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Table 1 Overview of the features of the studies

From: Digital pills: a scoping review of the empirical literature and analysis of the ethical aspects

Paper IDaCountryStudy designStudy populationAim(s) of the studyREC/IRBb Approval
Au-yeung 2011 [32]USA3 prospective observational studies30 patients with Tuberculosis, 8 with Heart Failure, 43 with HypertensioncEvaluate the system and characterize technical performance.Yes
Belknap 2013 [33]USAFeasibility study: prospective and observational.30 patients with active tuberculosis (TB)Evaluate accuracy, safety and acceptability of the system.Yes
Browne 2015 [34]USAProspective observational cohort-study5 patients with type II diabetesCharacterize the at-home adherence patterns of patients through modern methods of visual analytics.Yes
Browne 2018 [35]USARandomized cross-over study12 patients with active tuberculosisAddress Good Manufacturing Practice methods to combine the ingestion sensor with oral medications.Yes
Chai 2017a [36]dUSAProspective descriptive study16 patient with acute fractureseReport data on opioid ingestion patterns detected by DPYes
Chai 2017b [37]dUSAPilot study: Prospective, non-randomized and observational.10 patients with acute fracturesDetermine the feasibility the digital pill system to measure opioid ingestion patternsYes
Dicarlo 2016 [38]USAFeasibility study: prospective, non-randomized, observational.37 patients with hypertensionRecord patterns of medication-taking, step count, daily blood pressure and weight. Study safety and acceptability of digital pillsYes
Eisenberg 2013 [39]SwitzerlandExploratory study: open-label, non-randomised and prospective.20 patients after kidney transplant under Enteric-coated mycophenolate sodium (ECMPS)Evaluate the detection accuracy, usability, and safety of DP combined with ECMPS in kidney transplants.Yes
Frias 2017 [40]USAPilot study: prospective, open-label, cluster-randomized (three arms).109 adults with uncontrolled Hypertension and type II diabetesStudy the effect of digital pills on blood pressure, glycemic and lipid control, engagement, and provider decision making.Yes
Kane 2013 [41]USAPilot study: observational, non randomised.28 subjects with schizophrenia (16) or bipolar disorder (12)Compare the detection accuracy to that of a directly observed method. Characterise safety and user satisfaction.Yes
Kopelowicz 2017 [42]USAPilot study: observational, open-label and non-randomised.49 subjects with bipolar disorder, major depressive disorder, or schizophreniaEvaluate the functionality of an integrated call center in optimizing the use of the digital pills and assess its use.Yes
Moorhead 2017 [43]USAPost hoc studies based on a study following a cluster randomised design.113 patients with uncontrolled hypertension.Study the incremental impact of seeing versus not seeing DP medication dose reminders on medication-taking and assess the safety of the digital pills with respect to possible risk of overdosing.Yes
Naik 2017 [44]UKProspective registry-based observational study.151 patients with uncontrolled hypertensionfCharacterize patterns of medication use. Assess usability and acceptability of digital pills.Yes
Noble 2016 [45]UKProspective observational study.39 patients with uncontrolled hypertensionReport and summarise the first use of digital pills by pharmacists to establish blood pressure management recommendations.Not required
Peters-strickland 2016 [46]USAPhase II open-label observational study.67 patients with schizophreniaAssess the usability of the system, satisfaction, safety and tolerability.Yes
Peters-strickland 2018 [47]USASix formative human factors studies129 patients with confirmed diagnosis of schizophrenia, bipolar I disorder, or major depressive disorder (MDD)Assess the safe and effective use of a system. Assess whether the three intended groups of users (patients, healthcare providers, and caregivers) can appropriately use the technology.Yes
Rohatagi 2016 [48]USAPhase 4 exploratory observational study: open-label and single-arm.58 stable patients with a diagnosis of bipolar I disorder (n = 35) or MDD (n = 23)Obtain descriptive feedback from patients, assess safety and summarize patient adherenceYes
Thompson 2017 [49]UKProspective observational study21 patients with either established cardiovascular disease or high multifactorial riskTest the system in a group of patients at elevated cardiovascular risk attending a cardiac prevention and rehabilitation programN/A
  1. a First author and publication year
  2. b Research Ethics Committee (REC) or Institutional Review Board (IRB)
  3. cOnly 40 completed the study
  4. d this study used a version of the ingestible sensor and wearable patch produced by a different company
  5. e Only 15 patients completed the study
  6. f 167 patients were enrolled in the registry, but 16 were excluded from the study