Risk of Aneurysm Rupture (ROAR) study: protocol for a long-term, longitudinal, UK multicentre study of unruptured intracranial aneurysms. Issue 3 (16th March 2023)

• Record Type: Journal Article
• Authors: Hall, Samuel; Birks, Jacqueline; Anderson, Ian; Bacon, Andrew; Brennan, Paul M; Bennett, David; Chavredakis, Emmanuel; Critchley, Giles; Dow, Graham; Downer, Jonathan; Galea, James; Grover, Patrick; Gurusinghe, Nihal; Helmy, Adel; Kounin, Gueorgui; Mukerji, Nitin; Patel, Hiren; Patel, Jash; Ross, Nicholas; St George, Jerome; Teo, Mario; Tolias, Christos Michael; Tzerakis, Nikolaos; Uff, Christopher; van Beijum, Janneke; Veighey, Kristin; White, Edward; Whitfield, Peter; Bulters, Diederik Oliver
• Other Names: author non-byline.; Ewbank Frederick author non-byline.; Mitrasinovic Stefan author non-byline.; Croft Oliver author non-byline.; Townsend Dominic author non-byline.; Kalra Neeraj author non-byline.; Kirkpatrick Imogen author non-byline.; Handy Nicole author non-byline.; Rossdeutsch Alex author non-byline.; Courtney Ellie author non-byline.; Stone Zoe author non-byline.; Loan James author non-byline.; Wiggins Anthony author non-byline.; Park Jay author non-byline.; Rafferty Niamh author non-byline.; McSorley Nathan author non-byline.; Anand Ajitesh author non-byline.; Nazari Armin author non-byline.; Sokratous Giannis author non-byline.; Taweel Basel author non-byline.; Goyal Kartik author non-byline.; Norris John author non-byline.; Culley Hannah-Marie author non-byline.; Arora Mukul author non-byline.; Hollingworth Milo author non-byline.; Burns Megan author non-byline.; Armstrong Benjamin author non-byline.; Bhatt Harsh author non-byline.; Lowes David author non-byline.; Faulkner Debra author non-byline.; Hill Ciaran author non-byline.; Dasgupta Debayan author non-byline.; Yaqub Shuja author non-byline.; Phuah Yuzhi author non-byline.; Sluijters Olivier author non-byline.; Oskooee Neda author non-byline.; Pamar Viraj author non-byline.; Elmenofi Tarek author non-byline.; Ekert Justyna author non-byline.; Fung Alex author non-byline.; Legge Rebecca author non-byline.; Deepak Srihari author non-byline.; Veerappan Vigneshwar author non-byline.; Gupta Swarnava author non-byline.; Sasane Sumeet author non-byline.; Tan May Ting author non-byline.; Ferguson Lucie author non-byline.; Myers Matthew author non-byline.; Bonardi Antonio author non-byline.; Tetlow Holly author non-byline.; Dunkerley Charlotte author non-byline.; Pandey Malvika author non-byline.; Giffin William author non-byline.; Lokman Iqbal Bin author non-byline.; Hurst Danielle author non-byline.; Ahari Daniel author non-byline.; Borg Anouk author non-byline.; Papadias Thanos author non-byline.; Kehoe Kristy author non-byline.; Cheong Jeremy author non-byline.; Davies Isabella author non-byline.; Peplowska Taisha author non-byline.; Ulrich James author non-byline.; Draz Mohammed author non-byline.; Krivankova Barbora author non-byline.; Homyer Katy author non-byline.; Evans Vivienne author non-byline.; Tominey Steven author non-byline.; Chaudhary Attika author non-byline.; Tengku Sabrina author non-byline.; Middleton Eilidh author non-byline.; Lub Sytske author non-byline.; Ismahel Hassan author non-byline.; Wilinska Michalina author non-byline.; Duncan Nicola author non-byline.; Igoli Joanne author non-byline.; Sandaram Ritika author non-byline.; Hodnett Rebecca author non-byline.; Nazar Naadir author non-byline.; Sorr Omar Ouaret author non-byline.; Camp Fatima author non-byline.; Ferreira Tom author non-byline.; Fisher Benjamin author non-byline.; Rajashekar Devika author non-byline.; Dumbrell Rachel author non-byline.; Muthukumar Ananya author non-byline.; Anas Mohammad author non-byline.; Nwosu Lilian author non-byline.; Holmes Ariadne author non-byline.; Ogbu Ikenna author non-byline.; Pasca Madalina author non-byline.; Patel Veer author non-byline.; Dashti Mustafa author non-byline.; Sibanda Zeluleko author non-byline.; Hwang Erin author non-byline.; Adil Zara author non-byline.; Matloob Samir author non-byline.; Chow Vanessa author non-byline.; Sun Rosa author non-byline.; Vimal Aparnu author non-byline.; Chaudri Talhah author non-byline.; Baldwin Lauren author non-byline.; Maripi Haritha author non-byline.; Borbas Balint author non-byline.; Mujeeb Mariyam author non-byline.;
• Is Part Of: BMJ open. Volume 13:Issue 3(2023)
• Publication Date: 2023-03-16
• Subjects: epidemiology -- stroke -- neurosurgery; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2022-070504
• Languages: English
• ISSNs: 2044-6055

Abstract

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 .