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BackgroundRefractory angina (RA) is a chronic condition characterized by the presence of debilitating angina symptoms due to established reversible ischemia in the presence of obstructive coronary artery disease (CAD). Treatments for this condition have undergone major developments in recent decades; however, the treatment for RA remains a challenge for medicine. In this sense, the Coronary Sinus Reducer System (CSRS) stands as the last line of therapy for ineligible patients for revascularization with reversible ischemia. The purpose of this report is to evaluate the potential burden on the National Health Service (NHS) and measure the health effects in terms of both quantity (life years) and quality-of-life aspects related to the reducer.MethodsTwo different economic evaluation models were developed as part of the analysis. The budget impact was developed to estimate the potential burden on the NHS from incremental uptake of the use of the reducer in the target population. The utility cost analysis compares and evaluates the quality of life and health resource use and costs between the two alternatives, based on the research of Gallone et al. A deterministic and probabilistic sensitivity analysis was carried out to characterize the uncertainty around the parameters of the model.ResultsIn the budget impact analysis (BIA), the reducer is shown to be more expensive in the first 2 years of the model, due to the gradual uptake in the market and the cost of the device. Starting from the third year, assuming maintenance of effectiveness, there are savings in terms of resource absorption in direct healthcare costs arising from hospitalizations, emergency department accesses, coronarography, and visits avoided.ConclusionThe BIA and cost-effectiveness model show that the reducer device, despite an increase in resources absorbed in the first years of implementation and use, has the potential to result in increased quality of life in patients with RA. These costs are largely offset in the short term by the improved clinical outcomes achievable leading to savings from the third year onward in the BIA and a dominance ratio in the cost–utility analysis.

More than 10 million Europeans show signs of mild cognitive impairment (MCI), a transitional stage between normal brain aging and dementia stage memory disorder. The path MCI takes can be divergent; while some maintain stability or even revert to cognitive norms, alarmingly, up to half of the cases progress to dementia within 5 years. Current diagnostic practice lacks the necessary screening tools to identify those at risk of progression. The European patient experience often involves a long journey from the initial signs of MCI to the eventual diagnosis of dementia. The trajectory is far from ideal. Here, we introduce the AI-Mind project, a pioneering initiative with an innovative approach to early risk assessment through the implementation of advanced artificial intelligence (AI) on multimodal data. The cutting-edge AI-based tools developed in the project aim not only to accelerate the diagnostic process but also to deliver highly accurate predictions regarding an individual's risk of developing dementia when prevention and intervention may still be possible. AI-Mind is a European Research and Innovation Action (RIA H2020-SC1-BHC-06-2020, No. 964220) financed between 2021 and 2026. First, the AI-Mind Connector identifies dysfunctional brain networks based on high-density magneto- and electroencephalography (M/EEG) recordings. Second, the AI-Mind Predictor predicts dementia risk using data from the Connector, enriched with computerized cognitive tests, genetic and protein biomarkers, as well as sociodemographic and clinical variables. AI-Mind is integrated within a network of major European initiatives, including The Virtual Brain, The Virtual Epileptic Patient, and EBRAINS AISBL service for sensitive data, HealthDataCloud, where big patient data are generated for advancing digital and virtual twin technology development. AI-Mind's innovation lies not only in its early prediction of dementia risk, but it also enables a virtual laboratory scenario for hypothesis-driven personalized intervention research. This article introduces the background of the AI-Mind project and its clinical study protocol, setting the stage for future scientific contributions.

Background: Prolactinoma, the most common pituitary adenoma, is usually treated with dopamine agonist (DA) therapy like cabergoline. Surgery is second-line therapy, and radiotherapy is used if surgical treatment fails or in relapsing macroprolactinoma. Objective: This study aimed to provide economic evidence for the management of prolactinoma in Italy, using a cost-of-illness and cost-utility analysis that considered various treatment options, including cabergoline, bromocriptine, temozolomide, radiation therapy, and surgical strategies. Methods: The researchers conducted a systematic literature review for each research question on scientific databases and surveyed a panel of experts for each therapeutic procedure’s specific drivers that contributed to its total cost. Results: The average cost of the first year of treatment was €2,558.91 and €3,287.40 for subjects with microprolactinoma and macroprolactinoma, respectively. Follow-up costs from the second to the fifth year after initial treatment were €798.13 and €1,084.59 per year in both groups. Cabergoline had an adequate cost-utility profile, with an incremental cost-effectiveness ratio (ICER) of €3,201.15 compared to bromocriptine, based on a willingness-to-pay of €40,000 per quality-adjusted life year (QALY) in the reference economy. Endoscopic surgery was more cost-effective than cabergoline, with an ICER of €44,846.64. Considering a willingness-to-pay of €40,000/QALY, the baseline findings show cabergoline to have high cost utility and endoscopic surgery just a tad above that. Conclusions: Due to the favorable cost-utility profile and safety of surgical treatment, pituitary surgery should be considered more frequently as the initial therapeutic approach. This management choice could lead to better outcomes and an appropriate allocation of healthcare resources.

Introduction: An ostomy is a procedure in which an opening is made in the abdominal wall to establish a communication between the intestinal or urinary system and the external environment. Peristomal skin complications pose a constant challenge for the majority of individuals with a stoma, as they represent the most common postoperative complication. The aim of this study was to develop an economic evaluation model for assessing the costs associated with peristomal skin complications. Methods: In order to identify these costs, a survey was conducted in collaboration with the Coloplast Ostomy Forum group with the aim of mapping and documenting the timelines and all activities in the management of these complications. The data obtained from the survey were subsequently analyzed using the Activity Based Costing methodology. Results: The results of this analysis clearly indicate that the expenditure for initial visits is higher compared to subsequent ones, and that severe peristomal skin complications impose a greater economic burden than less severe complications. Specifically, the average total cost for managing severe peristomal skin complications amounts to € 104.6. Conclusion: This kind of analysis could provide support to decision-makers in dealing with a more accurate estimate of costs related to healthcare processes, aiming to implement rates able to “cover” the overall cost of certain healthcare activities. Specifically, there is currently no specific rate aimed at defining the value associated with the care and management of this type of complication, so this study confirms that this is an economic challenge that the National Health Service must address.

