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Background: The National Institute of Health and Social Care Research (NIHR) Health Informatics Collaborative (HIC) for Hearing Health has been established in the UK to curate routinely collected hearing health data to address research questions. This study defines priority research areas, outlines its aims, governance structure and demonstrates how hearing health data have been integrated into a common data model using pure tone audiometry (PTA) as a case study. Methods: After identifying key research aims in hearing health, the governance structure for the NIHR HIC for Hearing Health is described. The Observational Medical Outcomes Partnership (OMOP) was chosen as our common data model to provide a case study example. Results: The NIHR HIC Hearing Health theme have developed a data architecture outlying the flow of data from all of the various siloed electronic patient record systems to allow the effective linkage of data from electronic patient record systems to research systems. Using PTAs as an example, OMOPification of hearing health data successfully collated a rich breadth of datapoints across multiple centres. Conclusion: This study identified priority research areas where routinely collected hearing health data could be useful. It demonstrates integration and standardisation of such data into a common data model from multiple centres. By describing the process of data sharing across the HIC, we hope to invite more centres to contribute and utilise data to address research questions in hearing health. This national initiative has the power to transform UK hearing research and hearing care using routinely collected clinical data. [ABSTRACT FROM AUTHOR]

Background: The economic impact of managing long COVID in primary care is unknown. We estimated the costs of primary care consultations associated with long COVID and explored the relationship between risk factors and costs. Methods: Data were obtained on non-hospitalised adults from the Clinical Practice Research Datalink Aurum primary care database. We used propensity score matching with an incremental cost method to estimate additional primary care consultation costs associated with long COVID (12 weeks after COVID-19) at an individual and UK national level. We applied multivariable regression models to estimate the association between risk factors and consultations costs beyond 12 weeks from acute COVID-19. Results: Based on an analysis of 472,173 patients with COVID-19 and 472,173 unexposed individuals, the annual incremental cost of primary care consultations associated with long COVID was £2.44 per patient and £23,382,452 at the national level. Among patients with COVID-19, a long COVID diagnosis and reporting of longer-term symptoms were associated with a 43% and 44% increase in primary care consultation costs respectively, compared to patients without long COVID symptoms. Older age, female sex, obesity, being from a white ethnic group, comorbidities and prior consultation frequency were all associated with increased primary care consultation costs. Conclusions: The costs of primary care consultations associated with long COVID in non-hospitalised adults are substantial. Costs are significantly higher among those diagnosed with long COVID, those with long COVID symptoms, older adults, females, and those with obesity and comorbidities. [ABSTRACT FROM AUTHOR]

Background: Endometriosis affects 190 million women and those assigned female at birth worldwide. For some, it is associated with debilitating chronic pelvic pain. Diagnosis of endometriosis is often achieved through diagnostic laparoscopy. However, when isolated superficial peritoneal endometriosis (SPE), the most common endometriosis subtype, is identified during laparoscopy, limited evidence exists to support the common decision to surgically remove it via excision or ablation. Improved understanding of the impact of surgical removal of isolated SPE for the management of chronic pelvic pain in women is required. Here, we describe our protocol for a multi-centre trial to determine the effectiveness of surgical removal of isolated SPE for the management of endometriosis-associated pain. Methods: We plan to undertake a multi-centre participant-blind parallel-group randomised controlled clinical and cost-effectiveness trial with internal pilot. We plan to randomise 400 participants from up to 70 National Health Service Hospitals in the UK. Participants with chronic pelvic pain awaiting diagnostic laparoscopy for suspected endometriosis will be consented by the clinical research team. If isolated SPE is identified at laparoscopy, and deep or ovarian endometriosis is not seen, participants will be randomised intraoperatively (1:1) to surgical removal (by excision or ablation or both, according to surgeons' preference) versus diagnostic laparoscopy alone. Randomisation with block-stratification will be used. Participants will be given a diagnosis but will not be informed of the procedure they received until 12 months post-randomisation, unless required. Post-operative medical treatment will be according to participants' preference. Participants will be asked to complete validated pain and quality of life questionnaires at 3, 6 and 12 months after randomisation. Our primary outcome is the pain domain of the Endometriosis Health Profile-30 (EHP-30), via a between randomised group comparison of adjusted means at 12 months. Assuming a standard deviation of 22 points around the pain score, 90% power, 5% significance and 20% missing data, 400 participants are required to be randomised to detect an 8-point pain score difference. Discussion: This trial aims to provide high quality evidence of the clinical and cost-effectiveness of surgical removal of isolated SPE. Trial registration: ISRCTN registry ISRCTN27244948. Registered 6 April 2021. [ABSTRACT FROM AUTHOR]

