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

I. Baiardini, P. J. Bousquet, Z. Brzoza, G. W. Canonica, E. Compalati, A. Fiocchi, W. Fokkens, R. G. Van Wijk, S. La Grutta, C. Lombardi, M. Maurer, A. M. Pinto, E. Ridolo, G. E. Senna, I. Terreehorst, A. Todo Bom, J. Bousquet, T. Zuberbier, F. Braido

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish
Pages (from-to)290-295
Number of pages6
JournalAllergy: European Journal of Allergy and Clinical Immunology
Volume65
Issue number3
DOIs
Publication statusPublished - Mar 2010

Fingerprint

Hypersensitivity
Quality of Life
Clinical Trials
Patient Outcome Assessment
Patient Reported Outcome Measures
Health
Social Change
Population
Consensus
Language
Asthma
Economics
Psychology
Physicians

Keywords

  • Health-related quality of life
  • Patient-reported outcomes

ASJC Scopus subject areas

  • Immunology
  • Immunology and Allergy

Cite this

Recommendations for assessing Patient-Reported Outcomes and Health-Related quality of life in clinical trials on allergy : A GA2LEN taskforce position paper. / Baiardini, I.; Bousquet, P. J.; Brzoza, Z.; Canonica, G. W.; Compalati, E.; Fiocchi, A.; Fokkens, W.; Van Wijk, R. G.; La Grutta, S.; Lombardi, C.; Maurer, M.; Pinto, A. M.; Ridolo, E.; Senna, G. E.; Terreehorst, I.; Bom, A. Todo; Bousquet, J.; Zuberbier, T.; Braido, F.

In: Allergy: European Journal of Allergy and Clinical Immunology, Vol. 65, No. 3, 03.2010, p. 290-295.

Research output: Contribution to journalArticle

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, Bom, AT, Bousquet, J, Zuberbier, T & Braido, F 2010, 'Recommendations for assessing Patient-Reported Outcomes and Health-Related quality of life in clinical trials on allergy: A GA2LEN taskforce position paper', Allergy: European Journal of Allergy and Clinical Immunology, vol. 65, no. 3, pp. 290-295. https://doi.org/10.1111/j.1398-9995.2009.02263.x
Baiardini, I. ; Bousquet, P. J. ; Brzoza, Z. ; Canonica, G. W. ; Compalati, E. ; Fiocchi, A. ; Fokkens, W. ; Van Wijk, R. G. ; La Grutta, S. ; Lombardi, C. ; Maurer, M. ; Pinto, A. M. ; Ridolo, E. ; Senna, G. E. ; Terreehorst, I. ; Bom, A. Todo ; 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. In: Allergy: European Journal of Allergy and Clinical Immunology. 2010 ; Vol. 65, No. 3. pp. 290-295.
@article{fb2cb4cb60a2437cbf146929f43f42ce,
title = "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 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.",
keywords = "Health-related quality of life, Patient-reported outcomes",
author = "I. Baiardini and Bousquet, {P. J.} and Z. Brzoza and Canonica, {G. W.} and E. Compalati and A. Fiocchi and W. Fokkens and {Van Wijk}, {R. G.} and {La Grutta}, S. and C. Lombardi and M. Maurer and Pinto, {A. M.} and E. Ridolo and Senna, {G. E.} and I. Terreehorst and Bom, {A. Todo} and J. Bousquet and T. Zuberbier and F. Braido",
year = "2010",
month = "3",
doi = "10.1111/j.1398-9995.2009.02263.x",
language = "English",
volume = "65",
pages = "290--295",
journal = "Allergy: European Journal of Allergy and Clinical Immunology",
issn = "0105-4538",
publisher = "Wiley-Blackwell",
number = "3",

}

TY - JOUR

T1 - Recommendations for assessing Patient-Reported Outcomes and Health-Related quality of life in clinical trials on allergy

T2 - A GA2LEN taskforce position paper

AU - Baiardini, I.

AU - Bousquet, P. J.

AU - Brzoza, Z.

AU - Canonica, G. W.

AU - Compalati, E.

AU - Fiocchi, A.

AU - Fokkens, W.

AU - Van Wijk, R. G.

AU - La Grutta, S.

AU - Lombardi, C.

AU - Maurer, M.

AU - Pinto, A. M.

AU - Ridolo, E.

AU - Senna, G. E.

AU - Terreehorst, I.

AU - Bom, A. Todo

AU - Bousquet, J.

AU - Zuberbier, T.

AU - Braido, F.

PY - 2010/3

Y1 - 2010/3

N2 - 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.

AB - 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.

KW - Health-related quality of life

KW - Patient-reported outcomes

UR - http://www.scopus.com/inward/record.url?scp=76249087769&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=76249087769&partnerID=8YFLogxK

U2 - 10.1111/j.1398-9995.2009.02263.x

DO - 10.1111/j.1398-9995.2009.02263.x

M3 - Article

C2 - 19930232

AN - SCOPUS:76249087769

VL - 65

SP - 290

EP - 295

JO - Allergy: European Journal of Allergy and Clinical Immunology

JF - Allergy: European Journal of Allergy and Clinical Immunology

SN - 0105-4538

IS - 3

ER -