[All evidence is real world evidence.]

Area of Science:

• Clinical research methodology
• Evidence-based medicine

Background:

• Randomized controlled trials (RCTs) are criticized for limited generalizability to diverse patient populations in clinical practice.
• Real-world evidence (RWE) from sources like patient registries and electronic health records is proposed as a solution.

Purpose of the Study:

• To address the limitations of RCTs in clinical practice.
• To highlight the importance of evaluating all forms of evidence, including RWE, for clinical decision-making.

Main Methods:

• Discussion of the nature of evidence, including RCTs and RWE.
• Emphasis on the critical appraisal of evidence reliability and its support for decision-making factors.
• Introduction of the GRADE framework for transparent evidence presentation.

Main Results:

• All evidence, regardless of source (RCT or observational), is considered real-world evidence.
• Increased "realness" of evidence can introduce bias.
• A systematic evaluation of evidence is necessary to support clinical recommendations.

Conclusions:

• The careful evaluation of evidence, considering factors like health problem importance, benefit-risk balance, and patient values, is essential.
• Transparent presentation of evidence using frameworks like GRADE (Grading of Recommendations Assessment, Development and Evaluation) is ideal for evidence-to-decision (EtD) processes.