Short-course subcutaneous treatment with PQ Grass strongly improves symptom and medication scores in grass allergy.

BACKGROUND: A modified grass allergen subcutaneous immunotherapy (SCIT) product with MicroCrystalline Tyrosine and monophosphoryl lipid-A as an adjuvant system (Grass MATA MPL [PQ Grass]) is being developed as short-course treatment of grass-pollen allergic rhinitis (SAR) and/or rhinoconjunctivitis. We sought to evaluate the combined symptom and medication score (CSMS) of the optimized cumulative dose of 27,600 standardized units (SU) PQ Grass in a field setting prior to embarking on a pivotal Phase III trial. METHODS: In this exploratory, randomized, double-blind, placebo-controlled trial subjects were enrolled across 14 sites (Germany and the United States of America). Six pre-seasonal subcutaneous injections of PQ Grass (using conventional or extended regimens) or placebo were administered to 119 subjects (aged 18-65 years) with moderate-to-severe SAR with or without asthma that was well-controlled. The primary efficacy endpoint was CSMS during peak grass pollen season (GPS). Secondary endpoints included Rhinoconjunctivitis Quality of Life Questionnaire standardized (RQLQ-S) and allergen-specific IgG4 response. RESULTS: The mean CSMS compared to placebo was 33.1% (p = .0325) and 39.5% (p = .0112) for the conventional and extended regimens, respectively. An increase in IgG4 was shown for both regimens (p < .01) as well as an improvement in total RQLQ-S for the extended regimen (mean change -0.72, p = .02). Both regimens were well-tolerated. CONCLUSIONS: This trial demonstrated a clinically relevant and statistically significant efficacy response to PQ Grass. Unprecedented effect sizes were reached for grass allergy of up to ≈40% compared to placebo for CSMS after only six PQ Grass injections. Both PQ Grass regimens were considered equally safe and well-tolerated. Based on enhanced efficacy profile extended regime will be progressed to the pivotal Phase III trial.

Impact of perceptions of body size on obesity and weight management behaviour: a large representative population study in an African setting.

BACKGROUND: Perception of body size is an important psycho-cultural cause of obesity with wide racial and ethnic variations. METHOD: Cross-sectional household survey using multistage cluster-randomised sampling. Prevalence estimates were weighted. Logistic regressions were done to determine the impact of perception of large body size on obesity and the impact of perception of own body size on weight-management behaviour. Adjusted odds ratios (AOR) were reported. RESULTS: The survey involved 6628 adults from 2843 households. More than a quarter of the population is either obese or overweight. Nearly half, 44.07% (95% confidence interval [CI]: 42.48-45.66%) of the population perceive large body size as desirable. Positive perception of large body size significantly increases the odds of obesity by 1.5 (AOR: 1.45; 95% CI: 1.09-1.9). Some 42.03% (95% CI: 35.52-48.55%) obese persons misperceive their weight to be normal. Perceiving own body size as normal decreases the odds of weight-losing behaviour (AOR: 0.019; 95% CI: 0.014-0.026). CONCLUSION: There is a high level of veneration of large body size in southeast Nigeria, and this has a significant impact on obesity burden. Perception of own body size has a significant impact on weight-management behaviour. Health-promotion policies aimed at changing the social desirability of large body size and misperception of body size are recommended.

Skin cancer risk and shade: comparing the risk of foresters with other outdoor workers.

BACKGROUND: Keratinocyte carcinoma (KC) is an increasingly important public health problem with an especially high prevalence in outdoor workers. In contrast to other occupations, foresters spend most of their outdoor time under the shade of trees. OBJECTIVES: We aimed to compare the unique sun exposure patterns and sun protection behaviour of foresters with those of other outdoor workers and their relation to the KC risk. METHODS: In July 2018, a cross-sectional study was conducted at an international forestry fair using a questionnaire about health awareness and skin cancer screening by dermatologists to assess the prevalence of KC. RESULTS: A total of 591 participants (78.7% male; mean age 46.8 ± 16.2 years) including 193 foresters were enrolled. Of all foresters, 72% experienced sunburns (solar erythema) within the past year and 50% of them experienced the worst sunburn during work. Foresters were most likely to often/always wear protective clothes (29.0%) but were least likely to often/always avoid midday sun (23.8%) and stay in the shade (31.1%). Having an outdoor profession or spending hours outside for leisure was negatively associated with sun protection. Skin examination revealed an overall KC prevalence of 16.7%, with 16.5% of foresters being affected. CONCLUSION: Despite being protected by trees, the risk of KC for foresters is comparable to that of other professional groups. Shade alone may not provide sufficient protection. Additional sun protection measures are necessary.

