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.

Oncoplastic breast surgery: A guide to good practice.

Oncoplastic Breast Surgery has become standard of care in the management of Breast Cancer patients. These guidelines written by an Expert Advisory Group; convened by the Association of Breast Surgery (ABS) and the British Association of Plastic, Reconstructive and Aesthetic Surgeons (BAPRAS), are designed to provide all members of the breast cancer multidisciplinary team (MDT) with guidance on the best breast surgical oncoplastic and reconstructive practice at each stage of a patient's journey, based on current evidence. It is hoped they will also be of benefit to the wide range of professionals and service commissioners who are involved in this area of clinical practice.

The nature and importance of women's goals for immediate and delayed breast reconstruction.

OBJECTIVES: Increasingly, women undergo breast reconstruction (BR) surgery to restore health-related and psychosocial quality of life after mastectomy. Most research focuses on BR outcomes rather than women's pre-surgical expectations of, and goals for, immediate (IBR) or delayed (DBR) procedures, yet such information could support women's decision-making. This study aimed to investigate women's BR goals, whether they differed according surgery timing (IBR or DBR), and the importance women placed on them. METHODS: Seventy-six women considering DBR (n = 50) or IBR (n = 26) at a UK hospital were encouraged to clarify their BR goals and rate the importance of achieving each one. Content analysis categorised and counted the frequency of the goals they reported. RESULTS: Fifteen goal categories (7 surgical, e.g. scarring; 8 psychosocial/lifestyle, e.g. feeling feminine) were identified. Many (e.g. scarring, intimacy) were reported by a similar percentage of women in each surgical group, however, differences were identified (e.g. breast sensation was not mentioned by women considering IBR). Women reported more psychosocial (n = 206) than surgical goals (n = 160). Further, an independent t-tests revealed that women in both groups placed significantly more importance on the psychosocial (M = 9.4) than surgical goals (M = 8.5). CONCLUSIONS: This study highlights the variety of goals women have for BR, the importance they attach to them, and differences and similarities between those seeking IBR and DBR. Future research should consider whether BR goals are met, how goal achievement influences satisfaction with outcome over time and how best to incorporate goals into pre-surgical treatment decision-making.

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.

'Everybody's Different: The Appearance Game'. A randomised controlled trial evaluating an appearance-related board game intervention with children aged 9-11 years.

This study evaluated the effectiveness of an educational board game aimed at increasing knowledge of appearance-related issues, positive body image, media literacy, and acceptance of appearance diversity with British school children. Two hundred and fifty-nine children, aged 9-11 (Mage = 10.26), from three primary schools in South-West England participated in a two-arm matched cluster randomised controlled trial. Outcome measures were collected pre-, post- and at two-week follow-up. Knowledge of appearance-related issues significantly increased in the intervention group, compared to the control group post-intervention, but was not maintained at follow-up. There were no significant differences between groups for body appreciation, media literacy or acceptance of visible difference. Of the intervention arm, 78 % (n=117) they would like to play again and 85.3 % (n=128) thought other children would like to play. Qualitative data suggests participants learned the key messages of the game. The findings suggest 'Everybody's Different: The Appearance Game' is an enjoyable way to increase knowledge of appearance-related issues. In future, researchers should consider how to increase body appreciation, media literacy and acceptance of appearance diversity, for example by increasing the dosage of the game or using it in conjunction with discussions and lessons surrounding appearance diversity and appearance-altering conditions.

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.

A systematic review of patient reported outcome measures (PROMs) used in child and adolescent burn research.

INTRODUCTION: Patient reported outcome measures (PROMs) can identify important information about patient needs and therapeutic progress. The aim of this review was to identify the PROMs that are being used in child and adolescent burn care and to determine the quality of such scales. METHODS: Computerised and manual bibliographic searches of Medline, Social Sciences Index, Cinahl, Psychinfo, Psycharticles, AMED, and HAPI, were used to identify English-language articles using English-language PROMs from January 2001 to March 2013. The psychometric quality of the PROMs was assessed. RESULTS: 23 studies met the entry criteria and identified 32 different PROMs (31 generic, 1 burns-specific). Overall, the psychometric quality of the PROMs was low; only two generic scales (the Perceived Stigmatisation Questionnaire and the Social Comfort Scale) and only one burns-specific scale (the Children Burn Outcomes Questionnaire for children aged 5-18) had psychometric evidence relevant to this population. CONCLUSIONS: The majority of PROMs did not have psychometric evidence for their use with child or adolescent burn patients. To appropriately identify the needs and treatment progress of child and adolescent burn patients, new burns-specific PROMs need to be developed and validated to reflect issues that are of importance to this population.

