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The Semmelweis Framework: structuring evidence foundations and expert opinion in clinical practice guidelines
Blin Nagavci1, Margaret Renn Andrews2,3, Jens Vikse4,5,6
1Doctoral School of Clinical Medicine, Semmelweis University, Budapest, Hungary. dr.bnagavci@gmail.com.
BMC Medical Research Methodology
|July 18, 2026
Summary
The Semmelweis Framework standardizes expert opinion in clinical guidelines by classifying recommendations based on evidence. This structured approach enhances transparency and integrity when evidence is limited.
Area of Science:
- Clinical Practice Guidelines
- Health Research Methodology
Background:
- Expert opinion is crucial in guideline development when evidence is scarce.
- Unstandardized use of expert opinion presents a methodological gap.
- The Semmelweis Framework was developed to address this gap.
Purpose of the Study:
- To develop a methodological tool for structuring expert opinion in clinical guidelines.
- To provide a standardized approach for using expert opinion when evidence is limited, indirect, or absent.
Main Methods:
- A meta-epidemiological study analyzed expert opinion use in 2,296 recommendations.
- A methodological review synthesized definitions of expert opinion from 98 guideline manuals.
- The framework was refined through multi-reviewer application and development of a Preconditions Checklist.
Main Results:
- The Semmelweis Framework classifies recommendations into four classes based on evidentiary foundation.
- It distinguishes between recommendations with direct evidence, indirect evidence, non-comparative evidence, and expert judgment.
- A Preconditions Checklist ensures integrity and transparency for recommendations relying on expert opinion.
Conclusions:
- The Semmelweis Framework reframes the role of expert opinion in clinical guidelines.
- It offers a structured approach with safeguards and new classification systems.
- This framework addresses a significant methodological gap in guideline development.
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