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1. Cost-effectiveness of craniotomy versus decompressive craniectomy for UK patients with traumatic acute subdural haematoma

Author

Emma Toman, David K Menon, Antonio Belli, Sridevi Nagarajan, Julie Woodfield, Ruichong Ma, Jason J Chang, Jonathan Cook, Mark Kotter, Vin Shen Ban, Martin Smith, John D Pickard, Diederik Bulters, Giles Critchley, Damian Holliman, Nicole Keong, Andrew King, Catherine McMahon, Carole Turner, Peter Whitfield, Mark Wilson, Melvin Stone, Paul Brennan, David Turner, Garry Barton, Angelos G Kolias, Simon Shaw, Sean Christie, Dmitri Shastin, Allison Hirst, Soumya Mukherjee, Gareth Roberts, Simon Thomson, Peter J Hutchinson, Alexis Joannides, Emanuel Cirstea, Ashish Bindra, Vairavan Narayanan, David Menon, Francesca Hill, Ashwin Kumaria, Franco Servadei, Rhys Thomas, Midhun Mohan, Silvia Tarantino, Ioana Moldovan, Sara Venturini, Tariq Khan, Marianne Hare, Louise Young, Joan Grieve, Ardalan Zolnourian, Paula Carroll, Diederik Oliver Bulters, Mathew Guilfoyle, Lisa Julien, Barbara Gregson, Martin Hunn, Richard Nelson, Stuart Smith, Shahid Khan, András Büki, Deepak Gupta, Christos Tolias, David A Turner, Christopher Madden, Paul Johnston, Peter John Hutchinson, Patrick Holton, Panagiota Gkolia, Nicola Owen, Kesava Reddy, Hani Marcus, Ibrahim Jalloh, Shabin Joshi, Ian Anderson, Himanshu Shekhar, Daniel Holsgrove, Erin Lewis, Tracey Moore, Marios C Papadopoulos, Paula Kareclas, Peter Kirkpatrick, Laura Parker, Martina Stippler, Sarah Pyne, Peter J Kirkpatrick, James Piercy, Neil Davidson, Prasanna Epaliyanage, Barbara A Gregson, Christopher Uff, Malik Zaben, Charlotte Eglinton, Linetty Makawa, Jane Perez, Louise Harrison, Mutwakil Abdulla, Garry R Barton, Mathew Joseph, Anthony Bell, Sarah Trippier, Michael Canty, Jonathan Pollock, Manjul Tripathi, Harry Mee, Ivan Timofeev, Ellie Edlmann, Nadia Scantlebury, Joseph Frantzias, Yahia Al-Tamimi, Kismet Hossain-Ibrahim, Ciaran Hill, Elisa Visentin, Sonia Raj, Ioannis Fouyas, Siobhan Kearney, Karen Caldwell, Tamara Tajsic, Belinda Gunning, Emma Clarkson, Manjunath Prasad, Mary Kambafwile, Tim Lawrence, Emily Galea, Sebastian Ille, Hadie Adams, Shumaila Hasan, Matthew G Stovell, Edoardo Viaroli, Adel E Helmy, Ivan S Timofeev, Kirsty Grieve, Liz Corteen, Janet Corn, Mohammad Naushahi, Richard Mair, Kamila Walker, Selma Tülü, Chipo Chitsenega, Geetha Boyapati, Muhammad Bhatti, Natalia Ermalai, Joseph Merola Liudmila, Laurence Glanz, Lani Patterson, Colin Bergin, Maximina Ventura, Laura Ortiz-Ruiz de Gordoa, Husam Georges, Sam Jeffrey, Natasha Wilmhurst, Philip Kane, Geraint Sunderland, John Kitchen, Rushid Zakaria, Mathew JosephMathew JosephGallagher, Sonia Fernandez Lopez, Andrea D’Mello, Jo-Anna Conyngham, Miriam Taylor, Charlaine Reeve, Vasileios Arzoglou, Arif Zafar, Efosa Ukponmwan, Anastasios Giamouriadis, Adam Wahba, Patrick Easton, Rose Clegg, Grace Cole, Louise Finlay, Alex Leggate, Terrie-Louise Cromie, Javier Magan Ventura, Ruth Womer, Beverley Fulkner, Geraldine Ward, Kareen Damley, Emma Fleming, Roddy O’Kane, Indira Devi Bhagavatula, Dhananjaya Ishwar Bhat, Dhaval Prem Shukla, Kanti Konar, Nagesh Shanhag, Vaishali Nl Valluri, Manoj Kumar Tewari, Kaveri Sharma, Christine Lock, Chen Min Wei, Julian Han, Janell Kwok, Nicolas Kon, Kam King, Emmalin Nelton, Louis Anthony Whitworth, Sonja Stutzman, Caryn Harper, Alice Salazar, Rocco Armonda, George B Moses, Patricia Tanjucto, Jamie Ullman, Orseola Arapi, Betsy Moclair, Nrupen Baxi, John Adair Prall, Meghan Baldwin, Jamie Jones, Clare Gallagher, Ish Bains, Leodante Da Costa, Fahad Alkherayf, Rafael Ochoa Sanchez, Kostas Fountas, Thanasis Paschalis, Sandro Krieg, Maria Luisa, Gandia Gomez, Alfonso Legares, Ana Maria Castaño Leon, Gábor Lenzsér, Mukhtar Khan, Massimo Tomei, Ronie Romelean Jayapalan, Sarah C Pyne, A David Mendelow, Christopher Cowie, Carol Davis-Wilkie, Tapiwa Tungamirai, Kerstin Wolf, Natalia Igosheva, Alicia Gore, Michele Jillings, Christopher Bushell, and Peter McCabe

