Atrial fibrillation and autonomic nervous system: A translational approach to guide therapeutic goals

The autonomic nervous system (ANS) is known to play an important role in the genesis and maintenance of atrial fibrillation (AF). Biomolecular and genetic mechanisms, anatomical knowledges with recent diagnostic techniques acquisitions, both invasive and non-invasive, have enabled greater therapeutic goals in patients affected by AF related to ANS imbalance. Catheter ablation of ganglionated plexi (GP) in the left and right atrium has been proposed in varied clinical conditions. Moreover interesting results arise from renal sympathetic denervation and vagal nerve stimulation. Despite all this, in the scenario of ANS modulation translational strategies we necessary must consider the treatment or correction of dynamic factors such as obesity, obstructive sleep apnea, lifestyle, food, and stress. Finally, new antiarrhythmic drugs, gene therapy and “ablatogenomic” could be represent exciting future therapeutic perspectives

Concepts for the Development of Person-Centered, Digitally Enabled, Artificial Intelligence–Assisted ARIA Care Pathways (ARIA 2024)

The traditional healthcare model is focused on diseases (medicine and natural science) and does not acknowledge patients’ resources and abilities to be experts in their own lives based on their lived experiences. Improving healthcare safety, quality, and coordination, as well as quality of life, is an important aim in the care of patients with chronic conditions. Person-centered care needs to ensure that people’s values and preferences guide clinical decisions. This paper reviews current knowledge to develop (1) digital care pathways for rhinitis and asthma multimorbidity and (2) digitally enabled, person-centered care.1 It combines all relevant research evidence, including the so-called real-world evidence, with the ultimate goal to develop digitally enabled, patient-centered care. The paper includes (1) Allergic Rhinitis and its Impact on Asthma (ARIA), a 2-decade journey, (2) Grading of Recommendations, Assessment, Development and Evaluation (GRADE), the evidence-based model of guidelines in airway diseases, (3) mHealth impact on airway diseases, (4) From guidelines to digital care pathways, (5) Embedding Planetary Health, (6) Novel classification of rhinitis and asthma, (7) Embedding real-life data with population-based studies, (8) The ARIA-EAACI (European Academy of Allergy and Clinical Immunology) strategy for the management of airway diseases using digital biomarkers, (9) Artificial intelligence, (10) The development of digitally enabled, ARIA person-centered care, and (11) The political agenda. The ultimate goal is to propose ARIA 2024 guidelines centered around the patient to make them more applicable and sustainable

Concepts for the development of person-centred, digitally-enabled, Artificial Intelligence-assisted ARIA care pathways (ARIA 2024)

The traditional healthcare model is focused on diseases (medicine and natural science) and does not acknowledge patients' resources and abilities to be experts in their own life based on their lived experiences. Improving healthcare safety, quality and coordination, as well as quality of life, are important aims in the care of patients with chronic conditions. Person-centred care needs to ensure that people's values and preferences guide clinical decisions. This paper reviews current knowledge to develop (i) digital care pathways for rhinitis and asthma multimorbidity and (ii) digitally-enabled person-centred care (1). It combines all relevant research evidence, including the so-called real-world evidence, with the ultimate goal to develop digitally-enabled, patient-centred care. The paper includes (i) Allergic Rhinitis and its Impact on Asthma (ARIA), a two-decade journey, (ii) Grading of Recommendations, Assessment, Development and Evaluation (GRADE), the evidence-based model of guidelines in airway diseases, (iii) mHealth impact on airway diseases, (iv) from guidelines to digital care pathways, (v) embedding Planetary Health, (vi) novel classification of rhinitis and asthma, (vi) embedding real-life data with population-based studies, (vii) the ARIA-EAACI strategy for the management of airway diseases using digital biomarkers, (viii) Artificial Intelligence, (ix) the development of digitally-enabled ARIA Person-Centred Care and (x) the political agenda. The ultimate goal is to propose ARIA 2024 guidelines centred around the patient in order to make them more applicable and sustainable

