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.

Relative effectiveness and costs of antiulcer medications as a basis for rational prescribing.

To be maximally effective, antiulcer medications should relieve ulcer symptoms rapidly and promote rapid healing of an ulcer crater; after the cessation of a course of treatment the ulcer should not recur. A wide variety of agents is available. These are of similar efficiency in the control of ulcer symptoms and in the acceleration of the healing of the ulcer crater. However, evidence exists of differences in the rate of the recurrence of duodenal ulcers on the cessation of these drugs. Surface-active agents (bismuth complexes, sucralfate, prostaglandins and carbenoxolone) are consistently superior to H2-histamine receptor antagonist drugs (cimetidine and ranitidine). A high relapse rate produces more patients with active disease at any one time, hence more patients will be exposed to the complications of the disease, and will require active investigation and therapy. Because of the increased rate of relapse, the use of H2-receptor antagonist drugs as first-line intermittent healing therapy can be shown to be associated with an eight-fold (800%) increase in cost of pharmaceutical agents as compared with first-line treatment with bismuth salts; a four-fold increase compared with the cost of using antacid drugs; and a two-fold increase compared with the cost of using sucralfate. When maintenance therapy with H2-receptor antagonist agents is given instead of intermittent therapy with bismuth complexes, a 14-fold increase in pharmaceutical costs is incurred, with inferior results that have already been demonstrated under the conditions of a controlled clinical trial. These considerations of efficacy and cost suggest that H2-receptor antagonist drugs ought not to be first-line therapy for duodenal ulcers; rather, surface-active agents such as colloidal bismuth or sucralfate should be prescribed initially.