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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, Rasheed Zakaria, 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, 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. Specialist healthcare services for concussion/mild traumatic brain injury in England: a consensus statement using modified Delphi methodology

Author

Antonio Belli, Vanessa Raymont, Damian Holliman, Catherine McMahon, Peter Whitfield, Mark Wilson, Angelos G Kolias, Ben Jones, Richard Sylvester, Mario Ganau, Michael Parker, Shrouk Messahel, Peter John Hutchinson, Clint Gomes, Michael Grey, Michael Griffiths, Adel Helmy, Kanchan Sharma, Rupert Noad, Peter Jenkins, Emma Woodberry, Elika Karvandi, Timothy Griffiths, Philippa Griffiths, Tim Lawrence, Terence McLoughlin, Joanne Newton, and Daniel Tadmor

Subjects
Medicine
Abstract

Objective To establish a consensus on the structure and process of healthcare services for patients with concussion in England to facilitate better healthcare quality and patient outcome.Design This consensus study followed the modified Delphi methodology with five phases: participant identification, item development, two rounds of voting and a meeting to finalise the consensus statements. The predefined threshold for agreement was set at ≥70%.Setting Specialist outpatient services.Participants Members of the UK Head Injury Network were invited to participate. The network consists of clinical specialists in head injury practising in emergency medicine, neurology, neuropsychology, neurosurgery, paediatric medicine, rehabilitation medicine and sports and exercise medicine in England.Primary outcome measure A consensus statement on the structure and process of specialist outpatient care for patients with concussion in England.Results 55 items were voted on in the first round. 29 items were removed following the first voting round and 3 items were removed following the second voting round. Items were modified where appropriate. A final 18 statements reached consensus covering 3 main topics in specialist healthcare services for concussion; care pathway to structured follow-up, prognosis and measures of recovery, and provision of outpatient clinics.Conclusions This work presents statements on how the healthcare services for patients with concussion in England could be redesigned to meet their health needs. Future work will seek to implement these into the clinical pathway.

Published
2023
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3. Risk of Aneurysm Rupture (ROAR) study: protocol for a long-term, longitudinal, UK multicentre study of unruptured intracranial aneurysms

Author

Hiren Patel, James Galea, Giles Critchley, Nitin Mukerji, Nicholas Ross, Peter Whitfield, Jay Park, Harsh Bhatt, Megan Burns, Zoe Stone, Paul M Brennan, Jacqueline Birks, John Norris, Diederik Oliver Bulters, David Bennett, Stefan Mitrasinovic, Benjamin Fisher, Dominic Townsend, Kristin Veighey, Jonathan Downer, Rosa Sun, Andrew Bacon, Christos Michael Tolias, Justyna Ekert, Milo Hollingworth, Nikolaos Tzerakis, Ian Anderson, Edward White, Adel Helmy, Samir Matloob, Matthew Myers, Armin Nazari, Christopher Uff, Patrick Grover, Nathan McSorley, Alex Fung, Shuja Yaqub, Neeraj Kalra, James Ulrich, Rebecca Hodnett, Graham Dow, Steven Tominey, Mario Teo, Kristy Kehoe, Jeremy Cheong, Devika Rajashekar, Debayan Dasgupta, James Loan, Samuel Hall, Ajitesh Anand, Talhah Chaudri, Emmanuel Chavredakis, Nihal Gurusinghe, Gueorgui Kounin, Jash Patel, Jerome St George, Janneke van Beijum, Frederick Ewbank, Oliver Croft, Imogen Kirkpatrick, Nicole Handy, Alex Rossdeutsch, Ellie Courtney, Anthony Wiggins, Niamh Rafferty, Giannis Sokratous, Basel Taweel, Kartik Goyal, Hannah-Marie Culley, Mukul Arora, Benjamin Armstrong, David Lowes, Debra Faulkner, Ciaran Hill, Yuzhi Phuah, Olivier Sluijters, Neda Oskooee, Viraj Pamar, Tarek Elmenofi, Rebecca Legge, Srihari Deepak, Vigneshwar Veerappan, Swarnava Gupta, Sumeet Sasane, May Ting Tan, Lucie Ferguson, Antonio Bonardi, Holly Tetlow, Charlotte Dunkerley, Malvika Pandey, William Giffin, Iqbal Bin Lokman, Danielle Hurst, Daniel Ahari, Anouk Borg, Thanos Papadias, Isabella Davies, Taisha Peplowska, Mohammed Draz, Barbora Krivankova, Katy Homyer, Vivienne Evans, Attika Chaudhary, Sabrina Tengku, Eilidh Middleton, Sytske Lub, Hassan Ismahel, Michalina Wilinska, Nicola Duncan, Joanne Igoli, Ritika Sandaram, Naadir Nazar, Omar Ouaret Sorr, Fatima Camp, Tom Ferreira, Rachel Dumbrell, Ananya Muthukumar, Mohammad Anas, Lilian Nwosu, Ariadne Holmes, Ikenna Ogbu, Madalina Pasca, Veer Patel, Mustafa Dashti, Zeluleko Sibanda, Erin Hwang, Zara Adil, Vanessa Chow, Aparnu Vimal, Lauren Baldwin, Haritha Maripi, Balint Borbas, and Mariyam Mujeeb

