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Background: Dental caries is common in young people and has wide-ranging ramifications for health and quality of life. Text messaging interventions show promise as a means to promote oral health behaviour change among young people. This paper reports the internal pilot of the Brushing RemInder 4 Good oral HealTh (BRIGHT) trial, which is evaluating an intervention comprising an oral health classroom lesson and text messages about toothbrushing, on caries in young people. Pilot trial objectives were to evaluate the feasibility and appropriateness of recruitment and data collection methods, the randomisation strategy, and intervention delivery against progression criteria for the main trial. Methods: This is an internal pilot trial embedded within an assessor-blinded, two-arm, cluster randomised controlled trial. Participants were pupils aged 11–13 years (in year 7/S1 or year 8/S2) in secondary schools in England, Scotland, and Wales with above average pupil eligibility for free school meals. Following completion of pupil baseline questionnaires and dental assessments, year groups within schools were randomised to the intervention or control arm. Approximately 12 weeks later, participants completed a follow-up questionnaire, which included questions about sources of oral health advice to assess intervention contamination between year groups. At the end of the pilot phase, trial conduct was reviewed against pre-specified progression criteria. Results: Ten schools were recruited for the pilot, with 20 year groups and 1073 pupils randomised (average of 54 pupils per year group). Data collection methods and intervention delivery were considered feasible, the response rate to the follow-up questionnaire was over 80%, there was an indication of a positive effect on self-reported toothbrushing, and interest was obtained from 80% of the schools required for the main trial. Despite partial intervention contamination between year groups, within-school randomisation at the level of the year-group was considered appropriate for the main trial, and the sample size was revised to account for partial contamination. Facilitators and barriers to recruitment and data collection were identified and strategies refined for the main trial. Conclusions: Progression to the main trial of BRIGHT, with some design refinements, was concluded. The internal pilot was an efficient way to determine trial feasibility and optimise trial processes. Trial registration: ISRCTN registry, ISRCTN12139369, registered 10/05/2017 [ABSTRACT FROM AUTHOR]

Background: Two to 4% of emergency hospital admissions are caused by preventable adverse drug events. The estimated costs of such avoidable admissions in England were £530 million in 2015. The data-driven quality improvement in primary care (DQIP) intervention was designed to prompt review of patients vulnerable from currently prescribed non-steroidal anti-inflammatory drugs (NSAIDs) and anti-platelets and was found to be effective at reducing this prescribing. A process evaluation was conducted parallel to the trial, and this paper reports the analysis which aimed to explore response to the intervention delivered to clusters in relation to participants' perceptions about which intervention elements were active in changing their practice.Methods: Data generation was by in-depth interview with key staff exploring participant's perceptions of the intervention components. Analysis was iterative using the framework technique and drawing on normalisation process theory.Results: All the primary components of the intervention were perceived as active, but at different stages of implementation: financial incentives primarily supported recruitment; education motivated the GPs to initiate implementation; the informatics tool facilitated sustained implementation. Participants perceived the primary components as interdependent. Intervention subcomponents also varied in whether and when they were active. For example, run charts providing feedback of change in prescribing over time were ignored in the informatics tool, but were motivating in some practices in the regular e-mailed newsletter. The high-risk NSAID and anti-platelet prescribing targeted was accepted as important by all interviewees, and this shared understanding was a key wider context underlying intervention effectiveness.Conclusions: This was a novel use of process evaluation data which examined whether and how the individual intervention components were effective from the perspective of the professionals delivering changed care to patients. These findings are important for reproducibility and roll-out of the intervention.Trial Registration: ClinicalTrials.gov, NCT01425502 . [ABSTRACT FROM AUTHOR]

Background: Increasing age is the biggest risk factor for dementia, of which Alzheimer's disease is the commonest cause. The pathological changes underpinning Alzheimer's disease are thought to develop at least a decade prior to the onset of symptoms. Molecular positron emission tomography and multi-modal magnetic resonance imaging allow key pathological processes underpinning cognitive impairment - including β-amyloid depostion, vascular disease, network breakdown and atrophy - to be assessed repeatedly and non-invasively. This enables potential determinants of dementia to be delineated earlier, and therefore opens a pre-symptomatic window where intervention may prevent the onset of cognitive symptoms.Methods/design: This paper outlines the clinical, cognitive and imaging protocol of "Insight 46", a neuroscience sub-study of the MRC National Survey of Health and Development. This is one of the oldest British birth cohort studies and has followed 5362 individuals since their birth in England, Scotland and Wales during one week in March 1946. These individuals have been tracked in 24 waves of data collection incorporating a wide range of health and functional measures, including repeat measures of cognitive function. Now aged 71 years, a small fraction have overt dementia, but estimates suggest that ~1/3 of individuals in this age group may be in the preclinical stages of Alzheimer's disease. Insight 46 is recruiting 500 study members selected at random from those who attended a clinical visit at 60-64 years and on whom relevant lifecourse data are available. We describe the sub-study design and protocol which involves a prospective two time-point (0, 24 month) data collection covering clinical, neuropsychological, β-amyloid positron emission tomography and magnetic resonance imaging, biomarker and genetic information. Data collection started in 2015 (age 69) and aims to be completed in 2019 (age 73).Discussion: Through the integration of data on the socioeconomic environment and on physical, psychological and cognitive function from 0 to 69 years, coupled with genetics, structural and molecular imaging, and intensive cognitive and neurological phenotyping, Insight 46 aims to identify lifetime factors which influence brain health and cognitive ageing, with particular focus on Alzheimer's disease and cerebrovascular disease. This will provide an evidence base for the rational design of disease-modifying trials. [ABSTRACT FROM AUTHOR]

