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.

Technology is rapidly advancing and more sophisticated wearables capable of monitoring health concerns and potential diseases are entering the market. Meanwhile, regulations are just catching up and the new EU-wide General Data Protection Regulation (GDPR) will be implemented in May of 2018. This thesis reviews the concerns voiced by users when using wearables collecting their sensitive health data and compare them with the upcoming regulatory changes, to see if they address the many worries of users. The main goal of the GDPR is to bring ownership of the data back to the individual as well as harmonizing the market in the EU, but the question is if its focus is on the right things that users actually value and will their concerns be eased by the new regulations? A high-level review of the current and upcoming regulations on data collection was made as well as reviewing already discovered user concerns. The study was made using qualitative methodology and face-to-face interviews with users affected by medical conditions, in order to identify their perception of trust in wearable technology monitoring their health status. The results were analyzed using a thematic analysis where three main areas of concern were discovered. These where then compared to the literature review. The three areas of concern that were discovered are: a lack of control where users have a clear need of ownership of their personal data, the concern of companies abusing individual’s data for commercial purposes and a doubt in the level of trust users can put in the information they receive. The GDPR does address several of these concerns by bringing ownership of data back to the users. By strengthening the need for explicit consent from the companies, more transparent policies and security implementations of data integrity, the GDPR features several steps that could ensure the privacy of users such as distribution of data and “the right to be forgotten”. Upcoming research can go deeper into the GDPR and the future will tell if it is successful in its aim to empower the user as it might seem excellent on paper but face several challenges in reaching its goal.

Economic evaluations and network meta-analyses (NMAs) are complex methodologies. Increasing their transparency and accessibility could enhance confidence in the legitimacy of policy decisions informed by these analyses. Four systematic reviews were conducted to understand policymakers’ informational needs and to determine what guidance researchers have on how to present economic evaluations and NMAs. Qualitative interviews were conducted with Canadian policymakers, i.e., knowledge users, to understand barriers and facilitators to using and communicating economic evaluations and NMAs and with individuals in international health technology assessment organizations, i.e. knowledge producers, to explore current approaches to communicating economic evaluations and NMAs. A toolkit for NMAs and economic evaluations was proposed based on an integrated review of these findings and guided by the Knowledge-to-Action framework. Examples of tools were developed and applied to an economic evaluation and NMA of osteoporosis therapies. Systematic reviews and qualitative interviews found that communication approaches that provide robust content, identify contextual factors relevant to policy decisions and enhance clarity were valued. Twelve tools were proposed that enhance communication, education and access to resources for policymakers. Two of these tools were developed: Economic Guidance for Researchers and NMA Guidance for Researchers.

As the Canadian population continues to age efforts have been focussed on finding innovative strategies to promote active aging throughout the aging process and well into long-term care (LTC). The increased use of innovative technologies has been identified as a leading strategy to promote participation in health activities among older adults in LTC. However, technology use by older adults remains a challenge and participatory design (PD) frameworks must be used to design user-centered technologies with favourable acceptance and uptake. Hence, this thesis aimed to identify design requirements for an augmented reality health activity gaming platform for use in LTC. A participatory design framework was used with the objectives of (1) exploring the current attitudes, usage, benefits and challenges regarding the use of technology, (2) gathering preliminary data on the attitudes of older adults and staff in LTC regarding the inclusion of an augmented reality health activity platform and (3) reflecting on the process of employing a PD approach with older adults and other stakeholders in the context of LTC. Focus group data was used to perform qualitative inductive thematic analysis on older adult and staff discussions. The findings of the research included a current understanding of technological needs and uses within LTC, facilitators and barriers to technology uptake as well as the integration process of technology in LTC. In addition, findings included pragmatic design requirements for the augmented reality health activity platform at the selected LTC facility. This thesis research addresses the need to engage in PD activities to create a platform anchored in person-driven design rather than technology-driven design. This research ultimately builds the foundation for which future technology design teams should involve relevant stakeholders in the ideation, prototyping and evaluation of novel technologies for LTC.

