Synthesis and Characterization of Multilayered CrAlN/Al2O3 Tandem Coating Using HiPIMS for Solar Selective Applications at High Temperature.

The effect of applying a negative bias during deposition of a previously designed multilayer solar selective absorber coating was studied on two types of substrates (316L stainless steel and Inconel 625). The solar selective coating is composed of different chromium aluminum nitride layers deposited using a combination of radiofrequency (RF), direct current (DC), and high-power impulse magnetron sputtering (HiPIMS) technologies. The chemical composition is varied to generate an infrared reflective/absorber layer (with low Al addition and N vacancies) and two CrAlN intermediate layers with medium and high aluminum content (Al/Cr = 0.6 and 1.2). A top aluminum oxide layer (Al2O3) is deposited as an antireflective layer. In this work, a simultaneous DC-pulsed bias (-100 V, 250 kHz) was applied to the substrates in order to increase the film density. The optical performance, thermal stability, and oxidation resistance was evaluated and compared with the performance obtained with similar unbiased coating and a commercial Pyromark paint reference at 600, 700, and 800 °C. The coating remained stable after 200 h of annealing at 600 °C, with solar absorptance (α) values of 93% and 92% for samples deposited on stainless steel and Inconel, respectively, and a thermal emittance ε25°C of 18%. The introduction of additional ion bombardment during film growth through bias assistance resulted in increased durability, thermal stability, and working temperature limits compared with unbiased coatings. The solar-to-mechanical energy conversion efficiency at 800 °C was found to be up to 2 times higher than Pyromark at C = 100 and comparable at C = 1000.

Impact of ACCELERATE Paediatric Strategy Forums: a review of the value of multi-stakeholder meetings in oncology drug development.

In a landscape of an increasing number of products and histology and age agnostic trials for rare patient cancer, prioritization of products is required. Paediatric Strategy Forums, organized by ACCELERATE and the European Medicines Agency with participation of the US Food and Drug Administration, are multi-stakeholder meetings that share information to best inform pediatric drug development strategies and subsequent clinical trial decisions. Academia, industry, regulators, and patient advocates are equal members, with patient advocates highlighting unmet needs of children and adolescents with cancer. The 11 Paediatric Strategy Forums since 2017 have made specific and general conclusions to accelerate drug development. Conclusions on product prioritization meetings, as well as global master protocols, have been outputs of these meetings. Forums have provided information for regulatory discussions and decisions by industry to facilitate development of high-priority products; for example, 62% of high-priority assets (agreed at a Forum) in contrast to 5% of those assets not considered high priority have been the subject of a Paediatric Investigational Plan or Written Request. Where there are multiple products of the same class, Forums have recommended a focused and sequential approach. Class prioritization resulted in an increase in waivers for non-prioritized B-cell products (44% to 75%) and a decrease in monotherapy trials, proposed in Paediatric Investigation Plans (PIP) submissions of checkpoint inhibitors from 53% to 19%. Strategy Forums could play a role in defining unmet medical needs. Multi-stakeholder forums, such as the Paediatric Strategy Forum, serve as a model to improve collaboration in the oncology drug development paradigm.

Rescuing Drugs That are Discontinued in Adult Oncology Development for the Benefit of Children and Adolescents With Cancer - An ACCELERATE Multistakeholder Consensus.

