Human factors evaluation of a novel digital medicine system in psychiatry

Timothy Peters-Strickland,1 Ainslie Hatch,2 Anke Adenwala,3 Katie Atkinson,4 Benjamin Bartfeld5 1Global Clinical Development, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA; 2Clinical Sciences, Digital Medicine, Otsuka America Pharmaceutical, Inc., Princeton...

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Autores principales:	Peters-Strickland T, Hatch A, Adenwala A, Atkinson K, Bartfeld B
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2018
Materias:	digital medicine system drug-device combination human factors serious mental illness usability Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
Acceso en línea:	https://doaj.org/article/e926b295a2bd48baa27ea4c64a357043
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spelling	oai:doaj.org-article:e926b295a2bd48baa27ea4c64a3570432021-12-02T02:55:04ZHuman factors evaluation of a novel digital medicine system in psychiatry1178-2021https://doaj.org/article/e926b295a2bd48baa27ea4c64a3570432018-02-01T00:00:00Zhttps://www.dovepress.com/human-factors-evaluation-of-a-novel-digital-medicine-system-in-psychia-peer-reviewed-article-NDThttps://doaj.org/toc/1178-2021Timothy Peters-Strickland,1 Ainslie Hatch,2 Anke Adenwala,3 Katie Atkinson,4 Benjamin Bartfeld5 1Global Clinical Development, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA; 2Clinical Sciences, Digital Medicine, Otsuka America Pharmaceutical, Inc., Princeton, NJ, USA; 3Biostatistics, GfK Custom Research, LLC, Chicago, IL, USA; 4Human Factors Engineering, Proteus Digital Health, Redwood, CA, USA; 5Industrial Design Specialist, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA Background: 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. Methods: 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. Results: 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 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. Conclusion: The 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. Keywords: digital medicine system, drug–device combination, schizophrenia, bipolar disorder, major depressive disorder, aripiprazole, serious mental illness, usabilityPeters-Strickland THatch AAdenwala AAtkinson KBartfeld BDove Medical Pressarticledigital medicine systemdrug-device combinationhuman factorsserious mental illnessusabilityNeurosciences. Biological psychiatry. NeuropsychiatryRC321-571Neurology. Diseases of the nervous systemRC346-429ENNeuropsychiatric Disease and Treatment, Vol Volume 14, Pp 553-565 (2018)
institution	DOAJ
collection	DOAJ
language	EN
topic	digital medicine system drug-device combination human factors serious mental illness usability Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
spellingShingle	digital medicine system drug-device combination human factors serious mental illness usability Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429 Peters-Strickland T Hatch A Adenwala A Atkinson K Bartfeld B Human factors evaluation of a novel digital medicine system in psychiatry
description	Timothy Peters-Strickland,1 Ainslie Hatch,2 Anke Adenwala,3 Katie Atkinson,4 Benjamin Bartfeld5 1Global Clinical Development, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA; 2Clinical Sciences, Digital Medicine, Otsuka America Pharmaceutical, Inc., Princeton, NJ, USA; 3Biostatistics, GfK Custom Research, LLC, Chicago, IL, USA; 4Human Factors Engineering, Proteus Digital Health, Redwood, CA, USA; 5Industrial Design Specialist, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA Background: 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. Methods: 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. Results: 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 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. Conclusion: The 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. Keywords: digital medicine system, drug–device combination, schizophrenia, bipolar disorder, major depressive disorder, aripiprazole, serious mental illness, usability
format	article
author	Peters-Strickland T Hatch A Adenwala A Atkinson K Bartfeld B
author_facet	Peters-Strickland T Hatch A Adenwala A Atkinson K Bartfeld B
author_sort	Peters-Strickland T
title	Human factors evaluation of a novel digital medicine system in psychiatry
title_short	Human factors evaluation of a novel digital medicine system in psychiatry
title_full	Human factors evaluation of a novel digital medicine system in psychiatry
title_fullStr	Human factors evaluation of a novel digital medicine system in psychiatry
title_full_unstemmed	Human factors evaluation of a novel digital medicine system in psychiatry
title_sort	human factors evaluation of a novel digital medicine system in psychiatry
publisher	Dove Medical Press
publishDate	2018
url	https://doaj.org/article/e926b295a2bd48baa27ea4c64a357043
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Human factors evaluation of a novel digital medicine system in psychiatry

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