Involvement of Human Volunteers in the Development and Evaluation of Wearable Devices Designed to Improve Medication Adherence: A Scoping Review
Abstract
:1. Introduction
2. Method
2.1. Study Design
2.2. Inclusion Criteria
2.3. Exclusion Criteria
2.4. Data Sources and Search Period
2.5. Study Selection
2.6. Data Extraction
2.7. Data Synthesis and Analysis
- Idea validation: also called the ideation phase, during which ideas are collected that serve to answer questions on the challenges identified and possible solutions. Concept validation or idea chaining can entail different research approaches, including interviews, observations, and behavioral mapping of potential users [21];
- Prototyping validation: also called the prototyping phase. This aims to provide physical means for experimentation and encourages early failure/success in the form of a test product at a reduced cost. It also serves as an object of transition during interdisciplinary collaboration and communication, as well as emphasizing the importance of the ability to visualize/manipulate solutions [22];
- Product validation: testing the product throughout the development phase reduces, or even eliminates, the chances of error and problems in the product under development [23]. In the case of medical devices, product testing that involves any investigation with humans aimed at discovering or verifying clinical effects is called a clinical trial [16].
- Smartwatches: these are digital watches that offer features such as heart rate monitoring, activity tracking, and providing reminders [24]. These watches rely on a compatible smartphone to deliver data over a Bluetooth® connection and radio technology that provides solutions to meet specific connectivity needs [25]. As smartwatch apps can issue visual, verbal, audible, and vibrational alerts and reminders to wearers, they are useful for promoting medication adherence [26,27,28];
- Patches: these are thin, flexible, adhesive patch-like medical devices that use integrated circuits and nanomaterials to detect small amounts of toxins, proteins, DNA, or chemicals through the skin [29]. These wearable adhesive sensors can detect and record medication intake and emit vibrating signals at scheduled times for medication administration [30,31];
- Wristbands: these are equipped with sensors that can be used to monitor physical activity and the user’s heart rate and issue alerts for scheduled tasks. The bands also provide users with recommendations for health, fitness, and other warnings and can be programmed, for example, to receive reminders and notify the user when it is time to remove drugs to be administered from the bottles [32,33];
- Neckwear: these are devices that capture signs of swallowing and medication ingestion in the form of a necklace. They can also pair with mobile devices that receive and store data [11].
3. Results
3.1. Involvement of Human Volunteers in Idea Validation
3.2. Involvement of Human Volunteers in Prototype Validation
3.3. Involvement of Human Volunteers in Product Validation
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Number | Search Strategy |
---|---|
#1 | (wearable device) OR (wearable devices) OR (wearable electronic device) OR (wearable electronic devices) OR (wearable technologies) OR (wearable technology) OR (wearable health monitoring devices) OR (technologies wearable) OR (technology wearable) OR (device wearable) OR (devices wearable) OR (wearable wrist biosensor) OR (wearable*) OR smartwatch OR (smart watch) OR smartwatches OR (smart watches) OR wristband* OR (hearing aids) OR (hearing aid) OR (ear mold) OR (ear molds) OR (earmold) OR (earmolds) OR (electronic tattoo) OR (electronic tattoos) OR (optical tattoo) OR (optical tattoos) OR (head mounted display) OR (head mounted displays) OR (subcutaneous sensors) OR (subcutaneous sensor) OR (electronic footwear) OR (electronic textile) OR (wireless sensor) OR (body sensor) OR (body worn sensor) OR (electronic footwear) OR (electronic textiles) OR (wireless sensors) OR (body sensors) OR (body worn sensors) OR biosensor OR biosensors OR accelerometer* OR gyroscope* OR (optical sensor) OR (contact sensor) OR (optical sensors) OR (contact sensors) OR (wearable monitor) OR (wearable monitors) OR (chips diagnosis) OR (electronic skin) |
