Sistemas de avaliação de tecnologias de saúde: dispositivos médicos

As tecnologias de saúde, nomeadamente medicamentos, dispositivos médicos (DM), procedimentos médicos ou cirúrgicos, entre outros, têm ocupado uma posição de destaque no setor da saúde, e na vida dos seus utilizadores. A inovação e utilização de tecnologias de saúde, e consequente aumento das despesas fizeram emergir a necessidade de avaliação das tecnologias de saúde. Surge assim, a avaliação de tecnologias de saúde (ATS), que tem por objetivo abordar os impactos clínicos, económicos, organizacionais, sociais, legais e éticos de uma tecnologia de saúde, considerando o seu contexto médico específico, bem como as alternativas disponíveis. A ATS pretende que os processos sejam feitos de forma rigorosa, transparente, valorizando e garantindo a sustentabilidade do acesso aos cuidados em saúde. Seguindo a tendência europeia de implementação de políticas e modelos de ATS, Portugal criou o seu próprio sistema de avaliação de tecnologias. O Decreto-Lei nº 97/2015, de 1 de junho veio oficializar a criação do Sistema Nacional de Avaliação de Tecnologias de Saúde (SiNATS). O SiNATS vai permitir uma avaliação não só de medicamentos, mas também de DM e outras tecnologias tendo em consideração a avaliação técnica, terapêutica e económica das tecnologias de saúde com base em fatores sociais, políticos, éticos e a participação de entidades, como, a indústria, as instituições de ensino, as instituições de saúde, os investigadores, os profissionais de saúde, os doentes e as associações dos doentes. O SiNATS vai emitir recomendações e decisões sobre o uso das tecnologias de saúde e possibilitar o ganho em saúde e contribuir para a sustentabilidade do Serviço Nacional de Saúde (SNS). O SiNATS vem permitir a avaliação de DM. O sector dos DM é um sector caracterizado pela inovação, crescimento e também competitividade. A complexidade e especificidade deste sector devem por isso ser tidas em consideração aquando da sua análise. A implementação do SiNATS permitirá avaliar e reavaliar preços, comparticipações, recomendações, contratos ao longo do ciclo de vida de cada DM. No presente momento, ainda é difícil expor os processos através dos quais esta avaliação vai ser processada, uma vez que se aguarda a publicação de despachos e portarias referidos no Decreto-Lei nº 97/2015, de 1 de junho. Tendo em consideração a partilha de informação sobre políticas, métodos, procedimentos de ATS aplicada aos DM na Europa, foram analisados os casos de França e do Reino Unido com o objetivo de alargar o conhecimento acerca do que já é feito a nível Europeu e explorar se os mesmos poderiam ser adaptados à realidade portuguesa. Em França, a ATS está diretamente relacionada com a comparticipação de DM, já no Reino Unido, o National Institute and Centre of Excellence (NICE) tem a responsabilidade de avaliar os DM segundo procedimentos de ATS, mas não está diretamente relacionado com comparticipação. O NICE publica normas de orientação que auxiliam a decisão de aquisição ou não de um DM. Tendo em consideração a informação reunida e descrita, este trabalho também propõe um modelo hipotético sobre o sistema português de avaliação de DM. Este modelo aborda, ainda que não de forma exaustiva, os possíveis processos e procedimentos para a avaliação de DM. Este sistema caracteriza-se pela importância dada ao envolvimento dos stakeholders e partilha de informação com os mesmos, mas também na agilização dos processos, isto é, uma redução e simplificação dos processos de avaliação de DM. A reavaliação de DM durante a sua comercialização também ganha destaque, apontando que cada grupo genérico de dispositivos ou DM inovador dever ser reavaliado a cada cinco anos, ou sempre que informação emergente o justifique. Este modelo representa uma abordagem experimental sobre o futuro do SiNATS aplicado aos DM. A partilha de informação, os fóruns de discussão e o envolvimento da sociedade serão uma mais-valia para que a implementação do SiNATS aos DM seja feita de forma gradual e com a máxima transparência possível.

