A juventude da Avaliação de Tecnologias em Saúde (ATS), enquanto política institucional no âmbito nacional, sinaliza a necessidade de uma reflexão sobre como se deu sua implementação, sob as perspectivas de sua inserção na política de saúde e do campo científico. Ao final de sua primeira década, levantam-se as perguntas: a ATS se traduziu em uma política de saúde (policy) informada pela ciência? Sua fundamentação científica foi usada a serviço da política (politics)? Para compreender esse processo político, aplicamos a teoria de múltiplos fluxos formulada por John Kingdon. Estabeleceu-se um equilíbrio instável entre o uso da ciência para informar a política e o uso político da ciência. A sobrevivência dessa política dependerá não só da ciência, mas da arte de orquestrar os interesses dos vários agentes, de forma que a ATS se torne uma política de saúde de fortalecimento e sustentabilidade do SUS.

This paper deals with the interaction between technical regulations and social values in the pharmaceutical development. International regulation regarding medicines is analyzed departing from Tula Molina's distinction of material and social risk. First of all, I discuss the regulatory values of quality, safety and efficacy for medicines assessment. Secondly I focus on two subjects to illustrate the social risk associated with pharmaceuticals: the therapeutic value of innovations and the access to essential medicines. Finally, I propose that technical regulations should mention explicitly the social circumstances in which they will be implemented.

Background: Previous studies have demonstrated the feasibility of using an asthma app to support medication management and adherence but failed to compare with other measures currently used in clinical practice. However, in a clinical setting, any additional adherence measurement must be evaluated in the context of both the patient and physician perspectives so that it can also help improve the process of shared decision making. Thus, we aimed to compare different measures of adherence to asthma control inhalers in clinical practice, namely through an app, patient self-report and physician assessment. Methods: This study is a secondary analysis of three prospective multicentre observational studies with patients (≥13 years old) with persistent asthma recruited from 61 primary and secondary care centres in Portugal. Patients were invited to use the InspirerMundi app and register their inhaled medication. Adherence was measured by the app as the number of doses taken divided by the number of doses scheduled each day and two time points were considered for analysis: 1-week and 1-month. At baseline, patients and physicians independently assessed adherence to asthma control inhalers during the previous week using a Visual Analogue Scale (VAS 0-100). Results: A total of 193 patients (72% female; median [P25-P75] age 28 [19-41] years old) were included in the analysis. Adherence measured by the app was lower (1 week: 31 [0-71]%; 1 month: 18 [0-48]%) than patient self-report (80 [60-95]) and physician assessment (82 [51-94]) (p < 0.001). A negligible non-significant correlation was found between the app and subjective measurements (ρ 0.118-0.156, p > 0.05). There was a moderate correlation between patient self-report and physician assessment (ρ = 0.596, p < 0.001). Conclusions: Adherence measured by the app was lower than that reported by the patient or the physician. This was expected as objective measurements are commonly lower than subjective evaluations, which tend to overestimate adherence. Nevertheless, the low adherence measured by the app may also be influenced by the use of the app itself and this needs to be considered in future studies.

The Brazilian Ministry of Health has institutionalized two articulated processes in the field of health technology management: (i) the production, systematization and dissemination of health technology assessment, and (ii) the adoption of a flow for the incorporation, exclusion or alteration of new technologies by the Brazilian National Health System. Several advances have been made, such as standardization of methods; production and promotion of studies; institutional development and international cooperation in the area of health technology assessment; definition of the necessary requirements for the presentation of proposals; definition of deadlines; and expansion of the segments that compose the committee that is responsible for the analysis and recommendation. However, some difficulties remain: health technology assessment activities concentrated in the Ministry; low sustainability of the activities of production and dissemination of the assessments; low penetration of health technology assessment in health care institutions; activities of assessment/incorporation with low participation of users; non-transparent decision-making processes; and low integration of the health policy with the scientific and technological policy.

At the last National Conference of Industrial Sociology in Portugal (in March 1999) was presented a paper on the topic of “foresight as a technology and employment policy instrument” (A.B. Moniz) where there was a reference to the need of development of this kind of tools and instruments. This need is clear when one should neutralize the negative effects of such policies, and could support the positive influences, especially with the main aims of improvement of quality of working life. Thus, is today possible to make a first balance of the application in Portugal of a type of foresight analysis exercise: the Delphi method. After some of the uses of this method in Portugal on the fisheries socioeconomical system and on the relation between information society and employment, we present in this paper a first assessment of such experiments and present some recommendations for future uses of this foresight technique. We conclude that they must be applied within the context of socio-economical perspectives, and not only the technological ones, although they should include that dimension.

At the last National Conference of Industrial Sociology in Portugal (in March 1999) was presented a paper on the topic of “foresight as a technology and employment policy instrument” (A.B. Moniz) where there was a reference to the need of development of this kind of tools and instruments. This need is clear when one should neutralize the negative effects of such policies, and could support the positive influences, especially with the main aims of improvement of quality of working life. Thus, is today possible to make a first balance of the application in Portugal of a type of foresight analysis exercise: the Delphi method. After some of the uses of this method in Portugal on the fisheries socio economical system and on the relation between information society and employment, we present in this paper a first assessment of such experiments and present some recommendations for future uses of this foresight technique. We conclude that they must be applied within the context of socio-economical perspectives, and not only the technological ones, although they should include that dimension.

