BMJ Open (Aug 2023)

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

  • ,
  • Khalid Hamandi,
  • Julie Woodfield,
  • Smriti Agarwal,
  • Richard Edwards,
  • John Williamson,
  • Ravindran Visagan,
  • Rustam Al-Shahi Salman,
  • Howard Brydon,
  • Diederik Bulters,
  • Dawn Hennigan,
  • Paul Leach,
  • Conor Mallucci,
  • Nitin Mukerji,
  • Marios Papadopoulos,
  • Nicholas Ross,
  • Martin Tisdall,
  • Carole Turner,
  • Shungu Ushewokunze,
  • Raghu Vindlacheruvu,
  • Paul Brennan,
  • Phil White,
  • Sophie Hunter,
  • Karen Coy,
  • Julia Wade,
  • James Stewart,
  • Tom Hughes,
  • Laura Forsyth,
  • Kirsty Harkness,
  • David White,
  • Rupal Shah,
  • Sanjay Bhate,
  • Neil Kitchen,
  • Peter J Hutchinson,
  • Emanuel Cirstea,
  • Ramesh Nair,
  • Rebecca Hall,
  • Varduhi Cahill,
  • Tom Hayton,
  • Silvia Tarantino,
  • Christin Eltze,
  • Jack Lee,
  • Arlo Whitehouse,
  • Daniel Walsh,
  • Jacqueline Stephen,
  • Nicola Phillips,
  • Steff Lewis,
  • Susan Davies,
  • Mathew Guilfoyle,
  • Peter S Hall,
  • Andrew Stoddart,
  • Francesca Colombo,
  • Emma Richards,
  • Greg James,
  • Sarah Illingworth,
  • William B Lo,
  • Andrew Bacon,
  • Vijeya Ganesan,
  • Sabina Patel,
  • Aileen R Neilson,
  • Felicia Jennings,
  • Saba Raza-Knight,
  • Andrew Brodbelt,
  • Aswin Chari,
  • Hasan Asif,
  • Ian Kamaly-Asl,
  • Milan Makwana,
  • Zubair Tahir,
  • Allan MacRaild,
  • Rustam Al-Shahi Salman,
  • Grace Vassallo,
  • Ian Anderson,
  • Daniel Holsgrove,
  • Carole Chambers,
  • Sandra Williams,
  • Francesca Spickett-Jones,
  • Marios C Papadopoulos,
  • John Preston,
  • Edward White,
  • Adel Helmy,
  • Sarah Ali,
  • John Reid,
  • Daniel Brown,
  • Louis Taylor,
  • Christopher Uff,
  • Patrick Grover,
  • Azra Banaras,
  • Linetty Makawa,
  • Anil Israni,
  • Richard J Edwards,
  • William Muirhead,
  • Daniel Brooks,
  • Debbie Brown,
  • Ciaran Scott Hill,
  • Kerry Smith,
  • Beth Atkinson,
  • Michelle Fawcett,
  • Sifelani Tshuma,
  • Oliver Kennion,
  • Jo Howe,
  • James J M Loan,
  • Philip Clatworthy,
  • Claire Hudson,
  • Rebecca Hodnett,
  • Madalina Roman,
  • Mary Sikaonga,
  • Elaine Kinsella,
  • Mario Teo,
  • Venetia Giannakaki,
  • James Loan,
  • Lauren Harris,
  • Jack Wildman,
  • Emmanuel Chavredakis,
  • Nihal Gurusinghe,
  • Alex Rossdeutsch,
  • Anthony Wiggins,
  • Giannis Sokratous,
  • Lucie Ferguson,
  • Shakeelah Patel,
  • Sonia Raj,
  • Oishik Raha,
  • Janneke van Beijnum,
  • Pragnesh Bhatt,
  • Anna Bjornson,
  • Nicole Broomes,
  • Alistair Bullen,
  • Julian Cahill,
  • Mihai Danciut,
  • Ronneil Digpal,
  • Ioannis Fouyas,
  • Lauren S Harris,
  • Sohail Majeed,
  • Matthias Radatz,
  • Oliver Wroe Wright,
  • Jessica Teasdale,
  • Michelle Coakley,
  • Drahoslav Sokol,
  • Chandru Kaliaperumal,
  • Mairi MacDonald,
  • Sarah Risbridger,
  • Siobhan Kearney,
  • Ellaine Bosetta,
  • Thomas Doke,
  • Sonny Coskuner,
  • Christine Kamara,
  • Jonathan Gardner,
  • Imron Hamina,
  • Kishor Chaudhari,
  • Liliana Chapas,
  • Karen Caldwell,
  • Sarah Holland,
  • Tamara Tajsic,
  • Rachael Dore,
  • Taya Anderson,
  • Shelley Mayor,
  • Laura O'Malley,
  • Samantha Glover,
  • Janice Irvine,
  • Annika Walch,
  • Farah Muir,
  • Eng Tah Goh,
  • Andrew McDarby,
  • Michelle Bates,
  • Rebecca Hancox,
  • Claudia Kate Auyeung,
  • Elizabeth Goff,
  • Deanna Stephens,
  • Borislava Borislavova,
  • Ruth Worner,
  • Sandeep Buddha,
  • Lisa Tucker,
  • Sandra Dymond,
  • Andrew Mallick,
  • Janneke van Beijnum,
  • Dymona McAleer,
  • Belinda Gunning,
  • Emma Clarkson,
  • Cathy Stoneley,
  • Jibril Osman Farah,
  • Niamh Bohnacker,
  • Rosette Marimon,
  • Lydia Parker,
  • Puneet Sharma,
  • Oliver Wroe Wright,
  • Dan Holsgrove,
  • Danielle McLaughlan,
  • Tracey Marsden,
  • Kathryn Cawley,
  • Hellen Raffalli,
  • Imedla Mayor,
  • Dipek Ram,
  • Rebecca Keeping,
  • Katie Hennessy,
  • Ammar Kadhim,
  • Md Moidul Islam,
  • Manjunath Prasad,
  • Cheryl Webster,
  • Vicky Slater,
  • Saffnan Mohamed,
  • Saba Raza Knight,
  • Terri-Louise Cromie,
  • Allan Brown,
  • Ruth Pennington,
  • Charlene Campbell,
  • Anthony Ghosh,
  • Teresa Fitzpatrick,
  • Mohammed Patel,
  • Winnington Ruiz,
  • Mirriam Taylor,
  • Divina Anyog,
  • Katarzyna Tluchowska,
  • Jackson Nolasco,
  • Kleopatra Angelopoulou,
  • Bethany Welch,
  • Ida Ponce,
  • Lucy Bailey,
  • Mia Marsden,
  • Angelene Cope,
  • Deepthy Blesson,
  • Rachel Sutton,
  • Mary Kambafwile,
  • Jade McAndrew

DOI
https://doi.org/10.1136/bmjopen-2023-075187
Journal volume & issue
Vol. 13, no. 8

Abstract

Read online

Introduction The 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 analysis We 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 dissemination This 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 number ISRCTN41647111.