Examining confidential wholesale margin estimates in European countries for the price negotiation of patented drugs in Germany: a statistical model.

BACKGROUND: Based on the legal framework laid down in section 130b (9) of Book V of the German Social Code, various criteria are relevant for the negotiated price for new patented drugs in Germany. European reference prices (ERPs) are one criterion. The ERP is based on the ex-factory prices (EFPs) of the countries included in the European country basket. However, in some of these countries, the EFP is not published due to confidential wholesale margins. Wholesale margins must therefore be estimated and deducted from purchase prices. In this context literature-based estimates to date do not assume regressive margins with higher pharmaceutical prices. This assumption is questionable and can lead to systematically underestimated country prices, especially for high-priced drugs. Percentage wholesale margins in the majority of European countries develop to a comparable extent regressively with increasing prices. It should therefore be examined (1) whether statistical models can predict the margins of individual countries, in principle and especially for countries where margins are unknown and regressive trends are likely, and (2) to what extent the estimation of margins improves when regressive statistical models are used to estimate margins instead of cross-price averages published in the literature. METHODS: Qualitative preliminary research explores the basic wholesale pricing mechanisms in countries with confidential wholesale margins. Wholesale margins for reimbursable drugs were then modeled for regulated European countries. Estimation quality and impact of the model was compared to estimations based on average margins. RESULTS: In both regulated countries and in countries with confidential wholesale margins, percentage margins of wholesalers develop regressively as drug prices rise. Regressive courses of margins can be resiliently modeled for the regulated countries using a power distribution with significantly lower mean squared errors in a linear mixed model in comparison to literature-based estimations with country-specific cross-price averages. CONCLUSION: If there is reason to believe that margins are regressive, confidential wholesale margins are expected to be better estimated by the power function based on margins of regulated countries than by the published country-specific average margins, reducing significantly inaccurate effects on margin estimations of high-price drugs.

Cardiogenic shock and chronic kidney disease: Dangerous liaisons.

BACKGROUND: Chronic kidney disease (CKD) is one of the leading causes of death worldwide, closely interrelated with cardiovascular diseases, ultimately leading to the failure of both organs - the so-called "cardiorenal syndrome". Despite this burden, data related to cardiogenic shock outcomes in CKD patients are scarce. METHODS: FRENSHOCK (NCT02703038) was a prospective registry involving 772 patients with cardiogenic shock from 49 centres. One-year outcomes (rehospitalization, death, heart transplantation, ventricular assist device) were analysed according to history of CKD at admission and were adjusted on independent predictive factors. RESULTS: CKD was present in 164 of 771 patients (21.3%) with cardiogenic shock; these patients were older (72.7 vs. 63.9years) and had more comorbidities than those without CKD. CKD was associated with a higher rate of all-cause mortality at 1month (36.6% vs. 23.2%; hazard ratio 1.39, 95% confidence interval 1.01-1.9; P=0.04) and 1year (62.8% vs. 40.5%, hazard ratio 1.39, 95% confidence interval 1.09-1.77; P<0.01). Patients with CKD were less likely to be treated with norepinephrine/epinephrine or undergo invasive ventilation or receive mechanical circulatory support, but were more likely to receive renal replacement therapy (RRT). RRT was associated with a higher risk of all-cause death at 1month and 1year regardless of baseline CKD status. CONCLUSIONS: Cardiogenic shock and CKD are frequent "cross-talking" conditions with limited therapeutic options, resulting in higher rates of death at 1month and 1year. RRT is a strong predictor of death, regardless of preexisting CKD. Multidisciplinary teams involving cardiac and kidney physicians are required to provide integrated care for patients with failure of both organs.

Oxytocin and social learning in socially anxious men and women.