Background: The objective of healthy aging strategies is to support interventions targeting autonomy loss prevention, with the assumption that these interventions are likely to be efficient by simultaneously improving clinical outcomes and saving costs. Methods: We compare the economic impact of two interventions targeting frailty prevention in older European populations: a multicomponent intervention including physical activity monitoring, nutrition management, information and communications technology use and a relatively simple healthy aging lifestyle education program based on a series of workshops. Our sample includes 1,519 male and female participants from 11 European countries aged 70 years or older. Our econometric model explores trends in several outcomes depending on intervention receipt and frailty status at baseline. Results: Implementing a multicomponent intervention among frail older people does not lead to a lower use of care and do not prevent quality of life losses associated with aging. However, it impacts older people's sense of priorities and interest in the future. We find no statistically significant differences between the two interventions, suggesting that the implementation of a multicomponent intervention may not be the most efficient strategy. The impact of the interventions does not differ by frailty status at baseline. Conclusions: Our results show the need to implement healthy aging strategies that are more focused on people's interests.

ObjectivesTo assess the cost-effectiveness of switching from adjuvanted quadrivalent vaccine (aQIV) to high-dose quadrivalent influenza vaccine (HD-QIV) in those aged ≥65 years from the Italian National Health Service perspective.MethodsWe developed a decision tree model over a 1-year time-horizon to assess influenza-related costs and health outcomes. Two hospitalization approaches were considered: “hospitalization conditional on developing influenza” and “hospitalization possibly related to Influenza.” The first approach considered only hospitalizations with influenza ICD-9-CM diagnosis codes. The second included hospitalizations for cardiorespiratory events possibly related to influenza to better capture the “hidden burden”. Since comparative efficacy of high-dose quadrivalent influenza vaccine versus adjuvanted quadrivalent vaccine was lacking, we assumed relative efficacy versus a common comparator, standard-dose influenza quadrivalent vaccines (SD-QIV). We assumed the relative efficacy of HD-QIV vs. SD-QIV was 24.2 and 18.2% for the first and second hospitalization approaches, respectively, based on published information. Due to lack of comparative efficacy data for aQIV vs. SD-QIV, we assumed three different scenarios: 0, 6, and 12% relative efficacy in scenarios 1, 2, and 3, respectively.ResultsFor the first hospitalization approach, HD-QIV was a cost-effective alternative to aQIV in all scenarios at a willingness-to-pay threshold of €30,000 per Quality Adjusted Life Years. The incremental cost-effectiveness ratios across the scenarios were €7,301, €9,805, and €14,733, respectively, much lower than the willingness-to-pay per Quality Adjusted Life Years threshold. For the second hospitalization approach, HD-QIV was a dominant alternative to aQIV across all scenarios. The robustness of the results was confirmed in one-way and probabilistic sensitivity analyses.ConclusionSwitching to HD-QIV from aQIV for the older adult in Italy would improve health-related outcomes, and would be cost-effective or cost saving.

We study the effect of an amplification mechanism in a nonlinear vibration energy harvesting system where a ferromagnetic beam resonator is attached to the vibration source through an additional linear spring with a damper. The beam moves in the nonlinear double-well potential caused by interaction with two magnets. The piezoelectric patches with electrodes attached to the electrical circuit support mechanical energy transduction into electrical power. The results show that the additional spring can improve energy harvesting. By changing its stiffness, we observed various solutions. At the point of the optimal stiffness of the additional spring, the power output is amplified a few times depending on the excitation amplitude.

Abstract This paper presents a reliability analysis of the punching shear of flat slabs without shear reinforcement. The evaluation is performed for the codes ACI 318, Eurocode 2, Model Code 2010, and ABNT NBR 6118:2014. Six models were used for predicting the punching strength, the design models, the Critical Shear Crack Theory (CSCT), and a Nonlinear Finite Element Analysis (NLFEA) model. Reliability analysis was performed to evaluate the safety level of code provisions. Design code provisions were evaluated in terms of sufficient reliability criteria based on target reliability β=3.8. This target reliability was based in the Model Code 2010 criteria. This criterion represents an acceptable value level of safety in design of structures. The results showed that the reliability indexes β presented satisfactory for all slabs designed by the Model Code 2010. However, this paper also shows some of the tested slabs presented reliability index below 3.0, being the ACI 318 the code with the lowest reliability index.

BackgroundSymptomatic severe aortic stenosis is a congenital or acquired aortic valve disease that occurs when the aortic valve of the heart narrows. It represents the most common valvular disease in adults and generally has a degenerative nature. Transcatheter aortic valve implantation (TAVI), due to its non-invasive approach, has become the standard treatment in patients who are ineligible to surgery or at high surgical risk, and it is also increasingly being performed in patients at intermediate to low surgical risk. The aim is to analyze the heterogeneity and explore the limitations of current health technology assessments (HTAs) on TAVI.MethodsFor the purpose of this analysis, a review of the literature based on manual research was performed. A population, intervention, comparators, and outcome (PICO) model was used to gather the HTA reports assessing TAVI in the treatment of patients affected by symptomatic severe aortic valve stenosis at low surgical risk. Furthermore, a manual search has been developed to also include assessments from the Haute Autorité de Santé.ResultsAt the end of the investigation, a certain degree of heterogeneity in the evidence factored and in the recommendations on the technology has emerged. Relative to the clinical domains, the main drivers for the disparity are found in the type of evidence considered and in the use or not of the grading of recommendations, assessment, development, and evaluation (GRADE) methodology to evaluate the quality of the clinical evidence included. Another element concerns the chosen device generation assessed within the evaluation. In order to perform the economic evaluation, a cost-utility analysis and a budget impact model were developed. Despite some elements of heterogeneity, the economic assessments demonstrate a favorable or dominant cost-effectiveness profile for TAVI compared with surgical aortic valve replacement (SAVR).ConclusionDespite the presence of heterogeneity elements both in clinical and economic domains, HTA agencies reached the same recommendations on the use of TAVI. It emerged the need for a centralized vision on the “strong” domains, which means giving up freedom to local bodies to adapt to their context on the “soft” ones. This approach could have the potential to strengthen the role of HTA in Europe by ensuring faster decision-making and equity of access to health innovations and reduce the heterogeneity in the assessment methods.

