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Teaching staff report poorer mental health and wellbeing than the general working population. Intervention to address this issue is imperative, as poor wellbeing is associated with burnout, presenteeism, and adverse student mental health outcomes. The Wellbeing in Secondary Education (WISE) intervention is a secondary school-based programme aimed at improving the mental health and wellbeing of teachers and students. There are three components: awareness-raising for staff; a peer support service delivered by staff trained in Mental Health First Aid (MHFA); and Schools and Colleges Mental Health First Aid (MHFA) training for teachers. A cluster randomised controlled trial with integrated process and economic evaluation was conducted with 25 secondary schools in the UK (2016-2018). The intervention was largely ineffective in improving teacher mental health and wellbeing. This paper reports process evaluation data on acceptability to help understand this outcome. It adopts a complex systems perspective, exploring how acceptability is a dynamic and contextually contingent concept. Data sources were as follows: interviews with funders (n = 3); interviews with MHFA trainers (n = 6); focus groups with peer supporters (n = 8); interviews with headteachers (n = 12); and focus groups with teachers trained in Schools and Colleges MHFA (n = 7). Results indicated that WISE intervention components were largely acceptable. Initially, the school system was responsive, as it had reached a 'tipping point' and was prepared to address teacher mental health. However, as the intervention interacted with the complexities of the school context, acceptability became more ambiguous. The intervention was seen to be largely inadequate in addressing the structural determinants of teacher mental health and wellbeing (e.g. complex student and staff needs, workload, and system culture). Future teacher mental health interventions need to focus on coupling skills training and support with whole school elements that tackle the systemic drivers of the problem.

Background: Online activity has been linked to poor mental health in children and young people, particularly those with existing vulnerability who may inadvertently or otherwise access harmful content. It is suggested health and social care practitioners should address online activity during mental health consultations, but guidance about acceptable or effective ways to do this is lacking. This study sought to derive good practice guidance to support mental health practitioners to engage young people in conversations about their online activities and impact on mental health. Methods: A mixed-methods Delphi (consensus) study was conducted with a panel of mental health practitioners (n = 21) and a panel of young people (n = 22). Practitioners worked with children or young adults in the UK, mostly in statutory services (80.9%), in varied clinical roles, with 2 – 30 years of experience and most were female (87.5%). Young people were mostly female (77.3%), 13—22 years old, reported varied mental health diagnoses and had sought help from services. Across 3 rounds, panellists completed questionnaires which involved rating agreement with statements and answering open-ended questions. Iterative analysis informed subsequent questionnaire content. The percentage of participants rating their level of agreement with each statement was calculated. The threshold for inclusion as a good practice indicator (GPI) was 75% across both panels. Thematic analysis was used for free-text data. Results: Twenty-seven GPIs emerged covering 'who' (which young people) should be asked about online activities, 'when', 'what' should be discussed, and with what 'outcome'. Panels agreed conversations should be initiated with all young people from first meeting and regularly thereafter, with 'red flags' indicating a conversation may be pertinent. Core topics were identified with additional areas for patients presenting with disordered eating or self-harm. Panels emphasised conversations should be fluid, normalised, and encourage reflection and self-awareness. Conclusions: Mental health practitioners could empower young people to exercise agency in relation to online safety and capitalise on positive features. Findings also identify training needs for practitioners. Further research should explore real-world application of the GPIs and transferability to underrepresented groups within our panels, such as males and younger children. Ethnicity and deprivation were not recorded. [ABSTRACT FROM AUTHOR]

Background: Teachers are at heightened risk of poor mental health and well-being, which is likely to impact on the support they provide to students, and student outcomes. We conducted a cluster randomised controlled trial, to test whether an intervention to improve mental health support and training for high school teachers led to improved mental health and well-being for teachers and students, compared to usual practice. We also conducted a cost evaluation of the intervention.Methods and Findings: The intervention comprised (i) Mental Health First Aid training for teachers to support students; (ii) a mental health awareness session; and (iii) a confidential staff peer support service. In total 25 mainstream, non-fee-paying secondary schools stratified by geographical area and free school meal entitlement were randomly allocated to intervention (n = 12) or control group (n = 13) after collection of baseline measures. We analysed data using mixed-effects repeated measures models in the intention-to-treat population, adjusted for stratification variables, sex, and years of experience. The primary outcome was teacher well-being (Warwick-Edinburgh Mental Well-being Scale). Secondary outcomes were teacher depression, absence, and presenteeism, and student well-being, mental health difficulties, attendance, and attainment. Follow-up was at months 12 (T1) and 24 (T2). We collected process data to test the logic model underpinning the intervention, to aid interpretation of the findings. A total of 1,722 teachers were included in the primary analysis. Teacher well-being did not differ between groups at T2 (intervention mean well-being score 47.5, control group mean well-being score 48.4, adjusted mean difference -0.90, 95% CI -2.07 to 0.27, p = 0.130). The only effect on secondary outcomes was higher teacher-reported absence among the intervention group at T2 (intervention group median number of days absent 0, control group median number of days absent 0, ratio of geometric means 1.04, 95% CI 1.00 to 1.09, p = 0.042). Process measures indicated little change in perceived mental health support, quality of relationships, and work-related stress. The average cost of the intervention was £9,103 per school. The study's main limitations were a lack of blinding of research participants and the self-report nature of the outcome measures.Conclusions: In this study, we observed no improvements to teacher or student mental health following the intervention, possibly due to a lack of impact on key drivers of poor mental health within the school environment. Future research should focus on structural and cultural changes to the school environment, which may be more effective at improving teacher and student mental health and well-being.Trial Registration: www.isrctn.com ISRCTN95909211. [ABSTRACT FROM AUTHOR]

