the gap in diversity is an important matter to ensure ethics, good practices, regulatory compliance, patient safety and scientific validity. To achieve their recruitment goals and being patient centric, sponsors and investigational sites need to pay attention of this problem and put in place specific strategies. Mistrust of patients of minority groups toward clinical research is one of the main barriers along with lack of access to clinical trials (low awareness, communication barriers, distance to investigational sites). Adapted communication, community-based strategies are some of the useful strategies directed to the patients. Investigators may not encounter diverse populations in their area or may not be aware of unconscious bias when identifying patients suitable for a clinical trial. Looking for referrals and raising awareness of the risk of bias with training on culturally sounded approaches could help investigators to recruit more diverse populations. Lack of awareness and costs may prevent sponsors to focus on diversity but ethics, benefits of data acquisition and patient centricity should be enough motivators to modify this trend. Patients, investigators and sponsors have their own barriers to tackle the lack of diversity in clinical trials. The cultural background of all stakeholders is an important factor in those barriers. Only multidisciplinary approaches including human sciences would help to define patient recruitment strategies that would mitigate the current lack of diversity
The Effectiveness of Transcutaneous Electrical Nerve Stimulation Versus Carbamazepine in Trigeminal Neuralgia: A Randomized Controlled Trial
Authors:   University of Colima, School of Medicine, Colima, Mexico, Millan-Guerrero Rebecca , Isais-Millan Rebecca ,   University of Salamanca, Salamanca, Spain, Castillo-Varela Gabriel ,   University of Salamanca, Salamanca, Spain, Ceja-Espíritu Gabriel ,   University of Colima, School of Medicine, Colima, Mexico, Higareda-Almaraz Martha A. ,   Medical benefits. IMSS, Colima, Mexico
Published: February 2022

Objectives To determine if the treatment of refractory trigeminal neuralgia (TN) with transcutaneous electrical nerve stimulation (TENS) could lead to improved pain control. Materials and Methods We enrolled 20 patients with refractory TN in a double blinded, randomized, placebo-controlled clinical trial. Patients received either TENS for group 1 (n=10) or carbamazepine (CBZ) for group 2 (n=10). The visual analog pain scale (VAS) and the barrow neurological institute (BNI) pain scale, the number and duration of pain episodes and daily analgesic intake were analyzed for each group at 1 month, 2 months, 3 months, 1 year, 3 years and 5 years. Results The TENS group achieved better pain control than the CBZ group (p<0.05). Pain-free patients accounted for 60% in the TENS group and 50% in the CBZ group 1 month after initiating treatment, 100% and 77.77% at 3 months, 100% and 62.5% at 1 year, 100% and 50% at 3 years, respectively. The TENS group remained pain free for 3 years. At the 5-year mark, all members of the TENS group and the CBZ group presented pain recurrence. Conclusion TENS group scored significantly lower in pain scales compared with the CBZ group. TENS group was pain free for a longer period of time compared with the CBZ group. Significant differences between both groups favored TENS therapy, however the small sample size remains an important limitation of this study.
Remote Consent Clinical Research
Authors:   Senior Site Relations Manager, Atox Bio, 1000 Park Forty Plaza, Suite 210, Durham, NC 27713, USA, Sriram Preethi
Published: February 2022

Recruitment in clinical research trials can be challenging in trials that are time-sensitive and/or are rare disease and critical care trials. One of the hurdles for recruitment in these types of clinical trials is due to the consent process, and the need to have consent of the patient within a certain timeframe, or the patient unable to consent for themselves. This paper will discuss the usage of the utilization of remote consent options for these trials.
Beyond Placebo: Alternative Options to the Randomized Control Trial Design in Rare Disease Studies
Authors:   Clinical Research Professional, Morrisville, NC, USA, Sriram Preethi
Published: February 2022

