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Dimensions of ecological validity for usability evaluations in clinical settings

van Berkel, N; Clarkson, MJ; Xiao, G; Dursun, E; Allam, M; Davidson, BR; Blandford, A; (2020) Dimensions of ecological validity for usability evaluations in clinical settings. Journal of Biomedical Informatics , 110 , Article 103553. 10.1016/j.jbi.2020.103553. Green open access

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Abstract

The development, evaluation, and eventual deployment of novel medical devices is a complex process involving various areas of expertise. Although the need for a User Centred Design approach to the development of both hardware and software has long been established, both current regulatory guidelines and widespread evaluation approaches fail to reflect the challenges encountered during day-to-day clinical practice. As such, the results from these evaluations may not provide a realistic account of the problems encountered by users when introduced to clinical practice. In this paper, we present a case study on designing the evaluation of a novel device to support laparoscopic liver surgery. Through a reflective account of the design of our usability evaluation, we identify and describe seven primary dimensions of ecological validity encountered in clinical usability evaluations. These dimensions are: 'user roles', 'environment', 'training', 'scenario', 'patient involvement', 'software', and 'hardware'. We analyse three recently published clinical usability evaluation articles to assess (and illustrate) the applicability and completeness of these dimensions. Finally, we discuss the compromises encountered during clinical usability evaluations and how to best report on these considerations. The framework presented here aims to further the agenda of ecologically valid evaluation practice, reflecting the constraints of medical practice.

Type: Article
Title: Dimensions of ecological validity for usability evaluations in clinical settings
Location: United States
Open access status: An open access version is available from UCL Discovery
DOI: 10.1016/j.jbi.2020.103553
Publisher version: https://doi.org/10.1016/j.jbi.2020.103553
Language: English
Additional information: This version is the author accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions.
Keywords: Ecological considerations, Ecological validity, Healthcare, Study design, Usability evaluation
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Surgery and Interventional Sci
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Surgery and Interventional Sci > Department of Surgical Biotechnology
UCL > Provost and Vice Provost Offices > UCL BEAMS
UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Engineering Science
UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Engineering Science > Dept of Computer Science
UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Engineering Science > Dept of Med Phys and Biomedical Eng
URI: https://discovery.ucl.ac.uk/id/eprint/10111215
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