TY - JOUR
T1 - Targeted test evaluation
T2 - a framework for designing diagnostic accuracy studies with clear study hypotheses
AU - Korevaar, Daniël A
AU - Gopalakrishna, Gowri
AU - Cohen, Jérémie F
AU - Bossuyt, Patrick M
N1 - © The Author(s) 2019.
PY - 2019
Y1 - 2019
N2 - 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 defining meaningful hypotheses in diagnostic accuracy studies. Based on the role of the index test in the clinical pathway and the downstream consequences of test results, the consequences of test misclassifications can be weighed, to arrive at minimally acceptable criteria for pre-defined test performance: levels of sensitivity and specificity that would justify the test's intended use. Minimally acceptable criteria for test performance should form the basis for hypothesis formulation and sample size calculations in diagnostic accuracy studies.
AB - 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 defining meaningful hypotheses in diagnostic accuracy studies. Based on the role of the index test in the clinical pathway and the downstream consequences of test results, the consequences of test misclassifications can be weighed, to arrive at minimally acceptable criteria for pre-defined test performance: levels of sensitivity and specificity that would justify the test's intended use. Minimally acceptable criteria for test performance should form the basis for hypothesis formulation and sample size calculations in diagnostic accuracy studies.
U2 - https://doi.org/10.1186/s41512-019-0069-2
DO - https://doi.org/10.1186/s41512-019-0069-2
M3 - Article
C2 - 31890896
SN - 2397-7523
VL - 3
SP - 22
JO - Diagnostic and Prognostic Research
JF - Diagnostic and Prognostic Research
ER -