The goal of this study was to apply the principles of analytical quality by design (AQbD) to the analytical method for determining the radiochemical purity (PQR) of the radiopharmaceutical sodium iodide 131I oral solution, utilizing thin-layer chromatography (TLC) with a radio–TLC scanner, which also enables the evaluation of product quality. For AQbD, the analytical target profile (ATP), critical quality attributes (CQA), risk management, and the method operable design region (MODR) were defined through response surface methodology to optimize the method using MINITAB® 19 software. This study encompassed the establishment of a control strategy and the validation of the method, including the assessment of selectivity, linearity, precision, robustness, detection limit, quantification limit, range, and the stability of the sample solution. Under the experimental conditions, the method parameters of the TLC scanner were experimentally demonstrated and optimized with an injection volume of 3 µL, a radioactive concentration of 10 mCi/mL, and a carrier volume of 40 µL. Statistical analysis confirmed the method’s selectivity for the 131I iodide band Rf of 0.8, a radiochemical impurity IO3− Rf of 0.6, a linearity from 6.0 to 22.0 mCi/mL, and an intermediate precision with a global relative standard deviation (RSD) of 0.624%. The method also exhibited robustness, with a global RSD of 0.101%, a detection limit of 0.09 mCi/mL, and a quantification limit of 0.53 Ci/mL, meeting the prescribed range and displaying stability over time (at 0, 2, and 20 h) with a global RSD of 0.362%, resulting in consistent outcomes. The development of a method based on AQbD facilitated the creation of a design space and an operational space, with comprehensive knowledge of the method’s characteristics and limitations. Additionally, throughout all operations, compliance with the acceptance criteria was verified. The method’s validity was confirmed under the established conditions, making it suitable for use in the manufacturing process of sodium iodide 131I and application in nuclear medicine services.

Moringa oleifera Lam, commonly known as moringa, is a plant widely used both as a human food and for medicinal purposes around the world. This research aimed to evaluate the efficacy of the aqueous extract of Moringa oleifera leaves (MoAE) and benzyl isothiocyanate (BIT) in rats with induced breast cancer. Cancer was induced with 7,12-dimethylbenz[a]anthracene (DMBA) at a dose of 60 mg/kg by orogastric gavage once only. Forty-eight rats were randomly assigned to eight groups, each consisting of six individuals. The control group (healthy) was called Group I. Group II received DMBA plus saline. In addition to DMBA, Groups III, IV, and V received MoAE at 100, 250, and 500 mg/kg/day, respectively, while Groups VI, VII, and VIII received BIT at 5, 10, and 20 mg/kg/day, respectively. Treatment was carried out for 13 weeks. Secondary metabolite analysis results identified predominantly quercetin, caffeoylquinic acid, neochlorogenic acid, vitexin, and kaempferol, as well as tropone, betaine, loliolide, and vitexin. The administration of MoAE at a dose of 500 mg/kg and BIT at 20 mg/kg exhibited a notable decrease in both the total tumor count and the cumulative tumor weight, along with a delay in their onset. Furthermore, they improved the histological grade. A significant decrease in serum levels of VEGF and IL-1β levels was observed (p < 0.001) with a better effect demonstrated with MoAE at 500 mg/kg and BIT at 20 mg/kg. In conclusion, this study suggests that both the aqueous extract of Moringa oleifera leaves and the benzyl isothiocyanate possess antitumor properties against mammary carcinogenesis, and this effect could be due, at least in part, to the flavonoids and isothiocyanates present in the extract.

Abstract The rehabilitation and strengthening of concrete structures using carbon fiber reinforced polymers (CFRP) has become an interesting alternative for a series of important aspects. This material has a low specific weight, high tensile strength, corrosion and fatigue resistance, a high modulus of elasticity, and is a versatile material, with ease and speed in its application. Nevertheless, its consideration and design tend to require more sophisticated analyses to evaluate and predict the behavior of the strengthened structural element. For this reason, numerical methods, such as the Finite Element Method (FEM), can be used in such complex analyses to simulate to a high degree the actual performance of the structure. Thus, this work presents computer simulations of reinforced concrete beams shear strengthened with CFRP through the Finite Element Method in a customized ANSYS model. Special attention is given to the bond behavior between the CFRP sheets and the concrete surface of the beams through contact elements and bilinear cohesive zone models, which allowed for the identification of the debonding failure modes. Twenty-one reinforced concrete beams reported in the literature were simulated: twelve simply supported and nine continuous, with and without CFRP shear strengthening. The beams showed failure modes in shear, bending, concrete splitting, and debonding of the strengthening CFRP sheets. The numerical model developed predicted with good accuracy the beams' behavior in terms of load vs. displacement, load vs. strain, as well as their ultimate loads and failure modes.

A criação de espaços, onde actores como pais, familiares, escolas, professores e profissionais de saúde possam interagir, é uma alternativa para se obterrespostas de superação, no que concerne à vulnerabilidade da gravidez precoce. O objectivodeste artigo é de caracterizar a gravidez precoce de acordoaonível de conhecimento que as adolescentes doColégio Baptista do Huambo – Angola, possuem. A investigação realizada é de naturezaqualitativa. Para o efeito, empregou-se o método da observação directa, da entrevista e do questionário. Esta abordagemaponta a gravidez precoce como consequência da limitada educação sexual entre as adolescentes. Os resultados obtidosindicam que a gravidez precoce está associada à insuficiente educação das famílias e suaestruturação, aodesenvolvimento sexual precoce e aonível económico.

In this article, we investigate in different scenarios the feasibility of using massive multiple-input–multiple-output (mMIMO) with reconfigurable intelligent surfaces (RISs) to increase the throughput and coverage with high energy efficiency, considering sub-6 GHz, mmWave, and THz bands. With that objective, a centralized radio access network (C-RAN) suitable for beyond fifth-generation (B5G) systems is considered, where we integrate the base stations (BSs) with multiple RISs and IoT devices or user equipment. RISs with a large number of quasi-passive reflecting elements constitute a low-cost approach capable of shaping radio wave propagation and improving wireless connectivity. We consider a scenario where multiple RISs are combined with mMIMO in the uplink in order to provide connectivity to a smart city (with thousands of active low-power IoT devices), wirelessly, in the 3.6 GHz and 28 GHz bands. We also address a scenario where RISs are adopted with mMIMO in the downlink so as to offer connectivity to a stadium with a pitch, (and thousands of active users’ equipment) in the 28 GHz band. Finally, we also studied the connectivity at 100 GHz of a factory in which several RIS panels, replacing most of the BSs equipped with mMIMO, assure improved throughput and coverage. We concluded that RISs are capable of improving the performance in any of these analyzed scenarios at the different frequency bands, justifying that they are a key enabling technology for 6G.