Interest in the use of medical cannabis for the treatment of drug-resistant epilepsy in children has grown over the last decade; however, little is known about its potential benefits and harms, cost-effectiveness, or the perspectives of key stakeholders. In this thesis, a health technology assessment approach was adopted to assess the intended and unintended consequences of medical cannabis use in the treatment of pediatric drug-resistant epilepsy. This thesis comprises three main sections: (1) a living systematic review of the benefits and harms of medical cannabis for the treatment of pediatric epilepsy, including drug-resistant forms; (2) an economic evaluation of the cost-effectiveness of medical cannabis for the treatment of pediatric drug-resistant epilepsy, and (3) qualitative exploration of the perspectives of neurologists and parents of children with drug-resistant epilepsy about the use of medical cannabis in this population. While neurologists generally perceived medical cannabis as a viable treatment option for drug-resistant epilepsy in children, particularly after other treatments have failed, they identified several gaps in the evidence base, including a lack of long-term studies and a lack of evidence related to cannabinoids other than cannabidiol. This is in keeping with the findings of the living systematic review, which support a beneficial role for medical cannabis in reducing seizures associated with drug-resistant epilepsy, although the certainty of the evidence was moderate at best. Parents described experiencing many barriers to accessing medical cannabis for their children, primarily related to finding a health care provider to authorize its use, the high cost of cannabis-based treatments, and a lack of reimbursement through public or private insurance programs. However, cannabinoid oil may be a more cost-effective treatment for some types of pediatric drug-resistant epilepsy compared with antiepileptic drugs currently reimbursed by some provincial insurance programs. These findings suggest that medical cannabis is a potentially effective and cost-effective treatment for drug-resistant epilepsy that may addresses an unmet need. However, additional studies are needed to address uncertainty related to the long-term benefits and harms of cannabis-based products, particularly with respect to products available in Canada.

Antibiotic resistance is a global health concern. Its increasing development is seemingly due to the irresponsible use of antibiotics and their availability. To ensure the correct treatment of patients and avoid unnecessary strain on the individual and society as a whole, it is vital to ensure access to both new and old antibiotics where there is a distinct need. Temocillin is an antibiotic used in the treatment of febrile UTIs. It is currently unavailable in Sweden, although being well-established and proven effective in other European countries. Hence, this report aims to investigate the introduction of temocillin to the Swedish or Scandinavian market in regards to the economic, technical, medical, and regulatory possibilities and barriers. The research is based on literature, internet, and database reviews and empirical data collection through interviews with people of expertise within the fields of antibiotic resistance and concerned aspects. This study emphasizes the great potential of introducing temocillin to Sweden. The evident conclusion drawn is that a production of the antibiotic is not possible in Sweden in the near future. Despite this, an identified supply chain in Europe can enable a role for Sweden as a distribution country. Through a performed break-even analysis, the calculated break-even point and profit margins indicated a low risk of financial loss for a MAH acting as the supplier of temocillin, such as the company Eumedica S.A.. Only 1 % of the Swedish market would have to be covered to break even, and regardless of the estimated volumes of usage upon introduction being either 50 % or 25 % of the total medical need, a profit is likely. In addition, temocillin holds a great medical and social value. However, the obvious obstacle observed is its out-dated documentation. The dossier is of the wrong format, which complicates the regulatory procedure. Thus, this needs to be taken into consideration for an introduction to be possible.