Better therapies for childhood cancer remain an unmet need to improve the dismal prognosis of certain malignancies and to reduce the burden of toxicity. Rescuing discontinued or shelved drugs for children, adolescents, and young adults is a strategy to identify new uses for approved or investigational medicines outside the scope of their original medical indication. Our proposed multistakeholder consensus focuses on the development of innovative, patent-protected targeted agents, sourced from previously shelved or discontinued programs that have the potential to provide significant benefit to underserved patient populations, with unmet medical needs. There are several challenges to continuing/rescuing drugs for pediatric oncology development, which include the lack of information for decision making, corporate strategy considerations underlying the decision to invest in pediatric development, and the contracting and technology transfer complexities required to enable divestment and subsequent development. The multistakeholder approach for drug development has the advantage of conveying a consensus among academia, patient advocates, and importantly industry itself. We propose three areas of action to facilitate rescuing potentially beneficial drugs for children and adolescents with cancer: (i) initiatives to provide information to companies considering developing these drugs and a standards framework; (ii) incentives both in Europe and in the United States to encourage companies to develop pediatric-only drugs, with the reform of the EU Pharmaceutical Legislation posing an important opportunity; and (iii) communication of the issues to all stakeholders. Ultimately, this will benefit children and adolescents with cancer.

Paediatric Strategy Forum for medicinal product development of DNA damage response pathway inhibitors in children and adolescents with cancer: ACCELERATE in collaboration with the European Medicines Agency with participation of the Food and Drug Administration.

DNA damage response inhibitors have a potentially important therapeutic role in paediatric cancers; however, their optimal use, including patient selection and combination strategy, remains unknown. Moreover, there is an imbalance between the number of drugs with diverse mechanisms of action and the limited number of paediatric patients available to be enrolled in early-phase trials, so prioritisation and a strategy are essential. While PARP inhibitors targeting homologous recombination-deficient tumours have been used primarily in the treatment of adult cancers with BRCA1/2 mutations, BRCA1/2 mutations occur infrequently in childhood tumours, and therefore, a specific response hypothesis is required. Combinations with targeted radiotherapy, ATR inhibitors, or antibody drug conjugates with DNA topoisomerase I inhibitor-related warheads warrant evaluation. Additional monotherapy trials of PARP inhibitors with the same mechanism of action are not recommended. PARP1-specific inhibitors and PARP inhibitors with very good central nervous system penetration also deserve evaluation. ATR, ATM, DNA-PK, CHK1, WEE1, DNA polymerase theta and PKMYT1 inhibitors are early in paediatric development. There should be an overall coordinated strategy for their development. Therefore, an academia/industry consensus of the relevant biomarkers will be established and a focused meeting on ATR inhibitors (as proof of principle) held. CHK1 inhibitors have demonstrated activity in desmoplastic small round cell tumours and have a potential role in the treatment of other paediatric malignancies, such as neuroblastoma and Ewing sarcoma. Access to CHK1 inhibitors for paediatric clinical trials is a high priority. The three key elements in evaluating these inhibitors in children are (1) innovative trial design (design driven by a clear hypothesis with the intent to further investigate responders and non-responders with detailed retrospective molecular analyses to generate a revised or new hypothesis); (2) biomarker selection and (3) rational combination therapy, which is limited by overlapping toxicity. To maximally benefit children with cancer, investigators should work collaboratively to learn the lessons from the past and apply them to future studies. Plans should be based on the relevant biology, with a focus on simultaneous and parallel research in preclinical and clinical settings, and an overall integrated and collaborative strategy.

Assessing heavy metal pollution load index (PLI) in biomonitors and road dust from vehicular emission by magnetic properties modeling.

Vehicular traffic occupies a significant place among the sources of air pollution, due to population and urban growth that has led to an excessive increase in the vehicle fleet worldwide, and in Costa Rica as well. Vehicle emissions generate greenhouse gases (GHGs), particulate matter (PM), and heavy metals (HMs), due to combustion products from fossil-fuel engines, tire wear, and brake linings. HMs are important because they cannot be degraded or destroyed naturally; however, they can be diluted by physicochemical agents and be incorporated into trophic chains where they can be bioaccumulated causing significant negative effects on human well-being and ecological quality. This study aimed to assess the HM pollution load in biomonitors and road dust from vehicular emissions by chemical analyses and magnetic properties modeling. For this purpose, chemical and magnetic property analyses were carried out on samples of road dust and leaves of Cupressus lusitanica Mill. and Casuarina equisetifolia L., which were sampled during 2 different years in the Greater Metropolitan Area of Costa Rica known as GAM. Contamination factor (CF) and pollution load index (PLI) results showed significant metal pollution in some of the study sites. Contamination by the metals V, Cr, and Zn was most commonly present in the biomonitors, and for road dust, they were Cr, Zn, and Pb. The PLI estimates obtained with the validated support vector machine (SVM) magnetic properties models were consistent (sensitivity, specificity, and precision) with those obtained by chemical analysis, demonstrating the feasibility of this method for the identification of this index of contamination.

