Co-occurrence of otitis media with effusion and another environment-dependent disease (selected allergic conditions).

Introduction: Otitis media eith effusion (OME) is an inflammatory condition of the middle ear that involves accumulation of sterile fluid or effusion in the tympanic cavity with the tympanic membrane intact. The pathophysiology of OME is undoubtedly multifactorial. Aim: To assess the co-occurrence of OME, allergic rhinitis, and asthma. Material and methods: The study involved a group of 18,617 subjects aged 6-7 years, 13-14 years, or 20-44 years. ECRHS and ISAAC questionnaires, validated and adopted for Polish conditions, were used in the study. Results: OME increases the risk of developing allergic rhinitis by nearly two-fold (OR = 2.07, 95% CI: 1.738-2.479 in 6-7-year-olds; OR = 1.61, 95% CI: 1.299-1.995 in 13-14-year-olds, and OR = 1.55, 95% CI: 1.262-1.83 in 20-44-year-olds). Protective factors against otitis media with effusion include the number of siblings (the more children in the family, the higher the risk of chronic OM; OR = 2.00, 95% CI: 1.15-1.346) and consumption of dairy products rich in lactic acid bacteria. Conclusions: OME significantly more often co-exists with other conditions, particularly allergic rhinitis.

Validation of the Arabic Version of the European Community Respiratory Health Survey Screening Questionnaire.

Purpose: The European Community Respiratory Health Survey (ECRHS) questionnaire has been widely used in epidemiological studies to quantify respiratory symptoms and screen for asthma, but there is no formally validated Arabic version. This study developed an Arabic ECRHS screening questionnaire, comprehensively evaluated its reliability and validity, and used it to estimate the population prevalence of respiratory symptoms and asthma in Saudi Arabia. Methods: The ECRHS screening questionnaire was adapted to Arabic through translation and back-translation by bilinguals with consultation to a professional committee and lay panel. Reliability and validity were evaluated in a prospective, cross-sectional convenience sample of adults (>18 years) between January and July 2022 in Riyadh, Saudi Arabia. A subgroup completed the questionnaire again three weeks later to assess test-retest reliability. All respiratory symptom-positive participants were invited for spirometry to diagnose asthma according to GINA criteria. Internal consistency was assessed using Cronbach's α coefficient, test-retest reliability with Cohen κ coefficients, and reliability by calculating the sensitivity and specificity for diagnosing asthma. Results: Of 2500 invited individuals, 1881 participated (75.2%). A total of 668 (35.5%) participants reported respiratory symptoms according to the ECRHS questionnaire, and 157/1881 (8.3%) had a current diagnosis of asthma on ECRHS questions. Cronbach's α coefficient for internal consistency was 0.831, "good" internal consistency. The test-retest reliability (n = 303) was "excellent" for all questions (Cohen's κ≥0.75). A total of 543 (81.3%) screening-positive participants underwent spirometry, of whom 278 (52%) were diagnosed with asthma according to GINA guidelines, an overall estimated prevalence of 14.8%. Most questions showed good-to-fair specificity and variable sensitivity for physician-diagnosed asthma. Conclusion: This Arabic version of the ECRHS screening questionnaire is conceptually similar to the English version, comprehensible, and reliable. Many asthma cases remain hidden and undiagnosed. In addition to utility in epidemiological studies, the ECRHS screening questionnaire might be a simple, quick, and useful tool for asthma case finding.

Evaluation of selected aspects of the hygiene hypothesis and their effect on the incidence of allergy.

