Abstract

As life expectancy increases and medical technologies become more advanced, medical devices are being used more often at home by lay users—individuals without formal medical training. Lay users might be patients or nonprofessional caregivers, such as relatives or friends, who operate a device on someone else’s behalf. When developing medical devices for lay users, it is important to evaluate users’ ability to interact with the device safely and effectively in the home environment. Conducting home-based usability testing provides a unique opportunity to achieve this goal, understand the home environment, and see firsthand how the environment affects the lay users’ ability to use a device appropriately. This article focuses on unique aspects of home-based testing rather than providing suggestions and input regarding conducting usability tests in general. Home healthcare device usability tests can be conducted in various locations, including a usability lab, a conference room, a hotel suite, and of course, the patient’s home. Selecting the most appropriate test environment depends on the stage of device development and the test goals, as well as the importance of conducting testing in a controlled and consistent environment. It is valuable to conduct formative (i.e., exploratory) testing in the home to gain as many insights as possible regarding the actual use environments and whether users are likely to comply with prescribed device use when at home. Home-based testing enables researchers to learn about a device’s portability and placement inside, and sometimes outside, of the home. For example, if testing a respiratory therapy system that must be used continuously, the moderator could ask the participant to demonstrate how s/he positions the system when commuting or grocery shopping. The moderator might also want to learn how the user positions and uses the system while sleeping. However, it might be best to conduct a summative (i.e., validation) usability test—a test intended to validate device use-safety—in a more controlled environment, such as a usability lab or conference room set up to simulate the home environment. By testing in a controlled environment, the possibility of unexpected conditions and distractions that might arise in a home are removed, so tasks can be presented consistently and devices validated in a “cleaner” manner. Notably, the controlled environment should still represent the home environment and consist of more than a table and two chairs in an otherwise empty room. The home can be simulated by introducing realistic distractions, setting up certain pieces of furniture (e.g., a refrigerator and kitchen table; or a bed, dresser, and nightstand), and setting lighting levels to simulate daytime and/or nocturnal use. Conducting Home-Based Usability Tests of Home Healthcare Devices

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