Re-evaluation of shellac (E 904) as a food additive and a new application on the extension of use of shellac (E 904) in dietary foods for special medical purposes.

The present opinion deals with the re-evaluation of shellac (E 904) when used as a food additive and with the new application on the extension of use of shellac (E 904) in dietary foods for special medical purposes. The Panel derived an acceptable daily intake (ADI) of 4 mg/kg body weight (bw) per day for wax-free shellac (E 904) produced by physical decolouring, based on a NOAEL of 400 mg/kg bw per day and applying an uncertainty factor of 100. The Panel concluded that the ADI of 4 mg/kg bw per day should be considered temporary for wax-free shellac (E 904) produced by chemical bleaching, while new data are generated on the identity and levels of the organochlorine impurities in E 904. This ADI is not applicable for wax-containing shellac as a food additive. For several age groups, the ADI was exceeded at the 95th percentile in the non-brand-loyal exposure assessment scenario and maximum level exposure assessment scenario. Considering the low exceedance and the fact that both the exposure estimation and the toxicological evaluation of shellac were conservative, the panel concluded that the calculated exceedance of the ADI does not indicate a safety concern. The Panel recommended to the European Commission separating specifications for E 904 depending on the manufacturing process, chemical bleaching and physical decolouring, because they result in different impurities; revising the definition of the food additive to include a description of each manufacturing process; deleting information on wax-containing shellac from the EU specifications; revising the acid value for wax-free shellac produced by chemical bleaching; lowering the maximum limit for lead; to consider introducing limits for other toxic elements potentially present in shellac; including a maximum limit for chloroform and total inorganic chloride in the EU specification for shellac produced by chemical bleaching.

Description of Sheep Pox Outbreak in Spain in 2022-2023: Challenges Found and Lessons Learnt in Relation with Control and Eradication of This Disease.

Sheep pox and goat pox are infectious viral diseases that affect ovine and caprine animals and are caused by two viruses of the family Poxviridae, genus Capripoxvirus. Sheep pox has been traditionally endemic in Africa, the Middle East, and several Southeast Asian countries, but it is considered a transboundary disease capable of affecting previously free countries epidemically. It is a disease of compulsory immediate notification to the World Organization for Animal Health (WOAH) and the European Union (EU). On 19 September 2022, the disease reemerged in Spain, which had been free of it since 1968, causing a total of 30 outbreaks until 17 May 2023, when the last outbreak of the disease was reported. The control and eradication measures implemented were those laid down in EU legislation, based on the total stamping out of positive herds, zoning and restriction of movement, and strengthening of biosecurity and passive surveillance. This manuscript describes the outbreak, as well as assesses the challenges and lessons learned in relation to its management, with the aim of helping in the effective management of future outbreaks of this disease.

The role of pathologists in the diagnosis of occupational lung diseases: an expert opinion of the European Society of Pathology Pulmonary Pathology Working Group.

Occupational lung/thoracic diseases are a major global public health issue. They comprise a diverse spectrum of health conditions with complex pathology, most of which arise following chronic heavy workplace exposures to various mineral dusts, metal fumes, or following inhaled organic particulate reactions. Many occupational lung diseases could become irreversible; thus accurate diagnosis is mandatory to minimize dust exposure and consequently reduce damage to the respiratory system. Lung biopsy is usually required when exposure history is inconsistent with imaging, in case of unusual or new exposures, in case of unexpected malignancy, and in cases in which there are claims for personal injury and legal compensation. In this paper, we provide an overview of the most frequent occupational lung diseases with a focus on pathological diagnosis. This is a paper that summarizes the expert opinion from a group of European pathologists, together with contributions from other specialists who are crucial for the diagnosis and management of these diseases. Indeed, tight collaboration of all specialists involved in the workup is mandatory as many occupational lung diseases are misdiagnosed or go unrecognized. This document provides a guide for pathologists in practice to facilitate the accurate diagnosis of occupational lung disease. The review article reports relevant topics discussed during an educational course held by expert pathologists, active members of the Pulmonary Pathology Working Group of the European Society of Pathology. The course was endorsed by the University of Padova as a "winter school" (selected project in the call for "Shaping a World-class University" 2022).

Attitudes and behaviours of mental health professionals in the care of transgender people: A qualitative study.

