ArticleNeuropsychiatric disease and treatment2018
Human factors evaluation of a novel digital medicine system in psychiatry.
Article in Neuropsychiatric disease and treatment, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.
What it found
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The trial behind it
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Who cites it
7 citing papers in PubMed.
- Use of an Ingestible, Sensor-Based Digital Adherence System to Strengthen the Therapeutic Relationship in Serious Mental Illness.JMIR mental health · 2022Article
- Electronic Smart Blister Packages to Monitor and Support Medication Adherence: A Usability Study.Patient preference and adherence · 2022Article
- Mental Health Care Provider's Perspectives Toward Adopting a Novel Technology to Improve Medication Adherence.Psychiatric research and clinical practice · 2022Article
- A Brief Training Program to Support the Use of a Digital Pill System for Medication Adherence: Pilot Descriptive Study.JMIR formative research · 2021Article
- Digital pills: a scoping review of the empirical literature and analysis of the ethical aspects.BMC medical ethics · 2020Article
- Technological Interventions for Medication Adherence in Adult Mental Health and Substance Use Disorders: A Systematic Review.JMIR mental health · 2019Article
- The Association for Human Pharmacology in the Pharmaceutical Industry London Meeting 2018: Brexit and Other Challenges in Early Phase Drug Development.Frontiers in pharmacology · 2018Review
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe digital medicine system (DMS), a drug-device combination developed for patients with serious mental illness, integrates adherence measurement with pharmacologic treatment by embedding an ingestible sensor in a pill, allowing for information sharing among patients, health care providers (HCPs), and caregivers via a mobile interface. Studies conducted during the DMS development process aimed to minimize cognitive burden and use-related risks and demonstrated effective use of the technology.
methodsHuman factors (HF) studies assessed the system's safe and effective use by the intended users for the intended uses. The patient interface was tested in six formative HF studies followed by a validation study. The HCP/caregiver interface was tested in one study before validation. All tasks critical to safety or necessary for effective use were included. Formative studies identified use-related risks and the causes of use problems to guide design modification. Validation of the patient and HCP/caregiver interfaces assessed risks of the final product.
resultsDuring the patient formative studies, design improvements were made to address problems and mitigate risks thought to be associated with a suboptimal system design or patient understanding of the system. In the validation study of the patient interface, 35 patients attempted 23 performance tasks, for a total of 805 attempts; 783/805 attempts were completed with success. One close call, 15 failures, and 6 difficulties occurred on these user tasks; only 3 of these were on a critical task. Residual risks resistant to mitigation were found to be of low severity based on the US Food and Drug Administration 2016 guidance.
conclusionThe final design of the DMS reflects input by the intended user populations through a comprehensive development methodology. In alignment with the US Food and Drug Administration goals for HF studies, the system was found to be safe and effective for the intended users, uses, and use environments.
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