Concepts for the Development of Person-Centered, Digitally Enabled, Artificial Intelligence–Assisted ARIA Care Pathways (ARIA 2024)

Funding Information: This work has received funding from ARIA (Allergic Rhinitis and its Impact of Asthma); CATALYSE (Climate Action To Advance HeaLthY Societies in Europe), the European Union\u2019s Horizon Europe research and innovation program under grant agreement no. 101057131; FRAUNHOFER Institute for Translational Medicine and Pharmacology (ITMP), Immunology and Allergology, Berlin, Germany; University of Porto, Portugal; and MASK-air, which has been supported by EU grants (Impact of air Pollution on Asthma and Rhinitis [POLLAR] project of the European Institute of Innovation and Technology Health; Structural and Development Funds, R\u00E9gion Languedoc Roussillon and Provence-Alpes-C\u00F4te d\u2019Azur; Twinning, European Innovation Partnership on Active and Healthy Ageing, DG Sant\u00E9 and DG Connect); educational grants from Mylan-Viatris, Allergologisk Laboratorium K\u00F8benhavn, GlaxoSmithKline, Novartis, Stallerg\u00E8nes-Greer, and Noucor; and funding from Breathing Together Onlus Association (Associazione Respiriamo Insieme Onlus), Italy; Esp\u00EDritu Santo University, Samborond\u00F3n, Ecuador; Finnish Anti-Tuberculosis Association Foundation and Tampere Tuberculosis Foundation; GA 2 LEN; German Allergy Society AeDA (\u00C4rzteverband Deutscher Allergologen); IPOKRaTES (International Postgraduate Organization for Knowledge transfer, Research and Teaching Excellent Students) Lithuania Fund; Polish Society of Allergology (POLSKIE TOWARZYSTWO ALLERGOLOGICZNE); and University of Li\u00E8ge, Belgium. Funding Information: Conflicts of interest: J. Bousquet reports personal fees from Cipla, Menarini, Mylan, Novartis, Purina, Sanofi-Aventis, Teva, Noucor, other from KYomed-Innov, and other from Mask-air-SAS, outside the submitted work. M. Blaiss reports personal fees from Sanofi, personal fees from Regeneron, personal fees from ALK, personal fees from Merck, personal fees from AstraZeneca, personal fees from GSK, personal fees from Prollergy, personal fees from Lanier Biotherapeutics, and nonfinancial support from Bryn Phama, outside the submitted work. J. Lity\u0144ska reports personal fees from Evidence Prime Sp. z o.o., outside the submitted work. T. Iinuma reports grants from Sanofi, outside the submitted work. P. Tantilipikorn reports grants from Abbott, other from GSK, and other from Sanofi Aventis, outside the submitted work. T. Haahtela reports personal fees from Orion Pharma, outside the submitted work. Publisher Copyright: © 2024 The AuthorsThe traditional healthcare model is focused on diseases (medicine and natural science) and does not acknowledge patients’ resources and abilities to be experts in their own lives based on their lived experiences. Improving healthcare safety, quality, and coordination, as well as quality of life, is an important aim in the care of patients with chronic conditions. Person-centered care needs to ensure that people's values and preferences guide clinical decisions. This paper reviews current knowledge to develop (1) digital care pathways for rhinitis and asthma multimorbidity and (2) digitally enabled, person-centered care.1 It combines all relevant research evidence, including the so-called real-world evidence, with the ultimate goal to develop digitally enabled, patient-centered care. The paper includes (1) Allergic Rhinitis and its Impact on Asthma (ARIA), a 2-decade journey, (2) Grading of Recommendations, Assessment, Development and Evaluation (GRADE), the evidence-based model of guidelines in airway diseases, (3) mHealth impact on airway diseases, (4) From guidelines to digital care pathways, (5) Embedding Planetary Health, (6) Novel classification of rhinitis and asthma, (7) Embedding real-life data with population-based studies, (8) The ARIA-EAACI (European Academy of Allergy and Clinical Immunology) strategy for the management of airway diseases using digital biomarkers, (9) Artificial intelligence, (10) The development of digitally enabled, ARIA person-centered care, and (11) The political agenda. The ultimate goal is to propose ARIA 2024 guidelines centered around the patient to make them more applicable and sustainable.proofinpres

