No / Introduction Dementia Care Mapping (DCM) was originally developed as a clinical tool but has attracted interest as a potential observational measure of quality of life (QOL) and well-being of long-term care residents with dementia. DCM coding involves continuous observation over a 6-h period, with observers recording a Behavior Category Code (BCC, a recording of activity/interaction) and a Well/Ill Being (WIB) score at 5 min intervals. Method Descriptive data from several different research teams on the distribution and psychometric properties of DCM data were compiled and summarized. Results Issues and problems identified include: complex scoring algorithms, inter-rater reliability of the BCCs, limited variability of WIB values, associations between resident characteristics and DCM assessments, rater time burden, and comparability of results across study settings. Conclusions Despite the identified limitations, DCM has promise as a research measure, as it may come closer to rating QOL from the perspective of persons with dementia than other available measures. Its utility will depend on the manner in which it is applied and an appreciation of the measure's strength and limitations. Possible changes that might improve the reliability, validity, and practicality of DCM as a research tool include coding the predominant event (rather than the best event), shortening the observation period, and adding 0 as a neutral WIB coding option.

Research is a time-consuming endeavor which requires appropriate tools to manage often vast amounts of information. Militarization 2.0 is a research project aiming to explore Militarization in social media. The aim of this project is to design a user interface for supporting researchers in projects involving large amounts of data in qualitative studies. The project will follow the design process of the first version of the Militarization 2.0 research database interface. The design process involves user studies, interviews and design and testing of paper and digital prototypes. The results include the interface prototype as well as reflections on what tools proved useful in the design process.

The Canadian canola breeding sector met a transition from publicly funded breeding research to large private investments in research and development (R&D). The increasing use of biotechnology tools in the mid 1990s made the assignment of plant ownership technically possible while the legislative safeguards that were put in place during the same period enabled owners to take juristic actions against potential infringers. Today, canola breeding sector is dominated by large multinational firms. The generation of proprietary knowledge in the canola breeding sector has caused a freedom to operate issue. Private and public firms conducting canola R&D are seriously concerned about their ability to gain and preserve access to key technologies in an IPR world. <p>This thesis uses the tragedy of the anticommons framework to analyze the consequences of increased intellectual property protection in the canola breeding sector. Theory suggests that when a common resource is owned by multiple owners, each of the owners has the incentive to overcharge potential users, leading to the underuse of the resource. In R&D, different owners of complementary technologies may overcharge potential R&D firms that want to assemble different technological pieces to produce a new one. The result is forgoing research and development of new products.<p>The results of personal interviews with thirteen canola researchers and IP officers are presented and analyzed. The results suggest that the increase in the intellectual property protection in the last two decades in the canola breeding sector has led to difficulties with canola R&D. These difficulties take the form of reduced access to current, proprietary and public material. With hampered access to research input material, research output is not maximized and potential research may be forgone. Interviewees described how the increase in the intellectual property protection affects their personal and organizations ability to conduct research as well as some the implications of the new IP regime on the canola breeding sector. There is indication that canola breeding sector is moving towards a super-protectionism. Under these conditions, canola R&D firms, private and public, are in search for ways that will open access to enabling technologies and research areas. The creation of platform technologies and collaborations are the most prominent ones and are observed to increase in occurrence world wide.

The Canadian canola breeding sector met a transition from publicly funded breeding research to large private investments in research and development (R&D). The increasing use of biotechnology tools in the mid 1990s made the assignment of plant ownership technically possible while the legislative safeguards that were put in place during the same period enabled owners to take juristic actions against potential infringers. Today, canola breeding sector is dominated by large multinational firms. The generation of proprietary knowledge in the canola breeding sector has caused a freedom to operate issue. Private and public firms conducting canola R&D are seriously concerned about their ability to gain and preserve access to key technologies in an IPR world. <p>This thesis uses the tragedy of the anticommons framework to analyze the consequences of increased intellectual property protection in the canola breeding sector. Theory suggests that when a common resource is owned by multiple owners, each of the owners has the incentive to overcharge potential users, leading to the underuse of the resource. In R&D, different owners of complementary technologies may overcharge potential R&D firms that want to assemble different technological pieces to produce a new one. The result is forgoing research and development of new products.<p>The results of personal interviews with thirteen canola researchers and IP officers are presented and analyzed. The results suggest that the increase in the intellectual property protection in the last two decades in the canola breeding sector has led to difficulties with canola R&D. These difficulties take the form of reduced access to current, proprietary and public material. With hampered access to research input material, research output is not maximized and potential research may be forgone. Interviewees described how the increase in the intellectual property protection affects their personal and organizations ability to conduct research as well as some the implications of the new IP regime on the canola breeding sector. There is indication that canola breeding sector is moving towards a super-protectionism. Under these conditions, canola R&D firms, private and public, are in search for ways that will open access to enabling technologies and research areas. The creation of platform technologies and collaborations are the most prominent ones and are observed to increase in occurrence world wide.