Unique difficulties and challenges can arise for rare diseases and orphan disease indications within a clinical trial. Some of the challenges encountered by trials that are working on rare diseases can include recruitment and enrollment. One of the explanations for the challenges that are encountered in rare disease trials is because of the trial design of study, where the investigational product is being compared to the placebo. This review paper discusses the usage of placebo and when other options could be taken into consideration while creating the protocol, specifically with consideration to rare disease studies. It is essential for the investigators and those designing the protocol to consider alternative options from the standard randomized controlled trial. The aim of this paper is to review alternative trial design options. The trial designs discussed in this review paper include crossover trials, single arm studies and historical data, and n-of-1 trials.
The Digital Stethoscope in Telemedicine: A Health Camp Study
Authors:   Department of Plastic Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry 605006, India, Pathan Imran , Chittoria Ravi K. ,   Department of Plastic Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry 605006, India, Gupta Saurabh ,   Department of Plastic Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry 605006, India, Reddy Chirra L. ,   Department of Plastic Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry 605006, India, Mohan Padmalakshmi B. ,   Department of Plastic Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry 605006, India, Koliyath Shijina ,   Department of Plastic Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry 605006, India, K Nishad ,   Department of Plastic Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry 605006, India, Z Mohamed Ishaq ,   Telemedicine Infrastructure and Network Administrator, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry 605006, India
Published: February 2022

India is a vast country with limited human resources. People living in remote areas often have limited access to healthcare facilities. To address this need and to increase healthcare awareness, health camps have been established. These camps are often supervised by junior physicians. Telemedicine, and in particular use of a digital stethoscope may provide better diagnosis and better consultation to the patient by senior physicians located remotely. This article highlights the clinical use of a digital stethoscope in such a health camp.
The Promise of Small Data for Telemedicine in Chronic Condition Management: A Real-World Case Series
Authors:   IndividuALLytics, Inc., Ann Arbor, MI, USA, Schwartz Steven M. , Byrd Brigid ,   IndividuALLytics, Inc., Ann Arbor, MI, USA, Dempster Helen ,   Karantis 360, Hook, Hampshire, UK, Payne Tim ,   Karantis 360, Hook, Hampshire, UK
Published: February 2022

Connected care is defined as the “real-time, electronic communication between a patient and a provider, including telehealth, remote patient monitoring, and secure email communication between clinicians and their patients” (Alliance of Connected Care). Connected care can create a high-value interaction strategy with patients when it makes thoughtful use of commercially available digital health technologies with demonstrated both clinical and economic effectiveness. Karantis360™, is a home sensor technology that enables real-time tracking, data analytics and predictive care for personal (at home) care powered by IBM Watson Health. IndividuALLyticsTM is a telemedicine platform driven by a patent-pending an N-of-1 analytical engine and related digital dashboards that provides individual, patient-level evaluation of treatment response. The underlying technology combines disparate digital health technology data with the best evidence-base guidelines with N-of-1 methodology. The output allows for creation of personalized treatments empirically tested at the patient-level over time (aka over the course of care). When aggregated both within and across persons, the time-ordered data can build predictive pathways of behavior and ensure the relevant care and medical treatments are in place to support effective medical and self-management of chronic illness. This case-series report describes the implementation of a joint home sensor technology (big data) and an N-of-1 analytic engine (small data) with three elderly consented volunteer customers-patients of Karantis360™. Each person underwent successive, 2-week behavioral change treatment phases to determine usability, utility regarding medical and self-management and any proximal effects on health risks.
Design and Statistical Methods for Handling Covariates Imbalance in Randomized Controlled Clinical Trials: Dilemmas Resolved
Authors:   Department of Community Medicine, College of Health Sciences, Ladoke Akintola University of Technology, Ogbomoso, Oyo State, Nigeria, Egbewale Bolaji E.
Published: February 2022

Introduction In practice, between groups baseline imbalance following randomization not only opens effect estimate to bias in controlled trials, it also has certain ethical consequences. Both design and statistical approaches to ensure balanced treatment groups in prognostic factors are not without their drawbacks. This article identified potential limitations associated with design and statistical approaches for handling covariate imbalance in randomized controlled clinical trials (RCTs) and proffered solutions to them. Methods A careful review of literatures coupled with a robust appraisal of statistical models of methods involved in a way that compared their strength and weaknesses in trial environments, was adopted. Results Stratification breaks down in small sample size trials and may not accommodate more than two stratification factors in practice. On the other hand, minimization that balances for multiple prognostic factors even in small trials is not a pure random procedure and in addition, could present with complexities in computations. Overall, either minimization or stratification factors should be included in the model for statistical adjustment. Statistically, estimate of effect by change score analysis (CSA) is susceptible to direction and magnitude of imbalance. Only analysis of covariance (ANCOVA) yields unbiased effect estimate in all trial scenarios including situations with baseline imbalance in known and unknown prognostic covariates. Conclusion Design methods for balancing covariates between groups are not without their limitations. Both direction and size of baseline imbalance also have profound consequence on effect estimate by CSA. Only ANCOVA yields unbiased treatment effect and is recommended at all trial scenarios, whether or not between groups covariate imbalance matters.
Dendritic Cell Maturation is a Critical Step in Dendritic Cell Vaccine Preparation for Cancer Therapy
Authors:   Department of Immunology, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran, Farashi-Bonab Samad , Khansari Nemat ,   American Medical Diagnostic Laboratory, Garden Grove, CA 92843, USA
Published: February 2022

