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Real-world evidence

Evidence generated by analysing health data from routine practice to address a defined question.

Editorial update · October 6, 2026

Data need an analytical question

Routine records do not by themselves demonstrate an intervention’s effect. Define the population, exposure, comparator, outcome and analytical approach before interpreting an association.

Assess fitness for the purpose

Care records may lack variables needed for research or contain differences in dates, codes and follow-up. A dataset suitable for describing service use may not be suitable for estimating effectiveness or safety.

Explain the analysis and limitations

Justify design choices, missing-data handling and approaches to confounding. These studies can complement other evidence and illuminate practice, but conclusions remain bounded by the design and data.

Interpretation limits

The label real-world does not guarantee representativeness, quality or causality.

Original references

  1. Real-World Evidence

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Select tools by method, population and purpose. A thematic connection does not validate use in every case.

Educational content for framing research. Consult the original document, study population and methodology before interpreting a conclusion. Methodology

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