Suchergebnisse

International audience ; BACKGROUND: Small clinical trials are necessary when there are difficulties in recruiting enough patients for conventional frequentist statistical analyses to provide an appropriate answer. These trials are often necessary for the study of rare diseases as well as specific study populations e.g. children. It has been estimated that there are between 6,000 and 8,000 rare diseases that cover a broad range of diseases and patients. In the European Union these diseases affect up to 30 million people, with about 50% of those affected being children. Therapies for treating these rare diseases need their efficacy and safety evaluated but due to the small number of potential trial participants, a standard randomised controlled trial is often not feasible. There are a number of alternative trial designs to the usual parallel group design, each of which offers specific advantages, but they also have specific limitations. Thus the choice of the most appropriate design is not simple. METHODS: PubMed was searched to identify publications about the characteristics of different trial designs that can be used in randomised, comparative small clinical trials. In addition, the contents tables from 11 journals were hand-searched. An algorithm was developed using decision nodes based on the characteristics of the identified trial designs. RESULTS: We identified 75 publications that reported the characteristics of 12 randomised, comparative trial designs that can be used in for the evaluation of therapies in orphan diseases. The main characteristics and the advantages and limitations of these designs were summarised and used to develop an algorithm that may be used to help select an appropriate design for a given clinical situation. We used examples from publications of given disease-treatment-outcome situations, in which the investigators had used a particular trial design, to illustrate the use of the algorithm for the identification of possible alternative designs. CONCLUSIONS: The algorithm that we ...

International audience ; BACKGROUND: Small clinical trials are necessary when there are difficulties in recruiting enough patients for conventional frequentist statistical analyses to provide an appropriate answer. These trials are often necessary for the study of rare diseases as well as specific study populations e.g. children. It has been estimated that there are between 6,000 and 8,000 rare diseases that cover a broad range of diseases and patients. In the European Union these diseases affect up to 30 million people, with about 50% of those affected being children. Therapies for treating these rare diseases need their efficacy and safety evaluated but due to the small number of potential trial participants, a standard randomised controlled trial is often not feasible. There are a number of alternative trial designs to the usual parallel group design, each of which offers specific advantages, but they also have specific limitations. Thus the choice of the most appropriate design is not simple. METHODS: PubMed was searched to identify publications about the characteristics of different trial designs that can be used in randomised, comparative small clinical trials. In addition, the contents tables from 11 journals were hand-searched. An algorithm was developed using decision nodes based on the characteristics of the identified trial designs. RESULTS: We identified 75 publications that reported the characteristics of 12 randomised, comparative trial designs that can be used in for the evaluation of therapies in orphan diseases. The main characteristics and the advantages and limitations of these designs were summarised and used to develop an algorithm that may be used to help select an appropriate design for a given clinical situation. We used examples from publications of given disease-treatment-outcome situations, in which the investigators had used a particular trial design, to illustrate the use of the algorithm for the identification of possible alternative designs. CONCLUSIONS: The algorithm that we ...

International audience ; BACKGROUND: Small clinical trials are necessary when there are difficulties in recruiting enough patients for conventional frequentist statistical analyses to provide an appropriate answer. These trials are often necessary for the study of rare diseases as well as specific study populations e.g. children. It has been estimated that there are between 6,000 and 8,000 rare diseases that cover a broad range of diseases and patients. In the European Union these diseases affect up to 30 million people, with about 50% of those affected being children. Therapies for treating these rare diseases need their efficacy and safety evaluated but due to the small number of potential trial participants, a standard randomised controlled trial is often not feasible. There are a number of alternative trial designs to the usual parallel group design, each of which offers specific advantages, but they also have specific limitations. Thus the choice of the most appropriate design is not simple. METHODS: PubMed was searched to identify publications about the characteristics of different trial designs that can be used in randomised, comparative small clinical trials. In addition, the contents tables from 11 journals were hand-searched. An algorithm was developed using decision nodes based on the characteristics of the identified trial designs. RESULTS: We identified 75 publications that reported the characteristics of 12 randomised, comparative trial designs that can be used in for the evaluation of therapies in orphan diseases. The main characteristics and the advantages and limitations of these designs were summarised and used to develop an algorithm that may be used to help select an appropriate design for a given clinical situation. We used examples from publications of given disease-treatment-outcome situations, in which the investigators had used a particular trial design, to illustrate the use of the algorithm for the identification of possible alternative designs. CONCLUSIONS: The algorithm that we ...

