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J Allergy Clin Immunol Pract. 2014 Mar-Apr;2(2):123-9; quiz 130. doi: 10.1016/j.jaip.2014.01.005.

Allergen immunotherapy: clinical outcomes assessment.

Author information

1
Section of Allergy and Clinical Immunology, Imperial College London, National Heart and Lung Institute, Royal Brompton Hospital, London, United Kingdom.
2
Centre for Rhinology and Allergology Wiesbaden, Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital, Mannheim, Germany.
3
Section of Allergy and Clinical Immunology, Imperial College London, National Heart and Lung Institute, Royal Brompton Hospital, London, United Kingdom. Electronic address: m.calderon@imperial.ac.uk.

Abstract

Assessment of clinical outcomes is essential to evaluate the efficacy of allergen immunotherapy, both in clinical trials and in daily clinical practice. "Primary outcomes" used in sublingual and subcutaneous immunotherapy trials include the measurement of symptoms, the use of concomitant medications, and/or a combination of both of these measures. "Secondary outcomes" that have been measured include individual symptom scores, provocation allergen tests, visual analog scales, and health-related quality of life assessments. Currently, there is a lack of consistency in the selection of outcome parameters used, which represents a major problem when comparing the same therapeutic intervention. In this review, we examined the different primary and secondary outcome parameters that have been used in clinical trials; reviewed recommendations by European and US guidelines, and allergy groups; and explored which outcomes may be applicable for use in clinical practice.

KEYWORDS:

Allergen immunotherapy; Health-related quality of life; Outcome parameters; Sublingual immunotherapy

PMID:
24607037
DOI:
10.1016/j.jaip.2014.01.005
[Indexed for MEDLINE]
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