O Sistema Único de Saúde no Brasil (SUS) proporciona a incorporação de muitas tecnologias na área médica e, por conseguinte, pode estar exercendo um papel indireto na produção de conhecimento que não está sendo considerado como uma de suas qualidades. Objetivo: analisar se a incorporação de tecnologias pelo Sistema Único de Saúde no Brasil, mais especificamente fármacos, está associada a um aumento da produção de conhecimento científico nacional sobre estas tecnologias. Material e métodos: Trata-se de um estudo descritivo onde foram selecionados alguns fármacos distribuídos pelo Ministério da Saúde. Utilizando o PubMed analisou-se a produção de conhecimento no Brasil e em outros países do mundo sobre estas tecnologias. Comparou-se a posição do Brasil no ranking da produção científica mundial nos 3 anos antes da incorporação dos fármacos pelo SUS com a posição do Brasil no 4º, 5º e 6º anos após a incorporação destas tecnologias. Esta comparação foi feita utilizando teste não paramétrico de Wilcoxon. Resultados: a posição do Brasil no ranking da produção científica das tecnologias farmacológicas melhora para 70 das 90 tecnologias avaliadas. A posição geral média do Brasil passa de 68º para 45º após a incorporação (p < 0,0001). Conclusão: a incorporação de tecnologias farmacológicas pelo SUS está associada a um aumento da produção de conhecimento nacional sobre estas tecnologias / The Brazilian National Health System (SUS) is responsible for the incorporation of many health technologies, and thus, it could be having an indirect function in the scientific production that has not been considered as one of its qualities. Objective: to evaluate if the technologies incorporation by SUS is associated with an increment in national scientific production about those technologies. Material and methods: This is a descriptive study where it was selected some medications (pharmacologic technologies) that are offered by SUS. The PubMed database was used for the search of Brazilian and other countries scientific production about these technologies. The Brazilian international ranking position in the 3 years before SUS incorporation was compared with the position in the 4th, 5th and 6th years after the incorporation. Wilcoxon nonparametric test was used to perform this comparison. Results: the Brazilian international ranking position improves for 70 of the 90 technologies evaluated. The mean Brazilian ranking position went from 68th to 45th after incorporation (p < 0.0001). Conclusion: the incorporation of pharmacologic technologies by SUS is associated with an increment in the national knowledge production about these technologies

L'obiettivo di questo lavoro e' l'estensione dell'approccio basato su opzioni reali alla valutazione delle tecnologie sanitarie. l'approccio al problema e' duplice. da un lato si vuole capire quale contributo questo sviluppo possa fornire alla comprensione dei meccanismi di adozione e diffusione di nuove tecnologie in sanità. l'altro obiettivo e' realizzare una concreta applicazione di questo approccio alla valutazione, che e' ancora assente nella letteratura di economia sanitaria. la tecnologia scelta per l'applicazione è la positron emission tomography (pet). / This work aims to extend the real option approach to the evaluation of health care technologies. The aim is to do this from two different points of view. On one side we are interested in understanding what insights taking option values into account provides in the study of adoption behaviour by providers. On the other side, we aim to provide an application of this approach to the economic evaluation of a specific medical technology, which is still missing in the health economics literature. The technology that has been chosen for the application is positron emission tomography (pet).

The overall aim of this thesis has been to study the implementation process concerning the use of video conferencing in discharge planning, during and after a development project in a region in southeast Sweden. The research approach has been developed within a new interdisciplinary research area, Applied Health Technology. The main focus of the research has been on how the new IT solution has affected everyday work, and in what ways management supported staff during the implementation process. The study design has a qualitative approach. Phenomenological hermeneutics, content analysis and Participatory Action Research (PAR) have been used in the analysis process. Study I aimed to describe  primary healthcare nursing staff’s experiences of discharge planning, along with their concerns about using video conferencing in discharge planning sessions. It was found that there is need for improvement in communication and understanding between nursing staff working in hospitals and in primary healthcare, and need for nursing staff to obtain more information about how IT solutions could support their work. The aim of Study II was to examine the implementation process of using video conferencing in discharge planning, according to a theoretical framework composed from theories about implementation processes. It was found that implementation frameworks can be useful, and that framing the implementation process supports the exposure of factors and highlights relationships and states of dependency between those factors which may affect implementation. Study III set out to describe managers’ reflections about leading the implementation process of using video conferencing in the discharge planning session. The results indicate that managers experienced two leadership perspectives when they reflected on the implementation process. On one hand, they described a desired way of leading implementation, on the other hand they described an actual way of leading implementation. The aim of Study IV was to describe the reflections of professionals about what is needed in order to create what should become a new best practice using videoconferencing in the discharge planning sessions. The results indicate that the professionals experienced lack of knowledge and understanding about each other’s everyday work and that the absence of well-functioning common routines obstructed the process. The results also indicate that there is a lack of common arenas to enable discussions, negotiations and agreements about adopting new routines as the discharge planning process changes over time. This thesis contributes to the much-needed discussions about how to manage the many ongoing IT implementation processes in Swedish healthcare organizations, by highlighting challenges and difficulties that both healthcare professionals and managers have experienced during an implementation process. The results indicate that implementation frameworks can be useful when new IT solutions are introduced in healthcare, and that there is a need for dedicating time, space and support for involved professionals in designing their everyday work.

Despite the global progress made in improving health of people and increasing the life expectancy, Sub-Saharan Africa continues to be plagued by many health problems. Commercialization of health products from Sub-Saharan Africa presents opportunities to solve some of these health problems as well as generate economic returns. This thesis explored science based health product commercialization in sub-Saharan Africa through three studies. The objective was to identify opportunities and challenges facing health product commercialization in Sub-Saharan Africa. A qualitative case study approach was used and data collected using interviews. The first study involved looking at science based health product commercialization at a national level. Rwanda was chosen for this study. Thirty eight key informants selected from various institutions that form the health innovation system in Rwanda were interviewed. The results of the study show that opportunities exist in Rwanda for health product commercialization mainly because of the strong political will to support health innovation. However the main challenge is that there are no linkages between the actors involved in health innovation in Rwanda. The second study looked at health innovation at the level of a research institution. The Kenya Medical Research Institute (KEMRI) was studied where eight key informants were interviewed. The results show that KEMRI faced many challenges in its attempt at health product development, including shifting markets, lack of infrastructure, inadequate financing, and weak human capital with respect to innovation. However, it overcame them through diversification, partnerships and changes in culture. The third study looked at health technologies that are being developed in sub-Saharan Africa but have stagnated in laboratories. Thirty nine key informants were interviewed. A total of 25 technologies were identified, the majority being traditional plant medicines; other technologies identified included diagnostic tests and medical devices. Many of these technologies require further validation. Other key challenges to commercialization of these technologies that were identified included a lack of innovative culture amoung scientists and policy makers and lack of proof of concept funds including venture capital. Overall, this thesis identified opportunities for science based health commercialization in Africa, and also provides recommendations on how to overcome major challenges.

Despite the global progress made in improving health of people and increasing the life expectancy, Sub-Saharan Africa continues to be plagued by many health problems. Commercialization of health products from Sub-Saharan Africa presents opportunities to solve some of these health problems as well as generate economic returns. This thesis explored science based health product commercialization in sub-Saharan Africa through three studies. The objective was to identify opportunities and challenges facing health product commercialization in Sub-Saharan Africa. A qualitative case study approach was used and data collected using interviews. The first study involved looking at science based health product commercialization at a national level. Rwanda was chosen for this study. Thirty eight key informants selected from various institutions that form the health innovation system in Rwanda were interviewed. The results of the study show that opportunities exist in Rwanda for health product commercialization mainly because of the strong political will to support health innovation. However the main challenge is that there are no linkages between the actors involved in health innovation in Rwanda. The second study looked at health innovation at the level of a research institution. The Kenya Medical Research Institute (KEMRI) was studied where eight key informants were interviewed. The results show that KEMRI faced many challenges in its attempt at health product development, including shifting markets, lack of infrastructure, inadequate financing, and weak human capital with respect to innovation. However, it overcame them through diversification, partnerships and changes in culture. The third study looked at health technologies that are being developed in sub-Saharan Africa but have stagnated in laboratories. Thirty nine key informants were interviewed. A total of 25 technologies were identified, the majority being traditional plant medicines; other technologies identified included diagnostic tests and medical devices. Many of these technologies require further validation. Other key challenges to commercialization of these technologies that were identified included a lack of innovative culture amoung scientists and policy makers and lack of proof of concept funds including venture capital. Overall, this thesis identified opportunities for science based health commercialization in Africa, and also provides recommendations on how to overcome major challenges.