OBJECTIVES: The development of allergic conditions is largely dependent on the interactions between genetic (individual genetic predisposition) and environmental factors (exposure to risk factors). The aim of this study was an attempt to assess the influence of selected elements of the hygiene theory in the development of allergic diseases such as allergic rhinitis and asthma. MATERIAL AND METHODS: The study group consisted of 5518 women and 3868 men. The method that was used was the European Community Respiratory Health Survey II and International Study of Asthma and Allergies in Childhood questionnaire validated and adapted to Central and Eastern European conditions. The project was conducted in 8 urban areas (Gdansk, Wroclaw, Poznan, Katowice, Kraków, Lublin, Bialystok, Warsaw) and 1 rural area (Krasnystaw county). This study had 2 stages; the first stage involved grouping the 22 500 respondents based on their questionnaire responses with the use of a Personal Digital Assistant (PDA); the second stage involved 7000 subjects, who underwent additional assessments: skin prick tests (birch, grasses/cereals, Dermatophagoides pteronyssinus and Dermatophagoides farinae, molds [set I: Botrytis cinerea, Cladosporium herbarum, Alternaria tenuis, Curvularia lunata, Fusarium moniliforme, Helminthosporium], molds [set II: Aspergillus fumigatus, Mucor mucedo, Penicillium notatum, Pullularia pullulans, Rhizopus nigricans, Serpula lacrymans], cat, dog, molds Cladosporium herbarum, Alternaria tenuis) and spirometry tests. RESULTS: The age at which children attend the nursery school is critical to the development of allergic diseases; in allergic rhinitis, the risk of an IgE-dependent reaction is 2 times higher in the second than in the first year of life (p = 0.00147, p < 0.05), while in asthma, having a large number of siblings increases the risk of developing obstructive disease by almost 6 times (p = 0.00316, p < 0.05).The age at which children attend the nursery school is critical to the development of allergic diseases; in allergic rhinitis, the risk of an IgE-dependent reaction is 2 times higher in the second than in the first year of life (p = 0.00147, p < 0.05), while in asthma, having a large number of siblings increases the risk of developing obstructive disease by almost 6 times (p = 0.00316, p < 0.05). CONCLUSIONS: The hygiene theory is particularly applicable and can explain the relationship of selected habits in the development of allergic diseases. Int J Occup Med Environ Health. 2023;36(1):69-83.

The knowledge and attitudes of pharmacists related to the use of dietary supplements: An observational study in northeastern Italy.

Inappropriate use of dietary supplements can be potentially harmful to patients, especially given the uncontrolled information on the Internet and social media. The role that pharmacists play in advising citizens and purchasing these products can help improve their safer use, but the knowledge, attitudes, and practices of these professionals on this topic are still largely unknown. Pharmacists in the Italian Region of Friuli-Venezia Giulia (FVG) were surveyed from September 2020 to February 2021 using a 54-item online questionnaire. The questions were related to knowledge, attitudes, and practice. Data on gender, age, work experience, degree, and function in pharmacy were also collected. 232 questionnaires were completed, predominantly by women (71 %). The majority of respondents had a degree in Pharmacy (77 %) and were employed in a pharmacy (66 %) where they had worked for at least 10 years (61 %). Pharmacists' knowledge was rated as low, with one-third of participants above the median; knowledge was higher among more experienced pharmacists. Larger knowledge gaps were noted regarding the potential carcinogenicity of multivitamin misuse and the undesirable presence of unlabeled ingredients in dietary supplements. Employees were more likely than owners to report purchasing dietary supplements at the direct request of patients (p < 0.05). The low level of pharmacists' knowledge about the use of dietary supplements is unsatisfactory, with concerning impact on patient safety. Young professionals in particular would benefit from continuous education to better advise patients. Nevertheless, the European regulatory framework for the manufacture, sale and post-marketing surveillance of dietary supplements needs to be strengthened.

Agri-Food Wastes for Bioplastics: European Prospective on Possible Applications in Their Second Life for a Circular Economy.

Agri-food wastes (such as brewer's spent grain, olive pomace, residual pulp from fruit juice production, etc.) are produced annually in very high quantities posing a serious problem, both environmentally and economically. These wastes can be used as secondary starting materials to produce value-added goods within the principles of the circular economy. In this context, this review focuses on the use of agri-food wastes either to produce building blocks for bioplastics manufacturing or biofillers to be mixed with other bioplastics. The pros and cons of the literature analysis have been highlighted, together with the main aspects related to the production of bioplastics, their use and recycling. The high number of European Union (EU)-funded projects for the valorisation of agri-food waste with the best European practices for this industrial sector confirm a growing interest in safeguarding our planet from environmental pollution. However, problems such as the correct labelling and separation of bioplastics from fossil ones remain open and to be optimised, with the possibility of reuse before final composting and selective recovery of biomass.