International audience ; BACKGROUND: Small clinical trials are necessary when there are difficulties in recruiting enough patients for conventional frequentist statistical analyses to provide an appropriate answer. These trials are often necessary for the study of rare diseases as well as specific study populations e.g. children. It has been estimated that there are between 6,000 and 8,000 rare diseases that cover a broad range of diseases and patients. In the European Union these diseases affect up to 30 million people, with about 50% of those affected being children. Therapies for treating these rare diseases need their efficacy and safety evaluated but due to the small number of potential trial participants, a standard randomised controlled trial is often not feasible. There are a number of alternative trial designs to the usual parallel group design, each of which offers specific advantages, but they also have specific limitations. Thus the choice of the most appropriate design is not simple. METHODS: PubMed was searched to identify publications about the characteristics of different trial designs that can be used in randomised, comparative small clinical trials. In addition, the contents tables from 11 journals were hand-searched. An algorithm was developed using decision nodes based on the characteristics of the identified trial designs. RESULTS: We identified 75 publications that reported the characteristics of 12 randomised, comparative trial designs that can be used in for the evaluation of therapies in orphan diseases. The main characteristics and the advantages and limitations of these designs were summarised and used to develop an algorithm that may be used to help select an appropriate design for a given clinical situation. We used examples from publications of given disease-treatment-outcome situations, in which the investigators had used a particular trial design, to illustrate the use of the algorithm for the identification of possible alternative designs. CONCLUSIONS: The algorithm that we ...

