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The primary analysis in this trial will be comparison of the QuIC-A scores in the experimental group after exposure to the enhanced informed consent materials in addition to the standard PIS (standard of care) as compared with the control group after exposure to the standard PIS (standard of care). We will include all randomised patients for whom we have data on the initial QuIC-A (the primary endpoint). The patients recruited to the GBM cohort will not be included in the primary analysis.
Copyright and License information: ©2021 Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
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