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 language | English |
|---|---|
| Pages (from-to) | 290-295 |
| Number of pages | 6 |
| Journal | Allergy: European Journal of Allergy and Clinical Immunology |
| Volume | 65 |
| Issue number | 3 |
| DOIs | |
| Publication status | Published - Mar 2010 |
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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 journal › Article
}
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 -