The lack of implementation of well-designed public policies aimed at the conservation of natural ecosystems has resulted, at a global level, in the decline of ecosystem functioning and, consequently, of the contributions they make to people. The poor enforcement of important environmental legislation in Brazil-for instance, the "Atlantic Forest Law" (Law n.11.428/2006) and the "Forest Code" (Law n.12.651/2012)-could compromise the overall maintenance of ecosystems and the services they provide. To explore the implications of different levels of federal laws' enforcement within the Cantareira System Protected Area (PA)-a PA in southeastern Brazil that provides fresh water for 47% of the Sao Paulo Metropolitan Area-, we developed a conceptual framework to identify indirect and direct drives of biodiversity and ecosystem changes. We also projected four land-use scenarios to 2050 to test the effects of deforestation control and forest restoration practices on biodiversity and ecosystem services maintenance: the "business-as-usual" scenario (BAU), which assumes that all trends in land-use cover changes observed in the past will continue in the future, and three alternative exploratory scenarios considering the Atlantic Forest Law implementation, the partial implementation of the Forest Code and the full implementation of the Forest Code. Using the land-use maps generated for each scenario, we assessed the impacts of land-use changes on biodiversity conservation and soil retention. Our results revealed all alternative scenarios could increase biodiversity conservation (by 7%; 12%; and 12%, respectively), reduce soil loss (by 24.70%; 34.70%; and 38.12%, respectively) and sediment exportation to water (by 27.47%; 55.06%; and 59.28%, respectively), when compared to the BAU scenario. Our findings highlight the importance of restoring and conserving native vegetation for the maintenance and improvement of biodiversity conservation and for the provision of ecosystem services. ; A falta de implementação de políticas públicas voltadas para a conservação ambiental, tem resultado, em nível global, em impactos sobre a biodiversidade e o funcionamento dos ecossistemas e, consequentemente, na contribuição da natureza para as pessoas. A aplicação inadequada de importantes de leis ambientais no Brasil, como por exemplo, a "Lei da Mata Atlântica" (Lei nº 11.428 / 2006) e o "Código Florestal" (Lei nº 12.651 / 2012), podem comprometer a manutenção dos ecossistemas e dos serviços que eles fornecem. Neste estudo, nós desenvolvemos um mapa conceitual que busca identificar causas diretas e indiretas de mudanças – agentes de mudança – na biodiversidade e na provisão de serviços ecossistêmicos relacionados ao solo e à água, na Área de Proteção Ambiental (APA) Sistema Cantareira. A APA Sistema Cantareira, localizada no sudeste do Brasil, fornece água potável para 47% da Região Metropolitana de São Paulo. Além da abordagem conceitual, nós projetamos quatro cenários de mudança no uso da terra para o ano de 2050, a fim de analisar o impacto de diferentes níveis de aplicação de leis federais: o cenário "business-as-usual" (BAU), que pressupõe que as tendências na mudança de uso da terra observadas no passado continuarão no futuro, e três cenários alternativos, considerando a implementação da Lei da Mata Atlântica, a implementação parcial do Código Florestal e a implementação completa do Código Florestal. A partir dos mapas de uso da terra gerados, avaliamos os impactos de cada cenário na conservação da biodiversidade, na retenção de solos e na exportação de sedimentos para os corpos d'água. Nossos resultados mostraram que os três cenários alternativos podem aumentar a conservação da biodiversidade (em 7%; 12%; e 12%, respectivamente), reduzir a perda de solo (em 24,70%; 34,70%; e 38,12%, respectivamente) e reduzir a exportação de sedimentos para a água (em 27,47 %; 55,06%; e 59,28%, respectivamente), quando comparados ao cenário BAU. Este estudo destaca a importância da restauração e conservação da vegetação nativa para a manutenção da biodiversidade e melhoria na provisão de serviços ecossistêmicos relacionados ao solo e à água, em uma região estratégica para o abastecimento de água no Brasil. ; Fil: Dib, Viviane. Universidade Federal do Rio de Janeiro; Brasil ; Fil: Nalon, Marco Aurélio. Estado de São Paulo. Secretaria de Infraestrutura e Meio ambiente. Instituto Florestal; Brasil ; Fil: Amazonas, Nino Tavares. Universidade de Sao Paulo; Brasil ; Fil: Vidal, Cristina Yuri. Universidade do Sao Paulo. Escola Superior de Agricultura Luiz de Queiroz; Brasil ; Fil: Ortiz Rodríguez, Iván A. Scuola Normale Superiore. Classe di Scienze; Italia ; Fil: Danek, Jan. Czech Academy of Sciences; República Checa ; Fil: Oliveira, Maíra Formis de. Estado de São Paulo. Secretaria de Agricultura e Abastecimento; Brasil ; Fil: Alberti, Paola. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Tucumán. Instituto de Biodiversidad Neotropical. Universidad Nacional de Tucumán. Facultad de Ciencias Naturales e Instituto Miguel Lillo. Instituto de Biodiversidad Neotropical. Instituto de Biodiversidad Neotropical; Argentina ; Fil: Silva, Rafaela Aparecida da. Universidade Federal de Goiás; Brasil ; Fil: Precinoto, Raíza Salomão. Universidade Federal do Rio de Janeiro; Brasil ; Fil: Gomes, Taciana Figueiredo. Universidade de Sao Paulo; Brasil

International audience ; Background: A public health student service was set up by the French government in 2018 with the aim of increasing awareness of primary health promotion among the 47,000 students of medicine and other health professions. It is an annual program involving community-based actions on nutrition, physical activity, addiction or sexuality. Our objective was to evaluate its implementation at local level and the different experiences of the stakeholders.Methods: A quasi-experimental study using process evaluation was performed in a Faculty of Medicine in Paris. Quantitative and qualitative data were collected from medical students who carried out preventive health actions, in the institutions in which the actions took place and from a subsample of beneficiaries.Results: One hundred and eight actions were carried out by 341 students in 23 educational or social institutions, mostly high schools (n = 12, 52%). Two thirds of the students did not feel sufficiently prepared to deliver preventive health interventions (65.7%, 224/341); however the beneficiaries found that the interventions were good (278/280, 99,2%). Nineteen (83%) of the host institutions agreed to welcome health service students again, of which 9 required some modifications. For students, the reporting of a satisfactory health service experience was associated with the reporting of skills or knowledge acquisition (p < 0.01). Delivering actions in high schools and to a medium-sized number of beneficiaries per week was associated with students' satisfaction. No effect of gender or theme of prevention was observed. For 248/341 (72.7%) students, the public health service program prompts them to address prevention issues in the future.Conclusion: The public health service undertaken by medical students through the program is a feasible and acceptable means of delivering preventive actions. Reinforcement of training and closer interaction with the host institutions would improve results.

