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Journal article

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

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.

Authors

Del Giacco S; Canonica GW; Agache I; Price D; Roche N; Schunemann H; Allan K; Ansotegui I; Barbaglia S; Bernstein JA

Journal

Pragmatic and Observational Research, Vol. 16, No. 0, pp. 169–177

Publisher

Taylor & Francis

Publication Date

December 31, 2025

DOI

10.2147/por.s487342

ISSN

1179-7266

Labels

Sustainable Development Goals (SDG)

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