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Allergen immunotherapy: the growing role of observational and randomised trial “real-world evidence”
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  • Giovanni Paoletti,
  • Danilo Di Bona,
  • Derek Chu,
  • Davide Firinu,
  • Enrico Heffler,
  • Ioana Agache,
  • Marek Jutel,
  • Ludger Klimek,
  • Oliver Pfaar,
  • Ralph Mosges,
  • Audrey DunnGalvin,
  • Jon Genuneit,
  • Hans Jürgen Hoffmann,
  • Giorgio Walter Canonica
Giovanni Paoletti
IRCCS Istituto Clinico Humanitas
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Danilo Di Bona
Università degli Studi di Bari-Aldo Moro
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Derek Chu
McMaster University
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Davide Firinu
University of Cagliari
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Enrico Heffler
IRCCS Istituto Clinico Humanitas
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Ioana Agache
Transylvania University of Brasov
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Marek Jutel
Wroclaw Medical University
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Ludger Klimek
Zentrum für Rhinologie und Allergologie
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Oliver Pfaar
University Hospital Marburg, Philipps-Universität Marburg, Marburg, Germany.
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Ralph Mosges
Universitat zu Koln
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Audrey DunnGalvin
University College Cork (UCC)
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Jon Genuneit
Ulm University
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Hans Jürgen Hoffmann
Aarhus University Hospital
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Giorgio Walter Canonica
IRCCS Humanitas Research Hospital
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Abstract

Although there is a considerable body of knowledge about allergen immunotherapy (AIT), there is a lack of data on the reliability of real-world evidence (RWE) in AIT and consequently, a lack of information on how AIT effectively works in real life. To address the current unmet need for an appraisal of the quality of RWE in AIT, the European Academy of Allergy and Clinical Immunology Methodology Committee recently initiated a systematic review of observational studies of AIT, which will use the RELEVANT tool and the Grading of Recommendations Assessment, Development and Evaluation approach (GRADE) to rate the quality of the evidence base as a whole. The next step will be to develop a broadly applicable, pragmatic “real-world” database using systematic data collection. Based on the current RWE base, and perspectives and recommendations of authorities and scientific societies, a hierarchy of RWE in AIT is proposed, which places pragmatic trials and registry data at the positions of highest level of evidence. There is a need to establish more AIT registries that collect data in a cohesive way, using standardised protocols. This will provide an essential source of real-world data that can be easily shared, promoting evidence-based research and quality improvement in study design and clinical decision-making.

Peer review status:ACCEPTED

14 Jan 2021Submitted to Allergy
15 Jan 2021Submission Checks Completed
15 Jan 2021Assigned to Editor
15 Jan 2021Reviewer(s) Assigned
31 Jan 2021Review(s) Completed, Editorial Evaluation Pending
31 Jan 2021Editorial Decision: Revise Minor
09 Feb 20211st Revision Received
10 Feb 2021Submission Checks Completed
10 Feb 2021Assigned to Editor
10 Feb 2021Reviewer(s) Assigned
11 Feb 2021Review(s) Completed, Editorial Evaluation Pending
11 Feb 2021Editorial Decision: Accept