A Snapshot of Female Representation in Twelve Academic Psychiatry Institutions Around the World.

The study presented here aims at bringing a global perspective to the phenomenon of unequal representation of females in science by offering empirical data of female representation in neuroscience/schizophrenia academic or clinical departments in several institutions around the world. We took advantage of a budding network of scientists and colleagues from different countries to bring the data together. The data presented are related to sex, that is the biological distinction between males and females, based on genetics and reproductive anatomy, while gender, considered a cultural concept was harder to determine. We report data from two clinical/academic departments in Nigeria, Africa; 2 clinical/academic departments from Sudan, Africa; 1 clinical/academic department from South Africa, Africa; 3 academic institutions from Ireland, Europe; 1 clinical/academic institution from Spain, Europe; 2 academic institutions from Buenos Aires University, Argentina; and the Psychiatry Departments at Harvard Medical School, Boston, USA.

FEV1 decline in relation to blood eosinophils and neutrophils in a population-based asthma cohort.

BACKGROUND: The relationship between lung function decline and eosinophils and neutrophils has important therapeutic implications among asthmatics, but it has rarely been studied in large cohort studies. OBJECTIVE: The aim is to study the relationship between blood eosinophils and neutrophils and FEV1 decline in a long-term follow-up of a population-based adult asthma cohort. METHODS: In 2012-2014, an adult asthma cohort was invited to a follow-up including spirometry, blood sampling, and structured interviews, and n = 892 participated (55% women, mean age 59 y, 32-92 y). Blood eosinophils, neutrophils and FEV 1 decline were analyzed both as continuous variables and divided into categories with different cut-offs. Regression models adjusted for smoking, exposure to vapors, gas, dust, or fumes (VGDF), use of inhaled and oral corticosteroids, and other possible confounders were utilized to analyze the relationship between eosinophils and neutrophils at follow-up and FEV1 decline. RESULTS: The mean follow-up time was 18 years, and the mean FEV 1 decline was 27 ml/year. The annual FEV1 decline was related to higher levels of both blood eosinophils and neutrophils at follow-up, but only the association with eosinophils remained when adjusted for confounders. Further, the association between FEV1 decline and eosinophils was stronger among those using ICS. With EOS <0.3 × 109/L as reference, a more rapid decline in FEV1 was independently related to EOS ≥0.4 × 109/L in adjusted analyses. CONCLUSIONS AND CLINICAL RELEVANCE: Besides emphasizing the importance of smoking cessation and reduction of other harmful exposures, our real-world results indicate that there is an independent relationship between blood eosinophils and FEV1 decline among adults with asthma.

Prevalence of allergic sensitization to storage mites in Northern Europe.

BACKGROUND: Allergic sensitization to storage mites has mostly been related to occupational exposures like farming, grain/cattle handling, whereas for non-occupational settings, storage mite sensitization has been attributed to cross-reactivity with house dust mite (HDM) allergens. OBJECTIVE: We aimed to describe the prevalence of allergic sensitization to storage mites, co-sensitization to HDM allergens and respiratory symptoms in Denmark, Iceland, Norway and Sweden. METHODS: The population comprised of 1180 participants born 1945-1972 of the third follow-up of the population-based cohort European Community Respiratory Health Survey (ECRHS) in Aarhus, Bergen, Reykjavik and Uppsala. A clinical examination included skin prick tests (SPT) to Lepidoglyphus destructor, Tyrophagus putrescentiae, Acarus siro and common inhalant allergens, as well as standardized interviews. RESULTS: 8% were sensitized to HDM and 10% to storage mite, with some variation by study centre: Reykjavik 13%, Bergen 8% and Aarhus 7%. In Uppsala, only L destructor (3%) was measured. Storage mite sensitization was higher among men (11%) than women (8%). Among storage mite sensitized, 44% were also sensitized to HDM. Storage mite sensitization was associated with asthma and nasal allergies, but not with age, education, pet keeping or place of upbringing. CONCLUSIONS AND CLINICAL RELEVANCE: In this Northern European population-based study, allergic sensitization to storage mite was as common as HDM sensitization. Storage mite sensitization was, independently of HDM sensitization, associated with respiratory symptoms and asthma. Our findings suggest that storage mite sensitization should be evaluated with regard to inclusion into the common inhalant allergen panel in Northern Europe.

