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

doi:10.1111/j.1398-9995.2009.02263.x

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Wiley InterScience

Allergy

Volume 65 Issue 3, Pages 290 - 295

Published Online: 20 Nov 2009

Published with the European Academy of Allergy and Clinical Immunology (EAACI)

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POSITION PAPER

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

I. Baiardini ¹ , P. J. Bousquet ² , Z. Brzoza ³ , G. W. Canonica ¹ , E. Compalati ¹ , A. Fiocchi ⁴ , W. Fokkens ⁵ , R. G. van Wijk ⁶ , S. La Grutta ⁷ , C. Lombardi ⁸ , M. Maurer ⁹ , A. M. Pinto ¹⁰ , E. Ridolo ¹¹ , G. E. Senna ¹² , I. Terreehorst ⁵ , A. Todo Bom ¹³ , J. Bousquet ¹⁴ , T. Zuberbier ⁹ & F. Braido ¹

¹ Allergy & Respiratory Disease Clinic, Ospedale S.Martino Genova, Genova, Italy ; ² University hospital, Department of Biostatistics, Nimes, France; BESPIM ; ³ Department of Internal Diseases, Allergology and Clinical Immunology, Medical University of Silesia, Katowice, Poland ; ⁴ Department of Child and Maternal Medicine, The Melloni University Hospital, Milan, Italy ; ⁵ Department of Otorhinolaryngology, Academic Medical Center, Amsterdam, the Netherlands ; ⁶ Erasmus Medical Center in Rotterdam, the Netherlands ; ⁷ Environment and Health Unit, ARPA Sicilia and Institute of Biomedicine and Molecular Immunology (IBIM), Italian National Research Council (CNR), Palermo, Italy ; ⁸ Pneumoallergology Unit, S. Orsola FBF Hospital, Brescia, Italy ; ⁹ Department of Dermatology and Allergy, Allergie-Centrum-Charite/ECARF, Charité– Universitätsmedizin Berlin, Germany ; ¹⁰ Faculty of Medicine, Institute of Pathophysiology, Coimbra University, Coimbra, Portugal ; ¹¹ Clinical Sciences, University of Parma, Parma, Italy ; ¹² Allergy Service, Verona Major Hospital, Verona, Italy ; ¹³ Department of Immuno Allergology, Coimbra University Hospital, Coimbra, Portugal ; ¹⁴ Department of Respiratory Medicine, Montpellier University and INSERM U780, Montpellier, France

Correspondence Ilaria Baiardini, Allergy & Respiratory Disease Clinic, Ospedale S.Martino, Pad. Maragliano, Largo Rosanna Benzi 10, 16132 Genova, Italy.

Edited by: Marek Kowalski

KEYWORDS

health-related quality of life • patient-reported outcomes

To cite this article: Baiardini I, Bousquet PJ, Brzoza Z, Canonica GW, Compalati E, Fiocchi A, Fokkens W, van Wijk RG, La Grutta S, Lombardi C, Maurer M, Pinto AM, Ridolo E, Senna GE, Terreehorst I, Todo Bom A, Bousquet J, Zuberbier T, Braido F. Recommendations for assessing Patient-Reported Outcomes and Health-Related quality of life in clinical trials on allergy: a GA²LEN taskforce position paper. Allergy 2010; 65: 290–295.

ABSTRACT

The aim of this Global Allergy and Asthma European Network (GA²LEN) 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.

Accepted for publication 9 October 2009

DIGITAL OBJECT IDENTIFIER (DOI)

10.1111/j.1398-9995.2009.02263.x About DOI