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. 2024 Mar 2;6(1):vdae030.
doi: 10.1093/noajnl/vdae030. eCollection 2024 Jan-Dec.

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 , Heather Barrington  4 , Sabrina Bell  5 , Andrew R Brodbelt  1   2 , Helen Bulbeck  6 , Linda Dirven  7   8 , Paul L Grundy  9 , Abdurrahman I Islim  1   2 , Mohsen Javadpour  10 , Shelli D Koszdin  11 , Anthony G Marson  1   12 , Michael W McDermott  13 , Torstein R Meling  14 , Kathy Oliver, Puneet Plaha  15 , Matthias Preusser  16 , Thomas Santarius  17 , Nisaharan Srikandarajah  1 , Martin J B Taphoorn  7   8 , Carole Turner  17 , Colin Watts  18 , Michael Weller  19 , Paula R Williamson  4 , Gelareh Zadeh  20 , Amir H Zamanipoor Najafabadi  21 , Michael D Jenkinson  1   2 ; EORTC BTG, ICOM, EANO, SNO, RANO-PRO, BNOS, SBNS, BIMS, TBTC, International Brain Tumour Alliance, Brainstrust, and Brain Tumour Foundation of Canada
Collaborators, Affiliations

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

Christopher P Millward et al. Neurooncol Adv. .

Abstract

Background: 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.

Methods: 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.

Results: Thirty published articles and 18 ongoing studies were included, describing 47 unique clinical trials: Phase 2 n = 33, phase 3 n = 14. Common interventions included: Surgery n = 13, radiotherapy n = 8, and pharmacotherapy n = 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.

Conclusions: 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.

Keywords: COMET; clinical trial; core outcome set; meningioma; outcomes.

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Conflict of interest statement

MDJ received a grant from the National Institute for Health Research Health Technology Assessment program for the Radiation versus Observation for Atypical Meningioma (ROAM) trial (NIHR ID: 12/173/14). MDJ and SJM received a grant from the National Institute for Health Research Health Technology Assessment program for Surgeons Trial Of Prophylaxis for Epilepsy in seizure naïve patients with Meningioma (STOP’EM; NIHR ID: NIHR129748). TS founded and leads the Anaplastic Meningioma International Consortium (AMiCo). TS and MDJ co-founded the British-Irish Meningioma Society (BIMS). AGM is a National Institute for Health Research (NIHR) Senior Investigator and is also part-funded by NIHR ARC North West Coast. The views expressed in this article are those of the author(s) and not necessarily those of the NIHR, or the Department of Health and Social Care. MP has received honoraria for lectures, consultation or advisory board participation from the following for-profit companies: Bayer, Bristol-Myers Squibb, Novartis, Gerson Lehrman Group (GLG), CMC Contrast, GlaxoSmithKline, Mundipharma, Roche, BMJ Journals, MedMedia, Astra Zeneca, AbbVie, Lilly, Medahead, Daiichi Sankyo, Sanofi, Merck Sharp & Dome, Tocagen, Adastra, Servier. MW has received research grants from Quercis and Versameb, and honoraria for lectures or advisory board participation or consulting from Bayer, Curevac, Medac, Novartis, Novocure, Orbus, Philogen, Roche, and Sandoz.

Figures

Figure 1.
Figure 1.
PRISMA flow diagram depicting the identification, screening, eligibility, and inclusion of unique published studies and ongoing studies.
Figure 2.
Figure 2.
Reporting frequency of radiotherapy-related “adverse outcome” standardized outcome terms, along with the proportion of those with a specified measurement instrument.
Figure 3.
Figure 3.
Reporting frequency of pharmacotherapy-related “adverse outcome” standardized outcome terms, along with the proportion of those with a specified measurement instrument.
Figure 4.
Figure 4.
Reporting frequency of surgery-related “adverse outcome” standardized outcome terms, along with the proportion of those with a specified measurement instrument.
See this image and copyright information in PMC

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