This diploma thesis deals with the issue of sociological research on animal abuse. It identifies the basic problems that this research has to deal with, these problems are described in detail and a solution is proposed in the form of the construction of a new research tool. Subsequently, an attempt is made to validate this newly created research tool, its weaknesses and strengths are summed up and further possible research in this area is discussed. In the theoretical part of the thesis, the problem of animal abuse is introduced in the historical context first, and then a summary of basic problems of sociological exploration of this phenomenon is presented. The final chapter of this section addresses the issue of ethical aspects of animal abuse research. The methodological part presents the design of the research, the process of construction of a new research tool and the methods and approaches used. The analytical part summarizes the knowledge obtained during the cognitive interviews that were conducted in order to validate the newly created research tool. The benefits and limitations of the new instrument are discussed and proposals are made to continue the research on this issue.

Цель исследования – разработка методологии исследования нарративов в средствах массовой информации. Объект исследования – информационное поле средств массовой информации. Предмет исследования – нарративы и методологии их исследования. Научная новизна заключается в разработке нового подхода к анализу и интерпретации материалов, используемых в СМИ, использованию современных инструментов и технологий в целях более эффективного исследования и классификации нарративов в больших объемах информации. Апробация разработанной методологии включает тестирование методологии на большой выборке материалов из различных СМИ, а также участие в научных конференциях в ходе разработки методологии. Результаты работы – практическим результатом работы стала разработка методологии исследования нарративов СМИ и рекомендации по возможному использованию и улучшению результатов. / The purpose of the study is to develop a methodology for studying narratives in the media. The object of research is the information field of the media. The subject of the study is narratives and methodologies for their research. Scientific novelty lies in the development of a new approach to the analysis and interpretation of materials used in the media, the use of modern tools and technologies in order to more effectively study and classify narratives in large volumes of information. Approbation of the developed methodology includes testing the methodology on a large sample of materials from various media, as well as participation in scientific conferences during the development of the methodology. Results of the work - the practical result of the work was the development of a methodology for studying media narratives and recommendations for possible use and improvement of the results.

Na prática clínica, o enfermeiro precisa sistematizar o cuidado baseado em aspectos que visam garantir a segurança e a qualidade do cuidado aos pacientes. Entre esses aspectos salienta-se que os registros de enfermagem sejam realizados de maneira plena e, principalmente, que sejam compreendidos e valorizados. É nessa perspectiva que a utilização de uma terminologia e sistemas eletrônicos aliados ao processo de enfermagem ganham espaço, favorecendo a qualidade dos registros. A avaliação da qualidade desses registros pode se dar por meio de um instrumento denominado Quality of Diagnoses, Interventions and Outcomes (Q-DIO), publicado em língua inglesa e validado apenas na Suíça. O Q-DIO tem como principal objetivo avaliar a qualidade dos registros de enfermagem. Somado a isso, tem sido utilizado como um indicador para comparar a qualidade dos registros com e sem linguagem padronizada, definir metas, avaliar o impacto da implementação de programas educacionais e ainda, em sistemas de auditoria. Existe uma lacuna no Brasil, assim como nos Estados Unidos da América (EUA), de instrumentos que avaliem questões relativas à qualidade dos registros de enfermagem. Foi nessa perspectiva que esse estudo metodológico foi desenvolvido para validar o Q-DIO no Brasil e nos EUA. O Q-DIO é composto por 29 itens, dividido em quatro domínios (diagnósticos de enfermagem como processo, diagnósticos de enfermagem como produto, intervenções de enfermagem, resultados de enfermagem), composto por escala Likert de três pontos. Para validação do instrumento foram elegíveis registros de pacientes em pós-operatório de cirurgia cardíaca que tiveram registrados em prontuário o histórico, as evoluções e as prescrições de enfermagem entre um período mínimo de quatro dias. A amostra foi de 180 registros, distribuídos igualmente entre os três centros do estudo, dois no Brasil (centros 1 e 2) e um nos EUA (centro 3). Dentre as propriedades psicométricas, foram avaliadas fidedignidade (consistência interna e estabilidade) e a validade de constructo divergente. Os valores do alfa de Cronbach para as 29 questões foram superiores a 0,70 para todos os centros. Com relação à estabilidade, o coeficiente de correlação intraclasse variou entre 0,64 e 0,85 para intraobservador