Exploration and Analysis of Volunteers’ Participation in Hospice Care Service Mode from the Perspective of Multiple Mutual Aid / 中国医学伦理学

In an aging society, the coexistence of multiple diseases among the elderly is prominent, and the prevalence of malignant tumors continues to rise.It has positive practical significance that improving the quality of life of dying patients and developing hospice care. Based on welfare multivariate theory, volunteers joining the hospice care team is conducive to the diversified development of the hospice care. By carrying out voluntary services and giving dignity to the dying, the quality of death can be improved and social support can be reflected. Based on the theory of mutual aid, volunteer participation in hospice care services is conducive to promoting the improvement of social spiritual civilization and achieving a virtuous cycle of intergenerational mutual aid. The mode of volunteer participation in hospice care service is still being gradually explored. This paper aimed to propose that the government introduces relevant voluntary service policies to build a good social atmosphere; based on the knowledge, belief and practice model, carry out education and training for volunteers and promote the overall coordinated development of the service team; put forward suggestions on improving the volunteer service mechanism by reaching confidentiality agreements, and improving the willingness of the dying and their families to accept volunteer services, so as to provide reference for the sustainable development of hospice care.

Relationship of vitamin D with the anthropometric indicators and lifestyle of adults. Medellín. Colombia

Introduction: Serum vitamin D levels depend on sunlight, diet, and other factors. Objective: We aimed to determine serum vitamin D levels and evaluate their relationship with anthropometric indicators and lifestyle habits in apparently healthy volunteers. Materials and Methods: In this cross-sectional study (n=75), socio-demographic, anthropometric, and lifestyle habit-related data were collected. Serum vitamin D levels were determined with high performance liquid chromatography, food intake was measured by semiquantitative frequency and nutritional status was assessed by anthropometry. Chi-square test and also principal component analysis were used to analyze the relationship between some variables and vitamin D status. Spearman's test was used to determine correlations between quantitative variables. Results: 73% were women and 61% belonged to medium socio-economic level. Median vitamin D intake was 137 (83.1­227.3) IU/day. Based on body mass index (BMI), 44% individuals had overweight/obesity. The 68% exhibited deficient/insufficient vitamin D levels (Hypovitaminosis D). BMI classification and waist circumference (CW) were not related with vitamin D status; however, activities with higher sun exposure were highly related (p = 0.013). Sun exposure time explained variation in component 2 (16.60%), where most of the individuals with normal level were grouped. Sun exposure time was positively correlated with vitamin D status (r = 0.263; p = 0.023). Discussion: Excess weight and abdominal obesity are not always associated with hypovitaminosis D. Conclusions: The majority of individuals showed hypovitaminosis D but their status was not related with anthropometric indicators. A Sun exposure time was the only factor positively correlated with vitamin D status.

Introducción: Los niveles séricos de vitamina D dependen de la luz solar, la dieta y otros factores. Objetivo: Nuestro objetivo fue determinar los niveles séricos de vitamina D y evaluar su relación con indicadores antropométricos y estilos de vida en voluntarios aparentemente sanos. Materiales y métodos: En este estudio trasversal (n=75) se recogieron datos sociodemográficos, antropométricos y aquellos relacionados con hábitos y estilos de vida. La vitamina D se determinó por cromatografía liquida de alta eficiencia; la ingesta de alimentos, mediante frecuencia semicuantitativa, y el estado nutricional por antropometría. Para analizar la relación entre algunas variables y el estado de la vitamina D se usó la prueba de Chi cuadrado y también el análisis de componentes principales. Se empleó la prueba de Spearman para determinar la correlación entre variables cuantitativas. Resultados: El 73% eran mujeres y el 61% pertenecían a un estrato socioeconómico medio. La mediana de la ingesta de vitamina D fue de 137 (83,1­227,3) UI/día. Según el índice de masa corporal (IMC), el 44% de los individuos tenían sobrepeso/obesidad. El 68% mostro deficiencia/insuficiencia de vitamina D (hipovitaminosis D). La clasificación del IMC y la circunferencia abdominal no se relacionaron con el estado de la vitamina D; sin embargo, las actividades con una mayor exposición solar estuvieron altamente relacionadas (p=0,013). El tiempo de exposición solar explico la variación en el componente 2 (16,60%) donde se agruparon la mayoría de los individuos con niveles normales. El tiempo de exposición solar tuvo una correlación positiva con el estado de la vitamina D (r = 0,263; p = 0,023). Discusión: El exceso de peso y la obesidad abdominal no siempre se relacionan con la hipovitaminosis D. Conclusiones: La mayoría de los individuos presentaron hipovitaminosis D, pero su estado no se relacionó con los indicadores antropométricos. El tiempo de exposición al sol fue el único factor que se correlaciono positivamente con el estado de la vitamina D.

