Next Article in Journal
Anatomy and Imaging of Rat Prostate: Practical Monitoring in Experimental Cancer-Induced Protocols
Previous Article in Journal
In vivo Diagnosis of Primary Cutaneous Amyloidosis —The Role of Reflectance Confocal Microscopy
Open AccessArticle

Establishing Clinical Utility for Diagnostic Tests Using a Randomized Controlled, Virtual Patient Trial Design

1
Institute for Global Health Sciences, University of California, San Francisco, CA 94158, USA
2
Fielding School of Public Health, University of California, Los Angeles, CA 90095, USA
3
QURE Healthcare, San Francisco, CA 94133, USA
4
Jeter Lab Consulting, Columbia, SC 29203, USA
*
Author to whom correspondence should be addressed.
Diagnostics 2019, 9(3), 67; https://doi.org/10.3390/diagnostics9030067
Received: 28 March 2019 / Revised: 19 June 2019 / Accepted: 28 June 2019 / Published: 29 June 2019
(This article belongs to the Section Point-of-Care Diagnostics and Devices)
Demonstrating clinical utility for diagnostic tests and securing coverage and reimbursement requires high quality and, ideally, randomized controlled trial (RCT) data. Traditional RCTs are often too costly, slow, and cumbersome for diagnostic firms. Alternative data options are needed. We evaluated four RCTs using virtual patients to demonstrate clinical utility. Each study used a similar pre-post intervention, two round design to facilitate comparison. Representative samples of physicians were recruited and randomized into control and intervention arms. All physicians were asked to care for their virtual patients during two assessment rounds, separated by a multi-week time interval. Between rounds, intervention physicians reviewed educational materials on the diagnostic test. All physician responses were scored against evidence-based care criteria. RCTs using virtual patients can demonstrate clinical utility for a variety of diagnostic test types, including: (1) an advanced multi-biomarker blood test, (2) a chromosomal microarray, (3) a proteomic assay analysis, and (4) a multiplex immunofluorescence imaging platform. In two studies, utility was demonstrated for all targeted patient populations, while in the other two studies, utility was only demonstrated for a select sub-segment of the intended patient population. Of these four tests, two received positive coverage decisions from Palmetto, one utilized the study results to support commercial payer adjudications, and the fourth company went out of business. RCTs using virtual patients are a cost-effective approach to demonstrate the presence or absence of clinical utility. View Full-Text
Keywords: clinical utility; diagnostics; coverage; reimbursement; randomized controlled trials; virtual patients clinical utility; diagnostics; coverage; reimbursement; randomized controlled trials; virtual patients
MDPI and ACS Style

Peabody, J.; Tran, M.; Paculdo, D.; Valdenor, C.; Burgon, T.; Jeter, E. Establishing Clinical Utility for Diagnostic Tests Using a Randomized Controlled, Virtual Patient Trial Design. Diagnostics 2019, 9, 67.

Show more citation formats Show less citations formats
Note that from the first issue of 2016, MDPI journals use article numbers instead of page numbers. See further details here.

Article Access Map by Country/Region

1
Back to TopTop