This study explored healthcare professionals' perceived role in talking to adult patients about sharing their diagnosis with children. Semi-structured interviews were conducted to explore healthcare professionals' beliefs about how families could and should be supported when a parent has a serious illness. Participants were 24 healthcare professionals working in primary, secondary and tertiary NHS services in the UK with adult patients diagnosed with a serious illness. Data were analysed thematically. Many healthcare professionals reported systems to identify patients' family relationships, but this information was rarely used to initiate conversations on what and how to talk to children. It was frequently assumed that someone else in the healthcare system was supporting patients with family communication. Others reported there were more urgent priorities for the consultation or considered that talking to children was a private family matter. However, several professionals did undertake these conversations, viewing this as a central part of their role. Some healthcare professionals felt they had inadequate skills or confidence to raise talking to children with their patients and indicated a need for specific training to address this. The results highlight the importance of systematically documenting patients' relationships with children so that this information can be used to inform ongoing discussions with the healthcare team about what children have been told. Patients consistently report wanting support about how to talk to children and the benefits of effective communication are well documented. Dissemination of this evidence could encourage professionals across all specialities to include family-centred communication in routine patient care. Training resources are needed so that staff feel empowered and equipped to raise these sensitive subjects with their patients. [ABSTRACT FROM AUTHOR]

Recent extreme weather events have had severe impacts on UK crop yields, and so there is concern that a greater frequency of extremes could affect crop production in a changing climate. Here we investigate the impacts of future climate change on wheat, the most widely grown cereal crop globally, in a temperate country with currently favourable wheat-growing conditions. Historically, following the plateau of UK wheat yields since the 1990s, we find there has been a recent significant increase in wheat yield volatility, which is only partially explained by seasonal metrics of temperature and precipitation across key wheat growth stages (foundation, construction and production). We find climate impacts on wheat yields are strongest in years with compound weather extremes across multiple growth stages (e.g. frost and heavy rainfall). To assess how these conditions might evolve in the future, we analyse the latest 2.2 km UK Climate Projections (UKCP Local): on average, the foundation growth stage (broadly 1 October to 9 April) is likely to become warmer and wetter, while the construction (10 April to 10 June) and production (11 June to 26 July) stages are likely to become warmer and slightly drier. Statistical wheat yield projections, obtained by driving the regression model with UKCP Local simulations of precipitation and temperature for the UK's three main wheat-growing regions, indicate continued growth of crop yields in the coming decades. Significantly warmer projected winter night temperatures offset the negative impacts of increasing rainfall during the foundation stage, while warmer day temperatures and drier conditions are generally beneficial to yields in the production stage. This work suggests that on average, at the regional scale, climate change is likely to have more positive impacts on UK wheat yields than previously considered. Against this background of positive change, however, our work illustrates that wheat farming in the UK is likely to move outside of the climatic envelope that it has previously experienced, increasing the risk of unseen weather conditions such as intense local thunderstorms or prolonged droughts, which are beyond the scope of this paper. [ABSTRACT FROM AUTHOR]

Assessing the rarity and magnitude of very extreme flood events occurring less than twice a century is challenging due to the lack of observations of such rare events. Here we develop a new approach, pooling reforecast ensemble members from the European Flood Awareness System (EFAS), to increase the sample size available to estimate the frequency of extreme local and regional flood events. We assess the added value of such pooling, determine where in Central Europe one might expect the most extreme events, and evaluate how event severity is related to physiographic and meteorological catchment characteristics. We work with a set of 234 catchments from the Global Runoff Data Centre matched to EFAS catchments and for which the performance of simulated floods is good when compared to observed streamflow. We pool EFAS-simulated flood events for 10 perturbed ensemble members and lead times ranging from 22 to 46 d, where flood events are only weakly dependent (<0.25 average correlation across lead times). The resulting large ensemble (130 time series instead of 1) enables the analyses of very extreme events which occur less than twice a century. We demonstrate that such ensemble pooling produces more robust estimates with considerably reduced uncertainty bounds (by ∼80% on average) than observation-based estimates but may equally introduce biases arising from the simulated meteorology and hydrological model. Our results show that, for a given return period, specific floods are highest in steep, cold, and wet regions and are comparably low in regions with strong flow regulation through dams. Furthermore, our pooled flood estimates indicate that the probability of regional flooding is higher in Central Europe and Great Britain than in Scandinavia. We conclude that reforecast ensemble pooling is an efficient approach to increase sample size and to derive robust local and regional flood estimates in regions with good hydrological model performance. [ABSTRACT FROM AUTHOR]

