Cancer remains the leading cause of death worldwide and surgery remains the single most required intervention to treat cancer. Primary and secondary outcomes used in clinical trials of cancer oncology can often be categorised into three key domains: survival, adverse outcome and the impact on health-related quality of life. A search of the COMET (Core Outcome Measures in Effectiveness Trials) database indicates that six of the ten commonest cancers whose treatment pathways incorporate surgery already have a COS, with a further two developed for less common cancer types. The remaining four commonest cancer types (breast, thyroid, liver and cervical) lack an available COS for use in trials and clinical settings with surgery as the main intervention type. To address the absence of COS for the remaining surgically treated cancer types, we propose a novel approach to develop a meta-COS for all surgical oncology types which builds on the concept that there are overlapping outcomes across the existing surgical oncology COS. In the development of this meta-COS, we also pay attention to differences in the adverse outcome domain where specific harms may not have relevance or sufficient importance across different cancer types.
ContributorsMr. Joel Tay, University of Manchester / Health Education North West, UK (Principal Investigator)
Professor Aoife Lowery, University of Galway, Ireland
Professor Catherine Robinson, University of Manchester, UK
Professor Bilal Alkhaffaf, University of Manchester/Northern Care Alliance NHS Foundation Trust, UK
Professor Jane Blazeby, University of Bristol, UK
Professor Yoon Loke, University of East Anglia, UK
Professor Jamie Kirkham, University of Manchester, UK (Primary Supervisor)
Disease Category: Cancer
Disease Name: Cancer
Age Range: 18 - 100
Sex: Either
Nature of Intervention: Surgery
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Researchers
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Focus group(s)
- Systematic review
The development of the meta-COS will include the following stages:
(1) identification of an initial long list of outcomes from previously published COS, a review of outcomes from trials registered with ClinicalTrials.gov and
(2) focus groups with key stakeholder that is inclusive of cancer patients (having undergone surgery for cancer);
(3) a two-round online Delphi survey including;
(4) an online consensus meeting to agree on the final meta-COS for use in effectiveness trials.