Why you need to include human factors in clinical and empirical studies of in vitro point of care devices? Review and future perspectives

ABSTRACT

Use of in-vitro point of care devices – intended as tests performed out of laboratories and near patient – is increasing in clinical environments. International standards indicate that interaction assessment should not end after the product release, yet human factors methods are frequently not included in clinical and empirical studies of these devices. Whilst the literature confirms some advantages of bed-side tests compared to those in laboratories there is a lack of knowledge of the risks associated with their use. This article provides a review of approaches applied by clinical researchers to model the use of in-vitro testing. Results suggest that only a few studies have explored human factor approaches. Furthermore, when researchers investigated people-device interaction these were predominantly limited to qualitative and not standardised approaches. The methodological failings and limitations of these studies, identified by us, demonstrate the growing need to integrate human factors methods in the medical field.

KEYWORDS:

• Acceptance
• Clinical Studies
• Ergonomics
• Human Factors
• In Vitro Test
• Interaction
• Point-of-care
• POC
• Satisfaction
• Usability

Financial and competing interests disclosure

This research was supported by the National Institute for Health Research (NIHR) Diagnostic Evidence Co-operative London at Imperial College Healthcare NHS Trust. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.