Recommendations for assessing Patient‐Reported Outcomes and Health‐Related quality of life in clinical trials on allergy: a GA²LEN taskforce position paper

Abstract

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.

How not to miss autoinflammatory diseases masquerading as urticaria

“…Chronic spontaneous urticaria, that is, recurrent spontaneous wheals, angioedema or both occurring on a regular basis for more than 6 weeks, has a point prevalence of 0.5-1% in the European population (2). It is often associated with intolerance reactions to food and drugs, chronic infections and autoreactivity (i.e.…”

Health-Related Quality of Life and Rhinitis Control Measures in Allergic Rhinitis

“…Currently, assessment of PROs is rarely the primary, but rather a secondary outcome in clinical trials. The development of clinical trials in which PROs are the primary or co-primary outcome is recommended because appropriate tools are available [13].…”

“…All these viewpoints, which include symptoms, illness perception, quality of life, satisfaction with or adherence to treatment, health status, well-being, work productivity, as well as control of disease reported directly by the patients, without interpretation by physicians or others, are grouped under the definition of Patient-Reported Outcomes (PROs) [12•]. PROs focus the attention only on the patient, because she/he is the only person authorised to provide information about the personal experience of the disease, treatment and care [13].…”

Mean Platelet Volume in Children with Chronic Spontaneous Urticaria

“…However, most causes remain unknown. As in acute urticaria, chronic urticaria significantly adversely affects the quality of life not only in admission to emergency clinics but also in the social life (5).…”