The Mental Imagery for Suicidality in Students Trial (MISST): study protocol for a feasibility randomised controlled trial of broad-minded affective coping (BMAC) plus risk assessment and signposting versus risk assessment and signposting alone.

BACKGROUND: Going to university is an important milestone in many people's lives. It can also be a time of significant challenge and stress. There are growing concerns about mental health amongst student populations including suicide risk. Student mental health and counselling services have the potential to prevent suicide, but evidence-based therapies are required that fit these service contexts. The Broad-Minded Affective Coping intervention (BMAC) is a brief (6 sessions), positive imagery-based intervention that aims to enhance students access to past positive experiences and associated emotions and cognitions. Pilot data provides preliminary support for the BMAC for students struggling with suicidal thoughts and behaviours, but this intervention has not yet been evaluated in the context of a randomised controlled trial (RCT). The Mental Imagery for Suicidality in Students Trial (MISST) is a feasibility RCT that aims to determine the acceptability and feasibility of evaluating the BMAC as an intervention for university students at risk of suicide within a larger efficacy trial. Key feasibility uncertainties have been identified relating to recruitment, retention, and missing data. Intervention acceptability and safety will also be evaluated. METHOD: MISST is a feasibility randomised controlled trial design, with 1:1 allocation to risk assessment and signposting plus BMAC or risk assessment and signposting alone. Participants will be university students who self-report experiences of suicidal ideation or behaviour in the past 3 months. Assessments take place at baseline, 8, 16, and 24 weeks. The target sample size is 66 participants. A subset of up to 20 participants will be invited to take part in semi-structured qualitative interviews to obtain further data concerning the acceptability of the intervention. DISCUSSION: The BMAC intervention may provide an effective, brief talking therapy to help university students struggling with suicidal thoughts that could be readily implemented into university student counselling services. Depending on the results of MISST, the next step would be to undertake a larger-scale efficacy trial. TRIAL REGISTRATION: The trial was preregistered (17 December 2021) on ISRCTN (ISRCTN13621293) and ClinicalTrials.gov (NCT05296538).

A Feasibility Randomized Controlled Trial of a Parenting Intervention Offered to Women With Severe Mental Health Problems and Delivered in a Mother and Baby Unit Setting: The IMAgINE Study Outcomes.

Background: Approximately 1-2% of mothers may experience severe mental illness (SMI) requiring admission to an inpatient Mother and Baby Unit (MBU). MBUs aim to provide mental health assessment and treatment and strengthen the mother-infant relationship, essential for infant development. Whilst MBUs offer various interventions, they do not routinely offer structured parenting interventions. The Baby Triple P Positive Parenting Program (BTP) was developed to enhance parenting competence, psychological coping and the quality of partner and other social support. Guided by lived experience consultation, we aimed to determine the feasibility and acceptability of delivering BTP plus Treatment as Usual (TAU) in this setting. Method: A multi-site, parallel-group, single-blind pilot randomized controlled trial (registration: ISRCTN12765736) comparing BTP+TAU to TAU in participants, recruited from two MBUs in England. The Baby Triple P intervention consisted of eight parenting sessions, with the final four being delivered over the telephone following MBU discharge. Feasibility outcomes were participant intervention engagement and study retention. Clinical outcomes including maternal parenting competence, bonding and mental health outcomes were assessed at baseline, post-baseline/intervention (10 weeks) and six-month follow-up. Data were analyzed using descriptive statistics and linear regression models. An economic feasibility analysis was also conducted. Results: Thirty-seven of the 67 eligible participants consented; 34 were randomized (16 to BTP+TAU and 18 to TAU), of whom 20 were retained at post-intervention data collection and 21 at six-month follow-up. Twelve participants (75%) completed the intervention, which was rated as highly acceptable. Clinical outcomes signaled potential improvements in maternal parenting competence, bonding, mood and mental health symptomatology in participants who received the intervention. Healthcare resource use and EQ-5D-5L questionnaires were well-completed by participants. Delivering BTP in this setting is estimated to cost £443-822 per participant. Conclusions: This is the first trial of a parenting intervention in a MBU setting. BTP is feasible and acceptable to mothers with SMI, with a promising signal for treatment efficacy. Although minor modifications may be required for the collection of observer-rated measures post-MBU discharge, the findings indicate that a larger, definitive trial could be conducted, especially if the setting is extended to include perinatal mental health community settings.

Surgical Outcome Measures in a Cohort of Patients at High Risk of Breast Cancer Treated by Bilateral Risk-Reducing Mastectomy and Breast Reconstruction.

BACKGROUND: Women with breast cancer-related genetic pathogenic variants (e.g., BRCA1 , BRCA2 ) or with a strong family history carry lifetime risks of developing breast cancer of up to 80 to 90 percent. A significant proportion of these women proceed to bilateral risk-reducing mastectomy. The authors aimed to document the surgical morbidity of risk-reducing mastectomy and establish whether a diagnosis of breast cancer at the time of surgery impacted outcomes. METHODS: Clinical details of 445 women identified as having a greater than 25 percent lifetime risk of developing breast cancer who underwent risk-reducing mastectomy and breast reconstruction were interrogated for surgical outcomes such as planned, unplanned, and emergency procedures; complication rates; length of stay; and longevity of breast reconstruction. These outcome measures were recorded in women diagnosed with breast cancer perioperatively (cancer group) and those without malignancy (benign group). RESULTS: Median follow-up was similar in both groups (benign group, 70 months; cancer group, 73 months). Patients were older in the cancer group than in the benign group (43 years versus 39 years; p < 0.001). Women in the cancer group required more planned procedures to complete reconstruction than those in the benign group (four versus two; p = 0.002). Emergency procedures, unplanned surgical interventions (e.g., capsulectomy), and postreconstruction complication rates were similar between groups. One in five women overall required revision surgery. Patients with autologous reconstructions had a revision rate of 1.24 per 1000 person-years compared with 2.52 per 1000 person-years in the implant reconstruction group. CONCLUSIONS: Women contemplating risk-reducing mastectomy can be reassured that this is a safe and effective procedure but will likely take multiple interventions. This knowledge should be integral to obtaining informed consent. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, II.

