BACKGROUND: In some diagnostic accuracy studies, the test results of a series of patients with an established diagnosis are compared with those of a control group. Such case-control designs are intuitively appealing, but they have also been criticized for leading to inflated estimates of accuracy. METHODS: We discuss similarities and differences between diagnostic and etiologic case-control studies, as well as the mechanisms that can lead to variation in estimates of diagnostic accuracy in studies with separate sampling schemes ("gates") for diseased (cases) and nondiseased individuals (controls). RESULTS: Diagnostic accuracy studies are cross-sectional and descriptive in nature. Etiologic case-control studies aim to quantify the effect of potential causal exposures on disease occurrence, which inherently involves a time window between exposure and disease occurrence. Researchers and readers should be aware of spectrum effects in diagnostic case-control studies as a result of the restricted sampling of cases and/or controls, which can lead to changes in estimates of diagnostic accuracy. These spectrum effects may be advantageous in the early investigation of a new diagnostic test, but for an overall evaluation of the clinical performance of a test, case-control studies should closely mimic cross-sectional diagnostic studies. CONCLUSIONS: As the accuracy of a test is likely to vary across subgroups of patients, researchers and clinicians might carefully consider the potential for spectrum effects in all designs and analyses, particularly in diagnostic accuracy studies with differential sampling schemes for diseased (cases) and nondiseased individuals (controls).
BACKGROUND: In some diagnostic accuracy studies, the test results of a series of patients with an established diagnosis are compared with those of a control group. Such case-control designs are intuitively appealing, but they have also been criticized for leading to inflated estimates of accuracy. METHODS: We discuss similarities and differences between diagnostic and etiologic case-control studies, as well as the mechanisms that can lead to variation in estimates of diagnostic accuracy in studies with separate sampling schemes ("gates") for diseased (cases) and nondiseased individuals (controls). RESULTS: Diagnostic accuracy studies are cross-sectional and descriptive in nature. Etiologic case-control studies aim to quantify the effect of potential causal exposures on disease occurrence, which inherently involves a time window between exposure and disease occurrence. Researchers and readers should be aware of spectrum effects in diagnostic case-control studies as a result of the restricted sampling of cases and/or controls, which can lead to changes in estimates of diagnostic accuracy. These spectrum effects may be advantageous in the early investigation of a new diagnostic test, but for an overall evaluation of the clinical performance of a test, case-control studies should closely mimic cross-sectional diagnostic studies. CONCLUSIONS: As the accuracy of a test is likely to vary across subgroups of patients, researchers and clinicians might carefully consider the potential for spectrum effects in all designs and analyses, particularly in diagnostic accuracy studies with differential sampling schemes for diseased (cases) and nondiseased individuals (controls).
Authors: Andrew D Schweitzer; Tian Liu; Ajay Gupta; Karen Zheng; Stephen Seedial; Alexander Shtilbans; Mona Shahbazi; Dale Lange; Yi Wang; A John Tsiouris Journal: AJR Am J Roentgenol Date: 2015-05 Impact factor: 3.959
Authors: Eleanor A Ochodo; Gowri Gopalakrishna; Bea Spek; Johannes B Reitsma; Lisette van Lieshout; Katja Polman; Poppy Lamberton; Patrick M M Bossuyt; Mariska M G Leeflang Journal: Cochrane Database Syst Rev Date: 2015-03-11
Authors: Jenny McCleery; Shirlony Morgan; Kevin M Bradley; Anna H Noel-Storr; Olaf Ansorge; Chris Hyde Journal: Cochrane Database Syst Rev Date: 2015-01-30
Authors: Luis Alonso Pacheco; Carmina Bermejo López; José Carugno; Pedro Azumendi Gómez; Pilar Martinez-Ten; Antonio Simone Laganà; Simone Garzon Journal: Arch Gynecol Obstet Date: 2021-07-25 Impact factor: 2.344