Subjects
Medicine
Abstract

Objective To estimate the cost-effectiveness of craniotomy, compared with decompressive craniectomy (DC) in UK patients undergoing evacuation of acute subdural haematoma (ASDH).Design Economic evaluation undertaken using health resource use and outcome data from the 12-month multicentre, pragmatic, parallel-group, randomised, Randomised Evaluation of Surgery with Craniectomy for Patients Undergoing Evacuation-ASDH trial.Setting UK secondary care.Participants 248 UK patients undergoing surgery for traumatic ASDH were randomised to craniotomy (N=126) or DC (N=122).Interventions Surgical evacuation via craniotomy (bone flap replaced) or DC (bone flap left out with a view to replace later: cranioplasty surgery).Main outcome measures In the base-case analysis, costs were estimated from a National Health Service and Personal Social Services perspective. Outcomes were assessed via the quality-adjusted life-years (QALY) derived from the EuroQoL 5-Dimension 5-Level questionnaire (cost-utility analysis) and the Extended Glasgow Outcome Scale (GOSE) (cost-effectiveness analysis). Multiple imputation and regression analyses were conducted to estimate the mean incremental cost and effect of craniotomy compared with DC. The most cost-effective option was selected, irrespective of the level of statistical significance as is argued by economists.Results In the cost-utility analysis, the mean incremental cost of craniotomy compared with DC was estimated to be −£5520 (95% CI −£18 060 to £7020) with a mean QALY gain of 0.093 (95% CI 0.029 to 0.156). In the cost-effectiveness analysis, the mean incremental cost was estimated to be −£4536 (95% CI −£17 374 to £8301) with an OR of 1.682 (95% CI 0.995 to 2.842) for a favourable outcome on the GOSE.Conclusions In a UK population with traumatic ASDH, craniotomy was estimated to be cost-effective compared with DC: craniotomy was estimated to have a lower mean cost, higher mean QALY gain and higher probability of a more favourable outcome on the GOSE (though not all estimated differences between the two approaches were statistically significant).Ethics Ethical approval for the trial was obtained from the North West—Haydock Research Ethics Committee in the UK on 17 July 2014 (14/NW/1076).Trial registration number ISRCTN87370545.

Published
2024
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2. 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

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, 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, Dymona McAleer, Belinda Gunning, Emma Clarkson, Cathy Stoneley, Jibril Osman Farah, Niamh Bohnacker, Rosette Marimon, Lydia Parker, Puneet Sharma, 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, and Jade McAndrew

Subjects
Medicine
Abstract

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.

Published
2023
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4. Microdialysis

Author

Mathew Guilfoyle, Ivan Timofeev, and Peter Hutchinson

Published
2018

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