Introdução: Os níveis séricos de vitamina D dependem da luz solar, da dieta e de outros fatores. Objetivo: Nosso objetivo foi determinar os níveis séricos de vitamina D e avaliar sua relação com indicadores antropométricos e hábitos de vida em voluntários aparentemente saudáveis. Materiais e métodos: Neste estudo transversal (n=75), foram coletados dados sociodemográficos, antropométricos e relacionados a hábitos de vida. Os níveis séricos de vitamina D foram determinados por cromatografia liquida de alto desempenho, a ingestão de alimentos foi medida por frequência semiquantitativa e o estado nutricional foi avaliado por antropometria. O teste do qui-quadrado e a análise de componentes principais foram utilizados para analisar a relação entre algumas variáveis e o estado da vitamina D. O teste de Spearman foi usado para determinar as correlações entre as variáveis quantitativas. Resultados: 73% eram mulheres e 61% pertenciam a um nível socioeconômico médio. A ingestão media de vitamina D foi de 137 (83,1-227,3) UI/dia. Com base no índice de massa corporal (IMC), 44% dos indivíduos tinham sobrepeso/obesidade. Os 68% apresentaram níveis deficientes/insuficientes de vitamina D (hipovitaminose D). A classificação do IMC e a circunferência da cintura (CW) não foram relacionadas ao status da vitamina D; entretanto, as atividades com maior exposição ao sol foram altamente relacionadas (p = 0,013). O tempo de exposição ao sol explicou a variação no componente 2 (16,60%), onde a maioria dos indivíduos com nível normal foi agrupada. O tempo de exposição ao sol foi positivamente correlacionado com o status de vitamina D (r = 0,263; p = 0,023). Discussão: O excesso de peso e a obesidade abdominal nem sempre estão associados com a hipovitaminose D. Conclusões: A maioria dos indivíduos apresentou hipovitaminose D, mas seu status não foi relacionado com indicadores antropométricos. O tempo de exposição ao sol foi o único fator positivamente correlacionado com o status da vitamina D.

Consideraciones bioéticas sobre los incentivos a participantes voluntarios sanos en investigaciones Fase I

Los ensayos clínicos en Fase I se realzan con la participación de voluntarios sanos de prueban la seguridad y tolerabilidad de los productos farmacéuticos en investigación. En ellos, los participantes están expuestos a riesgos de medicamentos del estudio sin la posibilidad de un beneficio médico directo y, por lo general, deben pasar días o semanas en un centro de investigación. Los incentivos, como pagos monetarios se utilizan para incentivar la inscripción y compensar a los participantes por su tiempo. Estas características de los ensayos voluntarios sanos de fase I crean un contexto de investigación que difiere notablemente de la mayoría de las otras investigaciones clínicas, pues la mayoría de ellos son personas vulnerables económicamente. Este artículo presenta el objetivo de analizar factores bioéticos que inciden en el otorgamiento de incentivos a participantes voluntarios sanos en investigaciones Fase I.

Phase I Clinical Trials are conducted with the participation of healthy volunteers to test the safety and tolerability of pharmaceutical products. In them, participants are exposed to study drug risks without the possibility of direct medical benefit and usually must spend days or weeks at a research site. Incentives such as monetary payments are used to encourage enrollment and compensate participants for their time. These characteristics of Phase I healthy volunteer trials create a research context that differs markedly from most other clinical research, as most of them are financially vulnerable individuals. This paper aims to analyze bioethical factors that influence the granting of incentives to healthy volunteer participants in Phase I research.

Representaciones gráficas de la salud: una mirada desde los niños y niñas en desplazamiento en Medellín / Graphic Representations of Health: a Look From the Children in forced displacement in Medellín

(Figura 1) La imagen de la portada de la edición especial de pediatría hace parte de una experiencia de voluntariado social que realizo como pediatra en formación en la Fundación Posada de Moisés, una institución sin ánimo de lucro, creada en la ciudad de Medellín hace 21 años, con el objetivo social de prestar servicios de desarrollo integral a niñas, niños y adolescentes víctimas del desplazamiento forzado en Colombia, sin distinción de raza, procedencia o situación económica, generando impacto en más de 200 niños desde su creación, abarcando componentes académicos, psicológicos, alimentarios, pero el más importante la integración social por medio del amor y apoyo constante.

(Figure 1) The image on the cover of the Pediatrics special edition is part of a social volunteering experience that I carried out as a Pediatrics Resident at the Posada de Moisés Foundation, a non-profit institution, created in Medellín 21 years ago, with the social objective of providing integral development services to children and adolescents who are victims of forced displacement in Colombia, without distinction of race, origin or economic situation, generating an impact on more than 200 children since its creation, in academic, psychological, food scopes, but most important, in social integration through love and constant support.