OBJECTIVE: This study extended a classic self-referential learning paradigm by investigating the effects of intranasally-administered oxytocin in high and low socially anxious participants during social learning, as a function of social anxiety levels and sex. METHODS: In a randomized double-blinded design, 160 participants were either given intranasal oxytocin (24 I.U.) or placebo. Subsequently, while lying in an MR scanner, participants were shown neutral faces that were paired with positively, neutrally, or negatively valenced self-referential sentences, during which we measured self-reported arousal and sympathy of the facial stimuli, pupil dilation, and changes in the brain-oxygen-level dependent signal. Four-factor mixed analyses of variance with the between-subjects factors group (high socially anxious vs. low socially anxious), substance (oxytocin vs. placebo), and sex (male vs. female) and the within-subjects factor sentence valence (positive vs. neutral vs. negative) were conducted for each measure, respectively. RESULTS: Administration of intranasal oxytocin yielded an increase in sympathy ratings in high socially anxious compared to low socially anxious individuals and decreased arousal ratings for positively-conditioned faces in low socially anxious participants. As an objective physiological measure of arousal, pupil dilation mirrored the behavioral results. Oxytocin effects on neural activation in the insula interacted with anxiety levels and sex: low socially anxious individuals yielded lower activation under oxytocin than placebo; the converse was observed in high socially anxious individuals. This interaction also differed between sexes, as men yielded higher activation levels than women. These findings were more prominent for positively- and negatively-conditioned faces. Within the amygdala, high socially anxious men yielded higher activation than high socially anxious women in the left hemisphere, and low socially anxious men yielded higher activation than low socially anxious women from positively- and negatively-conditioned faces, though no influence of oxytocin was detected. CONCLUSION: These results suggest oxytocin-induced behavioral, physiological, and neural changes as a function of social learning in socially low and high anxious individuals. These findings challenge the amygdalocentric view of the role of emotions in social learning, instead contributing to the growing body of findings implicating the insula therein, revealing an interaction between oxytocin, sex, and emotional valence. Such discoveries raise an interesting set of questions regarding the computational goals of regions such as the insula in emotional learning and how neural activity can play a diagnostic or prognostic role in social anxiety, potentially leading to new treatment opportunities that may combine oxytocin and neurofeedback differentially for men and women.

Vaccination with structurally adapted fungal protein fibrils induces immunity to Parkinson's disease.

The pathological misfolding and aggregation of soluble α-synuclein into toxic oligomers and insoluble amyloid fibrils causes Parkinson's disease, a progressive age-related neurodegenerative disease for which there is no cure. HET-s is a soluble fungal protein that can form assembled amyloid fibrils in its prion state. We engineered HET-s(218-298) to form four different fibrillar vaccine candidates, each displaying a specific conformational epitope present on the surface of α-synuclein fibrils. Vaccination with these four vaccine candidates prolonged the survival of immunized TgM83+/- mice challenged with α-synuclein fibrils by 8% when injected into the brain to model brain-first Parkinson's disease or by 21% and 22% when injected into the peritoneum or gut wall, respectively, to model body-first Parkinson's disease. Antibodies from fully immunized mice recognized α-synuclein fibrils and brain homogenates from patients with Parkinson's disease, dementia with Lewy bodies and multiple system atrophy. Conformation-specific vaccines that mimic epitopes present only on the surface of pathological fibrils but not on soluble monomers, hold great promise for protection against Parkinson's disease, related synucleinopathies and other amyloidogenic protein misfolding disorders.

[Patient events in German urology: trend towards hybrid formats?] / Patientenveranstaltungen in der deutschen Urologie: Trend zu Hybridformaten?

BACKGROUND: Patient events are an important tool to respond to the increasing need of the public for health information. Through the "patient forum", the German Society of Urology (DGU) is committed to patient information and public relations at its annual congresses. The goal of the study was to evaluate the events from 2017-2019 and to compare them with the first digital patient forum in 2020. MATERIALS AND METHODS: Using a two-page standardized questionnaire, we surveyed the visitors of the presence patient forums (presence group = P) of the three annual congresses of the DGU 2017-2019 as well as the users of the digital event 2020 (online group = O). RESULTS: We obtained 71 records for 2017-2019 and 18 for 2020. The median age of visitors was 64 years (range 30-89). Males were 66% (P) vs. 83% (O) of participants (p = 0.005). The offer was rated overall as good to very good by both groups, i.e., 1.6 (P) vs. 1.6 (O; p = 0.7) on a scale from 1 to 6 with 1 being the highest rating. In line with the lower interaction in the digital format, the possibility to ask questions was rated worse with 1.5 (P) vs. 2.8 (O; p = 0.003). When asked about the desired future event format, two-thirds of the users of the digital patient forum were in favor of a hybrid event on-site and online. CONCLUSION: Patient events are suitable means of communication for the public and are rated well by visitors. In particular, interaction with experts is highly valued. Face-to-face formats are associated with a high logistical effort and high costs, and their reach is limited. In the future, hybrid formats could be a reasonable alternative, as they combine the advantages of online and face-to-face formats.

