Maudsley Charity

BACKGROUND: Polycystic ovary syndrome (PCOS) is the most common cause of anovulatory infertility. Obesity exacerbates the reproductive complications of PCOS; however, the management of obesity in women with PCOS remains a large unmet clinical need. Observational studies have indicated that bariatric surgery could improve the rates of ovulatory cycles and prospects of fertility; however, the efficacy of surgery on ovulation rates has not yet been compared with behavioural modifications and medical therapy in a randomised trial. The aim of this study was to compare the safety and efficacy of bariatric surgery versus medical care on ovulation rates in women with PCOS, obesity, and oligomenorrhoea or amenorrhoea. METHODS: or higher, were recruited from two specialist obesity management centres and via social media. Participants were randomly assigned at a 1:1 ratio to either vertical sleeve gastrectomy or behavioural interventions and medical therapy using a computer-generated random sequence (PLAN procedure in SAS) by an independent researcher not involved with any other aspect of the clinical trial. The median age of the entire cohort was 31 years and 79% of participants were White. The primary outcome was the number of biochemically confirmed ovulatory events over 52 weeks, and was assessed using weekly serum progesterone measurements. The primary endpoint included the intention-to-treat population and safety analyses were per-protocol population. This study is registered with the ISRCTN registry (ISRCTN16668711). FINDINGS: Participants were recruited from Feb 20, 2020 to Feb 1, 2021. 40 participants were assigned to each group and there were seven dropouts in the medical group and ten dropouts in the surgical group. The median number of ovulations was 6 (IQR 3·5-10·0) in the surgical group and 2 (0·0-4·0) in the medical group. Women in the surgical group had 2.5 times more spontaneous ovulations compared with the medical group (incidence rate ratio 2·5 [95% CI 1·5-4·2], p<0·0007). There were more complications in the surgical group than the medical group, although without long-term sequelae. There were 24 (66·7%) adverse events in the surgical group and 12 (30·0%) in the medical group. There were no treatment-related deaths. INTERPRETATION: Bariatric surgery was more effective than medical care for the induction of spontaneous ovulation in women with PCOS, obesity, and oligomenorrhoea or amenorrhoea. Bariatric surgery could, therefore, enhance the prospects of spontaneous fertility in this group of women. FUNDING: The Jon Moulton Charity Trust.

<ns3:p> The global priority of improving neonatal survival could be tackled through the universal implementation of cost-effective maternal and newborn health interventions. Despite 90% of neonatal deaths occurring in low-resource settings, very few evidence-based digital health interventions exist to assist healthcare professionals in clinical decision-making in these settings. To bridge this gap, Neotree was co-developed through an iterative, user-centered design approach in collaboration with healthcare professionals in the UK, Bangladesh, Malawi, and Zimbabwe. It addresses a broad range of neonatal clinical diagnoses and healthcare indicators as opposed to being limited to specific conditions and follows national and international guidelines for newborn care. This digital health intervention includes a mobile application (app) which is designed to be used by healthcare professionals at the bedside. The app enables real-time data capture and provides education in newborn care and clinical decision support <ns3:italic>via</ns3:italic> integrated clinical management algorithms. Comprehensive routine patient data are prospectively collected regarding each newborn, as well as maternal data and blood test results, which are used to inform clinical decision making at the bedside. Data dashboards provide healthcare professionals and hospital management a near real-time overview of patient statistics that can be used for healthcare quality improvement purposes. To enable this workflow, the Neotree web editor allows fine-grained customization of the mobile app. The data pipeline manages data flow from the app to secure databases and then to the dashboard. Implemented in three hospitals in two countries so far, Neotree has captured routine data and supported the care of over 21,000 babies and has been used by over 450 healthcare professionals. All code and documentation are open source, allowing adoption and adaptation by clinicians, researchers, and developers. </ns3:p>

BACKGROUND: Highly performing healthcare organizations benefit from robust failure management systems. This involves the ability to respond and recover from critical events, as well avoiding harm in the first place (crisis preparedness). Currently, the surgical community may lack an integrated toolbox for crisis readiness. The study aims to create a practical framework for crisis preparedness in surgery. STUDY DESIGN: A multimethod qualitative study was designed to identify and translate crisis preparedness interventions from high-reliability industries to clinical practice. The tools and strategies identified were subsequently developed and clinically adapted for healthcare use. The study used (1) observational fieldwork in commercial aviation; (2) semi-structured interviews with senior airline pilots, and (3) mixed focus groups with healthcare and aviation safety experts. A crisis preparedness framework was derived by thematic analysis using the framework method. Clinical adaptation was achieved using expert consensus methodology. RESULTS: Twenty-two aviation and healthcare experts participated in 17 interviews and 3 focus groups. A framework for crisis preparedness was derived, consisting of 6 behavioral interventions: (1) anticipate threats and errors by building situational awareness using cognitive tools; (2) brief teams about goals, deviations, operational risks, and contingency plans; (3) implement standard operating procedures using checklists; (4) rehearse emergency drills before critical phases of work; (5) set the tone for a positive working environment by establishing cultural norms and empowering individuals to speak up about safety issues; and (6) debrief performance outcomes to derive learning lessons. CONCLUSIONS: Surgical crisis preparedness requires integrated systems rather than isolated safety interventions. This study provides a framework and the tools to achieve this.

