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

Christopher P. Millward; Sumirat M. Keshwara; Terri S. Armstrong; Heather Barrington; Sabrina Bell; Andrew R. Brodbelt; Helen Bulbeck; Linda Dirven; Paul L. Grundy; Abdurrahman I. Islim; Mohsen Javadpour; Shelli D. Koszdin; Anthony G. Marson; Michael W. McDermott; Torstein R. Meling; Kathy Oliver; Puneet Plaha; Matthias Preusser; Thomas Santarius; Nisaharan Srikandarajah; Martin J.B. Taphoorn; Carole Turner; Colin Watts; Michael Weller; Paula R. Williamson; Gelareh Zadeh; Amir H. Zamanipoor Najafabadi; Michael D. Jenkinson; Oliver Hanemann

doi:10.1093/noajnl/vdae030

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

Christopher P. Millward^*
, Sumirat M. Keshwara
, Terri S. Armstrong
, Heather Barrington
, Sabrina Bell
, Andrew R. Brodbelt
, Helen Bulbeck
, Linda Dirven
, Paul L. Grundy
, Abdurrahman I. Islim
, Mohsen Javadpour
, Shelli D. Koszdin
, Anthony G. Marson
, Michael W. McDermott
, Torstein R. Meling
, Kathy Oliver
, Puneet Plaha
, Matthias Preusser
, Thomas Santarius
, Nisaharan Srikandarajah

Martin J.B. Taphoorn, Carole Turner, Colin Watts, Michael Weller, Paula R. Williamson, Gelareh Zadeh, Amir H. Zamanipoor Najafabadi, Michael D. Jenkinson, Oliver Hanemann

^*Corresponding author for this work

Peninsula Medical School

University of Liverpool
The Walton Centre NHS Foundation Trust
National Institutes of Health
Brainstrust – The Brain Cancer People
Brain Tumour Charity
Leiden University
Haaglanden Medisch Centrum
University Hospital Southampton NHS Foundation Trust
Royal College of Surgeons in Ireland
Department of Veterans Affairs
Florida International University
University of Copenhagen
International Brain Tumour Alliance
University of Oxford
Medical University of Vienna
University of Cambridge
University of Birmingham
University of Zurich
University of Toronto

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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.

Original language	English
Article number	vdae030
Journal	Neuro-Oncology Advances
Volume	6
Issue number	1
DOIs	https://doi.org/10.1093/noajnl/vdae030
Publication status	Published - 2 Mar 2024

ASJC Scopus subject areas

Surgery
Oncology
Neurology (clinical)

Keywords

clinical trial
COMET
core outcome set
meningioma
outcomes

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10.1093/noajnl/vdae030

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Millward, C. P., Keshwara, S. M., Armstrong, T. S., Barrington, H., Bell, S., Brodbelt, A. R., Bulbeck, H., Dirven, L., Grundy, P. L., Islim, A. I., Javadpour, M., Koszdin, S. D., Marson, A. G., McDermott, M. W., Meling, T. R., Oliver, K., Plaha, P., Preusser, M., Santarius, T., ... Hanemann, O. (2024). The outcomes measured and reported in intracranial meningioma clinical trials: A systematic review. Neuro-Oncology Advances, 6(1), Article vdae030. https://doi.org/10.1093/noajnl/vdae030

@article{4156ef6014ab4250a5ae3a3698e0a5b9,

title = "The outcomes measured and reported in intracranial meningioma clinical trials: A systematic review",

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 = "clinical trial, COMET, core outcome set, meningioma, outcomes",

author = "Millward, \{Christopher P.\} and Keshwara, \{Sumirat M.\} and Armstrong, \{Terri S.\} and Heather Barrington and Sabrina Bell and Brodbelt, \{Andrew R.\} and Helen Bulbeck and Linda Dirven and Grundy, \{Paul L.\} and Islim, \{Abdurrahman I.\} and Mohsen Javadpour and Koszdin, \{Shelli D.\} and Marson, \{Anthony G.\} and McDermott, \{Michael W.\} and Meling, \{Torstein R.\} and Kathy Oliver and Puneet Plaha and Matthias Preusser and Thomas Santarius and Nisaharan Srikandarajah and Taphoorn, \{Martin J.B.\} and Carole Turner and Colin Watts and Michael Weller and Williamson, \{Paula R.\} and Gelareh Zadeh and \{Zamanipoor Najafabadi\}, \{Amir H.\} and Jenkinson, \{Michael D.\} and Oliver Hanemann",

note = "Publisher Copyright: {\textcopyright} The Author(s) 2024. Published by Oxford University Press, the Society for Neuro-Oncology and the European Association of Neuro-Oncology.",

year = "2024",

month = mar,

day = "2",

doi = "10.1093/noajnl/vdae030",

language = "English",

volume = "6",

journal = "Neuro-Oncology Advances",

issn = "2632-2498",

publisher = "Oxford University Press",

number = "1",

}

Millward, CP, Keshwara, SM, Armstrong, TS, Barrington, H, Bell, S, Brodbelt, AR, Bulbeck, H, Dirven, L, Grundy, PL, Islim, AI, Javadpour, M, Koszdin, SD, Marson, AG, McDermott, MW, Meling, TR, Oliver, K, Plaha, P, Preusser, M, Santarius, T, Srikandarajah, N, Taphoorn, MJB, Turner, C, Watts, C, Weller, M, Williamson, PR, Zadeh, G, Zamanipoor Najafabadi, AH, Jenkinson, MD & Hanemann, O 2024, 'The outcomes measured and reported in intracranial meningioma clinical trials: A systematic review', Neuro-Oncology Advances, vol. 6, no. 1, vdae030. https://doi.org/10.1093/noajnl/vdae030

TY - JOUR

T1 - The outcomes measured and reported in intracranial meningioma clinical trials

T2 - A systematic review

AU - Millward, Christopher P.

AU - Keshwara, Sumirat M.

AU - Armstrong, Terri S.

AU - Barrington, Heather

AU - Bell, Sabrina

AU - Brodbelt, Andrew R.

AU - Bulbeck, Helen

AU - Dirven, Linda

AU - Grundy, Paul L.

AU - Islim, Abdurrahman I.

AU - Javadpour, Mohsen

AU - Koszdin, Shelli D.

AU - Marson, Anthony G.

AU - McDermott, Michael W.

AU - Meling, Torstein R.

AU - Oliver, Kathy

AU - Plaha, Puneet

AU - Preusser, Matthias

AU - Santarius, Thomas

AU - Srikandarajah, Nisaharan

AU - Taphoorn, Martin J.B.

AU - Turner, Carole

AU - Watts, Colin

AU - Weller, Michael

AU - Williamson, Paula R.

AU - Zadeh, Gelareh

AU - Zamanipoor Najafabadi, Amir H.

AU - Jenkinson, Michael D.

AU - Hanemann, Oliver

PY - 2024/3/2

Y1 - 2024/3/2

N2 - 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.

AB - 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.

KW - clinical trial

KW - COMET

KW - core outcome set

KW - meningioma

KW - outcomes

UR - https://www.scopus.com/pages/publications/85190274983

UR - https://pearl.plymouth.ac.uk/pms-research/1107/

U2 - 10.1093/noajnl/vdae030

DO - 10.1093/noajnl/vdae030

M3 - Article

AN - SCOPUS:85190274983

SN - 2632-2498

VL - 6

JO - Neuro-Oncology Advances

JF - Neuro-Oncology Advances

IS - 1

M1 - vdae030

ER -

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

Abstract

ASJC Scopus subject areas

Keywords

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