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

Christopher P Millward ^1,2, Sumirat M Keshwara ^1,2, Terri S Armstrong ³

¹Institute of Systems, Molecular, and Integrative Biology, University of Liverpool, UK.
²Department of Neurosurgery, The Walton Centre NHS Foundation Trust, Liverpool, UK.
³Neuro-Oncology Branch, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland, USA.
⁴Institute of Population Health, University of Liverpool, UK.
⁵The Brain Tumour Charity, Hampshire, UK.
⁶Brainstrust-The Brain Cancer People, Isle of Wight, UK.
⁷Department of Neurology, Leiden University Medical Center, Leiden, The Netherlands.
⁸Department of Neurology, Haaglanden Medical Center, The Hague, The Netherlands.
⁹Department of Neurosurgery, University Hospital Southampton, Southampton, UK.
¹⁰National Centre for Neurosurgery, Beaumont Hospital, Dublin, Ireland.
¹¹Veterans Affairs Healthcare System, Palo Alto, California, USA.
¹²Department of Neurology, The Walton Centre NHS Foundation Trust, Liverpool, UK.
¹³Division of Neuroscience, Florida International University, Miami, Florida, USA.
¹⁴Department of Neurosurgery, Copenhagen University Hospital, Copenhagen, Denmark.
¹⁵International Brain Tumour Alliance, Tadworth, UK (K.O.).; Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.
¹⁶Division of Oncology, Department of Medicine, Medical University of Vienna, Vienna, Austria.
¹⁷Department of Neurosurgery, Addenbrooke's Hospital & University of Cambridge, Cambridge, UK.
¹⁸Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK.
¹⁹Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland.
²⁰Department of Surgery, University of Toronto, Toronto, Canada.
²¹Department of Ophthalmology, Leiden University Medical Centre, Haaglanden Medical Center, Haga Teaching Hospitals, Leiden, The Netherlands.

⁰Institute of Systems, Molecular, and Integrative Biology, University of Liverpool, UK.

Neuro-Oncology Advances +

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April 10, 2024

View abstract on PubMed

Summary

Standardizing outcome measurement in meningioma clinical trials is crucial for comparative analysis. This review identified heterogeneous outcomes, paving the way for a core outcome set to improve future research in meningioma treatment.

Area Of Science

Neuro-oncology
Clinical Trial Methodology
Evidence Synthesis

Background

Meningioma clinical trials utilize surgery, radiotherapy, and pharmacotherapy.
Lack of standardized outcome measurement hinders comparative analysis of meningioma trials.
This systematic review aimed to consolidate outcomes reported in meningioma studies.

Purpose Of The Study

To systematically review and summarize outcomes measured in meningioma clinical trials.
To identify and categorize the diverse range of outcomes reported.
To lay the groundwork for developing a standardized outcome set for meningioma research.

Main Methods

Conducted systematic literature and trial registry searches for intracranial meningioma trials.
Extracted and deduplicated reported outcomes, noting definitions and measurement methods.
Classified unique outcomes using the Core Outcome Measures in Effectiveness Trials (COMET) taxonomy.

Main Results

Analyzed 47 unique meningioma clinical trials (30 published, 18 ongoing).
Identified 659 verbatim outcomes, reduced to 415 unique terms after deduplication.
Grouped outcomes into 115 standardized terms, 29 outcome domains, and 5 core areas using COMET taxonomy.

Conclusions

Significant heterogeneity exists in outcome measurement across meningioma clinical trials.
Identified standardized outcome terms will undergo prioritization via eDelphi and consensus meetings.
The ultimate goal is to establish a core outcome set for future meningioma clinical trials.

Keywords:

COMET clinical trial core outcome set meningioma outcomes