e 0,68 a 0,82 para interobservador, o que indica níveis satisfatórios e excelentes de concordância. Na validade de constructo divergente observou-se diferença estatística significativa entre as médias da soma dos 29 itens do instrumento entre os três centros. O centro 1 (registros eletrônicos com linguagem padronizada) apresentou média de 36,8(±4,5) [IC95%: 35,63-37,94]; o centro 2 (registros manuais sem linguagem padronizada) obteve média de 11,533(±6,2) [IC95%:9,93-13,14]; o centro 3 (registros eletrônicos sem linguagem padronizada) teve média de 31,2(±5,3) [IC95%: 29,87-32,63]. Esses resultados indicam que o Q-DIO é fidedigno e válido para avaliar a qualidade de registros de enfermagem eletrônicos ou não, e que utilizem ou não linguagem padronizada no Brasil; também nos EUA esse instrumento se mostrou fidedigno e válido para dados eletrônicos sem uso de terminologia padrão. / In clinical practice, nurses must systematize their practice based in certain aspects intended to ensure the safety and quality of the patient care. Among such aspects should be noted that the nursing records must be fully completed, understood, and valued. Taking this into consideration, the use of terminology and electronic systems along with the nursing processes favor the quality of nursing records. The assessment of the quality of such records may be obtained through an instrument called Quality of Diagnoses, Interventions and Outcomes (Q-DIO), published in English and validated in Switzerland. The Q-DIO's main objective is to assess the quality of the nursing records, although it has also been used as an indicator to compare the quality of records with and without standardized language, to set goals, to evaluate the impact of implementing educational programs, and to give some help in audit systems. There is a lack of instruments capable of assessing issues related to the quality of nursing records in Brazil and in the United States (U.S.). It was because of it that this methodological study was developed: to validate the Q-DIO instrument in Brazil and in the U.S. The Q-DIO is composed of 29 items, divided into four domains (nursing diagnoses as process, nursing diagnoses as product, nursing interventions, and nursing outcomes), composed of a three-point Likert scale. To validate the instrument, records from patients in the period after a cardiac surgery, and who had in their historical records trends and nursing prescriptions between a minimum of four days, were selected. The sample has a total of 180 records, divided equally between the three study centers, being two located in Brazil (center 1 and 2) and one in the U.S. (center 3). Among the psychometric properties, reliability (internal consistency and stability) and divergent construct validity were those evaluated. The values of Cronbach's Alpha for the 29 questions were superior to 0.70 for all centers. Regarding stability, the intraclass correlation coefficient ranged between 0.64 to 0.85 for intraobserver, and 0.68 to 0.82 for inter-observer, which indicates excellent and satisfactory levels of agreement. In divergent construct validity, statistically significant differences were observed in the average of the sum of the 29 items of the instrument among the three centers. Center 1 (electronic records with standardized language) had an average of 36.8 (± 9.5) [95%CI: 35.63-37.94]; center 2 (manual records without standardized language) had an average of 11.53 (± 6,2) [95%CI: 9.93-13.14]; and center 3 (electronic records without standardized language) presented an average of 31.2 (± 5.3) [95%CI: 29.87-32.63]. These results indicate that Q-DIO is valid and reliable for assessing the quality of nursing records, being them electronic or not, using standardized language or not, at least in Brazil. In the U.S., this instrument has also proved to be reliable and valid for electronic nursing records without use of standardized language. / En la práctica clínica el enfermero precisa sistematizar el cuidado a partir de aspectos que objetivan garantizar seguridad y calidad del cuidado a los pacientes. Entre esos aspectos destacamos que los registros de enfermería sean realizados de manera plena y principalmente que sean comprendidos, valorados. Es en esta perspectiva, que la utilización de una terminología y de sistemas electrónicos coligados al proceso de enfermería obtienen espacio favoreciendo la calidad de los registros. La evaluación de la calidad de dichos registros puede ser a través de un instrumento nombrado Quality of Diagnoses, Interventions and Outcomes (Q-DIO) publicado en idioma inglés y validado solamente en Suiza. Q-DIO posee por objetivo principal evaluar la calidad de los registros en enfermería. A eso se suma su utilización como un indicador para comparar la calidad de registros con y sin lenguaje patrón, establecer fines, evaluar impacto de la implementación de programas educativos y aún, en sistemas de auditoría. Existe una falla en Brasil, así como en Estados Unidos de América (EUA) sobre instrumentos que evalúen cuestiones relacionadas a la calidad de los registros de enfermería. Fue en esa perspectiva que este estudio metodológico ha sido desarrollado para validar el Q-DIO en