'They were aware of who I was as a person': Patients' and health professionals' experiences of using the PEGASUS intervention to facilitate decision-making around breast reconstruction.

OBJECTIVE: Many women choose to have breast reconstruction after mastectomy; however, decision-making can be difficult and expectations are often unmet. The PEGASUS intervention (Patient Expectations and Goals: Assisting Shared Understanding of Surgery) was developed to support shared decision-making by helping women and healthcare professionals to clarify and discuss their individual expectations around surgery. This study aimed to explore patients' and health professionals' experiences of using the intervention and its implementation. METHODS: Forty interviews were conducted with participants in a large scale, multi-site trial of the effectiveness of PEGASUS, from 'intervention' (n=16) and 'usual care' groups (n=11), and healthcare professionals (n=13). Data were analysed using thematic analysis. RESULTS: 'Usual care' participants described feeling overwhelmed in decision-making ('bombarded'), often using their own research to break down information ('process of elimination'). In contrast, intervention group participants described PEGASUS providing focus ('focus amongst the frenetic'), and increased connection with clinicians ('more than a number'). Healthcare professionals described increased focus on patient priorities ('shifting focus'), but stressed the need for whole team buy-in ('collective commitment'). CONCLUSIONS: The PEGASUS intervention offered a qualitatively different experience to individuals considering breast reconstruction, with potential to enhance patients' and healthcare professionals' feelings of shared decision-making and patient-centred care. TRIAL REGISTRATION: ISRCTN 18000391 (https://doi.org/10.1186/ISRCTN18000391) 27/01/2016.

A study protocol of the effectiveness of PEGASUS: a multi-centred study comparing an intervention to promote shared decision making about breast reconstruction with treatment as usual.

BACKGROUND: Increasingly, women elect breast reconstruction after mastectomy. However, their expectations of surgery are often not met, and dissatisfaction with outcome and ongoing psychosocial concerns and distress are common. We developed a patient-centered intervention, PEGASUS:(Patients' Expectations and Goals: Assisting Shared Understanding of Surgery) which supports shared decision making by helping women clarify their own, individual goals about reconstruction so that they can discuss these with their surgeon. Our acceptability/feasibility work has shown it is well received by patients and health professionals alike. We now need to establish whether PEGASUS improves patients' experiences of breast reconstruction decision making and outcomes. The purpose of this study is, therefore, to examine the effectiveness of PEGASUS, an intervention designed to support shared decision making about breast reconstruction. METHODS: A multi-centered sequential study will compare the impact of PEGASUS with usual care, in terms of patient reported outcomes (self-reported satisfaction with the outcome of surgery, involvement in decision making and in the consultation) and health economics. Initially we will collect data from our comparison (usual care) group (90 women) who will complete standardized measures (Breast-Q, EQ5D -5 L and ICECAP- A) at the time of decision making, 3, 6 and 12 months after surgery. Health professionals will then be trained to use PEGASUS, which will be delivered to the intervention group (another 90 women completing the same measures at the time of decision making, and 3, 6 and 12 months after surgery). Health professionals and a purposefully selected sample of participants will be interviewed about whether their expectations of reconstruction were met, and their experiences of PEGASUS (if appropriate). DISCUSSION: PEGASUS may have the potential to provide health professionals with an easily accessible tool aiming to support shared decision making and improve patients' satisfaction with breast reconstruction. Results of this study will be available at the end of 2019. TRIAL REGISTRATION: ISRCTN 18000391 (DOI 10.1186/ISRCTN18000391) 27/01/2016.

Heightened autoantibody immune response to citrullinated calreticulin in bronchiectasis: Implications for rheumatoid arthritis.