Gastric emptying in patients with cholelithiasis and in patients following cholecystectomy: measurement by ultrasonography / 中华麻醉学杂志

Objective:To evaluate the gastric emptying in the patients with cholelithiasis and in the patients following cholecystectomy by ultrasonography.Methods:Thirty patients with cholelithiasis, 30 post-cholecystectomy patients and 30 healthy volunteers, of either sex, aged 18-64 yr, with body mass index of 18-30 kg/m 2, of American Society of Anesthesiologists Physical Status classification Ⅰor Ⅱ, were selected and divided into cholelithiasis group (group CH), post-cholecystectomy group (group PC) and healthy volunteer group (group HV). The indigestion scores of the enrolled subjects in the past 3 months were assessed; the subjects took a semi-solid test meal (300 kcal) in the fasting state, and the cross-sectional area (CSA) of the gastric sinus was measured using ultrasound at fasting (T 0) and 5, 15, 30, 45, 60, 90 and 120 min after the test meal was taken (T 1-7). The gastric emptying fraction at T 5, 6 was calculated. The gastric half-emptying time and remaining area of the gastric sinus at T 7 were also calculated. Results:Compared with group HV, dyspepsia scores were significantly increased within the past 3 months ( P<0.05), the CSA of the gastric sinus was increased at T 3-7, the gastric emptying fraction was decreased at T 5-6, the gastric half-emptying time was prolonged, and the remaining area of the gastric sinus was increased at T 7 in group CH and group PC ( P<0.05). Compared with group CH, the CSA of the gastric sinus was significantly increased at T 4-7, the gastric emptying fraction was decreased at T 5, 6, the gastric half-emptying time was prolonged, and the remaining area of the gastric sinus was increased at T 7 in group PC ( P<0.05). Conclusions:Gastric emptying time is longer in the patients with cholelithiasis and in the patients following cholecystectomy than in healthy subjects and is further prolonged after cholecystectomy in the patients.

Construction of training program system for hospice care volunteers / 中国实用护理杂志

Objective:To construct the training program system for hospice care volunteers and provide reference for the training of hospice care volunteers in China.Methods:The training program system for hospice care volunteers was initially determined by using the method of literature analysis and investigation, and 16 experts were consulted by two rounds of letters using the method of expert inquiry from May to July 2022, and finally the training program system was established.Results:The effective recovery rate of the two rounds of expert consultation questionnaire was 100%, the expert authority coefficient was 0.88, and the Kendall coordination coefficient was 0.141, 0.131 (both P<0.05). The final training program system for hospice care volunteers contained 7 first-class indicators including training objectives, training objects, training contents, training methods, training hours, training resources and training evaluation, 27 second-class indicators and 92 third-class indicators. Conclusions:The training program system for hospice care volunteers constructed in this study has high reliability and scientificity, and has a good guiding role and reference value for the training of hospice care volunteers.

Review of Research on Volunteer Action Ethics in Public Health Emergencies / 中国医学伦理学

【Objective:】 To summarize the research status, problems and countermeasures of ethical issues related to volunteer action in public health emergencies by reviewing relevant literature. 【Methods:】 Using four keywords: public health emergencies, volunteers, ethics, and research, this paper searched the Chinese and English databases for the literature published from December 2006 to December 2021 (15 years in total) on "ethical research on volunteer action in public health emergencies". After searching, it was found that there were not many related papers. A total of 31 papers were retrieved, and only 23 papers were selected. 【Results:】 The ethical problems faced by volunteers in public health emergencies were complex and diverse, and the individual ethical behavior of volunteers was affected by many factors. The strategies to solve the relevant ethical issues were not yet perfect. 【Conclusions:】 The ethical issues related to volunteer actions in public health emergencies needed to be further studied.

Does the Number of Stimuli Influence the Formation of the Endogenous Components of the Event-Related Auditory Evoked Potentials?

Abstract Introduction The number of stimuli is important to determine the quality of auditory evoked potential records. However, there is no consensus on that number in studies, especially in the sample studied. Objectives To investigate the influence of the number of rare stimuli on forming N2 and P3 components, with different types of acoustic stimuli. Methods Cross-sectional, descriptive, comparative study, approved by the ethics committee of the institution. The sample comprised 20 normal hearing adults of both sexes, aged 18 to 29 years old, with normal scores in the mental state examination and auditory processing skills. The event-related auditory evoked potentials were performed with nonverbal (1 kHz versus 2 kHz) and verbal stimuli (/BA/ versus /DA/). The number of rare stimuli varied randomly in the recordings, with 10, 20, 30, 40, and 50 presentations. Results P3 latency was significantly higher for nonverbal stimuli with 50 rare stimuli. N2 latency did not show any difference between the type and number of stimuli. The absolute P3 and N2-P3 amplitudes showed significant differences for both types of stimuli, with higher amplitude for 10 rare stimuli, in contrast with the other ones. The linear tendency test indicated significance only for the amplitude - as the number of rare stimuli increased, the amplitude tended to decrease. Conclusion The components were identifiable in the different numbers of rare stimuli and types of stimuli. The P3 and N2-P3 latency and amplitude increased with fewer verbal and nonverbal stimuli. Recording protocols must consider the number of rare stimuli.

