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- Pharmacoeconomic analysis methodsPublication . Tonin, Fernanda; Leonart, Leticia P.; Casas, CesarIn the last years, the growing interest of healthcare professionals, policy-makers, and other stakeholders in enlarging the role of economic evaluations was driven by several factors such as evidence-based healthcare culture, patient-centered actions, and quality-linked incentives, associated with an essential increase in financial constraints and pressures on healthcare budgets. Pharmacoeconomics, as a branch of health economics, focuses on balancing the costs and benefits (i.e., consequences) of intervention towards using limited resources, aiming at maximizing value to patients, healthcare payers, and society. These concepts are part of the Health Technology Assessment process that informs clinical and governmental players about medical, social, and economic implications of the development, diffusion, and health technologies. This chapter aims to provide an overview of the essential concepts in pharmacoeconomic analysis methods, including studies classification (e.g., budget-impact analysis, cost-minimization analysis, cost-effectiveness analysis, cost-utility analysis), types of costs and outcomes, modeling approaches (e.g., decision trees or state transition models), and new trending analysis (e.g., the value of information and value-based healthcare analyses), and additionally discuss some recommendations for future studies towards evidence synthesis and practical application.
- The pathway towards low carbon schools: criteria, targets and solutionsPublication . Lizana, Jesús; Chacartegui Ramírez, Ricardo; Almeida, Susana Marta; Manteigas, VítorThis book presents the research work carried out in the European project ClimACT within the Interreg SUDOE Programme. The book collects the main research activities and findings to promote a low-carbon economy in schools, where we developed a special collaboration and awareness between authorities, researchers, companies, non-governmental organizations (NGOs), and school communities on the road to sustainable school buildings. The project brings together partners and associated entities with complementary functions from SUDOE countries (Spain, France, Portugal, United Kingdom, and Andorra) that coordinate the exchange of good practices and applications of joint solutions to common challenges that affect sustainability and the effective management of energy and the environment in schools. The project involved 39 pilot schools and had a budget of 1.3 million euros, 72% obtained as a part of the European territorial cooperation objective known as Interreg, which is financed by one of the European structural funds: the European Regional Development Fund (ERDF).
- Methodological considerations in injury burden of disease studies across Europe: a systematic literature reviewPublication . Charalampous, Periklis; Pallari, Elena; Gorasso, Vanessa; von der Lippe, Elena; Devleesschauwer, Brecht; Pires, Sara M.; Plass, Dietrich; Idavain, Jane; Ngwa, Che Henry; Noguer, Isabel; Padron-Monedero, Alicia; Sarmiento, Rodrigo; Majdan, Marek; Ádám, Balázs; AlKerwi, Ala’a; Cilovic-Lagarija, Seila; Clarsen, Benjamin; Corso, Barbara; Cuschieri, Sarah; Dopelt, Keren; Economou, Mary; Fischer, Florian; Freitas, Alberto; García-González, Juan Manuel; Gazzelloni, Federica; Gkitakou, Artemis; Gulmez, Hakan; Hynds, Paul; Isola, Gaetano; Jakobsen, Lea S.; Kabir, Zubair; Kissimova-Skarbek, Katarzyna; Knudsen, Ann Kristin; Konar, Naime Meriç; Ladeira, Carina; Lassen, Brian; Liew, Aaron; Majer, Marjeta; Mechili, Enkeleint A.; Mereke, Alibek; Monasta, Lorenzo; Mondello, Stefania; Morgado, Joana Nazaré; Nena, Evangelia; Ng, Edmond S. W.; Niranjan, Vikram; Nola, Iskra Alexandra; O’Caoimh, Rónán; Petrou, Panagiotis; Pinheiro, Vera; Ortiz, Miguel Reina; Riva, Silvia; Samouda, Hanen; Santos, João Vasco; Santoso, Cornelia Melinda Adi; Milicevic, Milena Santric; Skempes, Dimitrios; Sousa, Ana Catarina; Speybroeck, Niko; Tozija, Fimka; Unim, Brigid; Uysal, Hilal Bektaş; Vaccaro, Fabrizio Giovanni; Varga, Orsolya; Vasic, Milena; Violante, Francesco Saverio; Wyper, Grant M. A.; Polinder, Suzanne; Haagsma, Juanita A.Background: Calculating the disease burden due to injury is complex, as it requires many methodological choices. Until now, an overview of the methodological design choices that have been made in the burden of disease (BoD) studies in injury populations is not available. The aim of this systematic literature review was to identify existing injury BoD studies undertaken across Europe and to comprehensively review the methodological