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



Millward, Christopher P ORCID: 0000-0001-7727-1157, Keshwara, Sumirat M, Armstrong, Terri S, Barrington, Heather, Bell, Sabrina, Brodbelt, Andrew R, Bulbeck, Helen, Dirven, Linda, Grundy, Paul L, Islim, Abdurrahman I
et al (show 19 more authors) (2024) The outcomes measured and reported in intracranial meningioma clinical trials: A systematic review. Neuro-oncology advances, 6 (1). vdae030-vdae030.

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Abstract

<h4>Background</h4>Meningioma clinical trials have assessed interventions including surgery, radiotherapy, and pharmacotherapy. However, agreement does not exist on what, how, and when outcomes of interest should be measured. To do so would allow comparative analysis of similar trials. This systematic review aimed to summarize the outcomes measured and reported in meningioma clinical trials.<h4>Methods</h4>Systematic literature and trial registry searches were performed to identify published and ongoing intracranial meningioma clinical trials (PubMed, Embase, Medline, CINAHL via EBSCO, and Web of Science, completed January 22, 2022). Reported outcomes were extracted verbatim, along with an associated definition and method of measurement if provided. Verbatim outcomes were deduplicated and the resulting unique outcomes were grouped under standardized outcome terms. These were classified using the taxonomy proposed by the "Core Outcome Measures in Effectiveness Trials" (COMET) initiative.<h4>Results</h4>Thirty published articles and 18 ongoing studies were included, describing 47 unique clinical trials: Phase 2 <i>n</i> = 33, phase 3 <i>n</i> = 14. Common interventions included: Surgery <i>n</i> = 13, radiotherapy <i>n</i> = 8, and pharmacotherapy <i>n</i> = 20. In total, 659 verbatim outcomes were reported, of which 84 were defined. Following de-duplication, 415 unique verbatim outcomes remained and were grouped into 115 standardized outcome terms. These were classified using the COMET taxonomy into 29 outcome domains and 5 core areas.<h4>Conclusions</h4>Outcome measurement across meningioma clinical trials is heterogeneous. The standardized outcome terms identified will be prioritized through an eDelphi survey and consensus meeting of key stakeholders (including patients), in order to develop a core outcome set for use in future meningioma clinical trials.

Item Type: Article
Uncontrolled Keywords: EORTC BTG, ICOM, EANO, SNO, RANO-PRO, BNOS, SBNS, BIMS, TBTC, International Brain Tumour Alliance, Brainstrust, and Brain Tumour Foundation of Canada
Divisions: Faculty of Health and Life Sciences
Faculty of Health and Life Sciences > Institute of Life Courses and Medical Sciences
Faculty of Health and Life Sciences > Institute of Life Courses and Medical Sciences > School of Medicine
Faculty of Health and Life Sciences > Institute of Population Health
Faculty of Health and Life Sciences > Institute of Systems, Molecular and Integrative Biology
Depositing User: Symplectic Admin
Date Deposited: 30 Apr 2024 08:34
Last Modified: 30 Apr 2024 08:35
DOI: 10.1093/noajnl/vdae030
Open Access URL: https://doi.org/10.1093/noajnl/vdae030
Related URLs:
URI: https://livrepository.liverpool.ac.uk/id/eprint/3180667