Investigation of the feasibility of clinical trials in breast reconstruction

Background Breast cancer affects one in eight women and approximately 40% will require a mastectomy. The loss of a breast can dramatically impact upon quality of life. Breast reconstruction is offered to improve outcomes. Making decisions about reconstructive surgery, however, is challenging, and women and health-care professionals need to assess the likely benefits of surgery against the risks of adverse outcomes. Decisions are informed by published outcomes and surgeon and patient preferences. Well-designed studies, such as multicentre, randomised, controlled trials (RCTs) provide the best evidence, but few RCTs have been undertaken in breast reconstruction. The aim of this study was therefore to explore the need for and the feasibility of RCTs in breast reconstruction. Methods Three systematic literature reviews (SRs) were done to critically appraised and summarise the quality of outcome reporting in breast reconstruction. Semistructured qualitative interviews were conducted with women and health-care professionals to explore decision making and attitudes to RCTs in breast reconstruction. The clinical outcomes SR included 123 observational studies and 11 RCTs. The majority were at high-risk of bias, and outcome reporting was heterogeneous. The cosmetic outcome SR included 122 studies. Cosmetic results were assessed by patients and health-care professionals, but the methodology was inconsistent. The patient-reported outcome SR included 62 studies, only 60% of which were considered methodologically robust. Findings 62 interviews with women and health-care professionals showed that decision making in breast reconstruction was complex. A third of women reported decisional regret, and insufficient time and information were identified as barriers to decision making. Inequalities in access to care, however, emerged as the most significant determinant of women's reconstructive experience. Both women and health-care professionals accepted RCTs in breast reconstruction in particular circumstances. Interpretation There is an urgent need for well-designed studies with standardised outcome assessment in breast reconstruction. Selected randomised trials may be feasible, but they are unlikely to address the key questions. Service reorganisation and interventions to improve decision making are needed to improve outcome for women considering breast reconstruction in the UK. Funding University of Bristol.