Adaptive regulation or governmentality: patient safety and the changing regulation of medicine

Studies from across the world have shown that clinical mistakes are a major threat to the safety of patient care (World Health Organisation 2004). For the National Health Service (NHS) of England and Wales it is estimated that one in ten hospital patients experience some form of error, and each year these cost the service over £2billion in remedial care (Department of Health 2000). Unsurprisingly, ‘patient safety’ is now a major international health policy priority, questioning the efficacy of existing regulatory practices and proposing a new ethos of learning. Within England and Wales, the National Patient Safety Agency (NPSA) has been created to lead policy development and champion service-wide learning, whilst throughout the NHS the National Reporting and Learning System (NRLS) has been introduced to enable this learning (NPSA 2003). This paper investigates the extent to which, in seeking to better manage the threats to patient safety, this policy agenda represents a transition in medical regulation.

Reconfiguring or reproducing intra-professional boundaries? Specialist expertise, generalist knowledge and the ‘modernization’ of the medical workforce

Efforts to ‘modernize’ the clinical workforce of the English National Health Service have sought to reconfigure the responsibilities of professional groups in pursuit of more effective, joined-up service provision. Such efforts have met resistance from professions eager to protect their jurisdictions, deploying legitimacy claims familiar from the insights of the sociology of professions. Yet to date few studies of professional boundaries have grounded these insights in the specific context of policy challenges to the inter- and intra-professional division of labour, in relation the medical profession and other health-related occupations. In this paper we address this gap by considering the experience of newly instituted general practitioners (family physicians) with a special interest (GPSIs) in genetics, introduced to improve genetics knowledge and practice in primary care. Using qualitative data from four comparative case studies, we discuss how an established intra-professional division of labour within medicine—between clinical geneticists and GPs—was opened, negotiated and reclosed in these sites. We discuss the contrasting attitudes towards the nature of genetics knowledge and its application of GPSIs and geneticists, and how these were used to advance conflicting visions of what the nascent GPSI role should involve. In particular, we show how the claims to knowledge of geneticists and GPSIs interacted with wider policy pressures to produce a rather more conservative redistribution of power and responsibility across the intra-professional boundary than the rhetoric of modernization might suggest.

The dynamics of professions and development of new roles in public services organizations: the case of modern matrons in the English NHS

This study contributes to research examining how professional autonomy and hierarchy impacts upon the implementation of policy designed to improve the quality of public services delivery through the introduction of new managerial roles. It is based on an empirical examination of a new role for nurses – modern matrons – who are expected by policy-makers to drive organizational change aimed at tackling health care acquired infections (HCAI) in the National Health Service (NHS) within England. First, we show that the changing role of nurses associated with their ongoing professionalization limits the influence of modern matrons over their own ranks in tackling HCAI. Second, the influence of modern matrons over doctors is limited. Third, government policy itself appears inconsistent in its support for the role of modern matrons. The attempts of modern matrons to tackle HCAI appear more effective where infection control activity is situated in professional practice and where modern matrons integrate aspirations for improved infection control within mainstream audit mechanisms in a health care organization.

Consideraciones críticas sobre el prestigio y la diginidad personal y profesional de los bibliotecarios