Background: Pain is often poorly managed in people who have a dementia. Little is known about how this patient population is managed in hospital, with research to date focused mainly on care homes. This study aimed to investigate how pain is recognised, assessed and managed in patients with dementia in a range of acute hospital wards, to inform the development of a decision support tool to improve pain management for this group.Methods: A qualitative, multi-site exploratory case study. Data were collected in four hospitals in England and Scotland. Methods included non-participant observations, audits of patient records, semi-structured interviews with staff and carers, and analysis of hospital ward documents. Thematic analysis was performed through the lens of decision making theory.Results: Staff generally relied on patients' self-report of pain. For patients with dementia, however, communication difficulties experienced because of their condition, the organisational context, and time frames of staff interactions, hindered patients' ability to provide staff with information about their pain experience. This potentially undermined the trials of medications used to provide pain relief to each patient and assessments of their responses to these treatments. Furthermore, given the multidisciplinary environment, a patient's communication about their pain involved several members of staff, each having to make sense of the patient's pain as in an 'overall picture'. Information about patients' pain, elicited in different ways, at different times and by different health care staff, was fragmented in paper-based documentation. Re-assembling the pieces to form a 'patient specific picture of the pain' required collective staff memory, 'mental computation' and time.Conclusions: There is a need for an efficient method of eliciting and centralizing all pain-related information for patients with dementia, which is distributed in time and between personnel. Such a method should give an overall picture of a patient's pain which is rapidly accessible to all involved in their care. This would provide a much-needed basis for making decisions to support the effective management of the pain of older people with dementia in hospital. [ABSTRACT FROM AUTHOR]

There are growing calls for cancer screening to become more personalised by considering a range of risk factors, rather than a one-size-fits-all, age-based approach. The aim of this public involvement was to co-create a comic book about bowel cancer screening to be used as a visual elicitation tool in research focus groups with members of the public and healthcare professionals, as part of the At Risk study, to discuss their attitudes toward personalised bowel cancer screening, which would involve considering different risk factors. This article critically reflects on the co-creation process to develop the comic book, benefits and challenges, and some lessons learned to inform other researchers considering a similar approach. In total, ten public contributors (5 men and 5 women) from two public involvement networks participated in two successive online workshops to develop six fictional characters, two for each level of bowel cancer risk (low, moderate and high risk). This tool was then used in the At Risk study comprising five focus groups involving 23 participants, including members of the public (n = 12) and healthcare professionals (n = 11). The co-created comic book was a generally well-received research tool able to generate discussion about a complex topic, bowel cancer risk, in an accessible way. It was suggested that the comic book may also be extended beyond the research context to inform bowel cancer screening decisions and raise awareness of risk factors. Plain English summary: A national screening programme for bowel cancer was set up in 2006. This is offered every two years to people aged 60–74 in England and 50–74 in Scotland. Bowel cancer is the fourth most common cancer in the UK and the risk of developing bowel cancer increases with age. Smoking, alcohol, diet and lack of exercise also increase the risk. An individual can change their lifestyle to reduce their risk. But if someone has a history of bowel cancer in their family, or has had another type of cancer themselves, they are still more likely to develop bowel cancer. Certain ethnic groups are also at higher risk. There are calls to tailor the bowel cancer screening programme to each person's level of risk. This needs to be acceptable to those who are offered screening. In our study, we spoke to members of the public and healthcare professionals to find out their views on this. This is a complex topic, and we decided to create a comic book to help people understand the issues and encourage discussion. We worked with an artist and ten public contributors to create the comic book. We held two online workshops and presented the comic book at a network for different ethnic groups in our region. Here we discuss what we learned from this creative process. We focus on: diversity in the workshops; the purpose of the comic book; language and humour; visual style; developing the characters; the setting for the story; cultural sensitivity and stigma. [ABSTRACT FROM AUTHOR]

Background: There is an increased need for prevention and early intervention surrounding young people's health and well-being. Schools offer a pivotal setting for this with evidence suggesting that focusing on health within schools improves educational attainment. One promising approach is the creation of School Health Research Networks which exist in Wales and Scotland, but are yet to be developed and evaluated in England. Methods: This qualitative process evaluation aimed to identify the main barriers and facilitators to implementing a pilot School Health Research Network in the South West of England (SW-SHRN). Semi-structured interviews were conducted with school staff, local authority members, and other key stakeholders. Interview data were analysed using the 7-stage framework analysis approach. Results: Four main themes were identified from the data: (1) 'Key barriers to SW-SHRN' (competing priorities of academic attainment and well-being, schools feeling overwhelmed with surveys and lack of school time and resource); (2) 'Key facilitators to SW-SHRN: providing evidence-based support to schools' (improved knowledge to facilitate change, feedback reports and benchmarking and data to inform interventions); (3) 'Effective dissemination of findings' (interpretation and implementation, embedding findings with existing evidence and policy, preferences for an online platform as well personalised communication and the importance of involving young people and families); and (4) 'Longer-term facilitators: ensuring sustainability' (keeping schools engaged, the use of repeat surveys to evaluate impact, informing school inspection frameworks and expanding reach of the network). Conclusion: This study identifies several barriers to be addressed and facilitators to be enhanced in order to achieve successful implementation of School Health Research Networks in England which include providing a unique offering to schools that is not too burdensome, supporting schools to take meaningful action with their data and to work closely with existing organisations, services and providers to become meaningfully embedded in the system. [ABSTRACT FROM AUTHOR]

Background: With the improvements to text mining technology and the availability of large unstructured Electronic Healthcare Records (EHR) datasets, it is now possible to extract structured information from raw text contained within EHR at reasonably high accuracy. We describe a text mining system for classifying radiologists' reports of CT and MRI brain scans, assigning labels indicating occurrence and type of stroke, as well as other observations. Our system, the Edinburgh Information Extraction for Radiology reports (EdIE-R) system, which we describe here, was developed and tested on a collection of radiology reports.The work reported in this paper is based on 1168 radiology reports from the Edinburgh Stroke Study (ESS), a hospital-based register of stroke and transient ischaemic attack patients. We manually created annotations for this data in parallel with developing the rule-based EdIE-R system to identify phenotype information related to stroke in radiology reports. This process was iterative and domain expert feedback was considered at each iteration to adapt and tune the EdIE-R text mining system which identifies entities, negation and relations between entities in each report and determines report-level labels (phenotypes). Results: The inter-annotator agreement (IAA) for all types of annotations is high at 96.96 for entities, 96.46 for negation, 95.84 for relations and 94.02 for labels. The equivalent system scores on the blind test set are equally high at 95.49 for entities, 94.41 for negation, 98.27 for relations and 96.39 for labels for the first annotator and 96.86, 96.01, 96.53 and 92.61, respectively for the second annotator. Conclusion: Automated reading of such EHR data at such high levels of accuracies opens up avenues for population health monitoring and audit, and can provide a resource for epidemiological studies. We are in the process of validating EdIE-R in separate larger cohorts in NHS England and Scotland. The manually annotated ESS corpus will be available for research purposes on application. [ABSTRACT FROM AUTHOR]

