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
Author:
Loan James J MORCID, Bacon Andrew, van Beijnum Janneke, Bhatt PragneshORCID, Bjornson AnnaORCID, Broomes Nicole, Bullen AlistairORCID, Bulters DiederikORCID, Cahill JulianORCID, Chavredakis EmmanuelORCID, Colombo FrancescaORCID, Danciut Mihai, Digpal Ronneil, Edwards Richard JORCID, Ferguson LucieORCID, Forsyth Laura, Fouyas Ioannis, Ganesan VijeyaORCID, Grover PatrickORCID, Gurusinghe NihalORCID, Hall Peter SORCID, Harkness Kirsty, Harris Lauren S, Hayton Tom, Helmy AdelORCID, Holsgrove Daniel, Hutchinson Peter JORCID, Israni Anil, Kinsella Elaine, Lewis SteffORCID, Majeed Sohail, Mallucci ConorORCID, Mukerji Nitin, Nair Ramesh, Neilson Aileen RORCID, Papadopoulos Marios CORCID, Radatz Matthias, Rossdeutsch Alex, Raza-Knight Saba, Stephen Jacqueline, Stoddart AndrewORCID, Teo MarioORCID, Turner CaroleORCID, Wade JuliaORCID, Walsh DanielORCID, White David, White Phil, Wildman Jack, Wroe Wright Oliver, Uff ChristopherORCID, Ushewokunze Shungu, Vindlacheruvu Raghu, Kitchen Neil, Al-Shahi Salman RustamORCID
Abstract
IntroductionThe top research priority for cavernoma, identified by a James Lind Alliance Priority setting partnership was ‘Does treatment (with neurosurgery or stereotactic radiosurgery) or no treatment improve outcome for people diagnosed with a cavernoma?’ This pilot randomised controlled trial (RCT) aims to determine the feasibility of answering this question in a main phase RCT.Methods and analysisWe will perform a pilot phase, parallel group, pragmatic RCT involving approximately 60 children or adults with mental capacity, resident in the UK or Ireland, with an unresected symptomatic brain cavernoma. Participants will be randomised by web-based randomisation 1:1 to treatment with medical management and with surgery (neurosurgery or stereotactic radiosurgery) versus medical management alone, stratified by prerandomisation preference for type of surgery. In addition to 13 feasibility outcomes, the primary clinical outcome is symptomatic intracranial haemorrhage or new persistent/progressive focal neurological deficit measured at 6 monthly intervals. An integrated QuinteT Recruitment Intervention (QRI) evaluates screening logs, audio recordings of recruitment discussions, and interviews with recruiters and patients/parents/carers to identify and address barriers to participation. A Patient Advisory Group has codesigned the study and will oversee its progress.Ethics and disseminationThis study was approved by the Yorkshire and The Humber—Leeds East Research Ethics Committee (21/YH/0046). We will submit manuscripts to peer-reviewed journals, describing the findings of the QRI and the Cavernomas: A Randomised Evaluation (CARE) pilot trial. We will present at national specialty meetings. We will disseminate a plain English summary of the findings of the CARE pilot trial to participants and public audiences with input from, and acknowledgement of, the Patient Advisory Group.Trial registration numberISRCTN41647111.
Funder
National Institute for Health and Care Research
Cited by
5 articles.
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