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Recommendations for assessing patient-reported outcomes and health-related quality of life in clinical trials on allergy: a GA(2)LEN taskforce position paper.

The aim of this Global Allergy and Asthma European Network (GA(2)LEN) 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.

Allergic respiratory diseases in the elderly.

In industrialized countries there has been a significant increase in life expectancy, but chronic diseases are still important causes of death and disability in the elderly. Individuals over 65 years of age have a decrease in organic functions and lungs can lose more than 40% of their capacity. Although asthma and allergic rhinitis are more common in young people their prevalence in the elderly is increasing and the mortality reported in these patients is high. Asthmatic airways show an accumulation of activated eosinophils and lymphocytes determining structural changes of the bronchi. Local allergic inflammation, changes in T cell phenotypes and in apoptosis contribute to systemic inflammation. An increased risk of respiratory infections and neoplasic diseases has been recognized. These patients have increased susceptibility to atherosclerosis and cardiovascular diseases. Metabolic diseases are associated with an impairment of lung function and with systemic inflammation. Summing up older asthmatic patients have an increased risk to premature disability and death. A proper therapeutic approach to asthma can minimize this evolution. To identify the triggers is an important goal that allows reducing medication needs. Corticosteroids dampen allergic inflammation; therefore, they are the first choice in the treatment of patients with persistent asthma and rhinitis. Second-generation H1 receptor antagonists have reduced side effects and can be used if necessary. The elderly may have difficult access to health care. They should be educated about their disease and receive a written treatment plan. This information improves the quality of life, socialization and disease outcome in older people.