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The Estimand Framework in Diagnostic Accuracy Studies.
Alexander Fierenz1, Mouna Akacha2, Norbert Benda3
1Institute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Statistics in Medicine
|September 17, 2025
Summary
This study introduces the estimand concept for diagnostic accuracy studies. It defines key attributes and strategies for handling interfering events, improving study planning and interpretation.
Area of Science:
- Medical Research Methodology
- Diagnostic Test Evaluation
Background:
- Diagnostic accuracy studies assess a test's ability to detect or rule out conditions.
- Interfering events can impact test results and study validity.
- Clear definition of the clinical question is crucial for study design.
Purpose of the Study:
- To introduce the estimand concept for diagnostic accuracy studies.
- To define strategies for handling interfering events in these studies.
- To improve the structure, exchange, and interpretation of diagnostic accuracy research.
Main Methods:
- Introduction of the estimand concept, comprising population, target condition, index test, accuracy measure, and handling strategies for interfering events.
- Development of six distinct strategies for managing interfering events.
- Illustration using a fictitious computed tomography scan study to bridge study objectives and estimation methods.
Main Results:
- The estimand concept provides a framework for defining the specific effect estimated in diagnostic accuracy studies.
- Defined estimands enhance the planning phase of studies.
- Improved interdisciplinary communication and interpretation of study results are facilitated.
Conclusions:
- The estimand concept offers a structured approach to diagnostic accuracy study design.
- Handling interfering events through defined strategies is essential for robust study conduct.
- This framework supports clearer research objectives and more reliable findings in diagnostic accuracy research.
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