ABSTRACT
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ABSTRACT The CONSORT 2010 statement provides minimum guidelines for reporting randomized trials. Its widespread use has been instrumental in ensuring transparency in the evaluation of new interventions. More recently, there has been a growing recognition that interventions involving artificial intelligence (AI) need to undergo rigorous, prospective evaluation to demonstrate impact on health outcomes. The CONSORT-AI (Consolidated Standards of Reporting Trials-Artificial Intelligence) extension is a new reporting guideline for clinical trials evaluating interventions with an AI component. It was developed in parallel with its companion statement for clinical trial protocols: SPIRIT-AI (Standard Protocol Items: Recommendations for Interventional Trials-Artificial Intelligence). Both guidelines were developed through a staged consensus process involving literature review and expert consultation to generate 29 candidate items, which were assessed by an international multi-stakeholder group in a two-stage Delphi survey (103 stakeholders), agreed upon in a two-day consensus meeting (31 stakeholders) and refined through a checklist pilot (34 participants). The CONSORT-AI extension includes 14 new items that were considered sufficiently important for AI interventions that they should be routinely reported in addition to the core CONSORT 2010 items. CONSORT-AI recommends that investigators provide clear descriptions of the AI intervention, including instructions and skills required for use, the setting in which the AI intervention is integrated, the handling of inputs and outputs of the AI intervention, the human-AI interaction and provision of an analysis of error cases. CONSORT-AI will help promote transparency and completeness in reporting clinical trials for AI interventions. It will assist editors and peer reviewers, as well as the general readership, to understand, interpret and critically appraise the quality of clinical trial design and risk of bias in the reported outcomes.
RESUMO A declaração CONSORT 2010 apresenta diretrizes mínimas para relatórios de ensaios clínicos randomizados. Seu uso generalizado tem sido fundamental para garantir a transparência na avaliação de novas intervenções. Recentemente, tem-se reconhecido cada vez mais que intervenções que incluem inteligência artificial (IA) precisam ser submetidas a uma avaliação rigorosa e prospectiva para demonstrar seus impactos sobre os resultados de saúde. A extensão CONSORT-AI (Consolidated Standards of Reporting Trials - Artificial Intelligence) é uma nova diretriz para relatórios de ensaios clínicos que avaliam intervenções com um componente de IA. Ela foi desenvolvida em paralelo à sua declaração complementar para protocolos de ensaios clínicos, a SPIRIT-AI (Standard Protocol Items: Recommendations for Interventional Trials - Artificial Intelligence). Ambas as diretrizes foram desenvolvidas por meio de um processo de consenso em etapas que incluiu revisão da literatura e consultas a especialistas para gerar 29 itens candidatos. Foram feitas consultas sobre esses itens a um grupo internacional composto por 103 interessados diretos, que participaram de uma pesquisa Delphi em duas etapas. Chegou-se a um acordo sobre os itens em uma reunião de consenso que incluiu 31 interessados diretos, e os itens foram refinados por meio de uma lista de verificação piloto que envolveu 34 participantes. A extensão CONSORT-AI inclui 14 itens novos que, devido à sua importância para as intervenções de IA, devem ser informados rotineiramente juntamente com os itens básicos da CONSORT 2010. A CONSORT-AI preconiza que os pesquisadores descrevam claramente a intervenção de IA, incluindo instruções e as habilidades necessárias para seu uso, o contexto no qual a intervenção de IA está inserida, considerações sobre o manuseio dos dados de entrada e saída da intervenção de IA, a interação humano-IA e uma análise dos casos de erro. A CONSORT-AI ajudará a promover a transparência e a integralidade nos relatórios de ensaios clínicos com intervenções que utilizam IA. Seu uso ajudará editores e revisores, bem como leitores em geral, a entender, interpretar e avaliar criticamente a qualidade do desenho do ensaio clínico e o risco de viés nos resultados relatados.
ABSTRACT
resumen está disponible en el texto completo
ABSTRACT The SPIRIT 2013 statement aims to improve the completeness of clinical trial protocol reporting by providing evidence-based recommendations for the minimum set of items to be addressed. This guidance has been instrumental in promoting transparent evaluation of new interventions. More recently, there has been a growing recognition that interventions involving artificial intelligence (AI) need to undergo rigorous, prospective evaluation to demonstrate their impact on health outcomes. The SPIRIT-AI (Standard Protocol Items: Recommendations for Interventional Trials-Artificial Intelligence) extension is a new reporting guideline for clinical trial protocols evaluating interventions with an AI component. It was developed in parallel with its companion statement for trial reports: CONSORT-AI (Consolidated Standards of Reporting Trials-Artificial Intelligence). Both guidelines were developed through a staged consensus process involving literature review and expert consultation to generate 26 candidate items, which were consulted upon by an international multi-stakeholder group in a two-stage Delphi survey (103 stakeholders), agreed upon in a consensus meeting (31 stakeholders) and refined through a checklist pilot (34 participants). The SPIRIT-AI extension includes 15 new items that were considered sufficiently important for clinical trial protocols of AI interventions. These new items should be routinely reported in addition to the core SPIRIT 2013 items. SPIRIT-AI recommends that investigators provide clear descriptions of the AI intervention, including instructions and skills required for use, the setting in which the AI intervention will be integrated, considerations for the handling of input and output data, the human-AI interaction and analysis of error cases. SPIRIT-AI will help promote transparency and completeness for clinical trial protocols for AI interventions. Its use will assist editors and peer reviewers, as well as the general readership, to understand, interpret and critically appraise the design and risk of bias for a planned clinical trial.
