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Participants' perspectives of their involvement in medical device trials: A focus groups study

Yes / Medical technologies have the potential to improve quality and efficiency of healthcare. The design of clinical trials should consider participants' perspectives to optimise enrolment, engagement and satisfaction. This study aims to assess patients' perceptions of their involvement in medical device trials, to inform the designs of future medical technology implementation and evaluation.
Four focus groups were undertaken with a total of 16 participants who had participated in a study testing hospital inpatient remote monitoring devices. Interviews were audio-recorded, transcribed verbatim and underwent thematic analysis.
Four main themes emerged: patients' motivations for participating in medical device research; patients' perceptions of technology in medicine; patients' understanding of trial methodology; and patients' perceptions of the benefits of involvement in medical device trials. The appeal of new technology is a contributing factor to the decision to consent, although concerns remain regarding risks associated with technology in healthcare settings. Perceived benefits of participating in device trials include extra care, social benefits and comradery with other participants seen using the devices, although there is a perceived lack of confidence in using technology amongst older patients.
Future device trials should prioritise information sharing with participants both before and after the trial. Verbal and written information alongside practical demonstrations can help to combat a lack of confidence with technology. Randomised trials and those with placebo- or sham-controlled arms should not be considered as barriers to participation. Study results should be disseminated to participants in lay format as soon as possible, subject to participant permission. / The patients in this study were participating in a randomised controlled trial funded by a Health Foundation Innovating for Improvement Award (Grant number: GIFTS 7643 CRM 2674). Candice Downey is in possession of a Doctoral Research Fellowship (DRF-2016-09- 037) supported by the National Institute for Health Research. DGJ received funding support through an NIHR Research Professorship. The research is supported by the NIHR infrastructure at Leeds.

Identiferoai:union.ndltd.org:BRADFORD/oai:bradscholars.brad.ac.uk:10454/19493
Date20 June 2023
CreatorsKitchen, W.R., Downey, C.L., Brown, J.M., Jayne, D.G., Randell, Rebecca
Source SetsBradford Scholars
LanguageEnglish
Detected LanguageEnglish
TypeArticle, Accepted manuscript
Rights© The Author(s) 2022. Reproduced in accordance with the publisher's self-archiving policy., Unspecified

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