ABSTRACT
O assentimento infantil é uma exigência ética em pesquisas com crianças, porém sua comunicação eficaz tem sido um desafio. Neste relato, descrevemos a construção teórica e metodológica de um termo de assentimento infantil em formato de história em quadrinhos. A experiência foi realizada em uma escola municipal de Teresina, Piauí, com 32 crianças entre oito e dez anos. As etapas consistiram no estudo das questões éticas envolvidas, na construção da arte sequencial, na observação participante, em ajustes na história em quadrinhos e na aplicação e assinatura do termo de assentimento. A experiência resultou em um termo com legibilidade de Flesch de 91,81 sobre as questões éticas na pesquisa com crianças. O assentimento infantil em formato de história em quadrinhos apresentou linguagem acessível, lúdica e legibilidade adequada para comunicar pesquisa com crianças.
Child assent is an ethical requirement in research with children, however effective communication has been a challenge. In this report we describe the theoretical and methodological construction of a child assent term in comic book format. The experience was carried out in a municipal school of Teresina-Piaui with 32 children between eight and ten years old. The steps consisted of the study of ethical issues, the construction of sequential art, in participant observation, in adjustments to the comic strip and in the application and signature of the assent term. The experience resulted in a term with Flesch readability of 91.81 on ethical issues in research with kids. The childish nod in comic book format presented accessible, playful language and adequate legibility to communicate research with children.
El asentimiento infantil es una exigencia ética en investigaciones con niños. Sin embargo, la comunicación eficaz ha sido un desafío. En este relato describimos la construcción teórica y metodológica de un término de asentimiento infantil en formato de cómics. La experiencia ha sido realizada en una escuela municipal de Teresina, Piauí, con 32 niños entre ocho y diez años. Las etapas consistieron en el estudio de las cuestiones éticas, en la construcción del arte secuencial, en la observación participante, en ajustes en los cómics y en la aplicación y firma del término de asentimiento. La experiencia resultó en un término con legibilidad de Flesch de 91,81 sobre las cuestiones éticas en la investigación con niños. El asentimiento infantil en formato de cómics presentó lenguaje accesible, lúdica y legibilidad adecuada para comunicar investigación con niños.
Subject(s)
Child Welfare , Ethics, Research , Scientific Research and Technological Development , Health Communication , Comic Book , LegislationABSTRACT
Este escrito presenta un recorrido retrospectivo de la transición de pacientes del Hospital de Pediatría "Dr. Juan P. Garrahan", centro de referencia nacional, a centros asistenciales de adultos. Se describen sus antecedentes y se destacan dos hitos que consideramos centrales como inicio de una trayectoria hospitalaria en transición de ya 24 años: la conformación de la Unidad de Adolescencia y Transición y la creación del Comité de Transición. A continuación se describen acciones que se desarrollaron en forma transversal en toda la institución, entre ellas programas de investigación, becas de formación, realización de jornadas, publicaciones institucionales y producciones artísticas. Finalmente planteamos un horizonte para este recorrido y los desafíos para la proyección futura de la transición de pacientes (AU)
This paper presents a retrospective review of the transition of patients from the Hospital de Pediatría "Dr. Juan P. Garrahan," a national reference center, to adult care centers. It describes the background and highlights two milestones that we consider central to the beginning of a 24-year hospital transition trajectory: the creation of the Adolescence and Transition Unit and the establishment of the Transition Committee. We then describe actions developed transversally throughout the institution, including research programs, training fellowships, conferences, institutional publications, and artistic productions. Finally, we propose a vision for this journey and discuss the challenges for the future projection of patient transition (AU)
Subject(s)
Humans , Adolescent , Patient Care Team , Adolescent , Transition to Adult Care/history , Transition to Adult Care/organization & administration , Hospitals, Pediatric , Chronic DiseaseABSTRACT
The Research Ethics Committee (CEP) has become an essential mechanism for social control in Brazilian research involving human subjects, contributing to the development of studies guided by ethical standards and to the protection of research participants. This article analyzes the performance of CEP in Western Amazonian institution, its history, operating conditions, trends, and different aspects between 2018 to 2022. The theoretical framework addresses the history of research involving human subjects, the origins and evolution of bioethics in the international context, bioethics in Brazil, and regulations on the ethical analysis of research. The data were collected through the Brazil Platform and reports from the institution's CEP. The CEP evaluated 865 research protocols, most of which were from Health Sciences. Additionally, it was observed that during 2018 to 2022 the covid-19 pandemic had a negative impact on the number of projects submitted for evaluation to the CEP. The 57% drop in the number of projects registered during 2020/2022 reveals the negative impact of this event on the execution of projects with human participants.