Background: For people experiencing homelessness and problem substance use, access to appropriate services can be challenging. There is evidence that the development of trusting relationships with non-judgemental staff can facilitate service engagement. Peer-delivered approaches show particular promise, but the evidence base is still developing. Methods: The study used mixed methods to assess the feasibility, acceptability and accessibility of a peer-delivered, relational intervention to reduce harms and improve health/well-being, quality of life and social functioning, for people experiencing homelessness and problem substance use. Four Peer Navigators were employed to support individuals (n = 68 total, intervention participants). They were based in outreach services and hostels in Scotland and England. Qualitative interviews were conducted with intervention participants, Peer Navigators and staff in services, and observations were conducted in all settings. Quantitative outcomes relating to participants' substance use, physical and mental health, and quality of the Peer Navigator relationship, were measured via a 'holistic health check' with six questionnaires completed at two time-points. Results: The intervention was found to be acceptable to, and feasible and accessible for, participants, Peer Navigators, and service staff. Participants reported improvements to service engagement, and feeling more equipped to access services independently. The lived experience of the Peer Navigators was highlighted as particularly helpful, enabling trusting, authentic, and meaningful relationships to be developed. Some challenges were experienced in relation to the 'fit' of the intervention within some settings. Among participants there were reductions in drug use and risky injecting practices. There were increases in the number of participants receiving opioid substitution therapy. Overall, the intervention was positively received, with collective recognition that the intervention was unique and highly valuable. While most of the measures chosen for the holistic health check were found to be suitable for this population, they should be streamlined to avoid duplication and participant burden. Conclusions: The study established that a peer-delivered, relational harm reduction intervention is acceptable to, and feasible and accessible for, people experiencing homelessness and problem substance use. While the study was not outcomes-focused, participants did experience a range of positive outcomes. A full randomised controlled trial is now required to assess intervention effectiveness. Trial registration: Study registered with ISRCTN: 15900054. [ABSTRACT FROM AUTHOR]

Background: Epidemiological studies have repeatedly observed a markedly higher risk for coronary artery disease (CAD) in Scotland as compared to England. Up to now, it is unclear whether environmental or genetic factors might explain this phenomenon.Methods: Using UK Biobank (UKB) data, we assessed CAD risk, based on the Framingham risk score (FRS) and common genetic variants, to explore the respective contribution to CAD prevalence in Scotland (n = 31,963) and England (n = 317,889). We calculated FRS based on sex, age, body mass index (BMI), total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), systolic blood pressure (SBP), antihypertensive medication, smoking status, and diabetes. We determined the allele frequency of published genome-wide significant risk CAD alleles and a weighted genetic risk score (wGRS) for quantifying genetic CAD risk.Results: Prevalence of CAD was 16% higher in Scotland as compared to England (8.98% vs. 7.68%, P < 0.001). However, the FRS only predicted a marginally higher CAD risk (less than 1%) in Scotland (12.5 ± 10.5 vs.12.6 ± 10.6, P = 0.03). Likewise, the overall number of genome-wide significant variants affecting CAD risk (157.6 ± 7.7 and 157.5 ± 7.7; P = 0.12) and a wGRS for CAD (2.49 ± 0.25 in both populations, P = 0.14) were remarkably similar in the English and Scottish population. Interestingly, we observed substantial differences in the allele frequencies of individual risk variants. Of the previously described 163 genome-wide significant variants studied here, 35 variants had higher frequencies in Scotland, whereas 37 had higher frequencies in England (P < 0.001 each).Conclusions: Neither the traditional risk factors included in the FRS nor a genetic risk score (GRS) based on established common risk alleles explained the higher CAD prevalence in Scotland. However, we observed marked differences in the distribution of individual risk alleles, which emphasizes that even geographically and ethnically closely related populations may display relevant differences in the genetic architecture of a common disease. [ABSTRACT FROM AUTHOR]

Background: Access to high-quality palliative care is inadequate for most people living and dying with serious illness. Policies aimed at optimising delivery of palliative and end of life care are an important mechanism to improve quality of care for the dying. The extent to which palliative care is included in national health policies is unknown. We aimed to identify priorities and opportunities for palliative and end of life care in national health policies in the UK. Methods: Documentary analysis consisting of 1) summative content analysis to describe the extent to which palliative and end of life care is referred to and/or prioritised in national health and social care policies, and 2) thematic analysis to explore health policy priorities that are opportunities to widen access to palliative and end of life care for people with serious illness. Relevant national policy documents were identified through web searches of key government and other organisations, and through expert consultation. Documents included were UK-wide or devolved (i.e. England, Scotland, Northern Ireland, Wales), health and social care government strategies published from 2010 onwards. Results: Fifteen policy documents were included in the final analysis. Twelve referred to palliative or end of life care, but details about what should improve, or mechanisms to achieve this, were sparse. Policy priorities that are opportunities to widen palliative and end of life care access comprised three inter-related themes: (1) integrated care – conceptualised as reorganisation of services as a way to enable improvement; (2) personalised care – conceptualised as allowing people to shape and manage their own care; and (3) support for unpaid carers – conceptualised as enabling unpaid carers to live a more independent lifestyle and balance caring with their own needs. Conclusions: Although information on palliative and end of life care in UK health and social care policies was sparse, improving palliative care may provide an evidence-based approach to achieve the stated policy priorities of integrated care, personalised care, and support for unpaid carers. Aligning existing evidence of the benefits of palliative care with the three priorities identified may be an effective mechanism to both strengthen policy and improve care for people who are dying. [ABSTRACT FROM AUTHOR]