New European Academy of Allergy and Clinical Immunology definition on pollen season mirrors symptom load for grass and birch pollen-induced allergic rhinitis.

BACKGROUND: The use of allergen immunotherapy (AIT) for allergic rhinitis and its clinical efficacy in clinical trials depends on the effective determination of pollen allergen exposure time periods. We evaluate pollen data from Germany to examine the new definitions on pollen season and peak pollen period start and end as proposed by the European Academy of Allergy and Clinical Immunology (EAACI) in a recently published Position Paper. The aim was to demonstrate the ability of these definitions to mirror symptom loads for grass and birch pollen-induced allergic rhinitis based on real-life data. METHODS: Data coming from four pollen monitoring stations in the Berlin and Brandenburg area in Germany and for 3 years (2014-2016) were used to investigate the correlation of season definitions, birch and grass pollen counts and total nasal symptom and mediation scores as reported by patients in "Patients Hay fever Diaries" (PHDs). After the identification of pollen periods on the basis of the EACCI criteria, a statistical analysis was employed, followed by a detailed graphical investigation. RESULTS: The analysis revealed that the definitions of pollen season as well as peak pollen period start and end as proposed by the EAACI are correlated to symptom loads for grass and birch pollen-induced allergic rhinitis reported by patients in PHDs. CONCLUSION: Based on our analysis, the validity of the EAACI definitions on pollen season is confirmed. Their use is recommended in future clinical trials on AIT as well as in daily routine for optimal patient care.

Possible effect of landscape design on IgE recognition profiles of two generations revealed with micro-arrayed allergens.

The aim of this study was to investigate possible effects of landscape design on the IgE sensitization profile toward inhalant allergens in patients with respiratory allergy from Uzbekistan where green areas have been changed during the last two decades by a State program. Sera from two different generations of Uzbek (n=58) and, for control purposes, from two generations of Austrian (n=58) patients were analyzed for IgE reactivity to 112 different micro-arrayed allergen molecules by ImmunoCAP ISAC technology. Changes in molecular IgE sensitization profiles to pollen allergens in the young vs the middle-aged Uzbek population were associated with replanting, whereas those in the Vienna populations reflected natural changes in plant growth. Our data indicate that anthropologic as well as natural changes in the biome may have effects on IgE sensitization profiles already from one to another generation.

Defining pollen exposure times for clinical trials of allergen immunotherapy for pollen-induced rhinoconjunctivitis - an EAACI position paper.

BACKGROUND: Clinical efficacy of pollen allergen immunotherapy (AIT) has been broadly documented in randomized controlled trials. The underlying clinical endpoints are analysed in seasonal time periods predefined based on the background pollen concentration. However, any validated or generally accepted definition from academia or regulatory authorities for this relevant pollen exposure intensity or period of time (season) is currently not available. Therefore, this Task Force initiative of the European Academy of Allergy and Clinical Immunology (EAACI) aimed to propose definitions based on expert consensus. METHODS: A Task Force of the Immunotherapy and Aerobiology and Pollution Interest Groups of the EAACI reviewed the literature on pollen exposure in the context of defining relevant time intervals for evaluation of efficacy in AIT trials. Underlying principles in measuring pollen exposure and associated methodological problems and limitations were considered to achieve a consensus. RESULTS: The Task Force achieved a comprehensive position in defining pollen exposure times for different pollen types. Definitions are presented for 'pollen season', 'high pollen season' (or 'peak pollen period') and 'high pollen days'. CONCLUSION: This EAACI position paper provides definitions of pollen exposures for different pollen types for use in AIT trials. Their validity as standards remains to be tested in future studies.

Spatial and temporal variations in airborne Ambrosia pollen in Europe.

The European Commission Cooperation in Science and Technology (COST) Action FA1203 "SMARTER" aims to make recommendations for the sustainable management of Ambrosia across Europe and for monitoring its efficiency and cost-effectiveness. The goal of the present study is to provide a baseline for spatial and temporal variations in airborne Ambrosia pollen in Europe that can be used for the management and evaluation of this noxious plant. The study covers the full range of Ambrosia artemisiifolia L. distribution over Europe (39°N-60°N; 2°W-45°E). Airborne Ambrosia pollen data for the principal flowering period of Ambrosia (August-September) recorded during a 10-year period (2004-2013) were obtained from 242 monitoring sites. The mean sum of daily average airborne Ambrosia pollen and the number of days that Ambrosia pollen was recorded in the air were analysed. The mean and standard deviation (SD) were calculated regardless of the number of years included in the study period, while trends are based on those time series with 8 or more years of data. Trends were considered significant at p < 0.05. There were few significant trends in the magnitude and frequency of atmospheric Ambrosia pollen (only 8% for the mean sum of daily average Ambrosia pollen concentrations and 14% for the mean number of days Ambrosia pollen were recorded in the air). The direction of any trends varied locally and reflected changes in sources of the pollen, either in size or in distance from the monitoring station. Pollen monitoring is important for providing an early warning of the expansion of this invasive and noxious plant.