Patient and public priorities for breast cancer research: a qualitative study in the UK.

OBJECTIVE: Internationally recognised specialist breast cancer scientists, clinicians and healthcare professionals have published breast cancer research gaps that are informing research funding priorities in the UK and worldwide. We aimed to determine the breast cancer research priorities of the public to compare with those identified by clinicians and scientists. DESIGN: We conducted a qualitative study and thematic analysis using 'listening events' where patients with breast cancer and public representatives used a patient's breast cancer journey to identify research themes. PARTICIPANTS AND SETTING: Female participants were recruited from attendees at participating hospitals and support groups in the northwest of England, including patients, their family and friends as well as staff at a local retail centre. INTERVENTION: A framework approach was used to analyse transcribed discussions until thematic saturation was reached. MAIN OUTCOME MEASURES: Breast cancer research priorities were identified from participant discussions and compared with the published gaps identified by scientists and healthcare professionals. RESULTS: Thematic saturation was reached after 27 female participants participated in listening events. Our participants consistently focused on improved methods of dissemination of information and improving education on the signs and symptoms of breast cancer. This was not highlighted by scientists or healthcare professionals. There was strong emphasis on quality of life-related issues such as side effects of treatment. There was some agreement between the priorities deduced by our study and those of the professionals in the areas of screening, prevention and breast reconstruction. CONCLUSION: Our study identified some research themes that were not identified by scientists and healthcare professionals in two earlier landmark studies. This highlights the importance of including patients and public representatives when setting research priorities. The results should be used to guide investigators when planning future studies and for funding bodies in allocating resources for future projects.

Systematic review of the effectiveness of polyurethane-coated compared with textured silicone implants in breast surgery.

BACKGROUND: Silicone gel implants are used worldwide for breast augmentation and breast reconstruction. Textured silicone implants are the most commonly placed implant, but polyurethane-coated implants are increasingly being used in an attempt to ameliorate the long-term complications associated with implant insertion. METHODS: This systematic review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. Electronic searches of MEDLINE, EMBASE, the Cochrane Library and www.ClinicalTrials.gov were undertaken in March 2014 using keywords. RESULTS: Following data extraction, 18 studies were included in the review, including four core studies of textured silicone implants and five studies reporting outcomes for polyurethane-coated silicone implants. There are no clear data reporting revision rates in patients treated with polyurethane implants. In the primary reconstructive setting, capsular contracture rates with silicone implants are 10-15% at 6 years, whilst studies of polyurethane implants report rates of 1.8-3.4%. In the primary augmentation setting, core studies show a capsular contracture rate of 2-15% at 6 years compared with 0.4-1% in polyurethane-coated implants; however, the polyurethane studies are limited by their design and poor follow-up. CONCLUSIONS: The use of polyurethane implants should be considered a safe alternative to textured silicone implants. It is likely that an implant surface does influence short- and long-term outcomes; however, the extent of any benefit cannot be determined from the available evidence base. Future implant studies should target the short- and long-term benefits of implant surfacing by procedure with defined outcome measures; a head-to-head comparison would help clarify outcomes.

Current attitudes to breast reconstruction surgery for women at risk of post-mastectomy radiotherapy: A survey of UK breast surgeons.

Decision-making for women requiring reconstruction and post-mastectomy radiotherapy (PMRT) includes oncological safety, cosmesis, patient choice, potential delay/interference with adjuvant treatment and surgeon/oncologist preference. This study aimed to quantitatively assess surgeons' attitudes and perceptions about reconstructive options in this setting, and to ascertain if surgical volume influenced advice given. A questionnaire was sent to surgical members of the UK Association of Breast Surgery (ABS) in March-June 2014. The questionnaire elicited information on surgeon volume, reconstructive practice and drivers influencing decision-making. Response rate was 42% (148/355), representing 71% of UK breast units. Delayed breast reconstruction (DBR) was offered more commonly than immediate implant, delayed-immediate or immediate autologous reconstruction (p < 0.05). Cosmesis was thought to be equivalent between IBR and DBR by 15% of surgeons, and 26% believe IBR and DBR offer similar Health-related Quality of Life (HRQoL). Surgeon volume had no effect on reconstruction choice. Common decision-making drivers included negative effects of radiotherapy upon reconstructive and cosmetic outcome. The majority of surgeons (77%) believe the current evidence base is insufficient to guide decision-making. Despite surgeons believing that cosmesis and quality of life are not equivalent between IBR and DBR, DBR remains the commonest approach to this difficult clinical scenario. Surgeons perceive they are using a variety of newer techniques such as Delayed-Immediate Reconstruction and Acellular Dermal Matrices to try to ameliorate the effects of PMRT. This survey demonstrates that there is wide variation in reported surgical practice in this difficult setting. There is widespread acknowledgement of the lack of evidence to guide decision-making.