Changing incentives to ACCELERATE drug development for paediatric cancer.

BACKGROUND: More effective incentives are needed to motivate paediatric oncology drug development, uncoupling it from dependency on adult drug development. Although the current European and North-American legislations aim to promote drug development for paediatrics and rare diseases, children and adolescents with cancer have not benefited as expected from these initiatives and cancer remains the first cause of death by disease in children older than one. Drug development for childhood cancer remains dependent on adult cancer indications and their potential market. The balance between the investment needed to execute a Paediatric Investigation Plan (PIP) in Europe and an initial Paediatric Study Plan (iPSP) in the US, coupled with the potential financial reward has not been sufficiently attractive to incite the pharmaceutical industry to develop drugs for rare indications such as childhood cancer. METHODS: We propose changes in the timing and nature of the rewards within the European Paediatric Medicine Regulation (PMR) and Regulation on Orphan Medicinal Products (both currently under review), which would drive earlier initiation of paediatric oncology studies and provide incentives for drug development specifically for childhood indications. RESULTS: We suggest modifying the PMR to ensure mechanism-of-action driven mandatory PIP and reorganization of incentives to a stepwise and incremental approach. Interim and final deliverables should be defined within a PIP or iPSP, each attracting a reward on completion. A crucial change would be the introduction of the interim deliverable requiring production of paediatric data that inform the go/no-go decisions on whether to take a drug forward to paediatric efficacy trials. CONCLUSION: Additionally, to address the critical gap in the current framework where there is a complete lack of incentives to promote paediatric-specific cancer drug development, we propose the introduction of early rewards in the Orphan Regulation, with a variant on the US-Creating Hope Act and its priority review vouchers.

Impact of the EU Paediatric Medicine Regulation on new anti-cancer medicines for the treatment of children and adolescents.

The European Paediatric Medicine Regulation was launched in 2007, aiming to provide better medicines for children. However, its benefit for paediatric patients with cancer has been questioned and the European Paediatric and Orphan Regulations have been under review since November, 2020. To ascertain the effect of the European Paediatric Medicine Regulation, all paediatric anti-cancer medicines assessed by the European Medicines Agency from 1995 to 2022 were identified and reviewed using the agency's public assessment reports, and all Paediatric Investigation Plans granted since 2007 were analysed. 16 new molecular entities (NMEs; ie, a drug that contains an active moiety that had never been approved before) have been approved since the regulation was launched in 2007. The number of paediatric marketing authorisations increased from 2007 but represented the same 17% of all anti-cancer drug marketing authorisations before and after 2007. After 2007, nine (56%) of 16 NMEs were first authorised both in adults and children. For seven NMEs, a first paediatric indication was approved with a median lag time of 6·4 years (range 1·2-21·5 years) after the first authorisation in adults. Half of NMEs were authorised for the treatment of malignancies responsible for only 5·4% of all European childhood cancer deaths, including three medicines for melanoma and thyroid cancer-adult cancers occurring very rarely in children. The increased number of paediatric anti-cancer NMEs after 2007 is a result of the major increase in new medicines authorised for adult cancers since 2005 rather than a direct effect of the Paediatric Regulation. Paediatric development of these NMEs was driven by their adult market and did not address major unmet medical needs of children and adolescents with cancer. An improved, fit-for-purpose regulatory environment that incentivises paediatric drug development based on mechanism of action, better incentives, and a systematic multi-stakeholder engagement, with greater investment from industry, public funding, and non-governmental organisations, will increase the number of new medicines approved in the future to cure more children and adolescents with cancer.