WHAT IS KNOWN ON THE SUBJECT?: Mental health professionals' beliefs about transgender individuals vary, often influenced by stereotypes. There's recognition of healthcare needs, but limited knowledge impacts decision-making. Stereotypes persist regarding why transgender individuals seek mental health care. WHAT THE PAPER ADDS TO EXISTING KNOWLEDGE?: Professionals' attitudes show both positive support and negative, discriminatory views. Lack of training and knowledge gaps hinder effective care for transgender individuals. Pathologising attitudes exist, associating gender diversity with mental health conditions. WHAT ARE THE IMPLICATIONS FOR PRACTICE?: Addressing training gaps is crucial for equitable care for transgender individuals. Challenging stereotypes and beliefs is necessary to reduce stigma and improve understanding. Enhancing knowledge and evidence-based tools will ensure safe and equal healthcare access. ABSTRACT: INTRODUCTION: Transgender people face against significant barriers in accessing mental health services due to, among other reasons, discrimination and a lack of expertise among professionals. AIM: To explore the beliefs and attitudes of professionals in the mental health network of the region of Murcia towards transgender people, focusing on aspects such as knowledge, perceptions, and prejudices about gender identity. METHOD: We carried out a qualitative study involving 14 participants, conducting semi-structured interviews based on prior knowledge of the topic. We asked the professionals about their experiences and challenges in their clinical interaction with transgender users and followed an inductive-deductive process to analyse the data. RESULTS: Two main themes were identified from the interviews, which were sub-categorised into different sub-themes: (a) beliefs about transgender people: underlying factors and origins of gender diversity, health needs, and stereotypes about the demand for health care; (b) attitudes and behaviours of professionals towards transgender people: pathologization and attitudes towards decision-making. DISCUSSION/IMPLICATIONS FOR PRACTICE: Our findings suggest that mental health professionals tend to oversimplify the factors underlying gender diversity and hold certain stereotypical beliefs about these users that oversimplify the complexity of their experiences.

Features and frequency of use of electronic health records in primary care across 20 countries: a cross-sectional study.

OBJECTIVES: Variation exists in the capabilities of electronic healthcare records (EHRs) systems and the frequency of their use by primary care physicians (PCPs) from different settings. We aimed to examine the factors associated with everyday EHRs use by PCPs, characterise the EHRs features available to PCPs, and to identify the impact of practice settings on feature availability. STUDY DESIGN: Cross-sectional study. METHODS: PCPs from 20 countries completed cross-sectional online survey between June and September 2020. Responses which reported frequency of EHRs use were retained. Associations between everyday EHRs use and PCP and practice factors (country, urbanicity, and digital maturity) were explored using multivariable logistic regression analyses. The effect of practice factors on the variation in availability of ten EHRs features was estimated using Cramer's V. RESULTS: Responses from 1520 out of 1605 PCPs surveyed (94·7%) were retained. Everyday EHRs use was reported by 91·2% of PCPs. Everyday EHRs use was associated with PCPs working >28 h per week, having more years of experience using EHRs, country of employment, and higher digital maturity. EHRs features concerning entering, and retrieving data were available to most PCPs. Few PCPs reported having access to tools for 'interactive patient education' (37·3%) or 'home monitoring and self-testing of chronic conditions' (34·3%). Country of practice was associated with availability of all EHRs features (Cramer's V range: 0·2-0·6), particularly with availability of tools enabling patient EHRs access (Cramer's V: 0·6, P < 0.0001). Greater feature availability of EHRs features was observed with greater digital maturity. CONCLUSIONS: EHRs features intended for patient use were uncommon across countries and levels of digital maturity. Systems-level research is necessary to identify the country-specific barriers impeding the implementation of EHRs features in primary care, particularly of EHRs features enabling patient interaction with EHRs, to develop strategies to improve systems-wide EHRs use.

Tribulus terrestris and Sport Performance: A Quantitative and Qualitative Evaluation of Its Advertisement and Availability via Online Shopping in Six Different Countries.

Dietary supplements are commonly used among athletes, and the Internet may be an easy source of these products. Tribulus terrestris is an herbal supplement with multiple properties. Of interest to athletes are reports that its consumption can lead to muscle mass gain and a faster recovery process. The objective of this cross-sectional study was to determine the availability of Tribulus terrestris via the Internet in six countries (Canada, Puerto Rico, Russia, Spain, Ukraine, and the United States of America) via a specifically designed computer program. The characteristics of the websites selling this substance, the country from which it can be purchased, the route of administration, and recommendations for its use were analyzed. The results of the study show that this supplement is marketed mainly in Russia, Ukraine, and Spain on many websites that are mostly dedicated to sports products. Just over half of the webpages (59.14%) identified only distribute this supplement within the same country. The main claims for its consumption refer to sports performance benefits, but there are also claims that it may improve male hormone levels and sexual function. Athletes should be encouraged to seek professional advice prior to ingesting this supplement to ensure that it is suitable for their specific training and sports objectives.

