학술논문
Risk of Aneurysm Rupture (ROAR) study: protocol for a long-term, longitudinal, UK multicentre study of unruptured intracranial aneurysms
Document Type
article
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; Mariyam Mujeeb
Source
BMJ Open, Vol 13, Iss 3 (2023)
Subject
Language
English
ISSN
2044-6055
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.