INTRODUCTION: In March 2020, a pandemic state was declared due to SARS-COV-2 (COVID-19). Patients with kidney disease, especially those on replacement therapies, proved more susceptible to severe infection. This rapid literature review aims to help understand how the pandemic impacted patient experience of kidney care. METHODS: It was conducted in accordance with Cochrane Rapid Review interim guidance. Search terms, 'coronavirus', 'kidney care', and 'patient-reported experience' and terms with similar semantic meaning, identified 1,117 articles in Medline, Scopus, and Worldwide Science. Seventeen were included in the narrative synthesis. RESULTS: The findings were summarised into three themes: remote consultation and telemedicine (n = 9); psychosocial impact (n = 2); and patient satisfaction and patient-reported experience (n = 6). Patients were mostly satisfied with remote consultations, describing them as convenient and allowing avoidance of hospital visits. Anxieties included missing potentially important clinical findings due to lack of physical examination, poor digital literacy, and technical difficulties. Psychosocial impact differed between treatment modalities-transplant recipients expressing feelings of instability and dread of having to return to dialysis, and generally, were less satisfied, citing reduced ability to work and difficulty accessing medications. Those on home dialysis treatments tended to feel safer. Findings focused on aspects of patient experience of kidney care during the pandemic rather than a holistic view. CONCLUSIONS: There was little direct evaluation of modality differences and limited consideration of health inequalities in care experiences. A fuller understanding of these issues would guide policy agendas to support patient experience during future public health crises.

BACKGROUND: Digital innovations incorporating clinical digital support can improve the delivery of perinatal and postnatal care, yet few interventions exist in primary care settings. OBJECTIVES: We aimed to adapt a digital quality improvement system (Neotree) from tertiary facilities to lower-level facilities providing Level 1 newborn care. METHODS: We conducted a mixed method stepwise study using the ADAPT framework. We conducted a needs and technology assessment of eight facilities in Lilongwe district, Malawi. We next adopted a user-centred approach to modify the clinical decision support and data capture functionalities to fit the new context. We completed 'think aloud' usability testing with six prospective users to refine the system, alongside qualitative research informed by behavioural science frameworks with 10 healthcare professionals to identify potential barriers and facilitators to implementation. Finally, we carried out a stakeholder assessment to identify a potential pathway to scale. RESULTS: The adapted application was highly usable achieving a mean System Usability Scale (SUS) score of 92.5 among prospective users during the final round of testing. Our qualitative findings indicated Neotree was anticipated to be acceptable among healthcare professionals. We found high levels of motivation to implement Neotree, but key perceived implementation barriers included psychological and physical capability (such as skills and knowledge in neonatal care), as well as physical opportunity (e.g. human resources, equipment and adequate space for newborn care). CONCLUSION: Using a stepwise user-centred approach, we successfully adapted a digital quality improvement intervention (Neotree) ready for real-world piloting in community hospital and primary health centres in Malawi.

BACKGROUND: Clinical research is key to improving the outcomes of patients with metastatic breast cancer (MBC). However, participation is low, with little data on patients' attitudes and experiences of clinical research. This study aimed to explore the experience and attitude of patients in accessing and participating in clinical research in the UK. METHODS: An online survey, available between May and November 2021, was open to people living with MBC in the UK; this was complemented with by qualitative interviews. FINDINGS: 768 responses were received (766 female, 2 male); median age was 51-60 years with 235 (31 %) having de novo disease. 660 (86 %) respondents were confident in their understanding of clinical research. Discussion of participation in research with an oncologist was reported by 173 (23 %) respondents. Accessing new treatments was the most common reason for study participants wanting to take part in research, 737 (96 %). Of the 107 (14 %) respondents who had taken part in clinical trials, 77 (72 %) reported a positive experience. 276 (36 %) would consider travelling to participate in research and 430 (56 %) would be more likely to travel if expenses were met. Themes emerging from the qualitative interviews include 'lack of information', 'barriers to participation' and 'participants research priorities'. INTERPRETATION: This is the largest UK prospective study in regards to the views of MBC patients towards research. It demonstrates keenness to be involved in research, but participants face barriers as well as a lack of opportunity for participation. Key messages include importance of clinical staff in providing research information, need to develop patient accessible information, and to support travel costs. Improvements within the UK health care system are necessary to enable MBC patients to have equitable access to clinical research.

