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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.
Millward, Christopher P; Armstrong, Terri S; Barrington, Heather; Bell, Sabrina; Brodbelt, Andrew R; Bulbeck, Helen; Crofton, Anna; Dirven, Linda; Georgious, Theo; Grundy, Paul L; Islim, Abdurrahman I; Javadpour, Mohsen; Keshwara, Sumirat M; Koszdin, Shelli D; Marson, Anthony G; McDermott, Michael W; Meling, Torstein R; Oliver, Kathy; Plaha, Puneet; Preusser, Matthias; Santarius, Thomas; Srikandarajah, Nisaharan; Taphoorn, Martin J B; Turner, Carole; Watts, Colin; Weller, Michael; Williamson, Paula R; Zadeh, Gelareh; Zamanipoor Najafabadi, Amir H; Jenkinson, Michael D.
Afiliación
  • Millward CP; Institute of Systems, Molecular and Integrative Biology, University of Liverpool, Liverpool, UK drcpm@liverpool.ac.uk.
  • Armstrong TS; Department of Neurosurgery, The Walton Centre NHS Foundation Trust, Liverpool, UK.
  • Barrington H; Neuro-Oncology Branch, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland, USA.
  • Bell S; Institute of Population Health, University of Liverpool, Liverpool, UK.
  • Brodbelt AR; The Brain Tumour Charity, Fleet, UK.
  • Bulbeck H; Institute of Systems, Molecular and Integrative Biology, University of Liverpool, Liverpool, UK.
  • Crofton A; Department of Neurosurgery, The Walton Centre NHS Foundation Trust, Liverpool, UK.
  • Dirven L; Brainstrust - the brain cancer people, Cowes, UK.
  • Georgious T; Department of Neurosurgery, The Walton Centre NHS Foundation Trust, Liverpool, UK.
  • Grundy PL; Department of Neurology, Leiden University Medical Center, Leiden, The Netherlands.
  • Islim AI; Department of Neurology, Haaglanden Medical Center, The Hague, The Netherlands.
  • Javadpour M; The Brain Tumour Charity, Fleet, UK.
  • Keshwara SM; Department of Neurosurgery, University Hospital Southampton NHS Foundation Trust, Southampton, UK.
  • Koszdin SD; Institute of Systems, Molecular and Integrative Biology, University of Liverpool, Liverpool, UK.
  • Marson AG; Department of Neurosurgery, The Walton Centre NHS Foundation Trust, Liverpool, UK.
  • McDermott MW; National Centre for Neurosurgery, Beaumont Hospital, Dublin, Ireland.
  • Meling TR; Institute of Systems, Molecular and Integrative Biology, University of Liverpool, Liverpool, UK.
  • Oliver K; Department of Neurosurgery, The Walton Centre NHS Foundation Trust, Liverpool, UK.
  • Plaha P; Pharmacy, Veterans Affairs Healthcare System, Palo Alto, California, USA.
  • Preusser M; Institute of Systems, Molecular and Integrative Biology, University of Liverpool, Liverpool, UK.
  • Santarius T; Department of Neurology, The Walton Centre NHS Foundation Trust, Liverpool, UK.
  • Srikandarajah N; Division of Neuroscience, Florida International University, Miami, Florida, USA.
  • Taphoorn MJB; Department of Neurosurgery, Geneva University Hospitals, Geneva, Switzerland.
  • Turner C; International Brain Tumour Alliance, Tadworth, UK.
  • Watts C; Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.
  • Weller M; Division of Oncology, Department of Medicine I, Medical University of Vienna, Vienna, Austria.
  • Williamson PR; Department of Neurosurgery, Addenbrooke's Hospital, Cambridge, UK.
  • Zadeh G; Institute of Systems, Molecular and Integrative Biology, University of Liverpool, Liverpool, UK.
  • Zamanipoor Najafabadi AH; Department of Neurosurgery, The Walton Centre NHS Foundation Trust, Liverpool, UK.
  • Jenkinson MD; Department of Neurology, Leiden University Medical Center, Leiden, The Netherlands.
BMJ Open ; 12(5): e057384, 2022 05 09.
Article en En | MEDLINE | ID: mdl-35534067
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias Meníngeas / Meningioma Tipo de estudio: Guideline / Prognostic_studies / Systematic_reviews Aspecto: Ethics Límite: Humans Idioma: En Revista: BMJ Open Año: 2022 Tipo del documento: Article Pais de publicación: Reino Unido

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias Meníngeas / Meningioma Tipo de estudio: Guideline / Prognostic_studies / Systematic_reviews Aspecto: Ethics Límite: Humans Idioma: En Revista: BMJ Open Año: 2022 Tipo del documento: Article Pais de publicación: Reino Unido