Subjects
Medicine
Abstract

Introduction Unruptured intracranial aneurysms (UIA) are common in the adult population, but only a relatively small proportion will rupture. It is therefore essential to have accurate estimates of rupture risk to target treatment towards those who stand to benefit and avoid exposing patients to the risks of unnecessary treatment. The best available UIA natural history data are the PHASES study. However, this has never been validated and given the known heterogeneity in the populations, methods and biases of the constituent studies, there is a need to do so. There are also many potential predictors not considered in PHASES that require evaluation, and the estimated rupture risk is largely based on short-term follow-up (mostly 1 year). The aims of this study are to: (1) test the accuracy of PHASES in a UK population, (2) evaluate additional predictors of rupture and (3) assess long-term UIA rupture rates.Methods and analysis The Risk of Aneurysm Rupture study is a longitudinal multicentre study that will identify patients with known UIA seen in neurosurgery units. Patients will have baseline demographics and aneurysm characteristics collected by their neurosurgery unit and then a single aggregated national cohort will be linked to databases of hospital admissions and deaths to identify all patients who may have subsequently suffered a subarachnoid haemorrhage. All matched admissions and deaths will be checked against medical records to confirm the diagnosis of aneurysmal subarachnoid haemorrhage. The target sample size is 20 000 patients. The primary outcome will be aneurysm rupture resulting in hospital admission or death. Cox regression models will be built to test each of the study’s aims.Ethics and dissemination Ethical approval has been given by South Central Hampshire A Research Ethics Committee (21SC0064) and Confidentiality Advisory Group support (21CAG0033) provided under Section 251 of the NHS Act 2006. The results will be disseminated in peer-reviewed journals.Trial registration number ISRCTN17658526.

Published
2023
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4. Imaging timing after glioblastoma surgery (INTERVAL-GB): protocol for a UK and Ireland, multicentre retrospective cohort study