Background: Dendritic cell (DC) vaccine is a hopeful approach for cancer treatment. In clinical trials, DC vaccines have produced clinical responses in some cancer patients. However, DC vaccines efficacy is not satisfactory in most types of cancer and more efforts must be done to improve their effectiveness in advanced cancers. Understanding the influence of tumor cells and tumor stromal cells on DCs and the antitumor activity of ex vivo generated DCs in the tumor microenvironment can help to augment antitumor efficiency of ex vivo generated DCs. In a fibrosarcoma tumor model, we explored effects of the tumor microenvironment on the antitumor efficacy of ex vivo generated DCs. Methods: DCs were generated from mouse bone marrow precursor cells in the presence of granulocyte-macrophage colony-stimulating factor (GM-CSF) and interleukin-4 (IL-4). DCs were pulsed with tumor antigens and matured in the presence of tumor necrosis factor-alpha (TNF-α), lipopolysaccharide (LPS), or TNF-α plus LPS. Mature or immature DCs were injected subcutaneously before tumor inoculation or were directly injected into the tumor tissue. Results: Tumor antigen-pulsed DCs matured in the presence of TNF-α plus LPS showed appropriate functionality in vitro, including IL-12 secretion and induction of lymphocyte proliferation. Tumor lysate-loaded DCs matured in the presence of TNF-α did not show appropriate antitumor function in vivo. Injection of antigen-unpulsed mature DCs two days before tumor inoculation resulted in antitumor effects. In contrast, injection of immature DCs directly into the tumor tissue enhanced the tumor growth. Conclusion: These results suggest that tumor cells, tumor stromal cells, or tumor derived factors can influence DCs to have tumor-promoting function. Appropriate maturation induction in ex vivo generated DCs and manipulating the tumor microenvironment before DC vaccination may improve antitumor activity of DC vaccines in cancer patients.
Current Status of Human Immunodeficiency Virus Vaccines
Authors:   Department of Immunology, Center of Personalized Nanomedicine, Herbert Wertheim College of Medicine, Florida International University, Miami, FL 33199, USA, Sosa Daniela , Jayant Rahul Dev ,   Department of Immunology, Center of Personalized Nanomedicine, Herbert Wertheim College of Medicine, Florida International University, Miami, FL 33199, USA, Kaushik Ajeet ,   Department of Immunology, Center of Personalized Nanomedicine, Herbert Wertheim College of Medicine, Florida International University, Miami, FL 33199, USA, Nair Madhavan ,   Department of Immunology, Center of Personalized Nanomedicine, Herbert Wertheim College of Medicine, Florida International University, Miami, FL 33199, USA
Published: February 2022

Highly Active Antiretroviral Therapies (HAARTs) have been developed to treat HIV+ individuals, increasing the quality and quantity of life of many HIV+ patients. Despite these effective strategies, human immunodeficiency virus infection and acquired immune deficiency syndrome (HIV/AIDS) epidemic continues to uphold globally with 39 million infected individuals.
Immunobiology of Anticancer Virotherapy With Newcastle Disease Virus in Cancer Patients
Authors:   Department of Immunology, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran, Farashi-Bonab Samad , Khansari Nemat ,   Department of Vaccination Research, Gandhis Hospital Laboratory, Tehran, Iran
Published: February 2022

