Interpreting changes in consecutive laboratory results: clinician's perspectives on clinically significant change

Abstract

Background: Clinical laboratory tests are inevitably affected by various factors. Therefore, when comparing consecutive test results, it is crucial to consider the inherent uncertainty of the test. Clinical laboratories use reference change value (RCV) to determine a significant change between 2 results. Whereas the criteria for the interpretation of consecutive results by clinicians are not well known. We investigated the clinician's interpretation of a clinically significant change in consecutive laboratory test results and compared them to RCV. Methods: We performed a questionnaire survey on clinicians, which comprised 2 scenarios with 22 laboratory test items suggesting initial test results. Clinicians were asked to choose a result showing clinically significant change. RCV of the analytes from EFLM database were collected. Results: We received 290 valid questionnaire responses. Clinicians’ opinions on clinically significant change was inconsistent between clinicians and scenarios, and was generally larger than RCV. Clinicians commented that they were not familiar with the variability of the laboratory tests. Conclusions: Clinicians' opinions on clinically significant changes were more prominent than RCV. Meanwhile, they tended to neglect the analytical and biological variation. Laboratories should properly guide clinicians on the RCV of tests for better decision-making on patients’ clinical states. © 2023 Elsevier B.V.