Calreticulin (CRT) and citrullinated (citCRT) are implicated in rheumatoid arthritis (RA) pathology. citCRT binds to RA shared epitopes (SE) on HLA-DR molecules with high affinity and triggers pro-inflammatory events in adjacent cells. The aim of the study was to detect the presence of citCRT prior to developing RA and evaluate if citCT is a target for autoantibodies in RA cohorts with and without lung disease. Antibodies were assessed by ELISA against native CRT, citCRT and general protein citrullination, in sera from 50 RA patients without lung disease, 122 bronchiectasis (BR) patients, 52 bronchiectasis patients with RA (BRRA), 87 asthma patients and 77 healthy controls (HC). Serum citCRT was detected by immunoblotting and mass spectrometry. Genomic DNA was genotyped for HLA-DRB1 alleles. Patients were assessed for DAS28, rheumatoid factor, and anti-cyclic citrullinated peptide antibodies. Extracellular citCRT was detected in BR patients sera prior to them developing RA. A citCRT SE binding peptide GEWKPR261citQIDNPDYK was identified. Anti-CRT antibodies were observed in 18% of BR patients with or without RA. Anti-citCRT antibodies were observed in ∼35% of BR or RA patients, increasing to 58% in BRRA patients. In the RA alone patients 7/20 (35%) who were negative for RF and anti-CCP were anti-CRT antibody positive and had higher DAS28 scores than triple negative RA alone patients. Three of the four BR patients who developed RA over 18 months were anti-citCRT+ve SE+ve. The detection of citCRT in BR and development of anti-citCRT in BR patients suggests citCRT antigens are early targets of antigenicity in these patients, especially in SE+ve patients prior to the onset of RA.

Facilitating shared decision-making with breast augmentation patients: Acceptability of the PEGASUS intervention.

BACKGROUND: PEGASUS is an intervention to facilitate shared decision-making by helping prospective patients consider their expectations of surgery, so that surgeons have a clear understanding of their individual goals. To date, shared decision-making interventions within aesthetic surgery are lacking. The present mixed methods study therefore explored the acceptability of implementing PEGASUS into routine private practice with breast augmentation patients and aesthetic providers. METHOD: Seventeen women presenting for breast augmentation surgery from three practices received the PEGASUS intervention pre-operatively and completed a process evaluation post-operatively. Semi-structured interviews exploring 3 aesthetic providers' experiences of using PEGASUS were subjected to a thematic analysis, whilst a content analysis was conducted on the 77 goals identified by patients. RESULTS: The majority of patients reported that the PEGASUS intervention was relevant, helpful and useful, and they felt comfortable during it. Qualitatively, patients and aesthetic providers found that PEGASUS enabled them to reflect on and discuss about their expectations from surgery. Aesthetic providers discussed some of the issues and barriers associated with implementing PEGASUS in routine private practice, factors that must be considered prior to further evaluation. CONCLUSION: This study provides preliminary support for the acceptability of PEGASUS to breast augmentation patients and to aesthetic providers working in the private sector.

The acceptability of PEGASUS: an intervention to facilitate shared decision-making with women contemplating breast reconstruction.

Good practice guidelines recommend that women who undergo mastectomy are offered reconstructive surgery. However, many who choose this option report a degree of decisional regret and dissatisfaction because their pre-surgical expectations were not met. This paper reports an acceptability study of a new intervention (PEGASUS) that aims to support shared decision-making by eliciting women's pre-surgical expectations and setting patient-centred goals. Eighteen women contemplating breast reconstruction completed the PEGASUS intervention. Semi-structured interviews were conducted with 12 women and 3 health professionals to explore their experiences of using PEGASUS. Interview transcripts were subjected to a thematic analysis, and a content analysis was conducted on 79 goals that the 18 women identified. Feedback was extremely positive--women found that completing PEGASUS alongside a discussion with a specially trained health professional helped them prepare for the surgical consultation and increased their trust in their surgeon. Staff reported that PEGASUS facilitated patient-centred discussions and informed the decisions made about potential surgery. This preliminary study suggests that this novel intervention is acceptable to patients and health professionals alike. Further work is needed to evaluate its efficacy and then its effectiveness with a larger sample of women, and its potential use with other patient groups.

Uterus transplantation trial: Psychological evaluation of recipients and partners during the post-transplantation year.

