BMJ Open (May 2022)
Development of ‘Core Outcome Sets’ for Meningioma in Clinical Studies (The COSMIC Project): protocol for two systematic literature reviews, eDelphi surveys and online consensus meetings
- ,
- James Snyder,
- Nisaharan Srikandarajah,
- Boris Krischek,
- Matthias Preusser,
- Michael Weller,
- Timothy J Kaufmann,
- Thomas Santarius,
- Carole Turner,
- Michael D Cusimano,
- Paula R Williamson,
- Michael McDermott,
- Michael D Jenkinson,
- Justin Wang,
- Mohsen Javadpour,
- Andrea Saladino,
- Anthony G Marson,
- David James,
- Chaya Brodie,
- Daniel M Fountain,
- Roland Goldbrunner,
- Felix Sahm,
- Sylvia Kurz,
- Colin Watts,
- Julian Spears,
- Amir H Zamanipoor Najafabadi,
- Simon Walling,
- Andrew Morokoff,
- Ghazaleh Tabatabai,
- Helen Shih,
- Linda Dirven,
- Puneet Plaha,
- Helen Bulbeck,
- David Schultz,
- Christian Mawrin,
- Jens Schittenhelm,
- Farshad Nassiri,
- Martin J B Taphoorn,
- Manfred Westphal,
- Warren Selman,
- C Oliver Hanemann,
- Patrick Y Wen,
- Mirjam Renovanz,
- Evanthia Galanis,
- Alireza Mansouri,
- Priscilla K Brastianos,
- Christine Jungk,
- Heather Barrington,
- Aaron Cohen-Gadol,
- Gelareh Zadeh,
- Abdurrahman I Islim,
- Christopher P Millward,
- Theo Georgious,
- Andrew R Brodbelt,
- Karolyn Au,
- Felix Behling,
- Nicholas Butowski,
- Ana Castro,
- Marta Couce,
- Francesco Dimeco,
- Craig Erker,
- Michelle Felicella,
- Norbert Galldiks,
- Caterina Giannini,
- Christel Herold-Mende,
- Luke Hnenny,
- Craig Horbinski,
- Gerhard Jungwirth,
- Daniel Lachance,
- Christian Lafougere,
- Katrin Lamszus,
- Serge Makarenko,
- Tathiana Malta,
- Jennifer Moliterno-Gunel,
- Houtan Noushmehr,
- Arie Perry,
- Aditya Ragunathan,
- David Raleigh,
- Franz Ricklefs,
- Antonio Santacroce,
- Christian Schichor,
- Andrew Sloan,
- Matija Snuderl,
- Erik Sulman,
- Suganth Suppiah,
- Marcos Tatagiba,
- Marco Timmer,
- Andreas Von Deimling,
- Tobias Walbert,
- Stephen Yip,
- Gabriel Zada,
- Viktor Zherebitskiy,
- Derek Tsang,
- Kenneth Aldape,
- Terri S Armstrong,
- Sabrina Bell,
- Anna Crofton,
- Paul L Grundy,
- Sumirat M Keshwara,
- Shelli D Koszdin,
- Michael W McDermott,
- Torstein R Meling,
- Kathy Oliver,
- Jill Barnhartz-Sloan,
- Wenya Linda Bi,
- Carlos Carlotti,
- Katharine Drummond,
- Ian F Dunn,
- Brent Griffith,
- Rintaro Hashizume,
- Raymond Y Huang,
- Ian Lee,
- Jeff C Liu,
- Yasin Mamatjan,
- David Munoz,
- Ho-Keung Ng,
- Farhad Pirouzmand,
- Laila M Poisson,
- Bianca Pollo,
- Nils O Schmidt,
- Daniela Tirapelli,
- Joerg C Tonn,
- Michael A Vogelbaum,
- Adriana M Workewych
Affiliations
- The Royal College of Emergency Medicine, London, London, UK
- James Snyder
- 1 The Center for Applied Genomics, Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania, USA
- Nisaharan Srikandarajah
- 4 Department of Neurosurgery, Walton Centre NHS Foundation Trust, Liverpool, UK
- Boris Krischek
- Matthias Preusser
- Division of Oncology, Department of Medicine 1, Medizinische Universitat Wien, Wien, Austria
- Michael Weller
- Department of Neurology and Clinical Neuroscience Center, University Hospital Zurich, Zurich, Switzerland
- Timothy J Kaufmann
- 2 Department of Radiology, Mayo Clinic, Rochester, Minnesota, USA
- Thomas Santarius
- Division of Neurosurgery, Department of Clinical Neurosciences, University of Cambridge & Addenbrooke`s Hospital, Cambridge, UK
- Carole Turner
- 2 Department of Clinical Neurosciences, University of Cambridge, Cambridge, UK
- Michael D Cusimano
- 1 Neurosurgery, St. Michael`s Hospital, Toronto, Ontario, Canada
- Paula R Williamson
- Department of Health Data Science, University of Liverpool, Liverpool, UK
- Michael McDermott
- Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK
- Michael D Jenkinson
- Institute of Systems, Molecular and Integrative Biology, University of Liverpool, Liverpool, Merseyside, UK
- Justin Wang
- Paediatric Intensive Care Unit, Birmingham Children’s Hospital NHS Foundation Trust, Birmingham B4 6NH, UK
- Mohsen Javadpour
- 1Royal College of Surgeons in Ireland, Dublin, Ireland