Background: Outcomes following myocardial infarction (MI) are improved by uptake and maintenance of physical activity (PA), but little is understood regarding patients experience of maintaining an active lifestyle once immediate support, such as cardiac-rehabilitation (CR), has ended.Aim: The purpose of this study was to investigate MI survivors' attitude and appraisal towards PA and the perceived barriers, motivators and facilitators for maintaining PA long-term.Methods: Semi-structured interviews were carried out with 18 adults (mean age 60.5, range 37-73 years) from England and Scotland, who were a minimum of 5 months post-MI (mean 29 months, range 5-122 months). There were comparatively more male participants (n = 13, 72 %) than female (n = 5, 28 %). Overall 12 (67 %) participants had attended CR. The interviews were transcribed verbatim and thematic analysis was performed using qualitative data analysis software NVivo.Results: Data analysis indicated that the following four core themes influenced MI survivors' behaviour and attitude towards PA: (1) MI as a teachable moment for behaviour change, (2) affective response to MI: enjoyment versus fear, (3) cognitive response to MI: self-perception, attitude and self-efficacy, and (4) access to support and resources, including PA facilities and social support. Participants highlighted a lack of available guidance on maintaining PA behaviour change following CR and that advice on the frequency and intensity of exercise to follow was often unclear and confusing. Feelings of vulnerability and fear of overexertion were apparent, affecting participants self-efficacy to exercise.Conclusions: Current CR programmes fail to address PA belief systems and perceptions of self-efficacy to exercise. Interventions that address feelings of vulnerability and fear of overexertion may be beneficial. Providing ongoing PA advice and access to social support may facilitate patients to maintain changes in PA. [ABSTRACT FROM AUTHOR]

Background: Palliative care day services provide a safe environment for people with palliative care needs, enabling them to access a range of services while acting as a respite services for family caregivers. Viewed as marginal services, they are often under resourced and under researched. The aim of this study was to understand how palliative day care services contribute to client care from the perspective of management and hospice multidisciplinary teams. Methods: A descriptive qualitative study, using six focus groups conducted with staff at three United Kingdom hospices in England, Scotland and Northern Ireland. Thirty-five participants were recruited, including management and staff. Discussions were transcribed and analysed thematically. Results: Four key themes emerged: (1) variations of care, beyond heterogeneity of patients; (2) unclear referrals and inconsistent patient population; (3) recognising strengths and challenges and (4) an uncertain future. A major focus of group discussions was the model of care and the benefits of the service, however the importance of demonstrating services' effectiveness and value for money was highlighted. Conclusions: Management and hospice staff believed day-services to be a helpful introduction to palliative care, providing both social and medical support. Economic pressures and patient demand were influencing them to move from a social model to a hybrid model. Further research is needed to understand the effectiveness of the service. [ABSTRACT FROM AUTHOR]

Background: Palliative Care Day Services (PCDS) offer supportive care to people with advanced, progressive illness who may be approaching the end of life. Despite the growth of PCDS in recent years, evidence of their costs and effects is scarce. It is important to establish the value of such services so that health and care decision-makers can make evidence-based resource allocation decisions. This study examines and estimates the costs and effects of PCDS with different service configurations in three centres across the UK in England, Scotland and Northern Ireland. Methods: People who had been referred to PCDS were recruited between June 2017 and September 2018. A pragmatic before-and-after descriptive cohort study design analysed data on costs and outcomes. Data on costs were collected on health and care use in the 4 weeks preceding PCDS attendance using adapted versions of the Client Service Receipt Inventory (CSRI). Outcomes, cost per attendee/day and volunteer contribution to PCDS were also estimated. Outcomes included quality of life (MQOL-E), health status (EQ-5D-5L) and capability wellbeing (ICECAP-SCM). Results: Thirty-eight attendees were recruited and provided data at baseline and 4 weeks (centre 1: n = 8; centre 2: n = 8, centre 3: n = 22). The cost per attendee/day ranged from £121–£190 (excluding volunteer contribution) to £172–£264 (including volunteer contribution) across the three sites. Volunteering constituted between 28 and 38% of the total cost of PCDS provision. There was no significant mean change at 4 week follow-up from baseline for health and care costs (centre 1: £570, centre 2: -£1127, centre 3: £65), or outcomes: MQOL-E (centre 1: − 0.48, centre 2: 0.01, centre 3: 0.24); EQ-5D-5L (centre 1: 0.05, centre 2: 0.03, centre 3: − 0.03) and ICECAP-SCM (centre 1:0.00, centre 2: − 0.01, centre 3: 0.03). Centre costs variation is almost double per attendee when attendance rates are held constant in scenario analysis. Conclusions: This study highlights the contribution made by volunteers to PCDS provision. There is insufficient evidence on whether outcomes improved, or costs were reduced, in the three different service configurations for PCDS. We suggest how future research may overcome some of the challenges we encountered, to better address questions of cost-effectiveness in PCDS. [ABSTRACT FROM AUTHOR]

Background: Scotland has disproportionately high rates of suicide compared with England. An analysis of trends may help reveal whether rates appear driven more by birth cohort, period or age. A 'birth cohort effect' for England & Wales has been previously reported by Gunnell et al. (B J Psych 182:164-70, 2003). This study replicates this analysis for Scotland, makes comparisons between the countries, and provides information on 'vulnerable' cohorts.Methods: Suicide and corresponding general population data were obtained from the National Records of Scotland, 1950 to 2014. Age and gender specific mortality rates were estimated. Age, period and cohort patterns were explored graphically by trend analysis.Results: A pattern was found whereby successive male birth cohorts born after 1940 experienced higher suicide rates, in increasingly younger age groups, echoing findings reported for England & Wales. Young men (aged 20-39) were found to have a marked and statistically significant increase in suicide between those in the 1960 and 1965 birth cohorts. The 1965 cohort peaked in suicide rate aged 35-39, and the subsequent 1970 cohort peaked even younger, aged 25-29; it is possible that these 1965 and 1970 cohorts are at greater mass vulnerability to suicide than earlier cohorts. This was reflected in data for England & Wales, but to a lesser extent. Suicide rates associated with male birth cohorts subsequent to 1975 were less severe, and not statistically significantly different from earlier cohorts, suggestive of an amelioration of any possible influential 'cohort' effect. Scottish female suicide rates for all age groups converged and stabilised over time. Women have not been as affected as men, with less variation in patterns by different birth cohorts and with a much less convincing corresponding pattern suggestive of a 'cohort' effect.Conclusions: Trend analysis is useful in identifying 'vulnerable' cohorts, providing opportunities to develop suicide prevention strategies addressing these cohorts as they age. [ABSTRACT FROM AUTHOR]