Expert Perspectives on Next Generation Health Guidelines: How to Integrate RWE in EBM

Stefano Del Giacco,1,* Giorgio Walter Canonica,2,* Ioana Agache,3 David Price,4,5 Nicolas Roche,6 Holger Schunemann,7,8 Keith Allan,9 Ignacio Ansotegui,10 Simona Barbaglia,11 Jonathan A Bernstein,12 Matteo Bonini,13,14 Sinthia Bosnic-Anticevich,15,16 Jean Bousquet,17,18 Fulvio Braido,19,20 Victoria Carter,21 Herberto Jose Chong-Neto,22 Danilo Di Bona,23 Kirsty Fletton,5 Sandra Gonzalez Diaz,24 Vandana Ayyar Gupta,25 Richard Hubbard,26 Jonathan Iaccarino,27 Ibon Eguiluz-Gracia,28 Cristina Jacomelli,5 Janwillem Kocks,4,29– 31 Jerry Krishnan,3 Vera Mahler,32 Mario Morais-Almeida,33 Daniel Moreles,34 Paola Muti,35,36 Susanna Palkonen,37 Nikolaos G Papadopoulos,38,39 Ruby Pawankar,40 Christina Reeb,32 Helen Reddel,41 Isabel Rojo,42 Dermot Ryan,43 Lydia Sodhi,4 Maria Torres,28,44 Tonya Winders,45 Kevin C Wilson46 1Department of Medical Sciences and Public Health, University of Cagliari, Monserrato, Cagliari, Italy; 2Personalized Medicine, Asthma and Allergy, Humanitas Clinical and Research Hospital IRCCS, Rozzano, Milan, Italy; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy; 3Faculty of Medicine, Transylvania University, Brasov, Romania; 4Observational and Pragmatic Research Institute, Singapore; 5Centre of Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UK; 6Respiratory Medicine Department, Hôpitaux Universitaires Paris Centre, Hôpital Cochin, AP-HP and Université Paris Cité, Paris, France; 7Department of Health Research Methods, Evidence, and Impact, and of Medicine, McMaster University, Hamilton, ON, Canada; 8McMaster GRADE Centre & Department of Biomedical Sciences, Humanitas University, Milan, Italy; 9Department of Patient and Community Engagement, University Hospitals of Leicester, Leicester, UK; 10Department of Allergy and Immunology, Hospital Quironsalud Bizkaia, Bilbao, Spain; 11Leadership Team, Respiriamo Insieme Association, Padova, Italy; 12Division of Immunology/Allergy Section, Department of Internal Medicine, University of Cincinnati College of Medicine, Cincinnati, OH, USA; 13Department of Public Health and Infectious Diseases, Sapienza University, Rome, Italy; 14National Health and Lung Institute (NHLI), Imperial College London, London, UK; 15Macquarie Medical School, Faculty of Medicine, Health and Human Sciences, Macquarie University, Sydney, Australia; 16Woolcock Institute of Medical Research, Glebe, MSW, 2037, Australia; 17Institute of Allergology, Charité – Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany; 18Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Allergology and Immunology, Berlin, Germany; 19Respiratory Clinic, Department of Internal Medicine, University of Genoa, Genoa, Italy; 20IRCCS Ospedale Policlinico San Martino, Genoa, Italy; 21Optimum Patient Care Global, Cambridge, United Kingdom; Observational and Pragmatic Research Institute, Singapore; 22Division of Allergy and Immunology-Complexo Hospital de Clinicas-Department of Pediatrics-Federal University of Paraná, Curitiba, Brazil; 23Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy; 24Universidad Autónoma de Nuevo León, Faculty of Medicine and Hospital Universitario “Dr. José Eleuterio González”, Regional Center of Allergy and Clinical Immunology, Gonzalitos y Madero s/n Colonia Mitras Centro, Monterrey, Nuevo León, CP 64460, Mexico; 25Data & Analytics, NICE, Manchester, UK; 26School of Medicine, University of Nottingham, Nottingham, UK; 27American College of Chest Physicians, Glenview, IL, USA; 28Medicine Department and Allergy Unit, University of Malaga, Malaga, Spain; 29General Practitioners Research Institute, Groningen, the Netherlands; 30Groningen Research Institute Asthma