ABSTRACT

Background:
Mobility is a meaningful aspect of an individual’s health whose quantification can provide clinical insights. Wearable sensor technology can quantify walking behaviors (a key aspect of mobility) through continuous passive monitoring.

Objective:
Our objective was to characterize the analytical performance (accuracy and reliability) of a suite of digital measures of walking behaviors as critical aspects in the practical implementation of digital measures into clinical studies.

Methods:
We collected data from a wrist-worn device (the Verily Study Watch) worn for multiple days by a cohort of volunteer participants without a history of gait or walking impairment in a real-world setting. On the basis of step measurements computed in 10-second epochs from sensor data, we generated individual daily aggregates (participant-days) to derive a suite of measures of walking: step count, walking bout duration, number of total walking bouts, number of long walking bouts, number of short walking bouts, peak 30-minute walking cadence, and peak 30-minute walking pace. To characterize the accuracy of the measures, we examined agreement with truth labels generated by a concurrent, ankle-worn, reference device (Modus StepWatch 4) with known low error, calculating the following metrics: intraclass correlation coefficient (ICC), Pearson r coefficient, mean error, and mean absolute error. To characterize the reliability, we developed a novel approach to identify the time to reach a reliable readout (time to reliability) for each measure. This was accomplished by computing mean values over aggregation scopes ranging from 1 to 30 days and analyzing test-retest reliability based on ICCs between adjacent (nonoverlapping) time windows for each measure.

Results:
In the accuracy characterization, we collected data for a total of 162 participant-days from a testing cohort (n=35 participants; median observation time 5 days). Agreement with the reference device–based readouts in the testing subcohort (n=35) for the 8 measurements under evaluation, as reflected by ICCs, ranged between 0.7 and 0.9; Pearson r values were all greater than 0.75, and all reached statistical significance (P<.001). For the time-to-reliability characterization, we collected data for a total of 15,120 participant-days (overall cohort N=234; median observation time 119 days). All digital measures achieved an ICC between adjacent readouts of >0.75 by 16 days of wear time.

Conclusions:
We characterized the accuracy and reliability of a suite of digital measures that provides comprehensive information about walking behaviors in real-world settings. These results, which report the level of agreement with high-accuracy reference labels and the time duration required to establish reliable measure readouts, can guide the practical implementation of these measures into clinical studies. Well-characterized tools to quantify walking behaviors in research contexts can provide valuable clinical information about general population cohorts and patients with specific conditions.

Physical Activity
Walking Measures
Digital Biomarkers