Upper limb deficits post stroke affect up to 60% of stroke survivors. The assessment of motor deficits post stroke is important for identifying rehabilitation goals and assessing treatment efficacy. Current clinical tools used to assess motor impairment utilize clinical observation to describe the performance of diagnostic motor tasks. However there are some concerns regarding the ability of these scales to fully describe the quality of performance, and detect small but important changes which reflect motor recovery. Kinematic analysis has been increasingly suggested to augment clinical assessment; however, current kinematic tools are not well suited to the time and financial constraints of a clinical environment. The objective of this thesis was to investigate the feasibility of utilizing low-cost, depth sensing technology (Kinect sensor) to augment the current upper limb stroke assessment. Study one characterizes the accuracy of the Kinect sensor, and defines optimal markers and conditions for data collection. Results revealed sufficient ability to quantify metrics for the hand, and the trunk. Study two explored the feasibility of clinical use for the Kinect sensor, specifically its ability to distinguish kinematic performance between the affected and less-affected limbs within an individual, and differences in the affected limb between individuals. Results from study 2 indicated that the Kinect is able to identify interlimb differences and correlations with upper limb impairment scores for some kinematic metrics. Findings from this thesis suggest a potential use for the Kinect in a clinical environment for the purposes of upper limb stroke assessment; however, there are many factors and limitations which need to be considered prior to its use.

Zugl.: Berlin, Techn. Universiẗat, Diss., 2008.

Systematic reviews - appraisal and synthesis of all primary research - are increasingly being used to inform policy and practice in health care. Therefore, it is important to understand how the key questions in systematic reviews are identified and prioritised and whether they are relevant to policy makers, practitioners and members of the public. Research priority setting (RPS) is usually defined as any interpersonal activity that leads to the selection of topics and/or choices of key questions to investigate . Diverse approaches to setting research priorities are used in different countries, regions and organisations. There is no consensus in the literature on the most effective processes with which to set these priorities. However, these decisions define the quality and implications of the evidence, and syntheses of it, available to patients, public and policy makers to help them make informed decisions. My initial scoping work, was to design and conduct a survey across an influential international systematic review organisation (Cochrane Collaboration ) on how they set priorities for their reviews. We identified 13 structured approaches to setting priorities. As part of the project, we developed an evaluation framework that demonstrated whether the priority setting processes meet the values and principles of the Cochrane Collaboration. Subsequently, we developed an equity lens for research priority setting exercises to inform the design of research priority setting processes to ensure that they consider the priorities of disadvantaged groups along with advantaged groups. We used the equity lens to do a second evaluation on the priority setting processes in the Cochrane Collaboration. Both evaluation frameworks demonstrated that the Cochrane Collaboration requires better designed priority setting approaches and must be more transparent in reporting those processes. The evaluation of research priority setting exercises in the Cochrane Collaboration, along with the wider literature, demonstrates that research priority setting exercises cannot be evaluated in isolation from organisational cultures, values and context. Therefore, the next step of the project focused on a specific stakeholder group (major research funders) with significant influence on research, including support for systematic reviews. We selected 11 national research agencies in the UK, Netherlands, France, Norway, Denmark, Germany, Australia, Canada, and the USA. We devised and used a checklist based on Chalmers and Glasziou’s “avoidable research waste” framework (and evaluated the processes and policies of these agencies using this checklist). As previous evaluations had demonstrated, this second evaluation found a lack of transparency in the process of setting priorities for research and other related organisational and policy issues. Increased funding is needed for methodological research to evaluate research practices and to monitor how funding research projects is done and reported. My evaluation of funding agencies and the Cochrane Collaboration found a similar lack of transparency and accountability in the context of conflicting values among stakeholders that decreases accountability and scrutiny of researchers and their institutions. However, the projects have led to organisational and policy changes in the two key stakeholder groups (the Cochrane Collaboration and selected funding agencies). Officials of national health research funding agencies have approached me to collaborate with them to address the issues raised by my work on reducing research waste. This led to the establishment of Funders Forum - the Ensuring Value in Research (EViR) Funders’ Collaboration and Development Forum - to enable agencies in various countries to exchange their experience in addressing issues and creating work groups to address them. The Forum is chaired by individuals from three major research funders: NIHR (UK), ZonMW (Netherlands) and Patient-Centered Outcomes Research Institute (PCORI; USA). The Forum organises several meetings to establish common principles, standards and work plans to achieve the common objective around reducing research waste and adding value for research for a national research funder.