#2 | (medication adherence) OR (medication compliance) OR (medication non adherence) OR (medication nonadherence) OR (medication non-adherence) OR (medication noncompliance) OR (medication non-compliance) OR (medication persistence) OR (therapeutic adherence) OR (therapeutic adherence and compliance) OR (treatment adherence) OR (treatment adherence and compliance) OR (compliance patient) OR (patient adherence) OR (adherence patient) OR (patient cooperation) OR (cooperation patient) OR (patient non-compliance) OR (non-compliance patient) OR (patient non compliance) OR (patient nonadherence) OR (nonadherence patient) OR (patient noncompliance) OR (noncompliance patient) OR (patient non-adherence) OR (non-adherence patient) OR (patient non adherence) OR (treatment compliance) OR (compliance treatment) OR (treatment compliances) OR (therapeutic compliance) OR (compliance therapeutic) OR (compliances therapeutic) OR (therapeutic compliances) |
#3 | #1 AND #2 |
Author | Country of Origin | Type of Technology | Technology Description | Study Design | Ethics Committee and Informed Consent |
---|---|---|---|---|---|
Idea Validation | |||||
Choi et al., 2013 [11] | USA | Neckwear | Neckwear device with a proposed system that reminds patients when to take their medications and the proper dose of each pill and monitors medication ingestion in real-time | Survey | Not reported |
Rosner et al., 2015 * [33] | Romania | Wristband | Development of a medication reminder system that delivers alarms effectively through a user-sensitive design to be easily integrated into patients’ and caregivers’ daily routines | Survey | Not reported |
Stekler et al., 2018 [34] | USA | Smartwatch | Wrist worn sensor using Bluetooth technology for motion sensing and gesture recognition, tags on medication bottles, a smartphone app, and real-time adherence reminders | Survey | Yes |
Deustch; Burgsteiner, 2019 [35] | Austria | Smartwatch | Smartwatch-based assistance system which can set medication reminders and get help from relatives at the push of a single button | Experimental study | Not reported |
Prototype Validation | |||||
Espinoza et al., 2009 [25] | Mexico | Smartwatch | User interface for informing (coaching) older adults on the medications and doses to take | Survey | Not reported |
Abraham et al., 2013 [36] | USA | Patch | Electronic skin patch designed to deliver discreet tactile reminder stimuli | Experimental study | Yes |
Abraham et al., 2015 [37] | USA | Patch | Electronic skin patch designed to deliver discreet tactile reminder stimuli | Experimental study | Yes |
Rosner et al., 2015 * [33] | Romania | Wristband | Development of a medication reminder system that delivers alarms effectively through a user-sensitive design to be easily integrated into patients’ and caregivers’ daily routines | Survey | Not reported |
Marquard et al., 2018 [38] | USA | Wristband | Detection of pill-taking behavior, triggering pill-taking reminders for wrist wearers | Survey | Yes |
Product Validation | |||||
Browne et al., 2019 [29] | USA | Patch | Small adhesive-backed detector patch worn on the torso and a paired mobile device | Randomized controlled trial | Yes |
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Marengo, L.L.; Barberato-Filho, S. Involvement of Human Volunteers in the Development and Evaluation of Wearable Devices Designed to Improve Medication Adherence: A Scoping Review. Sensors 2023, 23, 3597. https://doi.org/10.3390/s23073597
Marengo LL, Barberato-Filho S. Involvement of Human Volunteers in the Development and Evaluation of Wearable Devices Designed to Improve Medication Adherence: A Scoping Review. Sensors. 2023; 23(7):3597. https://doi.org/10.3390/s23073597
Chicago/Turabian StyleMarengo, Lívia Luize, and Silvio Barberato-Filho. 2023. "Involvement of Human Volunteers in the Development and Evaluation of Wearable Devices Designed to Improve Medication Adherence: A Scoping Review" Sensors 23, no. 7: 3597. https://doi.org/10.3390/s23073597
APA StyleMarengo, L. L., & Barberato-Filho, S. (2023). Involvement of Human Volunteers in the Development and Evaluation of Wearable Devices Designed to Improve Medication Adherence: A Scoping Review. Sensors, 23(7), 3597. https://doi.org/10.3390/s23073597