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The aim of this cross-sectional observational study was to explore quality of life and well-being in patients with drug-induced anaphylaxis. Two validated tools were used: the Drug Hypersensitivity Quality-of-Life Questionnaire (DrHy-Q) and the Psychological General Well-Being Index (PGWBI). Sixty-five patients (13 males) underwent data analysis. The mean DrHy-Q score was 62.82 ± 12.1. Mean PGWBI score was 64.03 ± 17.66. DrHy-Q score was significantly correlated with PGWBI total score (r = -0.314; P = 0.011) and with the following domains: Anxiety (r = -0.260; P = 0.036), Depressed mood (r = -0.406; P = 0.001), Positive well-being (r = -0.251; P = 0.004), and General Health (r = -0.352; P = 0.004). Compared with the Italian reference population, patients had a significantly reduced PGWBI total and domain score. Our results highlight for the first time how impaired HRQoL and distress commonly feature in survivors to anaphylactic reactions to drug.

To cite this article: Dias GAC, Pires GV, Valle SOR, Franca AT, Papi JA, Dortas SD Jr, Levy SAP, Baiardini I, Canonica GW. Cross-cultural adaptation of the Brazilian-Portuguese version of the chronic urticaria quality-of-life questionnaire - CU-Q2oL. Allergy 2011; 66: 1487–1493 Summary Background: Chronic urticaria (CU) is a debilitating skin disorder that affects patients’ health related quality of life and the only questionnaire prepared specifically to CU is the Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL). Objective: The purpose of this study was to cross-culturally adapt and validate the CU-Q2oL Brazilian-Portuguese version. Methods: Forward and back translation by three bilingual translators followed by pre-test was used to adapt the questionnaire. The CU-Q2oL was self-administered along with the Dermatology Life Quality Index (DLQI) in 112 patients with CU. Disease activity was assessed using the Urticaria Activity Score. Factor analysis was used to identify scales of the Brazilian portuguese CU-Q2oL. Internal consistency, convergent validity and known-group validity was determined. Reproducibility was evaluated by interclass correlation coefficient (ICC). Multiple linear regression was used to determine the predicting factors of CU-Q2oL results. Results: Factor analysis revealed a three-dimensional structure: sleep/mental status/eating (I), pruritus/impact on life activities (II) and swelling/limits/look (III), which explained 52.49% of the total variance. All scales showed excellent internal consistency. External construct validity was supported by correlations between the CU-Q2oL and DLQI. The tool was found to be able to differentiate between patients with high and low levels of urticaria activity. Test-retest reliability was good to excellent (ICC = 0.69–0.86). Disease severity and urticaria type were the only factors predicting results. Conclusions: The CU-Q2oL Brazilian portuguese version was easily filled out, well accepted by the patients, demonstrated an acceptable validity and reliability and might be used to evaluate treatment outcomes and in clinical research.

To cite this article: Baiardini I, Braido F, Bindslev-Jensen C, Bousquet PJ, Brzoza Z, Canonica GW, Compalati E, Fiocchi A, Fokkens W, Gerth van Wijk R, Gimenez-Arnau A, Godse K, Grattan C, Grob JJ, La Grutta S, Kalogeromitros D, Kocaturk E, Lombardi C, Mota-Pinto A, Ridolo E, Saini SS, Sanchez-Borges M, Senna GE, Terreehorst I, Todo Bom A, Toubi E, Bousquet J, Zuberbier T, Maurer M. Recommendations for assessing patient-reported outcomes and health-related quality of life in patients with urticaria: a GA2LEN taskforce position paper. Allergy 2011; 66: 840–844. Abstract The aim of this Global Allergy and Asthma European Network (GA2LEN) consensus report is to provide recommendations and suggestions for assessing patient-reported outcomes (PROs) including health-related quality of life in patients with urticaria. We recommend that PROs should be used both in clinical trials and routine practice for the evaluation of urticaria patients. We suggest that PROs should be considered as the primary outcome of future clinical trials. Two validated and disease-specific instruments for assessing PROs are available, the urticaria activity score (for symptoms) and the chronic urticaria questionnaire on quality of life CU-Q2oL. This latter tool, CU-Q2oL, is available in many languages and should be preferred, where available, over more generic instruments for assessing urticaria-specific effects on quality of life. CU-Q2oL is only suited for the investigation of patients with chronic spontaneous urticaria. Similar instruments for other forms of urticaria have yet to be developed and validated. Also, tools for assessing other chronic spontaneous urticaria PROs besides quality of life and symptoms are needed.

The GA 2 LEN taskforce on Patient-Reported Outcomes (PROs) and Health-Related Quality of Life (HRQoL) published in 2009 a position paper concerning PROS and HRQoL assessment in clinical trials on allergy. Because of the specificity of this topic in asthma and rhinitis, specific recommendations are needed. The aim of this position paper is to define PROs and their meaning in asthma and rhinitis research, explore the available tools to provide criteria for a proper choice, identify patientrelated factor which could influence PROs assessment, define specific recommendations for assessment, analysis and results spreading, underline the unexplored areas and unmet needs. PROs assessment is gaining increasing importance, and it must be performed with a rigorous methodological procedure and using validated tools. This approach enables to better understand patient-related factors influencing clinical trials and real-life management outcomes, identify patients subgroups that can benefit from specific treatment and management plan and tailor treatment to address PROs (not only physician-defined targets) to improve asthma and rhinitis management.

