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Protocol for a novel approach to developing a single pan-specialty 'meta-core outcome set': An example from the field
Joel Tay1, Jane Blazeby2, Adam O'Neill3
1Centre for Biostatistics, Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK.
Background:
Understanding outcomes of surgery performed with curative intent for different cancer types allows comparisons to be made provided consistent outcomes are selected and measured. At present core outcome sets (COS) that represent the minimum outcomes measured and reported in any clinical trial for a given condition exists for six of the ten most prevalent cancer types but it is uncertain whether this can be used to inform the development of a meta-COS (core outcome set) for any cancer type requiring a surgical operation with curative intent. This paper describes our study protocol to develop a meta-COS for surgical oncology.
Methods:
Three stages of work will be conducted : (1) identification of a long list of outcomes including adverse events from previously published COS, a review of outcomes from trials registered with ClinicalTrials.gov, and focus groups with key stakeholders (inclusive of cancer patients having undergone surgery with curative intent for cancer or carers of such patients); (2) a two-round online Delphi survey including clinicians, patients or carers, and allied health professionals (such as dietitians, specialist nurses, physiotherapists, occupational health workers) to prioritise the outcomes; (3) an online consensus meeting using to agree on the final meta-COS.
Discussion:
The meta-COS for surgical oncology trials will ensure that a selection of relevant outcomes will be available for use in all research studies for any cancer type requiring a surgical intervention.
Registration:
This study titled "A meta-Core Outcome Set (COS) for surgical oncology" is registered on the COMET (Core Outcome Measures in Effectiveness Trials) Initiative database. ( https://www.comet-initiative.org/Studies/Details/3252).