A qualitative study of patients' motivations and expectations for dental implants.

OBJECTIVE: To explore patients' motivations and expectations for dental implants. DESIGN: Single-setting, qualitative interview study. SUBJECTS, SETTING AND METHOD: Semi-structured, telephone interviews were conducted with nine patients who had consulted a restorative dental practitioner with an interest in implantology about the possibility of replacing their missing teeth with dental implants. OUTCOME MEASURE: Interview transcripts were subjected to thematic analysis to identify relevant themes. RESULTS: The main theme to emerge was 'normality'. Participants expected implants to restore their oral-related quality of life to 'normal'. However, individual definitions of normality differed; some were appearance focused, while others were more concerned with functioning. Several participants who had completed implant treatment regarded their new prostheses as 'just like natural teeth'. CONCLUSIONS: Patients' belief that dental implants are just like natural teeth could be cause for concern if it leads them to treat them as such, and thereby not follow the recommended specialist care they require. The findings emphasise the importance of good dental practitioner-patient communication in assessing expectations of treatment and outcomes. Further studies should explore the expectations of patients of different ages and socioeconomic backgrounds and consider ways of eliciting patients' beliefs about implants before treatment takes place.

Evaluation of the effectiveness of Face IT, a computer-based psychosocial intervention for disfigurement-related distress.

Some people who have a visible difference (disfigurement) experience psychosocial adjustment problems that can lead to social anxiety and isolation. The aim of this study was to assess the effectiveness of a new computerised CBT-based intervention (Face IT) in reducing anxiety and appearance-related distress for individuals with visible differences. Face IT was tested against a non-intervention control group and standard CBT-based face-to-face delivery. Eighty-three participants were assessed at four time points using the Hospital Anxiety and Depression Scales, Derriford Appearance Scale-24, Body Image Quality of Life Inventory and Fear of Negative Evaluation (FNE). The findings indicate a significant reduction in anxiety and appearance-related distress in both the Face IT intervention and the face-to-face condition. Similar findings were reported for depressive symptoms and FNE. Results at the three and six months follow-up demonstrate increased improvements in psychological functioning with both interventions. This new online psychosocial intervention has been found to be effective at reducing anxiety, depression and appearance concerns amongst individuals with disfigurements, whilst increasing positive adjustment. A remote-access, computer-based intervention offers the potential to provide psychosocial support more easily and in a cost-effective manner to adults with appearance-related distress.

Understanding normality: a qualitative analysis of breast cancer patients concepts of normality after mastectomy and reconstructive surgery.

BACKGROUND: As survival rates increase, many people have to adjust to life after cancer. This includes adjusting to life after surgery. While previous research suggests that patients commonly strive to be 'normal' after mastectomy and reconstructive surgery, research surrounding individual perceptions of normality is lacking. AIM: The aim of this study was to explore concepts of normality within a sample of breast cancer patients eligible for reconstructive surgery following mastectomy. METHODS: A total of 35 semi structured interviews, with women who had undergone or were about to undergo breast reconstructive surgery following breast cancer, were analysed using thematic analysis. RESULTS: Four main themes emerged from the data. Women referred to looking normal (appearance); being able to fulfil everyday activities (behaviour); adapting to a new normal (reconstructing normality); and not being ill (health). The importance placed on each area of normality differed between patients. Additionally, patients used different standards to anchor concepts of normality. These included individual standards, social standards and clinical standards. DISCUSSION: The results indicate that although there are commonalities between patients' concepts of normality, it is important for health care professionals to recognise potential individual differences. This may usefully aid communication and help to manage expectations among patients considering surgical options.

Patient satisfaction in relation to nipple reconstruction: the importance of information provision.