Cannabis is a plant that is cultivated worldwide, and its use is internationally regulated, but some countries have been regulating its medicinal, social, and industrial uses. This plant must have arrived in Peru during the Spanish conquest and remains widely cultivated illicitly or informally to this day. However, new regulations are currently being proposed to allow its legal commercialization for medicinal purposes. Cannabis contains specific metabolites known as cannabinoids, some of which have clinically demonstrated therapeutic effects. It is now possible to quantitatively measure the presence of these cannabinoids in dried inflorescences, thus allowing for description of the chemical profile or “chemotype” of cannabinoids in each sample. This study analyzed the chemotypes of eight samples of dried inflorescences from cannabis cultivars in four different regions of Peru, and based on the significant variation in the cannabinoid profiles, we suggest their therapeutic potential. The most important medical areas in which they could be used include the following: they can help manage chronic pain, they have antiemetic, anti-inflammatory, and antipruritic properties, are beneficial in treating duodenal ulcers, can be used in bronchodilators, in muscle relaxants, and in treating refractory epilepsy, have anxiolytic properties, reduce sebum, are effective on Methicillin-resistant Staphylococcus aureus, are proapoptotic in breast cancer, can be used to treat addiction and psychosis, and are effective on MRSA, in controlling psoriasis, and in treating glioblastoma, according to the properties of their concentrations of cannabidiol, cannabigerol, and Δ9-tetrahydrocannabinol, as reviewed in the literature. On the other hand, having obtained concentrations of THC, we were able to suggest the psychotropic capacity of said samples, one of which even fits within the legal category of “non-psychoactive cannabis” according to Peruvian regulations.

Background: Over 20% of healthcare workers (HCWs) are active smokers. Smoking is a targeted issue for workplace health promotion (WHP) programs. Objective: Our study aims to evaluate the effectiveness of the Stop Smoking Promotion (SSP) intervention, a 6-hour training course for HCWs, which took place from May 2018 to July 2019. Methods: We compared HCWs who successfully quit smoking (n = 15) to those who did not (n = 25) in terms of Sickness Absence Days (SADs). Moreover, we conducted an econometric analysis by calculating the return on investment and implementing a break-even analysis. Findings: Among the 40 enrolled workers, a success rate of 37.5% was observed after a span of over two years from the SSP intervention (with nurses and physicians showed the best success rate). Overall, participants showed a noticeable absenteeism reduction after the SSP intervention, with a reduction rate of 85.0% in a one-year period. The estimated ROI for the hospital was 1.90, and the break-even point was 7.85. In other words, the organization nearly doubled its profit from the investment, and the success of at least eight participants balanced costs and profits. Conclusion: Our pilot study confirms that WHP programs are simple and cost-saving tools which may help improve control over the smoking pandemic in healthcare settings.

This document illustrates the results of a discussion of two multi-disciplinary expert panels on pricing and reimbursement of medicines. Experts work in different organizations. The discussion focused on comparator(s), endpoint(s), negotiation of prices of new medicines and/or indications to include in the List 648, as well as the role of cost-effectiveness in the price and reimbursement negotiation. The debate took place during the fourth edition of the Seminari di Mogliano, organized on the 30th of September/1st of October, 2021. The two panels agreed on a general need to enhance interaction among the different stakeholders, in the early assessment and negotiation phases, and to increase the transparency/reproducibility of the decisions taken. The experts have also emphasized the need (i) to improve clarity in the evaluation of additional therapeutic value and the place in therapy with respect to comparators and how comparators are identified; (ii) to create work groups to identify the most appropriate endpoint(s), for each therapeutic area and level of unmet needs; (iii) to provide for a systematic use of cost-effectiveness when an added therapeutic value is delivered by a new medicine. With regard to the 648 List, the experts advocated for an overall reorganization of the current rules governing the special uses of drugs.

Abstract Background To keep a high quality of assistance it is important for hospitals to invest in health technologies (HTs) that have the potential of improving health outcomes. Even though guidance exists on how HTs should be introduced, used and dismissed, there is a surprising gap in literature concerning the awareness of hospitals in the actual utilization of HTs. Methods We performed a systematic literature review of qualitative and quantitative studies aimed at investigating hospital contextual factors that influence the actual utilization of HTs. PubMed, Scopus, Web of Science, Econlit and Ovid Medline electronic databases were searched to retrieve articles published in English and Italian from January 2000 to January 2019. The quality of the included articles was assessed using the Critical Appraisal Skills Programme checklist for qualitative studies, Newcastle-Ottawa Scale for the cross-sectional studies and the Mixed Methods Appraisal Tool for mixed method studies. Results We included 33 articles, which were of moderate to high methodological quality. The included articles mostly addressed the contextual factors that impact the implementation of information and communication technologies (ICTs). Overall, for all HTs, the hospital contextual factors were part of four categories: hospital infrastructure, human resource management, financial resources and leadership styles. Conclusion Our systematic review reported that the contextual factors influencing the HTs utilization at hospital level are mainly explored for ICTs. Several factors should be considered when planning the implementation of a new HTs at hospital level. A potential publication bias might be present in our work, since we included articles published only in English and Italian Language, from January 2000 to January 2019. There remains a gap in the literature on the facilitators and barriers influencing the implementation and concrete utilization of medical and surgical HTs, suggesting the need for further studies for a better understanding.

BackgroundDiabetic Macular Edema (DME) is the most common cause of vision loss in diabetic patients. Currently, the Vascular Endothelial Growth Factor inhibitors (anti-VEGFs) are used as the first line of DME treatment and corticosteroid implants are usually used as a second-line treatment. These implants are a safe and effective therapeutic option that can improve the quality of life of DME patients by reducing the intravitreal injections number. We determined the economic impact related to DME, also from the social perspective, and the consequences of the increased use of the dexamethasone implant.MethodsThe analysis compares two scenarios: the first based on the current rate of recourse to the therapeutic alternatives available in the Italian healthcare setting (as is) and the second based on the assumption of an increased recourse to dexamethasone implants (to be). The results are expressed both in terms of the resource absorption associated with the two scenarios and in terms of the cost differential yielded by their comparison.ResultsThe increased use of the dexamethasone implant allows considerable savings in terms of healthcare professionals' time, follow-up and productivity lost by patients/caregivers. These savings would reduce healthcare costs for the management of DME patients in Italy by €2,058,238 in 5 years.ConclusionsTo optimize the healthcare resources allocation, it is necessary to implement treatments that yield not only cost reductions but also a clinical benefit for patients. The dexamethasone implant use is an example of DME management that generates value for patients, health system and society.