Author

Oliver Burton, Julie Woodfield, Daniel Richardson, Giles Critchley, Angelos Kolias, Thomas Santarius, Lewis Thorne, Peter Whitfield, Ola Rominiyi, Bharti Kewlani, Harsh Bhatt, Ahmed Ahmed, Michael O’Sullivan, Rasheed Zakaria, Michael D Jenkinson, Gerard Thompson, Paul M Brennan, Rory Piper, Seong Hoon Lee, Neil Barua, Engelbert Mthunzi, Sara Venturini, Daniel M Fountain, Najma Ahmed, Stephen J Price, Colin Watts, Michael T C Poon, Stuart Smith, Anand Pandit, Ryan K Mathew, Soham Bandyopadhyay, Rosa Sun, Setthasorn Zhi Yang Ooi, Victoria Wykes, William Bolton, Abdullah Egiz, Samantha J Mills, Babar Vaqas, Natalie Simon, Puneet Plaha, Georgios Solomou, Aswin Chari, Grainne McKenna, Melissa Gough, Simon Lammy, Sophie T Williams, Isabelle Williams, Andrew J Martin, Sam Hodgson, Robert Spencer, Adam Waldman, Armin Nazari, Joshua Erhabor, Omar Salim, Saad Moughal, Chinedu Brian Egu, Abdurrahman I Islim, Christopher P Millward, Suhaib Abualsaud, Michael Amoo, Neeraj Kalra, Agbolahan Sofela, Thomas C Booth, George E Richardson, Conor S Gillespie, Orla Mantle, Abigail Clynch, Jay J Park, Emily R Bligh, Avani Shanbhag, Moritz Steinruecke, Alvaro Yanez Touzet, Hannah Redpath, Gideon Adegboyega, Prithvi Bahu, Rosaline de Koning, Tomas Ferreira, Dana Hutton, Jashan Selvakumar, Tiffany TS Ye, Ashvin Kuri, Robin Borchert, Bea Duric, Elena Roman, Kristy Kehoe, Jeremy Cheong, Lauren Harris, Mohammad A Mustafa, Hidayatul Abdullmalek, Chinelo Afulukwe, Abdelsalam Nedal Al-Sousi, Yahia Al-Tamimi, Ajitesh Anand, Peter Bodkin, Ion Boiangiu, Abbey Boyle, Christiaan Bredell, Talhah Chaudri, Ana Cios, Iona Cleer, David Coope, Ian Coulter, Harriet Davis, Paolo Jose De Luna, Nayan Dey, Justyna O Ekert, Jinendra Ekanayake, Anna Elso, Tom Flannery, Kwan Wai Fung, Rahul Ganguly, Sanay Goyal, Emily Hardman, Theodore Hirst, Kelvin Sunn Hoah, Kismet Hossain-Ibrahim, Lena Mary Houlihan, Sami Squali Houssaini, Sadid Hoque, Mahnoor Javed, Siddarth Kannan, Efthymia Maria Kapasouri, Andrew Keenlyside, Prerna Khanna, Kunalika Sathish Kumar, Eunkyung Lee, Robert Magouirk, Riccardo Masina, Adele Mazzoleni, Patrick McAleavey, Daniel McSweeney, Trinh Ton Nu Ngoc, Shiva A Nischal, Jonathan Pesic-Smith, Peter Peterson, Isaac Phang, Shyam Pujara, Marwa Mohammed Elrasheed Saad, Shinjan Sangal, Veekshith Shetty, Irtiza Syed, Jesvin Tom Sunny, Anca-Mihaela Vasilica, Daniel O’Flaherty, Arslan Khaliq Raja, Daniele Ramsay, Renitha Reddi, Dorina Roy, Jeremiah Samkutty, Edward Jerome St George, Preethi Subramanian, Vaibhav Sundaresan, Kieron Sweeney, Boon Hoe Tan, Nicole Turnbull, Yuewei Tao, Rebecca Tweedie, Anastasia Tzatzidou, Kathrin Whitehouse, Jack Wildman, Karl Williams, Kelvin Sunn Yap, Mahir Yousuff, Asaad Zulfiqar, Sophie Camp, and Setthasorn ZY Ooi

