The outcomes measured and reported in intracranial meningioma clinical trials: A systematic review
Authors: Millward Christopher P , Keshwara Sumirat M , Armstrong Terri S , Barrington Heather , Bell Sabrina , Brodbelt Andrew R , Bulbeck Helen , Dirven Linda , Grundy Paul L , Islim Abdurrahman I , Javadpour Mohsen , Koszdin Shelli D , Marson Anthony G , McDermott Michael W , Meling Torstein R , Oliver Kathy , Plaha Puneet , Preusser Matthias , Santarius Thomas , Srikandarajah Nisaharan , Taphoorn Martin J B , Turner Carole , Watts Colin , Weller Michael , Williamson Paula R , Zadeh Gelareh , Zamanipoor Najafabadi Amir H , Jenkinson Michael D ,   EORTC BTG, ICOM, EANO, SNO, RANO-PRO, BNOS, SBNS, BIMS, TBTC, International Brain Tumour Alliance, Brainstrust, and Brain Tumour Foundation of Canada, Aldape Kenneth , Islim Abdurrahman I , Au Karolyn , Barnhartz-Sloan Jill , Linda Bi Wenya , Behling Felix , Brastianos Priscilla K , Brodie Chaya , Butowski Nicholas , Carlotti Carlos , Castro Ana , Cohen-Gadol Aaron , Couce Marta , Cusimano Michael D , DiMeco Francesco , Drummond Katharine , Dunn Ian F , Erker Craig , Felicella Michelle , Fountain Daniel M , Galanis Evanthia , Galldiks Norbert , Giannini Caterina , Goldbrunner Roland , Griffith Brent , Hashizume Rintaro , Hanemann C Oliver , Herold-Mende Christel , Hnenny Luke , Horbinski Craig , Huang Raymond Y , James David , Jenkinson Michael D , Jungk Christine , Jungwirth Gerhard , Kaufmann Timothy J , Krischek Boris , Kurz Sylvia , Lachance Daniel , Lafougère Christian , Lamszus Katrin , Lee Ian , Liu Jeff C , Makarenko Serge , Malta Tathiana , Mamatjan Yasin , Mansouri Alireza , Mawrin Christian , McDermott Michael , Millward Christopher P , Moliterno-Gunel Jennifer , Morokoff Andrew , Munoz David , Nassiri Farshad , Noushmehr Houtan , Ng Ho-Keung , Perry Arie , Pirouzmand Farhad , Poisson Laila M , Pollo Bianca , Ragunathan Aditya , Raleigh David R , Renovanz Mirjam , Ricklefs Franz , Sahm Felix , Saladino Andrea , Santacroce Antonio , Santarius Thomas , Schittenhelm Jens , Schichor Christian , Schultz David , Schmidt Nils O , Selman Warren , Shih Helen , Sloan Andrew , Spears Julian , Snuderl Matija , Snyder James , Suppiah Suganth , Sulman Erik , Tabatabai Ghazaleh , Tatagiba Marcos , Timmer Marco , Tirapelli Daniela , Tonn Joerg C , Tsang Derek , Vogelbaum Michael A , von Deimling Andreas , Walbert Tobias , Walling Simon , Wang Justin Z , Wen Patrick Y , Westphal Manfred , Workewych Adriana M , Yip Stephen , Zada Gabriel , Zadeh Gelareh , Zherebitskiy Viktor 
Published: March 2024

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.