Uric acid and acute kidney injury in high-risk patients for developing acute kidney injury undergoing cardiac surgery: A prospective multicenter study.

PURPOSE: It is unclear whether preoperative serum uric acid (SUA) elevation may play a role in the development of acute kidney injury (AKI) associated with cardiac surgery (CSA-AKI). We conducted a cohort study to evaluate the influence of preoperative hyperuricemia on AKI in patients at high risk for developing SC-AKI. DESIGN: Multicenter prospective international cohort study. SETTING: Fourteen university hospitals in Spain and the United Kingdom. PARTICIPANTS: We studied 261 consecutive patients at high risk of developing CSA-AKI, according to a Cleveland score ≥ 4 points, from July to December 2017. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: AKIN criteria were used for the definition of AKI. Multivariable logistic regression models and propensity score-matched pairwise analysis were used to determine the adjusted association between preoperative hyperuricemia (≥7 mg/dL) and AKI. Elevated preoperative AUS (≥7 mg/dL) was present in 190 patients (72.8%), whereas CSA-AKI occurred in 145 patients (55.5%). In multivariable logistic regression models, hyperuricemia was not associated with a significantly increased risk of AKI (adjusted Odds Ratio [OR]: 1.58; 95% confidence interval [CI]: 0.81-3; P = .17). In propensity score-matched analysis of 140 patients, the hyperuricemia group experienced similar adjusted odds of AKI (OR 1.05, 95%CI 0.93-1.19, P = .37). CONCLUSIONS: Hyperuricemia was not associated with an increased risk of AKI in this cohort of patients undergoing cardiac surgery at high risk of developing CSA-AKI.

Recombinant ADAMTS13 in Congenital Thrombotic Thrombocytopenic Purpura.

BACKGROUND: Congenital thrombotic thrombocytopenic purpura (TTP) results from severe hereditary deficiency of ADAMTS13. The efficacy and safety of recombinant ADAMTS13 and standard therapy (plasma-derived products) administered as routine prophylaxis or on-demand treatment in patients with congenital TTP is not known. METHODS: In this phase 3, open-label, crossover trial, we randomly assigned patients in a 1:1 ratio to two 6-month periods of prophylaxis with recombinant ADAMTS13 (40 IU per kilogram of body weight, administered intravenously) or standard therapy, followed by the alternate treatment; thereafter, all the patients received recombinant ADAMTS13 for an additional 6 months. The trigger for this interim analysis was trial completion by at least 30 patients. The primary outcome was acute TTP events. Manifestations of TTP, safety, and pharmacokinetics were assessed. Patients who had an acute TTP event could receive on-demand treatment. RESULTS: A total of 48 patients underwent randomization; 32 completed the trial. No acute TTP event occurred during prophylaxis with recombinant ADAMTS13, whereas 1 patient had an acute TTP event during prophylaxis with standard therapy (mean annualized event rate, 0.05). Thrombocytopenia was the most frequent TTP manifestation (annualized event rate, 0.74 with recombinant ADAMTS13 and 1.73 with standard therapy). Adverse events occurred in 71% of the patients with recombinant ADAMTS13 and in 84% with standard therapy. Adverse events that were considered by investigators to be related to the trial drug occurred in 9% of the patients with recombinant ADAMTS13 and in 48% with standard therapy. Trial-drug interruption or discontinuation due to adverse events occurred in no patients with recombinant ADAMTS13 and in 8 patients with standard therapy. No neutralizing antibodies developed during recombinant ADAMTS13 treatment. The mean maximum ADAMTS13 activity after recombinant ADAMTS13 treatment was 101%, as compared with 19% after standard therapy. CONCLUSIONS: During prophylaxis with recombinant ADAMTS13 in patients with congenital TTP, ADAMTS13 activity reached approximately 100% of normal levels, adverse events were generally mild or moderate in severity, and TTP events and manifestations were rare. (Funded by Takeda Development Center Americas and Baxalta Innovations; ClinicalTrials.gov number, NCT03393975.).

Dental pain in Brazilian preschool children: association with the severity of dental caries and impact on oral health-related quality of life.

