Chronic Rhinosinusitis Outcome Registry (CHRINOSOR): Establishment of an International Outcome Registry Driven by mHealth Technology

Publikation: Bidrag til tidsskriftReviewForskningfagfællebedømt

  • Sven F. Seys
  • Peter W. Hellings
  • Isam Alobid
  • Emilie Bequignon
  • Carlo Cavaliere
  • André Coste
  • Lauren Deneyer
  • Zuzana Diamant
  • Julia Eckl-Dorna
  • Wytske J. Fokkens
  • Simon Gane
  • Philippe Gevaert
  • Christiane Holbaek-Haase
  • Clemens Holzmeister
  • Claire Hopkins
  • Valérie Hox
  • Caroline Huart
  • Roger Jankowski
  • Mark Jorissen
  • Anette Kjeldsen
  • Lisa Knipps
  • Bibi Lange
  • Rik van der Lans
  • Anu Laulajainen-Hongisto
  • Kenneth Larsen
  • David T. Liu
  • Valerie Lund
  • Gert Mariën
  • Simonetta Masieri
  • Geoffrey Mortuaire
  • Joaquim Mullol
  • Sietze Reitsma
  • Philippe Rombaux
  • Sven Schneider
  • Andreas Steinsvik
  • Peter Valentin Tomazic
  • Sanna K. Toppila-Salmi
  • Laura Van Gerven
  • Thibaut Van Zele
  • Paula Virkkula
  • Martin Wagenmann
  • Claus Bachert

Background: Real-world evidence (RWE) is a valuable instrument to better understand the patient journey and effectiveness of therapies. RWE on the prevalence of uncontrolled chronic rhinosinusitis (CRS) and CRS natural course of disease across Europe is scarce. In addition, there is limited RWE that enables comparison of the effectiveness of marketed therapies including topical or systemic corticosteroids, sinus surgery, or biologics. Objective: To establish an international CHRonic rhINOSinusitis Outcome Registry (CHRINOSOR) based on real-world data collection enabled by mobile health technology. Methodology: A digital platform, Galenus Health, supporting patients and physicians in the management of chronic respiratory diseases, is used to collect data on patient profile, disease history, patient outcomes, and a set of relevant clinical outcomes. Adult patients with a diagnosis of CRS are eligible for inclusion. Results: A collaborative scientific network of 17 university ear-nose-throat (ENT) clinics from 10 European countries has been established with the aim to collect real-world data in a longitudinal and standardized manner. The Galenus Health digital platform is currently being implemented in these ENT clinics taking into account legal, privacy, and data security aspects. Up to 300 patients have already been included. Conclusions: CHRINOSOR is a collaborative effort that aims at improving our understanding of CRS, its comorbidities, and the effectiveness of its treatments. Ultimately, these insights will guide us as scientific community to develop future care pathways informed by RWE.

OriginalsprogEngelsk
TidsskriftJournal of Allergy and Clinical Immunology: In Practice
Vol/bind11
Udgave nummer2
Sider (fra-til)431-438.e2
ISSN2213-2198
DOI
StatusUdgivet - 2023

Bibliografisk note

Funding Information:
The study is funded by Novartis Pharma AG and GSK, and was in part financially supported by Sanofi and Regeneron .

