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Authors: Laura Douze 1 ; Jessica Schiro 1 and Sylvia Pelayo 2 ; 1

Affiliations: 1 Univ. Lille, Inserm, CHU Lille, ULR 2694 - METRICS (Évaluation des Technologies de Santé et des Pratiques Médicales), F-59000 Lille, France ; 2 Inserm, Tech4Health, F-59000 Toulouse, France

Keyword(s): Usability, Medical Device, Clinical Study.

Abstract: This scoping review is interested in mapping the clinical studies protocols of medical devices on usability evaluation. The research question is as follows: How is usability of medical devices evaluated in clinical studies? The paper presents some first results from a sample of 47 protocols within a set of 188 potentially eligible protocols. Results highlight that a non-negligible part of usability evaluations are carried out combined with clinical studies. Very often, usability outcomes are part of the secondary outcomes of the clinical study. The most claimed usability-related outcomes are ease of use, handling and satisfaction. Usability is mainly addressed through questionnaires which provide actually perceived usability (not usability per se). Some protocols appear to be quite comprehensive in terms of usability evaluation methods.

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Paper citation in several formats:
Douze, L.; Schiro, J. and Pelayo, S. (2021). Usability Evaluation of Medical Devices during Clinical Studies: First Results of a Scoping Review. In Proceedings of the 14th International Joint Conference on Biomedical Engineering Systems and Technologies - ClinMed; ISBN 978-989-758-490-9; ISSN 2184-4305, SciTePress, pages 293-299. DOI: 10.5220/0010385602930299

@conference{clinmed21,
author={Laura Douze. and Jessica Schiro. and Sylvia Pelayo.},
title={Usability Evaluation of Medical Devices during Clinical Studies: First Results of a Scoping Review},
booktitle={Proceedings of the 14th International Joint Conference on Biomedical Engineering Systems and Technologies - ClinMed},
year={2021},
pages={293-299},
publisher={SciTePress},
organization={INSTICC},
doi={10.5220/0010385602930299},
isbn={978-989-758-490-9},
issn={2184-4305},
}

TY - CONF

JO - Proceedings of the 14th International Joint Conference on Biomedical Engineering Systems and Technologies - ClinMed
TI - Usability Evaluation of Medical Devices during Clinical Studies: First Results of a Scoping Review
SN - 978-989-758-490-9
IS - 2184-4305
AU - Douze, L.
AU - Schiro, J.
AU - Pelayo, S.
PY - 2021
SP - 293
EP - 299
DO - 10.5220/0010385602930299
PB - SciTePress

- Science and Technology Publications, Lda.
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