Table 2 Data fields extracted from identified feasibility studies
Field | Definition | Allowed values |
|---|---|---|
Title | Free text | |
Authors | Last name, initials | Free text |
Journal | Name | Free text |
Year | 2014, 2015, 2016, 2017, 2018 | |
DOI | Digital object identifier. A unique alphanumeric string used to identify content and provide a persistent link to the manuscript’s online location. | Free text |
Category | The type of study according to the authors’ objectives. | Sensor performance, algorithm development, operational feasibility, software development |
Therapeutic area | A knowledge field that focuses on research and development of treatments for diseases and pathologic findings, as well as prevention of conditions that negatively impact the health of an individual. | Selected from a list of FDA-approved drugs by therapeutic area, https://www.centerwatch.com/drug-information/fda-approved-drugs/therapeutic-areas, with “pre-natal’’ included as an additional therapeutic area. |
Medical condition | An abnormal state of health that interferes with normal or regular feelings of wellbeing. | Free text |
Concept of interest | The aspect of an individual’s clinical, biological, physical, or functional state, or experience that the assessment is intended to capture (or reflect). | Free text |
Outcome assessment | The measureable characteristic that is influenced or affected by an individuals’ baseline state or an intervention as in a clinical trial or other exposure. | Free text |
Comparator measure | The measure used to benchmark the digital measure against. | Free text |
Technology | A description of the sensor casing and modality as experienced by the participant. | Adhesive patch, camera, chest strap, continuous glucose monitor, holter monitor, implantable, smart clothing, smart phone, smart shoe, smart watch, tablet, wearable, Wearable sensor array. |
Sensor(s) | The component of the technology that detects or measures a physical property and records, indicates, or otherwise responds to it. | Free text |
Make, model manufacturer | The make, model and manufacturer of the technology. | Free text |
Wear location | Where the technology is positioned on the participant’s body. | Free text |
Algorithm/ analysis software | Name and version. | Free text |
Sample size | Total number of participants in the feasibility study. | N |
Participant age | Infants <1year | Infants, children, adolescents, adults, older adults |
Children 1–10 | ||
Adolescent 11–17 | ||
Adult 18–64 | ||
Older adult 65+ | ||
Participant gender | Gender or sex. | Male, female, both, unknown |