Brasil y EUA. Q-DIO está compuesto de 29 puntos, dividido en cuatro aspectos (diagnósticos de enfermería como proceso, diagnósticos de enfermería como producto, intervenciones de enfermería, resultados de enfermería), compuesto por escala Likert de tres puntos. Para validación del instrumento han sido elegidos registros de pacientes en pos operatorio de cirugía cardiaca, que tuvieron registrados en prontuario o histórico y las evoluciones y prescripciones de enfermería entre un periodo mínimo de cuatro días. La muestra fue de 180 registros, distribuidos igualmente entre los tres centros del estudio; dos en Brasil (centro 1 y 2) y uno en EUA (centro 3). Entre las propiedades psicométricas fueron evaluadas la fidedignidad (consistencia interna y estabilidad) y la validez del constructo divergente. Los valores de Alfa de Cronbach para las 29 cuestiones fueron superiores a 0,70 para todos los centros. En lo que se refiere a la estabilidad, el coeficiente de correlación intra-clase tuvo variación entre 0,64 y 0,85 para intra-observador y 0,68 a 0,82 para inter-observador, lo que indica niveles satisfactorios y excelentes de concordancia. En la validad de constructo divergente se pudo observar una diferencia estadística significativa entre las medias de la suma de los 29 puntos del instrumento entre los tres centros. El centro 1 (registros electrónicos con lenguaje patrón) presentó media de 36,8 (+_ 4,5) [IC95%: 35,63 – 37,94], centro 2 (registros manuales sin lenguaje patrón) obtuvo media de 11,53 (+_ 6,2) [IC 95%: 9,93-13,14] y el centro 3 (registros electrónicos sin lenguaje patrón) con media de 31,2 (+_5,3) [IC95%: 29,87-32,63]. Tales resultados indican que Q-DIO es fidedigno y válido para evaluar la calidad de los registros de enfermería, sean ellos electrónicos o no, y que utilicen lenguaje patrón o no en Brasil, así como, en EUA dicho instrumento también se ha mostrado fidedigno y válido para datos electrónicos sin uso de la terminología patrón.

Na prática clínica, o enfermeiro precisa sistematizar o cuidado baseado em aspectos que visam garantir a segurança e a qualidade do cuidado aos pacientes. Entre esses aspectos salienta-se que os registros de enfermagem sejam realizados de maneira plena e, principalmente, que sejam compreendidos e valorizados. É nessa perspectiva que a utilização de uma terminologia e sistemas eletrônicos aliados ao processo de enfermagem ganham espaço, favorecendo a qualidade dos registros. A avaliação da qualidade desses registros pode se dar por meio de um instrumento denominado Quality of Diagnoses, Interventions and Outcomes (Q-DIO), publicado em língua inglesa e validado apenas na Suíça. O Q-DIO tem como principal objetivo avaliar a qualidade dos registros de enfermagem. Somado a isso, tem sido utilizado como um indicador para comparar a qualidade dos registros com e sem linguagem padronizada, definir metas, avaliar o impacto da implementação de programas educacionais e ainda, em sistemas de auditoria. Existe uma lacuna no Brasil, assim como nos Estados Unidos da América (EUA), de instrumentos que avaliem questões relativas à qualidade dos registros de enfermagem. Foi nessa perspectiva que esse estudo metodológico foi desenvolvido para validar o Q-DIO no Brasil e nos EUA. O Q-DIO é composto por 29 itens, dividido em quatro domínios (diagnósticos de enfermagem como processo, diagnósticos de enfermagem como produto, intervenções de enfermagem, resultados de enfermagem), composto por escala Likert de três pontos. Para validação do instrumento foram elegíveis registros de pacientes em pós-operatório de cirurgia cardíaca que tiveram registrados em prontuário o histórico, as evoluções e as prescrições de enfermagem entre um período mínimo de quatro dias. A amostra foi de 180 registros, distribuídos igualmente entre os três centros do estudo, dois no Brasil (centros 1 e 2) e um nos EUA (centro 3). Dentre as propriedades psicométricas, foram avaliadas fidedignidade (consistência interna e estabilidade) e a validade de constructo divergente. Os valores do alfa de Cronbach para as 29 questões foram superiores a 0,70 para todos os centros. Com relação à estabilidade, o coeficiente de correlação intraclasse variou entre 0,64 e 0,85 para intraobservador e 0,68 a 0,82 para interobservador, o que indica níveis satisfatórios e excelentes de concordância. Na validade de constructo divergente observou-se diferença estatística significativa entre as médias da soma dos 29 itens do instrumento entre os três centros. O centro 1 (registros eletrônicos com linguagem padronizada) apresentou média de 36,8(±4,5) [IC95%: 35,63-37,94]; o centro 2 (registros manuais sem linguagem padronizada) obteve média de 11,533(±6,2) [IC95%:9,93-13,14]; o centro 3 (registros eletrônicos sem linguagem padronizada) teve média de 31,2(±5,3) [IC95%: 29,87-32,63]. Esses resultados indicam que o Q-DIO é fidedigno e válido para avaliar a qualidade de registros de enfermagem eletrônicos ou não, e que utilizem ou não linguagem padronizada no Brasil; também nos EUA esse instrumento se mostrou fidedigno e válido para dados eletrônicos sem uso de terminologia padrão. / In clinical practice, nurses must systematize their practice based in certain aspects intended