RESUMO A declaração SPIRIT 2013 tem como objetivo melhorar a integralidade dos relatórios dos protocolos de ensaios clínicos, fornecendo recomendações baseadas em evidências para o conjunto mínimo de itens que devem ser abordados. Essas orientações têm sido fundamentais para promover uma avaliação transparente de novas intervenções. Recentemente, tem-se reconhecido cada vez mais que intervenções que incluem inteligência artificial (IA) precisam ser submetidas a uma avaliação rigorosa e prospectiva para demonstrar seus impactos sobre os resultados de saúde. A extensão SPIRIT-AI (Standard Protocol Items: Recommendations for Interventional Trials - Artificial Intelligence) é uma nova diretriz de relatório para protocolos de ensaios clínicos que avaliam intervenções com um componente de IA. Essa diretriz foi desenvolvida em paralelo à sua declaração complementar para relatórios de ensaios clínicos, CONSORT-AI (Consolidated Standards of Reporting Trials - Artificial Intelligence). Ambas as diretrizes foram desenvolvidas por meio de um processo de consenso em etapas que incluiu revisão da literatura e consultas a especialistas para gerar 26 itens candidatos. Foram feitas consultas sobre esses itens a um grupo internacional composto por 103 interessados diretos, que participaram de uma pesquisa Delphi em duas etapas. Chegou-se a um acordo sobre os itens em uma reunião de consenso que incluiu 31 interessados diretos, e os itens foram refinados por meio de uma lista de verificação piloto que envolveu 34 participantes. A extensão SPIRIT-AI inclui 15 itens novos que foram considerados suficientemente importantes para os protocolos de ensaios clínicos com intervenções que utilizam IA. Esses itens novos devem constar dos relatórios de rotina, juntamente com os itens básicos da SPIRIT 2013. A SPIRIT-AI preconiza que os pesquisadores descrevam claramente a intervenção de IA, incluindo instruções e as habilidades necessárias para seu uso, o contexto no qual a intervenção de IA será integrada, considerações sobre o manuseio dos dados de entrada e saída, a interação humano-IA e a análise de casos de erro. A SPIRIT-AI ajudará a promover a transparência e a integralidade nos protocolos de ensaios clínicos com intervenções que utilizam IA. Seu uso ajudará editores e revisores, bem como leitores em geral, a entender, interpretar e avaliar criticamente o delineamento e o risco de viés de um futuro estudo clínico.
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Abstract The thickness and shade of a restoration will affect the transmission of light from the light-curing unit (LCU). This study determined the power (mW), spectral radiant power (mW/nm), and beam profile of different LCUs through various thicknesses and shades of a CAD-CAM resin composite (BRAVA Block, FGM). Five thicknesses: 0.5; 0.75; 1.0; 1.5, and 2.0 mm, in three shades: Bleach; A2 and A3.5 of a CAD-CAM resin (n = 5). Two single-peak LCUs: EL, Elipar DeepCure-S (3M Oral Care); and OP, Optilight Max (Gnatus), and one multiple-peak LCU: VL, VALO Grand (Ultradent), were used. The LCUs were positioned touching the surface of the BRAVA Block. The power and emission spectrum were measured using a fiberoptic spectrometer attached to an integrating sphere, and the beam profiles using a laser beam profiler. The effect of the material thickness on the light attenuation coefficients was determined. VL and EL delivered more homogeneous beam profiles than OP. The type of the BRAVA Block had a significant effect on the transmitted power, and wavelengths of transmitted light (p < 0.001). There was an exponential reduction in the power and emission spectrum as the thickness of the BRAVA Block increased (p < 0.001). The light transmission through the A2 shade was least affected by the thickness (p < 0.001). The attenuation coefficient was higher for the violet light and higher for A3.5 than the A2 or Bleach shades. No violet light from the VL could be detected at the bottom of 2.0 mm of the BRAVA Block.
ABSTRACT
resumen está disponible en el texto completo
ABSTRACT The SPIRIT 2013 statement aims to improve the completeness of clinical trial protocol reporting by providing evidence-based recommendations for the minimum set of items to be addressed. This guidance has been instrumental in promoting transparent evaluation of new interventions. More recently, there has been a growing recognition that interventions involving artificial intelligence (AI) need to undergo rigorous, prospective evaluation to demonstrate their impact on health outcomes. The SPIRIT-AI (Standard Protocol Items: Recommendations for Interventional Trials-Artificial Intelligence) extension is a new reporting guideline for clinical trial protocols evaluating interventions with an AI component. It was developed in parallel with its companion statement for trial reports: CONSORT-AI (Consolidated Standards of Reporting Trials-Artificial Intelligence). Both guidelines were developed through a staged consensus process involving literature review and expert consultation to generate 26 candidate items, which were consulted upon by an international multi-stakeholder group in a two-stage Delphi survey (103 stakeholders), agreed upon in a consensus meeting (31 stakeholders) and refined through a checklist pilot (34 participants). The SPIRIT-AI extension includes 15 new items that were considered sufficiently important for clinical trial protocols of AI interventions. These new items should be routinely reported in addition to the core SPIRIT 2013 items. SPIRIT-AI recommends that investigators provide clear descriptions of the AI intervention, including instructions and skills required for use, the setting in which the AI intervention will be integrated, considerations for the handling of input and output data, the human-AI interaction and analysis of error cases. SPIRIT-AI will help promote transparency and completeness for clinical trial protocols for AI interventions. Its use will assist editors and peer reviewers, as well as the general readership, to understand, interpret and critically appraise the design and risk of bias for a planned clinical trial.
RESUMO A declaração SPIRIT 2013 tem como objetivo melhorar a integralidade dos relatórios dos protocolos de ensaios clínicos, fornecendo recomendações baseadas em evidências para o conjunto mínimo de itens que devem ser abordados. Essas orientações têm sido fundamentais para promover uma avaliação transparente de novas intervenções. Recentemente, tem-se reconhecido cada vez mais que intervenções que incluem inteligência artificial (IA) precisam ser submetidas a uma avaliação rigorosa e prospectiva para demonstrar seus impactos sobre os resultados de saúde. A extensão SPIRIT-AI (Standard Protocol Items: Recommendations for Interventional Trials - Artificial Intelligence) é uma nova diretriz de relatório para protocolos de ensaios clínicos que avaliam intervenções com um componente de IA. Essa diretriz foi desenvolvida em paralelo à sua declaração complementar para relatórios de ensaios clínicos, CONSORT-AI (Consolidated Standards of Reporting Trials - Artificial Intelligence). Ambas as diretrizes foram desenvolvidas por meio de um processo de consenso em etapas que incluiu revisão da literatura e consultas a especialistas para gerar 26 itens candidatos. Foram feitas consultas sobre esses itens a um grupo internacional composto por 103 interessados diretos, que participaram de uma pesquisa Delphi em duas etapas. Chegou-se a um acordo sobre os itens em uma reunião de consenso que incluiu 31 interessados diretos, e os itens foram refinados por meio de uma lista de verificação piloto que envolveu 34 participantes. A extensão SPIRIT-AI inclui 15 itens novos que foram considerados suficientemente importantes para os protocolos de ensaios clínicos com intervenções que utilizam IA. Esses itens novos devem constar dos relatórios de rotina, juntamente com os itens básicos da SPIRIT 2013. A SPIRIT-AI preconiza que os pesquisadores descrevam claramente a intervenção de IA, incluindo instruções e as habilidades necessárias para seu uso, o contexto no qual a intervenção de IA será integrada, considerações sobre o manuseio dos dados de entrada e saída, a interação humano-IA e a análise de casos de erro. A SPIRIT-AI ajudará a promover a transparência e a integralidade nos protocolos de ensaios clínicos com intervenções que utilizam IA. Seu uso ajudará editores e revisores, bem como leitores em geral, a entender, interpretar e avaliar criticamente o delineamento e o risco de viés de um futuro estudo clínico.
