Kitchen, WR, Downey, CL orcid.org/0000-0001-9818-8002, Brown, JM orcid.org/0000-0002-2719-7064 et al. (2 more authors) (2022) Participants' Perspectives of Their Involvement in Medical Device Trials: A Focus Groups Study. Surgical Innovation, 29 (6). pp. 804-810. ISSN 1553-3506
Abstract
Background:
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.
Methods:
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.
Results:
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.
Conclusion:
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.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2022, © SAGE Publications. This is an author produced version of an article published in Surgical Innovation. Uploaded in accordance with the publisher's self-archiving policy. |
Keywords: | acute care surgery, colorectal surgery, general surgery, gastric surgery, biomedical engineering |
Dates: |
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Institution: | The University of Leeds |
Academic Units: | The University of Leeds > Faculty of Medicine and Health (Leeds) > School of Medicine (Leeds) > Inst of Clinical Trials Research (LICTR) (Leeds) |
Funding Information: | Funder Grant number NIHR National Inst Health Research drf-2016-09-037 |
Depositing User: | Symplectic Publications |
Date Deposited: | 05 May 2022 10:12 |
Last Modified: | 11 Jan 2023 02:13 |
Status: | Published |
Publisher: | SAGE |
Identification Number: | 10.1177/15533506221089824 |
Related URLs: | |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:186391 |