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

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.

Authors

Institutions

Publication Details

Journal
Pragmatic and Observational Research
Published
2025-09-01
DOI
https://doi.org/10.2147/por.s487342
Citations
1
Primary Topic
Asthma and respiratory diseases
Type
article
Field-Weighted Citation Impact
1.16
Controls
|||
ALL TIME
JAN
FEB
MAR
APR
MAY
JUN
JUL
AUG
SEP
OCT
article

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

Nicolás Roche, Vera Mahler, Vandana Ayyar Gupta, Helen Kathryn Reddel et al.
1 citations
Pragmatic and Observational Research
Asthma and respiratory diseases
1.16
article

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

Nicolás Roche, Vera Mahler, Vandana Ayyar Gupta, Helen Kathryn Reddel, Sinthia Bosnic‐Anticevich, Kirsty Fletton, Simona Barbaglia, Christina Reeb, Ignacio Javier Ansotegui, Fulvio Braido, Ioana Agache, Giorgio Walter Canonica, Dermot Ryan, Tonya Winders, Kevin C. Wilson, David Price, Herberto José Chong‐Neto, Paola C. Muti, Jonathan M. Iaccarino, Richard Hubbard, I Melba Gómez Rojo, Victoria Carter, Jerry A. Krishnan, Keith Allan, Sandra Nora González Díaz, Janwillem W.H. Kocks, Holger J. Schünemann, Stefano R. Del Giacco, Ibon Eguíluz‐Gracia, Jonathan A. Bernstein, Rute Almeida, Marı́a José Torres, Nikolaos G. Papadopoulos, Matteo Bonini, Cristina Jacomelli, Susanna Palkonen, Donald R. DiBona, Ruby Pawankar, Daniel Moreles, Lydia Sodhi
article en
1 citations

Abstract

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.

Pragmatic and Observational ResearchVol. Volume 16
University of Foggia (IT), Boston University (US), The University of Sydney (AU), European Medicines Agency (NL), American College of Chest Physicians (US), University Medical Center Groningen (NL), Humanitas University (IT), University of Nottingham (GB), Universidad Autónoma de Nuevo León (MX), University of Groningen (NL), University of Cagliari (IT), University of Milan (IT), University of Aberdeen (GB), National and Kapodistrian University of Athens (GR), Université Paris Cité (FR), Woolcock Institute of Medical Research (AU), University Hospitals of Leicester NHS Trust (GB), University of Manchester (GB), Transylvania University of Brașov (RO), National Institute for Health and Care Excellence (GB), Humboldt-Universität zu Berlin (DE), Foundation for Cardiovascular Biomedical Research and Gene and Cell Therapy (IT), Hôpital Cochin (FR), General Practitioners Research Institute (NL), MultiMedica (IT), Assistance Publique – Hôpitaux de Paris (FR), Lung Institute (US), ENT and Allergy (US), Fraunhofer Institute for Translational Medicine and Pharmacology (DE), Hospital Regional Universitario de Málaga (ES), CUF Porto Hospital (PT), Hospital Quirónsalud Barcelona (ES), Observational & Pragmatic Research Institute (SG), European Federation of Allergy and Airways Diseases Patients Associations (BE), Hospital Universitario Dr José Eleuterio Gonzalez (MX), Hospital de Clínicas Universidade Federal do Paraná (BR), Sydney Local Health District (AU), Ospedale Policlinico San Martino (IT), Hospital Juárez de México (MX), Impact (CA), IRCCS Humanitas Research Hospital (IT), Instituto de Investigación Biomédica de Málaga (ES), Freie Universität Berlin (DE), Charité - Universitätsmedizin Berlin (DE), Nippon Medical School (JP), Universidad de Málaga (ES), University of Genoa (IT), Paul Ehrlich Institut (DE), University of Cincinnati Medical Center (US), McMaster University (CA), University of Edinburgh (GB), Macquarie University (AU)
Openalex Percentile: Top 18%
Asthma and respiratory diseases
1.16
DOIOpen Access PDFOpenAlex
AI Navigator

Ask Laika to Summarize, Analyze, and Connect papers live on the map.

Summarize Papers & Methodologies

Extract key findings, datasets, and comparative methods across publications.

Benchmark Rankings & Visual Analytics

Rank top research institutions, authors, funders, topics, and journals by Field-Weighted Citation Impact (FWCI) and paper volume with instant charts.

Connect Distant Disciplines

Bridge topological clusters on the map to find hidden collaborative intersections.