Determinants of Admission to Critical Care Following Acute Recreational Drug Toxicity: A Euro-DEN Plus Study.

This study aimed to characterize patients admitted to critical care following Emergency Department (ED) presentation with acute recreational drug toxicity and to identify determinants of admission to critical care. A retrospective multicenter matched case-control study was conducted by the European Drug Emergency Network Plus (Euro-DEN Plus) over the period 2014-2021. The cases were ED presentations with acute recreational drug toxicity admitted to critical care, the controls consisted of ED presentations with acute recreational drug toxicity medically discharged directly from the ED. The potential determinants of admission to critical care were assessed through multivariable conditional stepwise logistic regression analysis and multiple imputation was used to account for the missing data. From 2014 to 2021, 3448 Euro-DEN Plus presentations involved patients admitted to critical care (76.9% males; mean age 33.2 years; SD 10.9 years). Patient age ≥35 years (as compared to ≤18 years) was a determinant of admission to critical care following acute recreational drug toxicity (adjusted odds ratio, aOR, 1.51, 95% confidence interval, CI, 1.15-1.99), along with polydrug use (aOR 1.39, 95% CI 1.22-1.59), ethanol co-ingestion (aOR 1.44, 95% CI 1.26-1.64), and the use of gamma-hydroxybutyrate/gamma-butyrolactone (GHB/GBL, aOR 3.08, 95% CI 2.66-3.57). Conversely, lower odds of admission to critical care were associated with the use of cocaine (aOR 0.85, 95% CI 0.74-0.99), cannabis (aOR 0.44, 95% CI 0.37-0.52), heroin (aOR 0.80, 95% CI 0.69-0.93), and amphetamine (aOR 0.65, 95% CI 0.54-0.78), as was the arrival to the ED during the night (8 p.m.-8 a.m., aOR 0.88, 95% CI 0.79-0.98). These findings, which deserve confirmation and further investigation, could contribute to a more complete understanding of the decision-making process underlying the admission to critical care of patients with acute recreational drug toxicity.

Addressing Cardiovascular Risk Across the Arc of a Woman's Life: Sex-Specific Prevention and Treatment.

PURPOSE OF REVIEW: Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in women in the United States of America. Despite this, women are underdiagnosed, less often receive preventive care, and are undertreated for CVD compared to men. There has been an increase in sex-specific risk factors and treatments over the past decade; however, sex-specific recommendations have not been included in the guidelines. We aim to highlight recent evidence behind the differential effect of traditional risk factors and underscore sex-specific risk factors with an intention to promote awareness, improve risk stratification, and early implementation of appropriate preventive therapies in women. RECENT FINDINGS: Women are prescribed fewer antihypertensives and lipid-lowering agents and receive less cardiovascular care as compared to men. Additionally, pregnancy complications have been associated with increased cardiovascular mortality later in life. Findings from the ARIC study suggest that there is a perception of lower risk of cardiovascular disease in women. The SWEDEHEART study which investigated sex differences in treatment, noted a lower prescription of guideline-directed therapy in women. Women are less likely to be prescribed statin medications by their providers in both primary and secondary prevention as they are considered lower risk than men, while also being more likely to decline and discontinue treatment. A woman's abnormal response to pregnancy may serve as her first physiological stress test which can have implications on her future cardiovascular health. This was supported by the CHAMPs study noting a higher premature cardiovascular risk after maternal complications. Adverse pregnancy outcomes have been associated with a 1.5-4.0 fold increase in future cardiovascular events in multiple studies. In this review, we highlight the differences in traditional risk factors and their impact on women. Furthermore, we address the sex-specific risk factors and pregnancy-associated complications that increase the risk of CVD in women. Adherence to GDMT may have implications on overall mortality in women. An effort to improve early recognition of CVD risk with implementation of aggressive risk factor control and lifestyle modification should be emphasized. Future studies should specifically report on differences in outcomes between males and females. Increased awareness and knowledge on sex-specific risks and prevention are likely to lower the prevalence and improve outcomes of CVD in women.