Comprehensive molecular profiling of sarcomas in adolescent and young adult patients: Results of the EORTC SPECTA-AYA international proof-of-concept study.

BACKGROUND: Adolescent and young adult (AYA) patients with cancer are poorly recruited to molecularly targeted trials and have not witnessed the advances in cancer treatment and survival seen in other age groups. We report here a pan-European proof-of-concept study to identify actionable alterations in some of the worst prognosis AYA cancers: bone and soft tissue sarcomas. DESIGN: Patients aged 12-29 years with newly diagnosed or recurrent, intermediate or high-grade bone and soft tissue sarcomas were recruited from six European countries. Pathological diagnoses were centrally reviewed. Formalin-fixed tissues were analysed by whole exome sequencing, methylation profiling and RNA sequencing and were discussed in a multidisciplinary, international molecular tumour board. RESULTS: Of 71 patients recruited, 48 (median 20 years, range 12-28) met eligibility criteria. Central pathological review confirmed, modified and re-classified the diagnosis in 41, 3, and 4 cases, respectively. Median turnaround time to discussion at molecular tumour board was 8.4 weeks. whole exome sequencing (n = 48), methylation profiling (n = 44, 85%) and RNA sequencing (n = 24, 50%) led to therapeutic recommendations for 81% patients, including 4 with germ line alterations. The most common were for agents targeted towards tyrosine kinases (n = 20 recommendations), DNA repair (n = 18) and the PI3K/mTOR/AKT pathway (n = 15). Recommendations were generally based on weak evidence such as activity in a different tumour type (n = 68, 61%), reflecting the dearth of relevant molecular clinical trial data in the same tumour type. CONCLUSIONS: We demonstrate here that comprehensive molecular profiling of AYA patients' samples is feasible and deliverable in a European programme.

Assessing magnetic properties of biomonitors and road dust as a screening method for air pollution monitoring.

Particulate matter (PM) pollution is one of the world's most serious environmental challenges. Among PM components, atmospheric heavy metals (HMs) are considered one of the main pollutants responsible for causing significant negative impacts on human health, and ecological quality. This study aimed to assess environmental magnetism as a simple and rapid method that can be used to evaluate heavy metal contamination in urban areas from the relationships between magnetic properties and heavy metal concentrations. For this purpose, road dust and leaf samples of two common evergreen species (Cupressus lusitanica/Casuarina equisetifolia) were sampled simultaneously for 2 years at sites with different levels of traffic pollution. The results found significant statistical correlations between the magnetic properties and the chemical substances of the plants studied, as Fe, Cr and V showed an r ≥ 0.9 and Cr and Zn r ≥ 0.7 with χlf in C. equisetifolia. The frequency-dependent magnetic susceptibility was found to be between 0% and 14% for plants, and 0% and 2% for road dust, suggesting a rather dissimilar particle size distribution for plants, and a less important contribution from the more hazardous ultrafine superparamagnetic magnetite for both. Confirming that magnetic analyses can be used to distinguish different degrees of urban air pollution.

Updating our understanding of health-related quality of life issues in children with cancer: a systematic review of patient-reported outcome measures and qualitative studies.