to ensure the safety and quality of the patient care. Among such aspects should be noted that the nursing records must be fully completed, understood, and valued. Taking this into consideration, the use of terminology and electronic systems along with the nursing processes favor the quality of nursing records. The assessment of the quality of such records may be obtained through an instrument called Quality of Diagnoses, Interventions and Outcomes (Q-DIO), published in English and validated in Switzerland. The Q-DIO's main objective is to assess the quality of the nursing records, although it has also been used as an indicator to compare the quality of records with and without standardized language, to set goals, to evaluate the impact of implementing educational programs, and to give some help in audit systems. There is a lack of instruments capable of assessing issues related to the quality of nursing records in Brazil and in the United States (U.S.). It was because of it that this methodological study was developed: to validate the Q-DIO instrument in Brazil and in the U.S. The Q-DIO is composed of 29 items, divided into four domains (nursing diagnoses as process, nursing diagnoses as product, nursing interventions, and nursing outcomes), composed of a three-point Likert scale. To validate the instrument, records from patients in the period after a cardiac surgery, and who had in their historical records trends and nursing prescriptions between a minimum of four days, were selected. The sample has a total of 180 records, divided equally between the three study centers, being two located in Brazil (center 1 and 2) and one in the U.S. (center 3). Among the psychometric properties, reliability (internal consistency and stability) and divergent construct validity were those evaluated. The values of Cronbach's Alpha for the 29 questions were superior to 0.70 for all centers. Regarding stability, the intraclass correlation coefficient ranged between 0.64 to 0.85 for intraobserver, and 0.68 to 0.82 for inter-observer, which indicates excellent and satisfactory levels of agreement. In divergent construct validity, statistically significant differences were observed in the average of the sum of the 29 items of the instrument among the three centers. Center 1 (electronic records with standardized language) had an average of 36.8 (± 9.5) [95%CI: 35.63-37.94]; center 2 (manual records without standardized language) had an average of 11.53 (± 6,2) [95%CI: 9.93-13.14]; and center 3 (electronic records without standardized language) presented an average of 31.2 (± 5.3) [95%CI: 29.87-32.63]. These results indicate that Q-DIO is valid and reliable for assessing the quality of nursing records, being them electronic or not, using standardized language or not, at least in Brazil. In the U.S., this instrument has also proved to be reliable and valid for electronic nursing records without use of standardized language. / En la práctica clínica el enfermero precisa sistematizar el cuidado a partir de aspectos que objetivan garantizar seguridad y calidad del cuidado a los pacientes. Entre esos aspectos destacamos que los registros de enfermería sean realizados de manera plena y principalmente que sean comprendidos, valorados. Es en esta perspectiva, que la utilización de una terminología y de sistemas electrónicos coligados al proceso de enfermería obtienen espacio favoreciendo la calidad de los registros. La evaluación de la calidad de dichos registros puede ser a través de un instrumento nombrado Quality of Diagnoses, Interventions and Outcomes (Q-DIO) publicado en idioma inglés y validado solamente en Suiza. Q-DIO posee por objetivo principal evaluar la calidad de los registros en enfermería. A eso se suma su utilización como un indicador para comparar la calidad de registros con y sin lenguaje patrón, establecer fines, evaluar impacto de la implementación de programas educativos y aún, en sistemas de auditoría. Existe una falla en Brasil, así como en Estados Unidos de América (EUA) sobre instrumentos que evalúen cuestiones relacionadas a la calidad de los registros de enfermería. Fue en esa perspectiva que este estudio metodológico ha sido desarrollado para validar el Q-DIO en Brasil y EUA. Q-DIO está compuesto de 29 puntos, dividido en cuatro aspectos (diagnósticos de enfermería como proceso, diagnósticos de enfermería como producto, intervenciones de enfermería, resultados de enfermería), compuesto por escala Likert de tres puntos. Para validación del instrumento han sido elegidos registros de pacientes en pos operatorio de cirugía cardiaca, que tuvieron registrados en prontuario o histórico y las evoluciones y prescripciones de enfermería entre un periodo mínimo de cuatro días. La muestra fue de 180 registros, distribuidos igualmente entre los tres centros del estudio; dos en Brasil (centro 1 y 2) y uno en EUA (centro 3). Entre las propiedades psicométricas fueron evaluadas la fidedignidad (consistencia interna y estabilidad) y la validez del constructo divergente. Los valores de Alfa de Cronbach para las 29 cuestiones fueron superiores a 0,70 para todos los centros. En lo que se refiere a la estabilidad, el coeficiente de correlación intra-clase