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Toward a better understanding about real-world evidence
Mei Liu1,2,3, Yana Qi1,2,3, Wen Wang1,2,3
1Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu, China.
European Journal of Hospital Pharmacy : Science and Practice
|December 3, 2021
Summary
Real-world evidence (RWE), generated from routine healthcare data, offers insights but is prone to biases. Understanding RWE methodology is crucial for accurate interpretation and informed healthcare decisions.
Area of Science:
- Healthcare research methodology
- Observational study design
- Real-world data analytics
Background:
- Growing interest in real-world evidence (RWE) derived from routine healthcare data.
- RWE sources include electronic health records and disease registries.
- RWE is susceptible to biases that can distort findings.
Purpose of the Study:
- To summarize the concept and methodological framework of RWE.
- To discuss methodological issues specific to routinely collected data and observational studies.
- To provide guidance on the appropriate interpretation and use of RWE.
Main Methods:
- Literature review and empirical research experience.
- Summarized RWE concept and methodological framework.
- Detailed discussion of methodological challenges in RWE.
Main Results:
- RWE utilizes observational studies and pragmatic clinical trials.
- Routinely collected data (RCD) is common but prone to bias.
- Key steps for RWE studies include clear questions, team development, data selection, robust design, transparent processing, bias control, and guideline adherence.
Conclusions:
- The volume of RWE is increasing significantly.
- Adequate methodological understanding is vital for RWE interpretation and application.
- Researchers and policymakers must recognize and address methodological pitfalls in RWE generation and interpretation.
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