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Development of a core outcome set for research and audit studies in reconstructive breast surgery

Potter, S.; Holcombe, C.; Ward, J. A.; Blazeby, J. M.


S. Potter

C. Holcombe

J. A. Ward

J. M. Blazeby


© 2015 The Authors. BJS published by John Wiley & Sons Ltd on behalf of BJS Society Ltd. Background Appropriate outcome selection is essential if research is to guide decision-making and inform policy. Systematic reviews of the clinical, cosmetic and patient-reported outcomes of reconstructive breast surgery, however, have demonstrated marked heterogeneity, and results from individual studies cannot be compared or combined. Use of a core outcome set may improve the situation. The BRAVO study developed a core outcome set for reconstructive breast surgery. Methods A long list of outcomes identified from systematic reviews and stakeholder interviews was used to inform a questionnaire survey. Key stakeholders defined as individuals involved in decision-making for reconstructive breast surgery, including patients, breast and plastic surgeons, specialist nurses and psychologists, were sampled purposively and sent the questionnaire (round 1). This asked them to rate the importance of each outcome on a 9-point Likert scale from 1 (not important) to 9 (extremely important). The proportion of respondents rating each item as very important (score 7-9) was calculated. This was fed back to participants in a second questionnaire (round 2). Respondents were asked to reprioritize outcomes based on the feedback received. Items considered very important after round 2 were discussed at consensus meetings, where the core outcome set was agreed. Results A total of 148 items were combined into 34 domains within six categories. Some 303 participants (51·4 per cent) (215 (49·5 per cent) of 434 patients; 88 (56·4 per cent) of 156 professionals) completed and returned the round 1 questionnaire, and 259 (85·5 per cent) reprioritized outcomes in round 2. Fifteen items were excluded based on questionnaire scores and 19 were carried forward to the consensus meetings, where a core outcome set containing 11 key outcomes was agreed. Conclusion The BRAVO study has used robust consensus methodology to develop a core outcome set for reconstructive breast surgery. Widespread adoption by the reconstructive community will improve the quality of outcome assessment in effectiveness studies. Future work will evaluate how these key outcomes should best be measured.


Potter, S., Holcombe, C., Ward, J. A., & Blazeby, J. M. (2015). Development of a core outcome set for research and audit studies in reconstructive breast surgery. British Journal of Surgery, 102(11), 1360-1371.

Journal Article Type Article
Publication Date Jan 1, 2015
Deposit Date Jul 30, 2015
Journal British Journal of Surgery
Print ISSN 0007-1323
Electronic ISSN 1365-2168
Publisher Wiley
Peer Reviewed Peer Reviewed
Volume 102
Issue 11
Pages 1360-1371
Keywords breast cancer, reconstructive surgery, visible difference, body image
Public URL
Publisher URL
Additional Information Corporate Creators : BRAVO Steering Group


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