Core Outcome Sets for Meningioma In Clinical studies (COSMIC): An international patient and healthcare professional consensus for research studies

TL;DR

This paper presents two core outcome sets for meningioma clinical studies, developed through international consensus among patients and healthcare professionals.

Contribution

The paper introduces COSMIC, the first internationally agreed-upon core outcome sets for meningioma research.

Findings

Eight core outcomes were common to both COSMIC: Intervention and COSMIC: Observation.

Role and social functioning were included in COSMIC: Observation but not in COSMIC: Intervention.

The COSMIC sets aim to standardize outcome measurement in future meningioma clinical studies.

Abstract

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.

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.

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.

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.

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