El Comité de Ética en Investigación (CEP) se ha convertido en un mecanismo esencial para el control social en la investigación brasileña con seres humanos, contribuyendo al desarrollo de estudios guiados por normas éticas y a la protección de los participantes en la investigación. Este artículo analiza el desempeño del CEP en la institución amazónica occidental, su historia, condiciones de funcionamiento, tendencias y diferentes aspectos entre 2018 y 2022. El marco teórico aborda la historia de la investigación con seres humanos, los orígenes y la evolución de la bioética en el contexto internacional, la bioética en Brasil y la normativa sobre el análisis ético de la investigación. Los datos se recogieron a través de la Plataforma Brasil y de informes del CEP de la institución. El CEP evaluó 865 protocolos de investigación, la mayoría de los cuales eran de Ciencias de la Salud. Además, se observó que durante 2018 a 2022 la pandemia de covid-19 tuvo un impacto negativo en el número de proyectos presentados para evaluación al CEP. La caída del 57% en el número de proyectos registrados durante 2020/2022 revela el impacto negativo de este evento en la ejecución de proyectos con participantes humanos.
Os Comitês de Ética em Pesquisa (CEPs) tornaram-se um mecanismo essencial para o controle social em pesquisas brasileiras envolvendo sujeitos humanos, contribuindo para o desenvolvimento de estudos regido por padrões éticos e para a proteção de participantes de pesquisas. Esse artigo analisa o desempenho de CEP em instituição da Amazonia Ocidental, sua história, condições operativas, tendências e diferentes aspectos entre 2018 e 2022. O enquadre teórico visa a história da pesquisa envolvendo sujeitos humanos, as origens e evolução da bioética no contexto internacional, bioética no Brasil e regulamentos de análise ética de pesquisa. Os dados foram coletados através da Plataforma Brasil e relatórios do CEP da instituição. O CEP avaliou 865 protocolos de pesquisa, a maioria deles de Ciências da Saúde. Adicionalmente, foi observado que de 2018 a 2022 a pandemia da covid-19 teve um impacto negativo no número de projetos submetidos para avaliação do CEP. A queda de 57% no número de projetos registrados em 2020/2022 revela o impacto negativo desse evento na execução de projetos com participantes humanos.
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Under the premise that the relevant laws and regulations in China do not specify the review subject of compassionate drug use,it is controversial who should bear the responsibility for the review and approval.This paper summarized and elaborated on the characteristics of compassionate drug use,and discussed the responsibilities,professionalism,and necessity of review of the ethics committee.It is believed that the ethics committee should serve as the review subject of compassionate drug use,and focus on doctor qualifications,risk-benefit ratio,informed consent forms,and conflicts of interest.
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“The Kampo Future Vision Study Group responsible for health and medical care of people” was established in 2016 with the aim of discussions to resolve various problems related to Kampo, and issued six proposals as important items. Among these proposals, the emphasized themes that are directly linked to clinical practice are “Kampo as a supportive treatment for cancer” and “Kampo as a countermeasure against frailty in the elderly.” The Japan Society of Oriental Medicine decided on a policy to be involved in these themes and established the Proposal-Discussing Committee (later absorbed into the Policy Advisory Committee). At first, the committee asked experts to present the research status of Kampo medicine as supportive care for cancer and as countermeasures against frailty. The committee, then, decided to lead clinical research by itself on frailty treatment with Kampo medicine. In such clinical research, evaluation criteria for judging therapeutic effects are necessary. Therefore, the existing well-defined diagnostic criteria were combined to create a Kampo frailty score. This article explains the Kampo frailty score, citing the supporting literature.
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Based on the data of a national sampling survey, this paper described and analyzed the understanding, attitude, behavior, and their differences and influencing factors of Chinese medical researchers on ethical review of biomedical research involving human subject. The survey found that researchers with master’s degree or below, working in scientific research institutes or universities, no overseas experience, living in the central region and not serving as committee members have relatively poor acquaintance of "ethical review" ; researchers with the characteristics of male, the younger age, living in the western region, knowing less about "ethical review" , agree more with the view that "ethical review consumes too much time and energy" ; researchers who serve as members of the ethics committee are more likely to participate in scientific research projects that have not passed the ethical review process. Therefore, recommendations are put forward: comprehensively popularizing the training of ethical review, focusing on strengthening the vulnerable groups and regions, strictly implementing ethical review laws and regulations, and strengthening evaluation and supervision, so as to improve the service quality and efficiency of ethical review in multiple directions.