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"What's in a name? That which we call a rose / By any other name would smell as sweet" (Juliet, from Romeo and Juliet by William Shakespeare). Shakespeare's implication is that a name is nothing but a word and it therefore represents a convention with no intrinsic meaning. Whilst this may be relevant to romantic literature, disease names do have real meanings, and consequences, in medicine. Hence, there must be a very good rational for changing the name of a disease that has a centuries-old historical context. A working group of representatives from national and international endocrinology and endocrine pediatric societies now proposes changing the name of "diabetes insipidus" to "Arginine Vasopressin Deficiency (AVP-D)" for central etiologies, and "Arginine Vasopressin Resistance (AVP-R)" for nephrogenic etiologies This editorial provides both the historical context and the rational for this proposed name change.
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Objective. To conduct an integrative review of all relevant research investigating the physical risk factors for injury within pre-professional ballet dancers, to provide insight that may benefit practitioners within these institutions and highlight areas for future research within this specialised population.Design. Studies were identified from the following electronic databases: MEDLINE via PubMed, SPORTDiscus via EBSCOhost, and Web of Science Core Collection via Web of Science. 8,415 titles were identified during the electronic search process. Five studies satisfied the inclusion criteria and were included in the review. The mod-ified Agency for Healthcare Research and Quality (AHRQ) scale for observational studies was used to assess study quality.Results. The review identified that the following physical characteristics may influ-ence prospective injury risk in pre-professional ballet dancers: age and maturation status, anthropometrics and body composition, strength and power, joint mobility and range of motion, specific dance function, and cardiorespiratory fitness.Limitations. The research identified lacked methodological quality. This, com-bined with the low number of studies identified, makes the design of screening pro-tocols challenging for practitioners.Originality. Despite the number of pre-professional balletic institutions worldwide, previous reviews have not used a systematic search strategy or investigated both sexes in this cohort. Due to the unique demands of ballet, an understanding of the inter-action between injury and physical characteristics is a critical step in order to reduce injury burden. Conclusions. This review succeeded in determining risk factors for injury within this population, but, due to insufficient evidence, could not provide robust screening recommendations
Objetivo. Llevar a cabo una revisión integradora de toda la investigación relevante sobre los factores de riesgo físico de las lesiones en los bailarines de ballet preprofesionales, para proporcionar una visión que pueda beneficiar a los profesionales de estas instituciones y resaltar las áreas para futuras investigaciones en esta población especializada. Diseño. Los estudios se identificaron en las siguientes bases de datos electrónicas: MEDLINE vía PubMed, SPORTDiscus vía EBSCOhost y Web of Science Core Collection vía Web of Science. Se identificaron 8.415 títulos durante el proceso de búsqueda electrónica. Cinco estudios cumplieron los criterios de inclusión y se incluyeron en la revisión. Para evaluar la calidad de los estudios, se utilizó la escala modificada de la Agency for Healthcare Research and Quality (AHRQ) para estudios observacionales. Resultados. La revisión identificó que las siguientes características físicas pueden influir en el riesgo prospectivo de lesiones en los bailarines de ballet preprofesionales: edad y estado de maduración, antropometría y composición corporal, fuerza y potencia, movilidad articular y amplitud de movimiento, función específica de la danza y aptitud cardiorrespiratoria. Limitaciones. La investigación identificada carecía de calidad metodológica. Esto, combinado con el bajo número de estudios identificados, hace que el diseño de protocolos de detección sea un reto para los profesionales. Originalidad. Las revisiones anteriores no han utilizado una estrategia de búsqueda sistemática ni han investigado ambos sexos en esta cohorte. Debido a las exigencias únicas del ballet, la comprensión de la interacción entre las lesiones y las características físicas es un paso fundamental para reducir la carga de lesiones. Conclusiones. Esta revisión logró determinar los factores de riesgo de lesiones dentro de esta población, pero, debido a la insuficiencia de evidencia, no pudo proporcionar recomendaciones sólidas de cribado.
Subject(s)
Mass Screening , Range of Motion, Articular , Dancing , Leg Injuries , Wounds and Injuries , Body Composition , Power, Psychological , Risk , Risk Factors , Forecasting , Health Services Research , Joints , Knee InjuriesABSTRACT
Background. Pneumonia is one of the leading causes of under-5 death in South Africa and accounts for a substantial burden of paediatric intensive care unit (PICU) admissions. However, little is known about PICU outcomes in HIV-exposed uninfected (HIV-EU) children with pneumonia, despite the growing size of this vulnerable population. Objectives. To determine whether HIV exposure without infection is an independent risk factor for mortality and morbidity in children admitted to PICU with pneumonia. Methods. This retrospective review included all patients with pneumonia admitted to the PICU at Chris Hani Baragwanath Academic Hospital between 1 January 2013 and 31 December 2014. Patients were classified as HIV-unexposed (HIV-U), HIV-EU and HIV-infected. Medical records were reviewed to determine survival to PICU discharge, duration of PICU admission and duration of mechanical ventilation. Survival analysis was used to determine the association between HIV infection/exposure with mortality, and linear regression was used to examine the association with length of stay and duration of mechanical ventilation. This study included 107 patients: 54 were HIV-U; 28 were HIV-EU; 23 HIV-positive; and 2 had an unknown HIV status. Results. Overall, 84% (n=90) survived to PICU discharge, with no difference in survival based on HIV infection or exposure. Both HIV-EU and HIV-U children had significantly shorter PICU admissions and fewer days of mechanical ventilation compared with HIV-infected children (p=0.011 and p=0.004, respectively). Conclusion. HIV-EU children behaved similarly to HIV-U children in terms of mortality, duration of PICU admission and length of mechanical ventilation. HIV infection was associated with prolonged length of mechanical ventilation and ICU stay but not increased mortality.