tuvo variación entre 0,64 y 0,85 para intra-observador y 0,68 a 0,82 para inter-observador, lo que indica niveles satisfactorios y excelentes de concordancia. En la validad de constructo divergente se pudo observar una diferencia estadística significativa entre las medias de la suma de los 29 puntos del instrumento entre los tres centros. El centro 1 (registros electrónicos con lenguaje patrón) presentó media de 36,8 (+_ 4,5) [IC95%: 35,63 – 37,94], centro 2 (registros manuales sin lenguaje patrón) obtuvo media de 11,53 (+_ 6,2) [IC 95%: 9,93-13,14] y el centro 3 (registros electrónicos sin lenguaje patrón) con media de 31,2 (+_5,3) [IC95%: 29,87-32,63]. Tales resultados indican que Q-DIO es fidedigno y válido para evaluar la calidad de los registros de enfermería, sean ellos electrónicos o no, y que utilicen lenguaje patrón o no en Brasil, así como, en EUA dicho instrumento también se ha mostrado fidedigno y válido para datos electrónicos sin uso de la terminología patrón.

Na prática clínica, o enfermeiro precisa sistematizar o cuidado baseado em aspectos que visam garantir a segurança e a qualidade do cuidado aos pacientes. Entre esses aspectos salienta-se que os registros de enfermagem sejam realizados de maneira plena e, principalmente, que sejam compreendidos e valorizados. É nessa perspectiva que a utilização de uma terminologia e sistemas eletrônicos aliados ao processo de enfermagem ganham espaço, favorecendo a qualidade dos registros. A avaliação da qualidade desses registros pode se dar por meio de um instrumento denominado Quality of Diagnoses, Interventions and Outcomes (Q-DIO), publicado em língua inglesa e validado apenas na Suíça. O Q-DIO tem como principal objetivo avaliar a qualidade dos registros de enfermagem. Somado a isso, tem sido utilizado como um indicador para comparar a qualidade dos registros com e sem linguagem padronizada, definir metas, avaliar o impacto da implementação de programas educacionais e ainda, em sistemas de auditoria. Existe uma lacuna no Brasil, assim como nos Estados Unidos da América (EUA), de instrumentos que avaliem questões relativas à qualidade dos registros de enfermagem. Foi nessa perspectiva que esse estudo metodológico foi desenvolvido para validar o Q-DIO no Brasil e nos EUA. O Q-DIO é composto por 29 itens, dividido em quatro domínios (diagnósticos de enfermagem como processo, diagnósticos de enfermagem como produto, intervenções de enfermagem, resultados de enfermagem), composto por escala Likert de três pontos. Para validação do instrumento foram elegíveis registros de pacientes em pós-operatório de cirurgia cardíaca que tiveram registrados em prontuário o histórico, as evoluções e as prescrições de enfermagem entre um período mínimo de quatro dias. A amostra foi de 180 registros, distribuídos igualmente entre os três centros do estudo, dois no Brasil (centros 1 e 2) e um nos EUA (centro 3). Dentre as propriedades psicométricas, foram avaliadas fidedignidade (consistência interna e estabilidade) e a validade de constructo divergente. Os valores do alfa de Cronbach para as 29 questões foram superiores a 0,70 para todos os centros. Com relação à estabilidade, o coeficiente de correlação intraclasse variou entre 0,64 e 0,85 para intraobservador e 0,68 a 0,82 para interobservador, o que indica níveis satisfatórios e excelentes de concordância. Na validade de constructo divergente observou-se diferença estatística significativa entre as médias da soma dos 29 itens do instrumento entre os três centros. O centro 1 (registros eletrônicos com linguagem padronizada) apresentou média de 36,8(±4,5) [IC95%: 35,63-37,94]; o centro 2 (registros manuais sem linguagem padronizada) obteve média de 11,533(±6,2) [IC95%:9,93-13,14]; o centro 3 (registros eletrônicos sem linguagem padronizada) teve média de 31,2(±5,3) [IC95%: 29,87-32,63]. Esses resultados indicam que o Q-DIO é fidedigno e válido para avaliar a qualidade de registros de enfermagem eletrônicos ou não, e que utilizem ou não linguagem padronizada no Brasil; também nos EUA esse instrumento se mostrou fidedigno e válido para dados eletrônicos sem uso de terminologia padrão. / In clinical practice, nurses must systematize their practice based in certain aspects intended to ensure the safety and quality of the patient care. Among such aspects should be noted that the nursing records must be fully completed, understood, and valued. Taking this into consideration, the use of terminology and electronic systems along with the nursing processes favor the quality of nursing records. The assessment of the quality of such records may be obtained through an instrument called Quality of Diagnoses, Interventions and Outcomes (Q-DIO), published in English and validated in Switzerland. The Q-DIO's main objective is to assess the quality of the nursing records, although it has also been used as an indicator to compare the quality of records with and without standardized language, to set goals, to evaluate the impact of implementing educational programs, and to give some help in audit systems. There is a lack of instruments capable of assessing issues related to the quality of nursing records in Brazil and in the United States (U.S.). It was because of