Development of a Core Outcome Set for Meningioma In Clinical Studies: The COSMIC project.

Meningiomas are the most common primary brain tumour and account for approximately one third of cases. 75% are benign (WHO grade I), ~25% are atypical (WHO grade II) and ~1-3% are malignant (WHO grade III). All meningioma have a long-term risk of recurrence that increases with tumour grade.

Treatment of meningioma involves surgery and sometimes radiotherapy. For recurrent meningioma treatment options are limited but further surgery and radiotherapy are used and there are no effective drugs. Even after successful treatment patients have long-term problems, for example, with quality of life, fatigue and epilepsy.

There is wide variability in the outcomes reported in meningioma clinical trials, and this limits the comparability of results. This is an unacceptable position for a clinical problem associated with long-term life-changing morbidity.

I propose to develop a meningioma core outcome set (COS), which would define the minimum outcomes that should always be reported in meningioma clinical effectiveness trials. The COS will reflect the interests of patients and healthcare professionals. This has been exceptionally beneficial to other areas of medical research, such as rheumatology and women’s health.

No COS for meningioma (or any brain tumour for that matter) currently exists. This COS will reflect key stakeholder opinion and provide a consistent set of outcomes to be reported in future trials, systematic reviews and clinical guidelines.

Contributors

Christopher Paul Millward
Prof Michael Jenkinson
Prof Paula Williamson
Prof Tony Marson
Dr Adam Noble
University of Liverpool

Mr Thomas Santarius
University of Cambridge

Further Study Information

Current Stage: Ongoing
Date: January 2020 - January 2023
Funding source(s): The Brain Tumour Charity


Health Area

Disease Category: Neurology

Disease Name: Meningiomas

Target Population

Age Range: 18 - 120

Sex: Either

Nature of Intervention: Any

Stakeholders Involved

- Charities
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Patient/ support group representatives

Study Type

- COS for clinical trials or clinical research
- COS for practice

Method(s)

- Consensus meeting
- Delphi process
- Focus group(s)
- Interview
- Systematic review

The meningioma COS will be developed by proceeding through the following five stages.

1) Identification of outcomes in meningioma clinical studies and how they are measured summarised in a systematic review.

2) Interviewing meningioma patients to understand what outcomes they believe are important.

3) Develop a long-list of outcomes, which will be reduced to a core set of outcomes through Delphi consensus methodology.

4) 3-round Delphi survey for all participants to reduce the long-list.

5) Finally, a face-to-face consensus meeting of key stakeholders to finalise the COS.

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