Recent extreme weather events have had severe impacts on UK crop yields, and so there is concern that a greater frequency of extremes could affect crop production in a changing climate. Here we investigate potential future impacts of climate projections on wheat, the most widely grown cereal crop globally, in a temperate country with currently favourable wheat-growing conditions. Past and projected climate conditions are considered for key wheat growth stages (Foundation, Construction and Production). Historically, following the plateau of UK wheat yields since the 1990s, we find there has been a recent significant increase in wheat yield volatility, which is partially explained by seasonal metrics of temperature and precipitation, including mean, extremes, and intra-seasonal variability. Strong associations between climate and yield anomalies occur during years with cumulative climate impacts across growth stages, when climate extremes 'escape' the ability of farmers to adapt through agronomic means. We then analyse the latest 2.2 km UK Climate Projections for the UK's three main wheat-growing regions. Climate projections indicate that on average across the three regions, the Foundation growth stage (broadly 1st October to 9th April) is likely to become warmer and wetter, while the Construction (10th April to 10th June) and Production (11th June to 26th July) stages are likely to become warmer and slightly drier. An analogue approach, comparing historical climate conditions with future climate projections, reveals a mixed picture of future climate conditions for UK crop yields. Projected warmer winter night temperatures are likely to prove beneficial in the Foundation stage, but concurrent increases in heavy rain may be detrimental. Similarly, warmer and drier mean conditions may enhance yields during the Production stage, but increases in high temperatures and heat variability may increase plant stress, while decreases in rainfall may also threaten adequate water supply. Since future climatic conditions are likely to move outside the historically observed range, there may be challenges for agriculture to adapt management practices to realise any potential benefits. [ABSTRACT FROM AUTHOR]

Background: Meeting the needs of relatives when a family member is dying can help facilitate better psychological adjustment in their grief. However, end of life experiences for families are likely to have been deleteriously impacted by the COVID-19 crisis. Understanding how families' needs can be met during a global pandemic will have current/future relevance for clinical practice and policy. Aim: To explore relatives' experiences and needs when a family member was dying during the COVID-19 pandemic. Design: Interpretative qualitative study using semi-structured interviews. Data were analysed thematically. Setting/participants: A total of 19 relatives whose family member died during the COVID-19 pandemic in the United Kingdom. Results: In the absence of direct physical contact, it was important for families to have a clear understanding of their family member's condition and declining health, stay connected with them in the final weeks/days of life and have the opportunity for a final contact before they died. Health and social care professionals were instrumental to providing these aspects of care, but faced practical challenges in achieving these. Results are presented within three themes: (1) entering into the final weeks and days of life during a pandemic, (2) navigating the final weeks of life during a pandemic and (3) the importance of 'saying goodbye' in a pandemic. Conclusions: Health and social care professionals can have an important role in mitigating the absence of relatives' visits at end of life during a pandemic. Strategies include prioritising virtual connectedness and creating alternative opportunities for relatives to 'say goodbye'. [ABSTRACT FROM AUTHOR]

Allergic diseases are on the increase and can affect the child's well-being. The aim of this survey was to assess regional schools' preparedness in dealing with anaphylaxis following the publication of national and international guidelines for schools in 2014. The survey was developed in 2015 and distributed to schools in Cumbria, North West England, UK between 2015 and 2016. Only 47% of the respondents (95% CI, 39-57%) felt confident to manage anaphylaxis. Schools without allergic pupils were significantly less likely to have a standard management protocol in place for emergencies compared to those with allergic pupils (p < 0.001). The majority of the schools indicated that further training was needed (81% (95% CI, 74-88%).Conclusion: At the time of the survey, schools' preparedness in the region, did not meet safety standards recommended by national and international organisations. Although schools have shown eagerness in accessing training in the management of anaphylaxis, tailored training for schools is not yet widely available. There is now an urgent need to design feasible training strategies that create a safe environment for allergic pupils across all UK schools. What is Known: • One quarter of the severe allergic reactions take place for the first time while at school with some of them being fatal. • School staff is ill-prepared in the management of anaphylaxis. Access to formal training is not widely available. What is New: • School staff remains unconfident in managing the severe allergic child. Training in the management of anaphylaxis is scarce, and when available, it does not offer the required depth to cover the holistic needs of allergic pupils. • Schools would welcome generic adrenaline autoinjectors and a national policy with central funding which would describe step by step the necessary measures for the management of anaphylaxis. [ABSTRACT FROM AUTHOR]

