International development and implementation of a core measurement set for research and audit studies in implant-based breast reconstruction: a study protocol

Outcome reporting in research studies of breast reconstruction is inconsistent and lacks standardisation. The results of individual studies therefore cannot be meaningfully compared or combined limiting their value. A core outcome set (COS) has been developed to address these issues and identified 11 key outcomes to be measured and reported in all future research and audit studies in reconstructive breast surgery (RBS). A COS represents what key outcomes should be measured. The next step is to determine how and when this should be done. The aim of this study is to develop a core measurement set (CMS) for use in research and audit studies in implant-based breast reconstruction.

Protocol: https://bmjopen.bmj.com/content/10/1/e035505

Contributors

Shelley Potter, Charlotte Davies, Christopher Holcombe, Eva Weiler-Mithoff, Joanna Skillman, Raghavan Vidya, Yazan Masannat, Walter Weber, Joerg Heil, Sherif Wilson, Steven Thrush, Lisa Whisker, Jane Blazeby, Chris Metcalfe, Kerry Avery

Further Study Information

Current Stage: Completed – pending publication
Date:
Funding source(s): This study is funded by the NIHR as part of a Clinician Scientist Award (CS-2016-16-019) and supported by the NIHR Biomedical Research Centre at University Hospitals Bristol NHS Foundation Trust and the University of Bristol.


Health Area

Disease Category: Other

Disease Name: N/A

Target Population

Age Range: 18 - 100

Sex: Female

Nature of Intervention: Surgery

Stakeholders Involved

- Clinical experts
- Consumers (patients)

Study Type

- Recommendations for outcome measures (measurement/how)

Method(s)

- Consensus meeting
- Delphi process
- Systematic review

The CMS will be developed in accordance with the guidance developed by the Core Outcome Measures in Effectiveness Trials initiative (COMET) and COnsensus-based Standards for the selection of health Measurement Instruments (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 (1) conceptual considerations in which the target population, procedures and settings are defined; (2) systematic reviews to identify existing clinical, patient-reported and cosmetic OMIs and, if appropriate, assess their quality using COSMIN methodology; (3) 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; (4) strategies to promote dissemination and adoption of the CMS.