Key result
Outcomes-based tech validation mimics clinical practice but faces key modeling and risk estimation challenges.
Why the study?
Outcomes-based approaches are preferred for technology validation but have challenges including multivariable modeling, end point selection, and estimating posttest risk.
Outcomes-based validation enables direct clinical application via risk stratification; leaves open challenges in unbiased technology assessment.
O utcomes-based approaches are the preferred methodol- ogy for technology validation.As discussed in part I of this review, the difficulties of performing an unbiased diagnostic evaluation are increasingly appreciated. 1 An outcomesbased approach is advantageous in that it mimics the clinical application of testing.By risk stratifying patients, the results of this approach can be applied directly to clinical practice.2 Nonetheless, outcomes-based technology validation is not without challenges and limitations.These issues include the need for multivariable modeling for observational data, end point selection, and limitations of estimating posttest risk.Finally, it is increasingly appreciated that the future "gold standard" for outcomes-based assessments will be demonstrating whether imaging can identify which therapeutic approach optimizes patient benefit rather than merely identifying risk.
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Hachamovitch et al. (2008) reported a review. Outcomes-based approaches for technology validation was evaluated. Outcomes-based approaches for technology validation mimic clinical application but face challenges including multivariable modeling, end point selection, and estimating posttest risk.
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