Accuracy and Reliability of a Suite of Digital Measures of Walking Generated Using a Wrist-Worn Sensor in Healthy Individuals: Performance Characterization Study (Preprint)

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 accuracy and reliability performance 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 by a cohort of volunteer participants for multiple days (1-10 days) in a real world setting. Based on 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, daily ambulatory time, walking bout duration, number of total walking bouts, number of long walking bouts, number of short walking bouts, peak 30-minute walking cadence, peak 30-minute walking pace. To characterize 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, Mean Error (ME), Mean Absolute Error (MAE). 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 1-30 days, and analyzing test-retest reliability based on ICCs between adjacent (non-overlapping) 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 eight measurements under evaluation, as reflected by ICCs, ranged between 0.7-0.9; Pearson R values were all greater than 0.75. 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). Here, all digital measures achieved an ICC between adjacent readouts > 0.75 by 16 days of wear time. CONCLUSIONS We characterized 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 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. CLINICALTRIAL NA