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. 2023 Aug 2;5(1):vdad096.
doi: 10.1093/noajnl/vdad096. eCollection 2023 Jan-Dec.

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

Ameeta Retzer  1   2   3 , Elin Baddeley  4 , Stephanie Sivell  4 , Hannah Scott  5 , Annmarie Nelson  4 , Helen Bulbeck  6 , Kathy Seddon  7 , Robin Grant  8 , Richard Adams  9 , Colin Watts  10 , Olalekan Lee Aiyegbusi  1   2   11   3   12 , Pamela Kearns  13   3   14 , Samantha Cruz Rivera  1   11 , Linda Dirven  15   16 , Melanie Calvert  1   2   11   3   17   12 , Anthony Byrne  4
Affiliations

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

Ameeta Retzer et al. Neurooncol Adv. .

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.

Keywords: Delphi; neuro-oncology; outcomes; primary glioma; trials.

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Conflict of interest statement

RG: funding: NIHR, UCB Pharma. OLA: funding: NIHR Birmingham BRC, NIHR ARC WM, UKRI, Health Foundation, Janssen, Gilead, GlaxoSmithKline. Personal fees: Gilead Sciences, Merck, GlaxoSmithKline. LD: funding: Innovative Medicines Initiative, European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group, Brain Tumour Charity. Neuro Oncology Journal Associate Editor. MC: Birmingham Health Partners Centre for Regulatory Science and Innovation and CPROR Director, NIHR senior investigator. Funding: NIHR, UKRI, NIHR Birmingham BRC, NIHR ARC WM, UK SPINE, European Regional Development Fund-Demand Hub and Health Data Research UK at the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust, Innovate UK (part of UKRI), Macmillan Cancer Support, UCB Pharma, Janssen, GlaxoSmithKline, Gilead. Personal fees: Astellas, Aparito, CIS Oncology, Halfloop, Takeda, Merck, Daiichi Sankyo, Glaukos, GlaxoSmithKline, Patient-Centered Outcomes Research Institute. A relative owns GlaxoSmithKline shares.

Figures

Figure 1.
Figure 1.
Illustration of core outcome set development process.
See this image and copyright information in PMC

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