Appropriately-designed randomised trials may be an acceptable method for addressing uncertainties implant-based breast reconstruction: Preliminary findings from the iBRA Randomisation Acceptability Survey
Association of Breast Surgery ePoster Library. Davies G. 05/13/19; 257149; P106
Dr. Gareth Davies
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P106
Topic: Oncoplastic and aesthetic surgery
Introduction: High-quality evidence to support best-practice in implant-based breast reconstruction (IBBR) is lacking. Randomised clinical trials (RCTs) are needed but these are challenging. iBRA is a four-phase study that aimed to inform the feasibility, design and conduct of an IBBR-RCT. Phase 3, the RCT acceptability survey, aimed to explore professionals' attitudes to a future trial. MethodsThe survey was developed by the iBRA steering group based findings from phases 1(national practice questionnaire) and 2(prospective audit). The survey was distributed electronically via the professional associations and trainee research network. Ethical approval was obtained. Results: 154 respondents included 76 consultant breast surgeons;14 consultant plastic surgeons and 33 specialist nurses. 70%(108/154) of respondents felt there was uncertainty regarding best-practice in IBBR but only a third (51/154) felt there was uncertainty regarding the use of mesh. The greatest areas of uncertainty were biological vs.synthetic mesh for subpectoral reconstruction (98/154,64%) and implant position (pre-vs.subpectoral;98/154,64%). Only half (85/154) felt that a RCT was needed but 70%(108/154) felt that an appropriately-designed RCT would be possible. Almost half (75/154) respondents would recruit to an RCT comparing subpectoral IBBR with biological vs. synthetic mesh and 40% (61/154) would recruit to a trial comparing pre-vs.subpectoral implant-placement. Implant loss at 12 months was considered the most important primary outcome for a future trial.ConclusionThe iBRA RCT acceptability survey supports the potential feasibility of an RCT in IBBR. Qualitative work is now needed explore these findings in more detail to optimise the success of a future trial.
Topic: Oncoplastic and aesthetic surgery
Introduction: High-quality evidence to support best-practice in implant-based breast reconstruction (IBBR) is lacking. Randomised clinical trials (RCTs) are needed but these are challenging. iBRA is a four-phase study that aimed to inform the feasibility, design and conduct of an IBBR-RCT. Phase 3, the RCT acceptability survey, aimed to explore professionals' attitudes to a future trial. MethodsThe survey was developed by the iBRA steering group based findings from phases 1(national practice questionnaire) and 2(prospective audit). The survey was distributed electronically via the professional associations and trainee research network. Ethical approval was obtained. Results: 154 respondents included 76 consultant breast surgeons;14 consultant plastic surgeons and 33 specialist nurses. 70%(108/154) of respondents felt there was uncertainty regarding best-practice in IBBR but only a third (51/154) felt there was uncertainty regarding the use of mesh. The greatest areas of uncertainty were biological vs.synthetic mesh for subpectoral reconstruction (98/154,64%) and implant position (pre-vs.subpectoral;98/154,64%). Only half (85/154) felt that a RCT was needed but 70%(108/154) felt that an appropriately-designed RCT would be possible. Almost half (75/154) respondents would recruit to an RCT comparing subpectoral IBBR with biological vs. synthetic mesh and 40% (61/154) would recruit to a trial comparing pre-vs.subpectoral implant-placement. Implant loss at 12 months was considered the most important primary outcome for a future trial.ConclusionThe iBRA RCT acceptability survey supports the potential feasibility of an RCT in IBBR. Qualitative work is now needed explore these findings in more detail to optimise the success of a future trial.
P106
Topic: Oncoplastic and aesthetic surgery
Introduction: High-quality evidence to support best-practice in implant-based breast reconstruction (IBBR) is lacking. Randomised clinical trials (RCTs) are needed but these are challenging. iBRA is a four-phase study that aimed to inform the feasibility, design and conduct of an IBBR-RCT. Phase 3, the RCT acceptability survey, aimed to explore professionals' attitudes to a future trial. MethodsThe survey was developed by the iBRA steering group based findings from phases 1(national practice questionnaire) and 2(prospective audit). The survey was distributed electronically via the professional associations and trainee research network. Ethical approval was obtained. Results: 154 respondents included 76 consultant breast surgeons;14 consultant plastic surgeons and 33 specialist nurses. 70%(108/154) of respondents felt there was uncertainty regarding best-practice in IBBR but only a third (51/154) felt there was uncertainty regarding the use of mesh. The greatest areas of uncertainty were biological vs.synthetic mesh for subpectoral reconstruction (98/154,64%) and implant position (pre-vs.subpectoral;98/154,64%). Only half (85/154) felt that a RCT was needed but 70%(108/154) felt that an appropriately-designed RCT would be possible. Almost half (75/154) respondents would recruit to an RCT comparing subpectoral IBBR with biological vs. synthetic mesh and 40% (61/154) would recruit to a trial comparing pre-vs.subpectoral implant-placement. Implant loss at 12 months was considered the most important primary outcome for a future trial.ConclusionThe iBRA RCT acceptability survey supports the potential feasibility of an RCT in IBBR. Qualitative work is now needed explore these findings in more detail to optimise the success of a future trial.
Topic: Oncoplastic and aesthetic surgery
Introduction: High-quality evidence to support best-practice in implant-based breast reconstruction (IBBR) is lacking. Randomised clinical trials (RCTs) are needed but these are challenging. iBRA is a four-phase study that aimed to inform the feasibility, design and conduct of an IBBR-RCT. Phase 3, the RCT acceptability survey, aimed to explore professionals' attitudes to a future trial. MethodsThe survey was developed by the iBRA steering group based findings from phases 1(national practice questionnaire) and 2(prospective audit). The survey was distributed electronically via the professional associations and trainee research network. Ethical approval was obtained. Results: 154 respondents included 76 consultant breast surgeons;14 consultant plastic surgeons and 33 specialist nurses. 70%(108/154) of respondents felt there was uncertainty regarding best-practice in IBBR but only a third (51/154) felt there was uncertainty regarding the use of mesh. The greatest areas of uncertainty were biological vs.synthetic mesh for subpectoral reconstruction (98/154,64%) and implant position (pre-vs.subpectoral;98/154,64%). Only half (85/154) felt that a RCT was needed but 70%(108/154) felt that an appropriately-designed RCT would be possible. Almost half (75/154) respondents would recruit to an RCT comparing subpectoral IBBR with biological vs. synthetic mesh and 40% (61/154) would recruit to a trial comparing pre-vs.subpectoral implant-placement. Implant loss at 12 months was considered the most important primary outcome for a future trial.ConclusionThe iBRA RCT acceptability survey supports the potential feasibility of an RCT in IBBR. Qualitative work is now needed explore these findings in more detail to optimise the success of a future trial.
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