Motivation of patients with inflammatory bowel disease to participate in a clinical trial.

Background: Clinical trials are designed to investigate innovative diagnostic and therapeutic strategies for patients. However, factors that influence patients with inflammatory bowel disease (IBD) and willingness to participate in a clinical trial are unknown. Methods: We developed a questionnaire and asked IBD patients about their willingness to hypothetically participate in a clinical trial and their current health-related quality of life by using the IBDQ. Results: Of 201 distributed questionnaires, 166 were returned and included in the analysis. One-hundred-one (61 %) patients declared their willingness to participate in a clinical trial hypothetically offered in their current situation, whereas 65 (39 %) declined. Among all patients, a trustful relationship between patient and doctor was most important for trial participation. The willingness to help others and to support medical progress were other key issues mentioned. In contrast, those patients inclined to refuse trial participation feared impairment of their current health status, potential side effects, medical examinations, and the expenditure of time and effort. Conclusion: In our cohort of IBD patients, approximately two-thirds were willing to participate in a clinical trial. We were able to identify a number of factors that should help physicians to directly address fears and break down barriers in order to increase the number of patients willing to participate in clinical trials.

Headache cessation by an educational intervention in grammar schools: a cluster randomized trial.

BACKGROUND AND PURPOSE: Headache is a common health problem in adolescents. There are a number of risk factors for headache in adolescents that are amenable to intervention. The aim of the study was to assess the effectiveness of a low-level headache prevention programme in the classroom setting to prevent these risk factors. METHODS: In all, 1674 students in 8th-10th grade at 12 grammar schools in greater Munich, Germany, were cluster randomized into intervention and control groups. A standardized 60-min prevention lesson focusing on preventable risk factors for headache (physical inactivity, coffee consumption, alcohol consumption and smoking) and providing instructions on stress management and neck and shoulder muscle relaxation exercises was given in a classroom setting. Seven months later, students were reassessed. The main outcome parameter was headache cessation. Logistic regression models with random effects for cluster and adjustment for baseline risk factors were calculated. RESULTS: Nine hundred students (intervention group N = 450, control group N = 450) with headache at baseline and complete data for headache and confounders were included in the analysis. Headache cessation was observed in 9.78% of the control group compared with 16.22% in the intervention group (number needed to treat = 16). Accounting for cluster effects and confounders, the probability of headache cessation in the intervention group was 1.77 (95% confidence interval = [1.08; 2.90]) higher than in the control group. The effect was most pronounced in adolescents with tension-type headache: odds ratio = 2.11 (95% confidence interval = [1.15; 3.80]). CONCLUSION: Our study demonstrates the effectiveness of a one-time, classroom-based headache prevention programme.

Personalized symptoms forecasting for pollen-induced allergic rhinitis sufferers.

Hay fever is a pollen-induced allergic reaction that strongly affects the overall quality of life of many individuals. The disorder may vary in severity and symptoms depending on patient-specific factors such as genetic disposition, individual threshold of pollen concentration levels, medication, former immunotherapy, and others. Thus, information services that improve the quality of life of hay fever sufferers must address the needs of each individual separately. In this paper, we demonstrate the development of information services that offer personalized pollen-induced symptoms forecasts. The backbone of these services consists of data of allergic symptoms reported by the users of the Personal Hay Fever Diary system and pollen concentration levels (European Aeroallergen Network) in several sampling sites. Data were analyzed using computational intelligence methods, resulting in highly customizable forecasting models that offer personalized warnings to users of the Patient Hay Fever Diary system. The overall system performance for the pilot area (Vienna and Lower Austria) reached a correlation coefficient of r = 0.71 ± 0.17 (average ± standard deviation) in a sample of 219 users with major contribution to the Pollen Hay Fever Diary system and an overall performance of r = 0.66 ± 0.18 in a second sample of 393 users, with minor contribution to the system. These findings provide an example of combining data from different sources using advanced data engineering in order to develop innovative e-health services with the capacity to provide more direct and personalized information to allergic rhinitis sufferers.

[Children and Adolescents--Preventive Activities are Effective]. / Kinder und Jugendliche--Präventive Maßnahmen wirken.

