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

Geoffrey J Tso1, Kaeli Yuen2, Susana Martins2

  • 1Center for Innovation to Implementation, VA Palo Alto Health Care System, Menlo Park, CA;; Center for Primary Care and Outcomes Research (PCOR), Stanford University School of Medicine, Stanford, CA;

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Summary

Ensuring clinical decision support (CDS) quality requires robust testing. This study highlights that while testing major pathways is feasible, comprehensive coverage of complex CDS logic remains a challenge due to numerous output combinations.

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Area of Science:

  • Medical Informatics
  • Health Systems Engineering
  • Clinical Software Quality Assurance

Background:

  • Clinical decision support (CDS) systems are increasingly complex.
  • Standardized testing methodologies for CDS are lacking, posing quality assurance challenges.
  • Accurate and reliable CDS is crucial for patient care and healthcare efficiency.

Purpose of the Study:

  • To evaluate the testing strategy for a complex clinical decision support system (ATHENA-HTN CDS) after guideline updates.
  • To analyze the logic flow and complexity of the encoded hypertension guidelines within the CDS.
  • To assess the effectiveness and coverage of a selected set of test cases.

Main Methods:

  • Updated hypertension guidelines were encoded into the ATHENA-HTN CDS.
  • A logic flow and complexity analysis guided the selection of 100 test cases.
  • The selected test cases aimed to cover major pathways within the CDS logic.
  • The effectiveness of the testing approach was analyzed based on coverage achieved.

Main Results:

  • The CDS encoding involved 26 decision points, resulting in 3120 potential output combinations.
  • The 100 selected test cases successfully covered all major logic pathways.
  • However, these test cases represented only 1% of all possible output combinations, indicating limited exhaustive coverage.
  • Test case selection significantly impacts overall testing coverage.

Conclusions:

  • Testing complex CDS logic, like that in ATHENA-HTN, presents significant challenges in achieving comprehensive coverage.
  • A strategic approach to test case selection is vital, considering system complexity, key pathways, and resource constraints.
  • Further research into effective test selection strategies for CDS is warranted to ensure system quality and reliability.