Strategies to enhance recruitment and consent to intensive care studies: a qualitative study with researchers and patient-public involvement contributors



Paddock, Katie ORCID: 0000-0003-1264-5845, Woolfall, Kerry ORCID: 0000-0002-5726-5304, Frith, Lucy ORCID: 0000-0002-8506-0699, Watkins, Megan, Gamble, Carrol ORCID: 0000-0002-3021-1955, Welters, Ingeborg ORCID: 0000-0001-8734-994X and Young, Bridget ORCID: 0000-0001-6041-9901
(2021) Strategies to enhance recruitment and consent to intensive care studies: a qualitative study with researchers and patient-public involvement contributors. BMJ OPEN, 11 (9). e048193-.

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Abstract

<h4>Objective</h4>Clinical trials and studies in intensive care units (ICUs) have complex consent processes and often encounter problems in recruiting patients. By interviewing research team members about the challenges in critical care research, we aimed to identify strategies to enhance recruitment and consent to ICU studies.<h4>Methods</h4>Semistructured interviews with UK-based researchers (N=17) and patient-public involvement (PPI) contributors (N=8) with experience of ICU studies. Analysis of transcripts of audio-recorded interviews drew on thematic approaches.<h4>Results</h4>Seven themes were identified. Participants emphasised the need for substitute decision-making processes in critical care studies, yet some researchers reported that research ethics committees (RECs) were reluctant to approve such processes. Researchers spoke about the potential benefits of research without prior consent (RWPC) for studies with narrow recruitment windows but believed RECs would not approve them. Participants indicated that the activity of PPI contributors was limited in critical care studies, though researchers who had involved PPI contributors more extensively were clear that their input when designing consent processes was important. Researchers and PPI contributors pointed to resource and staffing limitations as barriers to patient recruitment. Researchers varied in whether and how they used professional consultees as substitute decision-makers, in whether they approached families by telephone to discuss research and in whether they disclosed details of research participation to bereaved relatives.<h4>Conclusion</h4>Critical care research could benefit from RECs having expertise in consent processes that are suited to this setting, better staffing at research sites, more extensive PPI and an evidence base on stakeholder perspectives on critical care research processes. Guidance on professional consultee processes, telephoning relatives to discuss research, RWPC and disclosure of research participation to bereaved relatives could help to harmonise practice in these areas and enhance recruitment and consent to critical care studies.

Item Type: Article
Uncontrolled Keywords: intensive & critical care, qualitative research, adult intensive & critical care
Divisions: Faculty of Health and Life Sciences
Faculty of Health and Life Sciences > Institute of Infection, Veterinary and Ecological Sciences
Faculty of Health and Life Sciences > Institute of Life Courses and Medical Sciences
Faculty of Health and Life Sciences > Institute of Population Health
Faculty of Humanities and Social Sciences > School of Law and Social Justice
Faculty of Humanities and Social Sciences > School of the Arts
Depositing User: Symplectic Admin
Date Deposited: 08 Oct 2021 07:15
Last Modified: 18 Jan 2023 21:27
DOI: 10.1136/bmjopen-2020-048193
Open Access URL: https://bmjopen.bmj.com/content/bmjopen/11/9/e0481...
Related URLs:
URI: https://livrepository.liverpool.ac.uk/id/eprint/3139632

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