Venösa infarter används för att ge intravenösa läkemedel samt blodprovstagning. De venösa infarter som används inom sjukvården är perifera venkatetrar, midlines, PICC-lines och andra centralvenösa infarter. Midlinekatetern är en perifer infart med längre kateter och längre livslängd än en sedvanlig perifer venkateter, men räknas ej som en centralvenös infart. Indikation för midlines är patienter som är svårstuckna samt har behov av en perifer infart med en livslängd mellan fyra och fjorton dagar.  Syftet med studien var att undersöka patientsäkerheten av midlinekatetrar hos slutenvårdspatienter.  Studiens metod var en litteraturstudie med systematiskt tillvägagångssätt. I resultatet analyserades kvantitativa- och mixed method-artiklar. En induktiv analysmetod användes.  I resultatet framkom det att lokala och systemiska infektioner var relativt låga vid användning av midlinekatetrar. Dock var mekaniska komplikation av högre frekvens hos patienter med midlinekatetrar jämfört med centralvenösa infarter, men lägre än vid användning av perifera venkatetrar. Midlinekatetrar minskar även insättande av centralvenösa infarter vilka har högre risk för svåra komplikationer.  Slutsatsen är att midlinekatetrar, om de används vid rätt indikation, kan minska användning och därmed komplikationer från centralvenösa infarter samt minska lidande hos patienter på grund av upprepade nålstick. Mer svensk forskning behövs då inga svenska artiklar identifierades. Även ett behov av ytterligare forskning med ett patientcentrerat perspektiv fastställdes. / Venous accesses are used to provide intravenous drugs as well as to draw blood samples. The types of venous accesses that are used in hospitals are peripheral venous catheters, midline catheters, PICC-lines and other central venous access devices. A midline catheter is a peripheral access with a longer catheter and longer lifespan than a conventional peripheral venous catheter, but does not count as a central venous access. Indications for midlines are patients with difficult venous accesses and patients with the need of an access with a lifespan between four to 14 days.  The aim of this review was to investigate the patient safety of midline catheters in hospitalised patients.  The method of the study was a review with a systematic approach. Quantitative and mixed method articles were analysed. An inductive analysis method was used.  The results showed that local and systemic infections were relatively low in the use of midline catheters. However, the prevalence of mechanical complications among patients were higher in midline catheters than in central venous devices, but lower than in peripheral venous catheters. Midline catheters can also reduce the use of central venous accesses, which have a higher risk of severe complications.  The conclusion is that midline catheters, if used with the right indication, could decrease the  use and complications from central venous catheters and decrease patient suffering. More Swedish research is needed as no Swedish articles were found. Furthermore a need for additional research with a patient-centered perspective was identified.

Introduction Identifying key differences between the manufacturer's submitted analysis and the Canada's Common Drug Review (CDR) economic reanalysis is a crucial step toward creating more appropriate models by manufacturers. We compared manufacturers’ submitted analysis to CDR reanalysis in order to identify any variations in incremental costs utility ratio (ICUR) and 3-year Budget impact analysis (BIA). We assessed the willingness to pay (WTP) threshold and CDR critiques on manufacturers’ clinical and economic reports. Method A pair of reviewers extracted data regarding therapeutic category, percent price reduction requested by CDR, WTP, and the critiques on the manufacturers' clinical and economic reports in publicly available CDR reports from 2018 to 2022. We used Wilcoxon rank test to assess the difference between mean incremental QALY, ICUR, and BIA in manufacturers and CDR reanalysis reports and chi-square tests and logistic regression to assess the relationship between the variables and the final CDR recommendation. Results Of 178 reports assessed, 31 received "do not reimburse" recommendation and 147 received "reimburse with criteria or conditions". The median ICUR in manufacturer's analysis was $138,658/QALY and significantly lower than ICUR reanalyses by CDR of $380,251/QALY. The ICUR in manufacturers' submitted reports was 2.5-fold lower than in the CDR reanalysis ($138,658/QALY versus $380,251/QALY). The CDR reanalysis median for 3-year BIA was $4,575,102 which was 27% higher than the manufacturers submitted 3-year BIA (p value<0.001). The most frequent CDR critiques were clinical effectiveness and the uncertainty of evidence in cost-effectiveness analysis and miscalculations in the population of patients and the percentage of market share in BIA. From 2018 to 2020, $100,000 was the most frequent WTP threshold followed by a $50,000 threshold, but during 2021 and 2022, the CDR only used $50,000 as a WTP threshold. Conclusion Manufacturers may tend to underestimate the costs or overestimate the effect of their medications. / Thesis / Master of Science (MS)