Climate change and health: Changes in student environmental knowledge and awareness due to the implementation of a mandatory elective at the Medical Faculty of Ulm?

Background and objectives: According to the World Health Organization, climate change constitutes the single greatest threat to human health. However, the health care system contributes to climate change worldwide through its high CO2 emissions. In order to make future physicians more aware of this issue and to expand medical education to include climate-related aspects, the mandatory 28 academic hours elective "Climate Change and Health" for students of human medicine in the preclinical study stage was implemented at the Medical Faculty of Ulm in the 2020/21 winter semester. Our accompanying study investigated 1. in what form the topic of climate change can be successfully integrated into the study of human medicine in a manner that includes student opinions and2. whether being required to take an elective on the topic led to changes in student environmental knowledge and awareness. Methodology: Personal individual interviews were conducted with all n=11 students after the course in a pilot that was carried out in the 2020/21 winter semester to determine course feasibility and student acceptance. The students were also able to evaluate the course using an evaluation form and were asked to complete a questionnaire on their environmental knowledge and awareness before and after the course. The course was revised on the basis of the results and offered again in the 2021 summer semester with an intervention group (n=16, participation in the mandatory elective) and a comparison group (n=25, no participation in the mandatory elective). The intervention group was asked to evaluate the course on the evaluation form. Both groups completed the environmental questionnaire at the same time. Results: The positive feedback from students for both semesters indicates a good feasibility and acceptance of the course. Student environmental knowledge was increased in both semesters. However, there were only few observable changes in student environmental awareness. Conclusion: This paper illustrates how the topic of climate change and health can be embedded into medical studies. The students considered climate change an important topic and drew added value from the course for their future work in healthcare. The study shows that knowledge transfer at the university level is an effective way to educate the young generation on climate change and its impacts.

Determination of Mucoadhesion of Polyvinyl Alcohol Films to Human Intestinal Tissue.

The absorption of drugs with narrow absorption windows in the upper small intestine can be improved with a mucoadhesive drug delivery system such as enteric films. To predict the mucoadhesive behaviour in vivo, suitable in vitro or ex vivo methods can be performed. In this study, the influence of tissue storage and sampling site on the mucoadhesion of polyvinyl alcohol film to human small intestinal mucosa was investigated. Tissue from twelve human subjects was used to determine adhesion using a tensile strength method. Thawing of tissue frozen at -20 °C resulted in a significantly higher work of adhesion (p = 0.0005) when a low contact force was applied for one minute, whereas the maximum detachment force was not affected. When the contact force and time were increased, no differences were found for thawed tissue compared to fresh tissue. No change in adhesion was observed depending on the sampling location. Initial results from a comparison of adhesion to porcine and human mucosa suggest that the tissues are equivalent.

A multi-site trial of an electronic health integrated physical activity promotion intervention in breast and endometrial cancers survivors: MyActivity study protocol.

Despite the known benefits of moderate-to-vigorous physical activity (MVPA) for breast and endometrial cancer survivors, most are insufficiently active, interventions response is heterogeneous, and MVPA programming integration into cancer care is limited. A stepped care approach, in which the least resource-intensive intervention is delivered first and additional components are added based on individual response, is one strategy to enhance uptake of physical activity programming. However, the most effective intervention augmentation strategies are unknown. In this singly randomized trial of post-treatment, inactive breast and endometrial cancer survivors (n = 323), participants receive a minimal intervention including a Fitbit linked with their clinic's patient portal and, in turn, the electronic health record (EHR) with weekly feedback delivered via the portal. MVPA progress summaries are sent to participants' oncology team via the EHR. MVPA adherence is evaluated at 4, 8, 12, 16 and 20 weeks; non-responders (those meeting ≤80% of the MVPA goal over previous 4 weeks) at each timepoint are randomized once for the remainder of the 24-week intervention to one of two "step-up" conditions: (1) online gym or (2) coaching calls, while responders continue with the minimal Fitbit+EHR intervention. The primary outcome is ActiGraph-measured MVPA at 24 and 48 weeks. Secondary outcomes include symptom burden and functional performance at 24 and 48 weeks. This trial will inform development of an effective, scalable, and tailored intervention for survivors by identifying non-responders and providing them with the intervention augmentations necessary to increase MVPA and improve health outcomes. Clinical Trials Registration # NCT04262180.

