Designing a definitive randomised clinical trial in implant-based breast reconstruction: A qualitative study.
Association of Breast Surgery ePoster Library. Davies G. 05/13/19; 257162; P119
Dr. Gareth Davies
REGULAR CONTENT
Login now to access Regular content available to all registered users.
Abstract
Discussion Forum (0)
Rate & Comment (0)
P119
Topic: Oncoplastic and aesthetic surgery
Introduction: Mesh-assisted implant-based breast reconstruction (IBBR) has become established as the standard of care despite a lack of high-quality evidence to support its safety or effectiveness. Well-designed randomised trials (RCTs) are ideally needed. The audit phase of the iBRA study demonstrated equivocal short-term outcomes in patients undergoing IBBR with biological and synthetic mesh and with pre and subpectoral techniques supporting a future trial. This study, the third phase of iBRA explored surgeons' perceptions of the acceptability of future RCTs in IBBR. MethodsSemi-structured qualitative interviews were undertaken with a purposive sample of 33 health professionals (HPs) involved in IBBR to explore their attitudes to the feasibility of RCTs. Interviews were transcribed verbatim and data analysed thematically using constant comparative techniques. Sampling, data collection and analysis were undertaken iteratively and concurrently until data saturation was achieved. Results: Many HPs appreciated the limited quality of evidence supporting IBBR techniques. Whilst some supported the need for definitive RCTs in IBBR, others demonstrated reservations about their feasibility and suitability. Lack of equipoise and limited appreciation of the value and design of pragmatic RCTs were central to many concerns. Around half felt randomisation of implant position (pre vs subpectoral) and mesh used (biological vs synthetic) were acceptable, whilst others opposed this.ConclusionDespite some opposition to RCTs in IBBR, certain designs may be acceptable and feasible. To provide the much-needed evidence, efforts must focus on engaging the reconstructive community in a future RCT and improving understanding of the benefits of high-quality pragmatic RCTs.
Topic: Oncoplastic and aesthetic surgery
Introduction: Mesh-assisted implant-based breast reconstruction (IBBR) has become established as the standard of care despite a lack of high-quality evidence to support its safety or effectiveness. Well-designed randomised trials (RCTs) are ideally needed. The audit phase of the iBRA study demonstrated equivocal short-term outcomes in patients undergoing IBBR with biological and synthetic mesh and with pre and subpectoral techniques supporting a future trial. This study, the third phase of iBRA explored surgeons' perceptions of the acceptability of future RCTs in IBBR. MethodsSemi-structured qualitative interviews were undertaken with a purposive sample of 33 health professionals (HPs) involved in IBBR to explore their attitudes to the feasibility of RCTs. Interviews were transcribed verbatim and data analysed thematically using constant comparative techniques. Sampling, data collection and analysis were undertaken iteratively and concurrently until data saturation was achieved. Results: Many HPs appreciated the limited quality of evidence supporting IBBR techniques. Whilst some supported the need for definitive RCTs in IBBR, others demonstrated reservations about their feasibility and suitability. Lack of equipoise and limited appreciation of the value and design of pragmatic RCTs were central to many concerns. Around half felt randomisation of implant position (pre vs subpectoral) and mesh used (biological vs synthetic) were acceptable, whilst others opposed this.ConclusionDespite some opposition to RCTs in IBBR, certain designs may be acceptable and feasible. To provide the much-needed evidence, efforts must focus on engaging the reconstructive community in a future RCT and improving understanding of the benefits of high-quality pragmatic RCTs.
P119
Topic: Oncoplastic and aesthetic surgery
Introduction: Mesh-assisted implant-based breast reconstruction (IBBR) has become established as the standard of care despite a lack of high-quality evidence to support its safety or effectiveness. Well-designed randomised trials (RCTs) are ideally needed. The audit phase of the iBRA study demonstrated equivocal short-term outcomes in patients undergoing IBBR with biological and synthetic mesh and with pre and subpectoral techniques supporting a future trial. This study, the third phase of iBRA explored surgeons' perceptions of the acceptability of future RCTs in IBBR. MethodsSemi-structured qualitative interviews were undertaken with a purposive sample of 33 health professionals (HPs) involved in IBBR to explore their attitudes to the feasibility of RCTs. Interviews were transcribed verbatim and data analysed thematically using constant comparative techniques. Sampling, data collection and analysis were undertaken iteratively and concurrently until data saturation was achieved. Results: Many HPs appreciated the limited quality of evidence supporting IBBR techniques. Whilst some supported the need for definitive RCTs in IBBR, others demonstrated reservations about their feasibility and suitability. Lack of equipoise and limited appreciation of the value and design of pragmatic RCTs were central to many concerns. Around half felt randomisation of implant position (pre vs subpectoral) and mesh used (biological vs synthetic) were acceptable, whilst others opposed this.ConclusionDespite some opposition to RCTs in IBBR, certain designs may be acceptable and feasible. To provide the much-needed evidence, efforts must focus on engaging the reconstructive community in a future RCT and improving understanding of the benefits of high-quality pragmatic RCTs.
Topic: Oncoplastic and aesthetic surgery
Introduction: Mesh-assisted implant-based breast reconstruction (IBBR) has become established as the standard of care despite a lack of high-quality evidence to support its safety or effectiveness. Well-designed randomised trials (RCTs) are ideally needed. The audit phase of the iBRA study demonstrated equivocal short-term outcomes in patients undergoing IBBR with biological and synthetic mesh and with pre and subpectoral techniques supporting a future trial. This study, the third phase of iBRA explored surgeons' perceptions of the acceptability of future RCTs in IBBR. MethodsSemi-structured qualitative interviews were undertaken with a purposive sample of 33 health professionals (HPs) involved in IBBR to explore their attitudes to the feasibility of RCTs. Interviews were transcribed verbatim and data analysed thematically using constant comparative techniques. Sampling, data collection and analysis were undertaken iteratively and concurrently until data saturation was achieved. Results: Many HPs appreciated the limited quality of evidence supporting IBBR techniques. Whilst some supported the need for definitive RCTs in IBBR, others demonstrated reservations about their feasibility and suitability. Lack of equipoise and limited appreciation of the value and design of pragmatic RCTs were central to many concerns. Around half felt randomisation of implant position (pre vs subpectoral) and mesh used (biological vs synthetic) were acceptable, whilst others opposed this.ConclusionDespite some opposition to RCTs in IBBR, certain designs may be acceptable and feasible. To provide the much-needed evidence, efforts must focus on engaging the reconstructive community in a future RCT and improving understanding of the benefits of high-quality pragmatic RCTs.
Code of conduct/disclaimer available in General Terms & Conditions
{{ help_message }}
{{filter}}