Mieke Bus

7 111 Determining Diagnostic Accuracy Further research needs to be conducted in order to evaluate the true value of the techniques in UTUC described in this thesis. Current available data are too preliminary to evaluate these new technologies and implement them into the diagnostic work-up of patients with UTUC. As UTUC is a rare disease, data are sparse and should be used wisely. In the future, well-con- ducted studies should start for the evaluation of diagnostic technologies in the upper uri- nary tract. Several groups have published guidelines on how to perform and report a study in order to assess diagnostic accuracy. As it involves the use of a medical device instead of a pharmacological product, the optimal way to proceed is following the IDEAL evaluation criteria, described by the Balliol collaboration. (26, 27) This evaluation equals surgical innovation to the different phases of the pharmacological research and consists of independent phases (1: Idea/Innovation, 2a: Development, 2b: Exploration, 3: Assessment, 4: Long-term Studies). To develop these technologies into a diagnostic test, results should be compared with the standard test at use. In the case of enhanced tumour visualization systems, the standard test is WL-URS (including biopsies), where techniques aiming for optical biopsy use histology as gold standard. The IDEAL methodology can be combined with the STARD statement. The STARD statement has been developed to improve the accuracy and completeness of reporting studies of diagnostic accuracy. (28) Before implementing a diagnostic technique in the diagnostic work-up of UTUC, clinical studies should provide a full diagnostic accuracy analysis according to the STARD recommendations, including sensitivity, specificity, positive predictive value and negative predictive value.