- Andrea Saladino
- Anthony G Marson
- Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK
- David James
- professor of fetomaternal medicine
- Chaya Brodie
- Daniel M Fountain
- Division of Neurosurgery, Department of Clinical Neurosciences, University of Cambridge & Addenbrooke`s Hospital, Cambridge, UK
- Roland Goldbrunner
- Felix Sahm
- Department of Neuropathology, University of Heidelberg, Heidelberg, Germany
- Sylvia Kurz
- Colin Watts
- Institute of Cancer and Genomic Studies, University of Birmingham, Birmingham, UK
- Julian Spears
- 28 Department of Medical Imaging, Division of Diagnostic and Therapeutic Neuroradiology, St. Michael’s Hospital, University of Toronto, Department of Medical Imaging, Division of Diagnostic and Therapeutic Neuroradiology, St. Michael’s Hospital, University of Toronto, Pessac, France
- Amir H Zamanipoor Najafabadi
- Department of Neurosurgery, University Neurosurgical Center Holland, Leiden University Medical Center, Haaglanden Medical Center and Haga Teaching Hospitals, Leiden and The Hague, The Netherlands
- Simon Walling
- Andrew Morokoff
- Ghazaleh Tabatabai
- 5University Hospital Tuebingen, Tuebingen, Germany
- Helen Shih
- 2 Radiation Oncology, Massachusetts General Hospital, Boston, Massachusetts, USA
- Linda Dirven
- 1 Department of Neurology, Leiden University Medical Center, Leiden, The Netherlands
- Puneet Plaha
- Department of Neursurgery, Oxford University Hospitals NHS Foundation Trust, Oxford, UK
- Helen Bulbeck
- Brainstrust, Cowes, UK
- David Schultz
- 5Neurology, Flinders Medical Centre, Bedford Park, SA, Australia
- Christian Mawrin
- Jens Schittenhelm
- 1 Department of Neuropathology, Institute of Pathology and Neuropathology, University Hospital of Tuebingen, Eberhard Karls University of Tuebingen, Tuebingen, Germany
- Farshad Nassiri
- 1 Division of Neurosurgery, University of Toronto, Toronto, Ontario, Canada
- Martin J B Taphoorn
- Department of Neurology, Leiden University Medical Center, Leiden, Zuid-Holland, The Netherlands
- Manfred Westphal
- Warren Selman
- C Oliver Hanemann
- Patrick Y Wen
- Center for Neuro-Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA
- Mirjam Renovanz
- 2 Department of Neurosurgery, Eberhard Karls University of Tuebingen, Baden-Württemberg, Germany
- Evanthia Galanis
- Division of Medical Oncology, Mayo Clinic Rochester, Rochester, Minnesota, USA
- Alireza Mansouri
- Department of Neurosurgery, Penn State Cancer Institute, Hershey, Pennsylvania, USA
- Priscilla K Brastianos
- Harvard Medical School, Boston, Massachusetts, USA
- Christine Jungk
- Department of Neurosurgery, University Hospital Heidelberg, Heidelberg, Germany
- Heather Barrington
- 1 Department of Health Data Science, University of Liverpool, Liverpool, UK
- Aaron Cohen-Gadol
- Gelareh Zadeh
- 1 Division of Neurosurgery, University of Toronto, Toronto, Ontario, Canada
- Abdurrahman I Islim
- Department of Neurosurgery, Manchester Centre for Clinical Neurosciences, Manchester, UK
- Christopher P Millward
- 1 Institute of Systems, Molecular and Integrative Biology, University of Liverpool, Liverpool, UK
- Theo Georgious
- Brain Tumor Charity, Fleet, UK
- Andrew R Brodbelt
- Institute of Systems, Molecular & Integrative Biology, University of Liverpool, Liverpool, UK
- Karolyn Au
- University of Alberta, Edmonton, Canada
- Felix Behling
- Nicholas Butowski
- Ana Castro
- Department of Anesthesiology, Hospital Pedro Hispano, Matosinhos, Portugal
- Marta Couce
- Francesco Dimeco
- Department of Neurological Surgery, Fondazione IRCCS Istituto Nazionale Neurologico Carlo Besta, Milano, Italy
- Craig Erker
- Michelle Felicella
- Norbert Galldiks
- Caterina Giannini
- Christel Herold-Mende
- Luke Hnenny
- Craig Horbinski
- Gerhard Jungwirth
- Daniel Lachance
- Christian Lafougere
- Katrin Lamszus
- Serge Makarenko
- Tathiana Malta
- Jennifer Moliterno-Gunel
- Houtan Noushmehr
- Arie Perry
- Aditya Ragunathan
- David Raleigh
- Franz Ricklefs
- Antonio Santacroce
- Christian Schichor
- Andrew Sloan
