Evidence map›Paper›PMID 36180121›Full record

ArticleBMJ open2022

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 and 6 more

Abstract read
In one paragraph

Article in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Review
  5. Article
  6. Article
  7. Quantitative TEuropean radiology · 2024
    Article
  8. Article
  9. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Ameeta RetzerCentre for Patient Reported Outcomes Research, Institute for Applied Health Research, University of Birmingham, Birmingham, UK.ORCID 0000-0002-4156-8386
Stephanie SivellMarie Curie Palliative Care Research Centre, Division of Population Medicine, Cardiff University School of Medicine, College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK.
Hannah ScottCambridge Public Health, University of Cambridge School of Clinical Medicine, University of Cambridge, Cambridge, UK.
Annmarie NelsonMarie Curie Palliative Care Research Centre, Division of Population Medicine, Cardiff University School of Medicine, College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK.
Helen Bulbeckbrainstrust, Cowes, UK.
Kathy SeddonCardiff University, Cardiff, UK.
Robin GrantDepartment of Clinical Neurosciences, Royal Infirmary of Edinburgh, Edinburgh, UK.
Richard AdamsCentre for Trials Research, Cardiff University, Cardiff, UK.
Colin WattsInstitute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.ORCID 0000-0003-3531-8791
Olalekan Lee AiyegbusiCentre for Patient Reported Outcomes Research, Institute for Applied Health Research, University of Birmingham, Birmingham, UK.ORCID 0000-0001-9122-8251
Pamela KearnsInstitute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.
Samantha Cruz RiveraCentre for Patient Reported Outcomes Research, Institute for Applied Health Research, University of Birmingham, Birmingham, UK.ORCID 0000-0002-1566-6804
Linda DirvenDepartment of Neurology, Leiden University Medical Center, Leiden University, Leiden, The Netherlands.
Elin BaddeleyMarie Curie Palliative Care Research Centre, Division of Population Medicine, Cardiff University School of Medicine, College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK.ORCID 0000-0002-7571-4820
Melanie CalvertCentre for Patient Reported Outcomes Research, Institute for Applied Health Research, University of Birmingham, Birmingham, UK.ORCID 0000-0002-1856-837X
Anthony ByrneMarie Curie Palliative Care Research Centre, Division of Population Medicine, Cardiff University School of Medicine, College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK Anthony.Byrne2@wales.nhs.uk.

Funding

Cancer Research UK 25354
6 · The paper itself

Abstract

introductionPrimary 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.

Indexed as

Brain NeoplasmsGliomaClinical Trials as TopicDelphi TechniqueHumansOutcome Assessment, Health CareQuality of LifeResearch DesignStakeholder ParticipationTreatment OutcomeAdult palliative careClinical trialsNeurological oncologyQUALITATIVE RESEARCH

Identifiers

PMID36180121
PMCPMC9528585

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.