Table 1 Inclusion criteria adopted to enable the identification of suitable feasibility studies
Pre-review | Reported results of original data collection (for example, meta-analyses, editorials, letters, opinion pieces, and methods papers were excluded). |
Population | Collected data from human participants (for example, studies that reported results of a computer simulation were excluded). |
Stated a specific therapeutic area. | |
Defined a participant population that either: | |
a. Included participants from the target population or; b. Included participants that would be generalizable to the target population. | |
Intervention | Included at least one mobile technology meeting our definition for objective outcome (efficacy or safety) data capture. |
Defined the specific technology used. | |
Comparator | Specified a comparator (sensor performance and algorithm development studies only). |
Outcome | Evaluated mobile technology/ies capturing objective outcomes data (for example, studies examining as the primary technology were excluded). |
When mobile technology/ies were used as a therapeutic intervention, the study reported outcomes data. | |
Study design | Described a feasibility study in line with our definition; specifically, a feasibility study addresses one or more of the following components: a. Performance of an outcome of interest against a comparator where the outcome of interest could be related to: i. Measurement performance of sensor and/or; ii. Algorithm performance (clinical endpoints); b. Human factors considerations (acceptability, tolerability and usability); c. Participant adherence; d. Completeness of data. |
Captured data outside of a clinical setting or captured data in an inpatient or clinic setting specifically to enable out-of-clinic use. | |
Reported data from a participant sample (for example, case studies were excluded; however, n-of-1 studies12 were considered in scope). | |
Country of origin is reported to have “high’’ or “very high’’ human development by the United Nations Human Development Index, http://hdr.undp.org/en/composite/HDI. |