Subject(s)
Humans , Male , Female , Pneumonia , Intensive Care Units, Pediatric , HIV Infections , Risk Factors , Intensive Care Units , MortalityABSTRACT
INTRODUCTION: Hemophilia is a coagulation disorder; it is a recessive disease linked to the X chromosome. In patients with hemophilia (PWH), regional anesthetic blocks have been considered a contraindication. Safety has been increased by performing them guided by Ultrasound. The objective of our work is to show our experience in PWH and peripheral nerve blocks. MATERIAL AND METHOD: 41 PWH were operated under regional analgesia with Ultrasound-Guided Peripheral Nerve Blocks associated with general anesthesia in the period 2006-2019. All patients were Hemophilia A. Three patients had inhibitors. The mean age was 35 years. 40 lower limb blocks and 2 upper limb blocks were performed. The Sonosite® equipment model Micromaxx was used. RESULTS: All patients presented adequate peripheral nerve block for an average time of 12.5 hours (8-24). There were no complications. CONCLUSIÓN: The present study shows that Ultrasound-Guided Peripheral Nerve Blocks in PCH is a safe procedure, which reduces the requirements of opioids and the side effects of them, improving the postoperative period and the recovery of patients.
INTRODUCCIÓN: La hemofilia es un trastorno de la coagulación, es una enfermedad recesiva ligada al cromosoma X. En pacientes con hemofilia (PCH) los bloqueos regionales anestésicos se han considerado una contraindicación. Se ha aumentado la seguridad realizándolos guiados por Ecografía. El objetivo de nuestro trabajo es mostrar nuestra experiencia en PCH y bloqueos de nervios periféricos. MATERRIAL Y MÉTODO: 41 PCH fueron operados bajo analgesia regional con Bloqueos de Nervios Periféricos Guiados por Ecografía asociado a la anestesia general en el período 2006-2019. Todos los pacientes eran hemofilia A. Tres pacientes presentaban inhibidores. La edad media fue de 35 años. Se realizaron 40 bloqueos de miembros inferiores y 2 bloqueos miembros superiores. Se utilizó el equipo Sonosite® modelo Micromaxx. RESULTADOS: Todos los pacientes presentaron adecuado bloqueo de nervio periférico durante un tiempo promedio de 12,5 h (8-24). No se presentaron complicaciones. CONCLUSIÓN: El presente estudio muestra que los Bloqueos de Nervios Periféricos Guiados por Ecografía en PCH es un procedimiento seguro, que reduce los requisitos de los opioides y los efectos secundarios de ellos, mejorando el posoperatorio y la recuperación de los pacientes.
Subject(s)
Humans , Child , Adolescent , Adult , Middle Aged , Peripheral Nerves/diagnostic imaging , Ultrasonography, Interventional , Hemophilia A/complications , Nerve Block/methods , Anesthesia, GeneralABSTRACT
Objective: Eating behavior is affected by psychological and neurocognitive factors. However, little is known about this relationship in anxious patients. Our aim was to investigate the associations between impulsivity, inhibitory control, energy-dense food consumption, and body mass index (BMI) in women with generalized anxiety disorder (GAD). Methods: In this cross-sectional study, 51 adult females with GAD answered the Barratt Impulsiveness Scale (BIS-11) and participated in a go/no-go task using food images. Anthropometric measurements were evaluated. A food frequency questionnaire and a snack test were used to study eating behavior. Pearson correlation and multiple linear regression were performed to analyze the variables of interest, adjusted by age. Results: Impulsivity predicted intake of sugar (p = 0.016, 95%CI 0.67-6.05), total fat (p = 0.007, 95%CI 0.62-3.71), and saturated fat (p = 0.004, 95%CI 0.30-1.48). The snack test showed a positive correlation between presence of impulsivity and intake of biscuits (R = 0.296; p = 0.051). Response inhibition to food images in the go/no-go task paradigm did not predict BMI or food intake. Conclusion: Impulsivity was predictive of higher sugar and saturated fat intake in women diagnosed with GAD. Our findings add to the literature regarding the association between neuropsychological factors and food consumption in this specific population.
Subject(s)
Humans , Female , Adult , Anxiety Disorders/complications , Eating/psychology , Feeding Behavior/psychology , Impulsive Behavior , Anxiety Disorders/psychology , Body Mass Index , Cross-Sectional Studies , Surveys and QuestionnairesABSTRACT
Background@#and Purpose The association between hemoglobin A1c (HbA1c) and stroke risk along with its subtypes is rarely reported. We aimed to investigate the association between HbA1c and the risk of incident stroke in patients with type 2 diabetes based on real world data from three healthcare systems. @*Methods@#We performed a retrospective cohort study of 27,113 African Americans and 40,431 whites with type 2 diabetes. Demographic, anthropometric, laboratory, and medication information were abstracted from the National Patient-Centered Clinical Research Network common data model. Incident stroke events including both ischemic and hemorrhagic stroke were defined. @*Results@#During a mean follow-up period of 3.79±1.68 years, 7,735 patients developed stroke (6,862 ischemic and 873 hemorrhagic). Multivariable-adjusted hazard ratios across levels of HbA1c at baseline (<6.0%, 6.0% to 6.9% [reference group], 7.0% to 7.9%, 8.0% to 8.9%, 9.0% to 9.9%, and ≥10%) were 1.07, 1.00, 1.13, 1.23, 1.27, and 1.37 (Ptrend <0.001) for total stroke, 1.02, 1.00, 1.13, 1.20, 1.24, and 1.35 (Ptrend <0.001) for ischemic stroke, and 1.40, 1.00, 1.14, 1.47, 1.47, and 1.51 (Ptrend=0.002) for hemorrhagic stroke. When we used an updated mean value of HbA1c, the U-shaped association of HbA1c with stroke risk did not change. This U-shaped association was consistent among patients of different subgroups. The U-shaped association was more pronounced among patients taking antidiabetic, lipid-lowering, and antihypertensive medications compared with those without these medications. @*Conclusions@#These data suggest that diabetes management may have to be individualized according to the guideline recommendations rather than intensively attempting to lower HbA1c.
