Measurement Uncertainty in Clinical Validation Studies of Sensors.

Accurate clinical sensors and devices are essential to support optimal medical decision-making, and accuracy can be demonstrated through the conduct of clinical validation studies using validated reference sensors and/or devices for comparison. Typically unmeasurable, the true reference value can be substituted with an accepted physiological measurement with an associated uncertainty. We describe a basic model of measurement uncertainty that specifies the factors that may degrade the accuracy of an observed measurement value from a sensor, and we detail validation study design strategies that may be used to quantify and minimize these uncertainties. In addition, we describe a model that extends the observed measurement uncertainty to the resultant clinical decision and the factors that may impact the uncertainty of this decision. Clinical validation studies should be designed to estimate and minimize uncertainty that is unrelated to the sensor accuracy. The contribution of measurement observation uncertainty to clinical decision-making should be minimized but also acknowledged and incorporated into the clinical decision-making process.

A Procedural Electroencephalogram Simulator for Evaluation of Anesthesia Monitors.

BACKGROUND: Recent research and advances in the automation of anesthesia are driving the need to better understand electroencephalogram (EEG)-based anesthesia end points and to test the performance of anesthesia monitors. This effort is currently limited by the need to collect raw EEG data directly from patients. METHODS: A procedural method to synthesize EEG signals was implemented in a mobile software application. The application is capable of sending the simulated signal to an anesthesia depth of hypnosis monitor. Systematic sweeps of the simulator generate functional monitor response profiles reminiscent of how network analyzers are used to test electronic components. RESULTS: Three commercial anesthesia monitors (Entropy, NeuroSENSE, and BIS) were compared with this new technology, and significant response and feature variations between the monitor models were observed; this includes reproducible, nonmonotonic apparent multistate behavior and significant hysteresis at light levels of anesthesia. CONCLUSIONS: Anesthesia monitor response to a procedural simulator can reveal significant differences in internal signal processing algorithms. The ability to synthesize EEG signals at different anesthetic depths potentially provides a new method for systematically testing EEG-based monitors and automated anesthesia systems with all sensor hardware fully operational before human trials.

Evaluation of a Novel Mobile Exergame in a School-Based Environment.

Physical inactivity is increasing among children globally and has been directly linked to the growing problems of overweight and obesity. We aim to assess the impact of a new mobile exergame, MobileKids Monster Manor (MKMM), in a school-based setting. MKMM, developed with input from youth to enhance physical activity, is wirelessly connected to an accelerometer-based activity monitor. Forty-two healthy students (11.3 ± 1.2 years old and 0.28 ± 1.29 body-mass index [BMI] z-score) participated in a randomized 4-week crossover study to evaluate the game intervention. The two study arms consisted of week-long baseline, game intervention/control, washout, and control/game intervention phases. All participants were required to wear an activity monitor at all times to record steps and active minutes for the study duration. MKMM was used during each arm's respective intervention week, during which children were asked to play the game at their convenience. When children were exposed to the game, an increase compared with the control phase of 2,934 steps per day (p = 0.0004, 95% CI 1,434-4,434) and 46 active minutes per day (p = 0.001, 95% CI 20-72) from baseline (12,299 steps/day and 190 active minutes/day) was observed. A linear regression model showed that MKMM yielded a greater increase in steps and active minutes per day among children with a higher BMI z-score, showing 10 percent more steps per day and 14 percent more active minutes per day relative to baseline, per unit increase in BMI z-score. In conclusion, MKMM increased steps and active minutes in a school-based environment. This suggests that mobile exergames could be useful tools for schools to promote physical activity and combat obesity in adolescents.