design choices and assumption parameters that have been made to calculate years of life lost (YLL) and years lived with disability (YLD) in these studies. Methods: We searched EMBASE, MEDLINE, Cochrane Central, Google Scholar, Web of Science, and the grey literature supplemented by hand-searching, for BoD studies. We included injury BoD studies that quantified the BoD expressed in YLL, YLD, and disability-adjusted life years (DALY) in countries within the European Region between early 1990 and mid-2021. Results: We retrieved 2,914 results of which 48 performed an injury-specific BoD assessment. Single-country independent and Global Burden of Disease (GBD)-linked injury BoD studies were performed in 11 European countries. Approximately 79% of injury BoD studies reported the BoD by external cause-of-injury. Most independent studies used the incidence-based approach to calculate YLDs. About half of the injury disease burden studies applied disability weights (DWs) developed by the GBD study. Almost all independent injury studies have determined YLL using national life tables. Conclusions: Considerable methodological variation across independent injury BoD assessments was observed; differences were mainly apparent in the design choices and assumption parameters towards injury YLD calculations, implementation of DWs, and the choice of a life table for YLL calculations. The development and use of guidelines for performing and reporting of injury BoD studies are crucial to enhance transparency and comparability of injury BoD estimates across Europe and beyond.
- Hemin ameliorates the inflammatory activity in the inflammatory bowel disease: a non-clinical study in rodentsPublication . Silva, Inês; Correia, Rita; Pinto, Rui; Mateus, VanessaBackground: Inflammatory bowel disease (IBD) is a chronic inflammatory disorder of the gastrointestinal tract. Currently, there is no cure, and pharmacological treatment aims to induce and maintain remission in patients, so it is essential to investigate new possible treatments. Hemin is a heme-oxygenase inducer that can confer anti-inflammatory, cytoprotective, and antiapoptotic effects; therefore, it can be considered an asset for different gastrointestinal pathologies, namely for IBD. Aim: This experiment aims to evaluate the efficacy and safety of hemin, in a chronic 2,4,6-trinitrobenzene sulfonic acid (TNBS)-induced colitis model in rodents. Methods: The induction of chronic colitis consisted of five weekly intrarectal administrations of 1% TNBS. Then, the mice were treated daily with 5 mg/kg/day or 10 mg/kg/day of hemin, through intraperitoneal injections, for 14 days. Results: Hemin demonstrated an anti-inflammatory effect through the reduction in tumor necrosis factor (TNF)-α levels, fecal calprotectin, and fecal hemoglobin. It was also found to be safe in terms of extraintestinal manifestations since hemin did not promote renal and/or hepatic changes. Conclusions: Hemin could become an interesting tool for new possible pharmacological approaches in the management of IBD.
- How hydroxyurea alters the gut microbiome: a longitudinal study involving Angolan children with sickle cell anemiaPublication . Delgadinho, Mariana; Ginete, Catarina; Santos, Brígida; Fernandes, Carolina; Silva, Carina; Miranda, Armandina; Vasconcelos, Jocelyne Neto de; Brito, MiguelSickle cell anemia (SCA) is an inherited hematological disorder and a serious global health problem, especially in Sub-Saharan Africa. Although hydroxyurea (HU) is the leading treatment for patients with SCA, its effects on the gut microbiome have not yet been explored. In this context, the aim of this study was to investigate this association by characterizing the gut microbiome of an Angolan SCA pediatric population before and after 6 months of HU treatment. A total of 66 stool samples were obtained and sequenced for the 16S rRNA gene (V3-V4 regions). Significant associations were observed in alpha and beta-diversity, with higher values of species richness for the children naïve for HU. We also noticed that children after HU had higher proportions of several beneficial bacteria, mostly short-chain fatty acids (SCFAs) producing species, such as Blautia luti, Roseburia inulinivorans, Eubacterium halli, Faecalibacterium, Ruminococcus, Lactobacillus rogosae, among others. In addition, before HU there was a higher abundance of Clostridium_g24, which includes C. bolteae and C. clostridioforme, both considered pathogenic. This study provides the first evidence of the HU effect on the gut microbiome and unravels several microorganisms that could be considered candidate biomarkers for disease severity and HU efficacy.
