Browsing by Author "Bousquet, PJ"
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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 paperPublication . Baiardini, A; Bousquet, PJ; Brzoza, Z; Canonica, GW; Compalati, E; Fiocchi, A; Fokkens, W; Van Wijk, RG; La Grutta, S; Lombardi, C; Maurer, M; Mota-Pinto, A; Ridolo, E; Senna, GE; Terreehorst, I; Todo-Bom, A; Bousquet, J; Zuberbier, T; Braido, FThe 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.
- Recommendations for assessing patient-reported outcomes and health-related quality of life in patients with urticaria: a GA(2) LEN taskforce position paperPublication . Baiardini, I; Braido, F; Bindslev-Jensen, C; Bousquet, PJ; Brzoza, Z; Canonica, GW; Compalati, E; Fiocchi, A; Fokkens, W; Gerth van Wijk, R; Giménez-Arnau, A; Godse, K; Grattan, C; Grobb, 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, MThe aim of this Global Allergy and Asthma European Network (GA(2)LEN) 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-Q(2)oL. This latter tool, CU-Q(2)oL, 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-Q(2)oL 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.
- Specific recommendations for PROs and HRQoL assessment in allergic rhinitis and/or asthma: a GA(2)LEN taskforce position paperPublication . Braido, F; Bousquet, PJ; Brzoza, Z; Canonica, GW; Compalati, E; Fiocchi, A; Fokkens, W; Gerth van Wijk, R; La Grutta, S; Lombardi, C; Maurer, M; Mota-Pinto, A; Ridolo, E; Senna, GE; Terreehorst, I; Todo-Bom, A; Bousquet, J; Zuberbier, T; Baiardini, IThe 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 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.