Subjects
Medicine
Abstract

Introduction Glioblastoma is the most common malignant primary brain tumour with a median overall survival of 12–15 months (range 6–17 months), even with maximal treatment involving debulking neurosurgery and adjuvant concomitant chemoradiotherapy. The use of postoperative imaging to detect progression is of high importance to clinicians and patients, but currently, the optimal follow-up schedule is yet to be defined. It is also unclear how adhering to National Institute for Health and Care Excellence (NICE) guidelines—which are based on general consensus rather than evidence—affects patient outcomes such as progression-free and overall survival. The primary aim of this study is to assess MRI monitoring practice after surgery for glioblastoma, and to evaluate its association with patient outcomes.Methods and analysis ImagiNg Timing aftER surgery for glioblastoma: an eVALuation of practice in Great Britain and Ireland is a retrospective multicentre study that will include 450 patients with an operated glioblastoma, treated with any adjuvant therapy regimen in the UK and Ireland. Adult patients ≥18 years diagnosed with glioblastoma and undergoing surgery between 1 August 2018 and 1 February 2019 will be included. Clinical and radiological scanning data will be collected until the date of death or date of last known follow-up. Anonymised data will be uploaded to an online Castor database. Adherence to NICE guidelines and the effect of being concordant with NICE guidelines will be identified using descriptive statistics and Kaplan-Meier survival analysis.Ethics and dissemination Each participating centre is required to gain local institutional approval for data collection and sharing. Formal ethical approval is not required since this is a service evaluation. Results of the study will be reported through peer-reviewed presentations and articles, and will be disseminated to participating centres, patients and the public.

Published
2022
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5. Risk of Aneurysm Rupture (ROAR) study: protocol for a long-term, longitudinal, UK multicentre study of unruptured intracranial aneurysms

Author

Samuel Hall, Jacqueline Birks, Ian Anderson, Andrew Bacon, Paul M Brennan, David Bennett, Emmanuel Chavredakis, Giles Critchley, Graham Dow, Jonathan Downer, James Galea, Patrick Grover, Nihal Gurusinghe, Adel Helmy, Gueorgui Kounin, Nitin Mukerji, Hiren Patel, Jash Patel, Nicholas Ross, Jerome St George, Mario Teo, Christos Michael Tolias, Nikolaos Tzerakis, Christopher Uff, Janneke van Beijum, Kristin Veighey, Edward White, Peter Whitfield, and Diederik Oliver Bulters

Subjects
Adult, Subarachnoid Hemorrhage/etiology, Risk Factors, United Kingdom/epidemiology, Intracranial Aneurysm/surgery, Humans, Multicenter Studies as Topic, General Medicine, Aneurysm, Ruptured/epidemiology
Abstract

IntroductionUnruptured intracranial aneurysms (UIA) are common in the adult population, but only a relatively small proportion will rupture. It is therefore essential to have accurate estimates of rupture risk to target treatment towards those who stand to benefit and avoid exposing patients to the risks of unnecessary treatment. The best available UIA natural history data are the PHASES study. However, this has never been validated and given the known heterogeneity in the populations, methods and biases of the constituent studies, there is a need to do so. There are also many potential predictors not considered in PHASES that require evaluation, and the estimated rupture risk is largely based on short-term follow-up (mostly 1 year). The aims of this study are to: (1) test the accuracy of PHASES in a UK population, (2) evaluate additional predictors of rupture and (3) assess long-term UIA rupture rates.Methods and analysisThe Risk of Aneurysm Rupture study is a longitudinal multicentre study that will identify patients with known UIA seen in neurosurgery units. Patients will have baseline demographics and aneurysm characteristics collected by their neurosurgery unit and then a single aggregated national cohort will be linked to databases of hospital admissions and deaths to identify all patients who may have subsequently suffered a subarachnoid haemorrhage. All matched admissions and deaths will be checked against medical records to confirm the diagnosis of aneurysmal subarachnoid haemorrhage. The target sample size is 20 000 patients. The primary outcome will be aneurysm rupture resulting in hospital admission or death. Cox regression models will be built to test each of the study’s aims.Ethics and disseminationEthical approval has been given by South Central Hampshire A Research Ethics Committee (21SC0064) and Confidentiality Advisory Group support (21CAG0033) provided under Section 251 of the NHS Act 2006. The results will be disseminated in peer-reviewed journals.Trial registration numberISRCTN17658526.

Published
2023

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