Preclinical studies support a protective role for aspirin in early diabetic retinopathy (DR), but the findings from randomized trials are limited. We present randomized evidence for the efficacy and safety of aspirin on DR outcomes. A substudy of the A Study of Cardiovascular Events in Diabetes (ASCEND) double-masked, randomized, placebo-controlled trial of 100 mg aspirin daily for the primary prevention of serious cardiovascular events in people with diabetes. Fifteen thousand four hundred eighty United Kingdom adults at least 40 years of age with diabetes. Linkage to electronic National Health Service Diabetic Eye Screening Programme records in England and Wales and confirmation of participant-reported eye events via medical record review were carried out. Log-rank methods were used for intention-to-treat analyses of time until the first primary efficacy and safety outcomes. The primary efficacy end point was the first record of referable disease after randomization, a composite of referable retinopathy or referable maculopathy based on the grading criteria defined by the United Kingdom National Screening Committee. The primary safety outcome was the first sight-threatening eye bleed, defined as clinically significant bleeding in the eye that resulted in unresolved visual loss or required an urgent intervention such as laser photocoagulation, vitreoretinal surgery, intraocular injection, or a combination thereof. Linkage data were obtained for 7360 participants (48% of those randomized in ASCEND). During the mean follow-up of 6.5 years, 539 participants (14.6%) experienced a referable disease event in the aspirin group, compared with 522 participants (14.2%) in the placebo group (rate ratio, 1.03; 95% confidence interval [CI], 0.91–1.16; P = 0.64). No statistically significant between-group difference was found in the proportions of sight-threatening eye bleed events (57 participants [0.7%] and 64 participants [0.8%], respectively; rate ratio, 0.89; 95% CI, 0.62–1.27). These data exclude any clinically meaningful benefits of aspirin for DR, but give reassurance regarding the ophthalmologic safety of aspirin. Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article. [ABSTRACT FROM AUTHOR]

Preclinical studies support a protective role for omega-3 fatty acids (FAs) on diabetic retinopathy (DR), but these observations have not been confirmed in randomized trials. We present randomized evidence for the effects of omega-3 FAs on DR outcomes. A substudy of the A Study of Cardiovascular Events iN Diabetes (ASCEND) double-blind, randomized, placebo-controlled trial of 1 g omega-3 fatty acids (containing 460 mg eicosapentaenoic acid and 380 mg docosahexaenoic acid) daily for the primary prevention of serious cardiovascular events, in 15 480 UK adults at least 40 years of age, with diabetes. Fifteen thousand four hundred eighty adults at least 40 years of age from the United Kingdom with diabetes from the ASCEND cohort. Linkage to electronic National Health Service Diabetic Eye Screening Programme records in England and Wales and confirmation of participant-reported eye events via medical record review. Log-rank and stratified log-rank methods were used for intention-to-treat analyses of time until the main outcomes of interest. The primary efficacy endpoint was time to the first postrandomization recording of referable disease, a composite of referable retinopathy (R 2 or R 3a/s) or referable maculopathy (M 1) based on the grading criteria defined by the United Kingdom National Screening Committee. Secondary and tertiary outcomes included the referable disease outcome stratified by the severity of DR at baseline, any progression in retinopathy grade, and incident diabetic maculopathy. Linkage data were obtained for 7360 participants (48% of those who were randomized in ASCEND). During their mean follow-up of 6.5 years, 548 participants (14.8%) had a referable disease event in the omega-3 FAs group, compared with 513 participants (13.9%) in the placebo group (rate ratio, 1.07; 95% confidence interval, 0.95–1.20; P = 0.29). There were no statistically significant between-group differences in the proportion of events for either of the secondary or tertiary outcomes. Representing the largest prospective test of its kind to date, these data exclude any clinically meaningful benefits of 1 g daily omega-3 FAs on DR. Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article. [ABSTRACT FROM AUTHOR]

Abstract Implant based reconstruction accounts for over half of breast reconstruction performed in the UK. Patients with implant based breast reconstructions undergoing post mastectomy radiotherapy are at increased risk of capsular contracture and reconstructive failure. This study sought to determine the effect of treatment dose radiotherapy on the bulk mechanical, surface chemical properties of silicone implants as well as their cellular response. Silicone breast implant shells were submitted to treatment dose radiotherapy, 2.67 Gy (one daily fraction) and 40.05 Gy (15 fractions) using non-irradiated shells as controls. Bulk mechanical and surface chemical properties of the shells were evaluated using tensile and tear testing, attenuated total reflectance – fourier transform infrared spectroscopy (ATR-FTIR), water contact angle measurements. HDFa cells were seeded on the shells and Alamar Blue assay was performed to study cell metabolic activity. Cell morphology was evaluated using phalloidin and DAPI staining. There was no significant difference in tensile, tear strength and Young's modulus however there was reduction in maximum elongation following irradiation. Irradiation of the shells did not significant alter spectroscopy measurements nor wettability of the shells. Cell metabolism was not significantly affected by irradiation. Further analysis is warranted of the micromechanical properties to fully elucidate the effect of irradiation on the breast implant which could explain the increased rate of capsular contracture and reconstructive failure in patients undergoing post-mastectomy radiotherapy. Highlights • Implant based breast reconstruction (IBBR) accounts for over half of breast reconstructions performed in the UK • Patients with IBBR who receive post mastectomy radiotherapy are at increased risk of implant related complication • Implants tested with radiation therapy demonstrated no overall change in mechanical or surface chemical properties [ABSTRACT FROM AUTHOR]