Esta ponencia expone unas reflexiones sobre el prestigio y la dignidad profesional de la bibliotecología en el estado de Nuevo León, México. Analiza y critica: a) la falta de categorías profesionales en Nuevo León en contraste con la UNAM; menciona también como varios bibliotecologos del IMSS Nuevo Leon lucharon porque se tipificara en el contrato colectivo la categoria de Bibliotecologo Profesional y cuya lucha ganaron; b) las actitudes represoras y dictatoriales por parte de las mafias administrativas y academicas de las principales universidades que no permiten la superacion de las amplias mayorias de bibliotecologos y que censuran la libertad de expresion y pensamiento en Nuevo Leon; c) aboga porque los bibliotecologos deban tener mistica de servicio como si se tratara de un "apostolado" en contra del "monetarismo" o "mercenarismo" que en la actualidad mueve a los bibliotecologos nuevoleoneses. En el aspecto gremial critica la charlataneria y oportunimo demagogico de gremios como los de AMBAC de Nuevo Leon, que se aprovechan de las ineptitudes de los gobiernos en todos los niveles en materia bibliotecaria y utilizan las desgracias naturales apelando a sentimentalismos de la gente solo para salir en la foto y en la prensa, pero sin analizar, criticar ni denunciar las fallas estructurales de fondo del Estado mexicano y de los tres niveles de gobierno. ABSTRACT This paper analyses some reflections about the professional prestige and dignity of librarianship in the state of Nuevo Leon, Mexico. It analyses and criticises: a) the lack of professional categories for librarians with B.A.s or Masters degrees in Nuevo Leon, in contrast, for example with Mexico’s National Autonomous University (UNAM); it also assesses how several librarians with B.A. undergraduate degrees from the Mexican National Institute of Social Security (IMSS) the national health service system) in the Nuevo Leon state-wide fought to obtain a Professional B.A. Undergraduate Degre Librarian Labor Cagegory status to be signed and included in the labor IMSS union collective contract and how eventually they won; b) it also criticises the repressive and dictatorial attitudes on the side of the top managerial and academic mafias from the major Nuevo Leon universities who do not allow free and equal academic and professional development opportunities of the vast majorities of librarians with or without B.A. degrees and whom also censor their freedom of expression and thought in Nuevo Leon librarianship; c) it advocates for librarians to have an honest service mystique as if they were doing a sort of "apostleship" against the "monetarist" and "mercenarist" practices that currently practice librarians in Nuevo Leon state. As for the library guild activities, it criticises the demogogical charlatanism and opportunism of guilds such as AMBAC (standing from the Mexico-wide Mexican Library Association, Nuevo Leon chapter), where their leaders only take advantage of the ineptitudes of the three levels of the Mexican government (municipal, state, and federal) on library issues, and they use the natural disasters against libraries or librarians by appealing to people’s sentimentalisms just to appear themselves in the picture and in the press, but without analysing, criticising and denouncing the deep structural faults underneath the Mexican State, and from all the three levels of the Mexican governments.

Reformas na gestão hospitalar:análise dos efeitos da empresarialização

Tese de Doutoramento em Ciências Sociais na Especialidade de Administração da Saúde

A satisfação dos profissionais no setor da saúde

Dissertação de Mestrado, Gestão de Recursos Humanos, Escola Superior de Gestão, Hotelaria e Turismo, Faculdade de Ciências Humanas e Sociais, Universidade do Algarve, 2015

Patient experiences of a bariatric group programme for managing obesity:a qualitative interview study

Objectives: People with obesity experience a range of physical and psychological ill-health outcomes. This study examined patients’ experiences of a group-based programme for the management of morbid obesity delivered within the UK National Health Service. The focus of the study was on the emerging dynamic of the group and patients’ perceptions of its impact on health outcomes. Design: A qualitative interview study was conducted and involved patients recruited from a Tier 3 bariatric service in South West England. Verbatim transcripts were analysed using thematic analysis. Methods: Twenty patients (12 females) with a BMI ≥ 35 kg/m2 participated in a semi-structured one-to-one interview. Participants had been registered with the bariatric service for at least 6 months. None of the participants had had bariatric surgery. Results: Most participants felt that they had benefited from participating in the group programme and talked about the group as a resource for lifestyle change. Participants’ narratives centred on the emergence of a sense of self based upon their participation in the group: establishing psychological connections to other patients, or shared social identity, was regarded as a key mechanism through which the programme's educational material was accessed, and underpinned the experience of social support within the group. Through interaction with other patients, involving the sharing of personal experiences and challenges, participants came to experience their weight ‘problem’ through a collective lens that they felt empowered them to initiate and sustain individual lifestyle change. Discussion: Bariatric care groups have the potential to support lifestyle change and weight loss and may help address the psychological needs of patients. Nurturing a sense of shared social identity amongst patients with morbid obesity should be a core aim of the care pathway and may provide the foundation for successful translation of dietetic content in group programmes.