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To analyze the main factors influencing the ethical review work of municipal hospitals in Shanxi Province by investigating the current situation of the construction and operation of ethics committees, and to put forward reasonable suggestions for improving the work of ethics committees. Questionnaire surveys and interviews were used to investigate the composition of ethics committees, systems and standard operating procedures, personnel training, review project methods, time limits, etc. of 24 hospitals at municipal levels in Shanxi Province. The establishment and system of ethics committees in tertiary hospitals at prefecture and city level were basically reasonable, and they could actively play the role of ethics committees. At present, most hospitals do not pay enough attention to the work of ethics committees, lack of full-time staff and systematic training, resulting in insufficient ethics review capabilities. The construction of the ethics committee of the second-level hospital is a mere formality, and no substantive work has been carried out. It is recommended to strengthen the supervision, increase the training of ethics committees and researchers, improve the information management of ethics committees, and establish regional ethics committees to further improve the ability and efficiency of ethics review.
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To ensure the rights and safety of the subjects and improve the quality of clinical trials, the author analyzed and discussed the deviation type and typical cases from 184 cases of protocol violation reviewed by the ethics committee in 56 clinical trials in a tertiary hospital in 2020. Among the 184 cases of violating the protocol, there were 29 major protocol violation cases and its proportion is 16%; 99 cases (54%) violated the GCP principle; 56 cases of other violations of the protocol that require to be reported, accounting for 30%. Through the case analysis of the researcher gave the wrong doses to subjects without following the protocol and drug administration did not conform to the rules, analyzed and discussed from the five perspectives of the research protocol design, the researcher, the clinical trial institution, the sponsor and the ethics committee, and put forward solutions and suggestions, so as to provide reference to improve the compliance of clinical trial protocol, reduce the risk of subjects and protect their rights and safety and ensure the successful progress of clinical trials.
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This paper took a hospital in Anhui province as an example, aimed at the problems existing in the protection of human subjects’ rights and interests in China, and put forward relevant suggestions from the ethical perspective. The suggestions included shaping the international vision, playing the core role of ethics committee, strengthening the construction of legal and regulatory protection mechanism, setting up the human research protection committee and actively promoting the construction of subject protection system. These measures will effectively promote the construction and improvement of the rights and interests protection system of human subjects in China.
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In order to explore the ethical review experience of organ donation and transplantation after the death of citizens, and provide reference value for medical institutions to carry out corresponding ethical review. By using descriptive research, purpose sampling method and the principle of data saturation, 10 members and secretaries of ethics committee on clinical application of organ transplantation technology were finally selected as respondents for semi-structured interviews. The Colaizzi 7-step analysis method was adopted to analyze, summarize and refine the theme. The results showed that the ethical review experience of organ donation and transplantation after the death of citizens included four themes: the responsibilities of ethics committee, the key points of ethics review, the form of ethics review conference and its advantages and disadvantages, and the construction of the ethics committee of organ transplantation. Therefore, there are defects in the ethical review of organ donation and transplantation in medical institutions at present. These can be remedied by enriching elements of the ethical review following the four principles of medical ethics, refining the laws related to organ donation after citizens’ death, constructing a reasonable and efficient pattern of ethical review conference, and establishing a robust and appropriate operation mode of organ transplantation ethics committee.
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The construction of clinical application and ethics committee of human organ transplantation technology is constantly improving in China. The review of clinical application and ethics committee of human organ transplantation technology should follow the principle of prudence, with high requirements for timeliness and cumbersome preparation, and living organ transplantation needs to weigh the risk benefit ratio of both donors and recipients. According to the problems often existing in China’s clinical application and ethics committee of human organ transplantation technology, such as lack of supervision and guidance, lack of unified standard operating procedures, insufficient attention to the rights and interests of organ donors after citizens’death, the difficulties to judge and implement of brain death, lack of psychological assessment requirements and procedures, inadequate informed consent, etc. It can be solved from the following aspects: ensuring the independence of ethical review, strengthening the risk benefit ratio assessment of both donors and recipients of living organ transplantation, standardizing the review content, strictly implementing informed consent and medical psychological assessment to reduce the risks of both sides, enriching review methods to ensure timeliness, and strengthening the ethical review and supervision of organ donation.