Background: Gypsies and Travellers are known to have poor health status and access to health services, even in comparison with other ethnic minority groups. People from this stigmatized ethnic group are rarely consulted about their health needs or health service provision. Optimal infant feeding in the first year of life has the potential to improve lifelong health. Objective: The aim of this study was to explore mothers and grandmothers’ views on feeding in the first year of life, including the support provided by health professionals. Methods: Semi‐structured interviews were conducted with a purposively selected sample of 22 mothers and grandmothers of English Gypsy, Irish Traveller and Romanian Roma ethnicity between November 2011 and February 2012 in a city in south‐west England. Results: Few women perceived themselves as requiring help from health professionals in infant feeding, as acceptable and accessible support was available from within their own communities. Roma mothers described a tradition of breast‐feeding and appropriately timed weaning, while English Gypsies and Irish Travellers customarily practised less healthy infant feeding. When mothers requested support, health service provision was often found inadequate. Conclusion: Exploring the views of Gypsies and Travellers is important to gain insight into the provision of health services for this marginalized ethnic group. This study has implications for policy and the practice of health professionals, in indicating the customary feeding behaviours of some Gypsy and Travellers, and highlighting areas meriting culturally sensitive health promotion. [ABSTRACT FROM AUTHOR]

Abstract: Objective: To review the selection and use of health-related utility values for economic models included in National Institute for Health and Clinical Excellence (NICE) Technology Appraisals. Method: A cross-sectional review of reports of economic models submitted to the Technology Appraisals program was undertaken to review the health-related utility data included. Data reviewed included identification and selection of data and the methods used for utility elicitation. The methods used were compared with those from the 2004 Methods Guide issued by NICE. Results: Appraisals conducted after the implementation of the NICE 2004 Methods Guide were reviewed. After exclusion of documents that did not include a de novo cost-utility analysis, 71 submissions (53 manufacturer submissions, 18 assessment group reports) from 39 appraisals were identified, containing 284 unique utility values. Variation was found in the selection, elicitation, valuation, and use of the utility values. Thirty-nine submissions (55%) took utility values from published studies, of which only 31% were identified through a systematic review. Forty-seven (66%) submissions contained health state descriptions reported by patients, and 55 (77%) submissions applied a valuation set derived from the general population. The EQ-5D was used in 35 (49%) submissions, and mapping to a generic health-related quality of life measure was performed in 19 (27%) submissions. Conclusions: Only 56% of submissions to NICE and assessment reports included utility values that met the NICE 2004 reference case. This highlights variation in the methods used to select and incorporate utility values in economic models for NICE Technology Appraisals. [Copyright &y& Elsevier]

Focuses on medical-related issues in Great Britain. Involvement of otolaryngologists in providing hearing aids to adults within the National Health Services; Complications of hysterectomy; Association between deficiency of vitamin D and hyperparathyroidism.

Sustainable drainage systems (SuDS) can be a key tool in the management of extremes of rainfall, due to their capacity to attenuate and treat surface water. Yet, implementation is a complex process, requiring buy-in from multiple stakeholders. Buy-in is often undermined by a lack of practical evidence and monitoring of implemented SuDS. In this paper, we present a collaborative case study between a local authority, university and the UK Environment Agency. This partnership approach enabled the installation of SuDS and monitoring equipment to address surface runoff in the north east of England. Ultrasonic sensors were installed in the drainage network to evaluate the attenuation of surface water. SuDS were installed during an atypically wet spring, followed by a hot and dry summer, providing a range of conditions to assess their performance. Results demonstrate that there was a statistically significant difference in the detected flow level in manholes downstream of the SuDS interventions. Several challenges occurred, from signal obstacles in wireless telecommunication services, to logistical constraints of installing sensors in the drainage network, and issues with the adoption of property level SuDS. These issues require further research. Qualitative support for partnership working was crucial to increase the capacity for delivering SuDS. To ensure the success of future schemes and likelihood of SuDS uptake, partnership working and engaging with communities is vital. [ABSTRACT FROM AUTHOR]

Focuses on the inequalities of health status as material and immaterial consequences of lower income, professional or social status in the society in Great Britain. Evaluation of the healthcare systems from several countries; Scrutiny on the incentive provided as part of the market mechanism; Issues related to the healthcare reforms.