127 women who had previously undergone surgical nipple reconstruction completed self-report questionnaires to assess body image, anxiety, depression, information preference, and satisfaction with surgical outcome, information provision, and the decision to undergo the procedure. Whilst most women were satisfied with the outcome of surgery and of their decision to have nipple reconstruction, this study highlights the importance of information provision that meets patients' needs at the time of decision-making, in particular information about likely nipple sensation after surgery.

'Your whole life, your whole world, it changes': partners' experiences of living with rheumatoid arthritis.

OBJECTIVES: Research suggests that rheumatoid arthritis (RA) can have a negative psychosocial impact on partners, as well as patients. However, until now there has been very little in-depth qualitative research in this area. The aim of this study was to explore the experiences of partners of people with RA. METHODS: Semi-structured interviews were conducted with a heterogeneous sample of eight partners of people with RA (six men, two women, age range 48-73 years). Transcripts were analysed thematically. RESULTS: Five overarching themes emerged: psychological burden in partners was substantial, as they experienced frustration and distress at watching their partner suffer and tried to protect their spouse from emotional and physical distress. 'It's a restricted life': partners reported having to cut back on previously enjoyable shared activities and had difficulty making future plans. Adjusting lives: partners had to make considerable adjustments to many aspects of their lives, and had adopted practical and psychological ways to cope. 'It's a joint approach': many partners discussed adopting a joint approach to managing the RA. Met and unmet support needs varied considerably, and many partners felt that a joint approach to treatment taken by health professionals is needed, which involves and recognizes their role. CONCLUSIONS: Partners of people with RA are vital to the patients' disease management, but the data show that many carry a substantial psychosocial burden. Healthcare professionals should be aware of this, so that couples coping with RA can be better supported.

Partner experiences of breast reconstruction post mastectomy.

The aim of this small-scale, qualitative study was to explore partners' experiences of breast reconstruction after mastectomy. Interviews with 6 men, analysed using thematic analysis identified key themes of Involvement in the Decision-Making Process, Giving and Seeking Support, Opportunity to Talk, and Adapting Behaviour. Whilst most participants wanted to be involved in the decision-making process, they reported having experienced barriers to this, including difficulty in talking to others and expressing their true feelings about the surgery. Participants described difficulties with intimate contact after their partner had undergone surgery due to reactions to the appearance and feel of the reconstructed breast and a fear of hurting their partner and of reopening scars. This study highlights the need to recognise the role of the partner's involvement and of their own experiences during this time. The findings are of value to healthcare professionals, in particular specialist nurses, who work with women undergoing breast reconstruction and indicate areas where further research is needed.

Psychological distress surrounding diagnosis of malignant and nonmalignant skin lesions at a pigmented lesion clinic.

This study aimed prospectively to investigate psychological distress throughout the diagnostic process in an outpatient pigmented lesion clinic (PLC). Psychological distress was measured at pre clinical diagnosis, post clinical diagnosis, pre histological diagnosis (including a benign follow-up) and post histological diagnosis stages using standard anxiety measurement scales and a study specific measure of satisfaction with care. In total 324 patients undergoing investigation of a suspicious skin lesion consented to take part out of a cohort of 463 patients who attended the PLC in a 6 month period. Using recognised cut-off scores, 27% of women on clinic arrival reported clinically high levels of anxiety, in comparison with 10% of men (p < 0.0001). Patients given an immediate benign post clinical diagnosis reported a reduction in anxiety (p < 0.0001) but patients requiring a biopsy reported elevated levels of anxiety. Approximately, 30% of these biopsy patients reported clinically high levels of anxiety both before and after diagnosis. Patients who received a post histological diagnosis of malignant melanoma also reported the pre histological stage at the clinic as more distressing than waiting for and receiving results (p < 0.01). Patient's quality of life prior to diagnosis was excellent, but emotional functioning (p < 0.05), insomnia (p

Psychological aspects of breast reconstruction: a review of the literature.

