Human factors evaluation of a novel digital medicine system in psychiatry

Neuropsychiatric Disease and Treatment
Timothy Peters-StricklandBenjamin Bartfeld

Abstract

The 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. Human 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. During 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 t...Continue Reading

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