Use of 3x2 tables with an intention to diagnose approach to assess clinical performance of diagnostic tests: meta-analytical evaluation of coronary CT angiography studies.

OBJECTIVE

To determine whether a 3 × 2 table, using an intention to diagnose approach, is better than the "classic" 2 × 2 table at handling transparent reporting and non-evaluable results, when assessing the accuracy of a diagnostic test.

DESIGN

Based on a systematic search for diagnostic accuracy studies of coronary computed tomography (CT) angiography, full texts of relevant studies were evaluated to determine whether they could calculate an alternative 3 × 2 table. To quantify an overall effect, we pooled diagnostic accuracy values according to a meta-analytical approach.

DATA SOURCES

Medline (via PubMed), Embase (via Ovid), and ISI Web of Science electronic databases.

ELIGIBILITY CRITERIA

Prospective English or German language studies comparing coronary CT with conventional coronary angiography in all patients and providing sufficient data for a patient level analysis.

RESULTS

120 studies (10,287 patients) were eligible. Studies varied greatly in their approaches to handling non-evaluable findings. We found 26 studies (including 2298 patients) that allowed us to calculate both 2 × 2 tables and 3 × 2 tables. Using a bivariate random effects model, we compared the 2 × 2 table with the 3 × 2 table, and found significant differences for pooled sensitivity (98.2 (95% confidence interval 96.7 to 99.1) v 92.7 (88.5 to 95.3)), area under the curve (0.99 (0.98 to 1.00) v 0.93 (0.91 to 0.95)), positive likelihood ratio (9.1 (6.2 to 13.3) v 4.4 (3.3 to 6.0)), and negative likelihood ratio (0.02 (0.01 to 0.04) v 0.09 (0.06 to 0.15); (P<0.05)).

CONCLUSION

Parameters for diagnostic performance significantly decrease if non-evaluable results are included by a 3 × 2 table for analysis (intention to diagnose approach). This approach provides a more realistic picture of the clinical potential of diagnostic tests.