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Beyond Accuracy: Methodological Advances for Assessing the Clinical Impact of Infectious Disease Diagnostics
Kimberly C Claeys1, Andrea M Prinzi2, Tristan T Timbrook3
1Department of Pharmacy Science and Health Outcomes Research, University of Maryland School of Pharmacy, Baltimore, Maryland, USA.
Open Forum Infectious Diseases
|October 24, 2025
Summary
Evaluating infectious disease in vitro diagnostic tests (IVDs) requires new methods beyond traditional approaches. This review discusses advanced frameworks and designs to better assess real-world IVD effectiveness and improve patient care.
Area of Science:
- Clinical diagnostics
- Health services research
- Evidence-based medicine
Background:
- Assessing the clinical impact of infectious disease in vitro diagnostic tests (IVDs) is complex.
- Traditional methods for evaluating therapy interventions are insufficient for IVDs due to context and implementation factors.
Purpose of the Study:
- To review methodological considerations for improving evidence generation for infectious disease IVDs.
- To discuss novel analytical approaches and study designs for evaluating IVDs.
Main Methods:
- Review of methodological challenges and solutions, including the target trial framework.
- Discussion of novel frameworks like Benefit-Risk Evaluation of Diagnostics and Desirability of Outcome Ranking Management of Antimicrobial Therapy.
- Exploration of hybrid effectiveness-implementation study designs.
Main Results:
- Identified design and analysis challenges that can lead to bias in IVD evaluation.
- Presented novel frameworks and study designs for holistic assessment of real-world IVD outcomes.
- Highlighted the importance of practical, real-world evidence for IVD evaluation.
Conclusions:
- Novel methodologies are needed to adequately capture the complexity of IVD effectiveness.
- Advanced frameworks and designs can improve the assessment of real-world IVD outcomes.
- Better evidence generation for IVDs can inform clinical decision-making, policy, and patient outcomes.
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