Test Case Selection in Pre-Deployment Testing of Complex Clinical Decision Support Systems

Abstract

Clinical decision support (CDS) systems with complex logic are being developed. Ensuring the quality of CDS is imperative, but there is no consensus on testing standards. We tested ATHENA-HTN CDS after encoding updated hypertension guidelines into the system. A logic flow and a complexity analysis of the encoding were performed to guide testing. 100 test cases were selected to test the major pathways in the CDS logic flow, and the effectiveness of the testing was analyzed. The encoding contained 26 decision points and 3120 possible output combinations. The 100 cases selected tested all of the major pathways in the logic, but only 1% of the possible output combinations. Test case selection is one of the most challenging aspects in CDS testing and has a major impact on testing coverage. A test selection strategy should take into account the complexity of the system, identification of major logic pathways, and available resources.