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Resumen El propósito de este artículo es desambiguar el concepto de "eutanasia", describir las conductas que equivocadamente son asociadas a ella, y diferenciar aquellas que no son eutanasia de aquella única que sí lo es. Además, se hacen las consideraciones bioéticas mínimas en relación con los términos de "eutanasia", "matar" y "dejar morir", y se discuten en pacientes conscientes e inconscientes.
Abstract The purpose of this original paper is to clarify the term "euthanasia", describing the varied conducts wrongly associated with it and distinguishing those that are not euthanasia from the only one that certainly is. Additionally, basic bioethical considerations are presented regarding the terms "euthanasia," "killing" and "letting die," and discussed in relation to conscious and unconscious patients.
Resumo O objetivo deste artigo é desambiguar o conceito de eutanásia, descrever as condutas que, de forma equivocada, são associadas a ele e diferenciar as que não são eutanásia daquela única que realmente é. Além disso, são feitas considerações bioéticas mínimas quanto aos termos "eutanásia", "matar" e "deixar morrer", os quais são discutidos com relação a pacientes conscientes e inconscientes.
Subject(s)
Humans , Euthanasia , Euthanasia, Active , Value of Life , Ethics , JurisprudenceABSTRACT
Objetivo general. Crear un índice con base en la hipotenusa de Pitágoras para representar cualquier estado refractivo y facilitar los análisis estadísticos de los pacientes amétropes. Métodos. 3964 pacientes de una base de datos de Optiláser (Centro de cirugía refractiva en Bogotá, Colombia) del año 2014 fueron seleccionados para demostrar la aplicabilidad del índice de ametropía propuesto. Los pacientes no habían sido sometidos a ningún tipo de procedimiento quirúrgico. Otro ejemplo para ilustrar la aplicabilidad del índice de ametropía viene de la investigación Madre Canguro Integral llevada a cabo entre 2013 y 2014 en el Hospital de San Ignacio, Bogotá, en la cual 311 bebés nacidos prematuramente y en buen estado de salud fueron evaluados. Los meridanos principales de las ametropías se tomaron como catetos de un triángulo rectángulo para calcular la hipotenusa que fue tomada como índice de ametropía. Seguidamente, se determinó la correlación de Spearman entre el índice de ametropía y el ángulo visual expresado con mínimo ángulo de resolución (MAR). Resultados. La correlación de Spearman entre el índice de ametropía y el mínimo ángulo de resolución es 0,834. Por tanto, es estadísticamente significativa (p:< 0,001) y suficiente para validar el índice propuesto. Conclusiones. El índice de ametropía es un instrumento válido para la evaluación, manejo y análisis estadístico de las ametropías.
Objetivo geral. Criar um índice, baseado na hipotenusa de Pitágoras, para representar qualquer estado refrativo e facilitar a análise estatística de pacientes com ametropia. Métodos. 3964 pacientes de um banco de dados do OPTILASER (Centro de Cirurgia Refrativa de Bogotá, Colômbia) em 2014, foram selecionados para demonstrar a aplicabilidade do Índice de Ametropia proposto. Os pacientes não tinham sido submetidos a nenhum tipo de procedimento cirúrgico. Outro exemplo para ilustrar a aplicabilidade do Índice de Ametropia, vem da pesquisa "Mãe Canguru Integral", realizada entre 2013 e 2014, no Hospital de San Ignacio, Bogotá, onde 311 bebês nascidos prematuramente e com boa saúde foram avaliados. Os meridianos principais da ametropia são tomados como catetos de um triângulo retângulo para calcular a hipotenusa que será tomada como o índice de ametropia. Em seguida, foi determinada a correlação de Spearman entre o Índice de Ametropia e o Ângulo Visual expresso com o Ângulo Mínimo de Resolução (Mínimo Ángulo de Resolución, MAR). Resultados. A correlação de Spearman entre o Índice de Ametropia e o Ângulo Mínimo de Resolução é de 0,834, o que é estatisticamente significativo (p <0,001) e suficiente para validar o Índice proposto. Conclusões. O índice de ametropia é um instrumento válido para a avaliação, manejo e análise estatística das ametropia.
General Objective. To create a suitable Index, based on Pythagoras' hypotenuse, to represent any refractive state and to facilitate statistical analyses of ametropic patients. Methods. 3964 patients from a database of OPTILASER (Refractive Surgery Center in Bogotá, Colombia) for the year 2014 were selected to demonstrate the applicability of the proposed Index of Ametropia. The patients had not been previously subjected to any kind of surgical procedure. Another example to illustrate the applicability of the proposed Index of Refraction comes from a database of an investigation "Madre Canguro Integral" (Integral Kangaroo Mother), carried out between 2013 and 2014 at Hospital San Ignacio, Bogotá in which 311 healthy prematurely-born babies were evaluated Principal meridians of ametropias are taken as catheti of a right triangle in order to calculate the Hypotenuse which will be taken as the Index of Ametropia. Spearman Correlation, between the Index of Ametropia and the Visual Acuity expressed as the Minimum Angle of Resolution (MAR), are determined. Results. Spearman Correlation between the Index of Ametropia and the Minimum Angle of Resolution is 0,834 statistically significant (p: < 0,001) ample enough to validate the proposed Index of Ametropia. Conclusions. The Index of Ametropia is a valid instrument for the assessment, management and statistical analysis of ametropias.