The value to consider user needs throughout the development of medical devices has been acknowledged in the field of health technology assessment. Yet, user needs are narrowly conceptualised and are mainly examined from an ergonomic perspective. By focusing on the user-device interaction per se with a view to detect use errors and to create design solutions that promote intended use, the dominant approach to user needs research fails to adequately elaborate upon symbolic and practice-related dimensions in the user-technology relationship. Moreover, whilst the examination of user needs from a User standpoint is clearly required, it is also crucial to investigate how the medical device industry understands and addresses this issue, since it is these understandings that will eventually be projected onto the technology. The present research sought to provide a cross-actor account on the issue of user needs by examining the perspectives of two key stakeholders: the users and the medical device manufacturer. Using the example of home blood pressure (BP) monitoring, a qualitative programme of research explored, on the one hand, the process of integrating home blood pressure monitors (HBPMs) into daily life as well as the elements that are conducive to building trust in this technology, and on the other, the practices the medical device manufacturer adopts to capture its users and their needs. The results suggest that people engage with home BP monitoring in an effort to develop an experiential understanding of their health condition reproducing the dominant discourse around the benefits of self-care. Nevertheless, communicating this practice outside the home was not always without tension since concerns around the ascription of undesired identities were expressed. Home measurements were occasionally performed to check the dependability of technology – arguably an unintended device use – indicating the importance of establishing trust in the artefact. Building trust in HBPMs appeared to be a multifaceted phenomenon that was not limited to the perceived trustworthiness of the technology but implicated a network of other trustworthy relationships with humans, institutions and technologies. Medium-to-large medical device manufacturers appear to appreciate the value of a user needs-informed approach to medical device development employing a series of routes, more or less direct and formalised, to reach their user. The challenge for the industry is to synthesise the evidential base deriving from individual user studies to create a higher order knowledge base. The term ‘symbolic’ – also employed in the title of this thesis – signifies people’s representations, reasoning and meanings constructed around the use or production of home medical technology whilst the term ‘practical’ (or practice-related) refers to actions, activities, and routines pertaining to these two aspects.