Managed entry agreements (MEA) represent one of the main topics of discussion between the European National Payers Authorities. Several initiatives on the subject have been organized over the past few years and the scientific literature is full of publications on the subject. There is currently little international sharing of information between payers, mainly as a result of the confidentiality issues. There are potential benefits from the mutual sharing of information, both about the existence of MEAs and on the outcomes and results. The importance of involving all the players in the decision-making process on market access for a medicinal product (MP) is that it may help to make new therapies available to patients in a shorter time. The aim of this project is to propose a new pathway of value-based MEA (VBMEA), based on the analysis of the current Italian pricing and reimbursement framework. This requires elaboration of a transparent appraisal and MEA details with at least a 24-month contract. The price of the MP is therefore valued based on the analysis of the VBMEA registries of the Italian Medicines Agency. Although the proposal focuses on the Italian context, a similar approach could also be adapted in other nations, considering the particularities of the single health technology assessment (HTA)/payer system.

Objective: Next-generation sequencing (NGS) technology, changing the diagnostic approach, has become essential in clinical settings, and its adoption by public health laboratories is now the practice. Despite this, as technological innovations, its intake requires an evaluation of both the clinical utility and the economic investment, especially considering the rare disease scenario. This study evaluated the analytical validity and the budget impact of an NGS-Ion Torrent™ approach for the molecular germline diagnosis of two musculoskeletal rare diseases.Methods: Two cohorts of 200 and 199 patients with suspect or clinical diagnosis of multiple osteochondromas (MO) and osteogenesis imperfecta (OI) previously evaluated with a single-gene diagnostic protocol were re-analyzed using a targeted NGS assay. Analytical validity was assessed by comparing NGS and single-gene protocol. A budget impact analysis using real-world cost data-considering the healthcare perspective— was performed by applying activity-based costing (ABC). The cost considered consumables, personnel, and equipment. Additional costs not related to NGS activities were not considered. Sensitivity analysis was performed.Results: The NGS method showed a higher (for MO) and comparable (for OI) diagnostic sensitivity than the traditional techniques, apart from always reducing the time and costs of diagnosis. Overall, the cost saving per patient is € 765 for OI and € 74 for MO. Materials represented the highest cost driver of the NGS process. A time saving—proportional to the panel size—has been assessed in both cases.Conclusions: Our targeted NGS diagnostic approach decreases time to diagnosis and costs, appearing to be beneficial and recommended both for patients and from a healthcare perspective in routine diagnosis also considering very small gene panels and a low patient flow. The adequate analytical sensitivity always required the additional Sanger sequencing step of the low- and non-covered regions. A more accurate strategy evaluation is suggested in the case of ultra-rare/complex diseases, large gene-panel, or non-reference diagnostic centers.

A timely, confirmed diagnosis of Idiopathic Pulmonary Fibrosis (IPF) has a significant impact on the evolution of the disease. The current model of care in the Lazio region (in Italy) was assessed on the basis of real-world data provided by the four reference centers responsible for diagnosing and treating IPF. The 5-year, population-based, retrospective longitudinal study provided the data that is at the basis of the current proposal for a new clinical and therapeutic pathway (DTCP) and has been shared with regional decision makers. A DTCP must be defined and based on four pillars: GPs, pulmonologists, IPF centers, and telemedicine. Each must play a role within a sort of hub-and-spoke model. IPF centers remain the hubs, while spokes are identified in trained GPs and pulmonologists.

Abstract Background Patients’ increasing needs and expectations require an overall assessment of hospital performance. Several international agencies have defined performance indicators sets but there exists no unanimous classification. The Impact HTA Horizon2020 Project wants to address this aspect, developing a toolkit of key indicators to measure hospital performance. The aim of this review is to identify and classify the dimensions of hospital performance indicators in order to develop a common language and identify a shared evidence-based way to frame and address performance assessment. Methods Following the PRISMA statement, PubMed, Cochrane Library and Web of Science databases were queried to perform an umbrella review. Reviews focusing on hospital settings, published January 2000–June 2019 were considered. The quality of the studies selected was assessed using the AMSTAR2 tool. Results Six reviews ranging 2002–2014 were included. The following dimensions were described in at least half of the studies: 6 studies classified efficiency (55 indicators analyzed); 5 studies classified effectiveness (13 indicators), patient centeredness (10 indicators) and safety (8 indicators); 3 studies responsive governance (2 indicators), staff orientation (10 indicators) and timeliness (4 indicators). Three reviews did not specify the indicators related to the dimensions listed, and one article gave a complete definition of the meaning of each dimension and of the related indicators. Conclusions The research shows emphasis of the importance of patient centeredness, effectiveness, efficiency, and safety dimensions. Especially, greater attention is given to the dimensions of effectiveness and efficiency. Assessing the overall quality of clinical pathways is key in guaranteeing a truly effective and efficient system but, to date, there still exists a lack of awareness and proactivity in terms of measuring performance of nodes within networks. The effort of classifying and systematizing performance measurement techniques across hospitals is essential at the organizational, regional/national and possibly international levels to deliver top quality care to patients.

