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1. 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

Author

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, and Adriana M Workewych

Subjects
Medicine
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

Published
2022
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2. Development of 'Core Outcome Sets' for Meningioma in Clinical Studies (The COSMIC Project)

Author

Christopher P, Millward, Terri S, Armstrong, Heather, Barrington, Sabrina, Bell, Andrew R, Brodbelt, Helen, Bulbeck, Anna, Crofton, Linda, Dirven, Theo, Georgious, Paul L, Grundy, Abdurrahman I, Islim, Mohsen, Javadpour, Sumirat M, Keshwara, Shelli D, Koszdin, Anthony G, Marson, Michael W, McDermott, Torstein R, Meling, Kathy, Oliver, Puneet, Plaha, Matthias, Preusser, Thomas, Santarius, Nisaharan, Srikandarajah, Martin J B, Taphoorn, Carole, Turner, Colin, Watts, Michael, Weller, Paula R, Williamson, Gelareh, Zadeh, Amir H, Zamanipoor Najafabadi, Michael D, Jenkinson, Viktor, Zherebitskiy, and Neurology

Subjects
Consensus, Delphi Technique, Clinical Trials and Supportive Activities, Clinical Sciences, BIMS, BNOS, core outcome set, meningioma, SNO, and Brain Tumour Foundation of Canada, EANO, Clinical Research, International Brain Tumour Alliance, Meningeal Neoplasms, Humans, TBTC, Brainstrust, Cancer, Other Medical and Health Sciences, SBNS, Neurosciences, clinical trial, General Medicine, Brain Disorders, Treatment Outcome, Research Design, ICOM, RANO-PRO, Public Health and Health Services, EORTC BTG, Meningioma, Systematic Reviews as Topic
Abstract

IntroductionMeningioma 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 analysisTwo 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 disseminationInstitutional 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 numberCOMET study ID 1508

Published
2022

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