# 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.

## Key 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.