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) 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 two-round Delphi process and stage (5) comprised a consensus meeting to finalise 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. 77/96 participants 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 seven outcome domains (Survival, Adverse Events, Activities of Daily Living, Health-related Quality of Life, Seizure Activity, Cognitive Function and Physical Function) was finalised by 13 participants at the consensus meeting.
Conclusions
A COS for glioma trials was developed, comprising seven outcome domains. Additional research will identify appropriate measurement tools and further validate this COS.
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) 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 two-round Delphi process and stage (5) comprised a consensus meeting to finalise 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. 77/96 participants 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 seven outcome domains (Survival, Adverse Events, Activities of Daily Living, Health-related Quality of Life, Seizure Activity, Cognitive Function and Physical Function) was finalised by 13 participants at the consensus meeting.
Conclusions
A COS for glioma trials was developed, comprising seven outcome domains. Additional research will identify appropriate measurement tools and further validate this COS.
| Original language | English |
|---|---|
| Article number | vdad096 |
| Journal | Neuro-oncology advances |
| Early online date | 2 Aug 2023 |
| DOIs | |
| Publication status | E-pub ahead of print - 2 Aug 2023 |