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.
The aim of the BRAVO (BreastReconstruction AndValid Outcomes) study was to use a robust consensus process to develop a core outcome set for effectiveness studies
in RBS.
S. Potter1, C. Holcombe3, J. A. Ward1 and J. M. Blazeby1,2, on behalf of the BRAVO Steering Group*
1Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, and 2University Hospitals Bristol Foundation NHS
Trust, Bristol, and, 3Royal Liverpool and Broadgreen University Hospitals NHS Trust, Liverpool, UK
Correspondence to: Miss S. Potter, Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, 39 Whatley Road,
Clifton, Bristol BS8 2PS, UK (e-mail: shelley.potter@bristol.ac.uk)
Disease Category: Other
Disease Name: N/A
Age Range: 18 - 100
Sex: Female
Nature of Intervention: Surgery
- Device manufacturers
- Charities
- Clinical experts
- Consumers (patients)
- Patient/ support group representatives
- COS for clinical trials or clinical research
- Delphi process
- Consensus meeting
- Interview
- Systematic review
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.