Table 3.
Identified gaps and recommendations | Case study [27] | ||
Gap 1: Quantitative, nonsurrogate, sensor-based adherence data were not reported in 29.9% of screened manuscripts that captured BioMeT data outside the clinical or laboratory setting. | |||
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Recommendation 1: Investigators are encouraged to develop and/or use BioMeT sensors to capture sensor-based adherence data in addition to their primary purpose. | This study aimed to evaluate adherence to a physical activity among students recruited from 20 schools. Quantitative adherence data were derived from wrist-worn accelerometers, considered a direct reflection of wear-time. | |
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Recommendation 2: Where feasible, we encourage investigators to collect and report adherence data that are a direct reflection of actual use, rather than a surrogate. | N/Aa | |
Gap 2: BioMeT manufacturer or model and software information was missing for 10% and 68% of included tools, respectively. | |||
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Recommendation 3: In addition to reporting the BioMeT manufacturer or model and software used for generating adherence data (where applicable), we recommend that investigators provide a clear description of the sensor or sensors capturing adherence data. | BioMeT model: GENEActiv wrist-worn device (ActivInsights Ltd). Sensor description: 3-axis accelerometer. Software: GENEActiv PC software (version 2.9), with subsequent signal processing performed in R-package (GGIR; version 1.2-2). | |
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Recommendation 4: We recommend that investigators describe the algorithm or algorithms that convert sample-level measurements into a measurement of adherence. If a description is not available from the manufacturer, this should be stated. | The paper included the data sampling frequency (100 Hz); a description of the signal processing steps including calibration; the epoch length (5 seconds) over which the sample-level data were averaged; and the units (milligravitational units; m g). A description of the nonwear detection algorithm was summarized as, “Non-wear is estimated on the basis of the SD and value range of each axis, calculated for 60-min windows with 15-min sliding window. The window is classified as non-wear if, for at least two of the three axes, the SD is less than 13 mg or the value range is less than 50 mg.” | |
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Recommendation 5: We recommend that investigators describe the analytic validation data supporting the adherence algorithm; that is, the data indicating that adherence per the BioMeT is an accurate estimate of actual use. If analytic validation data is not available, this should be stated. | A reference to previous verification and analytic validation work was included. | |
Gap 3: Heterogeneity of adherence definitions increased alongside decreasing resolution of adherence data reported. | |||
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Recommendation 6: We recommend that investigators using BioMeTs that are either passive (designed to capture data passively over long periods) or session-based (designed for user engagement at certain time points, for which the duration of use is meaningful) report primary adherence as a continuous variable of time; that is, total minutes or hours or days, or average hours per day, days per week, and so on. Example of a passive BioMeT: smart clothing. Example of a session-based BioMeT: connected exercise equipment. | The BioMeT was categorized as passive, as the wrist-worn accelerometer was designed to capture data continuously over 3 separate periods of 7 days. Adherence was reported as the total hours of wear-time, and hours per day of wear-time. | |
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Recommendation 7: We recommend that investigators using BioMeTs that are task based (designed for user engagement at certain time points, for which the duration of use is not meaningful) report primary adherence as a continuous variable; that is, the number of tasks or days completed. Example of a task-based BioMeT: connected scale. | N/A, as the BioMeT was categorized as passive rather than task based. | |
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Recommendation 8: We recommend that categorical adherence data are reported only in addition to continuous adherence data; for example, the percentage of participants with use >x hours per day or percentage of participants completing >y tasks. | Categorical adherence data included the number of participants with ≥16 hours of wear-time per day. | |
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Recommendation 9: We recommend that categorical definitions of adherence be based on clinical validation data indicating the level of adherence associated with a clinically meaningful change in the outcome of interest, when available. If clinical validation data are not available, this should be stated. | The investigators include a reference to previous work that adopted the threshold of ≥16 hours of wear-time per day and describe another study that compared thresholds of 8 hours, 16 hours, and 24 hours of wear-time. |
aN/A: not applicable.