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

© 2020, The Author(s). 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

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

The comparative impact of conservative treatment versus superficial venous surgery, for the treatment of venous leg ulcers: a systematic review of the impact on patient quality of life

Objectives: Leg ulcers are known to have a profound effect on patient quality of life; however, the influence of different treatment approaches is unclear. This review aims to evaluate the comparative impact of conservative treatments and superficial venous surgery, for venous leg ulcers, on patient Quality of Life. Data sources: Three electronic databases (PsycInfo, Medline, and CINAHL), and reference lists of relevant articles, were searched. Two-hundred and nine articles were initially identified, and sixteen articles were included in the review. Results: The results lend cautious support to the suggestion that all treatment has a positive effect on quality of life, regardless of type, whilst wound status also appears to be an important factor. Conclusions: Some evidence suggests that surgical treatment methods may lead to greater improvements in patient quality of life than compression bandaging alone; however, future research may focus on the psychological mechanisms underlying such changes

The comparative impact of conservative treatment versus superficial venous surgery, for the treatment of venous leg ulcers: A systematic review of the impact on patients' quality of life

Objectives: Leg ulcers are known to have a profound effect on patient quality of life; however, the influence of different treatment approaches is unclear. This review aims to evaluate the comparative impact of conservative treatments and superficial venous surgery, for venous leg ulcers, on patient Quality of Life. Data sources: Three electronic databases (PsycInfo, Medline, and CINAHL), and reference lists of relevant articles, were searched. Two-hundred and nine articles were initially identified, and sixteen articles were included in the review. Results: The results lend cautious support to the suggestion that all treatment has a positive effect on quality of life, regardless of type, whilst wound status also appears to be an important factor. Conclusions: Some evidence suggests that surgical treatment methods may lead to greater improvements in patient quality of life than compression bandaging alone; however, future research may focus on the psychological mechanisms underlying such changes

The CARe Burn Scale—Adult Form: Translation and linguistic validation into Finnish

Background: Burn injury can dramatically deteriorate health-related quality of life. Effective burn care may minimize the impact of the burn injury and ensure optimal functional outcome. This requires continuous improvement in burn care and assessment of treatment results. The aim of this study was to translate, culturally adapt and linguistically validate the CARe Burn Scale—Adult Form, a burn-specific patient-reported outcome measure, into Finnish. Methods: The translation process followed the International Society for Pharmacoeconomics and Outcomes Research guidelines consisting of forward and backward translations, pilot-testing and cognitive debriefing interviews of five burn patients, and proofreading before finalizing. The process involved expert panel meetings and continuous discussion between the developers of the Scale and the research group. Results: In the forward translation 10 amendments were required. After the backward translation, 12 items were reworded. Cognitive debriefing interviews led to three alterations enhancing the comprehensiveness and accuracy of the translation. The translation was reviewed by burn occupational therapists for practicality, resulting in 12 modifications. Minor grammatical changes were made after proofreading. Conclusion: The Finnish version is the first foreign translation of the CARe Burn Scale. It is equivalent to the original Scale and ready for psychometric validation with burn patients in Finland