Table 1.
Device | |||||
---|---|---|---|---|---|
Metadata Name | Pre-Specified Value? | Application-Dependent? | Metadata Item APDM | Metadata Item WATCH-PD | |
Device UID | No | No | |||
Brand | Yes | No | APDM | Apple | |
Model | Yes | No | Opal | iPhone and Apple Watch | |
Hardware version | Yes | No | Opal v.2 | Apple Watch Series 5 Apple iPhone 11 |
|
Firmware version | Yes | No | 20190315 | Apple Watch Series 5 Apple iPhone 11 |
|
Body site | Yes | No | Each wrist | Most affected wrist (Apple Watch) | |
Orientation | Yes | No | Sensors are positioned with device’s charging ports oriented toward more distal body locations | Watch orientation set during initial setup, with watch ‘crown’ positioned facing the hand. Watch on most-affected side | |
Hub/App | Yes | No | Mobility Lab Hub | BrainBaseline version ‘WATCH-PD’ | |
Metadata version | Yes | No | V1.0 | V1.0 | |
Sensor and Signal | |||||
Sensor type | Yes | No | Accelerometer, Magnetometer, Gyroscope, Barometer | Accelerometer, Gyroscope | |
Recording mode | Yes | No | Active | Active | |
Calibration | Yes | No | Opal calibration process | N/A | |
Outputs | Datatype | No | No | Numeric | Numeric |
Serialization | No | No | TBD | TBD | |
Units | No | No | os (gyro); m/s2 (accel); pT (mag); mPa (bar) | os (gyro); m/s2 (accel) | |
Scaling | Yes | No |
|
- | |
Filename of data file | No | No | |||
Data rate | Yes | No | 128 Hz from all sensors | 100 Hz accel and gyro in clinic 50 Hz accel in home-base passive monitoring |
|
Timing | Yes | No | Continuous data collection from all sensors during clinic assessment | Continuous data collection during clinic assessment. 7 day home based data collection |
|
Multiple data streams | Yes | No | Accelerometer [xyz], Magnetometer [xyz], Gyroscope [xyz], Barometer | Accelerometer [xyz], Gyroscope [xyz] | |
Participant/Population | |||||
Subject UID | No | No | |||
Demographics Inclusion/exclusion criteria |
Yes | Yes | Inclusion criteria from WATCH-PD protocol | Inclusion criteria from WATCH-PD protocol | |
Comorbidities | No | Yes | Not available | Not available | |
Analysis Metadata | |||||
Data pre-processing | Yes | No | Not available | Not available | |
Endpoint analysis | Yes | Yes | WATCH-PD SAP v1.0 | WATCH-PD SAP v1.0 | |
Experiment | |||||
Experiment UID | Yes | No | WATCH-PD | WATCH-PD | |
Protocol | Yes | Yes | WATCH-PD Protocol v3.0 | WATCH-PD Protocol v3.0 | |
Questionnaires and scales | Yes | Yes | MDS-UPDRS 2.10 |
In-clinic: MDS-UPDRS 2.10 In-home: Single item 7-point Likert response indicating current tremor severity |
|
Clinical assessments/Human observation | Yes | Yes | MDS-UPDRS 3.15, 3.16, 3.17; RUE 1 and LUE 2 assessments only |
In-clinic: MDS-UPDRS 3.15, 3.16, 3.17; RUE and LUE assessments only In-home: N/A—No human observation during home assessments |
|
Clinical follow-up frequency as a comparator for digital measures | Yes | Yes | Baseline, 1 month, 3 month, 6 month, 9 month, 12 month | Baseline, 1 month, 3 month, 6 month, 9 month, 12 month | |
Clinical correlations to digital measures | Yes | Yes | Sensor collection simultaneous with clinical assessments described above | In clinic, sensor collection simultaneous with clinical assessments described above | |
Active test details | Yes | Yes | Sensor collection simultaneous with clinical assessments as per protocol. | In clinic, sensor collection simultaneous with clinical assessment as per protocol. | |
Passive monitoring | Yes | Yes | N/A | At Home, 7 days passive monitoring. | |
Contextual Data | |||||
Environment | Yes | Yes | Clinic | Clinic, home | |
Environmental context (carer, temperature, indoor/outdoor, …) | Not available | Yes | Not available | Not available |
1 RUE: right upper extremity; 2 LUE: left upper extremity; N/A: not applicable.