| Title: |
Medical management and intervention (using neurosurgical resection or stereotactic radiosurgery) versus medical management alone for symptomatic brain cavernoma:the CARE pilot RCT |
| Authors: |
Salman, Rustam Al-Shahi; Kitchen, Neil; Forsyth, Laura; Ganesan, Vijeya; Hall, Peter S.; Harkness, Kirsty; Hutchinson, Peter J. A.; Lewis, Steff C.; Radatz, Matthias WR; Turner, Carole; Wade, Julia; White, David C. S.; White, Philip M. |
| Source: |
Salman, R A-S, Kitchen, N, Forsyth, L, Ganesan, V, Hall, P S, Harkness, K, Hutchinson, P J A, Lewis, S C, Radatz, M WR, Turner, C, Wade, J, White, D C S & White, P M 2025, 'Medical management and intervention (using neurosurgical resection or stereotactic radiosurgery) versus medical management alone for symptomatic brain cavernoma : the CARE pilot RCT', Health Technology Assessment, vol. 29, no. 38, 38. https://doi.org/10.3310/GJRS5321 |
| Publication Year: |
2025 |
| Collection: |
University of Bristol: Bristol Reserach |
| Description: |
Background: The top priority for research into symptomatic cerebral cavernous malformation (also known as brain cavernoma) is whether to have medical management and intervention (using neurosurgical resection or stereotactic radiosurgery) or medical management alone. Objectives: The primary objective was to assess the feasibility of performing a definitive randomised trial addressing this top priority. The secondary objectives were to set up a collaboration involving patient advocacy organisations and clinicians in the United Kingdom and Ireland; perform a QuinteT Recruitment Intervention to identify facilitators and address barriers to recruitment; and conduct a pilot randomised trial with ≈60 participants. Design: Prospective, randomised, open-label, assessor-blinded, parallel-group trial. A mixed-methods QuinteT Recruitment Intervention analysed sites’ screening logs and qualitative data from audio-recorded recruitment discussions, interviews with healthcare professionals and patients, investigator workshops and observation of meetings. Setting: Neuroscience hospitals in the United Kingdom and Ireland. Participants: We aimed to recruit ≈60 people of any age, gender and ethnicity who had mental capacity, resided in the United Kingdom/Ireland, and had a brain cavernoma that had caused symptoms due to intracranial haemorrhage, non-haemorrhagic progressive/persistent focal neurological deficit or epileptic seizure(s). Interventions: We identified and addressed barriers and facilitators to optimise informed consent and recruitment. Computerised, web-based randomisation assigned participants (1 : 1) to treatment of their symptomatic brain cavernoma with medical management and intervention (using neurosurgical resection or stereotactic radiosurgery) or medical management alone. Assignment was open to investigators, participants and carers but not clinical outcome event adjudicators. Main outcome measures: Feasibility outcomes included site engagement, recruitment, choice of surgical management, retention, adherence, ... |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| Relation: |
info:eu-repo/semantics/altIdentifier/pmid/40820590; info:eu-repo/semantics/altIdentifier/hdl/https://hdl.handle.net/1983/9e936feb-2611-4757-a32f-4b84d2a3e4f0 |
| DOI: |
10.3310/GJRS5321 |
| Availability: |
https://hdl.handle.net/1983/9e936feb-2611-4757-a32f-4b84d2a3e4f0; https://research-information.bris.ac.uk/en/publications/9e936feb-2611-4757-a32f-4b84d2a3e4f0; https://doi.org/10.3310/GJRS5321 |
| Rights: |
info:eu-repo/semantics/openAccess ; http://creativecommons.org/licenses/by/4.0/ |
| Accession Number: |
edsbas.C8A15AA1 |
| Database: |
BASE |