Medidas de efeito das intervenções em vozes saudáveis: uma revisão de escopo / Measurements of the effect of interventions on heathly voices: a scope review

RESUMO Objetivo mapear as medidas de avaliação vocal utilizadas para verificar o efeito da intervenção em indivíduos vocalmente saudáveis. Estratégia de pesquisa trata-se de uma revisão de escopo baseada na questão de pesquisa: "Quais as medidas de avaliação vocal utilizadas para verificar o efeito da intervenção em indivíduos vocalmente saudáveis?" A busca foi realizada de forma eletrônica nas bases de dados MEDLINE (PubMed), LILACS (BVS), Scopus (Elsevier), Web of Science (Clarivate), Embase e Cochrane. Critérios de seleção a seleção dos estudos foi baseada na leitura dos títulos, resumos, palavras-chave e textos completos, aplicando-se os critérios de elegibilidade. Foram extraídos os dados relacionados às informações bibliográficas da publicação, características da amostra e da intervenção, os efeitos da intervenção nas medidas de autoavaliação, perceptivo-auditivas, acústicas, aerodinâmicas, eletroglotográficas, resultado do exame laríngeo, entre outros. Os dados foram resumidos e apresentados de forma quantitativa e descritiva. Resultados foram selecionados 97 artigos, entre os 979 estudos mapeados nesta revisão. A análise acústica foi a medida mais utilizada (n=70, 72,3%) para verificar os efeitos do treinamento vocal nos estudos selecionados, seguida pela eletroglotografia (n= 55, 56,7%), autoavaliação (n= 38, 39,2%), aerodinâmica (n= 33, 34,0%), julgamento perceptivo-auditivo (n= 22, 22,7%) e exame laríngeo (n= 16, 16,5%). Conclusão a análise acústica é a medida utilizada na maioria dos estudos para verificar o efeito da intervenção em indivíduos vocalmente saudáveis.

ABSTRACT Purpose to map the vocal assessment measures used to verify the effect of the intervention in vocally healthy individuals. Research strategy This is a scope review based on the research question: What vocal assessment measures are used to verify the effect of the intervention in vocally healthy individuals? The search was carried out electronically in MEDLINE (PubMed), LILACS (BVS), Scopus (Elsevier), Web of Science (Clarivate), Embase and Cochrane databases. Selection criteria The selection of studies was based on reading the titles, abstracts, keywords and full texts, applying the eligibility criteria. Data related to the publication's bibliographic information, sample and intervention characteristics, the effects of the intervention on self-assessment, auditory-perceptual, acoustic, aerodynamic, electroglottographic measures, laryngeal examination results, among others, were extracted. The data were summarized and presented in a quantitative and descriptive way. Results 97 articles were selected, among the 979 studies mapped in this review. Acoustic analysis was the most used measure (n=70, 72.3%) to verify the effects of vocal training in the selected studies, followed by electroglottography (n= 55, 56.7%), self-assessment (n= 38, 39 .2%), aerodynamics (n= 33, 34.0%), auditory-perceptual judgment (n= 22, 22.7%) and laryngeal examination (n= 16, 16.5%). Conclusion Acoustic analysis is the measure used in most studies to verify the effect of the intervention in vocally healthy individuals.

Contribución de la Facultad de Biología de la Universidad de La Habana en el diagnóstico molecular del SARS-CoV-2 en el IPK / Contribution of the School of Biology of the University of Havana in the molecular diagnosis of SARS-CoV-2 at IPK

RESUMEN A finales del año 2019 el mundo conoció de la existencia y propagación de un nuevo coronavirus denominado SARS-CoV-2, capaz de provocar la enfermedad COVID-19. Las autoridades gubernamentales y de salud cubanas trazaron desde el principio estrategias de control epidemiológico, y fue el diagnóstico molecular por PCR en tiempo real una tarea de suma importancia para el control de la enfermedad en nuestro país. Un gran número de jóvenes profesionales y estudiantes de la Facultad de Biología de la Universidad de La Habana se sumaron a esta tarea. El presente trabajo aborda las principales actividades desarrolladas por estos últimos durante el diagnóstico molecular del SARS-CoV-2 en el Instituto de Medicina Tropical Pedro Kourí (IPK) en los primeros meses de la pandemia en nuestro país. El ejercicio de la profesión a partir de la puesta en práctica de habilidades y conocimientos teórico-prácticos, la adquisición de nuevos conocimientos, así como el fomento de valores éticos y morales como la solidaridad, el compañerismo y el trabajo mancomunado en colectivo, caracterizaron esta experiencia llena de desafíos y logros.

ABSTRACT At the end of 2019, the existence and spread of a novel coronavirus called SARS-CoV-2, responsible of the disease COVID-19 was known worldwide. From the beginning, the Cuban governmental and health authorities drawn up epidemiological control strategies, in which the molecular diagnosis by real-time PCR was of paramount importance for the control of the disease in our country. A large number of young professionals and students from the School of Biology of the University of Havana joined this task. This paper deals with the main activities performed by the students related to the molecular diagnosis of SARS-CoV-2 at the "Pedro Kourí" Institute of Tropical Medicine (IPK) in the first months of the pandemic in our country. The exercise of the profession in the implementation of the skills, and theoretical and practical knowledge; the acquisition of new knowledge; and the promotion of ethical and moral values such as solidarity, companionship, and joint work characterized this experience full of challenges and achievements.

