TL21: Evaluating Performance Measures where Patients Contribute a Measure in a Temporal Sequence
*Bipasa Biswas, FDA Keywords: A diagnostic test/device used to categorize the presence or absence of a condition of interest is evaluated against a reference standard to assess its performance measures. In monitoring devices where an activity is monitored over a time period, a patient contributes multiple events in a temporal sequence. It is easy to characterize event detection in the presence of a reference standard, by sensitivity which is the probability of detecting the event given that the event has actually occurred. However, specificity, which is the probability of a non-event given that the event did not occur, is not easily decipherable as it depends on the time window. Instead, counting the false positives and reporting the rate of false positives per time period may be an alternative to look at device performance. I would like to discuss possible ways to evaluate such devices and possible performance measures to evaluate performance. Examples include Uterine Monitors.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC