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

Paraskeva, Nicole; Tollow, Philippa; Clarke, Alex; White, Paul; Powell, Jane; Cox, Danielle; Harcourt, Diana

doi:10.1016/j.bjps.2021.11.033

Cited by 11 publications

(6 citation statements)

References 30 publications

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“… 17 The only intervention study to look at outcomes up to 12 months, is Paraskeva et al’s 2022 sequential trial looking at patients considering breast reconstruction. 22 Notably, the reduction of decision regret for patients exposed to the SDM intervention in this study, was not sustained at 12 months. Overall, existing evidence tells us that patients want SDM.…”

Section: Introductionmentioning

confidence: 60%

“…At the time of writing, only one paper extends follow-up to 6 months post-treatment 17. The only intervention study to look at outcomes up to 12 months, is Paraskeva et al’s 2022 sequential trial looking at patients considering breast reconstruction 22. Notably, the reduction of decision regret for patients exposed to the SDM intervention in this study, was not sustained at 12 months.…”

Section: Introductionmentioning

confidence: 81%

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Protocol paper for SMART OPS: Shared decision-making Multidisciplinary Approach – a Randomised controlled Trial in the Older adult Population considering Surgery

et al. 2023

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IntroductionThe Australian population presenting with surgical pathology is becoming older, frailer and more comorbid. Shared decision-making is rapidly becoming the gold standard of care for patients considering high-risk surgery to ensure that appropriate, value-based healthcare decisions are made. Positive benefits around patient perception of decision-making in the immediacy of the decision are described in the literature. However, short-term and long-term holistic patient-centred outcomes and cost implications for the health service require further examination to better understand the full impact of shared decision-making in this population.MethodsWe propose a novel multidisciplinary shared decision-making model of care in the perioperative period for patients considering high-risk surgery in the fields of general, vascular and head and neck surgery. We assess it in a two arm prospective randomised controlled trial. Patients are randomised to either ‘standard’ perioperative care, or to a multidisciplinary (surgeon, anaesthetist and end-of-life care nurse practitioner or social worker) shared decision-making consultation. The primary outcome is decisional conflict prior to any surgical procedure occurring. Secondary outcomes include the patient’s treatment choice, how decisional conflict changes longitudinally over the subsequent year, patient-centred outcomes including life impact and quality of life metrics, as well as morbidity and mortality. Additionally, we will report on healthcare resource use including subsequent admissions or representations to a healthcare facility up to 1 year.Ethics and disseminationThis study has been approved by the Hunter New England Human Research Ethics Committee (2019/ETH13349). Study findings will be presented at local and national conferences and within scientific research journals.Trial registration numberACTRN12619001543178.

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Section: Introductionmentioning

confidence: 60%

Section: Introductionmentioning

confidence: 81%

Protocol paper for SMART OPS: Shared decision-making Multidisciplinary Approach – a Randomised controlled Trial in the Older adult Population considering Surgery

et al. 2023

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“…Several decision aids have been developed to help women make decisions about breast reconstruction surgery 45 including, most recently, BRECONDA 46 and PEGASUS 47 . These, in particular, BRECONDA, have been shown to improve satisfaction with information and reduce decisional conflict in well designed clinical trials 46 .…”

Section: Discussionmentioning

confidence: 99%

Long-term patient-reported outcomes of immediate breast reconstruction after mastectomy for breast cancer: population-based cohort study

Johnson,

White,

Jeevan

et al. 2023

British Journal of Surgery

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Background Breast reconstruction is offered to improve quality of life for women after mastectomy for breast cancer, but information regarding the long-term patient-reported outcomes of different reconstruction procedures is currently lacking. The Brighter study aimed to evaluate long-term patient-reported outcomes after immediate breast reconstruction (IBR) in a population-based cohort. Methods Women who underwent mastectomy with IBR for breast cancer in England between 1 January 2008 and 31 March 2009 were identified from National Health Service Hospital Episode Statistics. Surviving women were invited to complete the BREAST-Q, EQ-5D-5L™, and ICECAP-A at least 12 years after the index procedure. Questionnaires were scored according to developers’ instructions and compared by IBR type. Results Some 1236 women underwent IBR; 343 (27.8 per cent) had 2-stage expander/implant, 630 (51.0 per cent) latissimus dorsi, and 263 (21.3 per cent) abdominal flap reconstructions, with a mean(s.d.) follow-up of 13.3(0.5) years. Women who underwent abdominal flap reconstruction reported higher scores in all BREAST-Q domains than those who had other procedures. These differences remained statistically significant and clinically meaningful after adjusting for age, ethnicity, geographical region, socioeconomic status, smoking, BMI, and complications. The greatest difference was seen in scores for satisfaction with breasts; women who had abdominal flap reconstructions reported scores that were 13.17 (95 per cent c.i. 9.48 to 16.87) points; P < 0.001) higher than those among women who had two-stage expander/implant procedures. Women who underwent latissimus dorsi reconstruction reported significantly more pain/discomfort on the EQ-5D-5L™, but no other differences between procedures were seen. Conclusion Long-term patient-reported outcomes are significantly better following abdominal flap reconstruction than other traditional procedure types. These findings should be shared with women considering IBR to help them make informed decisions about their surgical options.