Conocimientos, actitudes y percepción sobre el rol de los medios de comunicación respecto a la COVID-19 en estudiantes de Medicina de una universidad peruana / Knowledge, attitudes, and perception of the role of the media regarding COVID-19 in medical students from a peruvian university

RESUMEN Se realizó un estudio transversal en estudiantes de Medicina de una universidad privada de Lima. El objetivo fue describir el nivel de conocimientos y las actitudes sobre la COVID-19, además de su percepción sobre el rol de los medios de comunicación y de las redes sociales. El 32% no sabía que en los primeros cinco días de la enfermedad, las pruebas serológicas son preferibles para diagnosticar la COVID-19, comparadas con las pruebas moleculares; el 73% reportó estar dispuesto a trabajar como voluntario durante la pandemia y el 94% recibió información falsa sobre la COVID-19 en las redes sociales. Este estudio demuestra que la información sobre el uso de pruebas diagnósticas debe ser reforzada y que se debe tomar en cuenta el alto porcentaje de estudiantes dispuestos a ser voluntarios durante la pandemia de la COVID-19.

ABSTRACT A cross-sectional study was carried out on medical students from a private Peruvian university. The aim was to describe knowledge and attitudes towards COVID-19 as well as the student's perception of the role of media outlets and social media. Of the students, 32% did not know that during the first five days of illness, serological tests are preferred for diagnosing COVID-19 over molecular tests; 73% reported being willing to work as a volunteer during the pandemic, and 94% received false information regarding COVID-19 on social media. This study demonstrated that information regarding diagnostic tests should be reinforced and that the high percentage of students willing to volunteer during the COVID-19 pandemic should not be overlooked.

Comparison of different frequencies of transcutaneous electrical diaphragmatic stimulation in healthy subjects: a randomized crossover clinical trial / Comparação de diferentes frequências da estimulação diafragmática elétrica transcutânea em indivíduos saudáveis: ensaio clínico randomizado cruzado

Most transcutaneous electric diaphragmatic stimulation (TEDS) studies use a stimulation frequency (SF) of 30 Hz, although the reason for this SF value is not completely understood. Objective:The purpose of this study was to compare the acute effect of two TEDS frequencies on the respiratory muscle strength and endurance, muscle activation, muscle thickness, diaphragmatic mobility, cardiovascular variables and safety in healthy subjects. Methods:Randomized crossover clinical trial with 20 healthy subjects subjected to two interventions: SF=30 Hz group and SF=80 Hz group. TEDS was applied at the diaphragm motor points with a symmetric biphasicpulsed current (pulse duration= 500 µs) for 30 minutes. The evaluated outcomes were systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), respiratory muscle strength by maximal inspiratory pressure (MIP), maximal expiratory pressure (MEP), inspiratory peak flux (PIF), diaphragm thickness during inspiration (DTI) and expiration (DTE), diaphragm mobility and activation, and endurance (S-Index). Results:SF-30 Hz showed a reduction with respect to baseline values for SBP (p=0.04), HR (p<0.001), DTE (p=0.02), IPF (p=0.01), and S-Index (p=0.03). SF-80 Hz showed a reduction with respect to baseline values for HR (p<0.001) and an increase in MEP (p<0.001). However, these changes were not clinically important and there were no between-groups differences for any of the evaluated outcomes. No complications were observed. Conclusion:TEDS with SF-80 Hz produces similar effects to SF-30 Hz in healthy subjects and bothfrequencies proved to be safe (NCT03844711).

A maioria dos estudos utilizam a estimulação diafragmática elétrica transcutânea (EDET) com frequência (F) de estímulo de 30Hz e testar diferentes frequências torna-se necessário para uma aplicação otimizada. Objetivo: Foi comparar o efeito agudo de duas frequências diferentes da EDET sobre a força muscular respiratória e endurance, ativação diafragmática, espessura muscular e mobilidade diafragmática, variáveis cardiovasculares e segurança em indivíduos saudáveis. Métodos: Estudo randomizado cruzado com 20 indivíduos saudáveis submetidos a duas intervenções: Grupo I com F= 30Hz e Grupo II com F= 80Hz. A aplicação foi nos pontos motores do diafragma, com duração do pulso de 500µs, durante 30 minutos. Foram avaliados a pressão arterial sistólica (PAS) e diastólica (PAD), frequência cardíaca (FC), força muscular respiratória pela pressão inspiratória máxima (PImax), pressão expiratória máxima (PEmax), endurance e espessura muscular em inspiração (EDI) e expiração (EDE), mobilidade e ativação diafragmática. Resultados: O GI apresentou redução significativa em comparação às condições basais para os desfechos de PAS (p= 0.04), FC (p<0.001), EDI (p= 0,02), PIF (p= 0.01), e S-Index (p= 0.03). O GII apresentou redução significativa em comparação às condições basais para FC (p<0.001) e aumento da PEmax (p<0.001). Porém, estas alterações não foram clinicamente importantes e não houve diferença entre os grupos para nenhum desfecho avaliado. Nenhuma intercorrência foi observada. Conclusão: A EDET com F-80Hz produz efeitos semelhantes a F-30Hz em indivíduos saudáveis e ambas as frequências provaram ser seguras (NCT03844711).

