Toward a Framework for Outcome-Based Analytical Performance Specifications: A Methodology Review of Indirect Methods for Evaluating the Impact of Measurement Uncertainty on Clinical Outcomes

BACKGROUND For medical tests that have a central role in clinical decision-making, current guidelines advocate outcome-based analytical performance specifications. Given that empirical (clinical trial-style) analyses are often impractical or unfeasible in this context, the ability to set such specifications is expected to rely on indirect studies to calculate the impact of test measurement uncertainty on downstream clinical, operational, and...