Do we have to Include HCI Issues in Clinical Trials of Medical Devices?: – A Discussion

Digital devices play an important role in medical treatment and will in the future play a larger role in connection to cures of health-related issues.
Traditionally medicine has been tested by clinical double blind, randomized trials to document the efficacy and safety profile. When it comes to the use of digital devices in treatments the protocols from the field of medicine is adopted. The question is whether or not this evidence based approach is useful when dealing with digital devices and whether the understanding of the efficiency of a treatment can be obtained without also looking at usability and lifestyle issues.
Based on a case study of epilepsy, a literature study of protocols for investigating treatments using digital medical devices, the set-up of studies, the design of a current protocol for clinical trials, and finally preliminary results, we discuss if clinical trials have to include usability studies to determine if a treatment is effective.