Bioequivalence of amlodipine besylate tablets in Chinese healthy subjects / 中国临床药理学与治疗学

AIM: To evaluate the bioequivalence of two kinds of amlodipine besylate tablets in Chinese healthy subjects under fasting and fed conditions. METHODS: Twenty-four healthy subjects were enrolled, and a random, open, single-dose, two preparations, two sequences and double-crossover design was used to give the test or reference preparations under fasting and postprandial conditions. The concentration of metformin in plasma was detected by LC-MS/MS, and the main pharmacokinetic parameters were calculated to evaluate the bioequivalence. RESULTS: In fasting state, the mean of C

Study on pharmacokinetics of osmotic pump tablets of hydrochloride venlafaxine in Chinese healthy volunteers / 中国药理学通报

Aim To evaluate the pharmacokinetics and bioequivalence of two osmotic pump tablets of hydrochloride venlafaxine in Chinese healthy volunteers.Methods The fed test each enrolled twenty-six Chinese healthy volunteers in a randomized-sequence, open-label, two-period crossover single-dose oral test and reference preparations of hydrochloride venlafaxine extended-release tablets.The plasma concentrations of venlafaxine and its active metabolites O-desmethylvenlafaxine were determined by a validated liquid chromatography-tandem mass spectrometry(LC-MS/MS)method, and the pharmacokinetic parameters and bioequivalence of the two tablets were analyzed using PhoenixTM WinNonlin 6.4 software.Results The pharmacokinetic parameters of venlafaxine after single dose for the test and reference tablets were as follows: Cmax(58.50±19.47)vs(60.14±22.18)μg•L-1, AUC0-t(1 074.1±526.7)vs(1 057.9±539.7)μg•h•L-1, AUC0-∞(1 084.7±536.8)vs(1 067.8±554.0)μ g•h•L-1.The pharmacokinetic parameters of O-desmethylvenlafaxine were as follows: Cmax(101.63±29.64)vs(101.45±31.62)μg•L-1, AUC0-t(2 694.0±834.5)vs(2 702.9±946.4)μg• h•L-1, AUC0-∞(2 753.9±885.5)vs(2 753.2±988.4)μg•h•L-1.The 90% confidence intervals of the geometric mean ratios of Cmax, AUC0-t, AUC0-∞ for the test preparation and the reference preparationwere all within the equivalent interval of 80.00%-125.00%.Conclusion The test and reference preparations of hydrochloride venlafaxine extended-release tablets are bioequivalent in Chinese healthy volunteers under fed conditions.

Volunteer motivation in sports events in Brazil / Motivação de voluntários em eventos esportivos no Brasil

ABSTRACT The purpose was to analyze the potential differences in the motivation factors of volunteers according to the demographics; sex, level of education, and type of events in Brazil. The Volunteer Motivations Scale for International Sporting Events was administered to Brazilian volunteers via an online survey. Back-translation was used to ensure accuracy between the original scales. Confirmatory factor analysis was used to perform the transcultural adaptation. MANOVA was utilized to compare differences in demographic variables. Volunteers were motivated by two factors: Love of Sports and Community Involvement. The level of education verified significant differences only in the love of sport factor. The MANOVA revealed that the volunteers with a lower level of schooling (incomplete and elementary school) have higher levels of motivation (love for sport) compared to volunteers with high school, undergraduate, master's and PhD degrees. The interaction between sex and level of education indicated a significant difference in the same factor, and the interaction sex and type of event with the factor Community Involvement. Therefore, the results identify some differences in demographics. It is concluded that Volunteers' motivation is linked to the love of sport and involvement with the community and is related to sex and schooling, highlighting the importance of investigating volunteer motivations amongst sports events to promote positive development in management practices, specially to Brazilian sports events.

