Development of a core outcome set and identification of patient-reportable outcomes for primary brain tumour trials: protocol for the COBra study

Ameeta Retzer, Stephanie Sivell, Hannah Scott, Annmarie Nelson, Helen Bulbeck, Kathy Seddon, Robin Grant, Richard Adams, Colin Watts, Olalekan Lee Aiyegbusi, Pamela Kearns, Samantha Cruz Rivera, Linda Dirven, Elin Baddeley, Melanie Calvert, Anthony Byrne

Research output: Contribution to journalArticlepeer-review

Abstract

INTRODUCTION: Primary brain tumours, specifically gliomas, are a rare disease group. The disease and treatment negatively impacts on patients and those close to them. The high rates of physical and cognitive morbidity differ from other cancers causing reduced health-related quality of life. Glioma trials using outcomes that allow holistic analysis of treatment benefits and risks enable informed care decisions. Currently, outcome assessment in glioma trials is inconsistent, hindering evidence synthesis. A core outcome set (COS) - an agreed minimum set of outcomes to be measured and reported - may address this. International initiatives focus on defining core outcomes assessments across brain tumour types. This protocol describes the development of a COS involving UK stakeholders for use in glioma trials, applicable across glioma types, with provision to identify subsets as required. Due to stakeholder interest in data reported from the patient perspective, outcomes from the COS that can be patient-reported will be identified.

METHODS AND ANALYSIS: Stage I: (1) trial registry review to identify outcomes collected in glioma trials and (2) systematic review of qualitative literature exploring glioma patient and key stakeholder research priorities. Stage II: semi-structured interviews with glioma patients and caregivers. Outcome lists will be generated from stages I and II. Stage III: study team will remove duplicate items from the outcome lists and ensure accessible terminology for inclusion in the Delphi survey. Stage IV: a two-round Delphi process whereby the outcomes will be rated by key stakeholders. Stage V: a consensus meeting where participants will finalise the COS. The study team will identify the COS outcomes that can be patient-reported. Further research is needed to match patient-reported outcomes to available measures.

ETHICS AND DISSEMINATION: Ethical approval was obtained (REF SMREC 21/59, Cardiff University School of Medicine Research Ethics Committee). Study findings will be disseminated widely through conferences and journal publication. The final COS will be adopted and promoted by patient and carer groups and its use by funders encouraged.

PROSPERO REGISTRATION NUMBER: CRD42021236979.

Original languageEnglish
Article numbere057712
Number of pages8
JournalBMJ open
Volume12
Issue number9
DOIs
Publication statusPublished - 30 Sep 2022

Bibliographical note

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.

Keywords

  • Brain Neoplasms/therapy
  • Clinical Trials as Topic
  • Delphi Technique
  • Glioma/therapy
  • Humans
  • Outcome Assessment, Health Care/methods
  • Quality of Life
  • Research Design
  • Stakeholder Participation
  • Treatment Outcome

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