[Structure of outpatient urology care in Germany]. / Versorgungsstruktur der ambulanten Urologie in Deutschland.

BACKGROUND: Although urological specialist practices are central pillars of outpatient care, there is a lack of current data on the care structure of these practices. A description of the structures in large cities versus rural areas as well as gender effects and generational differences is needed not only as a baseline measure for further studies. MATERIALS AND METHODS: The survey includes data from the physician directory of the Stiftung Gesundheit as well as from the German Medical Association and the Federal Statistical Office. Colleagues were divided into subgroups. Based on the different subgroup sizes, statements about the care structure of outpatient urology in Germany can be made. RESULTS: While the majority of urologists in larger cities work in professional practice groups and care for fewer patients on average, in rural areas there is a particularly high proportion of individual practices with more inhabitants to be cared for per urologist. Female urologists work more frequently in the context of inpatient care. When female urology specialists choose to establish themselves, they are more likely to do so in practice groups and in urban areas. In addition, there is a shift in gender distribution: the younger the age subgroup considered, the higher the proportion of female urologists among all colleagues. CONCLUSIONS: This study is the first to describe the current structure of outpatient urology care in Germany. Future trends are already emerging that will significantly influence our way of working and the care of patients in the coming years.

A Molecular-Scale Understanding of Misorientation Toughening in Corals and Seashells.

Biominerals are organic-mineral composites formed by living organisms. They are the hardest and toughest tissues in those organisms, are often polycrystalline, and their mesostructure (which includes nano- and microscale crystallite size, shape, arrangement, and orientation) can vary dramatically. Marine biominerals may be aragonite, vaterite, or calcite, all calcium carbonate (CaCO3 ) polymorphs, differing in crystal structure. Unexpectedly, diverse CaCO3 biominerals such as coral skeletons and nacre share a similar characteristic: Adjacent crystals are slightly misoriented. This observation is documented quantitatively at the micro- and nanoscales, using polarization-dependent imaging contrast mapping (PIC mapping), and the slight misorientations are consistently between 1° and 40°. Nanoindentation shows that both polycrystalline biominerals and abiotic synthetic spherulites are tougher than single-crystalline geologic aragonite. Molecular dynamics (MD) simulations of bicrystals at the molecular scale reveal that aragonite, vaterite, and calcite exhibit toughness maxima when the bicrystals are misoriented by 10°, 20°, and 30°, respectively, demonstrating that slight misorientation alone can increase fracture toughness. Slight-misorientation-toughening can be harnessed for synthesis of bioinspired materials that only require one material, are not limited to specific top-down architecture, and are easily achieved by self-assembly of organic molecules (e.g., aspirin, chocolate), polymers, metals, and ceramics well beyond biominerals.

Cross-reactivity of human monoclonal antibodies with canine peripheral blood mononuclear cells.

In drug development, the dog is often used as a model for non-rodent preclinical safety studies. In particular, immunophenotyping in dogs can be important to characterize the toxicological profile of a test item. A wide range of antibodies specific to surface antigens is needed, however, commercially available antibodies to dog are scarce. To date, numerous studies have reported the cross-reactivity of human monoclonal antibodies with canine peripheral blood mononuclear cells (PBMC). In this study, we aimed to increase the number of canine-specific antibodies and took a rather novel approach to further determine cross-reactivity of 378 human recombinant antibodies lacking Fc regions to surface antigens on canine PBMC. The screening resulted in 30 human monoclonal antibodies well reactive to canine PBMC. Sequence homology of the targeted human and canine antigens was analyzed with Basic Local Alignment Search Tool. Thirteen human cross-reactive antibodies of interest were analyzed with cells from canine whole blood in combination with lineage markers. Finally, ten antibodies were identified as useful markers for the application in dog. Except for CD27, the remaining nine antibodies are already commercially available human cross-reactive antibodies. This study provides a new source for all ten antibodies described here.