Intensity-Duration-Frequency (IDF) curves usefully quantify extreme precipitation. Unfortunately, sparse, infrequent or short observations hinder the creation of robust IDF curves in many locations around the world. We present a global, multi-temporal (1 to 360 h) dataset of Gumbel parameters at 30 km resolution named PXR-2 (Parametrized eXtreme Rain). Using these data we show that the two Gumbel parameters typically scale robustly with event duration (r²>0.85, p<0.01). Thus, we propose a four-parameter IDF formula that allows estimates of rainfall intensity for a continuous range of durations, and describe the PXR-4 dataset that compiles these parameters. This parameter scaling property opens the door to estimating sub-daily IDF from daily records. We evaluate this characteristic for selected global cities and a rain gauge network in the United Kingdom. PXR aims to be of immediate use for engineers for designing critical infrastructure such as urban drainage systems, dams and highways, with potential applications in other fields of earth sciences. [ABSTRACT FROM AUTHOR]

Introduction: The past decade has seen a rapid increase in the volume and proportion of testing for sexually transmitted infections that are accessed via online postal self-sampling services in the UK. ASSIST (Assessing the impact of online postal self-sampling for sexually transmitted infections on health inequalities, access to care and clinical outcomes in the UK) aims to assess the impact of these services on health inequalities, access to care, and clinical and economic outcomes, and to identify the factors that influence the implementation and sustainability of these services., Methods and Analysis: ASSIST is a mixed-methods, realist evaluated, national study with an in-depth focus of three case study areas (Birmingham, London and Sheffield). An impact evaluation, economic evaluation and implementation evaluation will be conducted. Findings from these evaluations will be analysed together to develop programme theories that explain the outcomes. Data collection includes quantitative data (using national, clinic based and online datasets); qualitative interviews with service users, healthcare professionals and key stakeholders; contextual observations and documentary analysis. STATA 17 and NVivo will be used to conduct the quantitative and qualitative analysis, respectively., Ethics and Dissemination: This study has been approved by South Central - Berkshire Research Ethics Committee (ref: 21/SC/0223). All quantitative data accessed and collected will be anonymous. Participants involved with qualitative interviews will be asked for informed consent, and data collected will be anonymised.Our dissemination strategy has been developed to access and engage key audiences in a timely manner and findings will be disseminated via the study website, social media, in peer-reviewed scientific journals, at research conferences, local meetings and seminars and at a concluding dissemination and networking event for stakeholders., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.)

Breast cancer affects one in seven women worldwide during their lifetime. Widespread mammographic screening programs and education campaigns allow for early detection of the disease, often during its asymptomatic phase. Current practice in treatment and recurrence monitoring is based primarily on pathological evaluations but can also encompass genomic evaluations, both of which focus on the primary tumor. Although breast cancer is one of the most studied cancers, patients still recur at a rate of up to 15% within the first 10 years post-surgery. Local recurrence was originally attributed to tumor cells contaminating histologically normal (HN) tissues beyond the surgical margin, but advances in technology have allowed for the identification of distinct aberrations that exist in the peri-tumoral tissues themselves. One leading theory to explain this phenomenon is the field cancerization theory. Under this hypothesis, tumors arise from a field of molecularly altered cells that create a permissive environment for malignant evolution, which can occur with or without morphological changes. The traditional histopathology paradigm dictates that molecular alterations are reflected in the tissue phenotype. However, the spectrum of inter-patient variability of normal breast tissue may obfuscate recognition of a cancerized field during routine diagnostics. In this review, we explore the concept of field cancerization focusing on HN peri-tumoral tissues: we present the pathological and molecular features of field cancerization within these tissues and discuss how the use of peri-tumoral tissues can affect research. Our observations suggest that pathological and molecular evaluations could be used synergistically to assess risk and guide the therapeutic management of patients. © 2022 The Authors. The Journal of Pathology published by John Wiley & Sons Ltd on behalf of The Pathological Society of Great Britain and Ireland., (© 2022 The Authors. The Journal of Pathology published by John Wiley & Sons Ltd on behalf of The Pathological Society of Great Britain and Ireland.)

