Why you need to include human factors in clinical and empirical studies ofin vitropoint 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 peopledevice 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.

Evidence of bioequivalence and positive patient user handling of a tocilizumab autoinjector

“…In addition to bioequivalence, the current data were intended to demonstrate usability of the new delivery device; for patients with RA who may have weakened hand grip or reduced dexterity, the ability to successfully administer treatment is an essential component of effective therapy. Human factor studies are an essential tool to evaluate safe and appropriate use by assessing functionality and correct procedure and highlighting potential sources of error [18,19]. In recent years, several such studies have been published reporting the usability and safety of AI devices for various patient populations, including those with RA [2,[20][21][22].…”

Implementing lateral flow devices in long-term care facilities: experiences from the Liverpool COVID-19 community testing pilot in care homes— a qualitative study

“…Most of the evidence generated surrounding the application of LFDs has primarily focussed on test performance versus PCR, and mathematical modelling [ 12 – 16 ]. This is important research but overlooks complex real-world factors that may hinder test utilisation and performance in complex work environments such as care homes [ 17 – 20 ]. The practical and emotional work associated with the pandemic [ 21 , 22 ], could lead to substantial divergence between laboratory and real-world performance [ 23 ].…”

Rapid point-of-care testing for COVID-19: quality of supportive information for lateral flow serology assays

“…33 Particularly, POCTs are affected by several environmental and operator-related factors, 34 which have important implications on the efficacy, effectiveness and value of these testing kits in both the clinical and domestic settings. [35][36][37][38][39] For instance, tests that have been validated in a controlled laboratory environment may not perform as well in the context of real-world settings if individuals operating the device have little or no specialty training in POCTs or background laboratory training, 40 41 and operators struggle to understand and adhere to instructions included with the kits. 42 The ISO 62366 highlights the importance of the quality of the information of training materials, including accompanying information such as instructions for use.…”