RESUMO O objetivo foi analisar as potenciais diferenças nos fatores de motivação de voluntários de acordo com os dados demográficos; sexo, nível de escolaridade e tipo de eventos no Brasil. A Escala de Motivação de Voluntários para Eventos Esportivos Internacionais foi aplicada a voluntários brasileiros por meio de um questionário online. A retrotradução foi usada para garantir a precisão entre as escalas originais. A análise fatorial confirmatória foi utilizada para realizar a adaptação transcultural. MANOVA foi utilizada para comparar diferenças nas variáveis demográficas. Os voluntários foram motivados por dois fatores: Amor ao Esporte e Envolvimento Comunitário. O nível de escolaridade verificou diferenças significativas apenas no fator amor ao esporte. A MANOVA revelou que os voluntários com menor escolaridade (escola primaria e incompleta) possuem níveis de motivação (amor ao esporte) maiores comparado aos voluntários com ensino médio, graduação, mestrado e doutorado. A interação entre sexo e escolaridade indicou diferença significativa no mesmo fator, e a interação sexo e tipo de evento com o fator Envolvimento na Comunidade. Portanto, os resultados identificam algumas diferenças demográficas. Conclui-se que a motivação dos voluntários está atrelada ao amor ao esporte e envolvimento com a comunidade e possui relações com sexo e escolaridade, destacando a importância de investigar as motivações do voluntariado entre os eventos esportivos para promover o desenvolvimento positivo das práticas de gestão, especialmente dos eventos esportivos brasileiros.

Entrenamiento de voluntarios en Primera Ayuda Psicológica y estrategias de afrontamiento / Training of Volunteers in Psychological First Aid and Coping Strategies

Resumen. Objetivo. Analizar la eficacia del personal voluntario y profesional que asiste en emergencias (Bomberos Voluntarios, Defensa Civil, Cruz Roja) en un programa de entrenamiento en la Primera Ayuda Psicológica y su relación con indicadores de empatía y estrategias de afrontamiento. Método. Se realizó un estudio cuantitativo, comparativo correlacional, con una muestra de 198 voluntarios que pertenecen a instituciones que intervienen en emergencias. Se utilizó un programa de simulación sobre respuestas a víctimas de catástrofes (Sistema Interactivo de Primera Ayuda Psicológica y el Inventario de Valoración y Afrontamiento). Resultados. Los voluntarios que expresan que manejan mejor una situación estresante lograban un rendimiento más eficaz en el programa de simulación. La valoración del contexto como amenazante o indiferente, perjudicaba la ejecución del protocolo de PAP propuesto en la ejercitación mediante software.

Abstract. Objective. To analyze the effectiveness of volunteer and professional personnel who assist in emergencies (Volunteer Firefighters, Civil Defense, Red Cross) in a Psychological First Aid training program and its relationship with indicators of empathy and coping strategies. Method. A quantitative, comparative, and co-relational study was carried out with a sample of 198 volunteers belonging to institutions that intervene in emergencies. A simulation program on responses to victims of catastrophes was used, Interactive System in Psychological First Aid and the Coping Strategies Inventory. Results. Volunteers, who state that handle better stressful situations, achieve a more effective performance in the simulation program. The assessment of the context as threatening or indifferent impaired the execution of the proposed PFA protocol using software.

Volunteers for clinical trials: from the history of abuses and exploitation to the inclusion movement, and to an income resource / Voluntários para ensaios clínicos: de uma de história de abusos e exploração até o movimento de inclusão e fonte de renda / Voluntarios para ensayos clínicos: de una historia de abusos y explotación hasta el movimiento de inclusión y fuente de renta

Medical research is essential to develop new and better therapies, increase social standards and a better life for all of us. Scientific curiosity has helped to achieve many successful innovations, but history also demonstrates that research can lead to abuses of individuals neglecting autonomy and integrity of the human being. Since the 1960ies we have witnessed a continuous development of international regulations and ethics guidelines (soft law) in medical research, leading to a higher quality of scientific results. An important focus lies on recognizing human vulnerability and a therefore adapted informed consent procedure. Our modern clinical trials structure requires the inclusion of healthy volunteers in the first phases of the development of a new medicinal product, leading to new ethical questions and challenges. The Corona-Pandemic has accelerated vaccine development in a successful way also leading to a new importance of healthy volunteers in the medical research landscape.

A pesquisa médica é essencial para desenvolver novas e melhores terapias, aumentar os padrões sociais e uma vida melhor para todos nós. A curiosidade científica ajudou a alcançar muitas inovações bem-sucedidas, mas a história também demonstra que a pesquisa pode conduzira abusos de indivíduos, negligenciando a autonomia e a integridade do ser humano. Desde a década de 1960, temos testemunhado um desenvolvimento contínuo de regulamentos internacionais e de diretrizes éticas (soft law) em pesquisa médica, levando a resultados científicos de maior qualidade. Um foco importante está no reconhecimento da vulnerabilidade humana e, consequentemente, num procedimento de consentimento informado adaptado. A nossa estrutura moderna de ensaios clínicos requer a inclusão de voluntários saudáveis nas primeiras fases do desenvolvimento de um novo medicamento, suscitando novas questões e desafios éticos. A pandemia de coronavírus acelerou o desenvolvimento de vacinas de uma forma bem-sucedida, contribuindo também para uma maior importância de voluntários saudáveis no cenário da pesquisa médica.