Virotherapy with oncolytic viruses that preferentially infect and kill cancer cells is a novel and promising strategy for cancer treatment. Newcastle disease virus (NDV), which is pathogenic in birds, has beneficial clinical effects in cancer patients. NDV virotherapy is safe and elicits an antitumor response in patients affected by different types of cancers. The selective replication of NDV in tumor cells, the lack of genetic recombination, the lack of interaction with host cell DNA, and safety of NDV vaccination in cancer patients has resulted in NDV virotherapy to be accepted as a potentially attractive anticancer modality. However, more knowledge is needed to support the development of optimal NDV-based treatment modality for cancer. In this paper, the biological characteristics of NDV, the clinical effectiveness of NDV-based anticancer vaccination, immunobiology of NDV virotherapy in cancer patients, immune responses to NDV vaccines, and NDV-induced immunogenic cell death and apoptosis of cancer cells have been discussed in detail.
Neoantigen: A New Hope for Effective Cancer Immunotherapy
Authors:   Department of Immunology, School of Medicine, Tehran University of Medical Sciences,Tehran, Iran, Khansari Nemat
Published: February 2022

In recent years, immunotherapy with the aim of augmenting the body's immune system to recognize and destroy tumor cell has been widely investigated as a novel cancer therapy modality. Immune responses can be naturally generated against cancer cells. On the other hand, cancer cells can inhibit anticancer immune responses. In the past decades, vaccination with tumor specific/associated antigens and immunogenic vectors has been successfully used to increase antitumor immune responses. However, the choice of target antigen is imperative in designing a cancer vaccine.
Sprünge zur Gesundheitsförderung am Arbeitsplatz
Authors:   FG Sportwissenschaft, Universität Konstanz, Kramer Andreas
Published: February 2022

Bewegungsmangel ist Mitursache vieler Zivilisationskrankheiten und Zeitmangel ein häufiger Grund dafür. Im folgenden Beitrag wird ein kurzes, intensives Sprungtraining vorgestellt, das schon in der Weltraumforschung erfolgreich getestet wurde, sich ohne Zusatzgeräte in wenigen Minuten überall durchführen lässt und so problemlos in den Arbeitsalltag integriert werden kann.
Zuordnung und Übernahme von Verantwortung im Betrieb
Authors:   Betriebsärztliche Abteilung, ZDF, Mainz, Jung Detlev , Wichert Gregor ,   Hauptabteilung Personal, Stellvertretender Verwaltungsdirektor, ZDF, Mainz
Published: February 2022

Wie die moderne Gesellschaft sind auch Unternehmen durch eine hohe funktionale Differenzierung gekennzeichnet. Die Produktion von Waren und Dienstleistungen wird in Teilprozesse zerlegt – ein Teil der Agierenden hat die Verantwortung für die Ausführung, der andere für die Koordination dieser Prozesse. Fehlende Klarheit bei der Übertragung und der Annahme von Verantwortung gefährdet die Produktivität, lässt Projekte scheitern und beeinträchtigt die Gesundheit der Beschäftigten. Es lohnt sich daher, innerbetriebliche Abläufe und Prozesse, aber auch Schwierigkeiten unter dem Aspekt der Verantwortung zu betrachten.
„Man müsste sich mal wieder mehr bewegen ...“ – FC Fit – Ein Pilotprojekt für mehr Bewegung im Alltag bei Deutsche Post DHL
Authors:   Deutsche Post AG, SNL Human Resources Deutschland, Abt. 41 Arbeitsmedizin, Bonn, Bollmann Matthias , Schwan Thomas ,   Deutsche Post AG, SNL Human Resources Deutschland, Bonn, Tautz Andreas ,   Deutsche Post AG, SNL Human Resources Deutschland, Bonn
Published: February 2022

Viele Fitness-Angebote erreichen nur die, die schon fit sind. Andere hätten vielleicht Spaß an der Bewegung, aber der Anstoß, der nötige Antrieb fehlt. Dabei haben nicht selten Lebensereignisse wie eine Knieoperation, ein Jobwechsel oder eine Schwangerschaft zu dieser Situation geführt. Im Bewusstsein, dass sich diese Klientel auch unter den eigenen Beschäftigten findet – und hier vorrangig in den administrativen Bereichen – entstand im Konzerngesundheitsmanagement der Deutschen Post DHL Anfang 2019 die Idee, ein Programm für genau diese Zielgruppe zu entwickeln.
Impfstatus von jungen Arbeitnehmern – Eine Erhebung bei Berufsanfängern der Bundeswehr
Authors:   Bundeswehrkrankenhaus Hamburg und Bereich Arbeitsmedizin, Medizinische Fakultät, Otto-von-Guericke Universität, Magdeburg, Arnold Jana Nele , Gundlach Nils ,   Sanitätsversorgungszentrum Rotenburg (Wümme), Böckelmann Irina ,   Bereich Arbeitsmedizin, Medizinische Fakultät, Otto-von-Guericke Universität, Magdeburg, Sammito Stefan ,   Zentrum für Luft- und Raumfahrtmedizin der Luftwaffe, Köln
Published: February 2022