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Significant advancements have been made in the establishment of ethics committees within medical institu-tions.However,in order to achieve a high-quality development it is imperative to focus on such critical points as distinguishment between biomedical research and the clinical application of medical technologies,steadfast adherence to the fundamental princi-ples of ethical review,establishment of an ethics committee with independent administrative authority,establishing independent ethics review committees in large medical institutions based on specialty,and strengthening of ethical training for medical person-nel and biomedical researchers.
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The Regulations on Donation and Transplantation of Human Organs were issued on December 14， 2023. It was interpreted in terms of improving the human organ donation system and clarifying the responsibilities of the Red Cross Society； adding a new system for the acquisition and distribution of human organs， emphasizing the independence of the organ acquisition department， and implementing the priority right of organ distribution； strengthening the management of human organ transplantation， strictly limiting the scope of recipients of living organ transplantation； and regulating the operation of the ethics committee for human organ transplantation and stepping up the crackdown on violations of the regulations. This paper then considered how to implement and improve incentives for human organ donation， including the implementation of the priority rights of organ donors and their close relatives， the improvement of the organ donation compensation system， and the establishment of a humanitarian assistance system； the implementation of a system for the acquisition and distribution of organ donation organization； the acceleration of the construction of the personnel team of the organ acquisition organization； the increase of efforts to advocate and mobilise； and the enhancement of the construction of the ethics committee for human organ transplantation. The Regulations on Donation and Transplantation of Human Organs help to give fuller play to the enthusiasm and creativity in the field of organ transplantation， and all departments should revise the systems and administrative rules relating to human organ donation and transplantation in time， so as to facilitate the work of donation and transplantation of human organ.
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Resumo Utilizando como referencial teórico as Categorias de Campo, Capital e Habitus, o artigo tem como objetivo analisar se a institucionalização do Comitê Paralímpico Brasileiro foi determinante para o desenvolvimento esportivo paralímpico do Brasil. O estudo se configura como uma pesquisa qualitativa, tendo sua coleta de dados realizada a partir de entrevistas semiestruturadas com seis sujeitos (três atletas paralímpicos e três dirigentes esportivos paralímpicos). A institucionalização do Comitê Paralímpico Brasileiro foi fator fundamental para o desenvolvimento esportivo paralímpico do Brasil, dado que essa Entidade esportiva se tornou o coordenador central que sistematizou e efetuou um planejamento estratégico de caráter profissional, ancorado em três eixos (Governamental - Diretiva - Esportiva) que tiveram como princípios fundamentais o foco em práticas Organizacionais/Administrativas - Financeiras - Em Infraestrutura - Técnicas/Físicas/Esportivas. Essa sistematização estrutural fomentou a implementação de projetos e programas de prática esportiva paralímpica com o objetivo principal de formar e desenvolver atletas paralímpicos de rendimento.
Resumen Utilizando las Categorías Campo, Capital y Habitus como marco teórico, el artículo tiene como objetivo analizar si la institucionalización del Comité Paralímpico Brasileño fue decisiva para el desarrollo del deporte paralímpico en Brasil. El estudio se configura como una investigación cualitativa, con su recolección de datos realizada a partir de entrevistas semiestructuradas con seis sujetos (tres atletas paralímpicos y tres líderes deportivos paralímpicos). La institucionalización del Comité Paralímpico Brasileño fue un factor fundamental para el desarrollo del deporte paralímpico en Brasil, dado que esta Entidad deportiva se convirtió en el coordinador central que sistematizaba y realizaba una planificación estratégica de carácter profesional, anclada en tres ejes (Gobernativa - Directiva - Deportiva) que tuvo como principios fundamentales, el enfoque en las prácticas Organizativas/Administrativas - Financieras - En Infraestructura - Técnicas/Físicas/Deportivas. Esta sistematización estructural impulsó la implementación de proyectos y programas para el deporte paralímpico con el objetivo principal de formar y desarrollar atletas paralímpicos de alto rendimiento.