INTRODUCTION: Many neonatal deaths are avoidable using existing low-cost evidence-based interventions. This study evaluated the effectiveness and cost-effectiveness of Neotree, a digital quality improvement tool combining data capture with education and clinical decision support, implemented in a Zimbabwean hospital. METHODS: Neotree was implemented in Chinhoyi Provincial Hospital (CPH) in December 2020. Using data collected for all neonates admitted to CPH from March 2020 to October 2023, a single group interrupted time series analysis was conducted to estimate the impact of Neotree implementation. Subgroup analyses explored the impact in low birth weight (1.5-2.5 kg) neonates, a key group targeted by the intervention.Activity-based costing and expenditure approaches estimated costs of developing and implementing Neotree in CPH from a provider perspective. Both total within-study costs and total costs at scale were estimated and used to derive cost per life saved, cost per life year saved and cost per healthy life year (HLY) gained. RESULTS: 0.051). Cost-effectiveness analysis based on an assumed mortality impact in this subgroup suggests a within-study cost of around $28.44 per HLY gained, reducing to $6.35 per HLY gained at scale, substantially below the range of potential cost-effectiveness thresholds considered for Zimbabwe (US $17- US $855). CONCLUSION: Neotree is a potentially low-cost and highly cost-effective digital quality improvement tool to improve newborn care, morbidity and survival, while also providing quality data. This study contributes to limited economic evidence of mHealth tools in low-income and middle-income settings.

Abstract Objectives To estimate current, and 5- and 10-year projected, number of cases of cancer per year in transgender and gender diverse (TGD) people in England, overall and by tumour type, accounting for uptake of gender affirming care (GAC). Design Population-based epidemiological modelling study using an age-stratified Monte Carlo simulations approach and the NORDPRED method for predictions. Setting Models estimating cancer case numbers for TGD people in England based on publicly available 2023 cancer surveillance data and survey-based 2025 GAC access, and predicted at 5 and 10 years hence. Participants TGD people aged 15 years and above. Main outcome measures Primary cancer cases per year overall, by gender, age group, tumour type, and current and planned GAC. Results The estimated TGD population size in England is 441547 (95% uncertainty interval (UI) 429207- 452890). Total cases per year of cancer in TGD people is expected to be 966 (95% UI 882-1069) excluding non-melanoma skin. Most cases are expected to occur in people aged 60-64. The top 5 expected cancers in TGD people are breast (19%, n = 187, 95% UI 149-241), colorectal (12%, n = 117, 95% UI 106-129), lung (11%, n = 108, 95% UI 96-122), melanoma (7.1%, n = 69, 95% UI 64-74) and urinary (6.2%, n = 60, 95% UI 54-67). Total cases of cancer in TGD people are estimated to be 1740 (95% UI 1584-1934) in 5 years and 2258 (95% UI 2066-2507) in 10 years (excluding non-melanoma skin). If TGD people were able to access their planned level of GAC, this would reduce these figures to 1555 (95% CI 1386-1766) and 2012 (95% CI 1797-2282) respectively. Conclusions This study provides prediction of cancer cases in TGD people in England, supporting the planning of service provision and training. This is vital, as with increasing disclosure, and long wait times for GAC, cancer cases in TGD people are predicted to increase. Summary Boxes What is already known on this topic The annual number of cases of cancer in transgender and gender diverse (TGD) people in England is currently unknown as gender incongruence is not collected as part of the National Cancer Registration and Analysis Service. Some gender-affirming care (GAC) interventions are known to modulate cancer risk. Use of testosterone and chest reconstruction for transmasculine people is known to reduce their incidence of breast cancer compared to cisgender women. Use of oestradiol alongside medical or surgical androgen suppression has been shown to reduce the incidence of prostate cancer in transfeminine people while increasing their risk of breast cancer, compared to cisgender men. What this study adds This study found that there are likely to be approximately 966 cases of cancer (excluding non-melanoma skin) in TGD people per year in the UK. Though total annual cases of cancer in TGD people are expected to be 2258 in 10 years, improved access to gender-affirming care could reduce total cases to 2012 (a 11% reduction). These figures provide additional justification for funding to improve access to GAC via the National Health Service (NHS), as well as for training on the oncological needs of this population.