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

Area of Science:

• Health Services Research
• Clinical Epidemiology
• Pharmacoeconomics

Background:

• Evidence-based medicine (EBM) relies on rigorous evaluation of evidence, including clinical trials and real-world evidence (RWE).
• RWE offers insights into therapy effectiveness and safety, complementing data from randomized controlled trials (RCTs).
• Gaps in clinical trial data necessitate the integration of RWE for comprehensive healthcare decision-making.

Purpose of the Study:

• To develop recommendations for generating high-quality RWE.
• To guide the inclusion of RWE in evidence syntheses for healthcare decision-making.
• To focus on the application of RWE and EBM in airway diseases.

Main Methods:

• Discussion and consensus-building at the 2nd EAACI/REG Workshop.
• Identification of key topics for integrating RWE into EBM.
• Focus on developing an action plan for sharing findings and establishing quality benchmarks.

Main Results:

• Recognition of the need for an action plan to disseminate findings on RWE integration.
• Emphasis on careful consideration for incorporating Non-Randomized Studies of Interventions (NRSI) alongside RCTs.
• Highlighting the importance of patient collaboration, educational initiatives, and standardized data quality benchmarks.

Conclusions:

• A collaborative approach involving patients, clinicians, and regulators is crucial for meaningful integration of RWE.
• Standardized protocols and quality standards for registries are essential for ensuring RWE validity and accuracy.
• Developing a glossary of terms and setting quality thresholds will enhance understanding and reliability of RWE in EBM.