- Matija Snuderl
- Department of Pathology, New York University Langone Health and Grossman School of Medicine, New York, New York, USA
- Erik Sulman
- Suganth Suppiah
- Marcos Tatagiba
- Marco Timmer
- Andreas Von Deimling
- 4University of Heidelberg, Department of Neuropathology, Heidelberg, Germany
- Tobias Walbert
- Stephen Yip
- Gabriel Zada
- Viktor Zherebitskiy
- Derek Tsang
- 1Hospital for Sick Children, Toronto, ON, Canada
- Kenneth Aldape
- 2National Cancer Institute, Bethesda, MD, USA
- Terri S Armstrong
- 3 Neuro-Oncology Branch, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland, USA
- Sabrina Bell
- 5 The Brain Tumour Charity, Fleet, UK
- Anna Crofton
- 2 Department of Neurosurgery, The Walton Centre NHS Foundation Trust, Liverpool, UK
- Paul L Grundy
- 9 Department of Neurosurgery, University Hospital Southampton NHS Foundation Trust, Southampton, UK
- Sumirat M Keshwara
- 1 Institute of Systems, Molecular and Integrative Biology, University of Liverpool, Liverpool, UK
- Shelli D Koszdin
- 11 Pharmacy, Veterans Affairs Healthcare System, Palo Alto, California, USA
- Michael W McDermott
- 13 Division of Neuroscience, Florida International University, Miami, Florida, USA
- Torstein R Meling
- 14 Department of Neurosurgery, Geneva University Hospitals, Geneva, Switzerland
- Kathy Oliver
- 15 International Brain Tumour Alliance, Tadworth, UK
- Jill Barnhartz-Sloan
- Wenya Linda Bi
- Carlos Carlotti
- Katharine Drummond
- Ian F Dunn
- Brent Griffith
- Rintaro Hashizume
- Raymond Y Huang
- Ian Lee
- Jeff C Liu
- Yasin Mamatjan
- David Munoz
- Ho-Keung Ng
- Farhad Pirouzmand
- Laila M Poisson
- Bianca Pollo
- Nils O Schmidt
- Daniela Tirapelli
- Joerg C Tonn
- Michael A Vogelbaum
- Adriana M Workewych
- DOI
- https://doi.org/10.1136/bmjopen-2021-057384
- Journal volume & issue
-
Vol. 12,
no. 5
Abstract
Introduction Meningioma is the most common primary intracranial tumour in adults. The majority are non-malignant, but a proportion behave more aggressively. Incidental/minimally symptomatic meningioma are often managed by serial imaging. Symptomatic meningioma, those that threaten neurovascular structures, or demonstrate radiological growth, are usually resected as first-line management strategy. For patients in poor clinical condition, or with inoperable, residual or recurrent disease, radiotherapy is often used as primary or adjuvant treatment. Effective pharmacotherapy treatments do not currently exist. There is heterogeneity in the outcomes measured and reported in meningioma clinical studies. Two ‘Core Outcome Sets’ (COS) will be developed: (COSMIC: Intervention) for use in meningioma clinical effectiveness trials and (COSMIC: Observation) for use in clinical studies of incidental/untreated meningioma.Methods and analysis Two systematic literature reviews and trial registry searches will identify outcomes measured and reported in published and ongoing (1) meningioma clinical effectiveness trials, and (2) clinical studies of incidental/untreated meningioma. Outcomes include those that are clinician reported, patient reported, caregiver reported and based on objective tests (eg, neurocognitive tests), as well as measures of progression and survival. Outcomes will be deduplicated and categorised to generate two long lists. The two long lists will be prioritised through two, two-round, international, modified eDelphi surveys including patients with meningioma, healthcare professionals, researchers and those in caring/supporting roles. The two final COS will be ratified through two 1-day online consensus meetings, with representation from all stakeholder groups.Ethics and dissemination Institutional review board (University of Liverpool) approval was obtained for the conduct of this study. Participant eConsent will be obtained prior to participation in the eDelphi surveys and consensus meetings. The two systematic literature reviews and two final COS will be published and freely available.Trial registration number COMET study ID 1508
