Background: High rates of physical and cognitive morbidity in brain cancer impact on a range of patient and family quality of life domains. Brain cancer trials need to robustly measure and report patient-focused outcomes when assessing net benefit of interventions, helping patients to make informed choices about their care. Use of Patient Reported Outcomes (PROs) is hampered by methodological inconsistencies and reporting bias. Of glioma trials using PROs, only 14% met criteria for high quality reporting and there is no consensus on which domains of patient/family experience to assess. Core Outcome Sets (COS) help minimise these shortcomings. A COS defines the what to measure as a core minimum across all trials (e.g. symptoms, function) before the how of using individual tools (e.g. activity score) is determined. An agreed COS ensures consistent, high quality reporting of stakeholder agreed outcomes, allowing comparison/combination of results across trials, reducing waste.
Study Design: The COMET initiative (http://comet-initiative.org/ ) facilitates best practice in COS development. We will design a COS for all glioma trials using COMET methodology, emphasising the patient perspective and realising the power of aggregated data to provide practice-changing results.
There are five stages to this study in total:
Stage I: Review of the evidence base in two parts. Search A will identify the outcomes collected in LGG and HGG trials involving patients aged over 18 years and diagnosed with primary glioma. Search B will undertake a systematic review and qualitative synthesis of the outcomes important to patients with LGG and HGG, caregivers and other stakeholders.
Stage II: Semi-structured interviews with dyads of people with LGG or HGG, and their caregivers will be undertaken to understand their lived experience and outcomes which matter to them.
Stage III: Outcome list (derived from Stages I and II) to be used in a Delphi survey will be confirmed through review by the study team, including healthcare professionals, researchers, policy makers, and those with lived experience of glioma.
Stage IV: A 2-round Delphi process will be undertaken to establish consensus on the outcomes among all relevant stakeholders.
Stage V: A consensus meeting will be held with key stakeholders to finalise the proposed COS based on the outcomes agreed during the Delphi rounds.
Stage IV: Participants will review and ratify the outcome list, confirm the COS, and identify which of the outcomes are the patient reported. If appropriate, grade-specific subsets will be defined and agreed.
The methodological approach will reflect COMET recommendations on panel structure, scoring and cut off criteria for defining consensus. A final stakeholder meeting will use structured techniques to discuss the results and agree the final core set, which will be disseminated for use across UK glioma studies.
Protocol study is currently in submission to BMJ Open.
The systematic review is registered with PROSPERO (CRD42021236979).
Professor Anthony Byrne (PI) - Cardiff University
Dr Ameeta Retzer - University of Birmingham
Elin Baddeley - Cardiff University
Dr Stephanie Sivell - Cardiff University
Dr Hannah Scott - Cardiff University
Professor Annmarie Nelson - Cardiff University
Dr Kathy Seddon - Cardiff University
Professor Melanie Calvert - University of Birmingham
Dr Robin Grant - University of Edinburgh
Dr Helen Bulbeck - Cardiff University
Professor Richard Adams - Cardiff University
Professor Colin Watts - University of Birmingham
Dr Olalekan Lee Aiyegbusi - University of Birmingham
Professor Pamela Kearns - University of Birmingham
Dr Samantha Cruz Rivera - University of Birmingham
Dr Linda Dirven – Leiden University Medical Center, The Neterhlands; Haaglanden Medical Center, The Netherlands
Disease Category: Cancer
Disease Name: Gliomas
Age Range: 18 - 120
Sex: Either
Nature of Intervention: Any
- Charities
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Patient/ support group representatives
- COS for clinical trials or clinical research
- Consensus meeting
- Delphi process
- Interview
- Systematic review
First stage will involve a search of the evidence base, including: A) a review of outcomes included in trials reported in trial registries; and B) a systematic review; followed by interviews with patients and carers, and the use of consensus method to develop a Delphi process.