Background:
Gliomas are the most frequent intrinsic tumours of the central nervous system, with an unpredictable and variable trajectory. Glioma patients face complex neuro-cognitive, neuro-behavioural, and physical symptoms and side effects caused by the tumour and the treatment. People living with glioma, and those close to them, continue to experience varying and challenging neurocognitive and practical unmet needs, necessitating further support to help people cope with the effects of the glioma and its treatment. Understanding the individual needs of people with glioma can inform standardised processes in health systems to assess person-centred outcomes and improve care pathways that can detect and assess the unmet needs of glioma patients in NHS clinical settings to improve health outcomes.
Study Design:
This study follows an approach standardised by the Core Outcome Measurement in Effectiveness Trials (COMET) Initiative and COnsensus-based Standards for the selection of health status Measurement Instruments (COSMIN) to robustly develop the Core Outcomes Set, through three work packages (WP).
WP 1: A qualitative synthesis of existing evidence about patient care via a systematic review (WP1a) and a secondary analysis of interview data (WP1b) will be undertaken to conceptualise key domains, forming a draft core outcome set (WP1c)
WP 2: Components of the draft outcome set will be systematically prioritised by our stakeholders (those with lived experience of glioma, those involved in glioma care delivery, and routine data collection in clinical practice) (WP2a). Psychometric properties of existing patient-reported outcome measures will be assessed and mapped onto the draft outcome set where possible (WP2b). The core outcome set will be ratified with our stakeholders via a consensus meeting (WP2c).
WP 3: An implementation workshop with people living with glioma, Healthcare professionals, and NHS Digital Services representatives will be held to identify the contextual requirements for the collection of the COMBaT outcomes within NHS Wales digital systems
The methodological approach will reflect COMET recommendations on panel structure, scoring and cut-off criteria for defining consensus.
Relevant COS:
The COBra study (COMET ID: 1793; “Development of a core outcome set and identification of patient-reportable outcomes for primary brain tumour trials”) established a consensus-based COS for adult primary glioma interventional trials. However, there remains a critical gap in how these outcomes are implemented within routine clinical care to meet patient needs. This project extends the COBra findings from a clinical trial context to a clinical practice context, while focusing on the digital implementation of the COMBaT COS.
Dr Stephanie Sivell- Co-investigator
Marie Curie Research Centre, Cardiff University
Dr Ameeta Retzer- Co-investigator
Institute of Applied Health Research, University of Birmingham
Dr Noreen Hopwell-Kelly
Marie Curie Research Centre, Cardiff University
Vimeeka Raj Devarajan
Marie Curie Research Centre, Cardiff University
Prof. Anthony Byrne
Marie Curie Hospice
Prof. Andrew Carson-Stevens
Cardiff University
Dr James Powell
Velindre NHS Trust
Rhian Burke
Velindre NHS Trust
Dr Alasdair G Rooney
University of Edinburgh
Sarah Puntoni
NHS Wales Performance and Improvement
Dr Helen Bulbeck
brainstrust
Dr Kathy Seddon
Marie Curie Research Centre, Cardiff University
Dr Cressida Lorimer
University Hospital Sussex NHS Foundation Trust
Andrew Wright
Tessa Jowell
Cerys Harris
Marie Curie Research Centre, Cardiff University
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 practice
- Consensus meeting
- Delphi process
- Interview
- Systematic review
The study uses the following methods across three work packages:
WP 1. A systematic review of literature and a secondary analysis of interview transcripts from the COBra study to develop a draft list of outcomes.
WP2. A Delphi process to achieve consensus on a list of outcomes and a consensus meeting to generate a core outcome set.
WP3. An Implementation workshop to develop a strategy to use these outcomes in clinical settings.