BACKGROUND: Health-related quality of life (HRQOL) is a key concept in pediatric oncology. This systematic review aims to update the conceptual HRQOL model by Anthony et al. (Qual Life Res 23(3):771-789, 2014), covering physical, emotional, social and general HRQOL aspects, and to present a comprehensive overview of age- and disease-specific HRQOL issues in children with cancer. METHODS: Medline, PsychINFO, the Cochrane Database for Systematic Reviews (CDSR), and the COSMIN database were searched (up to 31.12.2020) for publications using patient-reported outcome measures (PROMs) and qualitative studies in children with cancer (8-14-year) or their parents. Items and quotations were extracted and mapped onto the conceptual model for HRQOL in children with cancer mentioned above. RESULTS: Of 2038 identified studies, 221 were included for data extraction. We identified 96 PROMS with 2641 items and extracted 798 quotations from 45 qualitative studies. Most items and quotations (94.8%) could be mapped onto the conceptual model. However, some adaptations were made and the model was complemented by (sub)domains for 'treatment burden', 'treatment involvement', and 'financial issues'. Physical and psychological aspects were more frequently covered than social issues. DISCUSSION: This review provides a comprehensive overview of HRQOL issues for children with cancer. Our findings mostly support the HRQOL model by Anthony et al. (Qual Life Res 23(3):771-789, 2014), but some adaptations are suggested. This review may be considered a starting point for a refinement of our understanding of HRQOL in children with cancer. Further qualitative research will help to evaluate the comprehensiveness of the HRQOL model and the relevance of the issues it encompasses.

Paediatric Strategy Forum for medicinal product development in mitogen-activated protein kinase pathway inhibitors: ACCELERATE in collaboration with the European Medicines Agency with participation of the Food and Drug Administration.

As the mitogen-activated protein kinase (MAPK) signalling pathway is activated in many paediatric cancers, it is an important therapeutic target. Currently, a range of targeted MAPK pathway inhibitors are being developed in adults. However, MAPK signals through many cascades and feedback loops and perturbing the MAPK pathway may have substantial influence on other pathways as well as normal development. In view of these issues, the ninth Paediatric Strategy Forum focused on MAPK inhibitors. Development of MAPK pathway inhibitors to date has been predominantly driven by adult indications such as malignant melanoma. However, these inhibitors may also target unmet needs in paediatric low-grade gliomas, high-grade gliomas, Langerhans cell histiocytosis, juvenile myelomonocytic leukaemia and several other paediatric conditions. Although MAPK inhibitors have demonstrated activity in paediatric cancer, the response rates and duration of responses needs improvement and better documentation. The rapid development and evaluation of combination approaches, based on a deep understanding of biology, is required to optimise responses and to avoid paradoxical tumour growth and other unintended consequences including severe toxicity. Better inhibitors with higher central nervous systempenetration for primary brain tumours and cancers with a propensity for central nervous system metastases need to be studied to determine if they are more effective than agents currently being used, and the optimum duration of therapy with MAPK inhibition needs to be determined. Systematic and coordinated clinical investigations to inform future treatment strategies with MAPK inhibitors, rather than use outside of clinical trials, are needed to fully assess the risks and benefits of these single agents and combination strategies in both front-line and in the refractory/relapse settings. Platform trials could address the investigation of multiple similar products and combinations. Accelerating the introduction of MAPK inhibitors into front-line paediatric studies is a priority, as is ensuring that these studies generate data appropriate for scientific and regulatory purposes. Early discussions with regulators are crucial, particularly if external controls are considered as randomised control trials in small patient populations can be challenging. Functional end-points specific to the populations in which they are studied, such as visual acuity, motor and neuro psychological function are important, as these outcomes are often more reflective of benefit for lower grade tumours (such as paediatric low-grade glioma and plexiform neurofibroma) and should be included in initial study designs for paediatric low-grade glioma. Early prospective discussions and agreements with regulators are necessary. Long-term follow-up of patients receiving MAPK inhibitors is crucial in view of their prolonged administration and the important involvement of this pathway in normal development. Further rational development, with a detailed understanding of biology of this class of products, is crucial to ensure they provide optimal benefit while minimising toxicity to children and adolescents with cancer.

Comparison between machine linear regression (MLR) and support vector machine (SVM) as model generators for heavy metal assessment captured in biomonitors and road dust.

