CRediT contribution statement
Rustam Al-Shahi Salman (https://orcid.org/0000-0002-2108-9222): Conceptualisation, Data curation, Formal analysis, Funding acquisition, Investigation, Methodology, Project administration, Resources, Supervision, Validation, Visualisation, Writing – original draft, Writing – reviewing and editing.
Neil Kitchen (https://orcid.org/0000-0002-1655-5970): Conceptualisation, Funding acquisition, Methodology, Project administration, Resources, Supervision, Validation, Visualisation, Writing – reviewing and editing.
Laura Forsyth (https://orcid.org/0000-0003-3853-0392): Data curation, Project administration, Writing – reviewing and editing.
Vijeya Ganesan (https://orcid.org/0000-0003-1864-6216): Funding acquisition, Validation, Writing – reviewing and editing.
Peter S Hall (https://orcid.org/0000-0001-6015-7841): Funding acquisition, Methodology, Supervision, Writing – reviewing and editing.
Kirsty Harkness (https://orcid.org/0000-0002-6733-6938): Funding acquisition, Resources, Supervision, Validation, Writing – reviewing and editing.
Peter JA Hutchinson (https://orcid.org/0000-0002-2796-1835): Funding acquisition, Resources, Writing – reviewing and editing.
Steff C Lewis (https://orcid.org/0000-0003-1210-2314): Conceptualisation, Data curation, Formal analysis, Funding acquisition, Methodology, Supervision, Validation, Visualisation, Writing – original draft, Writing – reviewing and editing.
Matthias WR Radatz (https://orcid.org/0009-0004-3342-0615): Conceptualisation, Funding acquisition, Methodology, Project administration, Resources, Writing – reviewing and editing.
Carole Turner (https://orcid.org/0000-0002-8297-4890): Funding acquisition, Resources, Writing – reviewing and editing.
Julia Wade (https://orcid.org/0000-0001-6486-6477): Conceptualisation, Data curation, Formal analysis, Funding acquisition, Investigation, Methodology, Project administration, Resources, Validation, Visualisation, Writing – original draft, Writing – reviewing and editing.
David CS White (https://orcid.org/0009-0003-1310-0238): Funding acquisition, Project administration, Resources, Writing – reviewing and editing.
Philip M White (https://orcid.org/0000-0001-6007-6013): Funding acquisition, Supervision, Writing – reviewing and editing.
Data-sharing statement
A de-identified individual participant data set will be prepared for sharing purposes. All requests for study data will need to be made in writing via e-mail to ECTUdatashare@ed.ac.uk. Access to the de-identified data may be granted following review by Chief Investigator and the Edinburgh Clinical Trials Unit Portfolio Management Committee.
Ethics statement
The Leeds East Research Ethics Committee (REC) approved the trial protocol (version 2.0, 22 March 2021) on 31 March 2021 (REC reference 21/YH/0046).
Information governance statement
The University of Edinburgh and NHS Lothian are committed to handling all personal information in line with the UK Data Protection Act (2018) and the General Data Protection Regulation (EU GDPR) 2016/679. Under the Data Protection legislation, The University of Edinburgh and NHS Lothian are joint Data Controllers, and you can find out more about how we handle personal data, including how to exercise your individual rights and the contact details for our Data Protection Officer here www.accord.scot/data-protection/our-privacy-notices.
Disclosure of interests
Full disclosure of interests: Completed ICMJE forms for all authors, including all related interests, are available in the toolkit on the NIHR Journals Library report publication page at https://doi.org/10.3310/GJRS5321.
Primary conflicts of interest: Rustam Al-Shahi Salman reports a NIHR Health Technology Assessment trial grant, paid to their employer, for the submitted work; a Chief Scientist Office Health Improvement, Protection and Services Research Committee Project Grant, paid to their employer, outside the submitted work; consulting fees from Recursion Pharmaceuticals and Bioxodes, paid to their employer; lecture fees from the European Stroke Masters, paid to their employer; endpoint adjudication fees from Novo Nordisk, paid to their employer; membership of funding committees for NIHR (EME and PGfAR); and employment by the UKCRC Network of registered clinical trials units, paid to their employer.
Neil Kitchen reports no disclosures.
Laura Forsyth reports no disclosures.
Vijeya Ganesan reports no disclosures.
Peter S Hall reports funding from NIHR HTA, paid to their employer, for the submitted work.
Kirsty Harkness reports an unrestricted educational grant from Medtronic for a stroke imaging study day in 2023, and being the South Yorkshire Integrated Stroke Delivery Network clinical lead.
Peter JA Hutchinson reports no disclosures.
Steff C Lewis reports being a member of the NIHR HTA General Funding Panel 2016–21.
Matthias WR Radatz reports being President of the British Radiosurgery Society.
Carole Turner reports no disclosures.
Julia Wade reports no disclosures.
David CS White reports funding from NIHR HTA, paid to their employer, for the submitted work.
Philip M White reports being immediate past Chair of the UK Neurointerventional Group.
Department of Health and Social Care disclaimer
This publication presents independent research commissioned by the National Institute for Health and Care Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, MRC, NIHR Coordinating Centre, the Health Technology Assessment programme or the Department of Health and Social Care.
This synopsis was published based on current knowledge at the time and date of publication. NIHR is committed to being inclusive and will continually monitor best practice and guidance in relation to terminology and language to ensure that we remain relevant to our stakeholders.
Trial registration
This trial is registered as ISRCTN41647111.
Funding
This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number NIHR128694.
Additional outputs
Loan JJM, Bacon A, van Beijnum J, Bhatt P, Bjornson A, Broomes N, et al. Feasibility of comparing medical management and surgery (with neurosurgery or stereotactic radiosurgery) with medical management alone in people with symptomatic brain cavernoma – protocol for the cavernomas: a randomised effectiveness (CARE) pilot trial. BMJ Open 2023;13:e075187. https://doi.org/10.1136/bmjopen-2023-075187
About this synopsis
The contractual start date for this research was in September 2020. This synopsis began editorial review in May 2024 and was accepted for publication in April 2025. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The Health Technology Assessment editors and publisher have tried to ensure the accuracy of the authors’ synopsis and would like to thank the reviewers for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this synopsis.
Copyright
Copyright © 2025 Al-Shahi Salman et al. This work was produced by Al-Shahi Salman et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This is an Open Access publication distributed under the terms of the Creative Commons Attribution CC BY 4.0 licence, which permits unrestricted use, distribution, reproduction and adaptation in any medium and for any purpose provided that it is properly attributed. See: https://creativecommons.org/licenses/by/4.0/. For attribution the title, original author(s), the publication source – NIHR Journals Library, and the DOI of the publication must be cited.
Published by the NIHR Journals Library (www.journalslibrary.nihr.ac.uk), produced by Newgen Digitalworks Pvt Ltd, Chennai, India (www.newgen.co).