Giovanni Paoletti1, Danilo Di Bona2, Derek K Chu3,4, Davide Firinu5, Enrico Heffler1, Ioana Agache6, Marek Jutel7, Ludger Klimek8, Oliver Pfaar9, Ralph Mösges10, Audrey DunnGalvin11, Jon Genuneit12,13, Hans Jürgen Hoffmann14, Giorgio Walter Canonica1. 1. Personalized Medicine, Asthma and Allergy, Humanitas Clinical and Research Center IRCCS and Department of Biomedical Sciences, Humanitas University, Milan, Italy. 2. Department of Emergency and Organ Transplantation, School and Chair of Allergology and Clinical Immunology, University of Bari - Aldo Moro, Bari, Italy. 3. Division of Immunology and Allergy, Department of Health Research Methods, Evidence and Impact, Department of Medicine, McMaster University, Hamilton, ON, Canada. 4. The Research Institute of St. Joe's Hamilton, Hamilton, ON, Canada. 5. Department of Clinical Sciences and Public Health, University of Cagliari, Cagliari, Italy. 6. Department of Allergy and Clinical Immunology, Faculty of Medicine, Transylvania University of Brasov, Brasov, Romania. 7. Department of Clinical Immunology, Wroclaw Medical University and "ALLMED"Medical Research Institute, Wroclaw, Poland. 8. Center for Rhinology and Allergology, Wiesbaden, Germany. 9. Section of Rhinology and Allergy, Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Marburg, Philipps-Universität Marburg, Marburg, Germany. 10. Faculty of Medicine, Institute of Medical Statistics and Computational Biology (IMSB), University of Cologne and CRI - Clinical Research International Limited, Cologne, Germany. 11. School of Applied Psychology and Department of Paediatrics & Child Health, University College Cork, Cork, Ireland. 12. Institute of Epidemiology and Medical Biometry, Ulm University, Ulm, Germany. 13. Pediatric Epidemiology, Department of Pediatrics, Medical Faculty, Leipzig University, Leipzig, Germany. 14. Department of Clinical Medicine, Aarhus University and Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus, Denmark.
Abstract
BACKGROUND: 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. METHODS: 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. KEY RESULTS: There is a need to establish more AIT registries that collect data in a cohesive way, using standardized protocols. CONCLUSIONS: 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.
BACKGROUND: 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. METHODS: 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. KEY RESULTS: There is a need to establish more AIT registries that collect data in a cohesive way, using standardized protocols. CONCLUSIONS: 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.
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Authors: Cristiano Caruso; Paolo Cameli; Elena Altieri; Maria Aliani; Pietro Bracciale; Luisa Brussino; Maria Filomena Caiaffa; Giorgio Walter Canonica; Stefano Centanni; Maria D'Amato; Stefano Del Giacco; Fausto De Michele; Elide Anna Pastorello; Girolamo Pelaia; Paola Rogliani; Micaela Romagnoli; Pietro Schino; Marco Caminati; Alessandra Vultaggio; Alessandro Zullo; Sara Rizzoli; Silvia Boarino; Gianfranco Vitiello; Francesco Menzella; Fabiano Di Marco Journal: Front Med (Lausanne) Date: 2022-09-02
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