Knowledge translation and exchange (KTE) is integral to the formation of evidence-informed policy. Prior to the work presented in this dissertation, a significant body of literature existed in the healthcare field regarding research-to-policy KTE; however, little was known about KTE between researchers and policymakers in the Canadian food safety system or the context-specific barriers that influence KTE. A mixed-methods approach was used, grounded in concepts from the healthcare literature, to explore Canadian food safety researchers’ KTE awareness and activities with policymakers, the barriers hindering KTE engagement and success, and timing and informational disparities between research and policy needs that may hinder KTE success. Canadian food safety researcher awareness of and engagement in KTE activities with policymakers was high. However engagement in activities identified as having the greatest potential for KTE success—i.e., collaboration with policymakers at all stages of the research process, provision of syntheses such as systematic reviews, and provision of a searchable database of research findings—was low relative to end-of-research dissemination of findings to policymakers. Several barriers were identified that limited KTE engagement and success from the researcher’s perspective, including an inability to identify relevant policymakers, high policymaker turnover, a lack of resources and support in the research organization, a perceived lack of KTE skills on the part of researchers, and an inability to break free from traditional publish-or-perish research roles. Apparent informational disconnects (i.e., research output not meeting policymakers’ apparent informational needs) were identified that may further hinder KTE and evidence-informed policymaking. While new methodologies, such as systematic review, have been adapted for food safety research, boosting researchers’ potential ability to produce policy-relevant evidence, a cultural shift must occur in research and policymaking organizations, if sustained KTE is to be successful. As well, significant future investment must be made on the part of research organizations and policymakers, if KTE barriers are to be mitigated. Future research should evaluate KTE tools (e.g., sustained linkages between researchers and policymakers, provision of syntheses, provision of access to a database of research findings) to identify specific methods that may facilitate research use in food safety policymaking. / Blake Graham Fellowship, Canadian Institutes of Health Research, Public Health Agency of Canada

INTRODUÇÃO: A Avaliação da Tecnologia em Saúde (ATS) tem por objetivo informar aos formuladores de políticas sobre as implicações do desenvolvimento, da difusão e do uso de tecnologias nos sistemas de saúde. A ATS, enquanto produção de conhecimento e política de saúde, disseminou-se nos países desenvolvidos e, mais tardiamente, nos países em desenvolvimento. No contexto brasileiro, foi publicada em 2009 a Política Nacional de Gestão de Tecnologias em Saúde (PNGTS) e, em 2011, foi criada a Comissão de Nacional Incorporação de Tecnologias no SUS (CONITEC). Os estudos realizados sobre a PNGTS têm focado na descrição dos relatórios de recomendação da CONITEC e na análise de aspectos metodológicos, porém, não abordaram a implementação dessa política de saúde. OBJETIVO: Compreender o processo de implementação da Política Nacional de Gestão de Tecnologias em Saúde (PNGTS), utilizando a CONITEC como estudo de caso. MÉTODOS: Trata-se de um estudo de caso único para o aprofundamento da compreensão do processo de implementação da PNGTS. A primeira etapa da pesquisa constituiu-se da análise de documentos formais (arcabouço legal e relatórios de recomendação da CONITEC do período de 2012 a 2016) para elaboração de estatísticas descritivas. Já a segunda etapa compôs-se da realização e da análise qualitativa de entrevistas com atores-chave. Todas as entrevistas foram gravadas, transcritas, inseridas no programa NVivo 12 e analisadas utilizando a abordagem temática. Os quadros teóricos utilizados para a análise qualitativa foram o de formação de agenda de Kingdon e a análise de implementação. Por fim, a terceira etapa objetivou a interpretação das informações quantitativas e qualitativas. RESULTADOS: O arcabouço legal estabeleceu um fluxo estruturado e definiu as evidências científicas exigidas para o processo de incorporação, alteração e exclusão de tecnologias no SUS. Foram analisados 199 relatórios de recomendação da CONITEC. O número anual de relatórios aumentou ao longo do período de estudo, com o pico em 2013 (n=54). Nos anos seguintes observou-se uma leve queda em 2014 (n=41), 2015 (n=44) e 2016 (n=31). O número anual de novas tecnologias incorporadas em 2013 (n=24) foi semelhante ao observado para 2014 (n=24) e 2015 (n=22), diminuindo em 2016 (n=13). O tipo de tecnologia mais frequentemente avaliada foi \"medicamentos\" (68,3%), seguido por \"procedimentos\" (20,1%). Dentre os 101 relatórios em que a tecnologia foi recomendada para incorporação: 83 (82,2%) referiram-se a demandas internas; 13 (12,9%), a demandas externas; 5 (4,9%), a demandas mistas. Desses, 88 (87,1%) não incluíram uma avaliação econômica em saúde completa, nem o cálculo da razão de custo-efetividade incremental. Em relação às 83 demandas internas, apenas 8 (9,6%) apresentaram um relatório completo de ATS; em contrapartida, dentre as 13 demandas externas, 10 (76,9%) apresentaram um relatório completo de ATS. Houve dificuldades relacionadas ao cumprimento das recomendações contidas nas normas da CONITEC, de modo que foram observadas diferenças relevantes entre as demandas internas e as externas quanto ao uso de evidências científicas (avaliação econômica em saúde) e às decisões favoráveis à incorporação da tecnologia no SUS. Na segunda etapa, a análise qualitativa identificou uma série de desafios para a implementação da CONITEC, notadamente: falta de estabilidade político-institucional, dificuldades para o desenvolvimento de estudos de avaliação econômica em saúde (pela indisponibilidade de dados clínicos e econômicos), além de limitações técnicas dos recursos humanos para lidar com os dados econômicos. A diferença entre as demandas internas e externas pode ser explicada pela legitimidade que as demandas internas possuem dentro do governo e pela necessidade de regulação das demandas externas. CONCLUSÃO: O uso de avaliação econômica em saúde na gestão de tecnologias no SUS ainda é incipiente, pois existem dificuldades estruturais e político-institucionais para o desenvolvimento e uso das evidências científicas. Outros critérios, para além dos que constam no arcabouço legal, são utilizados nos processos de incorporação da CONITEC / INTRODUCTION: Health Technology Assessment (HTA) aims to inform policy makers about the implications of the development, diffusion and use of technologies in health systems. HTA, as knowledge production and as health policy, has spread around the developed countries and, later, around developing countries. In the Brazilian context, the National Policy on Health Technology Management (PNGTS, in the Portuguese acronym) was published in 2009 and, in 2011, the National Committee for Health Technology Incorporation into the Brazilian public health system (CONITEC, in the Portuguese acronym) was created. Studies on the PNGTS have been observed to focus on the description of CONITEC\'s recommendation reports and on the analysis of methodological aspects, but have failed to address the implementation of this health policy. OBJECTIVE: To understand the process of implementation of the National Policy on Health Technology Management (PNGTS, in the Portuguese acronym), using CONITEC as a case study. METHODS: This is a single-case study to understand the PNGTS implementation process. The first phase of the research consisted in a quantitative analysis of formal documents (legal framework and CONITEC\'s recommendation reports) to produce descriptive statistics. In the second phase, interviews with stakeholders were carried out and qualitatively analyzed. All interviews were recorded, transcribed, uploaded to NVivo 12 and analyzed using the thematic analysis approach. The theoretical frameworks used for the qualitative analysis were Kingdon\'s agenda-setting and implementation analysis. Finally, the third phase aimed to interpret the quantitative and the qualitative information. RESULTS: The legal framework established a structured process and defined the scientific evidence required for the incorporation, alteration or exclusion of health technologies into or from the SUS (the Brazilian health system). A total of 199 CONITEC\'s recommendation reports were analyzed. The annual number of reports increased over the study period, peaking in 2013 (n = 54). In the following years, a slight decrease was observed: 2014 (n = 41), 2015 (n = 44) and 2016 (n = 31). The annual number of new technologies incorporated in 2013 (n = 24) was similar to that observed in 2014 (n = 24) and 2015 (n = 22), decreasing in 2016 (n = 13). The most frequently evaluated type of technology was \"medicines\" (68.3%), followed by \"procedures\" (20.1%). Of the 101 reports in which the technology was recommended for incorporation, 83 (82.2%) referred to internal demands, 13 (12.9%) to external demands, and 5 (4.9%) to mixed demands. Of these, 88 (87.1%) did not include either a full health economic evaluation or the calculation of the incremental cost-effectiveness ratio (ICER). Regarding the 83 internal demands, only 8 (9.6%) presented a full HTA report; on the other hand, among the 13 external demands, 10 (76.9%) presented a complete HTA report. There were difficulties related to