- Unveiling the occupational exposure to microbial contamination in conservation-restoration settingsPublication . Viegas, Carla; Cervantes, Renata; Dias, Marta; Gomes, Bianca; Pena, Pedro; Carolino, Elisabete; Twarużek, Magdalena; Kosicki, Robert; Soszczyńska, Ewelina; Viegas, Susana; Caetano, Liliana Aranha; Pinheiro, Ana CatarinaAssuring a proper environment for the fulfillment of professional activities is one of the Sustainable Development Goals and is contemplated in the One Health approach assumed by the World Health Organization. This particular study is applied to an often neglected sector of our society—the conservators/restorers—despite the many health issues reported by these professionals. Three different specialties (textiles, paintings, and wood sculptures) and locations were selected for evaluation by the placement of electrostatic dust cloths. After treatment of the samples, bacterial and fungal contamination was assessed, as well as mycotoxin determination, the presence of azole-resistant strains, and cytotoxicity of the microorganisms encountered. Bacteria were only present in one of the media used and showed relatively low numbers. The highest level of contamination by fungi was identified in one of the textiles settings. The textile area also showed the highest variability for fungi. Aspergillus sp. is one indicator of possible environmental issues, and A. sections Fumigati and Circumdati were particularly relevant in two of the settings and identified in all of them. No mycotoxins were detected and the large majority of the fungi identified were non-cytotoxic. Overall, these can be considered low-contaminated environments but attention should be given to the Aspergillus sp. contamination. Additional studies are needed not only to make these results more robust but also to test if the environmental sampling alone is the best approach in a setting where there is very little movement and dust displacement and where professionals are in very close proximity to the artifacts being treated, which may suggest the existence of a micro-atmosphere worth evaluating and comparing to the obtained results.
- A new time of reckoning, a time for new reckoning: views on health and society, tensions between medicine and the social sciences, and the process of medicalizationPublication . Cunha, Diogo Silva da; Raposo, Hélder AntónioThis article seeks to capture variations and tensions in the relationships between the health–illness–medicine complex and society. It presents several theoretical reconstructions, established theses and arguments are reassessed and criticized, known perspectives are realigned according to a new theorizing narrative, and some new notions are proposed. In the first part, we argue that relations between the medical complex and society are neither formal–abstract nor historically necessary. In the second part, we take the concept of medicalization and the development of medicalization critique as an important example of the difficult coalescence between health and society, but also as an alternative to guide the treatment of these relationships. Returning to the medicalization studies, we suggest a new synthesis, reconceptualizing it as a set of modalities, including medical imperialism. In the third part, we endorse replacing a profession-based approach to medicalization with a knowledge-based approach. However, we argue that such an approach should include varieties of sociological knowledge. In this context, we propose an enlarged knowledge-based orientation for standardizing the relationships between the health–illness–medicine complex and society.
- Anti-inflammatory effect of topiramate in a chronic model of TNBS-induced colitisPublication . Silva, Inês; Mendes, Priscila; Guerra, Sofia; Pinto, Rui; Mateus, VanessaInflammatory bowel disease (IBD) is characterized by a chronic and relapsing inflammatory response in the gastrointestinal tract, resulting in severe symptoms such as abdominal pain, vomiting, diarrhea, bloody stools, and weight loss. Currently, there is no cure, and the pharmacological treatment includes drugs that induce and keep the patient in remission, not reversing the underlying pathogenic mechanism. In the long term, these therapies may cause various side effects and complications, which has increased the need to investigate new, more effective, and safer pharmacological approaches. In preclinical studies, topiramate has demonstrated a potential anti-inflammatory effect by inhibiting the production of several pro-inflammatory cytokines. This study aimed to investigate the effect of topiramate in a chronic TNBS-induced colitis model in rodents. Experimental colitis was induced by four intrarectal administrations of 1% TNBS in female CD-1 mice. Topiramate 10 and 20 mg were administered intraperitoneally for 14 days. Several parameters were evaluated, such as body weight, alkaline phosphatase (ALP), fecal hemoglobin, fecal calprotectin, tumor necrosis factor (TNF)-α, and interleukin (IL)-10. Topiramate reduces TNBS-induced colonic damage in a model of chronic experimental colitis and normalizes stool consistency and anus appearance. Additionally, topiramate significantly reduced the concentration of ALP, fecal hemoglobin, fecal calprotectin, TNF-α, and IL-10, demonstrating it to be a promising pharmacological approach for treating IBD in the future.