Exposure to suspended particulate matter (PM), found in the air, is one of the most acute environmental problems that affect the health of modern society. Among the different airborne pollutants, heavy metals (HMs) are particularly relevant because they are bioaccumulated, impairing the functions of living beings. This study aimed to establish a method to predict heavy metal concentrations in leaves and road dust, through their magnetic properties measurements. For this purpose, machine learning, automatic linear regression (MLR), and support vector machine (SVM) were used to establish models for the prediction of airborne heavy metals based on leaves and road dust magnetic properties. Road dust samples and leaves of two common evergreen species (Cupressus lusitanica/Casuarina equisetifolia) were sampled simultaneously during two different years in the Great Metropolitan Area (GMA) of Costa Rica. MLR and SVM algorithms were used to establish the relationship between airborne heavy metal concentrations based on single (χlf) and multiple (χlf y χdf) leaf magnetic properties and road dust. Results showed that Fe, Cu, Cr, V, and Zn concentrations were well-simulated by SVM prediction models, with adjusted R2 values ≥ 0.7 in both training and test stages. By contrast, the concentrations of Pb and Ni were not well-simulated, with adjusted R2 values < 0.7 in both training and test stages. Heavy metal predicción models using magnetic properties of leaves from Casuarina equisetifolia, as collectors, yielded better prediction results than those based on the leaves of Cupressus lusitanica and road dust, showing relatively higher adjusted R2 values and lower errors (MAE and RMSE) in both training and test stages. SVM proved to be the best prediction model with variations between single (χlf) and multiple (χlf y χdf) magnetic properties depending on the element studied.

Worry and fear as predictors of fatalism by COVID-19 in the daily work of nurses. / Preocupação e medo como preditores de fatalismo por COVID-19 no cotidiano de trabalho dos enfermeiros.

OBJECTIVE: to analyze the relationship between the concern and fear of COVID-19 with fatalism in the daily work of nurses. METHOD: analytical cross-sectional study carried out with a total of 449 nurses. Data collection was performed using instruments validated in Peru. In the analysis, the Shapiro-Wilk test and the Spearman correlation coefficient were used, and two multiple regression models were estimated, with variable selection in stages. RESULTS: nurses had a moderate level of fatalism and a low level of fear and concern about COVID-19. The first statistical model, which included sociodemographic variables, explains only 3% of the fatalism variance. However, a second model that includes fear and perception explains 33% of it. CONCLUSION: Worry, fear and having been diagnosed with COVID-19 were predictors of fatalism. It is suggested the implementation of psycho-emotional interventions in daily work - aimed at Nursing professionals who present high levels of fear or concern - to reduce fatalism and prevent fatal consequences of the pandemic and promote health.

Patient-reported outcomes are under-utilised in evaluating supportive therapies in paediatric oncology - A systematic review of clinical trial registries.

BACKGROUND: Children with cancer suffer from numerous symptoms and side-effects, making supportive interventions indispensable to improve their quality of life. The gold standard for evaluating the latter is patient-reported outcome (PRO) assessment. This systematic review investigates the current practice of clinical outcome assessment (COA) in clinical trials on supportive interventions. METHODS: ClinicalTrials.gov and EudraCT were searched for trials including children and adolescents (≤21 years) with cancer receiving supportive care registered 2007-2020. The use of different types of COAs was analysed, focusing on PRO assessment and the domains measured with PRO measures (PROMs). Associations with trial characteristics were investigated using univariate and multivariable analyses. RESULTS: Of 4789 identified trials, 229 were included. Among them, 44.1 % relied on PROMs, the most commonly used COA. The proportion of trials using PROMs did not significantly differ over time. In the multivariable analysis, intervention type (higher PROM use in behavioural vs. medical interventional trials) and cancer type (higher PROM use in mixed and solid tumour samples vs. haematological samples) were significant predictors of PROM use. The majority of trials using PROMs (59.6 %) measured more than one health domain. 'Physical health' was the most frequently assessed domain (92.6 %). CONCLUSION: Less than half of registered clinical trials investigating supportive interventions for children with cancer used PROMs. This result is striking since supportive care explicitly focuses on patients' quality of life, which is best assessed using PROMs. Our systematic review underlines the need to identify barriers for PROM implementation and to improve PRO research in paediatric oncology.