Abstract Objectives Hydroxychloroquine has shown to have antiviral activity in vitro against coronaviruses, specifically SARS-CoV-2. It is believed to block virus infection by increasing endosomal pH required for virus cell fusion and glycosylation of viral surface proteins. In addition to its antiviral activity, hydroxychloroquine has an immune-modulating activity that may synergistically enhance its antiviral effect in vivo, making it a potentially promising drug for the prevention and the cure of SARS-CoV-19. However, randomized controlled trials are needed to assess whether it can be used safely to treat COVID-19 patients or to prevent infection. The main objective of the present study is to evaluate the efficacy of hydroxychloroquine for (I) the prevention of COVID-19 or related symptoms in SARS-CoV-2-exposed subjects, such as as household members/contacts of COVID-19 patients and (II) the treatment of early-phase asymptomatic or paucisymptomatic COVID-19 patients. Trial design This is a controlled, open label, cluster-randomized, superiority trial with parallel group design. Subjects will be randomized either to receive hydroxychloroquine or to observation (2:1). Participants SARS-CoV-2-exposed subjects, including household members and/or contacts of COVID-19 patients and healthcare professionals (Group 1) or patients with COVID-19 (positive PCR test on a rhinopharyngeal or oropharyngeal swab for SARS-CoV-2), asymptomatic or paucisymptomatic in home situations who are not undergoing treatment with any anti COVID-19 medication (Group 2), will be enrolled. Paucisymptomatic patients are defined as patients with a low number of mild symptoms. All subjects must be aged ≥18 years, male or female, must be willing and able to give informed consent and must not have any contraindications to take hydroxychloroquine (intolerance or previous toxicity for hydroxychloroquine/chloroquine, bradycardia or reduction in heart rhythm with arrhythmia, ischemic heart disease, retinopathy, congestive heart failure with use of diuretics, favism or glucose-6-phosphate dehydrogenase (G6PD) deficiency, diabetes type 1, major comorbidities such as advanced chronic kidney disease or dialysis therapy, known history of ventricular arrhythmia, any oncologic/hematologic malignancy, severe neurological and mental illness, current use of medications with known significant drug-drug interactions, and known prolonged QT syndrome or current use of drugs with known QT prolongation). The study is monocentric and will be conducted at Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS. Subjects will be enrolled from a large epidemic region (North-Central Italy). The Public Health Departments of several Italian regions will collaborate by identifying potentially eligible subjects. Intervention and comparator The participants will be randomized (2:1 randomization) to receive either hydroxychloroquine (Arm A) or to Observation (Arm B). Hydroxychloroquine will be administered with the following schedule: Group1: A loading dose hydroxychloroquine 400 mg twice daily on day 1, followed by a weekly dose of hydroxychloroquine 200 mg twice daily on days 8, 15 and 22, for a total of one month of treatment. Group 2: A loading dose hydroxychloroquine 400 mg twice daily on day 1 followed by 200 mg twice daily for a total of 5-7 days. The comparator in this trial is observation given that currently neither treatment is administered to asymptomatic or paucisymptomatic subjects, nor prophylaxis is available for contacts. Hydroxychloroquine will be shipped to subjects within 24 hours of randomization. Given the extraordinary nature of the COVID-19 pandemic, only telephonic interviews will be carried out and electronic Patient Reported Outcomes (ePRO) completed. During treatment, each subject will be contacted every other day for the first week and weekly thereafter (Group 2) or weekly (Group 1) by a study physician to assess early onset of any COVID-19 symptom or any adverse reaction to hydroxychloroquine and to check subject compliance. Furthermore, all subjects will receive periodic ePROs which may be completed through smartphone or tablets to record drug self-administration and onset of any symptom or adverse event. All subjects will be followed up for a total of 6 months by periodic telephonic interviews and ePROs. Main outcomes The primary endpoint/outcome measure for this trial is: for Group 1, the proportion of subjects who become symptomatic and/or swab-positive in each arm within one month of randomization; for Group 2, the proportion of subjects who become swab-negative in each arm within 14 days of randomization. Randomization All household members and/or contacts of each COVID-19 index case, and the COVID-19 patient himself/herself, fulfilling all inclusion criteria will be grouped into a single cluster and this cluster will be randomized (2:1) to either arm A or arm B. Information on each subject will be recorded in specific data records. Randomization lists will be stratified according to the following factors regarding COVID-19 index cases: 1. COVID-19 risk level on the basis of province of residence (high vs. low/intermediate); 2. Index case is a healthcare professional (yes vs.no) 3. Index case with COVID-19 treatment (yes vs. no) An independent statistician not otherwise involved in the trial will generate the allocation sequence, and COVID-19 response teams will be unaware of the allocation of clusters. Randomization will be performed through an interactive web-based electronic data-capturing database. An Independent Data Monitoring Committee has been established. Blinding (masking) This study is open label. Numbers to be randomized (sample size) For Group 1, a sample size of about 2000 SARS-CoV-2-exposed subjects such as household members and/or contacts of COVID-19 patients will take part in the study. Assuming around 1.5-2.0 asymptomatic household members and/or contacts for each COVID-19 patient, we expect to identify approximately 1000-1300 COVID-19 index cases to be randomized. An interim analysis on efficacy is planned using standard alpha-spending function. For Group 2, sufficient power for primary objective (negative swab within 14 days of randomization) will be reached given a sample size of 300 asymptomatic or paucisymptomatic COVID-19 subjects in home situations not treated for COVID-19 (25%-30% of about 1000-1300 expected index cases). Since up to date reduced evidence about COVID-19 infection epidemiology, the continuous update of diagnostic and therapeutic approaches, the sample size estimation could be updated after a one third of population will be recruited and eventually modified according to a substantial protocol amendment. An interim analysis at 100 enrolled COVID-19 patients is planned. We have planned a Generalized Estimating Equation analysis, which is more efficient than a cluster level analysis, to take advantage of subject-specific covariates. The above reported sample size analysis is therefore to be considered conservative. Trial Status The current version of the PROTECT trial protocol is ‘Final version, 15 April 2020’. The study started on 9th May 2020. The first patient was enrolled on 14th May 2020. Recruitment is expected to last through September 2020. Trial registration The PROTECT trial is registered in the EudraCT database (no. 2020-001501-24) and in ClinicalTrials.gov ( NCT04363827 ), date of registration 24 April 2020. Full protocol The full PROTECT protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interests of expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol (Protocol final version, 15th April 2020). The study protocol has been reported in accordance with Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).

Introduction: Adherence to long-term asthma control drugs is one of the key factors in improving disease management among patients with asthma. Poor adherence to long-term therapies significantly compromises the effectiveness of treatment and represents a problem in controlling the disease in terms of quality of life and economic impact. A budget impact analysis has been developed taking into account that Turbo+ technology (electronic monitoring device) can increase adherence to therapy in patients suffering from asthma. Methods: Coherently with the budget impact model methodology, we developed two different scenarios. One represents the clinical practice assuming a constant market share of 0,99% for Turbo+ and the other one assumes an incremental market share of Turbo+ over the time horizon considered. An increase in adherence to therapy will likely correspond to a reduction of exacerbations and a lower rate of hospitalizations, thus generating savings in terms of use of health resources. Results: The differential analysis shows an incremental saving in terms of resources absorbed by the National Health Service (NHS) over the time horizon considered. In the first year the savings are equal to € 795,658.64 and in the fifth year they are equal to € 3,520,636.34 for a total of resources saved in 5 years of € 10,882,028.50. Conclusions. The model shows how the diffusion of the Turbo+ programme can lead to savings in terms of health resources consumed by the NHS. Further analyses with new real-world data on adherence in asthmatic patients could be useful in confirming the results of the present analysis.

