Targeted test evaluation: a framework for designing diagnostic accuracy studies with clear study hypotheses

Most randomized controlled trials evaluating medical interventions have a pre-specified hypothesis, which is statistically tested against the null hypothesis of no effect. In diagnostic accuracy studies, study hypotheses are rarely pre-defined and sample size calculations are usually not performed, which may jeopardize scientific rigor and can lead to over-interpretation or "spin" of study findings. In this paper, we propose a strategy for...