Vaccination status of young employees: A survey of entrants in the Bundeswehr (German Federal Armed Forces) Objectives: In addition to the recommendations of the Standing Committee on Vaccination (STIKO) at the Robert-Koch-Institut, there are also jobrelated vaccination recommendations for special occupational groups. This applies equally to soldiers, but there is insufficient scientific data on vaccination rates. For this reason, the following study examined the extent of the vaccination gaps among young people entering the armed forces. Methods: As part of a cross-sectional study at Rotenburg (Wümme), Lower Saxony, the existing vaccination rates among soldiers in relation to tetanus, diphtheria, poliomyelitis, pertussis, measles, mumps, rubella, hepatitis A, hepatitis B and tick-borne encephalitis (TBE) were recorded and compared statistically between the three recruitment quarters (II/ to IV/2016). Results: The vaccination booklets of 247 recruits (age: 20.5 ± 2.7 years) from three quarters were recorded. The rate of unavailable vaccination booklets was 23.1 %. The vaccination rates were between 2 % for TBE and 75 % for measles. Whilst low vaccination protection rates were identified for TBE and hepatitis A/B in particular, the rates were also found to be as low as 44–60 % for the „typical“ tetanus, poliomyelitis and diphtheria vaccinations. There were high numbers of „expired“ full protection: these ranged from 19 % (diphtheria) to 50 % (hepatitis B). Conclusions: The results of the study indicate a clear lack of vaccination protection in a random sample of German citizens with an average age of 20 who started their service in the Bundeswehr as young professionals. Although, as expected, this was very low for vaccinations that are not standard STIKO vaccinations (hepatitis A, TBE), there were also significant vaccine deficiencies in the vaccinations recommended by STIKO in the young adults examined here. Keywords: military – vaccination – prevention – infection disease
Neues aus der psychotherapeutischen Versorgung
Authors:   Bundespsychotherapeutenkammer (BPtK), Berlin, Munz Dietrich , Mühlroth Beate ,   Bundespsychotherapeutenkammer (BPtK), Berlin
Published: February 2022

Die psychotherapeutische Versorgung ist im Wandel. Eine neue Richtlinie hatte bereits 2017 den Zugang zur Psychotherapie sowie Therapieabläufe reformiert. Für Krisen wurde das Angebot einer Akutbehandlung geschaffen. Hinzu kommt die kürzliche Anerkennung der systemischen Therapie als Richtlinienverfahren. Diese Neuerungen ermöglichen es Hilfesuchenden, schneller und passender Hilfe zu erhalten. Das kann helfen, Arbeitsunfähigkeit zu vermeiden. Doch noch immer warten Betroffene zu lange auf eine Psychotherapie.
Responsible patterns of production and consumption: The race for the achievement of SDGs in emerging markets
Authors:   CEIPA Business Center, Gomez-Trujillo Ana Maria , Velez-Ocampo Juan ,   Universidad de Antioquia, Castrillon-Orrego Sergio A. ,   Universidad EAFIT, Alvarez-Vanegas Alejandro ,   Universidad EAFIT, Manotas Eva Cristina ,   Universidad Nacional de Colombia sede Medellín
Published: February 2022

Since the end of the 20th century, the role of private multinational enterprises (MNEs) has been recognized as critical in implementing increased sustainable production and consumption atterns. Particularly after the creation of the Sustainable Development Goals (SDGs) and the Agenda 2030, this role has increased. In this sense, this paper aims to analyze the measures and actions taken by companies in their contribution to the achievement of the SDG 12. Through the identification of more than 52 metrics in sustainability reports of 854 firms, findings suggest that direct greenhouse gas emissions and indirect greenhouse gas emissions are the most often reported corporate metrics to measure their impact on specific SDGs. This reveals the importance of sustainability actions in emerging market firms as a mechanism to gain legitimacy when operating in foreign markets and as an opportunity to create more sustainable production models.