Addressing barriers and identifying facilitators to support informed consent and recruitment in the Cavernous malformations A Randomised Effectiveness (CARE) pilot phase trial: insights from the integrated QuinteT recruitment intervention (QRI).

Autor:	Wade J; Bristol Medical School, University of Bristol, 39 Whatley Road, Bristol, BS8 2PS, UK., Farrar N; Bristol Medical School, University of Bristol, 39 Whatley Road, Bristol, BS8 2PS, UK., Realpe AX; Bristol Medical School, University of Bristol, 39 Whatley Road, Bristol, BS8 2PS, UK., Donovan JL; Bristol Medical School, University of Bristol, 39 Whatley Road, Bristol, BS8 2PS, UK., Forsyth L; Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, NINE Edinburgh BioQuarter, 9 Little France Road, EH16 4UK, UK., Harkness KA; Department of Neurology, The Royal Hallamshire Hospital, Glossop Road, Sheffield, S10 2JF, UK., Hutchinson PJA; Department of Clinical Neurosciences, University of Cambridge, Cambridge Biomedical Campus, CB3 0QQ, UK., Kitchen N; Department of Neurosurgery, National Hospital for Neurology and Neurosurgery, University College London Hospitals NHS Foundation Trust, Queen's Square, London, WC1N 3BG, UK., Lewis SC; Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, NINE Edinburgh BioQuarter, 9 Little France Road, EH16 4UK, UK., Loan JJM; Centre for Clinical Brain Sciences, University of Edinburgh, 49 Little France Crescent, Edinburgh, EH16 4SB, UK., Stephen J; Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, NINE Edinburgh BioQuarter, 9 Little France Road, EH16 4UK, UK., Al-Shahi Salman R; Centre for Clinical Brain Sciences, University of Edinburgh, 49 Little France Crescent, Edinburgh, EH16 4SB, UK.
Jazyk:	angličtina
Zdroj:	EClinicalMedicine [EClinicalMedicine] 2024 Apr 18; Vol. 71, pp. 102557. Date of Electronic Publication: 2024 Apr 18 (Print Publication: 2024).
DOI:	10.1016/j.eclinm.2024.102557
Abstrakt:	Background: It was anticipated that recruitment to the Cavernous malformations: A Randomised Effectiveness (CARE) pilot randomised trial would be challenging. The trial compared medical management and surgery (neurosurgical resection or stereotactic radiosurgery) with medical management alone, for people with symptomatic cerebral cavernous malformation (ISRCTN41647111). Previous trials comparing surgical and medical management for intracranial vascular malformations failed to recruit to target. A QuinteT Recruitment Intervention was integrated during trial accrual, September 2021-April 2023 inclusive, to improve informed consent and recruitment. Methods: The QuinteT Recruitment Intervention combined iterative collection and analysis of quantitative data (28 trial site screening logs recording numbers/proportions screened, eligible, approached and randomised) and qualitative data (79 audio-recorded recruitment discussions, 19 interviews with healthcare professionals, 11 interviews with patients, 2 investigator workshops, and observations of study meetings, all subject to thematic, content or conversation analysis). We triangulated quantitative and qualitative data to identify barriers and facilitators to recruitment and how and why these arose. Working with the chief investigators and trial management group, we addressed barriers and facilitators with corresponding actions to improve informed consent and recruitment. Findings: Barriers identified included how usual care practices made equipoise challenging, multi-disciplinary teams sometimes overrode recruiter equipoise and logistical issues rendered symptomatic cavernoma diagnosis and assessment for stereotactic radiosurgery challenging. Facilitators identified included the preparedness of some neurosurgeons' to offer surgery to people otherwise offered medical management alone, multi-disciplinary team equipoise, and effective information provision presenting participation as a solution to equipoise regarding management. Actions, before and during recruitment, to improve inclusivity of site screening, approach and effectiveness of information provision resulted in 72 participants recruited following a 5-month extension, exceeding the target of 60 participants. Interpretation: QuinteT Recruitment Intervention insights revealed barriers and facilitators, enabling identification of remedial actions. Recruitment to a definitive trial would benefit from further training/support to encourage clinicians to be comfortable approaching patients to whom medical management is usually offered, and broadening the pool of neurosurgeons and multi-disciplinary team members prepared to offer surgery, particularly stereotactic radiosurgery. Funding: National Institute for Health and Care Research. Competing Interests: JW reports funding from the National Institute for Health and Care Research for this project, paid to the University of Bristol and membership of the National Institute for Health and Care Research, Research for Patient Benefit South West general funding committee. KAH reports an unrestricted educational grant from Medtronic for delivery of Stroke CT imaging day 2023 and is Clinical Lead of the South Yorkshire Integrated Stroke delivery Network. NK reports receiving personal income from consultancy with Amethyst UK Limited. RA-SS reports funding from the National Institute for Health and Care Research for this project, paid to The University of Edinburgh; funding from the Chief Scientist Office Health Improvement, Protection and Services Research Committee, Project Grant Platform randomised controlled trial for INTracerebral Haemorrhage (PLINTH): community-based feasibility study. Ref. HIPS/22/36, paid to The University of Edinburgh; consulting fees from Recursion Pharmaceuticals and Bioxodes, paid to The University of Edinburgh; participation in endpoint adjudication for Novo Nordisk, paid to the University of Edinburgh. SCL reports membership of the NIHR Health Technology Assessment general funding committee, 2016–21. JJML reports fellowship funding from the Wellcome Trust paid to the University of Edinburgh and covering his salary. The rest of the writing group declare no interests. (© 2024 The Authors.)
Databáze:	MEDLINE
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