compliance with the recommendations contained in CONITEC\'s legal framework, so that relevant differences were observed between internal and external demands regarding the use of scientific evidence (health economic evaluation) and positive recommendations for incorporation into the SUS. In the second stage, the qualitative analysis identified a series of challenges for CONITEC\'s implementation, such as: lack of political-institutional stability, difficulties in the development of health economic evaluation studies, lack of clinical and economic data, and technical limitations for human resources to deal with economic data. The difference between internal and external demands can be explained by the legitimacy that internal demands have within the government and, on the other hand, by the need to regulate external demands. CONCLUSION: The use of health economic evaluation in the management of technologies in the SUS is still incipient, because there are structural and political-institutional difficulties for the development and use of scientific evidence. Other criteria than those contained in the legal framework are used in CONITEC\'s incorporation process

Evidence-informed health policy making contributes to improved health outcomes by strengthening health systems. In addition, health policy decisions should take into consideration the needs and priorities of users of healthcare services. However, little research has been done to find best ways to facilitate evidence-informed and participatory health policymaking, particularly in low- and middle-income countries. This thesis is written based on three studies done in Ethiopia to fill this knowledge gap. In the first study, we examined whether, how and under what conditions evidence was used and service-users participated during the agenda-setting and policy formulation phases of selected policies in the ‘prevention of mother-to-child transmission of HIV’ program in Ethiopia using a multiple-case study design. In the second study, we identified strategies to facilitate evidence-informed health policy making using an online survey. In the third study, we identified strategies to facilitate participatory health policy making using a combined paper-based and Internet-based Delphi approach. The thesis does not have direct theoretical contribution. However, it will draw on two theoretical frameworks, namely Kingdon’s framework and the 3I+E framework. and use them in a setting from where they were originally developed. This thesis has two substantive and three methodological contributions. Substantively, the first study provides empirical evidence about the current practice of evidence-informed and participatory health policy making in a low-income, ‘revolutionary’ democratic country (Ethiopia). In addition, the studies have identified strategies to concretize the constitutional and policy provisions for evidence-informed and participatory health policy making in Ethiopia. The thesis has the following three methodological contributions. First, the studies explored the use of Kingdon’s multiple-streams framework and the 3I+E framework in predicting factors influencing agenda-setting and policy formulation phases, respectively, and in explaining the use of research evidence in informing these two phases in a ‘revolutionary’ democratic country where they have not previously been used. Second, the thesis has shown that paper-based and Internet-based Delphi could be combined in contexts with limited resources. Third, the thesis has demonstrated the possibility of training service-users as ‘peer’ researchers to collect and analyze data to inform their participation and maximize their contribution in surveys, forming a pyramid of participation. / Thesis / Doctor of Philosophy (PhD) / Evidence-informed health policy making can contribute to improved health outcomes by strengthening health systems. In addition, health policy decisions ultimately affect users of healthcare services. Thus, such decisions should take into consideration their needs and priorities. However, little research has been done to find best ways to facilitate evidence-informed and participatory health policymaking, particularly in low- and middle-income countries. This thesis is written based on three studies done in Ethiopia. In the first study, we examined whether, how and under what conditions evidence was used and service-users participated in the ‘prevention of mother-to-child transmission of HIV’ program in Ethiopia. In the second and third studies, we identified strategies to facilitate evidence-informed and participatory health policy making. In addition, we explored the possibility of combining Internet- and paper-based methods for consensus-building among policymakers, program managers, researchers, healthcare providers and service-users in settings with limited resources.