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“…There is no official costeffectiveness acceptability threshold in Norway. The 2015-2016 Norwegian government white paper on priority setting in the healthcare sector discusses a base threshold of 275,000 NOK (Norwegian Government, 2016). The base threshold may increase up to 825,000 NOK, depending on the patient groups' expected loss of QALYs under the current treatment strategy relative to the age-matched general population (absolute prognosis loss).…”

Section: Cost-effectiveness Acceptability Thresholdmentioning

confidence: 99%

“…Studies have shown that biomedical interventions, such as medical and surgical procedures to correct or ameliorate appearance differences, may improve social confidence (Myhre, Råbu & Feragen, 2021). However, biomedical interventions do not guarantee enhanced psychosocial functioning and therefore psychological interventions have evolved as an adjunct or alternative to biomedical approaches (Bemmels, Biesecker, Schmidt, Krokosky, Guidotti & Sutton, 2013; Paraskeva, Tollow, Clarke et al ., 2021; Rumsey & Harcourt., 2007). Psychosocial support for adolescents with a visible difference typically involves a wide range of therapeutic approaches and techniques drawn from cognitive behavioral therapy (CBT), social skills training (SST), and acceptance and commitment therapy (Harcourt, Hamlet, Feragen et al ., 2018).…”

Section: Introductionmentioning

confidence: 99%

Cost‐effectiveness analysis of a psychosocial web‐based intervention for adolescents distressed by a visible difference: Results from a randomized controlled trial in Norway

Kling

Asphaug

Feragen

2022

Scandinavian J Psychology

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Cost-effectiveness analysis of a psychosocial web-based intervention for adolescents distressed by a visible difference: Results from a randomized controlled trial in Norway. Scandinavian Journal of Psychology.Adolescents with a visible difference to the face or body (e.g., due to a congenital condition, illness, or injury), may be at risk of elevated psychological distress. Young Person's Face IT (YPF), a web-based psychosocial intervention, has displayed effectiveness, but no previous study has specifically evaluated its cost-effectiveness. The aim of our study was to investigate whether YPF could be a cost-effective alternative for psychosocial support to adolescents distressed by a visible difference, relative to care-as-usual (CAU). Within the context of a randomized controlled trial in Norway, 102 participants (43% boys) were allocated to intervention (n = 55) or waiting list control group (n = 47). Mean age was 13.9 years (SD = 1.71; range 11-18), and all self-identified as experiencing distress related to a visible difference. Participants answered questionnaires including measures of health-related quality of life and social anxiety at baseline and 3-month follow-up. A health economic evaluation using the method of cost-utility analysis was performed, including quality-adjusted life-years (QALYs). Results indicated that the incremental cost-effectiveness of YPF was 63,641 Norwegian kroner per QALYs gained, which is well within the acceptability threshold in the Norwegian healthcare sector. Hence, YPF could potentially be considered a cost-effective intervention for adolescents experiencing distress related to a visible difference, but more research is needed that includes comparisons of YPF to other health-and societal resources and long-term follow-ups. Our study also constitutes an addition to research as, compared to interventions for somatic diseases, there is a lack of studies exploring the cost-effectiveness of psychological interventions.

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

Cited by 11 publications

References 30 publications

Protocol paper for SMART OPS: Shared decision-making Multidisciplinary Approach – a Randomised controlled Trial in the Older adult Population considering Surgery

Protocol paper for SMART OPS: Shared decision-making Multidisciplinary Approach – a Randomised controlled Trial in the Older adult Population considering Surgery

Long-term patient-reported outcomes of immediate breast reconstruction after mastectomy for breast cancer: population-based cohort study

Cost‐effectiveness analysis of a psychosocial web‐based intervention for adolescents distressed by a visible difference: Results from a randomized controlled trial in Norway

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