Table 1

Published and unpublished study characteristics 

Study; NCT; country of provenienceSites (N)Patient age, M (SD); % women; diagnosisStudy type; duration (weeks); complementary psychological 
Included/analysed (N)Withdrawal total/for AEs (cases)Device
AE/SAE (events)
Adherence (outcome)Adherence (results)Other outcomesSOR
Peters-Strickland et al 25
646.6 (9.7); 25.4; 
8+2 safety follow-up;
67/NI18/622/1*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
Kopelowicz et al 26
316-13-215; USA
446.4 (13); 63.3; BD (22), MDD (12), 
schizophrenia  (15)
Non-comparative; 8; none.49/4911/117/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Unpublished; no NCT retrieved,
NI46.4 (NI); 63.8; BD (35), MDD (23)Non-comparative; 
16+4 safety; NI.
58/5511/2NI/0‡Number of IEM detection.
Subject patch use.
  • *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.