OBJECTIVE: To explore the psychology and well-being of the nine patients undergoing uterus transplantation (UTx) as part of the first clinical trial, during the first 12 months of which seven patients experienced graft survival with occasional mild rejection episodes and two patients experienced graft failure, with hysterectomy. DESIGN: Prospective observational study. SETTING: University hospital. PATIENT(S): Nine female uterine recipients and their partners. INTERVENTION(S): Psychological evaluations by questionnaires focusing on quality of life, mood, relationship, and fertility quality of life were conducted at inclusion and at 3, 6, and 12 months after UTx. MAIN OUTCOME MEASURE(S): Scores of four different questionnaires regarding mood, quality of life, fertility quality of life, and relationship. RESULT(S): In all questionnaire domains, the recipients and their partners showed a similar pattern at baseline, and the UTx group, including both recipients and partners, scored similarly or better when compared with relevant norm groups. Among the recipients there was a reversible decline in score of physical activity and increased bodily pain at 3 months past surgery. CONCLUSION(S): The results show that participants of this first UTx trial were psychologically stable both at baseline and during the first year, despite rejection episodes and possible worries about viability of graft. CLINICAL TRIAL REGISTRATION NUMBER: ClinicalTrials.govNCT01844362.

Use of a formal consensus development technique to produce recommendations for improving the effectiveness of adult mental health multidisciplinary team meetings.

BACKGROUND: Multidisciplinary team (MDT) meetings are the core mechanism for delivering mental health care but it is unclear which models improve care quality. The aim of the study was to agree recommendations for improving the effectiveness of adult mental health MDT meetings, based on national guidance, research evidence and experiential insights from mental health and other medical specialties. METHODS: We established an expert panel of 16 health care professionals, policy-makers and patient representatives. Five panellists had experience in a range of adult mental health services, five in heart failure services and six in cancer services. Panellists privately rated 68 potential recommendations on a scale of one to nine, and re-rated them after panel discussion using the RAND/UCLA Appropriateness Method to determine consensus. RESULTS: We obtained agreement (median ≥ 7) and low variation in extent of agreement (Mean Absolute Deviation from Median of ≤1.11) for 21 recommendations. These included the explicit agreement and auditing of MDT meeting objectives, and the documentation and monitoring of treatment plan implementation. CONCLUSIONS: Formal consensus development methods that involved learning across specialities led to feasible recommendations for improved MDT meeting effectiveness in a wide range of settings. Our findings may be used by adult mental health teams to reflect on their practice and facilitate improvement. In some other contexts, the recommendations will require modification. For example, in Child and Adolescent Mental Health Services, context-specific issues such as the role of carers should be taken into account. A limitation of the comparative approach adopted was that only five members of the panel of 16 experts were mental health specialists.

Development and validation of a computerized model of smiling: Modeling the percentage movement required for perception of smiling in unilateral facial nerve palsy.

BACKGROUND: The inability to smile stands out as a notable difficulty for individuals with facial nerve palsies; a problem that facial reanimation surgery aims to rectify. However, smile reconstruction currently lacks quantitative data by which to objectively measure outcomes. This study aims to identify the relative importance of different oral muscles in terms of smiling, and explore the percentage function that needs to be restored for a smile to be perceived by an observer. METHODS: A computer animation tool was developed to model the oral facial muscles and demonstrate the facial expressions produced by contraction of different muscle groups. By programming a variable unilateral paralysis of the zygomaticus major, the effects of 0-100% function of this muscle can also be seen in a further set of animations using the basic muscular structure of a smile to produce a computerized proxy smile. These animations were shown to 75 adults from the general population who reported those expressions they perceived as a smile. RESULTS: The only facial expression consistently associated with a perceived smile was caused by the combined contraction of the zygomaticus major and the levator anguli oris (P < 0.001). This concurs with previously reported observations of the human smile. Over 70% of the subjects were able to perceive a smile with just 40% function of the unilateral paralyzed zygomaticus major. CONCLUSIONS: These results present an objective target for facial reanimation surgery by which outcomes may be measured. This computerized model also provides a valuable tool for patient education during pre-operative consent.

The role of disgust emotions in the observer response to facial disfigurement.