Temporal lobe epilepsy (TLE) is the most common type of focal epilepsy and is frequently drug-resistant (DR) to antiseizure medication (ASM), corresponding to approximately one-third of the cases. When left inadequately treated, it can worsen the quality of life, cognitive deficits, and risk of death. The standard treatment for drug-resistant TLE is the surgical removal of the structures involved, with good long-term outcome rates of 60–70 % and a low rate of adverse effects. The goal of successful treatment is sustained seizure freedom. In our study, we evaluated sustained long-term (up to 23 years) surgical outcomes in 621 patients with DR-TLE associated with hippocampal sclerosis, who underwent a temporal lobectomy. We analyzed the main predictive factors that influence the surgical outcome related to seizure control, through a longitudinal and retrospective study, using a multivariable regression model. We found that 73.6% of the patients were free from disabling seizures (Engel Class I), maintained over time in 65% of patients followed up to 23 years after surgery. We found that four independent variables predicted seizure outcomes. The presence of dysmnesic and olfactory aura predicted a less favorable outcome. The history of febrile seizure and the surgical technique predicted a good outcome. Regarding the type of surgical technique, the standard anteromesial temporal lobectomy (ATL) led to significantly better outcomes (78.6% Engel Class I) when compared to the selective amygdalohippocampectomy via subtemporal approach (67.2% Engel Class I; p = 0.002), suggesting that the neuronal networks involved in the epileptogenic zone may be beyond mesial temporal structures. The multivariable regression model with the above-mentioned predictor variables revealed an ExpB = 3.627 (N = 621, p < 0.001), indicating that the model was able to distinguish between patients with a seizure-free. We conclude that epilepsy surgery is a safe procedure, with low rates of postoperative complications and good long-term results.

Background: The distribution of ostomy and incontinence devices takes place through different modalities according to the regional provisions in force. A first possibility is represented by direct distribution by the local health authorities. A second possibility consists of indirect distribution through affiliated retailers, typically pharmacies and authorized retailers of medical devices. A third form of distribution concerns home distribution. Methods: A survey has been administered to patients’ associations in order to investigate the degree of patients’ satisfaction with the distribution methods of medical devices necessary for the conditions associated with ostomy and incontinence and to provide an estimate of the indirect costs associated with distribution methods in the Italian healthcare context through the development of a budget impact model. Results: The distribution methods associated with a greater degree of satisfaction seem to be indirect and home distribution. Regarding the results of the budget impact mode, in our simulation, a diffusion of home distribution compared to direct and indirect distribution could lead to savings equal to 2,479,519 € over the three-year time horizon considered. Conclusion: The analysis conducted demonstrates how an increase in home distribution in the context of devices associated with people with ostomy or who practice self-catheterization can be associated with resource savings for the entire society (indirect costs avoided). The survey also demonstrates how this distribution method is associated with a good degree of satisfaction on the part of the users who use it.

A esquistossomose na apresentação testicular é rara, entretanto, diante da queixa de nódulo escrotal, principalmente em áreas endêmicas, esse diagnóstico pode ser considerado. Este trabalho relata o caso de um nódulo testicular causado por Schistosoma mansoni simulando uma neoplasia de testículo em um paciente de 46 anos, residente em Entre Rio de Minas, Minas Gerais, Brasil, que procurou serviço de urologia queixando dor e aumento da bolsa escrotal com evolução de 4 meses. Ao exame físico, apresentava aumento do testículo esquerdo e nódulo à palpação. Inicialmente, foi realizada uma Ultrassonografia com Doppler Colorido de testículo, que evidenciou múltiplas imagens ecogênicas dispersas pelo parênquima e baixa captação de fluxo à esquerda. Os resultados foram negativos para marcadores tumorais. Após retorno, uma Ressonância Magnética foi solicitada e evidenciou heterogeneidade difusa com áreas internas de baixo realce em T1 e T2 e realce heterogêneo ao meio de contraste, gerando suspeita de tumor seminomatoso testicular. A conduta final realizada foi a orquiectomia esquerda, sem biópsia prévia devido à alta probabilidade neoplásica. O laudo anatomopatológico evidenciou granulomas epitelioides com células gigantes envolvendo ovos característicos de Schistossoma sp., achados compatíveis com esquistossomose testicular. O paciente foi direcionado ao serviço de infectologia, onde solicitou-se sorologia para esquistossomose, apresentando IgG positivo e TGP acima do limite da normalidade. O paciente foi tratado com 6 comprimidos de Praziquantel 600 mg em dose única e manteve-se em acompanhamento. Apesar de os tumores malignos de células germinativas representarem a grande maioria das massas testiculares, um diagnóstico diferencial com esquistossomose testicular pode ser instituído, principalmente em áreas endêmicas. Uma vez que a diferenciação entre os granulomas esquistossomóticos e os tumores testiculares não é possível aos exames de imagem, a biópsia de congelamento transoperatória, já recomendada em caso de dúvida diagnóstica durante a cirurgia de exteriorização testicular (EAU, 2019) pode ser realizada para definição diagnóstica. Confirmada a esquistossomose, é discutível a possibilidade de um tratamento conservador com a terapia antiesquistossomótica usual na expectativa de regressão do nódulo e preservação do testículo.

Today, the internet is fundamental to social inclusion. There are many people that live in remote areas, and the only way to supply internet services is through the use of microwave terrestrial and satellite systems. Thus, it is important to have efficient tools to design and optimize these systems. In this paper, a tool with the objective to shorten the time spent in the design process of microwave terrestrial and satellite point-to-point links is presented. This tool can be applied in academia by engineering students, providing an extended analysis of many sections of a link project design, as well as in professional practice by telecommunication engineering departments, presenting a concise step-by-step interactive design process. This tool uses three-dimensional world visualization, with the Cesium Application Programming Interface (API), to display and analyze site-specific characteristics that can disrupt the link’s quality of service (QoS). Using this visualization, two ray-tracing algorithms were developed to analyze signal diffraction and reflection mainly throughout terrestrial links. Using this new algorithm, an innovative process for signal diffraction and reflection calculations was created. Using updated standards provided by the International Telecommunication Union Radiocommunication Sector (ITU-R), the characteristics of the defined simulated links could be predicted, thus providing the user with the metrics of signal quality and system link budget.