Background: Chronic urticaria (CU) is a common skin disorder that causes a substantial burden on patients’ quality-of-life (QoL). The aim of this work was to generate and validate a German version of the Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) and to provide reference assessments of QoL. Methods: The Italian CU-Q2oL was translated into German and administered to 157 CU patients. They also completed two well-established general dermatology QoL questionnaires, the Dermatology Life Quality Index (DLQI) and Skindex-29. Factor analysis was used to identify scales of the German CU-Q2oL. Correlation to the DLQI and Skindex-29 was used for validation. Multiple linear regression was used to determine which patient characteristics were associated with which dimensions of QoL. Results: The factor analysis identified six scales of the German CU-Q2oL: functioning, sleep, itching/embarrassment, mental status, swelling/eating, and limits looks, which accounted for 70% of the data variance. Five of these six scales showed good internal consistency, and another five demonstrated convergent validity. On a percentile scale, they had these median CU-Q2oL scores: 29 functioning, 44 sleep, 50 itching/embarrassment, 50 mental status, 31 swelling/eating, 31 limits looks. Disease severity significantly predicted scores on all scales. Age predicted functioning, sleep, itching/embarrassment, and swelling/eating. Sex predicted itching/embarrassment and limits looks. Conclusion: This study yielded a robust validation of the German version of the CU-Q2oL. It confirmed previous studies that CU has a clinically meaningful burden on QoL, especially for sleep and mental health, and that women are more severely affected by pruritus. The German CU-Q2oL should be widely adopted in clinical research on the treatment of CU.

The most fascinating options of the new asthma treatments are probably represented by monoclonal antibodies. In fact, these molecules are virtually able to interact with whatever specific antigen. Anyway, it is mandatory to understand the limits of this group of molecules, in terms of both efficacy and safety. In this review, we have analyzed different ways of interfering along the course of the cascade of the allergic reaction, targeting different molecules (CD4, TNF-alpha, IL-4, IL-5, IL-10, IL-12, endothelial adhesion molecules, IgE), showing the efficacy and the risks of each kind of treatment. In the end, we focused our attention on omalizumab, the monoclonal antibody targeting IgE. Although with some restrictions, represented by the high costs and the limitation of its use only to a specific subset of patients affected by allergic asthma, at present anti-IgE appear to be the only 'magic bullet' for the treatment of allergic asthma. In fact, it proved to reduce exacerbations and symptom scores, and to improve quality of life, with a very good safety profile.

Sleep is fundamental for physical and mental health as well as daytime performance and represents a crucial aspect in the personal representations of well-being. Sleep disturbances in patients with chronic disorders constitute a factor that contributes to exacerbate symptoms, complicate management, and affect mood and quality of life (QoL). Allergic diseases are a global health problem of increasing prevalence that affects up to 15% of the population in Western countries. Sleep problems associated with allergic diseases may play a role in worsening the burden of illness, contributing to impairment of the QoL. The aim of this review was to describe the most common causes leading to sleep disturbance in allergic patients and their consequences on the QoL. The possible negative effects of treatment on sleep parameters has been also considered.

Histamine is one of the most important steps in the phlogistic allergic reaction. Its activity is due to the link to specific receptors on the cellular surface. H1-receptors of second generation are the most currently prescribed drugs in allergic diseases for their high selectivity, little or no central sedative effect, rapid onset of action and long half lives. Antihistamines can modulate part of immunological mechanisms involved in the pathogenesis of allergic inflammation reducing mediator release and expression of adhesion molecules, regulating the release of cytokines, chemokines and consequently inflammatory cells recruitment. The anti-inflammatory effects of cetirizine, desloratadine and levocetirizine are reviewed. Quality of life is considered too, as a main parameter in a global evaluation of the antihistamine's effects.

Introduction: To date we have available specific instruments assessing health-related quality of life (HRQL) in rhinoconjunctivitis or in asthma, but not instruments evaluating rhinitis and asthma together, although they often coexist. The aim of our study was to develop and validate a specific quality of life (QoL) questionnaire for adult patients with rhinoconjunctivitis, asthma or both. Materials and methods: A pool of 42 items covering the main symptoms and problems related to respiratory allergy, was generated based on literature review and clinical experience. The items were randomly listed and presented to 148 consecutive outpatients 46 suffering from asthma (age 32.9 ± 14.3 years), 53 suffering from rhinoconjunctivitis (age 32.6 ± 11.5 years) and 49 from asthma and rhinoconjunctivitis (age 35.6 ± 12.2 years). The patients were asked to indicate which item they had directly experienced and for each of them, its importance on a four-point scale (1 = not important; 4 = very important). Twelve items were cancelled from the list, because of low importance or redundance. In the instrument validation phase, 104 patients (42 with rhinoconjunctivitis alone and 62 with asthma and rhinoconjunctivitis) were evaluated with the generic instrument SF-36 and the new questionnaire (RHINASTHMA). Results: RHINASTHMA was able to differentiate patients with rhinitis from those with both rhinitis and asthma. In stable condition, RHINASTHMA showed good reliability. The factor analysis extracted three factors with a good reliability (0.93, 0.87, 0.76). Discussion: RHINASTHMA is the first tool aimed at evaluating HRQL impairment in patients with rhinitis and/or asthma. It provides a short and simple assessment, and has overall psychometric properties. This is of relevance because of the frequent asthma–rhinitis comorbidity.

