BMJ Open (Apr 2021)
UK Chiari 1 Study: protocol for a prospective, observational, multicentre study
- ,
- Joseph Merola,
- Julie Woodfield,
- Linda D’Antona,
- Richard Edwards,
- Jothy Kandasamy,
- Paul Leach,
- Mano Shanmuganathan,
- Saurabh Sinha,
- Dominic Thompson,
- Lewis Thorne,
- Ahmed Toma,
- Shungu Ushewokunze,
- Laurence Watkins,
- James Stewart,
- Angelos G Kolias,
- Jayaratnam Jayamohan,
- Pasquale Gallo,
- Navneet Singh,
- Ashwin Kumaria,
- Rhannon Lobo,
- Marianne Hare,
- Louise Young,
- Ardalan Zolnourian,
- Rory J Piper,
- Daniel Thompson,
- Greg James,
- Georgios Tsermoulas,
- Rosa Sun,
- William B Lo,
- Wai Cheong Soon,
- Babar Vaqas,
- Muhammad Kamal,
- Fardad T Afshari,
- Edward W Dyson,
- Rodney Laing,
- Aabir Chakraborty,
- Adrian Casey,
- Adriana Baritchii,
- Alexandros Vyziotis,
- Ali Nader-Sephai,
- Alistair Jenkins,
- Amin Andalib,
- Anan Shtaya,
- Andrew Alalade,
- Andrew Brodbelt,
- Arup Ray,
- Asfand Baig Mirza,
- Aswin Chari,
- Barrie White,
- Benedetta Pettorini,
- Chandrasekaran Kaliaperumal,
- Danyal Khan,
- Dardis Ronan,
- David Choi,
- David Rowland,
- Edward Jerome St George,
- Eleni Maratos,
- Grainne McKenna,
- Hani Marcus,
- Hasan Asif,
- Hugo Layard Horsfall,
- Ian Kamaly-Asl,
- Ibrahim Jalloh,
- Jawad Naushahi,
- Joe M Das,
- John Duddy,
- Jonathan Funnell,
- Justyna Ekert,
- Kevin Tsang,
- Lizkerry Odeh,
- Makinah Haq,
- Mansoor Foroughi,
- Mark Nowell,
- Matthew Boissaud-Cooke,
- Melissa Gough,
- Menaka Paranathala,
- Micaela Uberti,
- Michael Cearns,
- Milan Makwana,
- Milo Hollingworth,
- Ming Yao Chong,
- Musa China,
- Nadia Salloum,
- Nicholas Haden,
- Nikolaos Tzerakis,
- Oscar MacCormac,
- Peter McGarrity,
- Rudrajit Kanjilal,
- Ryan Waters,
- Saeed Kayhanian,
- Samuel Jeffery,
- Setthasorn Zhi Yang Ooi,
- Shabin Joshi,
- Shady Elsayed,
- Shafqat Bukhari,
- Shailendra Magdum,
- Siddharth Sinha,
- Simon Lammy,
- Stana Bojanic,
- Stewart Griffiths,
- Teresa Scott,
- Thomas Carroll,
- Vasileios Raptopoulos,
- Vivek Josan,
- Yasir Chowdhury,
- Zubair Tahir
Affiliations
- Joseph Merola
- Julie Woodfield
- Linda D’Antona
- UCL Queen Square Institute of Neurology, London, UK
- Richard Edwards
- Public Health, University of Otago, Wellington, New Zealand
- Jothy Kandasamy
- Paul Leach
- Mano Shanmuganathan
- Saurabh Sinha
- Dominic Thompson
- Department of Paediatric Neurosurgery, Great Ormond Street Hospital, London, UK
- Lewis Thorne
- Victor Horsley Department of Neurosurgery, National Hospital for Neurology and Neurosurgery, London, UK
- Ahmed Toma
- Shungu Ushewokunze
- Laurence Watkins
- Department of Neurosurgery, National Hospital for Neurology and Neurosurgery, University College London Hospitals NHS Foundation Trust, London, UK
- James Stewart
- 1 Royal Marsden Hospital NHS Trust, London, UK
- Angelos G Kolias
- 2 Department of Clinical Neurosciences, University of Cambridge, Cambridge, UK
- Jayaratnam Jayamohan
- Department of Neurosurgery, John Radcliffe Hospital, Oxford, UK
- Pasquale Gallo
- Navneet Singh
- Ashwin Kumaria
- Rhannon Lobo
- Marianne Hare
- Louise Young
- 3Imperial College Healthcare NHS Trust
- Ardalan Zolnourian
- 7 University Hospital Southampton NHS Foundation Trust, Southampton, UK
- Rory J Piper
- Department of Neurosurgery, John Radcliffe Hospital, Oxford, UK
- Daniel Thompson
- Independent Statistical Consultant, Tallahassee, Florida, USA
- Greg James
- Georgios Tsermoulas
- Rosa Sun
- William B Lo
- 2 Neurosurgery, Birmingham Women`s and Children`s NHS Foundation Trust, Birmingham, UK
- Wai Cheong Soon
- Department of Neurosurgery, Queen Elizabeth Hospital, Birmingham, UK
- Babar Vaqas
- Muhammad Kamal
- Fardad T Afshari
- Department of Neurosurgery, Queen Elizabeth Hospital, Birmingham, UK
- Edward W Dyson
- Department of Neurosurgery, National Hospital for Neurology and Neurosurgery, University College London Hospitals NHS Foundation Trust, London, UK
- Rodney Laing
- Division of Neurosurgery, Department of Clinical Neurosciences, University of Cambridge, Cambridge, UK
- Aabir Chakraborty
- Adrian Casey
- Adriana Baritchii
- Alexandros Vyziotis
- Department of Neurosurgery, Manchester Centre for Clinical Neuroscience, Salford Royal Hospital, Northern Care Alliance, Manchester, UK