We conducted field bioassays with several known cerambycid pheromones in two zones of central-southern Chile: (1) Las Trancas (Ñuble region) and Coñaripe (Los Rios region) (Study 1) and (2) Rucamanque and Maquehue (La Araucania region) (Study 2). Up to eight compounds were tested individually, including 3-hydroxy-2-hexanone, (2R*,3S*)- and (2R*,3R*)-2,3-hexanediol, fuscumol, fuscumol acetate, monochamol, 2-methylbutanol, and geranylacetone. Compounds were loaded in plastic sachets placed in either multiple funnel or cross-vane panel traps hung in trees in a randomized block design (n = 3 or 4). The number of treatments and bioassay periods varied depending on the study. A total of 578 specimens belonging to 11 native species were collected, with the three captured in the highest numbers being Eryphus laetus (292 specimens), Calydon submetallicum (n = 234), and Chenoderus testaceus (n = 20). The three species are of economic importance: E. laetus is considered a minor pest in apple orchards, and the other two species infest Nothophagus hosts, including some timber species. Traps baited with 3-hydroxy-2-hexanone collected significant numbers of both sexes of the two most abundant species, and this compound was the only treatment that attracted C. submetallicum. (2R*,3R*)- and (2R*,3S*)-2,3-Hexanediols were also significantly attractive to E. laetus. Our results suggested that 3-hydroxy-2-hexanone and 2,3-hexanediols, which are known pheromone components of cerambycid species worldwide, are also likely to be conserved aggregation pheromone components among some species in western South America.

Italy has a well-established prominent system of national registries to support managed entry agreements (MEAs), monitoring innovative medicinal products (MPs) with clinical as well as economic uncertainties to ensure appropriate use and best value for money. The technological architecture of the registries is funded by pharmaceutical companies, but fully governed by the national medicines agency (AIFA). A desktop analysis was undertaken of data over a 15-year timeframe of all AIFA indication-based registries and associated EMA information. The characteristics of registries were evaluated, comparing orphan MPs vs. all MPs exploring cancer and non-cancer indications. OMP (orphan medicinal product) registries’ type vs. AIFA innovation status and EMA approval was reviewed. Of the 283 registries, 182 are appropriateness registries (35.2% relate to OMPs, with an almost equal split of cancer vs. non-cancer for OMPs and MPs), 35 include financial-based agreements [20% OMPs (2 non-cancer, 5 cancer)], and 60 registries are payment by result agreements [23.3% OMPs (4 non-cancer, 10 cancer)]. Most OMPs (53/88) came through the normal regulatory route. With the strengthening of the system for evaluation of innovation, fewer outcomes-based registries have been instigated. AIFA has overcome many of the challenges experienced with MEA through developing an integrated national web-based data collection system: the challenge that remains for AIFA is to move from using the system for individual patient decisions about treatment to reviewing the wealth of data it now holds to optimize healthcare.

Introduction. Influenza is a widespread acute respiratory disease and represents a serious Public Health problem, both from the NHS and society perspectives. The High Dose quadrivalent influenza vaccine (QIV HD) is a flu vaccine containing 4 times the antigens of a Standard Dose vaccine, resulting in demonstrated superior protection in the population aged 65 years and over. Methods. The analysis has been conducted from the perspective of the NHS. The CEA focuses on the comparison between QIV HD and the QIV SD vaccine. The BIM aims to estimate the potential economic impact for the National Health Service (NHS) resulting from the use of QIV HD in clinical practice in subjects aged 65 or over, when considering its introduction in combination with currently used vaccines, QIV SD and adjuvanted TIV. Results. In a scenario which considers hospitalizations possibly related to influenza, so including cardio-respiratory events, a dominant cost-effectiveness profile emerges in the comparison with QIV SD. In terms of budget impact, overall savings obtained by comparing the two scenarios regarding hospitalizations are equal to 92,766,429 € over the three years’ time horizon considered in the analysis. Conclusions. Nowadays, also considering the state of emergency due to the spread of the SARS-CoV-2 virus, it is crucial to implement innovative health technologies that improve the efficiency and sustainability of the health system. Also, it is essential to protect the elderly population, helping to avoid overload and healthcare systems disruption due to the many COVID-19 hospitalizations.

Although the construction of block pavements has grown fast in the last decades, there is still a need for simple tools that could be applied to design them. This paper analyzed and verified concrete block pavements for urban and local roads composed of rectangular concrete pavers with plane side surfaces (no interlocking effect). The examined blocks were laid on a bedding sand layer, a cement treated base layer and a granular unbound foundation layer. The commercial finite element (FE) software ANSYS® was used to calculate the response of the pavement when subjected to different loading, construction configurations. Three wheel positions, five blocks patterns, three bedding sand thicknesses and joints gaps have been considered to evaluate stress-strain condition on pavement materials. Fatigue and rutting verification was performed respectively for bound and unbound pavement materials using analytical curves available in the literature. At the end of this study, a proposal for a catalogue is presented. It has nine pavement sets, because it takes into account three values of subgrade capacity (30, 90, and 150 MPa of resilient modulus) and three levels of traffic (400,000, 1,500,000, and 4,000,000 passages of commercial vehicles during the service life). The obtained results provide an inexpensive procedure for the preliminary design of concrete block pavements. Keywords: Block pavement, Finite element model, Concrete pavers, Local roads, Urban roads

Brunfelsia grandiflora is an ancient plant widely used for its promising medicinal properties, although little explored scientifically. Despite being a rich source of phenolic compounds responsible in part for the proven anti-inflammatory activity, its characterization has not been carried out to date. The present work deals with the exhaustive identification and quantification of its phenolic fraction, along with its antioxidant activity. Decoction resulting from the bark as fine powder was filtered and lyophilized, and polyphenols were extracted from the resulting product by aqueous-organic solvents. Seventy-nine polyphenols were identified using LC-MSn. Hydroxycinnamates was the most abundant group of compounds (up to 66.8%), followed by hydroxycoumarins (15.5%), lignans (6.1%), flavonols (5.7%), phenolic simples (3.1), gallates (2.3%), flavanols (0.3%), and flavanones (0.2%). About 64% of the characterized phenols were in their glycosylated forms. The quantification of these phytochemicals by LC-QToF showed that this medicinal plant contained 2014.71 mg of phenolic compounds in 100 g dry matter, which evidences a great antioxidant potency determined by ABTS and DPPH assays. Therefore, Brunfelsia grandiflora represents an important source of polyphenols which supports its therapeutic properties scientifically proven.