ABSTRACT
Breast cancer (BC) is still the most common cancer among women worldwide. Amongst the subtypes of BC, triple negative breast cancer (TNBC) is characterized by deficient expression of estrogen, progesterone, and human epidermal growth factor receptor 2 receptors. These patients are therefore not given the option of targeted therapy and have worse prognosis as a result. Consequently, much research has been devoted to identifying specific molecular targets that can be utilized for targeted cancer therapy, thereby limiting the progression and metastasis of this invasive tumor, and improving patient outcomes. In this review, we have focused on the molecular targets in TNBC, categorizing these into targets within the immune system such as immune checkpoint modulators, intra-nuclear targets, intracellular targets, and cell surface targets. The aim of this review is to introduce and summarize the known targets and drugs under investigation in phase II or III clinical trials, while introducing additional possible targets for future drug development. This review brings a tangible benefit to cancer researchers who seek a comprehensive comparison of TNBC treatment options.
Subject(s)
Female , Humans , Breast Neoplasms , Drug Therapy , Estrogens , Immune System , Neoplasm Metastasis , Progesterone , Prognosis , ErbB Receptors , Triple Negative Breast NeoplasmsABSTRACT
PURPOSE: Inhaled corticosteroids (ICSs) are often considered an empirical therapy in the management of patients with cough. However, ICS responsiveness is difficult to interpret in daily clinical practice, as the improvements may include placebo effects or self-remission. We aimed to evaluate ICS and placebo treatment effects in adult patients with cough. METHODS: Electronic databases were searched for studies published until June 2018, without language restriction. Randomized controlled trials reporting the effects of ICSs compared with placebo in adult patients with cough were included. Random effects meta-analyses were conducted to estimate the treatment effects. Therapeutic gain was calculated by subtracting the percentage change from baseline in the cough score in the ICS treatment group from that in the placebo treatment group. RESULTS: A total of 9 studies were identified and 8 studies measuring cough severity outcomes were included for meta-analyses. Therapeutic gain from ICSs ranged from −5.0% to +94.6% across the studies included; however, it did not exceed +22%, except for an outlier reporting very high therapeutic gains (+45.6% to +94.6%, depending on outcomes). Overall ICS treatment effects in cough severity outcomes were small-to-moderate (standardized mean difference [SMD], −0.38; 95% confidence interval [CI], −0.54, −0.23), which were comparable between subacute and chronic coughs. However, pooled placebo treatment effects were very large in subacute cough (SMD, −2.58; 95% CI, −3.03, −2.1), and modest but significant in chronic cough (SMD, −0.46; 95% CI, −0.72, −0.21). CONCLUSIONS: Overall therapeutic gain from ICSs is small-to-moderate. However, placebo treatment effects of ICS are large in subacute cough, and modest but still significant in chronic cough. These findings indicate the need for careful interpretation of ICS responsiveness in the management of cough patients in the clinic, and also for rigorous patient selection to identify ICS-responders.
Subject(s)
Adult , Humans , Adrenal Cortex Hormones , Cough , Overall , Patient Selection , Placebo Effect , SteroidsABSTRACT
ABSTRACT The medical records of 983 patients diagnosed with the human immunodeficiency virus (HIV) were reviewed, 501 of whom were female and 482 were male. The mean age was 42.1 years, the mean number of years since diagnosis of HIV was 7.4, and the average duration of highly active antiretroviral therapy (HAART) was 51.7 months. The mean CD4 count at diagnosis was 268.5 cells/μL, but the most recent CD4 count was 461 cells/μL, and 85.8% of the patients were on HAART. The mean CD4 count was lower in those with a glomerular filtration rate (GFR) of < 60 ml/minute/1.73m2 compared to those patients with only proteinuria and a GFR of > 60 ml/minute/1.73m2. In the sample population, 76.9% of the patients had chronic kidney disease stage 3, 7.7% were in stage 4 and 15.4% in stage 5. There were 3.1% of patients with persistent proteinuria. Hypertension and diabetes mellitus were co-morbidities.
RESUMEN Se revisaron las historias clínicas de 983 pacientes diagnosticados con el virus de la inmunodeficiencia humana (VIH), 501 de los cuales eran mujeres, y 482 hombres. La edad promedio fue de 42.1 años, el número promedio de años a partir del diagnóstico de VIH fue 7.4, y la duración promedio de la terapia antirretroviral altamente activa (TARAA) fue de 51.7 meses. El conteo de CD4 promedio en el momento del diagnóstico fue de 268.5 células/μl pero el más reciente conteo de CD4 fue de 461 células/μl y el 85.8% de los pacientes se encontraban bajo terapia TARAA. El conteo de CD4 promedio fue menor en aquellos pacientes con una tasa de filtrado glomerular (TFG) de < 60 ml/minuto/1.73 m2, en comparación con los pacientes que tenían sólo proteinuria y una TFG de > 60 ml/minute/1.73 m2. En la población de la muestra, el 76.9% de los pacientes tenía enfermedad renal crónica en etapa 3, el 7.7% estaba en la etapa 4, y el 15.4% en la etapa 5. Había 3.1% de pacientes con proteinuria persistente. La hipertensión y la diabetes mellitus fueron comorbilidades.
Subject(s)
Humans , Male , Female , Adult , HIV Infections/epidemiology , Renal Insufficiency, Chronic/epidemiology , Prevalence , Risk Factors , Jamaica/epidemiologyABSTRACT
Abstract The combination of the restoration location, the hand preference of the operator using the light-curing unit (LCU), and the design of the LCU all can have an impact on the amount of the light delivered to the restoration. To evaluate the effect of left-handed or right-handed users, the position of the operator (dentist or assistant), and the LCU design on the irradiance, radiant exposure and emission spectrum delivered to the same posterior tooth. Two light emitting diode (LED) LCUs were tested: an angulated monowave LCU Radii-Cal (SDI, Victoria, Australia) and a straight aligned multi-peak LCU Valo Cordless (Ultradent, South Jordan, UT, USA). The irradiance values (mW/cm2), radiant exposure (J/cm2) and emission spectrum were measured using a sensor in maxillary left second molar tooth. The irradiance and radiant exposure were analyzed using three-way ANOVA followed by Tukey test (a=0.05). The emission spectra (nm) were analyzed descriptively. The interaction between LCU design, operator position, and hand preference significantly influenced the irradiance and radiant exposure (P<0.001). In all cases, Valo delivered significantly higher irradiance than Radii-Cal. The handedness and the operator position affected the irradiance and radiant exposure delivered from Valo. Operator position and access affect the irradiance and radiant exposure delivered to the maxillary left second molar. The irradiance and radiant exposure can be greater when a right-hand operator is positioned on the right side of the chair and a left-hand operator is positioned on the left side of the chair. This may result in better resin composite polymerization.
