| Title: |
The outcomes measured and reported in intracranial meningioma clinical trials: A systematic review |
| Authors: |
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; Aldape, K; Au, K; Barnhartz-Sloan, J; Linda Bi, W; Behling, F; Brastianos, PK; Brodie, C; Butowski, N; Carlotti, C; Castro, A; Cohen-Gadol, A; Couce, M; Cusimano, MD; DiMeco, F; Drummond, K; Dunn, IF; Erker, C; Felicella, M; Fountain, DM; Galanis, E; Galldiks, N; Giannini, C; Goldbrunner, R; Griffith, B; Hashizume, R; Hanemann, CO; Herold-Mende, C; Hnenny, L; Horbinski, C; Huang, RY; James, D; Jungk, C; Jungwirth, G; Kaufmann, TJ; Krischek, B; Kurz, S; Lachance, D; Lafougère, C; Lamszus, K; Lee, I; Liu, JC; Makarenko, S; Malta, T; Mamatjan, Y; Mansouri, A; Mawrin, C; McDermott, M; Moliterno-Gunel, J; Morokoff, A; Munoz, D; Nassiri, F; Noushmehr, H; Ng, H-K; Perry, A; Pirouzmand, F; Poisson, LM; Pollo, B; Ragunathan, A; Raleigh, DR; Renovanz, M; Ricklefs, F; Sahm, F; Saladino, A; Santacroce, A; Schittenhelm, J; Schichor, C; Schultz, D; Schmidt, NO; Selman, W; Shih, H; Sloan, A; Spears, J; Snuderl, M; Snyder, J; Suppiah, S; Sulman, E; Tabatabai, G; Tatagiba, M; Timmer, M; Tirapelli, D; Tonn, JC; Tsang, D; Vogelbaum, MA; von Deimling, A; Walbert, T; Walling, S; Wang, JZ; Wen, PY; Westphal, M; Workewych, AM; Yip, S; Zada, G; Zherebitskiy, V |
| Publisher Information: |
England; Oxford University Press |
| Publication Year: |
2024 |
| Collection: |
PEARL (Plymouth Electronic Archiv & ResearchLibrary, Plymouth University) |
| Subject Terms: |
COMET; clinical trial; core outcome set; meningioma; outcomes |
| Description: |
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 ... |
| Document Type: |
article in journal/newspaper |
| File Description: |
vdae030-; Electronic-eCollection; application/pdf |
| Language: |
English |
| ISSN: |
2632-2498 |
| Relation: |
E-ISSN:2632-2498; https://pearl.plymouth.ac.uk/handle/10026.1/22534 |
| DOI: |
10.1093/noajnl/vdae030 |
| Availability: |
https://pearl.plymouth.ac.uk/handle/10026.1/22534; https://doi.org/10.1093/noajnl/vdae030 |
| Accession Number: |
edsbas.6CB04F15 |
| Database: |
BASE |