Paediatric Strategy Forum for medicinal product development of multi-targeted kinase inhibitors in bone sarcomas: ACCELERATE in collaboration with the European Medicines Agency with participation of the Food and Drug Administration.

The eighth Paediatric Strategy Forum focused on multi-targeted kinase inhibitors (mTKIs) in osteosarcoma and Ewing sarcoma. The development of curative, innovative products in these tumours is a high priority and addresses unmet needs in children, adolescents and adults. Despite clinical and investigational use of mTKIs, efficacy in patients with bone tumours has not been definitively demonstrated. Randomised studies, currently being planned or in progress, in front-line and relapse settings will inform the further development of this class of product. It is crucial that these are rapidly initiated to generate robust data to support international collaborative efforts. The experience to date has generally indicated that the safety profile of mTKIs as monotherapy, and in combination with chemotherapy or other targeted therapy, is consistent with that of adults and that toxicity is manageable. Increasing understanding of relevant predictive biomarkers and tumour biology is absolutely critical to further develop this class of products. Biospecimen samples for correlative studies and biomarker development should be shared, and a joint academic-industry consortium created. This would result in an integrated collection of serial tumour tissues and a systematic retrospective and prospective analyses of these samples to ensure robust assessment of biologic effect of mTKIs. To support access for children to benefit from these novel therapies, clinical trials should be designed with sufficient scientific rationale to support regulatory and payer requirements. To achieve this, early dialogue between academia, industry, regulators, and patient advocates is essential. Evaluating feasibility of combination strategies and then undertaking a randomised trial in the same protocol accelerates drug development. Where possible, clinical trials and development should include children, adolescents, and adults less than 40 years. To respond to emerging science, in approximately 12 months, a multi-stakeholder group will meet and review available data to determine future directions and priorities.

Preventing COVID-19 as a nursing student through social networks in their family-social environment.

OBJECTIVE: to analyze and understand COVID-19 prevention by nursing students through social networks in their family-social environment. METHOD: a qualitative descriptive-interpretative study, developed in the nursing school of a public university in Lima, Peru, from October to December 2020. Students from the fourth and fifth year of studies participated. Data were collected with the technique of focus groups (2) and analyzed with thematic content analysis. RESULTS: two categories emerged: Using various social networks in times of pandemic; Considering themselves trained for COVID-19 prevention through social networks in their family-social circle. FINAL CONSIDERATIONS: nursing students carry out COVID-19 prevention in their family-social circle through social networks, showing satisfaction in the transmission of knowledge, considering the people's physical-emotional condition and local health status, perceiving themselves as agents of change, seeking people empowerment.

Standardizing nursing degree curriculum structure in Spain: A mixed-methods study.

BACKGROUND: Legislation regulating Spanish and European academic curricula prescribes a certain level of knowledge and skills any student must master. Spanish universities freely decide the number of credits assigned to each subject and in which year the subject will be taught. We hypothesize that this flexibility may give way to excessively heterogeneous training across universities in nursing degrees. Such curricula heterogeneity hinders inter-university transfers and weakens educational excellence. OBJECTIVES: 1) To review the existing differences in nursing degrees in Spanish universities; 2) to compare our results against current legislation; 3) to propose changes in the legislation, if necessary. DESIGN: Mixed-methods approach. SETTING: Spain. METHODS: We reviewed nursing degree curricula of all 60 Spanish universities. Inter-university differences were analyzed and checked against current legislation. A focus group proposed legislative changes accordingly. RESULTS: Several differences between public and private universities were statistically significant. During the first cycle, public universities´ course loads include more theoretical teachings, more credits in core subjects during the first year, and more compulsory subjects in second year. Private universities are more likely to offer external internships during the first cycle whereas the public ones are more likely to offer them during the second cycle. Public universities offer more credits under the following curricular blocks than private ones: "Nutrition/Dietetics," "Psychiatry," "Public and Community Health," and "Geriatrics." In turn, private universities offer more credits in the areas of "Theory/Methodology," "Ethics/Legislation," "English," and "Theology." Academic curricula meet most of the criteria established by the Spanish and European legislation. The proposed legislative changes aim at standardizing curricula by associating specific credits and their timeline to the teaching blocks. CONCLUSIONS: Nursing degree curricula among Spanish universities are highly heterogeneous. Legislative changes to homogenize teaching blocks would facilitate credit validations and student mobility across universities, in addition to increasing nursing degrees´ standardization and excellence.