Background: Links between participating in unhealthy behaviours, e.g. smoking, and an increased risk of developing some cancers are well established. Unemployed adults are more likely to participate in cancer-related health behaviours than their employed counterparts. However, evidence of whether this is true in young adults not in education, employment or training (NEET) compared to their 'non-NEET' peers is either limited or inconclusive. Using cross-sectional health data from across the UK, this study aims to investigate whether participation in cancer-related health behaviours varies by NEET status.Methods: Data for 16-24 year olds were extracted from the 2010-12 Health Surveys for England (HSE) and Scottish Health Surveys (SHeS). Information on economic activity in the last week was used to determine NEET status. Data on whether respondents had been seeking employment within the last four weeks and availability to start within the next two weeks allowed NEETs to be further identified as unemployed (UE) or economically inactive (EI). Logistic regression modelled the effect of being NEET on odds of being a current smoker; heavy drinker; not participating in sport; having eaten less than five portions of fruit or vegetables the day before survey interview and having an unhealthy body mass index (BMI). Analyses were performed before and after exclusion of EI NEETs.Results: Data were extracted for 4272 individuals, of which 715 (17%) were defined as NEET with 371 (52%) and 342 (48%) further classified as UE and EI respectively. Two NEETs could not be further defined as UE or EI due to missing information. Relative to non-NEETs, NEETs were significantly more likely to be current smokers, not participate in sport and have an 'unhealthy' BMI. These results held after adjustment for socio-demographic characteristics both before and after exclusion of EI NEETs. Before exclusion of EI NEETs, NEETs were significantly less likely to be heavy drinkers than non-NEETs. There was no significant difference in likelihood of heavy drinking between NEETs and non-NEETs when excluding EI NEETs.Conclusions: NEETs were generally at an increased risk of participating in cancer-related health behaviours than non-NEETs. As the likelihood of becoming NEET is greater in socioeconomically-disadvantaged groups, interventions to discourage unhealthy behaviours in NEETs may contribute to a reduction in health inequalities. [ABSTRACT FROM AUTHOR]

Background: Increasing evidence suggests that postnatal paternal depression is associated with adverse emotional, behavioural and cognitive outcomes in children. Despite this, few studies have determined the prevalence of fathers' depressive symptoms during the first few years of their children's lives and explored what factors are related to these symptoms. We estimated the prevalence and examined associated risk factors of paternal depressive symptoms in a nationally representative sample of fathers with children aged between 9 months and 7 years old from the Millennium cohort study. The risk factors examined were maternal depressive symptoms, marital conflict, child temperament, child gender, paternal education, fathers' ethnic background, fathers' employment status, family housing, family income and paternal age.Methods: Secondary data analysis was conducted using the UK Millennium cohort study, which consisted of data from England, Scotland, Wales and Northern Ireland of families with infants born in the year 2000/2001. Data from four sweeps were used from when children in the cohort were aged 9 months, 3, 5 and 7 years old (n = 5155-12,396).Results: The prevalence of paternal depressive symptoms over time was 3.6 % at 9 months, 1.2 % at 3 years old, 1.8 % at 5 years and 2.0 % at 7 years (using Kessler cut-off points to categorise high depressive symptoms vs low depressive symptoms). Linear regression trends (using continuous measures of depressive symptoms) indicated that both paternal and maternal depressive symptoms decreased over time, suggesting similar patterns of parents' depressive symptoms after the birth of a child, but the decrease was more evident for mothers. Paternal depressive symptoms were consistently associated with fathers' unemployment, maternal depressive symptoms and marital conflict. Socioeconomic factors such as rented housing when child was 9 months and low family income when child was 5 and 7 years were also associated with higher paternal depressive symptoms.Conclusions: Paternal depressive symptoms decreased among fathers when their children were aged between 9 months to 3 years old. Paternal unemployment, high maternal depressive symptoms and high marital conflict were important risk factors for paternal depressive symptoms. In light of our findings, we would recommend a more family centred approach to interventions for depression in the postnatal period. [ABSTRACT FROM AUTHOR]

Background: Despite improving evidence-based practice following clinical guidelines to optimise drug therapy, Type 2 diabetes (T2DM) still exerts a devastating toll from vascular complications and premature death. Biochemical remission of T2DM has been demonstrated with weight loss around 15kg following bariatric surgery and in several small studies of non-surgical energy-restriction treatments. The non-surgical Counterweight-Plus programme, running in Primary Care where obesity and T2DM are routinely managed, produces >15 kg weight loss in 33 % of all enrolled patients. The Diabetes UK-funded Counterpoint study suggested that this should be sufficient to reverse T2DM by removing ectopic fat in liver and pancreas, restoring first-phase insulin secretion. The Diabetes Remission Clinical Trial (DiRECT) was designed to determine whether a structured, intensive, weight management programme, delivered in a routine Primary Care setting, is a viable treatment for achieving durable normoglycaemia. Other aims are to understand the mechanistic basis of remission and to identify psychological predictors of response. Methods/Design: Cluster-randomised design with GP practice as the unit of randomisation: 280 participants from around 30 practices in Scotland and England will be allocated either to continue usual guideline-based care or to add the Counterweight-Plus weight management programme, which includes primary care nurse or dietitian delivery of 12-20weeks low calorie diet replacement, food reintroduction, and long-term weight loss maintenance. Main inclusion criteria: men and women aged 20-65years, all ethnicities, T2DM 0-6years duration, BMI 27-45 kg/m². Tyneside participants will undergo Magnetic Resonance (MR) studies of pancreatic and hepatic fat, and metabolic studies to determine mechanisms underlying T2DM remission. Co-primary endpoints: weight reduction ≥15 kg and HbA1c <48 mmol/mol at one year. Further follow-up at 2 years. Discussion: This study will establish whether a structured weight management programme, delivered in Primary Care by practice nurses or dietitians, is a viable treatment to achieve T2DM remission. Results, available from 2018 onwards, will inform future service strategy. Trial registration: Current Controlled Trials ISRCTN03267836. Date of Registration 20/12/2013 [ABSTRACT FROM AUTHOR]

The article presents information on a study which focuses on the role of parents as a care-giver for managing children's long-term kidney conditions at home. The mixed-method study is designed to use multidisciplinary teams for promoting parents' learning about care-delivery and monitoring care-giving. A combination of quantitative and qualitative methods will be used in the study involving the twelve children's kidney units in England, Scotland and Wales.

