A multi-centred sequential trial comparing PEGASUS, an intervention to promote shared decision making about breast reconstruction with usual care.

Decision making about breast reconstruction (BR) is complex. The Patients' Expectations and Goals: Assisting Shared Understanding of Surgery (PEGASUS) intervention aims to support shared decision making by helping women and clinicians clarify and discuss their expectations around reconstructive surgery. We conducted a multi-centred sequential trial comparing PEGASUS (n = 52) with usual care (UC) (n = 86) in women considering reconstruction, who completed outcome measures at baseline, and 3, 6 and 12 months post-surgery. The primary outcome was BR-specific quality of life (Breast-Q) 6 months post-intervention. Secondary outcomes were health-related quality of life (EQ-5D-5L), capabilities (ICECAP-A) and decisional regret, compared using t-tests and Cohen's d. Comparative analyses revealed no significant differences between groups in Breast-Q scores at any time point, except for a favourable effect for UC on psychological well-being at 3 months (t = -2.41, p = .019, d= -0.59). Intervention participants reported significantly higher, therefore improved, ICECAP-A (t = -2.13, p = .037, d = -0.45) and EQ VAS (t = -2.28, p = .026, d = -0.49) scores at 12 months compared to UC. Decisional regret was significantly lower in the PEGASUS group compared to the UC group at 6 months (t =2.06, p = .044, d= -0.51), but this was not sustained at 12 months. In conclusion, the PEGASUS intervention offers some benefits to women considering BR. At times, women experienced less decisional regret, improved health-related quality of life and capability well-being. Findings are discussed in the light of fidelity testing and embedding PEGASUS into practice.

PEGASUS: the Design of an Intervention to Facilitate Shared Decision-making in Breast Reconstruction.

Studies have found varying levels of satisfaction after breast reconstruction surgery with a substantial group of patients reporting some level of regret about their decision. The variable outcomes reported by women undergoing breast reconstruction surgery suggest a role for improved pre-operative communication and shared decision-making (SDM) between patient and health professional. Pragmatic approaches such as decision aids have been evaluated, but the aim of the Patient Expectations and Goals Assisting Shared Understanding of Surgery (PEGASUS) intervention is to facilitate closer interaction between the patient and clinical team. PEGASUS is a standardised two-stage process, in which patients' goals are first elicited, ranked in importance and recorded before being used to frame discussion and decision-making with the surgeon managing care. Following the Medical Research Council (MRC) model, feasibility and acceptability studies have already been reported and a 4-year multicentre randomised controlled trial of 180 participants is underway, (completion 2020). This paper therefore focuses on the design of the intervention itself, in line with recent advice that interventions, in comparison with evaluations, commonly lack a theoretical base and are often under reported. We report a retrospective application of the Capability, Opportunity, Motivation-Behaviour (COM-B) model to provide explicit detail of each step in the intervention design. This is intended to facilitate replication by other clinicians and to provide systematic guidance for others wishing to develop PEGASUS as a strategy for implementing SDM in other clinical populations. Trial Registration: ISRCTN 18000391 (DOI 10.1186/ISRCTN18000391) 27/01/2016.

First look: A mixed-methods study exploring women's initial experiences of their appearance after mastectomy and/or breast reconstruction✰.

OBJECTIVES: Increasing numbers of women are undergoing appearance-altering surgery for the treatment and/or prevention of breast cancer. However, women's experiences of seeing the results of their breast surgery for the first time, and the support available to them, are currently omitted from the research literature. This study aimed to explore women's initial experiences of seeing their appearance after mastectomy and/or breast reconstruction. DESIGN: An online mixed-methods survey explored participants' feelings and expectations before seeing their breast surgery for the first time, their experiences of looking at the results of their surgery, and the support they received. METHODS: Women (n = 128) who had undergone mastectomy and/or breast reconstruction following a diagnosis of invasive breast cancer, DCIS or increased risk of breast cancer participated. Data were analysed using descriptive statistics and qualitative content analysis. RESULTS: Most respondents had worried about looking at their breast/breast area for the first time, with 75% concerned about what they would see. Women found the experience moderately distressing, and younger women were particularly concerned about other people's reactions to their altered appearance. Approximately half of the women (51%) felt they received enough support, while 29% thought this aspect of care could be improved. Areas for improvement were suggested, including increased preparation, privacy and support. CONCLUSION: Women's experiences of looking at their breast/breast area and any donor site after surgery vary considerably. The results indicate important implications for provision of care and further research.