- Ali Nader-Sephai
- Alistair Jenkins
- Department of Neurosurgery, Royal Victoria Infirmary, Newcastle upon Tyne, UK
- Amin Andalib
- Anan Shtaya
- Andrew Alalade
- Andrew Brodbelt
- Arup Ray
- Asfand Baig Mirza
- Aswin Chari
- Department of Neurosurgery, Great Ormond Street Hospital, London, UK
- Barrie White
- Benedetta Pettorini
- Chandrasekaran Kaliaperumal
- Danyal Khan
- Queen Square Institute of Neurology, University College London, London, UK
- Dardis Ronan
- David Choi
- Department of Neurosurgery, National Hospital for Neurology and Neurosurgery, London, UK
- David Rowland
- Victor Horsely Department of Neurosurgery, National Hospital for Neurology and Neurosurgery, London, UK
- Edward Jerome St George
- Eleni Maratos
- Grainne McKenna
- Hani Marcus
- Hasan Asif
- Hugo Layard Horsfall
- Ian Kamaly-Asl
- Ibrahim Jalloh
- Jawad Naushahi
- Joe M Das
- John Duddy
- Jonathan Funnell
- Justyna Ekert
- Kevin Tsang
- Lizkerry Odeh
- Makinah Haq
- Mansoor Foroughi
- Mark Nowell
- Matthew Boissaud-Cooke
- Melissa Gough
- Department of Neurosurgery, Royal Victoria Infirmary Newcastle Hospitals NHS Trust, Newcastle, UK
- Menaka Paranathala
- Micaela Uberti
- Michael Cearns
- Milan Makwana
- Milo Hollingworth
- Ming Yao Chong
- Musa China
- Nadia Salloum
- Nicholas Haden
- Nikolaos Tzerakis
- Department of Neurosurgery, University Hospitals of North Midlands NHS Trust, Stoke-on-Trent, UK
- Oscar MacCormac
- Peter McGarrity
- Rudrajit Kanjilal
- Ryan Waters
- Saeed Kayhanian
- Samuel Jeffery
- Setthasorn Zhi Yang Ooi
- Shabin Joshi
- Shady Elsayed
- Shafqat Bukhari
- Shailendra Magdum
- Siddharth Sinha
- Victor Horsely Department of Neurosurgery, National Hospital for Neurology and Neurosurgery, London, UK
- Simon Lammy
- Stana Bojanic
- Stewart Griffiths
- Teresa Scott
- Critical Care, NHS Grampian, Aberdeen, UK
- Thomas Carroll
- physician
- Vasileios Raptopoulos
- Vivek Josan
- Yasir Chowdhury
- Zubair Tahir
- 1Great Ormond Street Hospital for Children NHS Foundation Trust, UK
- DOI
- https://doi.org/10.1136/bmjopen-2020-043712
- Journal volume & issue
-
Vol. 11,
no. 4
Abstract
Introduction Chiari 1 malformation (CM1) is a structural abnormality of the hindbrain characterised by the descent of the cerebellar tonsils through the foramen magnum. The management of patients with CM1 remains contentious since there are currently no UK or international guidelines for clinicians. We therefore propose a collaborative, prospective, multicentre study on the investigation, management and outcome of CM1 in the UK: the UK Chiari 1 Study (UKC1S). Our primary objective is to determine the health-related quality of life (HRQoL) in patients with a new diagnosis of CM1 managed either conservatively or surgically at 12 months of follow-up. We also aim to: (A) determine HRQoL 12 months following surgery; (B) measure complications 12 months following surgery; (C) determine the natural history of patients with CM1 treated conservatively without surgery; (D) determine the radiological correlates of presenting symptoms, signs and outcomes; and (E) determine the scope and variation within UK practice in referral patterns, patient pathways, investigations and surgical decisions.Methods and analysis The UKC1S will be a prospective, multicentre and observational study that will follow the British Neurosurgical Trainee Research Collaborative model of collaborative research. Patients will be recruited after attending their first neurosurgical outpatient clinic appointment. Follow-up data will be collected from all patients at 12 months from baseline regardless of whether they are treated surgically or not. A further 12-month postoperative follow-up timepoint will be added for patients treated with decompressive surgery. The study is expected to last three years.Ethics and dissemination The UKC1S received a favourable ethical opinion from the East Midlands Leicester South Research Ethics Committee (REC reference: 20/EM/0053; IRAS 269739) and the Health Research Authority. The results of the study will be published in peer-reviewed medical journals, presented at scientific conferences, shared with collaborating sites and shared with participant patients if they so wish.