and COPD (GRIAC), University of Groningen, University Medical Center Groningen, Groningen, the Netherlands; 31Department of Pulmonology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands; 32Paul-Ehrlich-Institut, Langen, Germany; 33Allergy Center, CUF Descobertas Hospital, Lisbon, Portugal; 34Data Analytics Taskforce, EMA – European Medicine Agency, Amsterdam, the Netherlands; 35Department of Biomedical, Surgical and Dental Health Sciences, University of Milan, Milan, Italy; 36IRCCS Multimedica, Milan, Italy; 37Secretariat EFA- European Federation of Allergy and Airways Diseases, Brussels, Belgium; 38Allergy and Clinical Immunology Unit, Second Pediatric Clinic, National and Kapodistrian University of Athens, Athens, Greece; 39University of Manchester, Manchester, UK; 40Asia Pacific Association of AllergyAsthma Clinical Immunology, Nippon Medical School, Tokio, Japan; 41The Woolcock Institute of Medical Research and Macquarie University, Sydney, New South Wales, Australia; Faculty of Medicine and Health, The University of Sydney; Sydney Local Health District, Sydney, Australia; 42Hospital Juárez de México, CMICA y SLAAI, Ciudad de México, Mexico; 43Centre for Population Health Sciences, Usher Institute, University of Edinburgh, Edinburgh, UK; 44Regional University Hospital, IBIMA-BIONAND, Malaga, Spain; 45Leadership Team, GAAPP – Global Allergy and Airways Patient Platform, Hendersonville, TN, USA; 46Department of Medicine, Boston University School of Medicine Boston, Boston, MA, USA*These authors contributed equally to this workCorrespondence: Stefano Del Giacco, Department of Medical Sciences and Public Health, Asse didattico “E1”, Cittadella Universitaria, Monserrato, Cagliari, 09042, Italy, Email [email protected]: Integrating real-world evidence (RWE) into evidence-based medicine (EBM) enhances healthcare decision-making. RWE provides insights into the real-world effectiveness and safety of therapies and health technologies, filling gaps that clinical trials may leave. EBM, which concentrates on therapeutic issues, depends on rigorous evaluation of evidence, including data from randomized controlled trials (RCTs) and RWE. Combining evidence from RCTs and RWE when forming recommendations offers a comprehensive understanding of benefits and risks by considering their strengths, limitations, and standardized methods. The 2nd European Academy of Allergy & Clinical Immunology/Respiratory Effectiveness Group (EAACI/REG) Workshop, held in Rome, Italy, on October 4th, 2023, discussed integrating RWE and EBM. The goals were to develop recommendations for high-quality RWE and its inclusion in evidence syntheses, with a particular focus on airway diseases. During the discussion, key topics emerged. An “action plan” is needed to share these topics in various formats. RCTs are currently seen as providing the strongest evidence, so how to incorporate Non-Randomized Studies of Interventions (NRSI) requires careful consideration. An educational plan and collaboration with patients’ organizations are also very important. A collaborative approach involving patients, clinicians, and regulators is essential for achieving meaningful results and can be adapted as needed for cultural differences. A “glossary” of terms used in this context will be created to improve understanding. Setting benchmarks for data quality and reliability, such as quality thresholds, in disease-specific studies requires collaboration with research method experts. Managing and recording registries according to standardized protocols and quality standards from well-designed registries will ensure the data is valid and accurate.Keywords: real world evidence, evidence-based medicine, real world data, registrie