ORCID
- Oliver Hanemann: 0000-0002-1951-1025
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.
DOI
10.1136/bmjopen-2021-057384
Publication Date
2022-05-09
Publication Title
BMJ Open
Volume
12
Issue
5
ISSN
2044-6055
Keywords
clinical trial, core outcome set, meningioma
First Page
57384
Last Page
57384
Recommended Citation
EORTC BTG, ICOM, EANO, SNO, RANO-PRO, BNOS, SBNS, BIMS, TBTC, International Brain Tumour Alliance, Brainstrust, and Brain Tumour Foundation of Canada., Millward, C., Armstrong, T., Barrington, H., Bell, S., Brodbelt, A., Bulbeck, H., Crofton, A., Dirven, L., Georgious, T., Grundy, P., Islim, A., Javadpour, M., Keshwara, S., Koszdin, S., Marson, A., McDermott, M., Meling, T., Oliver, K., Plaha, P., Preusser, M., Santarius, T., Srikandarajah, N., Taphoorn, M., Turner, C., Watts, C., Weller, M., Williamson, P., Zadeh, G., Zamanipoor Najafabadi, A., & Hanemann, O. (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', BMJ Open, 12(5), pp. 57384-57384. Available at: https://doi.org/10.1136/bmjopen-2021-057384
