Evaluations of medical device usability during clinical investigations: a scoping review of clinical study protocols.
Laura DouzeJessica SchiroLouise HeyndelsLionel PazartSylvia PelayoPublished in: Expert review of medical devices (2024)
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).
Keyphrases
- electronic health record
- healthcare
- end stage renal disease
- newly diagnosed
- ejection fraction
- chronic kidney disease
- big data
- health information
- prognostic factors
- clinical trial
- cross sectional
- machine learning
- peritoneal dialysis
- patient reported outcomes
- depressive symptoms
- artificial intelligence
- acute care
- double blind