Abstract Using the Field, Capital, and Habitus Categories as a theoretical framework, the article aims to analyze whether the institutionalization of the Brazilian Paralympic Committee was decisive for the development of Paralympic sports in Brazil. The study is configured as qualitative research, with its data collection conducted from semi-structured interviews with six subjects (three Paralympic athletes and three Paralympic sports managers). The institutionalization of the Brazilian Paralympic Committee was a fundamental factor for the development of Paralympic sports in Brazil, given that this sports entity became the central coordinator that systematize and carried out strategic planning of a professional nature, anchored in three axes (Governmental; Management; Sports) that had as fundamental principles the focus on Organizational/Administrative; Financial; Infrastructure; Technical/Physical/Sports practices. This structural systematization encouraged the implementation of projects and programs for Paralympic sports with the main objective of training and developing high-performance Paralympic athletes.
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Background: Confidence in the results reported by randomized clinical trials (RCTs) depends mainly on the internal validity of the trial and its conduct, but also on other aspects related to health research such as the complete reporting of conflicts of interest (COI), funding sources and approval by ethics committees. Bias in the study results may arise from any one of these elements. Prior studies have explored the reporting of these items in the medical literature, but there are no reports on RCTs published in Spanish and Latin American journals. This study aimed to evaluate the reporting of COIs, funding sources, and approval by ethics committees of RCTs published in Spanish and Latin American journals in dentistry, geriatrics and neurology. Methods: We did a systematic retrospective survey of all RCTs published from 1990 to 2018 in dentistry, neurology, and geriatrics journals published in Spain and Latin America and included in the BADERI database (Iberoamerican journals and trials database by its initials in Spanish). We completed with hand searching. We included RCTs with a recoverable full text published between 1990 and 2018. We extracted data on sources of funding, COI statements, and ethics reviews. The extraction of these items in the RCTs included was done independently by two pairs of reviewers and in parallel for each article, with a third independent reviewer resolving discrepancies. We analysed compliance for each item. Results: We identified RCTs in 69 journals from Spain and Latin American countries. Dentistry accounted for 75% (n = 52) of the journals, neurology 20.6% (n = 14), and geriatrics 4.4% (n = 3). Of the total number of RCTs included in this study (n = 392), only 102 (26%) reported the presence or absence of a COI, 103 (26%) studies reported funding, and 43 (36%) included the ethics committee approval. Conclusions: RCTs published in the Spanish language in dentistry, neurology, and geriatrics had poor compliance with the reporting of a COI, source of funding, and ethics committee approval. Future research should evaluate the accuracy and completeness of COI statements and their relationship to the funding source and direction of the results.
Subject(s)
Humans , Serial Publications , Conflict of Interest , Ethics Committees , Support of Research , Spain , Dentistry , Geriatrics , Latin America , NeurologyABSTRACT
Objetivos. Analizar el circuito de utilización de los medicamentos de alto costo (MAC) y los resultados clínicos obtenidos en un hospital de pediatría público de alta complejidad de Argentina y presentar una estrategia de selección replicable para otras instituciones de similares características de la región. Métodos: Estudio prospectivo, descriptivo, aleatorizado, conducido en el Hospital de Pediatría Juan P. Garrahan de la Ciudad Autónoma de Buenos Aires en el período entre el 1 de setiembre de 2018 y el 31 de marzo de 2019. Se evaluaron dos unidades de estudio, la unidad paciente y la unidad MAC. Resultados: Los MAC consumen 7.921.200 dólares estadounidenses (USD) anuales y representan el 41% del costo de los medicamentos del hospital de alta complejidad. El 50% del costo de los MAC estuvo representado por la gammaglobulina (medicamento utilizado en diferentes enfermedades). Los pacientes proceden de toda la Argentina y otros países y un 44% tiene cobertura de salud. Los diagnósticos para los que se prescribieron MAC con mayor frecuencia fueron los relacionados con patología oncológica (leucemia linfoide aguda, leucemia mieloblástica aguda). El 54% de los pacientes presentó mejoría atribuible directamente a la administración de los MAC, 39% no presentó cambios y el 7% empeoró. Conclusiones: La efectividad en los resultados clínicos y el análisis de los circuitos de aprobación indican que, además de la aprobación por las entidades nacional e internacionales, la evaluación responsable por parte de las instituciones efectoras, mediante la discusión interdisciplinaria basada en la mejor evidencia, contribuye a optimizar la utilización de los MAC y la seguridad de los pacientes (AU)