Background: Caesarean section rates have risen over the last 20 years. Elective Caesarean section rates have been shown to be linked to area deprivation in England, women in the most deprived areas were less likely to have an elective section than those in the most affluent areas. We examine whether individual social class, area deprivation or both are related to Caesarean sections in Scotland and investigate changes over time. Methods: Routine maternity discharge data from live singleton births in Scottish hospitals from three time periods were used; 1980-81 (n = 133,555), 1990-91 (n = 128,933) and 1999-2000 (n = 102,285). Multilevel logistic regression, with 3 levels (births, postcode sector and Health Board) was used to analyse emergency and elective Caesareans separately; analysis was further stratified by previous Caesarean section. The relative index of inequality (RII) was used to assess socioeconomic inequalities. Results: Between 1980-81 and 1999-2000 the emergency section rate increased from 6.3% to 11.9% and the elective rate from 3.6% to 5.5%. In 1980-81 and 1990-91 emergency Caesareans were more likely among women at the bottom of the social class hierarchy compared to those at the top (RII = 1.14, 95%CI 1.00-1.25 and RII = 1.13, 1.03-1.23 respectively) and also among women in the most deprived areas compared to those in the most affluent (RII = 1.18, 1.05-1.32 and RII = 1.13, 1.02-1.26 respectively). In 1999-2000 the odds of an elective section were lower for women at the bottom of the social class hierarchy than those at the top (RII = 0.87, 0.76-1.00) and also lower in women in the most deprived areas compared to those in the most affluent (RII = 0.85, 0.73-0.99). Conclusions: Both individual social class and area deprivation are independently associated with Caesarean sections in Scotland. The tendency for disadvantaged women to be more likely to receive emergency sections disappeared at the same time as the likelihood of advantaged groups receiving elective sections increased. [ABSTRACT FROM AUTHOR]

Background: Understanding and measuring mental health and wellbeing amongst teenagers has recently become a priority. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS) is validated for measuring mental wellbeing in populations aged 16 years and over in the UK. We report here a study designed to establish the validity and reliability of WEMWBS in teenagers in the UK. Methods: WEMWBS and comparator scales, together with socio-demographic information and self-reported health, were incorporated into a self-administered questionnaire given to pupils aged 13 to 16 years in six schools in Scotland and England. Psychometric properties including internal consistency, correlations with comparator scales, test-retest stability and unidimensionality were investigated for WEMWBS. Twelve focus groups were undertaken to assess acceptability and comprehensibility of WEMWBS and were taped, transcribed and analysed thematically. Results: A total of 1,650 teenagers completed the questionnaire (response rate 80.8%). Mean WEMWBS score was 48.8 (SD 6.8; median 49). Response scores covered the full range (from 14 to 70). WEMWBS demonstrated strong internal consistency and a high Cronbach's alpha of 0.87 (95% CI (0.85-0.88), n = 1517). Measures of construct validity gave values as predicted. The correlation coefficient for WEMWBS total score and psychological wellbeing domain of the Kidscreen-27 was 0.59 (95% CI [0.55; 0.62]); for the Mental Health Continuum Short Form (MHC-SF) was 0.65, 95% CI [0.62; 0.69]; and for the WHO (WHO-5) Well-being Index 0.57 (95% CI [0.53; 0.61]). The correlation coefficient for the Strengths and Difficulties Questionnaire (SDQ) was -0.44 (95% CI [-0.49; -0.40]) and for the 12-item General Health Questionnaire (GHQ12) -0.45 (95% CI [-0.49; -0.40]). Test-retest reliability was acceptable (Intraclass correlation coefficient (ICC) 0.66 (95% CI [0.59; 0.72] n = 212)). Confirmatory factor analysis demonstrated one underlying factor. WEMWBS was significantly associated with the Family Affluence Score (WEMWBS increased with increasing household socio-economic status) and had a positive association with the physical health dimension of the Kidscreen-27, but was unrelated to age, gender or location/school. Eighty students took part in focus groups. In general, although some students considered some items open to misunderstanding or misinterpretation, WEMWBS was received positively and was considered comprehensible, and acceptable. Conclusions: WEMWBS is a psychometrically strong population measure of mental wellbeing, and can be used for this purpose in teenagers aged 13 and over. [ABSTRACT FROM AUTHOR]

Background: Given that treatments for chronic lymphocytic leukaemia (CLL) are palliative rather than curative, evaluating the patient-perceived impacts of therapy is critical. To date, no utility (preference) studies from the general public or patient perspective have been conducted in CLL. The objective of this study was to measure preferences for health states associated with CLL treatment. Methods: This was a cross-sectional study of 89 members of the general population in the UK (England and Scotland). Using standard gamble, each participant valued four health states describing response status, six describing treatmentrelated toxicities based on Common Toxicity Criteria, and two describing line of treatment. The health states incorporated standardized descriptions of treatment response (symptoms have "improved," "stabilized," or "gotten worse"), swollen glands, impact on daily activities, fatigue, appetite, and night sweats. Utility estimates ranged from 0.0, reflecting dead, to 1.0, reflecting full health. Results: Complete response (CR) was the most preferred health state (mean utility, 0.91), followed by partial response (PR), 0.84; no change (NC), 0.78; and progressive disease (PD), 0.68. Among the toxicity states, grade I/II nausea and nausea/vomiting had the smallest utility decrements (both were -0.05), and grade III/IV pneumonia had the greatest decrement (-0.20). The utility decrements obtained for toxicity states can be subtracted from utilities for CR, PR, NC, and PD, as appropriate. The utilities for second- and third-line treatments, which are attempted when symptoms worsen, were 0.71 and 0.65, respectively. No significant differences in utilities were observed by age, sex, or knowledge/ experience with leukaemia. Conclusions: This study reports UK population utilities for a universal set of CLL health states that incorporate intended treatment response and unintended toxicities. These utilities can be applied in future cost-effectiveness analyses of CLL treatment. [ABSTRACT FROM AUTHOR]

