The outcomes measured and reported in intracranial meningioma clinical trials: A systematic review.

Autor:	Millward CP; Institute of Systems, Molecular, and Integrative Biology, University of Liverpool, UK.; Department of Neurosurgery, The Walton Centre NHS Foundation Trust, Liverpool, UK., Keshwara SM; Institute of Systems, Molecular, and Integrative Biology, University of Liverpool, UK.; Department of Neurosurgery, The Walton Centre NHS Foundation Trust, Liverpool, UK., Armstrong TS; Neuro-Oncology Branch, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland, USA., Barrington H; Institute of Population Health, University of Liverpool, UK., Bell S; The Brain Tumour Charity, Hampshire, UK., Brodbelt AR; Institute of Systems, Molecular, and Integrative Biology, University of Liverpool, UK.; Department of Neurosurgery, The Walton Centre NHS Foundation Trust, Liverpool, UK., Bulbeck H; Brainstrust-The Brain Cancer People, Isle of Wight, UK., Dirven L; Department of Neurology, Leiden University Medical Center, Leiden, The Netherlands.; Department of Neurology, Haaglanden Medical Center, The Hague, The Netherlands., Grundy PL; Department of Neurosurgery, University Hospital Southampton, Southampton, UK., Islim AI; Institute of Systems, Molecular, and Integrative Biology, University of Liverpool, UK.; Department of Neurosurgery, The Walton Centre NHS Foundation Trust, Liverpool, UK., Javadpour M; National Centre for Neurosurgery, Beaumont Hospital, Dublin, Ireland., Koszdin SD; Veterans Affairs Healthcare System, Palo Alto, California, USA., Marson AG; Institute of Systems, Molecular, and Integrative Biology, University of Liverpool, UK.; Department of Neurology, The Walton Centre NHS Foundation Trust, Liverpool, UK., McDermott MW; Division of Neuroscience, Florida International University, Miami, Florida, USA., Meling TR; Department of Neurosurgery, Copenhagen University Hospital, Copenhagen, Denmark., Oliver K, Plaha P; International Brain Tumour Alliance, Tadworth, UK (K.O.).; Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK., Preusser M; Division of Oncology, Department of Medicine, Medical University of Vienna, Vienna, Austria., Santarius T; Department of Neurosurgery, Addenbrooke's Hospital & University of Cambridge, Cambridge, UK., Srikandarajah N; Institute of Systems, Molecular, and Integrative Biology, University of Liverpool, UK., Taphoorn MJB; Department of Neurology, Leiden University Medical Center, Leiden, The Netherlands.; Department of Neurology, Haaglanden Medical Center, The Hague, The Netherlands., Turner C; Department of Neurosurgery, Addenbrooke's Hospital & University of Cambridge, Cambridge, UK., Watts C; Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK., Weller M; Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland., Williamson PR; Institute of Population Health, University of Liverpool, UK., Zadeh G; Department of Surgery, University of Toronto, Toronto, Canada., Zamanipoor Najafabadi AH; Department of Ophthalmology, Leiden University Medical Centre, Haaglanden Medical Center, Haga Teaching Hospitals, Leiden, The Netherlands., Jenkinson MD; Institute of Systems, Molecular, and Integrative Biology, University of Liverpool, UK.; Department of Neurosurgery, The Walton Centre NHS Foundation Trust, Liverpool, UK.
Jazyk:	angličtina
Zdroj:	Neuro-oncology advances [Neurooncol Adv] 2024 Mar 02; Vol. 6 (1), pp. vdae030. Date of Electronic Publication: 2024 Mar 02 (Print Publication: 2024).
DOI:	10.1093/noajnl/vdae030
Abstrakt:	Background: Meningioma clinical trials have assessed interventions including surgery, radiotherapy, and pharmacotherapy. However, agreement does not exist on what, how, and when outcomes of interest should be measured. To do so would allow comparative analysis of similar trials. This systematic review aimed to summarize the outcomes measured and reported in meningioma clinical trials. Methods: Systematic literature and trial registry searches were performed to identify published and ongoing intracranial meningioma clinical trials (PubMed, Embase, Medline, CINAHL via EBSCO, and Web of Science, completed January 22, 2022). Reported outcomes were extracted verbatim, along with an associated definition and method of measurement if provided. Verbatim outcomes were deduplicated and the resulting unique outcomes were grouped under standardized outcome terms. These were classified using the taxonomy proposed by the "Core Outcome Measures in Effectiveness Trials" (COMET) initiative. Results: Thirty published articles and 18 ongoing studies were included, describing 47 unique clinical trials: Phase 2 n  = 33, phase 3 n  = 14. Common interventions included: Surgery n  = 13, radiotherapy n  = 8, and pharmacotherapy n  = 20. In total, 659 verbatim outcomes were reported, of which 84 were defined. Following de-duplication, 415 unique verbatim outcomes remained and were grouped into 115 standardized outcome terms. These were classified using the COMET taxonomy into 29 outcome domains and 5 core areas. Conclusions: Outcome measurement across meningioma clinical trials is heterogeneous. The standardized outcome terms identified will be prioritized through an eDelphi survey and consensus meeting of key stakeholders (including patients), in order to develop a core outcome set for use in future meningioma clinical trials. Competing Interests: MDJ received a grant from the National Institute for Health Research Health Technology Assessment program for the Radiation versus Observation for Atypical Meningioma (ROAM) trial (NIHR ID: 12/173/14). MDJ and SJM received a grant from the National Institute for Health Research Health Technology Assessment program for Surgeons Trial Of Prophylaxis for Epilepsy in seizure naïve patients with Meningioma (STOP’EM; NIHR ID: NIHR129748). TS founded and leads the Anaplastic Meningioma International Consortium (AMiCo). TS and MDJ co-founded the British-Irish Meningioma Society (BIMS). AGM is a National Institute for Health Research (NIHR) Senior Investigator and is also part-funded by NIHR ARC North West Coast. The views expressed in this article are those of the author(s) and not necessarily those of the NIHR, or the Department of Health and Social Care. MP has received honoraria for lectures, consultation or advisory board participation from the following for-profit companies: Bayer, Bristol-Myers Squibb, Novartis, Gerson Lehrman Group (GLG), CMC Contrast, GlaxoSmithKline, Mundipharma, Roche, BMJ Journals, MedMedia, Astra Zeneca, AbbVie, Lilly, Medahead, Daiichi Sankyo, Sanofi, Merck Sharp & Dome, Tocagen, Adastra, Servier. MW has received research grants from Quercis and Versameb, and honoraria for lectures or advisory board participation or consulting from Bayer, Curevac, Medac, Novartis, Novocure, Orbus, Philogen, Roche, and Sandoz. (© The Author(s) 2024. Published by Oxford University Press, the Society for Neuro-Oncology and the European Association of Neuro-Oncology.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu