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' Ex-pectations 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 base-line, 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, there-fore 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 & nbsp;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.(c) 2021 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license ( http://creativecommons.org/licenses/by-nc-nd/4.0/ )

Automated summary

Decision making about breast reconstruction is complex. The PEGASUS intervention aims to support shared decision making and has shown benefits in reducing decisional regret and improving health-related quality of life and capability well-being.