Funding Information:
Conflicts of interest: S. F. Seys is an employee and shareholder of Galenus Health; and reports payment for lectures from Teva Pharmaceutical. I. Alobid reports grants, royalties or license, consulting fees, payment for lectures, participation to advisory board from Novartis , Sanofi , Salvat, Menarini, Roche , GSK, MSD, Galenus health, Viatris, and Olympus , and payment for expert testimony from Teladoc. E. Bequignon reports payment for lectures from GSK and Sanofi. C. Cavaliere reports consulting fees from GSK, Sanofi , Novartis , and AstraZeneca; and participation on advisory board from GSK, Sanofi , and Novartis. L. Deneyer was an employee of Galenus Health during conception of the study. Z. Diamant reports consulting fees from Sanofi- Genzyme , GSK, Antabio, and QPS-NL; payment for lectures from Medicom, Springer, and EUFOREA; and leadership role in EUFOREA, Respiratory Medicine and Allergy. J. Eckl-Dorna reports grants (institution) from AstraZeneca and Novartis; payment for lectures from Allergopharma; and participation on advisory board from GSK, AstraZeneca , and Bencard. W. J. Fokkens reports grants (institution: AMC) from GSK, Novartis , and Sanofi; consulting fees from Dianosic, Sanofi , GSK, and Novartis; payment for lectures from Sanofi , GSK, and Novartis; participation on advisory board from Lyra; and leadership roles in ERS (Secretary General), Rhinology (Editor-in-Chief), and Allergy (Associate Editor). S. Gane reports consulting fees and participation on advisory board from GSK, Sanofi- Genzyme , and UCB. P. Gevaert reports participation on advisory boards and fees for lectures from ALK-Albello, Argenx, AstraZeneca , Genentech , GSK, Novartis , Regeneron , Roche , Sanofi Genzyme , and Stallergenes-Greer. C. Hopkins reports advisory board fees from AstraZeneca , Dianosic, GSK, and Sanofi . V. Hox reports payments for lectures from Novartis; participation to advisory boards of Sanofi and GSK; and leadership role in EAACI. R. Jankowski reports grants, consulting fees, support for attending meetings, and participation on advisory board from Sanofi- Genzyme . A. Kjeldsen reports grants from AstraZeneca; participation on advisory board (until 2020) from Sanofi; and board role in Danish National medical board regarding inflammatory diseases of the nose and sinuses. R. van der Lans reports consulting fees and payment for lectures from GSK. A. Laulajainen-Hongisto reports consultancy fees from Galenus Health. V. Lund reports royalties or licenses from Elsevier; consulting fees from GSK; honoraria for lectures from Abbott , GSK, Novartis , and Sanofi; support for attending meetings from GSK; and participation on advisory board from GSK. G. Mariën is an employee and shareholder of Galenus Health. S. Masieri reports consulting fees from GSK, Sanofi , Novartis , and AstraZeneca; support for attending meetings from LoFarma, and Sanofi; and participation on advisory board from AstraZeneca , Sanofi , and Novartis . G. Mortuaire reports payments for lectures from Sanofi , SGK, Novartis , Dianosic, and Medtronic; support for travel from Audika; participation in advisory boards of Sanofi , GSK, Novartis , and Dianosic; and board role in ALK. J. Mullol reports grants from Viatris and Uriach Group/Noucor; payments for lectures from AstraZeneca , MSD, Mitsubishi-Tanabe, Uriach Group/Noucor, Viatris, Novartis , Sanofi- Genzyme , Regeneron Pharmaceuticals , and GSK; payments for expert testimony from Uriach and Sanofi; and participation on advisory board from Sanofi- Genzyme , AstraZeneca , Regeneron Pharmaceuticals , Novartis , Viatris, Uriach Group/Noucor, GSK, and Allakos. S. Reitsma reports grants (institution) from Sanofi and Novartis and consultancy fees from Sanofi, Novartis, and GSK. S. Schneider reports grants, payment for lectures, and participation on advisory board from Sanofi and Novartis . S. Toppila-Salmi reports grants from the Finish Society of Allergology and Immunology, state funding for university level research, Tampere Tuberculosis Foundation , Finnish Anti-Tuberculosis Association; and consulting fees from ALK-Albello, AstraZeneca , ERT, GSK, Novartis , Sanofi , and Roche Products . L. Van Gerven reports grants from FWO Vlaanderen and UZ Leuven; payments for lectures from ALK; and participation on advisory board from Hippo Dx. P. Virkkula reports payment for a lecture from Sanofi and consultancy fee from GSK. M. Wagenmann reports grants from ALK-Abello, GSK, Regeneron , AstraZeneca , Novartis , Sanofi , and Takeda; consulting fees from ALK, Genzyme , Novartis , Stallergenes, AstraZeneca , GSK, and Sanofi; payment for lectures from ALK-Abello, AstraZeneca , GSK, Leti Pharma, Sanofi , Allergopharma , Bencard Allergie, Infectopharm, Novartis , and Stallergenes; and leadership role in DGAKI (executive committee). C. Bachert reports grants or any contracts from GSK, Sanofi , Novartis , Galenus Health, and Meda. The rest of the authors declare that they have no relevant conflicts of interest.

Publisher Copyright:
© 2022 American Academy of Allergy, Asthma & Immunology

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