Social intrusions by observers are commonly reported by those with disfiguring conditions. This study examined the role of disgust emotions in the observer response. A group of students (N=48) completed quantitative questionnaires measuring extent of disfigurement, whilst viewing images of faces with varying disfigurements. Another group of students (N=84) completed quantitative questionnaires measuring level of disgust elicited by the same images. Disgust sensitivity was measured using the Disgust Scale Revised. Observers reported greater levels of disgust (p<.01) with increasing severity of facial disfigurement. Individuals with a higher disgust sensitivity reported increased levels of disgust in response to faces of mild (p=.03), moderate (p=.02) and severe (p<.01) disfigurement compared to those with a lower disgust sensitivity. This provides an explanatory framework for the avoidance reactions of observers and may be important in understanding variability in adjustment following disfigurement.

Clinical outcomes of facial transplantation: a review.

A total of 18 composite tissue allotransplants of the face have currently been reported. Prior to the start of the face transplant programme, there had been intense debate over the risks and benefits of performing this experimental surgery. This review examines the surgical, functional and aesthetic, immunological and psychological outcomes of facial transplantation thus far, based on the predicted risks outlined in early publications from teams around the world. The initial experience has demonstrated that facial transplantation is surgically feasible. Functional and aesthetic outcomes have been very encouraging with good motor and sensory recovery and improvements to important facial functions observed. Episodes of acute rejection have been common, as predicted, but easily controlled with increases in systemic immunosuppression. Psychological improvements have been remarkable and have resulted in the reintegration of patients into the outside world, social networks and even the workplace. Complications of immunosuppression and patient mortality have been observed in the initial series. These have highlighted rigorous patient selection as the key predictor of success. The overall early outcomes of the face transplant programme have been generally more positive than many predicted. This initial success is testament to the robust approach of teams. Dissemination of outcomes and ongoing refinement of the process may allow facial transplantation to eventually become a first-line reconstructive option for those with extensive facial disfigurements.

Facial transplantation revisited: findings from the very first public engagement exercise.

OBJECTIVES: Facial transplantation has emerged as a treatment option in facial reconstruction. In this pilot study, we investigate initial attitudes to this concept in relevant patient and health professional groups. METHOD: Attitudes towards facial transplantation as a procedure were examined among 200 participants, including 30 nurses, 30 doctors, 30 plastic surgeons, 30 renal transplant patients, 30 medical students, 30 members of the lay public and 20 patients with facial disfigurements through the use of a questionnaire. RESULTS: Identity was important for all participating groups with 83.5% positive about receiving a facial transplant provided no resemblance to donor. There was an inverse relationship between the side effects of the immunosuppressant regimen and organ rejection and the willingness to undergo facial transplantation when compared to other forms of organ transplantation. A relationship to the recipient and familiarity with a transplant programme were positively related to potential donation. CONCLUSION: This study identifies the key issues of altered identity and the understanding of immunosuppression and surgical risk as the focus for research and patient selection. The ethical aspects of facial transplantation are not addressed in this study, and have been addressed elsewhere.

A quantitative comparison of psychological and emotional health measures in 360 plastic surgery candidates: is there a difference between aesthetic and reconstructive patients?

This study examines the utility of the aesthetic and reconstructive categorization for making treatment decisions in patients seeking facial surgery. A total of 360 patients with aesthetic or combined functional aesthetic deficits were included. Validated psychological scales were used as outcome measures. All subjects showed clinically significant levels of appearance-related distress, with highest levels in the aesthetic and lowest levels in the functionally impaired group. Significant gender differences were not found on any psychological measures. A small negative correlation was found between age and distress. These findings challenge the validity of restricting treatment on the basis of an aesthetic distinction, since this is the group demonstrating the highest level of need. Neither age nor gender is a reliable discriminator. Subjective assessment of noticeability of disfigurement and associated psychological distress may be more useful in prioritizing treatment in systems with limited resources.

Differential judgements about disfigurement: the role of location, age and gender in decisions made by observers.

Psychological distress associated with disfiguring facial lesions is common. However, whilst the intrusive behaviour of observers is commonly reported, for example, staring, comments and questions, these factors which may influence the judgements of observers have not been well described. This is important as it may influence a subject's perception of how their appearance is viewed by the external world. This study is the first to investigate age and gender differences when measuring the importance of location in judgements about facial disfigurement. Observers were asked to rank the impact of simulated lesions in different positions on the face of Caucasian subjects. Age and gender varied in both groups. Our results show that lesions on the young and female subjects are ranked as having a greater impact than those on the old and male subjects. Lesions on central facial features have a higher impact than those located more peripherally. Both of these findings were not significantly influenced by observer age or gender. These results are discussed in terms of culturally derived attributions about appearance. It is also suggested that there is a scope to use feedback on how disfigurement is viewed by others as a therapeutic tool in clinical settings.

