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

Abstract

IntroductionMeningioma 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 analysisTwo 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 disseminationInstitutional 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 numberCOMET study ID 1508

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“…Among the tested methods to achieve agreement on selecting a potential core set of outcomes, the Delphi methodology has become popular, even though Delphi‐based studies must be of sufficient quality to be considered valid (Sinha et al, 2011). In fact, Delphi methodology is progressively spreading in scientific publications in the different medical specialities (Carter et al, 2021; Millward et al, 2022; Mitchell et al, 2022; Munblit et al, 2022; Prorok et al, 2022; Rosala‐Hallas et al, 2022) and also in dentistry (Alarcón, Sanz‐Sánchez, López‐Pacheco, et al, 2021; Alarcón, Sanz‐Sánchez, Shibli, et al, 2021; Sanz et al, 2019). This is partially due to the ability of the Delphi method to distil relevant problems where knowledge is unclear, and by applying a structured process of gathering information from experts and other stakeholders through subjective‐intuitive foresight thinking, a final agreement is reached.…”

Adult brain tumour research in 2024: Status, challenges and recommendations

“…The disproportionate focus on outcomes limits understanding of what individual patients want to achieve. COBRA and COSMIC are patient‐centred clinical trials co‐developed with patient and carer stakeholders that are starting to move these goalposts, ensuring that outcome sets are truly meaningful to patients in the real world [69, 70]. With personalised medicine, patients experience different clinical journeys: one size no longer fits all.…”

The outcomes measured and reported in intracranial meningioma clinical trials: A systematic review

“…COSMIC: Observation is being developed for use in observational clinical studies concerned with incidental, minimally symptomatic, and/or untreated cohorts of patients with intracranial meningioma, that are designed to inform monitoring and decision to treat strategies. 26 …”