Connect Sign InEthics, Stewardship, and Laboratory Tests with Unproven Clinical Benefit
Clinical laboratories often receive orders for tests that are outside the mainstream of clinical testing. Some of these are new/emerging tests for which there simply isn’t a lot of clinical experience. Some are research biomarkers that are primarily of interest to bench scientists. Some are panels or algorithms designed largely in response to marketing considerations. What these all have in common is a lack of clinical evidence demonstrating clinical utility, i.e., therapeutic benefit for patients as a consequence of the tests. How should clinical labs evaluate requests for such tests? Historically many laboratories have approached these requests from a financial and/or logistical perspective, approving the tests as long as they don’t overly burden the local laboratory (and provided that they are performed in a CLIA-licensed setting). This presentation will present an additional framework for consideration, namely bioethics. What is the ethical impact of such testing on the individual patient as well as on society as a whole? And how can potentially useful—but still unproven—laboratory tests be introduced into clinical settings in an ethically consistent manner?
Presented as part of a live Seattle Children's Hospital Webinar Series.
Originally published on July 10, 2018.
Dr. Jackson received his MD as well as his informatics master’s degree from the University of Utah. He completed a residency in clinical pathology from Dartmouth-Hitchcock Medical Center. Following residency he worked for a hospital IT department as well as a healthcare software startup company. He is currently the medical director at ARUP Laboratories responsible for pre-analytic services, business development, and IT. Dr. Jackson's research interests include economic analysis of diagnostic testing and physician utilization of laboratory tests. He is certified in clinical pathology by the American Board of Pathology.