A telephone survey to determine the experiences of children and their parents/carers, following the initiation of a new medicine

Objective: To determine what issues are experienced during the first few weeks of therapy by patients, and their parents/carers, when a child/young person has been prescribed a new medicine. Method: One hundred patients aged ≤18 years of age prescribed a new medicine for ≥6 weeks were recruited from a single UK National Health Service specialist paediatric hospital outpatient pharmacy. Six weeks after the first dispensing of their new medicine the patient or their parent/carer received telephone follow-up by a researcher and verbally completed a questionnaire containing both open and closed questions. Patient or parent/carer experiences were identified and analysed using thematic analysis and descriptive statistics. Results: Eighty-six participants were available for telephone follow-up. Six (7%) had not started their medicine. Paediatric patients and their parents/carers experienced a range of issues during the first few weeks after starting a new medicine. These included additional concerns/questions (24/80, 30%), administration issues (21/80, 26.3%), adverse effects (29/80, 36.3%) and obtaining repeat supplies (12/80, 15%). The Morisky Medication Adherence Scale indicated that 34/78 (43.6%) participants had a high adherence rating, 35/78 (44.9%) medium and 9/78 (11.5%) a low rating. Conclusions: Paediatric patients and their parents/carers experience a range of issues during the first few weeks after starting a new medicine. Further research is required to determine the type of interventions that may further support medicines use in this group of patients.

Utility and safety of invasive (fractional flow reserve) and non-invasive (cardiac magnetic resonance imaging) diagnostic tests in patients with NSTEMI

A prospective randomised controlled clinical trial of treatment decisions informed by invasive functional testing of coronary artery disease severity compared with standard angiography-guided management was implemented in 350 patients with a recent non-ST elevation myocardial infarction (NSTEMI) admitted to 6 hospitals in the National Health Service. The main aims of this study were to examine the utility of both invasive fractional flow reserve (FFR) and non-invasive cardiac magnetic resonance imaging (MRI) amongst patients with a recent diagnosis of NSTEMI. In summary, the findings of this thesis are: (1) the use of FFR combined with intravenous adenosine was feasible and safe amongst patients with NSTEMI and has clinical utility; (2) there was discordance between the visual, angiographic estimation of lesion significance and FFR; (3). The use of FFR led to changes in treatment strategy and an increase in prescription of medical therapy in the short term compared with an angiographically guided strategy; (4) in the incidence of major adverse cardiac events (MACE) at 12 months follow up was similar in the two groups. Cardiac MRI was used in a subset of patients enrolled in two hospitals in the West of Scotland. T1 and T2 mapping methods were used to delineate territories of acute myocardial injury. T1 and T2 mapping were superior when compared with conventional T2-weighted dark blood imaging for estimation of the ischaemic area-at-risk (AAR) with less artifact in NSTEMI. There was poor correlation between the angiographic AAR and MRI methods of AAR estimation in patients with NSTEMI. FFR had a high accuracy at predicting inducible perfusion defects demonstrated on stress perfusion MRI. This thesis describes the largest randomized trial published to date specifically looking at the clinical utility of FFR in the NSTEMI population. We have provided evidence of the diagnostic and clinical utility of FFR in this group of patients and provide evidence to inform larger studies. This thesis also describes the largest ever MRI cohort, including with myocardial stress perfusion assessments, specifically looking at the NSTEMI population. We have demonstrated the diagnostic accuracy of FFR to predict reversible ischaemia as referenced to a non-invasive gold standard with MRI. This thesis has also shown the futility of using dark blood oedema imaging amongst all comer NSTEMI patients when compared to novel T1 and T2 mapping methods.

