TY - JOUR
T1 - Core Outcome Sets for Meningioma In Clinical studies (COSMIC)
T2 - An international patient and healthcare professional consensus for research studies
AU - Millward, Christopher P
AU - Armstrong, Terri S
AU - Bell, Sabrina
AU - Brodbelt, Andrew R
AU - Bulbeck, Helen
AU - Dirven, Linda
AU - Grundy, Paul L
AU - Islim, Abdurrahman I
AU - Javadpour, Mohsen
AU - Keshwara, Sumirat M
AU - Koszdin, Shelli D
AU - Marson, Anthony G
AU - McDermott, Michael W
AU - Meling, Torstein R
AU - Oliver, Kathy
AU - Plaha, Puneet
AU - Preusser, Matthias
AU - Santarius, Thomas
AU - Srikandarajah, Nisaharan
AU - Taphoorn, Martin J B
AU - Turner, Carole
AU - Watts, Colin
AU - Weller, Michael
AU - Williamson, Paula R
AU - Zadeh, Gelareh
AU - Zamanipoor Najafabadi, Amir H
AU - Jenkinson, Michael D
N1 - © The Author(s) 2025. Published by Oxford University Press on behalf of the Society for Neuro-Oncology and the European Association of Neuro-Oncology.
PY - 2025/8
Y1 - 2025/8
N2 - 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.
AB - 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.
U2 - 10.1093/nop/npaf023
DO - 10.1093/nop/npaf023
M3 - Article
C2 - 40814431
SN - 2054-2577
VL - 12
SP - 700
EP - 713
JO - Neuro-Oncology Practice
JF - Neuro-Oncology Practice
IS - 4
ER -