Methods and analysis: The CMS will be developed in accordance with guidance developed by the COMET initiative and COSMIN group for the selection of outcome measurement instruments (OMIs) for relevant outcome domains included in the RBS COS. This will involve three phases with strategies to promote implementation as a final additional phase. The phases are i) Conceptual considerations in which the target population, procedures and settings are defined; ii) Systematic reviews to identify existing clinical, patient-reported and cosmetic OMIs and, if appropriate, assess their quality using COSMIN methodology; iii) A modified Delphi process including sequential Delphi surveys involving approximately 100 healthcare professionals and a face to face consensus meeting to agree and ratify which outcome definitions and OMIs should be used and standardised time points for assessment; iv) Strategies to promote dissemination and adoption of the CMS.
Ethics and dissemination: Ethical approval has been granted by University of Bristol Faculty Research Ethics Committee FREC ID 60221. Dissemination strategies will include scientific meeting presentations and peer-reviewed journal publications. Implementation activities will include engagement with journal editors and funders to promote uptake and use of the CMS.
- BTC (Bristol Trials Centre)
- core measurement set
- implant-based breast reconstruction