Evaluations of medical device usability during clinical investigations: a scoping review of clinical study protocols

Abstract

Objective: Combining clinical investigations with usability studies provides valuable information for medical devices evaluation. But both types of study are very different in terms of objectives and methodologies. How are usability studies integrated into clinical investigations in practice?

Methods: We searched the ClinicalTrials.gov database for clinical investigation protocols that included usability outcome(s) and analyzed them.

Results: 77 study protocols were identified for the analysis, including 102 outcomes related to usability in total. The most frequently assessed outcomes were satisfaction (53/102) and ease of use (33/102). The questionnaire was the most frequently planned technique (85/102) followed by interviews (24/102). Other methods were used, such as observation (9/102), mostly when the end users was a healthcare professional, and diary (6/102), mostly with patients.

Conclusion: Our study results showed that the collection of usability data can be included in a clinical investigation, with various levels of investment. Resource-light, rapid integration via a questionnaire will enable the collection of subjective data on the users' perceptions. When more resources are available, observation in accessible environments can be set up (especially during use by healthcare professionals in hospital) or interviews and/or diaries for home-based environments (especially by patients).

Keywords: Usability; clinical investigation; clinical investigation protocol; human factors; medical device; methodology.