Background: The optimal time to deliver adjuvant chemotherapy has not been defined., Methods: A retrospective study of consecutive patients receiving adjuvant anthracycline and/or taxane 1993-2010. Primary endpoint included 5-year disease-free survival (DFS) in patients commencing chemotherapy <31 versus ≥31 days after surgery. Secondary endpoints included 5-year overall survival (OS) and sub-group analysis by receptor status., Results: We identified 2003 eligible patients: 1102 commenced chemotherapy <31 days and 901 ≥31 days after surgery. After a median follow-up of 115 months, there was no difference in 5-year DFS rate with chemotherapy <31 compared to ≥31 days after surgery in the overall population (81 versus 82% hazard ratio (HR) 1.15, 95% confidence interval (95% CI) 0.92-1.43, p = 0.230). The 5-year OS rate was similar in patients who received chemotherapy <31 or ≥31 days after surgery (90 versus 91%, (HR 1.21, 95% CI 0.89-1.64, p = 0.228). For 250 patients with triple-negative breast cancer OS was significantly worse in patients who received chemotherapy ≥31 versus <31 days (HR = 2.18, 95% CI 1.11-4.30, p = 0.02)., Discussion: Although adjuvant chemotherapy ≥31 days after surgery did not affect DFS or OS in the whole study population, in TN patients, chemotherapy ≥31 days after surgery significantly reduced 5-year OS; therefore, delays beyond 30 days in this sub-group should be avoided., (© 2021. The Author(s), under exclusive licence to Springer Nature Limited.)

Background: Acute otitis media (AOM) is a common painful infection in children, with around 2.8 million cases presenting to primary care in England and Wales annually. Nearly all children who present to their general practitioner (GP) with AOM or AOM with discharge (AOMd) are treated with orally administered antibiotics. These can cause side effects; contribute to the growing problem of antimicrobial resistance, and more rarely, allergic reactions. Alternative treatments, such as an antibiotic eardrops, or 'delayed' orally administered antibiotics, could be at least as effective and safe as immediate orally administered antibiotics for children with AOMd., Methods/design: REST is a pragmatic, three-arm, individually randomised, non-inferiority trial being conducted in 175 GP practices across the United Kingdom (UK). The study aims to recruit 399 children aged (≥ 12 months and < 16 years) presenting to their GP with AOMd. Children will be randomised to one of three arms: immediate ciprofloxacin 0.3% eardrops; delayed orally administered amoxicillin (clarithromycin if penicillin allergic) or immediate orally administered amoxicillin (clarithromycin). Recruitment, including eligibility screening, randomisation and data collection, are conducted using the innovative, TRANSFoRm electronic trial management platform. Integrated within the primary care electronic medical records it provides automatic eligibility checking, part-filling of e-CRFs, study workflow management and routine NHS follow-up data collection. The primary outcome is time to resolution of all significant symptoms and will be collected by the parent using a Symptom Recovery Questionnaire (SRQ). Secondary outcomes, including cost-effectiveness, duration of moderately bad or worse symptoms and repeat AOMd episodes, will be collected at day-14 and at 3 months., Discussion: It is unclear whether prescribing orally administered antibiotics to children with AOMd results in a reduction in symptoms or a shorter duration of illness. The REST trial should allow us to compare the non-inferiority of: immediate topically administered ciprofloxacin ear drops, or delayed orally administered amoxicillin (clarithromycin) against immediate orally administered amoxicillin (clarithromycin). We aim to recruit 399 patients from 175 practices in the UK. Using the TRANSFoRm software to randomise participants to the trial will enable recruitment for a relatively uncommon condition., Trial Registration: Name of Registry: ISCRTN Registration Number: ISRCTN12873692. This contains all items required to comply with the World Health Organization Trial Registration Data Set Date of Registration: 24 April 2018 Name of Registry: EudraCT Registration Number: 2017-003635-10 Date of Registration: 6 September 2017.