Resumo A combinação da localização da restauração, a preferência de mão do operador ao utilizar aparelhos fotopolimerizadores (AFP) com luz emitida por diodo (LED) e o formato do AFP podem afetar a quantidade de luz fornecida à restauração. O objetivo foi avaliar o efeito de operadores canhotos e destros, a posição do operador (dentista ou auxiliar), e o formato do AFP na irradiância, energia radiante e espectro de luz entregue ao mesmo dente posterior. Dois AFP foram testados: um com formato angulado, onda única Radii-Cal (SDI, Victoria, Australia) e um formato reto multi-pico Valo Cordless (Ultradent, South Jordan, UT, USA). Os valores de irradiância (mW/cm²), energia radiante (J/cm²) e espectro de luz foram medidos utilizando um sensor no segundo molar superior esquerdo. A irradiância e energia radiante foram analisados utilizando ANOVA 3 fatores seguido por teste de Tukey (a=0.05). O espectro de luz (nm) foi analisado de forma descritiva. A interação entre o formato do AFP, posição do operador e preferência de mão foram significativamente influentes na irradiância e energia radiante (P<0.001). Em todos os casos, Valo teve irradiância significativamente maior que Radii-Cal. A mão dominante e a posição do operador afetaram a irradiância e energia radiante com o Valo. Posição do operador e acesso afetou a irradiância e exposição radiante entregue ao segundo molar superior esquerdo. A irradiância e exposição radiante teve melhores resultados quando AFP foi utilizado com a mão direita pelo operador posicionado na cadeira do lado direito e mão esquerda do operador posicionado do lado esquerdo da cadeira. Estes resultados podem levar a uma melhor polimerização da resina composta.
Subject(s)
Humans , Radiation Exposure , Dental Assistants , Curing Lights, Dental , Functional Laterality , Light , Equipment DesignABSTRACT
Abstract: The effects of tooth brushing could affect the long-term esthetic outcome of composite restorations. This study evaluated the effect of two different emission spectrum light-curing units on the surface roughness, roughness profile, topography and microhardness of bulk-fill composites after in vitro toothbrushing. Valo (multiple-peak) and Demi Ultra (single-peak) curing lights were each used for 10s to polymerize three bulk-fill resin composites: Filtek Bulk Fill Posterior Restorative (FBF), Tetric EvoCeram Bulk Fill (TET) and Surefil SDR Flow (SDR). After 30,000 reciprocal strokes in a toothbrushing machine, the roughness profile, surface roughness, surface morphology, and microhardness were examined. Representative SEM images were also obtained. When light-cured with the Demi Ultra, SDR showed the most loss in volume compared to the other composites and higher volume loss compared to when was light-cured with Valo. The highest surface roughness and roughness profile values were found in SDR after toothbrushing, for both light-curing units tested. FBF always had the greatest microhardness values. Light-curing TET with Valo resulted in higher microhardness compared to when using the Demi Ultra. Confocal and SEM images show that toothbrushing resulted in smoother surfaces for FBF and TET. All composites exhibited surface volume loss after toothbrushing. The loss in volume of SDR depended on the light-curing unit used. Toothbrushing can alter the surface roughness and superficial aspect of some bulk-fill composites. The choice of light-curing unit did not affect the roughness profile, but, depending on the composite, it affected the microhardness.
Subject(s)
Toothbrushing/adverse effects , Composite Resins/radiation effects , Curing Lights, Dental , Surface Properties/drug effects , Surface Properties/radiation effects , Time Factors , Materials Testing , Microscopy, Electron, Scanning , Reproducibility of Results , Analysis of Variance , Microscopy, Confocal , Composite Resins/chemistry , Light-Curing of Dental Adhesives/methods , Polymerization , Hardness/drug effects , Hardness/radiation effectsABSTRACT
Abstract Contemporary dentistry literally cannot be performed without use of resin-based restorative materials. With the success of bonding resin materials to tooth structures, an even wider scope of clinical applications has arisen for these lines of products. Understanding of the basic events occurring in any dental polymerization mechanism, regardless of the mode of activating the process, will allow clinicians to both better appreciate the tremendous improvements that have been made over the years, and will also provide valuable information on differences among strategies manufacturers use to optimize product performance, as well as factors under the control of the clinician, whereby they can influence the long-term outcome of their restorative procedures.
Subject(s)
Curing Lights, Dental , Dental Cements/chemistry , Light-Curing of Dental Adhesives/instrumentation , Light-Curing of Dental Adhesives/methods , Photoinitiators, Dental/chemistry , Polymerization , Absorption, Radiation , Dental Cements/radiation effects , Dental Restoration, Permanent/instrumentation , Dental Restoration, Permanent/methods , Polymerization/radiation effects , Radiation Dosage , Temperature , Time FactorsABSTRACT
Abstract This study measured the radiant power (mW), irradiance (mW/cm2) and emission spectra (mW/cm2/nm) of 22 new, or almost new, light curing units (LCUs): - Alt Lux II, BioLux Standard, Bluephase G2, Curing Light XL 3000, Demetron LC, DX Turbo LED 1200, EC450, EC500, Emitter C, Emitter D, KON-LUX, LED 3M ESPE, Led Lux II, Optilight Color, Optilight Max, Optilux 501, Poly Wireless, Radii cal, Radii plus, TL-01, VALO Cordless. These LCUs were either monowave or multiple peak light emitting diode (LED) units or quartz-tungsten-halogen LCUs used in anterior and posterior teeth. The radiant power emitted by the LCUs was measured by a laboratory grade laser power meter. The tip area (cm²) of the LCUs was measured and used to calculate the irradiance from the measured radiant power source. The MARC-Patient Simulator (MARC-PS) with a laboratory grade spectrometer (USB4000, Ocean Optics) was used to measure the irradiance and emission spectrum from each LCU three times at the sensor located on the facial of the maxillary central incisors and then separately at the occlusal of a maxillary second molar. The minimum acceptable irradiance level was set as 500 mW/cm2. Irradiance data was analyzed using two-way ANOVA and the radiant power data was analyzed by one-way ANOVA followed by Tukey test (a=0.05). In general, the irradiance was reduced at the molar tooth for most LCUs. Only the Valo, Bluephase G2 and Radii Plus delivered an irradiance similar to the anterior and posterior sensors greater than 500 mW/cm2. KON-LUX, Altlux II, Biolux Standard, TL-01, Optilux 501, DX Turbo LED 1200 LCUs delivered lower irradiance values than the recommended one used in molar region, KON-LUX and Altlux II LCUs used at the maxillary incisors. Bluephase G2 and Optilight Max delivered the highest radiant power and KON-LUX, Altlux II and Biolux Standard delivered the lowest power. The emission spectrum from the various monowave LED LCUs varied greatly. The multi-peak LCUs delivered similar emission spectra to both sensors.
