Involvement of Human Volunteers in the Development and Evaluation of Wearable Devices Designed to Improve Medication Adherence: A Scoping Review
Wearable devices designed to improve medication adherence can emit audible and vibrating alerts or send text messages to users. However, there is little information on the validation of these technologies. The aim of this scoping review was to investigate the involvement of human volunteers in the d...
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| Format: | Article |
| Language: | English |
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MDPI AG
2023-03-01
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| Series: | Sensors |
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| Online Access: | https://www.mdpi.com/1424-8220/23/7/3597 |
| _version_ | 1827746505720594432 |
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| author | Lívia Luize Marengo Silvio Barberato-Filho |
| author_facet | Lívia Luize Marengo Silvio Barberato-Filho |
| author_sort | Lívia Luize Marengo |
| collection | DOAJ |
| description | Wearable devices designed to improve medication adherence can emit audible and vibrating alerts or send text messages to users. However, there is little information on the validation of these technologies. The aim of this scoping review was to investigate the involvement of human volunteers in the development and evaluation of wearable devices. A literature search was conducted using six databases (MEDLINE, Embase, Scopus, CINAHL, PsycInfo, and Web of Science) up to March 2020. A total of 7087 records were identified, and nine studies were included. The wearable technologies most investigated were smartwatches (<i>n</i> = 3), patches (<i>n</i> = 3), wristbands (<i>n</i> = 2), and neckwear (<i>n</i> = 1). The studies involving human volunteers were categorized into idea validation (<i>n</i> = 4); prototype validation (<i>n</i> = 5); and product validation (<i>n</i> = 1). One of them involved human volunteers in idea and prototype validation. A total of 782 participants, ranging from 6 to 252, were included. Only five articles reported prior approval by a research ethics committee. Most studies revealed fragile methodological designs, a lack of a control group, a small number of volunteers, and a short follow-up time. Product validation is essential for regulatory approval and encompasses the assessment of the effectiveness, safety, and performance of a wearable device. Studies with greater methodological rigor and the involvement of human volunteers can contribute to the improvement of the process before making them available on the market. |
| first_indexed | 2024-03-11T05:25:19Z |
| format | Article |
| id | doaj.art-eb99840728e14f61b608f76ee0847176 |
| institution | Directory Open Access Journal |
| issn | 1424-8220 |
| language | English |
| last_indexed | 2024-03-11T05:25:19Z |
| publishDate | 2023-03-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Sensors |
| spelling | doaj.art-eb99840728e14f61b608f76ee08471762023-11-17T17:34:57ZengMDPI AGSensors1424-82202023-03-01237359710.3390/s23073597Involvement of Human Volunteers in the Development and Evaluation of Wearable Devices Designed to Improve Medication Adherence: A Scoping ReviewLívia Luize Marengo0Silvio Barberato-Filho1Graduate Program in Pharmaceutical Sciences, University of Sorocaba, Sorocaba 18023-000, SP, BrazilGraduate Program in Pharmaceutical Sciences, University of Sorocaba, Sorocaba 18023-000, SP, BrazilWearable devices designed to improve medication adherence can emit audible and vibrating alerts or send text messages to users. However, there is little information on the validation of these technologies. The aim of this scoping review was to investigate the involvement of human volunteers in the development and evaluation of wearable devices. A literature search was conducted using six databases (MEDLINE, Embase, Scopus, CINAHL, PsycInfo, and Web of Science) up to March 2020. A total of 7087 records were identified, and nine studies were included. The wearable technologies most investigated were smartwatches (<i>n</i> = 3), patches (<i>n</i> = 3), wristbands (<i>n</i> = 2), and neckwear (<i>n</i> = 1). The studies involving human volunteers were categorized into idea validation (<i>n</i> = 4); prototype validation (<i>n</i> = 5); and product validation (<i>n</i> = 1). One of them involved human volunteers in idea and prototype validation. A total of 782 participants, ranging from 6 to 252, were included. Only five articles reported prior approval by a research ethics committee. Most studies revealed fragile methodological designs, a lack of a control group, a small number of volunteers, and a short follow-up time. Product validation is essential for regulatory approval and encompasses the assessment of the effectiveness, safety, and performance of a wearable device. Studies with greater methodological rigor and the involvement of human volunteers can contribute to the improvement of the process before making them available on the market.https://www.mdpi.com/1424-8220/23/7/3597digital technologymobile health technologywearable electronic devicesmedication adherenceuser-centered designhuman volunteers |
| spellingShingle | Lívia Luize Marengo Silvio Barberato-Filho Involvement of Human Volunteers in the Development and Evaluation of Wearable Devices Designed to Improve Medication Adherence: A Scoping Review Sensors digital technology mobile health technology wearable electronic devices medication adherence user-centered design human volunteers |
| title | Involvement of Human Volunteers in the Development and Evaluation of Wearable Devices Designed to Improve Medication Adherence: A Scoping Review |
| title_full | Involvement of Human Volunteers in the Development and Evaluation of Wearable Devices Designed to Improve Medication Adherence: A Scoping Review |
| title_fullStr | Involvement of Human Volunteers in the Development and Evaluation of Wearable Devices Designed to Improve Medication Adherence: A Scoping Review |
| title_full_unstemmed | Involvement of Human Volunteers in the Development and Evaluation of Wearable Devices Designed to Improve Medication Adherence: A Scoping Review |
| title_short | Involvement of Human Volunteers in the Development and Evaluation of Wearable Devices Designed to Improve Medication Adherence: A Scoping Review |
| title_sort | involvement of human volunteers in the development and evaluation of wearable devices designed to improve medication adherence a scoping review |
| topic | digital technology mobile health technology wearable electronic devices medication adherence user-centered design human volunteers |
| url | https://www.mdpi.com/1424-8220/23/7/3597 |
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