PURPOSE: This study aimed to verify the association between dental pain and severity of dental caries (caries morbidity stages) and the impact on oral health-related quality of life (OHRQoL) in preschool children. METHODS: A cross-sectional study with 199 children (2-5 years old) enrolled at preschools in Capão do Leão-RS, Brazil. The self-report of mothers of children with a history of dental pain in the last 6 months and perception of their child's OHRQoL (ECOHIS) were obtained through a structured questionnaire. This questionnaire also collected independent variables. Children's oral examination was performed using the CAST instrument to determine caries morbidity stage. Crude and adjusted Poisson regression analysis was performed. RESULTS: The prevalence of dental pain was 14.57%. The chance of the occurrence of dental pain was higher among children diagnosed in morbidity [Prevalence ratio-PR: 5.29 (95% confidence interval-95% CI 1.91-14.61); p = 0.001] and severe morbidity [RP = 6.12 (95 CI% 2.25-16.64); p < 0.001] stages. Children with dental pain presented higher scores in the total ECOHIS [rate ratio = 7.11 (95% CI 4.55-11.09); p < 0.001] and in all of the domains of this instrument. Furthermore, children with a history of dental trauma [PR = 2.41 (95% CI 1.15-5.04); p < 0.001] and those whose reason for last visit to the dental office was for restorative/endodontic/extraction treatment [PR = 1.29 (95% CI 1.01-6.19); p = 0.049] had a higher prevalence of dental pain. CONCLUSION: A substantial prevalence of dental pain in the last 6 months and negative impact on children's OHRQoL was identified in this sample. Children diagnosed with carious dentin lesions and abscess and fistula were more likely to have dental pain.

The association between gender identity fluidity and health outcomes in transgender and gender diverse people in New Orleans and Los Angeles, USA.

Objectives: Most studies with transgender and gender diverse people (TGD) examine gender identity cross-sectionally. Gender identity and expression can fluctuate over time, which may have implications for health. The goal of our study was to compare mental health, substance use and healthcare utilization among 163 gender identity fluid (1 + identity change) and gender identity consistent (no change) TGD. Methods: Participants were recruited in New Orleans, LA and Los Angeles, CA and assessed at four-month intervals over 24 months between 2017 and 2021. We conducted logistic regression models to test for associations between gender identity fluidity and health outcomes at 24 months. In post hoc analyses, we explore how controlling for cross-sectional report of gender identity at 24 months may impact the association between gender identity fluidity and health outcomes. Results: We saw no significant differences across mental health and substance use indicators. Gender identity fluid participants had 5.9 times the adjusted odds (95 % Confidence Interval (CI): 1.9-18.4) of no recent healthcare visit compared to gender identity consistent participants. After controlling for cross-sectional report of gender identity, the association between gender identity fluidity and no recent healthcare visit remained significant (aOR = 4.6; 95 % CI: 1.4-14.8). Conclusions: Because providers have limited experience providing gender-affirming care or treating patients with fluid gender identities, gender identity fluid patients may avoid healthcare more than gender identity consistent patients. Our preliminary study highlights the need to measure gender identity longitudinally and examine the relationship between gender identity fluidity and health.

Examining the Performance of the Sexual Minority Adolescent Stress Inventory with Transgender and Gender-Diverse Youth and Sexual Minority Emerging Adults: A Methodological Study.

Purpose: We examined the psychometric properties and criterion validity of the Sexual Minority Adolescent Stress Inventory (SMASI) among 730 sexual minority (SM) and transgender and gender-diverse (TGD) youth aged 14 to 24 years who participated in a human immunodeficiency virus study. Methods: We tested the factor structure of the global scale and subscales and measurement invariance across age, gender identity, sex assigned at birth, sexual identity, ethnoracial identity, and city. For criterion validity, we regressed mental health and substance use measures on the global scale. Results: The global scale had excellent fit (comparative fit index = 0.95) and high reliability (omega = 0.89). Subscale model fit was adequate. We confirmed invariance by gender identity and age and established criterion validity. Conclusion: The SMASI exhibits strong psychometric properties among SM emerging adults and TGD youth. Modifications could enhance the SMASI to better capture both sexual and gender minority stress among ethnoracial minority youth.

Role of compliance in Helicobacter pylori eradication treatment: Results of the European Registry on H. pylori management.

