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. 2024 Mar 19;6(1):vdae042.
doi: 10.1093/noajnl/vdae042. eCollection 2024 Jan-Dec.

The outcomes measured and reported in observational studies of incidental and untreated intracranial meningioma: A systematic review

Collaborators, Affiliations

The outcomes measured and reported in observational studies of incidental and untreated intracranial meningioma: A systematic review

Christopher P Millward et al. Neurooncol Adv. .

Abstract

Background: The clinical management of patients with incidental intracranial meningioma varies markedly and is often based on clinician choice and observational data. Heterogeneous outcome measurement has likely hampered knowledge progress by preventing comparative analysis of similar cohorts of patients. This systematic review aimed to summarize the outcomes measured and reported in observational studies.

Methods: A systematic literature search was performed to identify published full texts describing active monitoring of adult cohorts with incidental and untreated intracranial meningioma (PubMed, EMBASE, MEDLINE, and CINAHL via EBSCO, completed January 24, 2022). Reported outcomes were extracted verbatim, along with an associated definition and method of measurement if provided. Verbatim outcomes were de-duplicated 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-three published articles and 1 ongoing study were included describing 32 unique studies: study designs were retrospective n = 27 and prospective n = 5. In total, 268 verbatim outcomes were reported, of which 77 were defined. Following de-duplication, 178 unique verbatim outcomes remained and were grouped into 53 standardized outcome terms. These were classified using the COMET taxonomy into 9 outcome domains and 3 core areas.

Conclusions: Outcome measurement across observational studies of incidental and untreated intracranial meningioma 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 observational studies.

Keywords: COMET; Core Outcome Set; incidental; meningioma; outcomes.

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Conflict of interest statement

M.D.J. 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). M.D.J. and S.J.M. 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). T.S. founded and leads the Anaplastic Meningioma International Consortium (AMiCo). T.S. and M.D.J. cofounded the British-Irish Meningioma Society (BIMS). A.G.M. 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. M.P. 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. M.W. 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 standardized outcome terms, along with the proportion of those defined vs undefined for each.

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