Antiplatelet therapy and clinical outcomes in cardiovascular diseases

Cardiovascular diseases (CVD) is a leading cause of death in the world. Despite effective treatment regimens for ischaemic heart disease (IHD) and ischaemic stroke, mortality and recurrence rates remain high. Antiplatelet therapy is on effective treatment and reduces the risk of recurrent heart attack and stroke. Nevertheless, there are patients who stopped or interrupted their antiplatelet therapy for certain reasons or some patients may be resistant or poor responders to antiplatelet therapy. Furthermore, there is evidence of rebound effect in platelet activity after antiplatelet cessation and this may associate with increased risk of cardiovascular event. This thesis is divided into five main chapters (chapters 3 to 7) which attempt to provide data to help resolve the uncertainty. Chapter 1 highlights the background of cardiovascular diseases and the global burden of cardiovascular and cerebrovascular diseases. The metabolism of platelets, antiplatelet therapy and current antiplatelet therapy guidelines are described, followed by discussion of the risk of cardiovascular event and changes in antiplatelet therapy. Chapter 2 describes the data source from Virtual International Stroke Trial Archive (VISTA) and National Health Service Greater Glasgow and Clyde (NHSGGC) Safe Haven, followed by definition of outcome measures. In chapter 3, Virtual International Stroke Trial Archive (VISTA) data was examined to test whether continue with the same antiplatelet therapy or changing to a new antiplatelet regimen reduces the risk of subsequent events in patients who experience a stroke whilst taking antiplatelet therapy. The findings indicate that subjects who switch to a new antiplatelet regimen after stroke did not have a lower early recurrence rate than subjects who continued with the same antiplatelet therapy. Observations on bleeding complications were similar in both groups. However, changing antiplatelet regimen after stroke was associated with more favourable functional outcome across a full scale modified Rankin Scale (mRS) at 90 days. In chapter 4, association between early or later initiation of antiplatelet with a recurrent ischaemic stroke and bleeding complications was assessed using VISTA data. The findings indicate that there was no association between a recurrent ischaemic stroke and timing of initiation of antiplatelet drug after stroke. However, early initiation was associated with increased risk of bleeding. In terms of functional outcomes, this study demonstrated that the mid-time and late initiation of antiplatelet therapy after acute stroke are associated with better functional outcomes compared with early initiation. In chapter 5, a nested case-control study was performed to explore the rate of antiplatelet cessation and interruption in a sample of patients with recent ischaemic stroke and to assess the risk of cardiovascular events associated with cessation and interruption of antiplatelet. It was found that there was no increased risk of cardiovascular event among patients who had early cessation or interrupted/stopped antiplatelet therapy within 90 days following acute ischaemic stroke. In chapter 6, the incidence and predictors of cardiovascular events after DAPT cessation were evaluated. The incidence of cardiovascular event while taking DAPT and following discontinuation of DAPT was 15.7% and 16.7% respectively. This study found that increasing age was associated with an increased risk of cardiovascular event, whereas, revascularization-treated patients and longer duration of DAPT, were each associated with a decreased risk. The duration of DAPT six months and less was associated a significantly higher risk for cardiovascular event. In chapter 7, an untargeted metabolomics analysis was performed while on DAPT (aspirin plus ticagrelor) and once they stopped ticagrelor to identify metabolite changes associated with cardiovascular events after stopping DAPT. Ten ACS patients were recruited in this study and data were analysed for seven patients. Three hundred eleven putative metabolites were identified. This study found 16 putative metabolites significantly altered following ticagrelor cessation. Of these, seven metabolites were from lipid pathway and down-regulated some up to 3-fold. On the other hand, adenosine, from nucleotide metabolism was upregulated up to 2.6-fold. It concluded that there are changes in numerous pathways following DAPT discontinuation and whether these changes differ in patients who have cardiovascular event after stopping DAPT warrant further investigation. In chapter 8, a summary of the findings of this thesis are presented as well as the future directions of research in this area.

Factores asociados a embarazo no deseado en mujeres en edad reproductiva en Colombia 2010