Background The present study aimed to develop a short validated patient-completed questionnaire, the RhinAsthma Patient Perspective (RAPP), to assess the health-related quality of life (HRQoL) in patients with asthma and comorbid allergic rhinitis in clinical practice. Methods A provisional RAPP questionnaire was formed from candidate items identified through retrospective analysis of 333 RHINASTHMA questionnaires. This was then tested on 150 asthma patients with allergic rhinitis. Results Psychometric analyses identified eight items fitting a unidimensional model to form RAPP. Internal consistency (Cronbach's alpha coefficient > 0.8) and agreement with RHINASTHMA (r = −0.31, P = 0.0001) were excellent. Criterion, discriminant, and convergent validity were good. Reliability in 47 stable patients was very good (intra-class and concordance correlation coefficients were 0.90 and 0.89, respectively). Responsiveness in 103 patients with health improvement or deterioration was significantly associated with changes in Global Rating Scale (r = −0.4965, P

Background: The goal of asthma therapy is to achieve an optimal level of disease control, but the relationship between asthma control, impact of comorbid rhinitis and health related quality of life (HRQoL) in real life remains unexplored. Objective: The aims of this real life study were to evaluate asthma control, the impact of asthma (with and without rhinitis) on HRQoL, the relationship between asthma control and HRQoL, and the role of rhinitis on asthma control and HRQoL. Methods: 122 asthma patients completed the Asthma Control Test, Rhinitis Symptoms score (T5SS) and RHINASTHMA. Results: Asthma control was unsatisfactory (44.27% of uncontrolled patients), as well as HRQoL. Controlled patients controlled showed significantly lower scores in all the RHINASTHMA domains compared to uncontrolled. Irrespective of their level of control, patients with rhinitis symptoms showed worse HRQoL in Upper Airways (UA) (P < 0.0001), Lower Airways (LA) (P < 0.001), and Global Summary (GS) (P < 0.0001). In patients with symptomatic rhinitis, RHINASTHMA were lower in controlled asthma patients (UA P = 0.002; LA P < 0.0001; RAI P < 0.01; GS P < 0.0001). Asthma control was associated with lower T5SS score (P = 0.034). Conclusion: Asthma control in real life is unsatisfactory. Rhinitis and asthma influence each other in terms of control and HRQoL. The control of rhinitis in asthma patients can lead to an optimization of HRQoL related to the upper airways, while this phenomenon is not so evident in asthma. These results suggest to strengthen the ARIA recommendation that asthma patients must be evaluated for rhinitis and vice versa.

Background: The clinical efficacy of sublingual immunotherapy (SLIT) in mite allergy and in mild disease is still a matter of debate, thus we performed a long-term clinical trial. Methods: The study was randomized, double-blind and placebo-controlled. After a 1-year assessment, 68 patients with mild rhinitis with/without asthma due to mites were randomized to drugs + placebo or drugs + SLIT for 2 years. Sublingual immunotherapy was given as soluble tablets of monomeric carbamylated allergoid. Clinical scores for asthma and rhinitis (0, absent to 3, severe) and drug consumption were assessed by diary card in the period November–February. Quality of life was assessed before and after each observation period and pharmaco-economy data were evaluated as well. Results: Fifty-six patients completed the study. The rate of dropouts was similar in the two groups. No relevant side effect was reported. There was a significant reduction of total clinical scores (P

Background: Few articles are available about chronic urticaria (CU) impact on patients’ quality of life (QoL). The aim of our study was to evaluate QoL in CU patients both focusing on health status and subjective satisfaction. We adopted two generic tools: SF-36 (an health status questionnaire) and SAT-P (a satisfaction profile). Methods: Twenty-one untreated patients (five males, 16 females; aged 46.3 ± 12.4) affected by CU, were enrolled. SF-36 and SAT-P scores of CU patients were compared with scores of a group of 27 patients with respiratory allergy. Published reference values of 608 and 241 Italian healthy subjects were used as controls, respectively, for SF-36 and SAT-P. Results: Patients with CU compared with allergic patients referred significantly lower scores in physical functioning (P = 0.046), role physical (P = 0.01), bodily pain (P = 0.0001), general health (P = 0.0043) and role emotional (P = 0.04), and compared with reference sample reported lower scores in all SF-36 domains (P