International audience ; Background: A public health student service was set up by the French government in 2018 with the aim of increasing awareness of primary health promotion among the 47,000 students of medicine and other health professions. It is an annual program involving community-based actions on nutrition, physical activity, addiction or sexuality. Our objective was to evaluate its implementation at local level and the different experiences of the stakeholders.Methods: A quasi-experimental study using process evaluation was performed in a Faculty of Medicine in Paris. Quantitative and qualitative data were collected from medical students who carried out preventive health actions, in the institutions in which the actions took place and from a subsample of beneficiaries.Results: One hundred and eight actions were carried out by 341 students in 23 educational or social institutions, mostly high schools (n = 12, 52%). Two thirds of the students did not feel sufficiently prepared to deliver preventive health interventions (65.7%, 224/341); however the beneficiaries found that the interventions were good (278/280, 99,2%). Nineteen (83%) of the host institutions agreed to welcome health service students again, of which 9 required some modifications. For students, the reporting of a satisfactory health service experience was associated with the reporting of skills or knowledge acquisition (p < 0.01). Delivering actions in high schools and to a medium-sized number of beneficiaries per week was associated with students' satisfaction. No effect of gender or theme of prevention was observed. For 248/341 (72.7%) students, the public health service program prompts them to address prevention issues in the future.Conclusion: The public health service undertaken by medical students through the program is a feasible and acceptable means of delivering preventive actions. Reinforcement of training and closer interaction with the host institutions would improve results.

BACKGROUND: A public health student service was set up by the French government in 2018 with the aim of increasing awareness of primary health promotion among the 47,000 students of medicine and other health professions. It is an annual program involving community-based actions on nutrition, physical activity, addiction or sexuality. Our objective was to evaluate its implementation at local level and the different experiences of the stakeholders. METHODS: A quasi-experimental study using process evaluation was performed in a Faculty of Medicine in Paris. Quantitative and qualitative data were collected from medical students who carried out preventive health actions, in the institutions in which the actions took place and from a subsample of beneficiaries. RESULTS: One hundred and eight actions were carried out by 341 students in 23 educational or social institutions, mostly high schools (n = 12, 52%). Two thirds of the students did not feel sufficiently prepared to deliver preventive health interventions (65.7%, 224/341); however the beneficiaries found that the interventions were good (278/280, 99,2%). Nineteen (83%) of the host institutions agreed to welcome health service students again, of which 9 required some modifications. For students, the reporting of a satisfactory health service experience was associated with the reporting of skills or knowledge acquisition (p < 0.01). Delivering actions in high schools and to a medium-sized number of beneficiaries per week was associated with students' satisfaction. No effect of gender or theme of prevention was observed. For 248/341 (72.7%) students, the public health service program prompts them to address prevention issues in the future. CONCLUSION: The public health service undertaken by medical students through the program is a feasible and acceptable means of delivering preventive actions. Reinforcement of training and closer interaction with the host institutions would improve results. SUPPLEMENTARY INFORMATION: The online version contains supplementary ...