it that this methodological study was developed: to validate the Q-DIO instrument in Brazil and in the U.S. The Q-DIO is composed of 29 items, divided into four domains (nursing diagnoses as process, nursing diagnoses as product, nursing interventions, and nursing outcomes), composed of a three-point Likert scale. To validate the instrument, records from patients in the period after a cardiac surgery, and who had in their historical records trends and nursing prescriptions between a minimum of four days, were selected. The sample has a total of 180 records, divided equally between the three study centers, being two located in Brazil (center 1 and 2) and one in the U.S. (center 3). Among the psychometric properties, reliability (internal consistency and stability) and divergent construct validity were those evaluated. The values of Cronbach's Alpha for the 29 questions were superior to 0.70 for all centers. Regarding stability, the intraclass correlation coefficient ranged between 0.64 to 0.85 for intraobserver, and 0.68 to 0.82 for inter-observer, which indicates excellent and satisfactory levels of agreement. In divergent construct validity, statistically significant differences were observed in the average of the sum of the 29 items of the instrument among the three centers. Center 1 (electronic records with standardized language) had an average of 36.8 (± 9.5) [95%CI: 35.63-37.94]; center 2 (manual records without standardized language) had an average of 11.53 (± 6,2) [95%CI: 9.93-13.14]; and center 3 (electronic records without standardized language) presented an average of 31.2 (± 5.3) [95%CI: 29.87-32.63]. These results indicate that Q-DIO is valid and reliable for assessing the quality of nursing records, being them electronic or not, using standardized language or not, at least in Brazil. In the U.S., this instrument has also proved to be reliable and valid for electronic nursing records without use of standardized language. / En la práctica clínica el enfermero precisa sistematizar el cuidado a partir de aspectos que objetivan garantizar seguridad y calidad del cuidado a los pacientes. Entre esos aspectos destacamos que los registros de enfermería sean realizados de manera plena y principalmente que sean comprendidos, valorados. Es en esta perspectiva, que la utilización de una terminología y de sistemas electrónicos coligados al proceso de enfermería obtienen espacio favoreciendo la calidad de los registros. La evaluación de la calidad de dichos registros puede ser a través de un instrumento nombrado Quality of Diagnoses, Interventions and Outcomes (Q-DIO) publicado en idioma inglés y validado solamente en Suiza. Q-DIO posee por objetivo principal evaluar la calidad de los registros en enfermería. A eso se suma su utilización como un indicador para comparar la calidad de registros con y sin lenguaje patrón, establecer fines, evaluar impacto de la implementación de programas educativos y aún, en sistemas de auditoría. Existe una falla en Brasil, así como en Estados Unidos de América (EUA) sobre instrumentos que evalúen cuestiones relacionadas a la calidad de los registros de enfermería. Fue en esa perspectiva que este estudio metodológico ha sido desarrollado para validar el Q-DIO en Brasil y EUA. Q-DIO está compuesto de 29 puntos, dividido en cuatro aspectos (diagnósticos de enfermería como proceso, diagnósticos de enfermería como producto, intervenciones de enfermería, resultados de enfermería), compuesto por escala Likert de tres puntos. Para validación del instrumento han sido elegidos registros de pacientes en pos operatorio de cirugía cardiaca, que tuvieron registrados en prontuario o histórico y las evoluciones y prescripciones de enfermería entre un periodo mínimo de cuatro días. La muestra fue de 180 registros, distribuidos igualmente entre los tres centros del estudio; dos en Brasil (centro 1 y 2) y uno en EUA (centro 3). Entre las propiedades psicométricas fueron evaluadas la fidedignidad (consistencia interna y estabilidad) y la validez del constructo divergente. Los valores de Alfa de Cronbach para las 29 cuestiones fueron superiores a 0,70 para todos los centros. En lo que se refiere a la estabilidad, el coeficiente de correlación intra-clase tuvo variación entre 0,64 y 0,85 para intra-observador y 0,68 a 0,82 para inter-observador, lo que indica niveles satisfactorios y excelentes de concordancia. En la validad de constructo divergente se pudo observar una diferencia estadística significativa entre las medias de la suma de los 29 puntos del instrumento entre los tres centros. El centro 1 (registros electrónicos con lenguaje patrón) presentó media de 36,8 (+_ 4,5) [IC95%: 35,63 – 37,94], centro 2 (registros manuales sin lenguaje patrón) obtuvo media de 11,53 (+_ 6,2) [IC 95%: 9,93-13,14] y el centro 3 (registros electrónicos sin lenguaje patrón) con media de 31,2 (+_5,3) [IC95%: 29,87-32,63]. Tales resultados indican que Q-DIO es fidedigno y válido para evaluar la calidad de los registros de enfermería, sean ellos electrónicos o no, y que utilicen lenguaje patrón o no en Brasil, así como, en EUA dicho instrumento también se ha mostrado fidedigno y válido para datos electrónicos sin uso de la terminología patrón.