The psychological management of facial transplantation.

Facial transplantation is a major advance in reconstructive surgery, providing enormous potential benefit in terms of improved function and cosmesis. Managing the challenges it brings depends on understanding both technical and psychological issues. Research on the psychological aspects of organ transplantation is a starting point; however, issues of altered appearance and identity, adjustment to change, the management of suboptimal adherence to immunosuppression, and how we present and understand risk, particularly related to immunosuppression and rejection, must all be addressed before the procedure becomes a clinical option. This review addresses the psychological issues highlighted in the Royal College of Surgeons Working Party Report on facial transplantation, describing how these have been addressed in the development of a clinical program.

Does severity predict distress? The relationship between subjective and objective measures of appearance and psychological adjustment, during treatment for facial lipoatrophy.

The intuitive or lay belief that the severity of a disfiguring condition predicts psychological distress is not demonstrated in clinical practice, nor in research studies. This within group study used standardised measures repeated at six month intervals, to investigate the relationship between subjective and objective measures of appearance and psychological adjustment in 51 patients undergoing treatment for facial lipoatrophy using a synthetic filler, Newfill. Results demonstrate a dissociation between objective and subjective measures with only subjective assessment predicting psychological outcomes. It is recommended that Moss's (2005) hypothesis of discrete group membership (normal/not normal) should be adapted to include an internal standard for comparison, and that all evaluations of treatment modifying disfigurement should include a standardised subjective measure of appearance.

Facial motion analysis of acid burn victims--development of a new facial motion impairment index.

OBJECTIVES: Evaluation of facial movement is necessary for the assessment of motor deficits and planning reconstructive surgery in facial burns. Clinicians recognise the need for an accurate and reproducible method of functional assessment. We propose a new facial functional impairment index (FFII) for assessing facial motor dysfunction due to severe burn injury and provide inter/intra-patient comparison for documenting rehabilitation. METHODS: The maximal static response assay (MSRA) was used to compare facial movement in 20 acid burn victims with 20 control subjects. Data compiled from 12 soft tissue landmarks was used to quantify rest and dynamic asymmetry, anatomic and non-anatomic motion and calculate the FMII. The Katz score, Nottingham index and number of affected aesthetic units provided insight into FFII efficacy. RESULTS: Patients with greater aesthetic disfigurement demonstrated significantly poorer anatomic function (c=0.62; p=0.03) as well as larger global facial functional impairment (c=0.52; p=0.08). CONCLUSION: Acid burns caused severe asymmetry and functional impairment. The FFII is a composite score of global function based on a reproducible method of data collection and it differentiated between acid burn victims and provided objective comparative measures. Software automation, integration of video and 3D data, appropriate graphical and pictorial depiction of variables and measurements, and further research into the accuracy of FFII as a marker of clinical recovery and assessment of function in facial burns, will enhance future clinical applications and potentially aid surgical reconstruction.

Psychological management and body image issues in facial transplantation.

Facial transplantation, although controversial, is proposed as a major advance in facial reconstructive surgery, with the first partial transplant having taken place in France in November 2005. Although the psychological impact of facial transplantation will not be understood until several procedures have been carried out, this article examines the psychological issues likely to arise with particular reference to body image. A detailed framework for anticipation and management of psychological change is proposed. Pre-operative preparation must include thorough psychological preparation for the patient and their family. The immediate post-operative period is likely to be challenging, and a detailed management plan is proposed emphasising early return to function; subsequent psychological issues including altered body image, anxiety, shame, depression, communication and behavioural avoidance are discussed and a management strategy based on cognitive behavioural principles is proposed for the first post-operative year. Previous discussion frames psychological outcome in terms of complication and risk, tending to downplay the potential advantages of a successful procedure; the focus of this paper is on ensuring psychological adjustment as an inevitable consequence of change.