Development of a core outcome set for use in adult primary glioma phase III interventional trials: A mixed methods study

Retzer, Ameeta, Baddeley, Elin, Sivell, Stephanie ORCID: https://orcid.org/0000-0003-0253-1860, Scott, Hannah, Nelson, Annmarie ORCID: https://orcid.org/0000-0002-6075-8425, Bulbeck, Helen, Seddon, Kathy, Grant, Robin, Adams, Richard ORCID: https://orcid.org/0000-0003-3915-7243, Watts, Colin, Aiyegbusi, Olalekan Lee, Kearns, Pamela, Rivera, Samantha Cruz, Dirven, Linda, Calvert, Melanie and Byrne, Anthony 2023. Development of a core outcome set for use in adult primary glioma phase III interventional trials: A mixed methods study. Neuro-Oncology Advances 5 (1) , vdad096. 10.1093/noajnl/vdad096

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Abstract

Background: Glioma interventional studies should collect data aligned with patient priorities, enabling treatment benefit assessment and informed decision-making. This requires effective data synthesis and meta-analyses, underpinned by consistent trial outcome measurement, analysis, and reporting. Development of a core outcome set (COS) may contribute to a solution. Methods: A 5-stage process was used to develop a COS for glioma trials from the UK perspective. Outcome lists were generated in stages 1: a trial registry review and systematic review of qualitative studies and 2: interviews with glioma patients and caregivers. In stage 3, the outcome lists were de-duplicated with accessible terminology, in stage 4 outcomes were rated via a 2-round Delphi process, and stage 5 comprised a consensus meeting to finalize the COS. Patient-reportable COS outcomes were identified. Results: In Delphi round 1, 96 participants rated 35 outcomes identified in stages 1 and 2, to which a further 10 were added. Participants (77/96) rated the resulting 45 outcomes in round 2. Of these, 22 outcomes met a priori threshold for inclusion in the COS. After further review, a COS consisting of 19 outcomes grouped into 7 outcome domains (survival, adverse events, activities of daily living, health-related quality of life, seizure activity, cognitive function, and physical function) was finalized by 13 participants at the consensus meeting. Conclusions: A COS for glioma trials was developed, comprising 7 outcome domains. Additional research will identify appropriate measurement tools and further validate this COS.

Item Type:	Article
Date Type:	Publication
Status:	Published
Schools:	Medicine
Publisher:	Oxford University Press
ISSN:	2632-2498
Date of First Compliant Deposit:	25 September 2023
Date of Acceptance:	31 July 2023
Last Modified:	12 Oct 2023 02:49
URI:	https://orca.cardiff.ac.uk/id/eprint/162723

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