Background: Health professionals, policy-makers and researchers need to be able to explore potential associations between prevalence rates and quality of care with a range of possible determinants including socioeconomic deprivation and morbidity levels to determine the impact of commissioning and service delivery. In the UK, data in England are only available nationally at practice postcode level. In Scotland, such data are available based on an aggregate of the practices population's postcodes. The use of data assigned to the practice postcode may underestimate the association between ill health and income deprivation. Here, we report on the impact of using data assigned to the practice population by comparing analyses using English and Scottish data. Results: Income deprivation based on data assigned to the practice postcode under-estimated deprivation compared to using income deprivation data assigned to the practice population for the five least deprived deciles, and over-estimated deprivation for the five most deprived deciles. The biggest differences were found for the most deprived decile. A similar trend was found for limiting long-term illness (LLTI). Differences between the QOF prevalence rates of the least and most deprived deciles using practice postcode data were similar (0.2% points or less) in England and Scotland for 8 out of 10 clinical domains. Using practice population assigned deprivation, differences in the prevalence rate between the least and most deprived deciles increase for all clinical domains. A similar trend was again found for LLTI. Using practice population assigned deprivation, differences for population achievement increase for all CHD quality indicators with the exception of beta-blockers (CHD10). With practice postcode assigned deprivation, significant differences between the least and most deprived deciles were found for 2 out 8 indicators, compared to 5 using practice population assigned deprivation. For LLTI differences between the lowest and most deprived deciles increased for all indicators when ill health assigned to the practice population was used. Conclusion: We have found, through comparing deprivation and ill health data assigned to either the practice postcode or the practice population postcode in Scotland, that analyses based on practice postcode assigned data under-estimated the relationship between deprivation and ill health for both prevalence and quality care. Given the importance of understanding the effect of deprivation and ill health on a range of determinants related to health care, policy makers should ensure that practice population data are available and used at national level in England and elsewhere where possible. [ABSTRACT FROM AUTHOR]

Background: Prior to using a generic patient-reported outcome measure (PRO), the measure should be validated within the target population. The purpose of the current study was to validate two generic measures in patients with type 2 diabetes. Methods: Patients with type 2 diabetes in Scotland and England completed two generic measures: EQ-5D and Psychological General Well-Being Index (PGWB). Two diabetes-specific measures were administered: ADS and DSC-R. Analyses assessed reliability and validity. Results: There were 130 participants (53 Scotland; 77 England; 64% male; mean age = 55.7 years). Responses on the EQ-5D and PGWB reflected moderate impairment consistent with previous diabetes samples: mean EQ-5D Index score, 0.75; EQ-5D VAS, 68.8; PGWB global score, 67.9. All scales of the PGWB demonstrated good internal consistency reliability (Cronbach's alpha = 0.77 to 0.97). The EQ-5D and PGWB demonstrated convergent validity through significant correlations with the ADS (r = 0.48 to 0.61), DSC-R scales (r = 0.33 to 0.81 except ophthalmology subscale), and Body Mass Index (r = 0.15 to 0.38). The EQ-5D and PGWB discriminated between groups of patients known to differ in diabetes-related characteristics (e.g., history of hypoglycemia). Conclusion: Results support the use of the EQ-5D and PGWB among patients with type 2 diabetes, possibly in combination with condition-specific measures. [ABSTRACT FROM AUTHOR]

Background: Contact centres are one of the most sedentary workplaces, with employees spending a very high proportion of their working day sitting down. About a quarter of contact centre staff regularly experience musculoskeletal health problems due to high levels of sedentary behaviour, including lower back pain. There have been no previous randomised studies specifically aiming to reduce sedentary behaviour in contact centre staff. To address this gap, the Stand Up for Health (SUH) study aims to test the feasibility and acceptability of a complex theory-based intervention to reduce sedentary behaviour in contact centres. Methods: The Stand Up for Health study has a stepped wedge cluster randomised trial design, which is a pragmatic design whereby clusters (contact centres) are randomised to time points at which they will begin to receive the intervention. All contact centre staff have the opportunity to experience the intervention. To minimise the resource burden in this feasibility study, data collection is not continuous, but undertaken on a selective number of occasions, so the stepped wedge design is "incomplete". Eleven contact centres in England and Scotland have been recruited, and the sample size is approximately 27 per centre (270 in total). The statistical analysis will predominantly focus on assessing feasibility, including the calculation of recruitment rates and rates of attrition. Exploratory analysis will be performed to compare objectively measured sedentary time in the workplace (measured using an activPAL™ device) between intervention and control conditions using a linear mixed effects regression model. Discussion: To our knowledge, this is the first stepped wedge feasibility study conducted in call centres. The rationale and justification of our novel staircase stepped wedge design has been presented, and we hope that by presenting our study design and statistical analysis plan, it will contribute to the literature on stepped wedge trials, and in particular feasibility stepped wedge trials. The findings of the study will also help inform whether this is a suitable design for other settings where data collection is challenging. Trial registration: The trial has been registered on the ISRCTN database: http://www.isrctn.com/ISRCTN11580369 [ABSTRACT FROM AUTHOR]

