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Maurer M.,Charite - Medical University of Berlin | Weller K.,Charite - Medical University of Berlin | Bindslev-Jensen C.,University of Southern Denmark | Gimenez-Arnau A.,University of the Sea | And 12 more authors.
Allergy: European Journal of Allergy and Clinical Immunology

Chronic spontaneous urticaria, formerly also known as chronic idiopathic urticaria and chronic urticaria (CU), is more common than previously thought. At any time, 0.5-1% of the population suffers from the disease (point prevalence). Although all age groups can be affected, the peak incidence is seen between 20 and 40 years of age. The duration of the disease is generally 1-5 years but is likely to be longer in more severe cases, cases with concurrent angioedema, in combination with physical urticaria or with a positive autologous serum skin test (autoreactivity). Chronic spontaneous urticaria has major detrimental effects on quality of life, with sleep deprivation and psychiatric comorbidity being frequent. It also has a large impact on society in terms of direct and indirect health care costs as well as reduced performance at work and in private life. In the majority of patients, an underlying cause cannot be identified making a causal and/or curative treatment difficult. Nonsedating H 1-antihistamines are the mainstay of symptomatic therapy, but treatment with licensed doses relieves symptoms effectively in <50% of patients. Although guideline-recommended updosing up to fourfold increases symptom control in many patients, a substantial number of patients have only little benefit from H1-antihistamines. Consequently, there is a great need for new therapeutic strategies. © 2010 John Wiley & Sons A/S. Source

Baiardini I.,Allergy and Respiratory Disease Clinic | Bousquet P.J.,University of Nimes | Brzoza Z.,Medical University of Silesia, Katowice | Canonica G.W.,Allergy and Respiratory Disease Clinic | And 13 more authors.
Allergy: European Journal of Allergy and Clinical Immunology

The aim of this Global Allergy and Asthma European Network (GA 2LEN) consensus report is to provide recommendations for patient-reported outcomes (PROs) evaluation in clinical trials for allergic diseases, which constitute a global health problem in terms of physical, psychological economic and social impact. During the last 40 years, PROs have gained large consideration and use in the scientific community, to gain a better understanding of patients' subjective assessment with respect to elements concerning their health condition. They include all health-related reports coming from the patient, without involvement or interpretation by physician or others. PROs assessment should be performed by validated tools (disease-specific tools when available or generic ones) selected taking into account the aim of the study, the expected intervention effects and the determinant and confounding factors or patient-related factors which could influence PROs. Moreover, each tool should be used exclusively in the patient population following the authors' indications without modification and performing a cross-cultural validation if the tool must be used in a language that differs from the original. The result analysis also suggests that the relevance of PROs results in any interventional study should include a pre-post assessment providing information concerning statistical differences within or among groups, rates of response for the PROs and a minimal important difference for the population. The report underlines the importance of further investigation on some topics, such as the quality assessment of existing PROs tools, the definition of inclusion and exclusion criteria and a more extensive evaluation of the correlation between PROs, besides health-related quality of life, and clinical data. © 2009 John Wiley & Sons A/S. Source

Braido F.,Allergy and Respiratory Disease Clinic | Baiardini I.,Allergy and Respiratory Disease Clinic | Balestracci S.,Allergy and Respiratory Disease Clinic | Vyshka S.,Allergy and Respiratory Disease Clinic | And 4 more authors.
Minerva Pneumologica

Aim. Adherence, that still remains a major problem in chronic disease, may be influenced by different factors related to the disease itself, to the treatment, to the patient-physician relationship and to the patient. This survey was aimed to investigate patient-related factors knowledge, behaviour, satisfaction and mood - which could limit adherence in chronic obstructive pulmonary disease (COPD) patients. Methods. COPD patients attending a visit were asked to fill in the Adherence Schedule in COPD (ASiC) and the Hospital Anxiety an Depression Scale (HADS). Results. Ninety COPD patients were enrolled. Cognitive questions revealed that 30% of them had poor disease knowledge and 25% was not able to recognize the worsening signs. Behavioural investigation showed that 51% hardly accepted their disease and 30% the limits due to it, while 70% was not able to record clinical parameters. Treatment satisfaction items showed that 74% was aware that treatment benefits were greater than disadvantages, 84% was conscious of the need of medication, although 25% stated that his own drug assumption was irregular; 20.6% of patients reported mild anxiety, 9-5% moderate and 6.4% severe. 14.8% of patients had mild depression, while 18% moderate and 8.2% severe. Conclusion. COPD patients present a specific pattern of knowledge, expectations and behaviours, which should be investigated and taken into account when planning interventions to improve disease adherence. Source

Braido F.,Allergy and Respiratory Disease Clinic | Bousquet P.J.,University of Nimes | Brzoza Z.,Medical University of Silesia, Katowice | Canonica G.W.,Allergy and Respiratory Disease Clinic | And 13 more authors.
Allergy: European Journal of Allergy and Clinical Immunology

The GA2LEN 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 patient-related 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. © 2010 John Wiley & Sons A/S. Source

Braido F.,Allergy and Respiratory Disease Clinic | Baiardini I.,Allergy and Respiratory Disease Clinic | Menoni S.,University of Genoa | Gani F.,Allergy Unit | And 5 more authors.

Objectives: Asthma trials suggest that patients reaching total disease control have an optimal Health Related Quality of Life (HRQoL). Moreover, rhinitis is present in almost 80% of asthmatics and impacts asthma control and patient HRQoL. We explored whether optimal HRQoL was reachable in a real-life setting, and evaluated the disease and patient related patterns associated to optimal HRQoL achievement. Methods and Findings: Asthma and rhinitis HRQoL, illness perception, mood profiles, rhinitis symptoms and asthma control were assessed by means of validated tools in patients classified according to GINA and ARIA guidelines. Optimal HRQoL, identified by a Rhinasthma Global Summary (GS) score ≤20 (score ranging from 0 to 100, where 100 represents the worst possible HRQoL), was reached by 78/209 (37.32%). With the exception of age, no associations were found between clinical and demographic characteristics and optimal HRQoL achievement. Patients reaching an optimal HRQoL differed in disease perception and mood compared to those not reaching an optimal HRQoL. Asthma control was significantly associated with optimal HRQoL (χ 2 = 49.599; p&0.001) and well-controlled and totally controlled patients significantly differed in achieving optimal HRQoL (χ 2 = 7.617; p&0.006). Conclusion: Approximately one third of the patients in our survey were found to have an optimal HRQoL. While unsatisfactory disease control was the primary reason why the remainder failed to attain optimal HRQoL, it is clear that illness perception and mood also played parts. Therefore, therapeutic plans should be directed not only toward achieving the best possible clinical control of asthma and comorbid rhinitis, but also to incorporating individualized elements according to patient-related characteristics. © 2012 Braido et al. Source

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