Background: Maternal and child health initiatives are embracing the use of electronic or mobile technology, a branch of digital health popularly referred to as eHealth or mHealth. While digital health can offer extensive benefits, it has raised various challenges. For instance, digital health programs are not often designed with a focus on equity in distribution nor are they designed from a gender equity standpoint. Although digital health interventions for maternal healthcare focuses predominantly on women as beneficiaries, few studies explore gendered power relations and how they impact the success of maternal and child health projects in African contexts such as Nigeria. This gap in literature risks excluding women from engaging in the digital space and can worsen the negative and unintended consequences of participating in digital health. This thesis examines the impact and implications of digital health interventions for maternal health in sub-Saharan Africa. -- Method: Two secondary and three primary studies described the various implications of digital health in sub-Saharan Africa more broadly and in rural Edo State, Nigeria, specifically. The secondary studies involved a review and a systematic review of the literature, the primary studies involved focus group discussions and in-depth interviews with pregnant or postpartum women who were beneficiaries of a digital health program and their community members. -- Results: The first paper illustrated exclusionary practices of digital health programs in sub-Saharan Africa, the second paper showed how digital health programs can challenge and redress harmful and unequal gender norms, roles, and power relations that privilege men over women. Observations from the third paper indicate that while mHealth programs are helpful to women in many ways, they are not enough on their own to undo entrenched systems of power through which men control women's reproductive lives. The fourth paper affirms that a community-centered approach to implementing digital health programs enhances women's acceptance and sustained use of digital health. The fifth paper shows how women navigate patriarchal environments through negotiation, collaboration and maneuvering to yield the best possible maternal health outcomes. -- Conclusion: At the core of all the studies was the need to understand and redress overarching factors contributing to ill health and exacerbating health inequities in maternal health through gender transformative approaches. Potentially unintended consequences, side effects, and negative effects of digital health impedes its many benefits, therefore, to achieve meaningful impact, gender and digital inclusion must remain a priority in the development, implementation, and evaluation of digital health. This thesis illuminated the needs of those with the greatest barriers to health technologies for maternal health thereby contributing to the discussion on digital health social justice with overarching themes on how to achieve equitable opportunities for all women and girls to access, use and benefit from digital health for maternal health.

Objectives: The use of interactive public engagement methods to elicit public values is becoming routine practice in health system planning, policy and evaluation; however, little systematic attention has been given to the analysis of how these values are articulated. This process will be examined with the use of deliberative discourse methods in the context of health technologies. Approach: The deliberations of a 14-person Citizens’ Reference Panel on Health Technologies were audiotaped and transcribed. The panel provided input to the Ontario Health Technology Advisory Committee in developing its recommendations. Discussion transcripts were analyzed using Gee’s (2005) ‘building tasks’ framework with a focus on identities, relationships, and politics. In depth language-context analysis was then used to study ‘situated meanings’ of social and ethical citizen values. Both levels of discourse analysis were then used to elicit the meso-level dynamics within the citizen panel deliberations. Results: Panel members used the provided materials, personal experience and other sources of information to express their values toward the technologies under review. In the group, members used their occupational, personal and cultural identities and adopted in-group citizen panel roles that involved summarizing small group discussions, challenging other members, providing information, providing expertise, interpreting information and facilitating. These individual roles were similar across meetings and members began to form relationships with their fellow citizens and make connections between the values involved in similar technologies. Conclusion: Discourse analysis methods can be used to draw in-depth insights from public engagement deliberations which contribute important new knowledge to the field of public deliberation and health policy. Further use and refinement of deliberative discourse methods will allow public values to be better understood and more adequately portrayed in the health technology assessment process. / Master of Science (MSc)