Allergy and Respiratory Disease Clinic

Genova, Italy

Allergy and Respiratory Disease Clinic

Genova, Italy
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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 | Year: 2010

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.


Ilaria B.,Allergy and Respiratory Disease Clinic | Fulvio B.,Allergy and Respiratory Disease Clinic | Omar F.,University of Turin | Rosaria C.,Allergy Unit | And 2 more authors.
Annals of Allergy, Asthma and Immunology | Year: 2011

Background: The impact of drug hypersensitivity has never been considered from the patient's perspective, and no questionnaire is currently available for this purpose. Objective: To develop and validate a questionnaire specifically designed for the assessment of quality of life in patients with drug hypersensitivity entitled the Drug Hypersensitivity Quality of Life Questionnaire (DrHy-Q). Methods: During the development procedure, an initial questionnaire of 34 items was generated and administered to 70 patients; the 20 most important items were detected and converted into questions evaluated with a 5-point Likert scale. This provisional questionnaire then underwent a validation procedure to assess its psychometric properties. The DrHy-Q and the Psychological General Well-Being Index (PGWBI) were completed by 365 patients (67.5% female; mean [SD] age, 40 [15] years). Results: Statistical analysis revealed a 1-dimensional structure for the DrHy-Q that explained up to 50.7% of the total variance and showed good levels of internal consistency for the extracted factor (Cronbach α = 0.928). The correlations between the DrHy-Q and the PGWBI scores were low. However, the DrHy-Q scores of patients who experienced anaphylactic shock were significantly higher than the scores from patients with other reactions (analysis of variance; F = 5.991; df = 4; P < .001). The test-retest associations were good (R = 0.995; P < .001). Conclusions: DrHy-Q met the standards for construct validity, internal consistency, and reliability, indicating that it is appropriate for use alone or in combination with other patient-reported outcome questionnaires to explore the subjective experiences of patients with drug hypersensitivity. © 2011 American College of Allergy, Asthma & Immunology.


Maurer M.,Charité - Medical University of Berlin | Weller K.,Charité - 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 | Year: 2011

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.


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 | Year: 2010

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.


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.
PLoS ONE | Year: 2012

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.


PubMed | Allergy and Respiratory Disease Clinic
Type: Journal Article | Journal: PloS one | Year: 2012

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.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 ((2)=49.599; p<0.001) and well-controlled and totally controlled patients significantly differed in achieving optimal HRQoL ((2)=7.617; p<0.006).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.

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