Health-related attitudes and behaviour are working already in the first years of life. Approaches of prevention for children and adolescents exist from structured programmes to promote healthy behaviour and to strengthen life skills through the support of parents to the qualification of professionals for the promotion of childhood resources. An essential starting point is the design of living conditions in which children and young people spend a lot of their time. An important goal of the BMBF-Förderschwerpunkt "Prevention Research" was the knowledge about which programmes, policies and approaches are effective and justify a transfer into practice. On looking back on the projects, some factors for the effectiveness of the measures could be identified: the presence of a reason, context reference, programme offerings and activation of all actors. The research projects also provide evidence of an increase in knowledge of effective evaluation since supply onset, although a binding standard of evaluation, the understanding of relevant outcome measures and other aspects are still lacking.

[Effectively Preventing Eating Disorders with the School-Based Programs "PriMa" and "Torera" for Adolescents in the 6th and 7th Grades]. / Essstörungen wirksam vorbeugen mit den Schulprogrammen "PriMa" und "Torera" für Jugendliche in Klasse 6 und 7.

The aim of this study was to assess the effects of 2 German school-based primary prevention programmes for (pre)adolescents, aged 11-13 years, with 9 manual-guided lessons. 92 (PriMa, n=1,553 girls) and 22 (Torera, n=256 boys, 277 girls) Thuringian secondary schools participated in controlled trials with pre-post assessment. Girls and students at risk showed significant improvements of conspicuous eating behaviour and body self-esteem with small to medium effect sizes. Implementation costs were € 2.50 per student.

Geographic and temporal variations in pollen exposure across Europe.

BACKGROUND: The EC-funded EuroPrevall project examined the prevalence of food allergy across Europe. A well-established factor in the occurrence of food allergy is primary sensitization to pollen. OBJECTIVE: To analyse geographic and temporal variations in pollen exposure, allowing the investigation of how these variations influence the prevalence and incidence of food allergies across Europe. METHODS: Airborne pollen data for two decades (1990-2009) were obtained from 13 monitoring sites located as close as possible to the EuroPrevall survey centres. Start dates, intensity and duration of Betulaceae, Oleaceae, Poaceae and Asteraceae pollen seasons were examined. Mean, slope of the regression, probability level (P) and dominant taxa (%) were calculated. Trends were considered significant at P < 0.05. RESULTS: On a European scale, Betulaceae, in particular Betula, is the most dominant pollen exposure, two folds higher than to Poaceae, and greater than five folds higher than to Oleaceae and Asteraceae. Only in Reykjavik, Madrid and Derby was Poaceae the dominant pollen, as was Oleaceae in Thessaloniki. Weed pollen (Asteraceae) was never dominant, exposure accounted for >10% of total pollen exposure only in Siauliai (Artemisia) and Legnano (Ambrosia). Consistent trends towards changing intensity or duration of exposure were not observed, possibly with the exception of (not significant) decreased exposure to Artemisia and increased exposure to Ambrosia. CONCLUSIONS: This is the first comprehensive study quantifying exposure to the major allergenic pollen families Betulaceae, Oleaceae, Poaceae and Asteraceae across Europe. These data can now be used for studies into patterns of sensitization and allergy to pollen and foods.

Effectiveness of reducing the risk of eating-related problems using the German school-based intervention program, "Torera", for preadolescent boys and girls.

Representative surveys indicate that eating disorders are an increasing problem, especially among (pre)adolescents. We assessed the effects of a German school-based primary prevention program ("Torera") for seventh graders. Torera especially relates to pathological eating behavior in the realm of bulimia nervosa or binge eating disorder. The program is built upon two previously evaluated modules for sixth graders with a gender-specific adaption. The coeducational intervention involves nine manual-guided lessons touching a wide range of eating-related problems. Twenty-two Thuringian secondary schools (n = 256 boys and 277 girls, aged 11-13 years at baseline) participated in a trial with 2 control groups (untreated and pretreated) with pre-post assessment. Primary outcomes were conspicuous eating behavior and body self-esteem, measured by standardized questionnaires (SCOFF, EAT-26D, and FBeK). Girls and students at risk showed significant improvement with small (d = 0.35) to medium (d = 0.66) effect sizes on eating behavior, significantly mediated by body self-esteem. Boys only improved with respect to eating attitudes, revealing a small effect size (d = 0.35). With relatively low implementation costs (about 2.50 per student), Torera provides an efficient model for reducing risky eating behavior and strengthening body self-esteem without negative side effects. To improve the effectiveness of the intervention, further research efforts focusing on at-risk groups (secondary prevention) and structural actions for prevention (e.g., offering healthy school catering) are needed.