Background: Ado-trastuzumab emtansine (T-DM1) is standard of care for patients with advanced HER2+ breast cancer who relapse within 6 months of adjuvant trastuzumab or progress on first-line anti-HER2 therapy. We evaluated its safety and efficacy in our real-world population., Methods: We identified patients on T-DM1 from 01/01/2014 to 12/03/2018 from our electronic records. Patients', tumour characteristics, safety and efficacy outcomes were recorded. Chi-squared/Fishers exact test and Kaplan-Meier methods were utilised., Results: 128 patients receiving T-DM1 were included in the analysis with a median age of 55 years (26-85). 89.8% of patients had ECOG PS 0-1 and 21.1% had presented with de novo metastatic disease. 57.8% had ER-positive disease and 38.3% central nervous system involvement. 88.3% of patients had received trastuzumab for advanced disease (with pertuzumab in 28.9%) and 11.7% had only received trastuzumab in the adjuvant setting. Grade ≥3 adverse events occurred in 35.9% of patients. These were liver toxicity (19.5%), anaemia (6.2%) and thrombocytopenia (4.7%). Peripheral neuropathy of any grade was reported in 21.9% of cases, bleeding in 9.4% and ejection fraction decline in 5 patients. Median progression-free survival was 8.7 months and overall survival 20.4 months. Prior pertuzumab did not influence survival outcomes., Conclusions: The safety of T-DM1 in our population is similar to available literature, although we observed higher rates of peripheral neuropathy and deranged liver function. These findings are relevant for the potential role of TDM-1 in the curative setting., Competing Interests: Declaration of Competing Interest Dr Battisti has received travel grants from Pfizer and Genomic Health and speaker fees from Pfizer. Dr Ring has received honoraria for ad hoc advisory boards and for ad hoc presentations from Lilly, Pfizer, Novartis, Roche and MSD. The other authors have no conflict of interest to declare., (Crown Copyright © 2020. Published by Elsevier Ltd. All rights reserved.)

Importance: Increasing BRCA1 and BRCA2 (collectively termed herein as BRCA) gene testing is required to improve cancer management and prevent BRCA-related cancers., Objective: To evaluate mainstream genetic testing using cancer-based criteria in patients with cancer., Design, Setting, and Participants: A quality improvement study and cost-effectiveness analysis of different BRCA testing selection criteria and access procedures to evaluate feasibility, acceptability, and mutation detection performance was conducted at the Royal Marsden National Health Service Foundation Trust as part of the Mainstreaming Cancer Genetics (MCG) Programme. Participants included 1184 patients with cancer who were undergoing genetic testing between September 1, 2013, and February 28, 2017., Main Outcomes and Measures: Mutation rates, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios were the primary outcomes., Results: Of the 1184 patients (1158 women [97.8%]) meeting simple cancer-based criteria, 117 had a BRCA mutation (9.9%). The mutation rate was similar in retrospective United Kingdom (10.2% [235 of 2294]) and prospective Malaysian (9.7% [103 of 1061]) breast cancer studies. If traditional family history criteria had been used, more than 50% of the mutation-positive individuals would have been missed. Of the 117 mutation-positive individuals, 115 people (98.3%) attended their genetics appointment and cascade to relatives is underway in all appropriate families (85 of 85). Combining with the equivalent ovarian cancer study provides 5 simple cancer-based criteria for BRCA testing with a 10% mutation rate: (1) ovarian cancer; (2) breast cancer diagnosed when patients are 45 years or younger; (3) 2 primary breast cancers, both diagnosed when patients are 60 years or younger; (4) triple-negative breast cancer; and (5) male breast cancer. A sixth criterion-breast cancer plus a parent, sibling, or child with any of the other criteria-can be added to address family history. Criteria 1 through 5 are considered the MCG criteria, and criteria 1 through 6 are considered the MCGplus criteria. Testing using MCG or MCGplus criteria is cost-effective with cost-effectiveness ratios of $1330 per discounted QALYs and $1225 per discounted QALYs, respectively, and appears to lead to cancer and mortality reductions (MCG: 804 cancers, 161 deaths; MCGplus: 1020 cancers, 204 deaths per year over 50 years). Use of MCG or MCGplus criteria might allow detection of all BRCA mutations in patients with breast cancer in the United Kingdom through testing one-third of patients. Feedback questionnaires from 259 patients and 23 cancer team members (12 oncologists, 8 surgeons, and 3 nurse specialists) showed acceptability of the process with 100% of patients pleased they had genetic testing and 100% of cancer team members confident to approve patients for genetic testing. Use of MCGplus criteria also appeared to be time and resource efficient, requiring 95% fewer genetic consultations than the traditional process., Conclusions and Relevance: This study suggests that mainstream testing using simple, cancer-based criteria might be able to efficiently deliver consistent, cost-effective, patient-centered BRCA testing.

Purpose: Falls are a major cause of disability and mortality due to injury. To reduce fall rates and improve health outcomes, it is important to design services based on patient experience and engagement. This study aimed to explore the experiences of older patients who fell during their hospital stay., Design: Five patients from two rehabilitation wards in the United Kingdom participated in this qualitative study., Methods: Semistructured interviews, incident reports, and medical records provided information about each fall. Thematic, discourse, and descriptive analysis were used to analyze data., Findings: The data demonstrated how a fall impacted patients' experience of rehabilitation and resulted in changes to mobility, self-confidence, management of falls risk, avoidance of daily activities, and increased assistance from others., Conclusions: Falling in hospital can influence patients' ability to reach their potential of an optimal level of functioning., Clinical Relevance: There is a need to place an equal and mutual understanding on the physical, psychological, and social impact of falling to reduce falls and improve functional outcomes.