A simple, no-cost method for 3D printed model identification.

3D printed models are often very similar in shape and can be inadvertently switched if the related patient is not identified correctly. Here, we present a free and simple method to imprint letters and numbers in a 3D model. CT scan data were used to create an STL file of a patient's mandible. We then used Blender software to modify it with numbers and letters. We chose to imprint a series of four letters and numbers on our 3D models. We chose representative letters and numbers of the Latin alphabet. Six models were printed with an Up plus 2 - easy 120 3D printer with different character sizes and shape to evaluate the readability. All models were printed without any failures. Regarding readability, 2 mistakes were made among ten readers. The favourite extrusion depth was 3 mm, and the largest model was preferred. Identification can be done at different times and by different means, but identifying the 3D model during its creation is safer. Moreover these identified 3D models could be saved in the digital patient medical file. The identification location should take into consideration the future indication of the 3D printed medical model. We recommend that 3D identification should be done using at least 7.5mm high, with a depth of 3mm. Our method allows easy, fast and free 3D text. This 3D text identification printing method may be a first step towards the legal use of 3D printed models made within the hospital.

Driving next-generation autophagy researchers towards translation (DRIVE), an international PhD training program on autophagy.

The European autophagy consortium Driving next-generation autophagy researchers towards translation (DRIVE) held its kick-off meeting in Groningen on the 14th and 15th of June 2018. This Marie Sklodowska-Curie Early Training Network was approved under the European Union's Horizon 2020 Research and Innovation Program and is funded for 4 years. Within DRIVE, 14 European research teams from academia and industry will train 15 PhD students through applied, cross-disciplinary and collaborative macroautophagy/autophagy research. The goal of DRIVE is to stimulate applied approaches in autophagy research and provide training towards translation, while advancing our knowledge on autophagy in specific physiological and pathological states. The strong focus on translation will prepare the PhD students to be at the forefront to exploit autophagy for the development of therapies directly benefitting patients. Thereby, DRIVE will contribute to filling the educational gap that currently exists between academia and industry, and will prepare its PhD students for alternative and highly flexible professional paths.

mHealth and telemedicine apps: in search of a common regulation.

Developments in information and communication technology have changed the way healthcare processes are experienced by both patients and healthcare professionals: more and more services are now available through computers and mobile devices. Smartphones are becoming useful tools for managing one's health, and today, there are many available apps meant to increase self-management, empowerment and quality of life. However, there are concerns about the implications of using mHealth and apps: data protection issues, concerns about sharing information online, and the patients' capacity for discerning effective and valid apps from useless ones. The new General Data Protection Regulation has been introduced in order to give uniformity to data protection regulations among European countries but shared guidelines for mHealth are yet to develop. A unified perspective across Europe would increase the control over mHealth exploitation, making it possible to think of mHealth as effective and standard tools for future medical practice.

Synthetic Biology: The Response of the Commission of the (Catholic) Bishops' Conferences of the European Community.

The Commission of the (Catholic) Bishops' Conferences of the European Community (COMECE) has issued an opinion on the ethics of synthetic biology (synbio). Examining synbio from religious and more general ethical perspectives, it examines synbio's potential pros and cons, as well as whether it is ethical in and of itself. Its conclusions mirror those of the ethical mainstream; namely, that synbio may present humanity with opportunities for both great advancement and great destruction. It suggests a prudent approach, and calls for regulation to be used to encourage positive outcomes while reducing the likelihood of negative ones.

Clinical markers of asthma and IgE assessed in parents before conception predict asthma and hayfever in the offspring.