AIM: This paper critically examines the research literature relating to the psychological aspects of breast reconstruction. Particular attention is given to the role of specialist breast care nurses in supporting women faced with the decision of whether or not to opt for reconstructive surgery. BACKGROUND: Breast reconstruction is intended to offer psychological benefits (e.g. improvements to quality of life, body image, anxiety and depression) to women treated by mastectomy following diagnosis of breast cancer. METHODS: A literature search was carried out on the PSYCHINFO, MEDLINE and CINAHL databases using the terms "breast reconstruction", "mastectomy", "reconstructive surgery", "breast surgery", "breast implants", "transverse rectus adominis myocutaneous (TRAM) flap" and "Lat-dorsi". Further relevant articles were identified from the reference lists of papers detected by this literature search. Finally, proceedings of recent psychological and surgical meetings were scrutinized to identify any conference papers on this topic. FINDINGS: A thorough search of the existing literature revealed a lack of theoretically based studies examining breast reconstruction in terms of relevant psychological constructs, especially in relation to coping and decision-making. This review highlights the methodological flaws with much of the existing research in this area, in particular the reliance upon retrospective designs and the inappropriate use of randomised controlled trials. Suggestions are given for further research in this topical area. CONCLUSIONS: Existing research into the psychological aspects of breast reconstruction is limited and not sufficiently conclusive to inform changes to policy and the provision of care. More methodologically rigorous research is needed.

Factors implicated in the decision whether or not to join the tamoxifen trial in women at high familial risk of breast cancer.

Why, given similar medical circumstances-high familial risk of breast cancer-will some women elect to join a trial of drugs designed to reduce that risk but others choose not to take part? The aim of this study was to identify measurable differences between women who elect to join a placebo-controlled, double-blind randomised trial of the drug tamoxifen and women who elect not to join. One hundred and six women attending a breast care clinic completed questionnaires covering demographic details, health locus of control, perception of risk and adequacy of medical communication. All were eligible for inclusion in the tamoxifen trial. Only half (n=53) of the sample elected to join, the other half (n=53) declined. Those who declined the trial were significantly more aware of lifestyle factors thought to influence the development of cancers-diet, exercise and oestrogen-prolonging activities (p<0.001), and they also appeared to find the information given by the hospital about tamoxifen harder to understand than did the group who had joined the trial (p=0.01). They could think of significantly fewer positive reasons for joining (p<0.001) and were significantly younger (p=0.001). Participants in both groups significantly overestimated the relative risks of breast cancer. The average estimation of risk for women aged 30 with a family history of breast cancer was 22 times higher than that given by their consultant. This gives rise to considerable concerns about the information underpinning informed consent.

Specialist nurse counsellor interventions at the time of diagnosis of breast cancer: comparing 'advocacy' with a conventional approach.

Over recent years, specialist breast care nurses have become increasingly recognized as core members of any breast care team within the UK. Part of the role is to support patients at the highly stressful stage of receiving a diagnosis. This paper describes an 'advocacy' style of nurse counsellor intervention which aims to improve patients' preparation for, and involvement in, the diagnostic consultation and provides a framework for future counselling support. One hundred and three women undergoing surgery following diagnosis of breast cancer or a benign breast lump were supported using either this advocacy intervention or a more conventional model of care. The aim was to identify the most effective and appropriate method of intervening at this important stage. Assessment took place before surgery, with 2-week and 6-month follow-ups, and included the Hospital Anxiety and Depression Scale, Rotterdam Symptom Check List and semi-structured interviews addressing perceived quality of care, involvement in decision-making and psycho-social functioning. Whilst the results of many measures were similar for women in the two intervention groups, qualitative data support the implementation of the advocacy method by the breast care nurse.

Synthesis and evaluation of 2-(arylamino)imidazoles as alpha 2-adrenergic agonists.

A series of 2-(arylamino)imidazoles was synthesized and evaluated for activity at alpha 1- and alpha 2-adrenoceptors. This class of agents has been shown to have potent and selective agonist activity at the alpha 2-adrenoceptors. The most potent member of this class, 2-[(5-methyl-1,4-benzodioxan-6yl)amino]imidazole, proved efficacious for the reduction of intraocular pressure upon topical administration and for the reduction of blood pressure upon intravenous administration. During the course of our studies, we developed a new reagent that allowed rapid assembly of the target compounds. This reagent, N-(2,2-diethoxyethyl)carbodiimide, was convenient to prepare and was stable under low-temperature storage conditions.