A Avaliação Tecnológica em Saúde (ATS) é uma sistemática que avalia os impactos clínicos, sociais e econômicos das tecnologias em saúde e tem como finalidade auxiliar os gestores na tomada de decisão quanto ao desenvolvimento, incorporação e descontinuação destas tecnologias. Agências de ATS têm destacado a importância da existência de métodos que visem padronizar e implantar esta sistemática em diferentes contextos. Assim, o objetivo geral desta tese é propor procedimentos para apoiar a avaliação tecnológica de equipamentos médico-hospitalares, por meio de uma pesquisa construtiva (Constructive Research) aplicada à terapia de hemodiálise. Os procedimentos propostos compõem um modelo adaptado do EuroScan, modelo desenvolvido por agências Europeias e indicado como boa prática pelo Ministério da Saúde do Brasil. Também são procedimentos ajustados às necessidades de pesquisadores de centros regionais de avaliação de equipamentos médico-hospitalares. Inicialmente, foi desenvolvida uma coleta de dados sobre os problemas de desenvolvimento e incorporação das tecnologias da saúde por meio de duas fontes: uma revisão sistemática de literatura sobre oportunidades de melhorias do EuroScan no mundo e discussões com pesquisadores no país. A partir destas investigações foi proposto um modelo preliminar de ATS, aplicado para o domínio Operacional e de Inovação na hemodiálise. Finalmente a aplicação foi validada e examinada por especialistas para a geração de um modelo final. Os principais procedimentos resultantes foram: (i) validação da relevância das avaliações para novos desenvolvimentos e incorporações tecnológicas do ponto de vista de diferentes especialistas, integrando diferentes áreas do conhecimento na ATS; (ii) operação de Observatórios Tecnológicos, auxiliando na definição das tecnologias e domínios a serem avaliadas; (iii) definição de técnicas para análise dos domínios de ATS, como o uso de séries temporais e o Technology Roadmap (TRM) para previsões sobre o futuro das inovações e o uso das dimensões da usabilidade e de incidentes críticos de riscos para os aspectos operacionais; e (iv) integração das diretrizes de ATS no Brasil em um único modelo, amparando pesquisadores não relacionados a saúde na compreensão sobre ATS e no desenvolvimento ágil de novos estudos tanto para equipamentos emergentes como em uso. Já a avaliação dos domínios selecionados para a hemodiálise resultou: (i) na identificação de um crescimento médio anual de 7% dos indicadores da terapia; (ii) no diagnóstico de usabilidade de máquinas eficazes, porém com possibilidades de gerarem maior satisfação aos usuários quanto: ao espaço entre elas, a redução dos desperdícios de água e materiais, aos planos de manutenção para evitar temperaturas elevadas, a capacitação visando mais atenção e treinamento para tarefas de apoio e aos aspectos de display (realimentação de dados e visualização); e (iii) na consolidação entre profissionais sobre um futuro promissor, para os próximos 10 anos no Brasil, da assistência homecare com máquinas de hemodiálise portáteis, mais seguras e sustentáveis. / The Health Technology Assessment (HTA) is a systematic evaluation of clinical, social and economic impacts of health technologies aiming to assist managers in the decision making process related to the development, consolidation and discontinuation of these technologies. HTA agencies have been highlighting the importance of methods to standardize and apply this systematic evaluation in different contexts. Thus, the general objective of this thesis is to propose procedures to support the technology assessment of medical-hospital equipment through a constructive research applied to hemodialysis therapy. The proposed procedures compose a EuroScan adapted model, which was developed by European agencies and is recommended as a good practice by the Brazilian Ministry of Health, and also are procedures adjusted to the needs of researchers in regional centers of medical equipment assessment. Initially, a data collection on the problems of developing and incorporating health technologies was carried out using two sources: a systematic review of the literature on opportunities to improve the EuroScan around the world and discussions with Brazilian researchers. Based on these investigations, it was proposed a preliminary HTA model applied to the hemodialysis’ Operational and Innovation domain. The application of the model was reviewed and evaluated by experts to produce a final version. The main resulting procedures were: (i) to validate the importance of assessments for new technological developments and incorporations considering the point of view of different experts from diverse knowledge areas; (ii) to operate Technological Observatories, assisting to define the technologies and domains to be evaluated; (iii) to set techniques for the analysis of HTA domains such as the use of time series and the Technology Roadmap (TRM) to make predictions about the future of innovations and the use of usability dimensions and critical incidents of risks to the operational aspects; and (iv) to integrate HTA Brazilian guidelines in a single model, supporting researchers not related to health in the understanding of HTA and fast development of new studies for both emerging and in use equipment. The assessment of the domains selected for hemodialysis led to: (i) the identification of an annual growth in therapy indicators (7% in average); (ii) the usability diagnosis of efficient machines, however with the potential to generate greater user satisfaction considering: distance between machines, reduction in the waste of water and materials, maintenance plans to avoid high temperatures, training aiming more attention to supporting tasks as well as focus on display aspects (data feedback and visualization); and (iii) the consolidation among professionals of a future, for the next 10 years in Brazil, based on homecare with portable machines, safer and more sustainable.