BACKGROUND: Mice models suggest epigenetic inheritance induced by parental allergic disease activity. However, we know little of how parental disease activity before conception influences offspring's asthma and allergy in humans. OBJECTIVE: We aimed to assess the associations of parental asthma severity, bronchial hyperresponsiveness (BHR), and total and specific IgEs, measured before conception vs. after birth, with offspring asthma and hayfever. METHODS: The study included 4293 participants (mean age 34, 47% men) from the European Community Respiratory Health Survey (ECRHS) with information on asthma symptom severity, BHR, total and specific IgEs from 1991 to 1993, and data on 9100 offspring born 1972-2012. Adjusted relative risk ratios (aRRR) for associations of parental clinical outcome with offspring allergic disease were estimated with multinomial logistic regressions. RESULTS: Offspring asthma with hayfever was more strongly associated with parental BHR and specific IgE measured before conception than after birth [BHR: aRRR = 2.96 (95% CI: 1.92, 4.57) and 1.40 (1.03, 1.91), respectively; specific IgEs: 3.08 (2.13, 4.45) and 1.83 (1.45, 2.31), respectively]. This was confirmed in a sensitivity analysis of a subgroup of offspring aged 11-22 years with information on parental disease activity both before and after birth. CONCLUSION & CLINICAL RELEVANCE: Parental BHR and specific IgE were associated with offspring asthma and hayfever, with the strongest associations observed with clinical assessment before conception as compared to after birth of the child. If the hypothesis is confirmed in other studies, parental disease activity assessed before conception may prove useful for identifying children at risk for developing asthma with hayfever.

Can an airway challenge test predict respiratory diseases? A population-based international study.

BACKGROUND: Evidence on the longitudinal association of airway responsiveness with respiratory diseases is scarce. The best indicator of responsiveness is still undetermined. OBJECTIVE: We investigated the association of airway responsiveness with the incidence of asthma, chronic obstructive pulmonary disease (COPD), and allergic rhinitis. METHODS: We studied 3851 subjects who underwent spirometry and methacholine challenge tests both at baseline (1991-1993), when they were 20 to 44 years old, and at follow-up (1999-2002) in the European Community Respiratory Health Survey. Airway responsiveness was defined based on the methacholine dose-response slope on both occasions. Incidence rate ratios for the association of airway responsiveness with disease occurrence were computed by using Poisson regression. RESULTS: With respect to reference (slope of the fourth quintile or greater), subjects with the greatest degree of airway responsiveness (slope less than the first quintile) showed the greatest risk of developing asthma, COPD, and allergic rhinitis (incidence rate ratios of 10.82, 5.53, and 4.84, respectively; all P < .01). A low slope predicted disease occurrence, even in subjects who did not reach a 20% decrease in FEV1 at the cumulative dose of 1 mg of methacholine (PD20 >1 mg). A decrease in slope over time was an independent predictor of disease risk. CONCLUSION: Airway responsiveness predicted new-onset asthma, COPD, and allergic rhinitis. Our study supports the use of a continuous noncensored indicator of airway responsiveness, such as the slope of the methacholine dose-response curve, in clinical practice and research because it showed clear advantages over PD20.

Array CGH analysis of a cohort of Russian patients with intellectual disability.

The use of array comparative genomic hybridization (array CGH) as a diagnostic tool in molecular genetics has facilitated the identification of many new microdeletion/microduplication syndromes (MMSs). Furthermore, this method has allowed for the identification of copy number variations (CNVs) whose pathogenic role has yet to be uncovered. Here, we report on our application of array CGH for the identification of pathogenic CNVs in 79 Russian children with intellectual disability (ID). Twenty-six pathogenic or likely pathogenic changes in copy number were detected in 22 patients (28%): 8 CNVs corresponded to known MMSs, and 17 were not associated with previously described syndromes. In this report, we describe our findings and comment on genes potentially associated with ID that are located within the CNV regions.

Reprint of: B cell elimination in systemic lupus erythematosus. Clin. Immunol. 146(2) 90-103.