BACKGROUND: Adherence to Helicobacter pylori (H. pylori) eradication treatment is a cornerstone for achieving adequate treatment efficacy. OBJECTIVE: To determine which factors influence compliance with treatment. METHODS: A systematic prospective non-interventional registry (Hp-EuReg) of the clinical practice of European gastroenterologists. Compliance was considered adequate if ≥90% drug intake. Data were collected until September 2021 using the AEG-REDCap e-CRF and were subjected to quality control. Modified intention-to-treat analyses were performed. Multivariate analysis carried out the factors associated with the effectiveness of treatment and compliance. RESULTS: Compliance was inadequate in 646 (1.7%) of 38,698 patients. The non-compliance rate was higher in patients prescribed longer regimens (10-, 14-days) and rescue treatments, patients with uninvestigated dyspepsia/functional dyspepsia, and patients reporting adverse effects. Prevalence of non-adherence was lower for first-line treatment than for rescue treatment (1.5% vs. 2.2%; p < 0.001). Differences in non-adherence in the three most frequent first-line treatments were shown: 1.1% with proton pump inhibitor + clarithromycin + amoxicillin; 2.3% with proton pump inhibitor clarithromycin amoxicillin metronidazole; and 1.8% with bismuth quadruple therapy. These treatments were significantly more effective in compliant than in non-compliant patients: 86% versus 44%, 90% versus 71%, and 93% versus 64%, respectively (p < 0.001). In the multivariate analysis, the variable most significantly associated with higher effectiveness was adequate compliance (odds ratio, 6.3 [95%CI, 5.2-7.7]; p < 0.001). CONCLUSIONS: Compliance with Helicobacter pylori eradication treatment is very good. Factors associated with poor compliance include uninvestigated/functional dyspepsia, rescue-treatment, prolonged treatment regimens, the presence of adverse events, and the use of non-bismuth sequential and concomitant treatment. Adequate treatment compliance was the variable most closely associated with successful eradication.

Making an accurate diagnosis of anterior mediastinal lesions: a proposal for a new diagnostic algorithm from the BTOG Thymic Malignancies Special Interest Group.

Due to the rising demand in cross-sectional thoracic imaging, anterior mediastinal lesions are being identified with increasing frequency. Following iterative and multidisciplinary discussions, the BTOG Thymic Malignancies Special Interest Group have developed an algorithm to standardise the diagnostic approach for these relatively uncommon but important conditions which span from benign (thymic remnant, thymic hyperplasia and thymic cysts) to suspected localised thymomas to suspected more aggressive malignancy (thymic carcinoma, lymphoma and germ cell tumours). For each condition, we provide a brief description, an overview of the key radiological findings and a description of the proposed algorithm including the rationale behind the recommendations. We also highlight the role of magnetic resonance (MR) imaging for the characterisation of anterior mediastinal masses in specific indications when the necessary local resources and expertise exist. In addition, we hope this provides the rationale for service development in MR of the anterior mediastinum where current resource and expertise requires development. Through this standardised pathway, we hope to drive improvements in patient care by rationalising surveillance schedules, avoiding unnecessary resections of benign entities with their associated morbidity and optimising the diagnostic work-up prior to the appropriate treatment of anterior mediastinal malignancies.

Psycho-emotional intervention with parents of very preterm babies during the first year: A single-arm pilot study.

Studies of intervention programs that aim to improve the emotional state of parents of children admitted to the neonatal intensive care units (NICU) are scarce in Spain. The aims of this single-arm pilot study are to get to know the emotional profile of parents of high-risk preterm newborns, and to explore parents' patterns of emotional well-being before and after a psychological program called the Parental Empowerment Program, to increase parental readiness levels. The sample was made up of 100 parents (50 couples) who participated in the program. Measurements were taken of post-traumatic stress, depression, and resilience at 1 month and 12 months. Repeated measurements and dyadic data analyses were performed. One month after the birth of the baby and prior to the start of the program, mothers show more symptoms of stress and depression than fathers. After the intervention, both parents experienced improvements in their mood levels. The evidence obtained seems to show that high resilience levels and low post-traumatic stress symptoms are associated with reduced depression levels after implementing the program. However, the heterogeneity of the responses obtained, the observed associations between stress, resilience, and maternal depression, along with the reciprocal influence between maternal and paternal depression 1 year after the intervention, highlight the need for a more in-depth exploration of the interplay between risk and protective factors in this population. Despite the identified potential threats to validity, further work in this direction is recommended, including the implementation of clinical trials to demonstrate intervention efficacy. The adaptation of the parents' mutual emotional adjustment at each stage would allow them to participate more actively in the baby's care.

[Hypertensive Emergency as the Debut of Paraneoplastic Cushing Syndrome]. / Emergencia hipertensiva como debut de síndrome de Cushing paraneoplásico.

We present the case of a patient with a history of renal-vascular hypertension treated with stent one year previously, who attended the emergency room due to hypertensive emergency and dyspnea. Once the first suspicion of renal artery restenosis was ruled out with CT angiography, the study was completed, confirming the diagnosis of lung cancer through imaging and pathological anatomy. In the hormonal study, elevation of ACTH, hypercortisolism and analytical data of hyperaldosteronism were detected. With the final diagnosis of Cushing's syndrome secondary to ectopic production of ACTH, medical treatment was started, without being able to receive anything else due to the death of the patient after a few days.