- Comparison of 3DCRT and IMRT out-of-field doses in pediatric patients using Monte Carlo simulations with treatment planning system calculations and measurementsPublication . Sá, Ana Cravo; Barateiro, Andreia; Bednarz, Bryan P.; Almeida, Pedro; Vaz, Pedro; Madaleno, TiagoPurpose: Out-of-field doses are given to healthy tissues, which may allow the development of second tumors. The use of IMRT in pediatric patients has been discussed, as it leads to a "bath" of low doses to large volumes of out-of-field organs and tissues. This study aims to compare out-of-field doses in pediatric patients comparing IMRT and 3DCRT techniques using measurements, Monte Carlo (MC) simulations, and treatment planning system (TPS) calculations. Materials and methods: A total dose of 54 Gy was prescribed to a PTV in the brain of a pediatric anthropomorphic phantom, for both techniques. To assess the out-of-field organ doses for both techniques, two treatment plans were performed with the 3DCRT and IMRT techniques in TPS. Measurements were carried out in a LINAC using a pediatric anthropomorphic phantom and thermoluminescent dosimeters to recreate the treatment plans, previously performed in the TPS. A computational model of a LINAC, the associated multileaf collimators, and a voxelized pediatric phantom implemented in the Monte Carlo N-Particle 6.1 computer program were also used to perform MC simulations of the out-of-field organ doses, for both techniques. Results: The results obtained by measurements and MC simulations indicate a significant increase in dose using the IMRT technique when compared to the 3DCRT technique. More specifically, measurements show higher doses with IMRT, namely, in the right eye (13,041 vs. 593 mGy), left eye (6,525 vs. 475 mGy), thyroid (79 vs. 70 mGy), right lung (37 vs. 28 mGy), left lung (27 vs. 20 mGy), and heart (31 vs. 25 mGy). The obtained results indicate that out-of-field doses can be seriously underestimated by TPS. Discussion: This study presents, for the first time, out-of-field dose measurements in a realistic scenario and calculations for IMRT, centered on a voxelized pediatric phantom and an MC model of a medical LINAC, including MLC with log file-based simulations. The results pinpoint significant discrepancies in out-of-field doses for the two techniques and are a cause of concern because TPS calculations cannot accurately predict such doses. The obtained doses may presumably increase the risk of the development of second tumors.
- HBM4EU chromates study: genotoxicity and oxidative stress biomarkers in workers exposed to hexavalent chromiumPublication . Tavares, Ana; Aimonen, Kukka; Ndaw, Sophie; Fučić, Aleksandra; Catalán, Julia; Duca, Radu Corneliu; Godderis, Lode; Gomes, Bruno C.; Janasik, Beata; Ladeira, Carina; Louro, Henriqueta; Namorado, Sónia; Nieuwenhuyse, An Van; Norppa, Hannu; Scheepers, Paul T. J.; Ventura, Célia; Verdonck, Jelle; Viegas, Susana; Wasowicz, Wojciech; Santonen, Tiina; Silva, Maria JoãoA study was conducted within the European Human Biomonitoring Initiative (HBM4EU) to characterize occupational exposure to Cr(VI). Herein we present the results of biomarkers of genotoxicity and oxidative stress, including micronucleus analysis in lymphocytes and reticulocytes, the comet assay in whole blood, and malondialdehyde and 8-oxo-2′-deoxyguanosine in urine. Workers from several Cr(VI)-related industrial activities and controls from industrial (within a company) and non-industrial (outwith company) environments were included. The significantly increased genotoxicity (p = 0.03 for MN in lymphocytes and reticulocytes; p < 0.001 for comet assay data) and oxidative stress levels (p = 0.007 and p < 0.001 for MDA and 8-OHdG levels in pre-shift urine samples, respectively) that were detected in the exposed workers over the outwith company controls suggest that Cr(VI) exposure might still represent a health risk, particularly, for chrome painters and electrolytic bath platers, despite the low Cr exposure. The within-company controls displayed DNA and chromosomal damage levels that were comparable to those of the exposed group, highlighting the relevance of considering all industry workers as potentially exposed. The use of effect biomarkers proved their capacity to detect the early biological effects from low Cr(VI) exposure and to contribute to identifying subgroups that are at higher risk. Overall, this study reinforces the need for further re-evaluation of the occupational exposure limit and better application of protection measures. However, it also raised some additional questions and unexplained inconsistencies that need follow-up studies to be clarified.