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Design aspects for prognostic factor studies
Peggy Sekula1, Inga Steinbrenner2, Ulla T Schultheiss2,3,4
1Institute of Genetic Epidemiology, Faculty of Medicine and Medical Center - University of Freiburg, Freiburg, Germany peggy.sekula@uniklinik-freiburg.de.
BMJ Open
|August 31, 2025
Summary
This article provides guidance for improving the quality of prognostic factor studies, which are essential for advancing stratified medicine. It details key concepts, aims, and designs for these crucial clinical studies.
Area of Science:
- Clinical Research
- Epidemiology
- Biostatistics
Background:
- Prognostic research is vital for stratified medicine but often suffers from limitations in quality and output.
- Improved understanding and guidance are necessary to enhance the quality of prognostic research.
- Prognostic factor studies are a key sub-area requiring specific attention.
Purpose of the Study:
- To describe key concepts and issues in prognostic factor studies.
- To provide guidance for improving the quality and output of prognostic research.
- To highlight standards and current practices in the field.
Main Methods:
- Overview of prognosis research.
- Detailed discussion of aims, estimands, and designs for prognostic factor studies.
- Focus on studies assessing a single factor with a binary outcome.
Main Results:
- Identification of key concepts and issues in prognostic factor studies.
- Highlighting of current standards and practices.
- Provision of a glossary and checklist for study design considerations.
Conclusions:
- Enhanced understanding and standardized approaches are needed for high-quality prognostic factor studies.
- This work aims to improve the clinical relevance and application of prognostic research.
- The article serves as a guide for researchers and readers interested in prognosis research design.
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