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 - EORTC BTG, ICOM, EANO, SNO, RANO-PRO, BNOS, SBNS, BIMS, TBTC, International Brain Tumour Alliance, Brainstrust, and Brain Tumour Foundation of Canada
N1 - © The Author(s) 2024. Published by Oxford University Press, the Society for Neuro-Oncology and the European Association of Neuro-Oncology.
PY - 2024
Y1 - 2024
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 - http://www.scopus.com/inward/record.url?scp=85190274983&partnerID=8YFLogxK
U2 - 10.1093/noajnl/vdae030
DO - 10.1093/noajnl/vdae030
M3 - Review
C2 - 38596717
SN - 2632-2498
VL - 6
JO - Neuro-Oncology Advances
JF - Neuro-Oncology Advances
IS - 1
M1 - vdae030
ER -