| Title: |
Core Outcome Sets for Meningioma In Clinical studies (COSMIC): An international patient and healthcare professional consensus for research studies |
| Authors: |
Millward, CP; Armstrong, TS; Bell, S; Brodbelt, AR; Bulbeck, H; Dirven, L; Grundy, PL; Islim, AI; Javadpour, M; Keshwara, SM; Koszdin, SD; Marson, AG; McDermott, MW; Meling, TR; Oliver, K; Plaha, P; Preusser, M; Santarius, T; Srikandarajah, N; Taphoorn, MJB; Turner, C; Watts, C; Weller, M; Williamson, PR |
| Publisher Information: |
Oxford University Press |
| Publication Year: |
2025 |
| Collection: |
Oxford University Research Archive (ORA) |
| Description: |
Background: Core Outcome Sets (COS) define the minimum outcomes that should be measured and reported in all clinical trials for a specific health condition or health area. The aim was to develop 2 COS for intracranial meningioma to be used in future clinical studies: COSMIC: Intervention for effectiveness trials and COSMIC: Observation for studies of incidental/untreated meningioma. Methods: A study advisory group was formed with representation from international stakeholder groups: EORTC BTG, ICOM, EANO, SNO, RANO-PRO, BNOS, SBNS, BIMS, TBTC, International Brain Tumour Alliance, and Brainstrust. Outcomes of potential relevance to key stakeholders were identified and rationalized to populate 2 eDelphi surveys. Participants were recruited internationally and asked to rate each outcome on its importance for inclusion in the COS. The 2 final COS were ratified through 2, one-day, online consensus meetings. Results: The COSMIC: Intervention eDelphi survey contained 25 items and was completed by 199 participants. Following the consensus meeting, 15 outcomes were included. The COSMIC: Observation eDelphi survey contained 17 items and was completed by 129 participants. Sixteen outcomes were included. Eight core outcomes were common to both COS; tumor growth, physical, emotional, and neurocognitive functioning, overall quality of life, progression-free survival, meningioma-specific mortality and overall survival. Role and social functioning were core outcomes in COSMIC: Observation but not COSMIC: Intervention. Conclusions: Uptake of these COS in relevant future meningioma clinical studies will ensure that stakeholder-determined, critically important outcomes are consistently measured and reported across similar clinical studies. |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| Relation: |
https://doi.org/10.1093/nop/npaf023 |
| DOI: |
10.1093/nop/npaf023 |
| Availability: |
https://doi.org/10.1093/nop/npaf023; https://ora.ox.ac.uk/objects/uuid:4c08f323-df52-4768-b977-8042f7e485d7 |
| Rights: |
info:eu-repo/semantics/openAccess ; CC Attribution (CC BY) |
| Accession Number: |
edsbas.88FB38FE |
| Database: |
BASE |