Objectives: The use of routine remote follow-up of patients with chronic kidney disease (CKD) is increasing exponentially. It has been suggested that online electronic patient-reported outcome measures (ePROMs) could be used in parallel, to facilitate real-time symptom monitoring aimed at improving outcomes. We tested the feasibility of this approach in a pilot trial of ePROM symptom monitoring versus usual care in patients with advanced CKD not on dialysis., Design: A 12-month, parallel, pilot randomised controlled trial (RCT) and qualitative substudy., Setting and Participants: Queen Elizabeth Hospital Birmingham, UK. Adult patients with advanced CKD (estimated glomerular filtration rate ≥6 and ≤15 mL/min/1.73 m 2 , or a projected risk of progression to kidney failure within 2 years ≥20%)., Intervention: Monthly online ePROM symptom reporting, including automated feedback of tailored self-management advice and triggered clinical notifications in the advent of severe symptoms. Real-time ePROM data were made available to the clinical team via the electronic medical record., Outcomes: Feasibility (recruitment and retention rates, and acceptability/adherence to the ePROM intervention). Health-related quality of life, clinical data (eg, measures of kidney function, kidney failure, hospitalisation, death) and healthcare utilisation., Results: 52 patients were randomised (31% of approached). Case report form returns were high (99.5%), as was retention (96%). Overall, 73% of expected ePROM questionnaires were received. Intervention adherence was high beyond 90 days (74%) and 180 days (65%); but dropped beyond 270 days (46%). Qualitative interviews supported proof of concept and intervention acceptability, but highlighted necessary changes aimed at enhancing overall functionality/scalability of the ePROM system., Limitations: Small sample size., Conclusions: This pilot trial demonstrates that patients are willing to be randomised to a trial assessing ePROM symptom monitoring. The intervention was considered acceptable; though measures to improve longer-term engagement are needed. A full-scale RCT is considered feasible., Trial Registration Number: ISRCTN12669006 and the UK NIHR Portfolio (CPMS ID: 36497)., Competing Interests: Competing interests: EB, MCh, NJI and JB report grants from NIHR. MCa is an NIHR Senior Investigator and receives funding from the NIHR Birmingham Biomedical Research Centre, the NIHR Surgical Reconstruction and Microbiology Research Centre and NIHR Applied Research Collaboration West Midlands at the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust, Health Data Research UK, Innovate UK (part of UK Research and Innovation), Macmillan Cancer Support, UCB Pharma and GSK. MC has received personal fees from Astellas, Takeda, Merck, Daiichi Sankyo, Glaukos, GSK and the Patient-Centered Outcomes Research Institute (PCORI) outside the submitted work. DK reports grants from Macmillan Cancer Support, Innovate UK, the NIHR, NIHR Birmingham Biomedical Research Centre, and NIHR SRMRC at the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust, and personal fees from Merck outside the submitted work., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.)

Young parents (aged 16-24 years) in the perinatal period are at an increased risk of poor mental health especially during the COVID-19 pandemic, due to multiple risk factors including social and economic instability. COVID-19 related restrictions had profound implications for the delivery of perinatal care services and other support structures for young parents. Investigating young parents' experiences during the pandemic, including their perceived challenges and needs, is important to inform good practice and provide appropriate support for young parents.Qualitative interviews were conducted with young parents (n = 21) during the COVID-19 pandemic in the United Kingdom from February - May 2021. Data were analysed using thematic analysis.Three key themes were identified to describe parents' experiences during the COVID-19 pandemic. Parents reported specific COVID-19 related anxieties and stressors, including worries around contracting the virus and increased feelings of distress due to uncertainty created by the implications of the pandemic. Parents described feeling alone both at home and during antenatal appointments and highlighted the absence of social support as a major area of concern. Parents also felt their perinatal care had been disrupted by the pandemic and experienced difficulties accessing care online or over the phone.This study highlights the potential impact of the COVID-19 pandemic on young parents, including their mental wellbeing and the perinatal support they were able to access. Insights from this study can inform the support and services offered to families going forward. Specifically, the findings emphasise the importance of (a) supporting both parents during perinatal appointments, (b) providing parents with mental health support early on and (c) finding ways to facilitate communication pathways between professionals and parents., (© 2022. The Author(s).)

Background: Health and social care professionals' ability to address the needs of patients and their relatives at end of life is likely to have been impacted by the COVID-19 pandemic., Aim: To explore health and social care professionals' experiences of providing end of life care during the COVID-19 pandemic to help inform current/future clinical practice and policy., Design: A qualitative interview study. Data were analysed using thematic analysis., Setting/participants: Sixteen health and social care professionals working across a range of clinical settings in supporting dying patients during the first wave (March-June 2020) of the COVID-19 pandemic in the United Kingdom., Results: Participants reported emotional and practical challenges to providing end of life care during the pandemic, including increases in patient numbers, reduced staffing levels and relying on virtual platforms for sensitive, emotive conversations with relatives. Participants were central to promoting connections between patients and their families at end of life and creating opportunities for a final contact before the death. However, the provision of support varied as a consequence of the pressures of the pandemic. Results are discussed under two themes: (1) challenges and facilitators to providing end of life care, and (2) support needs of relatives when a family member was dying during the COVID-19 pandemic., Conclusion: There is a need for flexible visiting arrangements at end of life during a pandemic. A systems-level approach is necessary to promote the wellbeing of health and social care professionals providing end of life care during and after a pandemic.

