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\begin{document}

\title{Allergen immunotherapy: the growing role of observational and randomised
trial ``real-world evidence''}



\author[1]{Giovanni Paoletti}%
\author[2]{Danilo Di Bona}%
\author[3]{Derek Chu}%
\author[4]{Davide Firinu}%
\author[1]{Enrico Heffler}%
\author[5]{Ioana Agache}%
\author[6]{Marek Jutel}%
\author[7]{Ludger Klimek}%
\author[8]{Oliver Pfaar}%
\author[9]{Ralph Mosges}%
\author[10]{Audrey DunnGalvin}%
\author[11]{Jon Genuneit}%
\author[12]{Hans Jürgen Hoffmann}%
\author[13]{Giorgio Walter Canonica}%
\affil[1]{IRCCS Istituto Clinico Humanitas}%
\affil[2]{Università degli Studi di Bari-Aldo Moro}%
\affil[3]{McMaster University}%
\affil[4]{University of Cagliari}%
\affil[5]{Transylvania University of Brasov}%
\affil[6]{Wroclaw Medical University}%
\affil[7]{Zentrum für Rhinologie und Allergologie}%
\affil[8]{ University Hospital Marburg, Philipps-Universität Marburg, Marburg, Germany.}%
\affil[9]{Universitat zu Koln}%
\affil[10]{University College Cork (UCC)}%
\affil[11]{Ulm University}%
\affil[12]{Aarhus University Hospital}%
\affil[13]{IRCCS Humanitas Research Hospital}%


\vspace{-1em}



  
  \date{June 17, 2024}


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\begin{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.%
\end{abstract}%



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