Objectives. To analyze the utilization circuit of high-cost medications (HCM) and the clinical results obtained in a tertiarycare public pediatric hospital in Argentina and to present a selection strategy that may be disseminated to other institutions of similar characteristics in the region. Methods: A prospective, descriptive, randomized study was conducted at Hospital de Pediatría Juan P. Garrahan in Buenos Aires between September 1, 2018 and March 31, 2019. Two study units were evaluated, the patient and the HCM. Results: HCMs account for 7,921,200 US dollars (USD) per year and represent 41% of the cost of drugs in this tertiary-care hospital. Gamma globulin (a drug used for different diseases) accounted for 50% of the cost of HCMs. Patients came from Argentina and other countries and 44% had a health insurance. Cancer (acute lymphoid leukemia, acute myeloblastic leukemia) was the diagnosis for which HCMs were most frequently prescribed. Fifty-four percent of patients showed improvement directly attributable to the administration of HCMs, 39% showed no change, and 7% worsened. Conclusions: The effectiveness in clinical outcomes and the analysis of approval circuits show that, in addition to approval by national and international entities, responsible evaluation by the effector institutions through interdisciplinary discussion based on the best evidence contributes to optimizing the use of HCMs and patient safety (AU)
Subject(s)
Pharmacy and Therapeutics Committee , Pharmaceutical Preparations/economics , Ethics Committees , Drug Costs/statistics & numerical data , Drug Utilization , Hospitals, Pediatric , Hospitals, Public , Prospective Studies , Patient Safety , Cost-Effectiveness AnalysisABSTRACT
Introdução: A atuação dos Núcleos de Avaliação de Tecnologias em Saúde (NATS) e das Comissões de Farmácia e Terapêutica (CFT) em hospitais de ensino pode ser potencializada para o fortalecimento da implementação da política de gestão de tecnologias em saúde no âmbito hospitalar. Entretanto, a organização e as formas como esses grupos se articulam é pouco conhecida. Objetivo: Analisar processos de trabalho de NATS e CFT instituídos em hospitais universitários federais sob a gestão da Empresa Brasileira de Serviços Hospitalares (Ebserh), identificando elementos organizacionais e níveis de articulações entre esses grupos, além das principais dificuldades enfrentadas. Métodos: Trata-se de uma pesquisa qualitativa exploratória, envolvendo estudo de casos múltiplos. As unidades hospitalares foram selecionadas após critério de inclusão. A coleta de dados empregou análise documental e entrevista semiestruturada com pessoas chaves dos processos. Resultados: Os resultados permitiram uma visão geral sobre como estão organizados e estruturados os NATS e as CFTs, bem como a identificação de diferentes níveis de articulação entre eles. Dos 8 hospitais estudados, 3 apresentaram nível alto de articulação, 4 apresentaram nível baixo e em um deles não foi observada a existência de articulação entre o NATS e a CFT. Entre os desafios enfrentados pelos grupos foram relatados a escassez de recursos humanos, incipiente estrutura administrativa ou espaço físico e necessidades de capacitação. Conclusão: Quatro dos hospitais apresentaram nível baixo de articulação entre o NATS e a CFT, indicando a necessidade de maior compreensão dos fatores intervenientes. Os resultados contribuem para o conhecimento institucional de cada grupo estudado e podem orientar ações de melhoria e fortalecimento da cultura da ATS para gestão de tecnologias nos ambientes hospitalares.
Introduction: The hospital-based HTA nuclei (NATS) in teaching hospitals and their interaction with the Pharmacy and Therapeutics Committee (PTC), can be an important strategy for strengthening HTA in the hospital environment. However, this relationship is not well known. Objective: To analyse NATS and PTC work processes that has been established in Federal University Hospitals administrated by Empresa Brasileira de Serviços Hospitalares Ebserh (The Brazilian Company of Hospital Services), identifying how they are organized, possible interfaces and difficulties and points of articulation between them. Methods: This is an exploratory qualitative research involving multiple-case study. Hospital units were selected by applying some inclusion criteria. The data were collected from document analysis and semi-structured interviews with key informants from both groups. Results: The results showed an overview about how the NATS and PTC are organized and structured, identificating different levels of articulation between them, with three of eight hospitals considered of high level. Among the challenges were pointed out the lack of human resources availability, administrative structure or physical space and training. Conclusion: Four hospitals demonstrated low level of articulation between the NATS and the PTC, indicating needs for understanding the intervening factors. This study contributes to the institutional knowledge for guiding actions to improve and strengthen the HTA culture at the hospital level.