Introduction: In the UK, smokers who use stop smoking services (SSSs) are four times more likely to stop smoking than smokers who do not. Attendance has declined, warranting the development of interventions to address this. StopApp is a novel, brief online behaviour change intervention designed to address common barriers to SSS attendance. It links to widely commissioned service management software that enables instant appointment booking at a user's location and time of choice., Methods and Analysis: A two-arm parallel group, individual participant feasibility randomised controlled trial of StopApp (intervention) compared with the standard promotion of and referral to SSSs (control). The study includes a nested qualitative process evaluation to assess the acceptability of the research processes, with a subsample of participants. Smokers aged over 16 years will be recruited via three routes: General Practice (GP), community settings and online. After consenting and the collection of baseline data, participants will be randomised to control or intervention groups. Participants in the intervention group receive a link to StopApp and those in the control group receive standard web-based information about the SSSs. All participants are told they can book a SSS appointment but are under no obligation to do so. Online follow-up 2 months post randomisation includes data on SSS use and carbon monoxide verified 4-week quit rates. The study aims to recruit 162 smokers., Ethics and Dissemination: Ethics approval has been granted by the West Midlands-Edgbaston NHS Research Ethics Committee. The findings will be reported in conferences and peer-reviewed publications; and will be used to design the parameters necessary for a definitive trial to ascertain the effectiveness of StopApp at increasing booking and attendance at SSSs compared with existing methods for encouraging uptake., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: To evaluate the cost-effectiveness of routine use of cell salvage during caesarean section in mothers at risk of haemorrhage compared with current standard of care., Design: Model-based cost-effectiveness evaluation alongside a multicentre randomised controlled trial. Three main analyses were carried out on the trial data: (1) based on the intention-to-treat principle; (2) based on the per-protocol principle; (3) only participants who underwent an emergency caesarean section., Setting: 26 obstetric units in the UK., Participants: 3028 women at risk of haemorrhage recruited between June 2013 and April 2016., Interventions: Cell salvage (intervention) versus routine care without salvage (control)., Primary Outcome Measures: Cost-effectiveness based on incremental cost per donor blood transfusion avoided., Results: In the intention-to-treat analysis, the mean difference in total costs between cell salvage and standard care was £83. The estimated incremental cost-effectiveness ratio (ICER) was £8110 per donor blood transfusion avoided. For the per-protocol analysis, the mean difference in total costs was £92 and the ICER was £8252. In the emergency caesarean section analysis, the mean difference in total costs was £55 and the ICER was £13 713 per donor blood transfusion avoided. This ICER is driven by the increased probability that these patients would require a higher level of postoperative care and additional surgeries. The results of these analyses were shown to be robust for the majority of deterministic sensitivity analyses., Conclusions: The results of the economic evaluation suggest that while routine cell salvage is a marginally more effective strategy than standard care in avoiding a donor blood transfusion, there is uncertainty in relation to whether it is a less or more costly strategy. The lack of long-term data on the health and quality of life of patients in both arms of the trial means that further research is needed to fully understand the cost implications of both strategies., Trial Registration Number: ISRCTN66118656., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.)

International guidelines recommend that severe asthma can only be diagnosed after contributory factors, including adherence, have been addressed. Accurate assessment of adherence is difficult in clinical practice. We hypothesised that electronic monitoring in children would identify nonadherence, thus delineating the small number with true severe asthma.Asthmatic children already prescribed inhaled corticosteroids were prospectively recruited and persistence of adherence assessed using electronic monitoring devices. Spirometry, airway inflammation and asthma control were measured at the start and end of the monitoring period.93 children (62 male; median age 12.4 years) were monitored for a median of 92 days. Median (range) monitored adherence was 74% (21-99%). We identified four groups: 1) good adherence during monitoring with improved control, 24% (likely previous poor adherence); 2) good adherence with poor control, 18% (severe therapy-resistant asthma); 3) poor adherence with good control, 26% (likely overtreated); and 4) poor adherence with poor control, 32%. No clinical parameter prior to monitoring distinguished these groups.Electronic monitoring is a useful tool for identifying children in whom a step up in treatment is indicated. Different approaches are needed in those who are controlled when adherent or who are nonadherent. Electronic monitoring is essential in a paediatric severe asthma clinic., Competing Interests: Conflict of interest: None declared., (Copyright ©ERS 2017.)