Resumo Este estudo mediu a potência (mW), irradiância (mW/cm2) e espectro da luz (mW/cm2/nm) emitida por 22 fontes de luz (Alt Lux II, BioLux Standard, Bluephase G2, Curing Light XL 3000, Demetron LC, DX Turbo LED 1200, EC450, EC500, Emitter C, Emitter D, KON-LUX, LED 3M ESPE, Led Lux II, Optilight Color, Optilight Max, Optilux 501, Poly Wireless, Radii cal, Radii plus, TL-01, VALO Cordless) disponíveis comercialmente. A potência emitida pelas fontes de luz foi medida usando um medidor laboratorial de potencia com grade a laser. A área (cm²) da ponta ativa efetiva das fontes de luz foi medida com paquímetro digital e utilizada para calcular a irradiância emitida. O simulador de paciente-MARC (MARC - PS) com espectrómetro (USB4000, Ocean Optics) foi usado para medir a irradiância e o espectro de luz emitida por cada fonte de luz na região anterior e posterior. Esta medição foi repetida por três vezes em dois sensores localizados na região anterior e posterior da arcada dentária. Os dados de irradiância foram analisados utilizando análise de variância em dois fatores, e os dados de potência foram analisados com análise de variância em fator único seguido pelo teste de Tukey (a=0,05). As fontes de luz Valo, Bluephase G2, Radii Plus emitiram irradiância semelhante tanto na região anterior como posterior com valores superiores ao mínimo de 500 mW/cm2. Seis fontes de luz emitiram irradiância menor que o recomendado (500 mW/cm2) quando usadas na região posterior: Kon-lux, Altlux II, Biolux Standard TL-01, Optilux 501, DX Turbo LED 1200 e duas quando usadas na região anterior: Kon-lux e Altlux II LCUs. As fontes Bluephase G2, Optilight Max emitiram os maiores valores de potência e as fontes de luz Altlux II e Biolux Standard emitiram os menores valores de potência. O espectro de luz das fontes LED de espectro único variou de forma evidente entre as fontes. As fontes LED multi pico de espectro emitiram espectros de luz similar para ambos os sensores. A fotoativação na região posterior tende a reduzir substancialmente a irradiância da maioria das fontes de luzes testadas.
Subject(s)
Humans , Curing Lights, Dental , Dental Restoration, Permanent , Lasers , Patient Simulation , Spectrum Analysis/instrumentation , Tooth/radiation effectsABSTRACT
Abstract The high irradiance and the different emission spectra from contemporary light curing units (LCU) may cause ocular damage. This study evaluated the ability of 15 eye protection filters: 2 glasses, 1 paddle design, and 12 dedicated filters to block out harmful light from a monowave (HP-3M ESPE) and a broad-spectrum (Valo, Ultradent) LED LCU. Using the anterior sensor in the MARC-Patient Simulator (BlueLight Analytics) the irradiance that was delivered through different eye protection filters was measured three times. The LCUs delivered a similar irradiance to the top of the filter. The mean values of the light that passed through the filters as percent of the original irradiance were analyzed using two-way ANOVA followed by Tukey test (a= 0.05). The emission spectra from the LCUs and through the filters were also obtained. Two-way ANOVA showed that the interaction between protective filters and LCUs significantly influenced the amount of light transmitted (p< 0.001). Tukey test showed that the amount of light transmitted through the protective filters when using the HP-3M-ESPE was significantly greater compared to when using the Valo, irrespective of the protective filter tested. When using the HP-3M-ESPE, the Glasses filter allowed significantly more light through, followed by XL 3000, ORTUS, Google Professional, Gnatus filters. The Valo filter was the most effective at blocking out the harmful light. Some protective filters were less effective at blocking the lower wavelengths of light (<420 nm). However, even in the worst scenario, the filters were able to block at least 97% of the irradiance.
Resumo A alta irradiância e diferentes espectros de luz emitidos por aparelhos fotopolimerizadores (Fp) podem causar danos oculares. Este estudo avaliou a capacidade de 15 filtros de proteção ocular em bloquear a luz prejudicial de um Fp convencional (HP-3M ESPE) e outro de largo espectro (Valo, Ultradent). Utilizando sensor anterior do equioamento MARC-Patient Simulator (BlueLight Analytics inc.) a irradiância que passou através dos diferentes filtros protetores foi mensuradas três vezes. Os valores médios da irradiância que passaram pelos filtros foram analisados usando Análise de variância fatorial e pelo teste de Tukey (a= 0.05). O espetro emitido dos Fps através dos filtros também foi obtido. A análise de variância mostrou que a interação entre os filtros protetores e Fps influenciou significantemente a quantidade de luz transmitida (p<0,001). O teste de Tukey mostrou que a quantidade que luz transmitida através dos protetores oculares quando usado o HP-3M ESPE foi significantemente maior quando comparado aos valores para o Valo, independentemente do filtro testado. Quando foi utilizado a fonte de luz HP-3M ESPE, o filtro de proteção ocular permitiu significativamente maior passagem de luz, seguido por XL 3000, ORTUS, Google Professional, e pelo filtro Gnatus. O filtro do Valo foi o mais eficiente ao bloquear a luz prejudicial. Alguns filtros foram menos eficazes ao bloquear menores comprimentos de onde (<420 nm). No entanto, mesmo no pior cenário dos resultados deste estudo, os filtros foram capazes de bloquear ao menos 97% da irradiância emitida pelas fontes de luz testadas.