Development of children’s hymenoptera venom allergy quality of life scale (CHVAQoLS)

BACKGROUND: Venom allergy is a rare but life-threatening disease and may have a considerable impact on the health-related quality of life (HRQoL) of patients, especially children. This paper presents development of the HRQoL scale for children and adolescents with Hymenoptera venom allergy (HVA). METHODS: The study sample consisted of 71 children, born between 1992 and 2000, who presented with a history of insect sting reaction when referred for consultation in the allergy center of Polish-American Children’s Hospital, Krakow, Poland, during the period from 2000 to 2010. The initial pool of 60 items - divided into 6 domains - was prepared. The items with intercorrelations higher than 0.7 were removed from each domain and then principal component analysis was conducted for each domain separately, to provide a one-dimensional subscale for each domain. Reliability of the subscales was assessed using Cronbach alpha coefficient in terms of Classical Test Theory and with rho coefficient in terms of Item Response Theory. The multidimensionality of the scale was tested using multi-trait scaling. RESULTS: Three to four items from each domain were subsequently selected to constitute six subscales. Rho coefficients for all the subscales reached 0.8, similar results were achieved with the Cronbach alpha coefficients. Multi-trait method showed that the majority of the items indicated stronger correlations with their own subscales than with other subscales, which proves that our constructed subscales measure different dimensions of HRQoL. CONCLUSIONS: The presented scale comprises high validity and reliability subscales measuring six dimensions of HRQoL related to Hymenoptera venom allergy in children and adolescents. Such information may be useful in everyday clinical practice

A randomized, 5-arm dose finding study with a mite allergoid SCIT in allergic rhinoconjunctivitis patients

Background: The safety and tolerability of a mite allergoid subcutaneous allergen immunotherapy (SCIT) product was previously established. The aim of this study (EudraCT number: 2011-000393-61) was to find the optimally safe and effective allergoid dose by evaluating several dosages in patients with house dust mite (HDM)-induced allergic rhinoconjunctivitis (ARC) using a titrated nasal provocation test (TNPT). Methods: In total, 290 adult ARC patients (148 females; 142 males) with established HDM allergy and with a positive TNPT were randomized to receive placebo or mite allergoid SCIT 6667, 20 000, 50 000 or 100 000 AUeq/ml for 12 months. Patients were updosed weekly, followed by monthly maintenance dosing. The primary study endpoint comprised the clinical response to TNPT after 12 months of treatment. Secondary endpoints included response to TNPT after 6 months, PNIF measurements, symptom and medication scores during the last 8 weeks of treatment, serum immunoglobulins and safety assessments. Results: After 12 months, a dose-response was observed showing statistically significant improvements in the TNPT with SCIT concentrations of >= 20 000 AUeq/ml, while no significantly different outcomes were reached after 6 months. Specific serum IgG and IgG4 levels were dose dependently increased. In the highest dose group, more treatment-emergent adverse events were observed compared with the lower dose groups. Conclusion: In this mite allergoid SCIT dose finding study in HDM-induced ARC, concentrations of >= 20 000 AUeq/ml showed both immunological effects and clinical efficacy in the TNPT compared with placebo. The risk-benefit ratio favours 20 000 AUeq/ml and 50 000 AUeq/ml strengths for further clinical development

Development of an allergy management support system in primary care

Bertine MJ Flokstra - de Blok,1,2 Thys van der Molen,1,2 Wianda A Christoffers,3 Janwillem WH Kocks,1,2 Richard L Oei,4 Joanne NG Oude Elberink,2,4 Emmy M Roerdink,5 Marie Louise Schuttelaar,3 Jantina L van der Velde,1,2 Thecla M Brakel,1,6 Anthony EJ Dubois2,5 1Department of General Practice, 2GRIAC Research Institute, 3Department of Dermatology, 4Department of Allergology, 5Department of Pediatric Pulmonology and Pediatric Allergy, University of Groningen, University Medical Center Groningen, 6Teaching Unit, Department of Social Psychology, University of Groningen, Groningen, The Netherlands Background: Management of allergic patients in the population is becoming more difficult because of increases in both complexity and prevalence. Although general practitioners (GPs) are expected to play an important role in the care of allergic patients, they often feel ill-equipped for this task. Therefore, the aim of this study was to develop an allergy management support system (AMSS) for primary care. Methods: Through literature review, interviewing and testing in secondary and primary care patients, an allergy history questionnaire was constructed by allergists, dermatologists, GPs and researchers based on primary care and specialists’ allergy guidelines and their clinical knowledge. Patterns of AMSS questionnaire responses and specific immunoglobulin E (sIgE)-test outcomes were used to identify diagnostic categories and develop corresponding management recommendations. Validity of the AMSS was investigated by comparing specialist (gold standard) and AMSS diagnostic categories. Results: The two-page patient-completed AMSS questionnaire consists of 12 (mainly) multiple choice questions on symptoms, triggers, severity and medication. Based on the AMSS questionnaires and sIgE-test outcome of 118 patients, approximately 150 diagnostic categories of allergic rhinitis, asthma, atopic dermatitis, anaphylaxis, food allergy, hymenoptera allergy and other allergies were identified, and the corresponding management recommendations were formulated. The agreement between the allergy specialists’ assessments and the AMSS was 69.2% (CI 67.2–71.2). Conclusion: Using a systematic approach, it was possible to develop an AMSS that allows for the formulation of diagnostic and management recommendations for GPs managing allergic patients. The AMSS thus holds promise for the improvement of the quality of primary care for this increasing group of patients. Keywords: allergy, development, diagnosis, management support system, primary car

The Data Registry of the European Competence Network on Mastocytosis (ECNM): Set Up, Projects, and Perspectives.

Mastocytosis is a unique hematologic neoplasm with complex biology and pathology and a variable clinical course. The disease can essentially be divided into cutaneous mastocytosis (CM) and systemic mastocytosis (SM). In adults, SM is diagnosed in most cases and manifests as either indolent or advanced disease. Patients with advanced SM have an unfavorable prognosis with reduced survival. However, so far, little is known about the prevalence of various categories of SM and about prognostic factors. In an attempt to learn more about the behavior and evolution of various forms of CM and SM, the European Competence Network on Mastocytosis (ECNM) initiated a mastocytosis registry in 2012. In this article, the set up and start phase of this registry are described. Until 2018, more than 3000 patients from 12 countries and 25 centers have been enrolled. In a majority of all patients, robust follow-up data and relevant clinical end points are available. Using this data set, a series of registry projects have been launched, with the aim to validate previously identified diagnostic and prognostic variables and to identify new disease-related and patient-related parameters in various forms of mastocytosis. Moreover, the core data set of the registry will be useful to establish multiparametric scoring systems through which prognostication and individualized management of patients with mastocytosis should improve in the foreseeable future