Best-BRA

Best-BRA is a pragmatic two-arm external pilot randomised controlled trial with an embedded QuinteT Recruitment Intervention and economic scoping for resource use. Women who need a mastectomy for breast cancer or risk reduction, elect an implant-based reconstruction and are considered suitable for either placement are randomised 1:1 between sub-pectoral and pre-pectoral reconstruction.

The outcomes are about feasibility rather than about breasts: recruitment, adherence to allocation, and outcome completion rates, reviewed at twelve months to decide whether a definitive trial can be run. The recruitment intervention runs in two phases, investigating why recruitment is difficult and then acting on what it finds, because randomised trials of reconstructive surgery are notoriously hard to fill.

The reason the trial exists is the gap the observational studies left. Mesh-assisted sub-pectoral reconstruction became the standard of care and pre-pectoral techniques were then widely adopted on the argument that they reduce postoperative pain, avoid implant animation and improve appearance, but the small observational studies show no clear difference in clinical or patient-reported outcomes and there is no comparative evidence of clinical or cost effectiveness. No Best-BRA results have been published and none are quoted here.