Clinical tests (TRL5 to TRL9) of the new corona virus have been mapped in order to obtain the current state of the art. The international base of the World Health Organization was mapped and complemented with national bases. After screening, 661 documents remained and were analyzed. There are studies in 25 countries, although they are concentrated in China. Companies finance less than 6% of studies. The vast majority of studies are in Phase Zero (preclinical), only 2% are already in progress and none has results yet. Their primary goals are therapeutics; however, a large majority are dedicated to Chinese medicine and only 245 are focusing on antiviral, immunotherapy and vaccine transnational technologies. There is a wide range of active compounds, mainly referring to hydroxychloroquine/chloroquine (31) and stem cells (22). The age groups of the patients focus especially on adolescents and adults and leave long-lived patients uncovered. 

This work analyzes the drugs used for patients with COVID-19 which are undergoing clinical trials and that go well beyond chloroquine. The data were obtained from the World Health Organization's International Clinical Trials Registration Platform. Geodistribution shows concentration in China, and only 5% of transnational partnerships. Clinical tests are concentrated in intermediate phases II and III. The classes of drugs go far beyond antimalarials, which have become popularly known, also comprising antivirals, anti-inflammatories, antibiotics, anticoagulants, antibodies, antifibrotics, antitumor agents, calcium channel blockers, corticosteroids, immunomodulators, immunosuppressants, enzyme inhibitors, mucolytics, vasoconstrictors and vasodilators, vitamins and mineral salts. The most tested antivirals are Ritonavir, Remdesivir, Lopinavir, Favipiravir and Arbidol, as well as their associations. Several tests combine antimalarials, antivirals and immunomodulators, the most studied being Favipiravir and Lopinavir associated with Ritonavir, Methylprednisolone, Remdesivir, Tocilizumab, Chloroquine and Hydroxychloroquine.

Objective: To analyze, through the systematic review method, the technological products developed by Nurses, published between 2014 and 2018. Methodology: Qualitative systematic review of articles published from 2014 to 2018 in English, Portuguese and Spanish. Technological productions focused on the hospital environment were listed. Technological production was classified according to: complexity, innovation content, impact and applicability based on the criteria determined by the Coordination of Superior Level Staff Improvement (Brazil). Results: 28 studies were selected. The most frequent technological productions were: manual/protocol and software/application (28.57%, respectively), teaching material (25%) and non-patentable process/technology (17.86%). There was a greater distribution of technological productions classified as medium complexity (78.6%); medium content of innovation (57.1%); the description of the impact was recurrent in software/application (60%), didactic material and non-patentable process/technology (12.5%, respectively) and, regarding the manual/protocol, the impact was not reported by the authors. The applicability was not clear in the studies, being interpreted from the profile of the production presented. Conclusion: There were more frequent technological productions of manuals/protocols and software/applications. There is a lack of description as to the applicability and impact (real or potential) of productions aimed at the hospital environment.

Abstract Background: Implantable cardiac defibrillators (ICDs) therapy for primary prevention (PP) of sudden cardiac arrest (SCA) is well-established but underutilized globally. The Improve SCA study has identified a cohort of patients called 1.5 primary prevention (1.5PP), based on PP patients with the presence of documented risk factors: non-sustained ventricular tachycardia, frequent premature ventricular contractions, left ventricular ejection fraction < 25%, and pre-syncope or syncope. Objective: This study evaluated the cost-effectiveness of ICD therapy compared to no ICD among 1.5PP patients in the Brazilian public healthcare system. Methods: Modified inputs to a published Markov model were applied to compare costs and outcomes of ICD therapy to no ICD therapy from the Brazilian payer’s perspective. Mortality and utility estimates were obtained from the IMPROVE SCA trial. Additional effectiveness inputs were sourced from the literature. Cost inputs were obtained from the Brazilian Unified Health System and the Ministry of Health. Costs were discounted at 4.7%; quality-adjusted life years (QALYs) were discounted at 1.45%. This study applied a willingness-to-pay (WTP) value of three times Brazil’s gross domestic product (GDP) in 2017, R$105,723 (Brazilian Real). Results: The total discounted lifetime costs for ICD therapy were R$100,920 compared to R$43,866 for no ICD therapy. Total discounted QALYs for ICD therapy and no ICD therapy were 9.85 and 7.15, respectively. The incremental cost effectiveness ratio was R$21,156 per QALY and less than the R$105,723 WTP threshold. Results from sensitivity analyses were consistent with base case results. Conclusions: ICD therapy compared to no ICD therapy is cost-effective in the 1.5PP population in Brazil. (Int J Cardiovasc Sci. 2021; [online].ahead print, PP.0-0)