Published and unpublished study characteristics
| Study; NCT; country of provenience | Sites (N) | Patient age, M (SD); % women; diagnosis | Study type; duration (weeks); complementary psychological intervention | Included/analysed (N) | Withdrawal total/for AEs (cases) | Device AE/SAE (events) | Adherence (outcome) | Adherence (results) | Other outcomes | SOR |
| Peters-Strickland et al
25; NCT02219009, 316-14-220; USA | 6 | 46.6 (9.7); 25.4; schizophrenia | Non-comparative; 8+2 safety follow-up; none. | 67/NI | 18/6 | 22/1* | Adh: detected/expected ingest events (regardless of time wearing sensor). mAdh: detected ingest/number of days with/>80% data coverage or ingest sensor detected over 24 hours. | Adh: 1.824/3.072 (59.4%). mAdh: M (SD): 73.9% (23.3%); median: 78.8%. Ingest errors: 6 patients 1 additional tablet each once (1% total ingest events). | Usability: SAUSS-HCP, HCP-perceived; patient satisfaction; call centre contact (frequency); wearable sensor time. |
Non-reg: adh; mAdh; patient satisfaction; HCP-perceived usability; call centre contact (frequency). Changed from first reg: 8 outcomes dropped; primary and secondary outcomes edited on ClinicalTrials.gov. |
| Kopelowicz et al
26; NCT02722967, 316-13-215; USA | 4 | 46.4 (13); 63.3; BD (22), MDD (12), schizophrenia (15) | Non-comparative; 8; none. | 49/49 | 11/1 | 17/NI† | Ingest adh: number of IEMs registered on digital health data server as ingested/number of treatment days with good patch wear; good patch coverage: 80% patch data on a given day or a detected IEM within 24 hours. | M ingest adh=88.6% days; good patch wear: 80.1% study days. No diff among dis. | Call centre functionality; overall patch wear time=total wear time/patient study time. | Non-reg: adh outcome (only functionality outcome reg). |
| Unpublished; no NCT retrieved, 316-13-204 | NI | 46.4 (NI); 63.8; BD (35), MDD (23) | Non-comparative; 16+4 safety; NI. | 58/55 | 11/2 | NI/0‡ | Number of IEM detection. Subject patch use. | NI. | CGI-S; CGI-I; usability. | NI. |
*Four reported infection-related adverse events not considered as related to the device.
†At least three reported infection-related adverse events not considered as related to the device.
‡At least 14 reported infection-related adverse events not considered as related to the device.
Adh, adherence; AE, adverse effects; BD, bipolar disorder; CGI-I, Clinical Global Impression-Improvement; CGI-S, Clinical Global Impression-Severity; diff, differences; dis, diseases; HCP, healthcare professional; IEM, ingestible event marker, ingestion; mAdh, modified adherence; MDD, major depressive disorder; N, number; NCT, National Clinical Trial Identifier; NI, no information; reg, registration; SAE, serious adverse effects; SAUSS-HCP, Subject Ability to Use System Scale - Healthcare Professional Version; SOR, selective outcome reporting.