ACCELERATE - Five years accelerating cancer drug development for children and adolescents.

Rapid evaluation and subsequent regulatory approval of new drugs are critical to improving survival and reducing long-term side-effects for children and adolescents with cancer. The international multi-stakeholder organisation ACCELERATE was created to advance the timely investigation of new anti-cancer drugs. ACCELERATE has enhanced communication and understanding between academia, industry, patient advocates and regulators. It has promoted a mechanism-of-action driven drug development approach and developed Paediatric Strategy Forums. These initiatives have facilitated prioritisation of medicinal products and a focused and sequential strategy for drug development where there are multiple potential agents. ACCELERATE has championed the early assessment of promising drugs in adolescents through their inclusion in adult early phase trials. ACCELERATE has strongly supported alignment between the European Medicines Agency and the US Food and Drug Administration and identification of unmet medical needs through multi-stakeholder collaboration. Early engagement between all stakeholders in the development of new drugs is critical. Innovative clinical trial designs are required, necessitating early discussion with sponsors and regulators. Amplifying the patient advocate voice through inclusion across the drug development continuum will lead to better, patient-centric trials. By these means, children and adolescents with cancer can maximally and rapidly benefit from innovative products to improve outcomes and reduce burdensome sequelae.

Incidence of cervical, breast and colorectal cancers between 2010 and 2015 in people living with HIV in France.

BACKGROUND: We aimed to evaluate the incidence rates between 2010 and 2015 for invasive cervical cancer (ICC), breast cancer (BC), and colorectal cancer (CRC) in people living with HIV (PLWH) in France, and to compare them with those in the French general population. These cancers are targeted by the national cancer-screening program. SETTING: This is a retrospective study based on the longitudinal data of the French Dat'AIDS cohort. METHODS: Standardized incidence ratios (SIR) for ICC and BC, and incidence rates for all three cancers were calculated overall and for specific sub-populations according to nadir CD4 cell count, HIV transmission category, HIV diagnosis period, and HCV coinfection. RESULTS: The 2010-2015 CRC incidence rate was 25.0 [95% confidence interval (CI): 18.6-33.4] per 100,000 person-years, in 44,642 PLWH (both men and women). Compared with the general population, the ICC incidence rate was significantly higher in HIV-infected women both overall (SIR = 1.93, 95% CI: 1.18-3.14) and in the following sub-populations: nadir CD4 ≤ 200 cells/mm3 (SIR = 2.62, 95% CI: 1.45-4.74), HIV transmission through intravenous drug use (SIR = 5.14, 95% CI: 1.93-13.70), HCV coinfection (SIR = 3.52, 95% CI: 1.47-8.47) and HIV diagnosis before 2000 (SIR = 2.06, 95% CI: 1.07-3.97). Conversely, the BC incidence rate was significantly lower in the study sample than in the general population (SIR = 0.56, 95% CI: 0.42-0.73). CONCLUSION: The present study showed no significant linear trend between 2010 and 2015 in the incidence rates of the three cancers explored in the PLWH study sample. Specific recommendations for ICC screening are still required for HIV-infected women and should focus on sub-populations at greatest risk.