Technology acceptance of a mobile portfolio app for teacher education: Pre-service teachers views on multimedia-based note-taking and mentoring in internships.

Mobile technologies are promising tools to scaffold teaching practice. In this study, we developed and tested a mobile app for teacher education. This mobile portfolio enables multimedia-based note-taking, reflection, and discussion with peers and mentors. We conducted two studies to explore the effect of design variants and use scenarios on the app's acceptance. In the first study with N = 83 pre-service primary school teachers, technology acceptance was higher for those using the app with multimedia note-taking functionality than for those using the same app with this functionality disabled. In the second study with N = 81 pre-service teachers, those using the app together with their mentor teachers reported levels of technology acceptance similar to those who used the app exclusively among themselves. In consequence, a mobile portfolio app would be met with higher acceptance if it builds reflection upon multimedia note-taking both with and without the inclusion of mentors.

Multiple-site decontamination in mechanically ventilated ICU patients: A real-life study.

INTRODUCTION: Decontamination regimen decreases acquired infection (ICU-AI) incidence but has remained controversial, mostly because it contains a course of intravenous antibiotic. Multiple-site decontamination (MSD), which does not include systemic antibiotics, has been less widely studied but is associated with lower risks of ventilator-associated pneumonia (VAP), bloodstream infection (BSI) and multidrug resistant micro-organism (MDRO) acquisition. We aimed to confirm these favorable outcomes. METHODS: A prospective pre/post-observational study was conducted in 5 ICUs in western France. Among them, 4 implemented MSD, whereas the fifth applied standard care (SC) throughout the study period. Patients who required intubation were eligible for study and divided into two groups: the MSD group if they were admitted to an ICU that already implemented MSD, or the SC group. The primary objective was to measure ICU-AI incidence. RESULTS: Close to 1400 (1346) patients were available for analysis (334 in the MSD and 1012 patients in the SC group). In a multivariable Poisson regression model, MSD was independently associated with decreased incidence of ICU-AI (IRR = 0.33; 95 %CI [0.18-0.60] p < 0.001). Non-parsimonious propensity-score matching resulted in 334 patient-pairs with well-balanced baseline characteristics. There was a lower incidence of ICU-AI(6.3 % vs 20.7 % p < 0.001), VAP (3.6 % vs 16.2 % p < 0.001) and BSI (3.0 % vs 7.2 % p = 0.029) in the MSD group as compared with the SC group. Five (1.5 %) and 11 (3.3 %) patients respectively acquired MDRO (p = 0.206). CONCLUSION: MSD is associated with decreased risk of ICU-AI, VAP and BSI, with no increase in MDRO acquisition.

[The Climate Change Challenge: How to get research into society through an online workshop]. / Herausforderung Klimawandel: Transfer von Wissenschaft in die Gesellschaft durch einen Online-Workshop.

BACKGROUND: According to the World Health Organisation, climate change poses the greatest health threat to humanity. At the same time, an environmentally friendly lifestyle has a positive impact on our health, such as a plant-based diet. In order to counter climate change, society needs to be informed about climate-friendly and health-promoting measures. Therefore, an online workshop was initiated at the Medical Faculty of Ulm. In an accompanying study, it was determined whether this leads to changes in environmental knowledge and awareness among the participants. METHODS: The online workshop consisted of four 2-hour sessions. Scientific basics on climate change and possible solutions were discussed. Other focuses were on health and the health system as well as environmental psychology and climate change denial. Participants could take part in an anonymous and voluntary online survey before (pretest) and after (posttest) the workshop. RESULTS: 86 participants took part in the workshop, of whom 24 attended all appointments and completed both surveys. While hardly any changes were observed in the subsection of environmental emotion, perception and behavior, there was a significant increase in environmental knowledge in the posttest. The workshop was evaluated very positively. Furthermore, many participants were motivated to make a personal contribution to climate protection after the workshop. CONCLUSION: The workshop serves as a good example of how medical scientific findings can be shared at a societal level. The participants already showed a high level of environmental awareness in the pretest, which is why the question remains open as to how people can be sensitized to the (health) threats posed by climate change who do not proactively sign up for such an offer themselves.