Airborne olive pollen counts are not representative of exposure to the major olive allergen Ole e 1.

Pollen is routinely monitored, but it is unknown whether pollen counts represent allergen exposure. We therefore simultaneously determined olive pollen and Ole e 1 in ambient air in Córdoba, Spain, and Évora, Portugal, using Hirst-type traps for pollen and high-volume cascade impactors for allergen. Pollen from different days released 12-fold different amounts of Ole e 1 per pollen (both locations P < 0.001). Average allergen release from pollen (pollen potency) was much higher in Córdoba (3.9 pg Ole e 1/pollen) than in Évora (0.8 pg Ole e 1/pollen, P = 0.004). Indeed, yearly olive pollen counts in Córdoba were 2.4 times higher than in Évora, but Ole e 1 concentrations were 7.6 times higher. When modeling the origin of the pollen, >40% of Ole e 1 exposure in Évora was explained by high-potency pollen originating from the south of Spain. Thus, olive pollen can vary substantially in allergen release, even though they are morphologically identical.

Mastitis severity induced by two Streptococcus uberis strains is reflected by the mammary immune response in vitro.

Streptococcus uberis is the most common environmental mastitis pathogen causing udder inflammations of different severities in dairy cows. The aim of the study was to investigate if the different clinical outcome of mastitis induced by different strains of S. uberis can be reflected in the mammary immune response. Mammary epithelial cells and somatic milk cells were treated with heat inactivated and living S. uberis of strain A and strain B in vitro. Strain A was repeatedly isolated from a chronically infected quarter during 8 months, and persisted in the quarter despite antibiotic treatment. Strain B caused an acute clinical mastitis and was not further isolated after a single antibiotic treatment. Treatment with Strain B induced a more pronounced increase of mRNA-expression of various immune factors (interleukin-8, interleukin-1beta, RANTES, and lactoferrin) in mammary epithelial cells than strain A. In contrast to mammary epithelial cells the response of removed somatic milk cells showed no differences between the stimulation with two S. uberis strains. Tumor necrosis factor-alpha mRNA expression was not differently induced by the two strains. In conclusion, the characteristics of different severities of mastitis that are induced by different S. uberis strains in vivo can also be reflected at the level of the immune response of the mammary gland in vitro.

[Effectiveness of the school-based prevention program TOPP on factors influencing adiposity in Thuringian schools]. / Evaluation der Wirkung des schulbasierten Präventionsprogramms TOPP "Teenager ohne pfundige Probleme" auf adipositasrelevante Faktoren an Thüringer Schulen.

The onset of puberty is considered a critical period for the development of overweight and obesity. For prevention purposes, we developed the school-based intervention program TOPP (Teenage Obesity Prevention Program), especially for boys. In order to test the effectiveness, we conducted a controlled study using a pre-post design. A total of 84 schools in Thuringian, Germany, with 1,199 boys participated in the study. Program effectiveness was analyzed with mostly standardized questionnaires referring to body-related self esteem, eating behavior, physical activity, teasing, and knowledge. The program was performed during the course of a school project within at least 3 weeks or during the regular school lessons for more than 6 weeks. After 9×90-minute, manual-based lessons, including interactive exercises and poster-based group discussions, significant improvement was only reached for nutritional knowledge. As a main outcome, it could be demonstrated how an area-wide prevention program with low costs could be successfully implemented. The school environment enables us to create a universal, socially equitable, and low-threshold access.

[Self-assessment of BMI data : verification of the practicability of a correction formula on a sample of 11- to 13-year-old girls]. / BMI-Selbstauskünfte : Überprüfung der Praktikabilität einer Korrekturformel an einer Stichprobe elf- bis 13-jähriger Mädchen.

The decision to measure or to ask about data concerning height and weight in order to calculate body mass index (BMI) has an influence on the economy and validity of the measurements. Although self-reported information is less expensive, this information may possibly have a bias on the determined prevalences of different weight groups. Using representative data from the KiGGS study with a comparison of directly measured and self-reported BMI data, Kurth and Ellert (2010) developed two correction formulas for prevalences resulting from self-reported information. The aim of the study was to examine the practicability of the proposed correction formulas on our own data concerning self-reported BMI data of 11- to 13-year-old girls (n=1,271) and to assess the plausibility of the corrected measurements. As a result, the prevalences of our own data changed in the expected direction both for underweight and for overweight. Both formulas were found to be practicable, the consideration of the subjective weight status (formula 2) resulted in a greater change in prevalences compared to the first correction formula.