論文內容著重在以下三個重點: 試驗免責、延展性授權與延展性專利範圍、書面描述要件。首先是35 U.S.C. § 271(e)(1)之Safe Harbor 緣由、案例、Integra v. Merck 一案之過程與後續影響以及271(e)(1)的試驗免責與研究工具的關係, 最後提出建議應限縮試驗免責範圍, 以強制授權或是明定專利法中的試驗免責範圍緩和基礎研究專利範圍過大現象(第二、三章)。 研究工具專利開發者多所採用之延展性授權與延展性專利範圍無非是想多獲得利益, 而研究工具專利對於生物科技發展是相當重要的, 第四章先以四方角色(大藥廠、大學與非營利機構、小藥廠與政府單位)討論研究工具對於本身的利益考量, 並且因試驗免責範圍不明, 延展性授權契約已是普遍存在, 詳細地討論其存在的意義, 並且分析已探討延展性授權金/契約議題文章, 另外對於延展性專利保護範圍, 明確指出哪一些核准專利是延展性保護範圍, 雖然2001年的三方會議已經明確地限制此類專利的核准, 由於Rochester v. G.D. Searle一案, 法院認為Rochester 專利包含延展性保護範圍, 歸因於未揭露出清楚的書面描述要件, 於是進行第五章書面描述要件的討論。 進而較詳細地探討生物機轉的途徑特性、功能性敘述必要性以及書面描述上的困難, 然後進行相關案件探討, 提出自己對於專利文件之書面描述要件的看法, 希望能在生物類研究工具專利保護範圍與書面描述要件中取平衡, 適切地保護研究工具發明。最後並提出總結與建議。 / Over the last twenty years, the biotechnology industry has grown very rapidly, and increased our understanding of incurable diseases. Research tools are playing important role to form the core of the pharmaceutical research, development, and testing. Because this industry is so research tool intensive, numerous problems have arisen stemming from the competing interests of the many players in this field. From the legislative history, the Hatch-Waxman Act embodies the legislative compromise balancing the competing interests of the pioneer pharmaceutical and allied research-based products industries with those of the generic drug industry. And the section 35 U.S.C. § 271(e)(1) statute provides a “safe harbor” from patent infringement based on activities that are reasonably related to obtaining FDA regulatory approval of drug products, but the plain language is fairly ambiguous. In Eli Lilly v. Medtronic, Supreme Court held the safe harbor extends to medical devices, despite the fact that § 271(e)(1) does not refer specifically to medical devices. Recently, for the case of Merck v. Integra, Federal Circuit announced that the term “solely” limits the safe harbor exemption from extending beyond uses of patented inventions that are reasonably related to those specified in § 271(e)(1). But Supreme Court rejected and held that § 271(e)(1) applies to uses of patented inventions that are reasonably related to the development and submission of any information to the FDA. The Court was silent on the potential applications and opened the questions of the safe harbor's application to patented research tools. These problems may be the reason that research tool providers attempt to request royalties such as reach-through royalties for covering the downstream compounds or products. They also try to file the patent application with the reach-through claim for claiming a future invention. However, the use of reach-through royalties is still controversial and causing a decrease in innovation. Patentees attempt to obtain reach-through claims for covering a future invention without actually describing in the written description. The Federal Circuit's holding in Rochester v. G.D. Searle that the Rochester's patents failed the written description requirement, and Rochester should curtail the use of reach-through claims. So far the USPTO has not been uniform in its application of written description requirement. We therefore propose a new test to determine whether, and under which circumstances, functional claiming may satisfy the written description requirement. One should not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification. The approach would provide sufficient incentive for pioneering inventions, preserve room for the future, and thus expect to promote progress and to advance the purposes of patent law.