ABSTRACT
Hasta 1983, cuando alcanzaba la increíble tasa de 118 casos por 100.000 habitantes, la fiebre tifoidea era la peor amenaza infecciosa en Santiago, Chile, ciudad que figuraba junto a Ciudad de México, El Cairo y Bombay, como una de las con mayor endemia en el mundo. El Ministerio de Salud respondió formando el Comité de Tifoidea de Chile, con participación de expertos nacionales y del grupo de Myron Levine, de la Universidad de Maryland, que llevó a cabo ingeniosas investigaciones, culpando al río Mapocho, cuyas aguas contaminadas con Salmonella typhi regaban los predios agrícolas vecinos, conformando así un ciclo largo de infección. Las vacunas antitíficas ensayadas (oral Ty21a atenuada y polisacárido capsular Vi inyectable) no mostraron eficacia, los portadores crónicos no se trataron, pero una campaña sanitaria a través de la televisión contribuyó decisivamente a mejorar los hábitos higiénicos de la población, fortalecida por el pánico que causó la llegada del cólera en 1991, y la fiebre tifoidea prácticamente desapareció del escenario.
Until 1983, when reached the incredible frequency of 118 cases for 100.000 habitants, typhoid fever was the worst infectious threat in Santiago, Chile, city that appeared next to Mexico City, Cairo and Bombay, as one of the most endemic in the world. The Ministry of Health responded with the creation of The Chilean Typhoid Committee, with the participation of national experts and Myron Levine's group, which carried out ingenious investigations blaming the Mapocho River, whose waters contaminated with Salmonella typhi irrigated the neighboring farms, thus conforming a long cycle of infection. Typhoid vaccines tested (strain Ty 21a oral and Vi capsular polysaccharide) did not show efficacy, chronic carriers were not treated, but a health campaign on television made a decisive contribution to improving hygiene habits of the population, strengthened by the panic caused by the arrival of cholera in 1991, and typhoid fever practically disappeared from the stage.
Subject(s)
Humans , History, 20th Century , Typhoid Fever/history , Typhoid Fever/prevention & control , Salmonella/isolation & purification , Water Microbiology , Typhoid-Paratyphoid Vaccines , Chile , VaccinationABSTRACT
Medicinal plants or Chinese materia medica (CMM) are now attracting worldwide attention as they have increasingly prominent advantages over chemical drugs in disease treatment and healthcare. Since the 1990s, World Health Organization (WHO) and International Organization for Standardization established the Technical Committee of Traditional Chinese Medicine (ISO/TC 249) have carried out the development of quality standards on medicinal plants or CMMs respectively, and a considerable number of monographs and international standards have been published. Since the two international organizations adhere to different principles, the standards they develop naturally have different emphasis. Driven by market demand and international trade, ISO mainly takes quality, efficacy and safety into consideration when developing standards, while WHO pays more attention to clinical practice, quality control and medication guidance. Up to now, there is a lack of comparative analysis on the records, background, principles, basic content, and main requirements of quality standards on medicinal plants or CMMs respectively published by WHO and ISO. Therefore, based on international standards of CMM developed by ISO/TC 249 platform and WHO Monographs on Selected Medicinal Plants, this paper systematically compares the purposes, selected principles, standard-developing process, basic content, and main quality requirements to summarize their similarities and differences, and find their merits, aiming to serve as a reference to the development of international standards for CMMs that helps them go global.
Subject(s)
Materia Medica/therapeutic use , Plants, Medicinal , Commerce , Internationality , Medicine, Chinese Traditional , Reference Standards , Drugs, Chinese Herbal/therapeutic use , ChinaABSTRACT
The expert committee is an important force in promoting the scientific,democratic,and standardized decision-making and management of hospitals.At present,although hospitals can establish a categorized expert committee system in accordance with the requirements of the health administrative department,there is still a gap between the role of the expert committee and the original intention of the system design.It is based on the perspec-tive of evaluation standards and normative document requirements for graded hospitals,summarizes and analyzes the main expert committee category system in hospitals,explores the problems,constraints,and improvement sug-gestions for the role of expert committees,in order to better promote scientific,democratic,and standardized deci-sion-making in hospitals.