La investigación médica es esencial para desarrollarterapias nuevas y mejores, aumentar los estándares sociales y una vida mejor para todos nosotros. La curiosidad científica ha ayudado a lograr muchas innovaciones exitosas, pero la historia también demuestra que la investigación puede conducir a abusos deindividuos que descuidan la autonomía y la integridad del ser humano.Desde la década de 1960 hemos sido testigos de un desarrollo continuo de las regulaciones internacionales y de las directriceséticas(soft law) en la investigación médica, lo que ha llevado a una mayor calidad de los resultados científicos. Un enfoque importante radica en el reconocimiento de la vulnerabilidad humana y, por lo tanto, en un procedimiento de consentimiento informado adaptado.Nuestra moderna estructura de ensayos clínicos requiere la inclusión de voluntarios sanos en las primeras fases del desarrollo de un nuevo medicamento, lo que genera nuevas cuestiones y desafíos éticos. La pandemia de coronavirus ha acelerado el desarrollo de vacunas de una manera exitosa, lo que también ha dado lugar a una nueva importancia de los voluntarios sanos en el panorama de la investigación médica.

The impact of serving in disaster relief among volunteers in Malaysia / 中华创伤杂志(英文版)

PURPOSE@#Malaysian disaster relief volunteers have a long and proud history of participating in relief missions within and outside the country. Despite of a plethora of researches into the various areas of disaster relief, there has been a little scholarly activity looking into the experiences of the medical volunteers worldwide and even less research on the experiences of the relief volunteers in Malaysia. Therefore, the purpose of this study is to identify the effect of disaster relief works on volunteers in Malaysia.@*METHODS@#This is a non-experimental cross-sectional design study, which was conducted using survey questionnaire to examine the incidence of burnout, posttraumatic stress disorder (PTSD) symptoms and the quality of life (QOL) among the disaster relief volunteers. And the study also examined the socio-demographic variables of the participants. In addition, the association between the sociodemographic variable and the preferred coping strategies was also investigated through self-reporting checklist.@*RESULTS@#The findings of this study revealed that 90.9% volunteers (n = 312) experienced some levels of recurring stress throughout their lives, which led to burnout. Also, 96.8% (n = 332) of the participants were categorized as having at least some symptoms of PTSD. However, self-reporting QOL measurements indicated that the participants are, in general, satisfied with their lives. Significant associations between the incidence of burnout, incidence of PTSD and QOL were identified. Both positive coping measures and behavioral or avoidant coping measures were also identified. Furthermore, a number of socio-demographic factors were also seen to interact significantly with burnout, PTSD and QOL.@*CONCLUSION@#This study provides some insights into the psychological challenges of disaster relief volunteers in Malaysia, and this impact can last a long time after the volunteers return to their hometowns. Several recommendations including practice development, policy and research were discussed in the study.

Exploration of screening criteria for healthy volunteers in human bioequivalence clinical trials / 中国临床药理学与治疗学

Human bioequivalence testing is an important part of evaluating the quality of a formulation. Although these drugs have a large amount of safety data and clinical application data, they may still have ethical risks in healthy subjects. The definition of healthy volunteers, the general inclusion and exclusion criteria, auxiliary inclusion and exclusion criteria, and inclusion and exclusion criteria considering drug specificity are summarized. The basis for determining whether abnormal test values are clinically significant when screening healthy subjects and the considerations for improving the screening pass rate are discussed. It is expected to provide useful reference for the smooth implementation of human bioequivalence testing.

Experience of a technical assistance project on strengthening a local national tuberculosis programme, Lusaka, Zambia: 2012-2015 / 国際保健医療

Objectives  The authors conducted a technical assistance project on tuberculosis (TB) control in Bauleni, Chelston, and Chilenje, Lusaka, Zambia in 2012-2015. Herein we describe the project activities and achievements. Methods  We trained community health volunteers (CHVs) and organized their activities. We evaluated the project considering the trends of TB cases, particularly the percent of bacteriologically confirmed TB cases among the presumptive (suspected) TB cases, and treatment outcomes.Results  We organized training for the CHVs of three areas. The CHVs conducted a total of 160 community sensitizations attended by over 50 000 community members. They visited their assigned patients 23 716 times. At Bauleni, the number of bacteriologically positive (bac+) cases exhibited a decreasing trend (r = −0.55, p=0.03), whereas that of the presumptive TB cases exhibited an increasing trend (r = 0.70, p = 0.004). At Chelston, both the numbers of bac+ cases and the presumptive TB cases exhibited increasing trends (r = 0.52, p = 0.046 and r = 0.68, p = 0.005, respectively). At Chilenje, the number of bac+ TB cases exhibited a decreasing trend (r = −0.84, p < 0.001), whereas that of the presumptive TB cases did not change (r = 0.09, p = 0.76). In all three areas, the proportions of the bac+ cases among the presumptive TB cases exhibited decreasing trends (p < 0.0001 at all three clinics). The treatment success rates improved in Chelston and Chilenje from 50.7% and 61.9%, respectively, in early 2011 to 78.3% and 97.0%, respectively, in late 2014 (both p < 0.001). The treatment success rates of Bauleni maintained at over 85% in most quarters. Conclusion  The activities of the project contributed to the strengthened local national TB programme, resulting in the decreased burden of TB in the areas.