Characterization of an In Vitro/Ex Vivo Mucoadhesiveness Measurement Method of PVA Films.

Transmucosal drug delivery systems can be an attractive alternative to conventional oral dosage forms such as tablets. There are numerous in vitro methods to estimate the behavior of mucoadhesive dosage forms in vivo. In this work, a tensile test system was used to measure the mucoadhesion of polyvinyl alcohol films. An in vitro screening of potential influencing variables was performed on biomimetic agar/mucin gels. Among the test device-specific factors, contact time and withdrawal speed were identified as influencing parameters. In addition, influencing factors such as the sample area, which showed a linear relationship in relation to the resulting work, and the liquid addition, which led to an abrupt decrease in adhesion, could be identified. The influence of tissue preparation was investigated in ex vivo experiments on porcine small intestinal tissue. It was found that lower values of Fmax and Wad were obtained on processed and fresh tissue than on processed and thawed tissue. Film adhesion on fresh, unprocessed tissue was lowest in most of the animals tested. Comparison of ex vivo measurements on porcine small intestinal tissue with in vitro measurements on agar/mucin gels illustrates the inter- and intra-individual variability of biological tissue.

Práticas da Psicologia no contexto carcerário Brasileiro: uma revisão sistemática / Psychology practices in the Brazilian prison context: a systematic review

Este texto apresenta resultados de uma pesquisa que teve como objetivo compreender a atuação da(o) profissional psicóloga(o) no contexto carcerário brasileiro a partir da literatura produzida e publicada nas principais bases de dados vinculadas ao CNPq. Foi realizado um levantamento nas bases de dados no ano de 2020 e selecionados 7 trabalhos para análise. Identificou-se que a maioria das publicações é de 2015, possuindo concentração geográfica maior na região Sudeste. Predominam discussões sobre o papel que a(o) psicóloga(o) deve exercer nesse espaço e qual a sua real atuação. Constatou-se que as práticas mais exercidas por psicólogas(os) no sistema prisional são os atendimentos individuais, a avaliação psicológica e a elaboração de documentos. Considera-se a necessidade de maiores discussões e pesquisas sobre a atuação de psicólogas no contexto carcerário, bem como a realização destas discussões durante a formação em psicologia.

This text presents the results of a research that aimed to understand the role of professional psychologists in the Brazilian prison context, based on the literature produced and published in the main databases linked to the CNPq. A survey was carried out in the databases in the year 2020 and 7 works were selected for analysis. It was identified that most publications are from 2015, with a greater geographic concentration in the Southeast region. Discussions about the role that (o) psychologist (o) should play in this space and what is her real role prevail. It was found that the practices most exercised by psychologists in the prison system are individual care, psychological assessment and preparation of documents. There is a need for further discussions and research on the role of psychologists in the prison context, as well as these discussions during training in psychology.

SILENCE: Capturing the Feeling of Inner Quietude.

Silent experiences are integral parts of human life, and despite such moments of silence-phenomena may falsely be perceived as moments of "nothings", they are in fact an essential part of human apperception and meaning-making. The significance of moments of silence (an internal, timeless state of being often perceived as solitary, spiritual-mystical, and unconscious, involuntary experiences) and silences (contextual states of temporally oriented and social experiences) is supported by the principles behind the concepts of Gestalten and zero signifiers, in that such absence can lead to greater understanding of meaning than any explicit and direct element ever could. The human experience of life is inseparably linked with the function of apperception as experiencing the presence in a combination with reconstruction of the past and imagination of the future. And as this dynamic across irreversibility of time is in any human experience it is as well present within experiences of silence. Furthermore, is the phenomenon of Einfühlung (the process of feeling in and through others, objects, and oneself) a crucial part of silence-phenomena, as it is uncovered to be connected with both silence as a facilitator of emergence of silence as well as silences affect the act of Einfühlung. Aesthetic experiences can in the form of poetic instants lead to moments of silence, through the human function of Einfühlung. Finally, an analysis of a passage from Lev Vygotsky's personal notebooks will support the line of reasoning the centrality of the existence of silence.