Background and Objective There is no agreement on the gold standard for detection and grading of chemotherapy-induced peripheral neurotoxicity (CIPN) in clinical trials. The objective is to perform an observational prospective study to assess and compare patient-based and physician-based methods for detection and grading of CIPN. Methods Consecutive patients, aged 18 years or older, candidates for neurotoxic chemotherapy, were enrolled in the United States, European Union, or Australia. A trained investigator performed physician-based scales (Total Neuropathy Score-clinical [TNSc], used to calculate Total Neuropathy Score-nurse [TNSn]) and supervised the patient-completed questionnaire (Functional Assessment of Cancer Treatment/Gynecologic Oncology Group-Neurotoxicity [FACT/GOG-NTX]). Evaluations were performed before and at the end of chemotherapy. On participants without neuropathy at baseline, we assessed the association between TNSc, TNSn, and FACT/GOG-NTX. Considering a previously established minimal clinically important difference (MCID) for FACT/GOG-NTX, we identified participants with and without a clinically important deterioration according to this scale. Then, we calculated the MCID for TNSc and TNSn as the difference in the mean change score of these scales between the 2 groups. Results Data from 254 participants were available: 180 (71%) had normal neurologic status at baseline. At the end of the study, 88% of participants developed any grade of neuropathy. TNSc, TNSn, and FACT/GOG-NTX showed good responsiveness (standardized mean change from baseline to end of chemotherapy >1 for all scales). On the 153 participants without neuropathy at baseline and treated with a known neurotoxic chemotherapy regimen, we verified a moderate correlation in both TNSc and TNSn scores with FACT/GOG-NTX (Spearman correlation index r = 0.6). On the same sample, considering as clinically important a change in the FACT/GOG-NTX score of at least 3.3 points, the MCID was 3.7 for TNSc and 2.8 for the TNSn. Conclusions ...

International audience ; Background: A public health student service was set up by the French government in 2018 with the aim of increasing awareness of primary health promotion among the 47,000 students of medicine and other health professions. It is an annual program involving community-based actions on nutrition, physical activity, addiction or sexuality. Our objective was to evaluate its implementation at local level and the different experiences of the stakeholders.Methods: A quasi-experimental study using process evaluation was performed in a Faculty of Medicine in Paris. Quantitative and qualitative data were collected from medical students who carried out preventive health actions, in the institutions in which the actions took place and from a subsample of beneficiaries.Results: One hundred and eight actions were carried out by 341 students in 23 educational or social institutions, mostly high schools (n = 12, 52%). Two thirds of the students did not feel sufficiently prepared to deliver preventive health interventions (65.7%, 224/341); however the beneficiaries found that the interventions were good (278/280, 99,2%). Nineteen (83%) of the host institutions agreed to welcome health service students again, of which 9 required some modifications. For students, the reporting of a satisfactory health service experience was associated with the reporting of skills or knowledge acquisition (p < 0.01). Delivering actions in high schools and to a medium-sized number of beneficiaries per week was associated with students' satisfaction. No effect of gender or theme of prevention was observed. For 248/341 (72.7%) students, the public health service program prompts them to address prevention issues in the future.Conclusion: The public health service undertaken by medical students through the program is a feasible and acceptable means of delivering preventive actions. Reinforcement of training and closer interaction with the host institutions would improve results.

International audience ; Background: A public health student service was set up by the French government in 2018 with the aim of increasing awareness of primary health promotion among the 47,000 students of medicine and other health professions. It is an annual program involving community-based actions on nutrition, physical activity, addiction or sexuality. Our objective was to evaluate its implementation at local level and the different experiences of the stakeholders.Methods: A quasi-experimental study using process evaluation was performed in a Faculty of Medicine in Paris. Quantitative and qualitative data were collected from medical students who carried out preventive health actions, in the institutions in which the actions took place and from a subsample of beneficiaries.Results: One hundred and eight actions were carried out by 341 students in 23 educational or social institutions, mostly high schools (n = 12, 52%). Two thirds of the students did not feel sufficiently prepared to deliver preventive health interventions (65.7%, 224/341); however the beneficiaries found that the interventions were good (278/280, 99,2%). Nineteen (83%) of the host institutions agreed to welcome health service students again, of which 9 required some modifications. For students, the reporting of a satisfactory health service experience was associated with the reporting of skills or knowledge acquisition (p < 0.01). Delivering actions in high schools and to a medium-sized number of beneficiaries per week was associated with students' satisfaction. No effect of gender or theme of prevention was observed. For 248/341 (72.7%) students, the public health service program prompts them to address prevention issues in the future.Conclusion: The public health service undertaken by medical students through the program is a feasible and acceptable means of delivering preventive actions. Reinforcement of training and closer interaction with the host institutions would improve results.

