Investigating the feasibility of randomised clinical trials in breast reconstruction

• Main Author: Potter, Shelley
• Published: University of Bristol 2011
• Subjects: 618.19059
• Online Access: http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.556750

Breast cancer affects one in eight women and approximately 40% will require a mastectomy. The loss of a breast may dramatically impact upon quality of life. Breast reconstruction (BR) is offered to improve outcomes. Making decisions regarding BR surgery, however, is challenging and women and healthcare professionals (HCPs) need to weigh-up 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 multi-centre randomised controlled trials (RCTs) provide the optimal evidence, but few RCTs have been undertaken in BR. The aim of this thesis was therefore to explore the need for and the feasibility of RCTs in BR. Three systematic literature reviews (SRs) critically appraised and summarised the quality of outcome reporting in BR and semi-structured qualitative interviews were conducted with women and HCPs to explore decision-making and attitudes to randomisation in BR. 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. Cosmesis was assessed by patients and HCPs, but the methodology was inconsistent. The patient-reported outcome SR included 62 studies, less than 60% of which were considered methodologically robust. Sixty-two interviews with women and HCPs demonstrated decision-making in BR to be 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 HCPs accepted RCTs in BR in particular circumstances. There is an urgent need for well-designed studies with standardised outcome assessment in BR. Selected randomised trials may be feasible, but they are unlikely to address the key questions in BR. Service re-organisation and interventions to improve decision-making are needed to improve outcome for women considering BR in the UK.