Systemic lupus erythematosus (SLE) is an autoimmune disorder with a worldwide distribution, potentially life-threatening with considerable morbidity. The elimination of pathogenic B cells has emerged as a rational therapeutic option. Many open label studies have reported encouraging results in which clinical and serological remission have invariably been described, often enabling the reduction of steroid and immunosuppressive treatment. However, the results from randomized controlled studies have been disappointing and several questions remain to be answered. In this review we will focus on results of B cell direct depletion in the treatment of patients with systemic lupus erythematosus.

European regulatory tools for advanced therapy medicinal products.

Increasing scientific knowledge and technical innovations in the areas of cell biology, biotechnology and medicine resulted in the development of promising therapeutic approaches for the prevention and treatment of human diseases. Advanced therapy medicinal products (ATMPs) reflect a complex and innovative class of biopharmaceuticals as these products are highly research-driven, characterised by innovative manufacturing processes and heterogeneous with regard to their origin, type and complexity. This class of ATMP integrates gene therapy medicinal products, somatic cell therapy medicinal products and tissue engineering products and are often individualized and patient-specific products. Multiple challenges arise from the nature of ATMPs, which are often developed by micro, small and medium sized enterprises, university and academia, for whom regulatory experiences are limited and regulatory requirements are challenging. Regulatory guidance such as the reflection paper on classification of ATMPs and guidelines highlighting product-specific issues support academic research groups and pharmaceutical companies to foster the development of safe and effective ATMPs. This review provides an overview on the European regulatory aspects of ATMPs and highlights specific regulatory tools such as the ATMP classification procedure, a discussion on the hospital exemption for selected ATMPs as well as borderline issues towards transplants/transfusion products.

The suggestions on the entry of Chinese medicines into European Community monographs for traditional herbal medicinal products / 国际中医中药杂志

Directive 2004/24/EC of the European Parliament and the Council entered into force on April 30th, 2004. After 7 years, there is no Chinese medicine to be registered successfully in European market as traditional herbal medicinal products. The thesis gives some ideas to tackle this problem. Procedure for the Preparation of Community Monographs for Traditional Herbal Medicinal Products (EMEA/HMPC/182320/2005) published by European Medicines Agency is an important guidance for traditional herbal products to enter European Community monographs. The thesis introduces and details the procedure as well as gives feasible suggestions about the procedure. It suggests that Chinese medicines enter European Community monographs first, and then apply the registration according to the directive 2004/24/EC. This is an easier access to European market.

[European Community procedure of marking for a reagent. Application to HIV 1 and 2 detection kits]. / Procédure de marquage Communauté européenne (marquage CE) d'un réactif. Application aux trousses de dépistage de l'infection par les VIH-1 et 2.

Kits for the detection of HIV infection are in vitro-diagnostic medical devices and are subject to special regulation to be marketed in the European Community. Before 1998, the Agence française de sécurité sanitaire des produits de santé was responsible for evaluating the new kits before allowing their marketing in France. The publication in the Official Journal of the European Community (L331 of December 7, 1998) of the European directive 98/79/CE of October 27, 1998 on in vitro diagnostics medical devices has changed the procedure for marketing approval of these kits in Europe. The aim of this review is to present the relevant conformity assessment procedures and its latest updates.

Research priorities in environmental health.

PIP: Environmental issues tend to greater political attention than do environmental health aspects. Therefore, when conflicts of interest occur with other environmental concerns, negative consequences for public health may result. For example, a strategy to substantially reduce indoor ventilation in many dwellings in Scandinavia in order to save energy has led to increased humidity levels and higher prevalences of house dust mites. Wood burning for local heating is promoted because it is a renewable source of energy, and diesel vehicles are promoted because they emit lower levels of carbon dioxide per kilometer compared to conventional gas engines, but both practices lead to increased emissions of fine particulates, which have been associated with adverse health effects. Increasing the level of resources available for research into environmental health is one way to help environmental health issues receive greater attention. Environmental health research initiatives taken by the European Commission, the European Science Foundation, and the World Health Organization's regional office for Europe are noted. Environmental health research is multidisciplinary and should encompass basic science as well as applied research. International collaboration is often very useful in environmental health research.^ieng