International audience ; Background: A public health student service was set up by the French government in 2018 with the aim of increasing awareness of primary health promotion among the 47,000 students of medicine and other health professions. It is an annual program involving community-based actions on nutrition, physical activity, addiction or sexuality. Our objective was to evaluate its implementation at local level and the different experiences of the stakeholders.Methods: A quasi-experimental study using process evaluation was performed in a Faculty of Medicine in Paris. Quantitative and qualitative data were collected from medical students who carried out preventive health actions, in the institutions in which the actions took place and from a subsample of beneficiaries.Results: One hundred and eight actions were carried out by 341 students in 23 educational or social institutions, mostly high schools (n = 12, 52%). Two thirds of the students did not feel sufficiently prepared to deliver preventive health interventions (65.7%, 224/341); however the beneficiaries found that the interventions were good (278/280, 99,2%). Nineteen (83%) of the host institutions agreed to welcome health service students again, of which 9 required some modifications. For students, the reporting of a satisfactory health service experience was associated with the reporting of skills or knowledge acquisition (p < 0.01). Delivering actions in high schools and to a medium-sized number of beneficiaries per week was associated with students' satisfaction. No effect of gender or theme of prevention was observed. For 248/341 (72.7%) students, the public health service program prompts them to address prevention issues in the future.Conclusion: The public health service undertaken by medical students through the program is a feasible and acceptable means of delivering preventive actions. Reinforcement of training and closer interaction with the host institutions would improve results.

Metadata only record ; Because of the lack of collaboration between social and ecological scientists, the study of coupled human and nature systems has not been directly studied. This study examines cases on five continents: Africa, Asia, North America, South America and Europe. Each area differs in ecological, socioeconomic, political, demographic and cultural setting. Still, the five studies are similar in that they address complex interactions of human and nature systems, consider and measure both human and ecological components, are composed of interdisciplinary teams, use integrated tools to collect both ecological and human data, and are context specific and longitudinal over periods of time.

Abstract Background Small clinical trials are necessary when there are difficulties in recruiting enough patients for conventional frequentist statistical analyses to provide an appropriate answer. These trials are often necessary for the study of rare diseases as well as specific study populations e.g. children. It has been estimated that there are between 6,000 and 8,000 rare diseases that cover a broad range of diseases and patients. In the European Union these diseases affect up to 30 million people, with about 50% of those affected being children. Therapies for treating these rare diseases need their efficacy and safety evaluated but due to the small number of potential trial participants, a standard randomised controlled trial is often not feasible. There are a number of alternative trial designs to the usual parallel group design, each of which offers specific advantages, but they also have specific limitations. Thus the choice of the most appropriate design is not simple. Methods PubMed was searched to identify publications about the characteristics of different trial designs that can be used in randomised, comparative small clinical trials. In addition, the contents tables from 11 journals were hand-searched. An algorithm was developed using decision nodes based on the characteristics of the identified trial designs. Results We identified 75 publications that reported the characteristics of 12 randomised, comparative trial designs that can be used in for the evaluation of therapies in orphan diseases. The main characteristics and the advantages and limitations of these designs were summarised and used to develop an algorithm that may be used to help select an appropriate design for a given clinical situation. We used examples from publications of given disease-treatment-outcome situations, in which the investigators had used a particular trial design, to illustrate the use of the algorithm for the identification of possible alternative designs. Conclusions The algorithm that we propose could be a useful tool for the choice of an appropriate trial design in the development of orphan drugs for a given disease-treatment-outcome situation.

Este libro está dedicado a la memoria del sociólogo Gino Germani. En la estructura del texto se reproduce la del Congreso Internacional sobre los límites de la democracia realizado en Roma a fines de 1980, en la Libera Universita Internazionale degli Studi Sociale. Este libro es una revisión crítica, histórica y sociológica de recientes procesos de transformación social y política que atañen de especial manera a la construcción de la democracia contemporánea. El lector encontrará importantes aportes analíticos que le serán útiles para la comprensión de las posibilidades y utopías de la nueva democracia latinoamericana, entendida no sólo como campo político y legal legítimo, sino también como la búsqueda de un amplio y permanente horizonte humano: el de la libertad.