Objetivo: Identificar factores sociodemográficos y de fecundidad, asociados a ocurrencia de embarazo no deseado en mujeres colombianas en edad reproductiva en el año 2010. Métodos: Se realizó estudio retrospectivo de corte transversal, basado en los datos de la ENDS Colombia-2010, del total de mujeres en edad fértil (13-49 años) que al momento de la encuesta se encontraban en embarazo. La variable de interés fue embarazo no deseado, se describió la población a estudio y se evaluó la posible asociación con variables sociodemográficas y de fecundidad, a través de análisis bivariado y multivariado. Se realizaron los mismos análisis por grupo de edad (adolescentes vs adultas). Resultados: La prevalencia de embarazo no deseado en las mujeres colombianas en el 2010 fue de 61,4 %. De acuerdo al modelo de regresión logística, no estar en unión a una pareja (OR: 4,01 IC95%: 3,066-5,269), tener hijos (OR: 2,040 IC95%: 1,581 – 2,631), estar en el quintil de menor riqueza (OR: 2,137 IC95%: 1,328-3,440), y ser adolescente (OR: 1,599 IC95%: 1,183-2,162), son factores que aumentan la probabilidad de tener un embarazo no deseado. Se encontraron diferencias en los factores asociados al realizar segmentación por edad. Conclusiones: La prevalencia de embarazo no deseado permanece alta en Colombia respecto a años anteriores y a otros países. Los resultados pueden ser de utilidad para el desarrollo de políticas en salud sexual y reproductiva teniendo en cuenta los factores asociados identificados priorizando a la población adolescente y de menor estatus socioeconómico, para la prevención de embarazo no deseado en Colombia.

Fazer mais ou fazer melhor?: O papel dos valores de vida e da interferência trabalho/família no desempenho profissional

Resumo: Sendo o trabalho e a família dois dos mais importantes domínios da vida, o presente estudo teve como objectivo analisar o impacto dos valores de vida (importância e prioridade atribuídas ao trabalho e à família) no desempenho profissional e na interferência da família sobre o trabalho (IFT) e do trabalho sobre a família (ITF). Participaram no estudo 245 trabalhadores do Serviço Nacional de Saúde, sujeitos a avaliação pelo SIADAP em 2008. Os resultados revelaram que os sujeitos que dão mais importância/prioridade à família tiveram melhores desempenhos do que aqueles que dão mais importância/prioridade ao trabalho. Pela análise da interferência de papéis, verificou-se que os indivíduos que dão mais importância/prioridade à família sentem maior 1FT do que aqueles que dão mais importância/prioridade ao trabalho, manifestando-se a ITF positivamente associada ao desempenho profissional. Não se verificou o efeito moderador da ITF/IFT sobre a relação dos valores de vida com o desempenho profissional. /ABSTRACT: Assuming work and family are two of the most important aspects of life, the current research was aimed at analyzing the impact of the values of life (importance and priority given to work and family) on professional performance, the interference of family on work (IFW) and of work on family (IWF). 245 workers of the National Health Service have participated in the research. They have been subjected to evaluation by SIADAP in 2008. The results have shown that individuals who give more importance/priority to the family have had better performances than those who give more importance/priority to work. From the analysis of role interference, it is possible to state that individuals who give more importance/priority to family feel more IFW than those who give more importance to work, and also that IWF is positively related to professional performance. The effect of IWF/IFW moderation on the relation of the values of life and professional performance hasn't been observed.

Characterizing human cysticercosis in Portugal 2006-2013

Cysticercosis results from the ingestion Taenia solium eggs directly by faecal-oral route or contaminated food or water. While, still considered a leading cause of acquired epilepsy in developed countries, this zoonosis has been controlled or eradicated in industrialized countries due to significant improvements in sanitation, pig rearing and slaughterhouse control systems. We developed a retrospective study on human neurocysticercosis (NCC) hospitalisations based on the national database resulting from National Health Service (NHS) hospital episodes except those of Madeira and Azores Islands. Between 2006 and 2013 there were 357 hospitalized NCC cases in Portugal. Annual frequency of cases between 2006-2013 kept stable (mean 45). NCC was most frequent in those aged 25-34 years (59; 16,5%) and those >75 years (65; 18,2%). Overall, mean age was 47,3 years (median age 45, standard deviation 41,1, mode 28) and 176 cases were in males (49,3%); no significant differences were observed between age and gender (t-student, p>0,05). In Norte Region cases tended to be older than in Lisboa and Vale do Tejo Region. The Directorate-General of Health established the National Observatory of Cysticercosis and Teniiasis which will define criteria for NCC cases monitoring and surveillance (hospitalized and non-hospitalized cases).