Background: There is a worldwide shortage of donor organs for transplantation. To overcome this, several countries have introduced an opt-out donor consent system. This system, soon planned for Scotland and England means individuals are automatically deemed to consent for organ donation unless they register an opt-out decision. This study was designed to explore the reasons underpinning donor choices for people who plan to actively opt-in to the register, take no action and be on the register via deemed consent, opt-out, and those who are unsure of their decision.Methods: This study reports the analysis of free-text responses obtained from a large survey of intentions towards opt-out legislation in Scotland, England and Northern Ireland (n = 1202). Of the n = 1202 participants who completed the questionnaire, n = 923 provided a free text response explaining their views. Thematic analysis was used to explore the reasons why participants plan to: opt-in (n = 646), follow deemed consent (n = 205), opt-out (n = 32) and those who were not sure (n = 40).Results: A key theme for people planning to opt-in is that it ensures one's donor choice is explicitly clear and unequivocal. Some regarded deemed consent as unclear and open to ambiguity, thus actively opting-in was viewed as a way of protecting against family uncertainty and interference. For the deemed consent group, a key theme is that it represents a simple effortless choice. This is important from both a pragmatic time-saving point of view and because it protects ambivalent participants from making a challenging emotive choice about organ donation. Key themes for those planning to opt-out relate to fears around medical mistrust and bodily integrity. Notably, both participants who plan to opt-out and opt-in perceived presumed consent as "authoritarian" and a method of increasing Government control of organs. In response, registering an active decision protected their freedom of choice.Conclusions: The findings highlight the importance of registering deliberate active consent for people who choose opt-in, due to concerns over possible family refusal under deemed consent. These findings could inform the development of communication campaigns that encourage family communication before the implementation of opt-out legislation. [ABSTRACT FROM AUTHOR]

Background: Cancer affects millions of individuals globally, with a mortality rate of over eight million people annually. Although palliative care is often provided outside of specialist services, many people require, at some point in their illness journey, support from specialist palliative care services, for example, those provided in hospice settings. This transition can be a time of uncertainty and fear, and there is a need for effective interventions to meet the psychological and supportive care needs of people with cancer that cannot be cured. Whilst Acceptance and Commitment Therapy (ACT) has been shown to be effective across diverse health problems, robust evidence for its effectiveness in palliative cancer populations is not extensive. Method: This mixed-methods study uses a single-case experimental design with embedded qualitative interviews to pilot test a novel intervention for this patient group. Between 14 and 20 patients will be recruited from two hospices in England and Scotland. Participants will receive five face-to-face manualised sessions with a psychological therapist. Sessions are structured around teaching core ACT skills (openness, awareness and engagement) as a way to deal effectively with challenges of transition into specialist palliative care services. Outcome measures include cancer-specific quality of life (primary outcome) and distress (secondary outcome), which are assessed alongside measures of psychological flexibility. Daily diary outcome assessments will be taken for key measures, alongside more detailed weekly self-report, through baseline, intervention and 1-month follow-up phases. After follow-up, participants will be invited to take part in a qualitative interview to understand their experience of taking part and acceptability and perceived effectiveness of the intervention and its components. Discussion: This study is the first investigation of using ACT with terminally ill patients at the beginning of their transition into palliative treatment. Using in-depth single-case approaches, we will refine and manualise intervention content by the close of the study for use in follow-up research trials. Our long-term goal is then to test the intervention as delivered by non-psychologist specialist palliative care practitioners thus broadening the potential relevance of the approach. Trial registration: Open Science Framework, 46033. Registered 19 April 2018. [ABSTRACT FROM AUTHOR]

Background: Almost one-half of 12-15 year olds living in deprived areas of the UK have dental caries (tooth decay) with few oral health promotion programmes aimed at children of this age. Mobile phone-based interventions such as short messaging service (SMS) interventions have been found effective at changing certain behaviours and improving health outcomes. This protocol describes the BRIGHT Trial, investigating the clinical and cost-effectiveness of a behaviour change intervention-classroom-based session (CBS) embedded in the curriculum and a series of SMS delivered to participants twice daily to remind them to brush their teeth, compared to usual curriculum and no SMS-to reduce the prevalence of dental caries in young people from deprived areas.Objectives: To investigate the clinical and cost-effectiveness of a complex intervention to improve the oral health of young people living in deprived areas.Methods/design: This is a school-based, assessor-blinded, two-arm cluster-randomised controlled trial with an internal pilot trial. Overall, the trial will involve approximately 5040 11-13 year olds in 42 schools with a 3-year follow-up. The trial will take place in secondary schools in England, Scotland and Wales. The primary outcome is the presence of carious lesions in permanent teeth at 3 years. Secondary outcomes are: number of carious teeth, frequency of twice-daily toothbrushing, plaque levels, gingivitis, child health-related quality of life and oral health-related quality of life. A cost-utility analysis will be conducted.Discussion: The findings of the trial have implications for embedding oral health interventions into school curricula guidance produced by national bodies, including departments for education and dental public health and guideline-development organisations.Trial Registration: ISRCTN registry, ISRCTN12139369 . Registered on 10 May 2017. [ABSTRACT FROM AUTHOR]

Background: While people who are homeless often experience poor mental and physical health and problem substance use, getting access to appropriate services can be challenging. The development of trusting relationships with non-judgemental staff can facilitate initial and sustained engagement with health and wider support services. Peer-delivered approaches seem to have particular promise, but there is limited evidence regarding peer interventions that are both acceptable to, and effective for, people who are homeless and using drugs and/or alcohol. In the proposed study, we will develop and test the use of a peer-to-peer relational intervention with people experiencing homelessness. Drawing on the concept of psychologically informed environments, it will focus on building trusting and supportive relationships and providing practical elements of support such as access to primary care, treatment and housing options. Methods: A mixed-method feasibility study with concurrent process evaluation will be conducted to explore the feasibility and acceptability of a peer-delivered, relational intervention for people with problem substance use who are homeless. Peer Navigators will be based in homelessness outreach and residential services in Scotland and England. Peer Navigators will work with a small number of participants for up to 12 months providing both practical and emotional support. The sample size for the intervention is 60. Those receiving the intervention must be currently homeless or at risk of homelessness, over the age of 18 years and self-report alcohol/drug problems. A holistic health check will be conducted in the first few months of the intervention and repeated towards the end. Health checks will be conducted by a researcher in the service where the Peer Navigator is based. Semi-structured qualitative interviews with intervention participants and staff in both intervention and standard care settings, and all Peer Navigators, will be conducted to explore their experiences with the intervention. Non-participant observation will be conducted in intervention and standard care sites to document similarities and differences between care pathways. Discussion: The SHARPS study will provide evidence regarding whether a peer-delivered harm reduction intervention is feasible and acceptable to people experiencing homelessness and problem substance use in order to develop a definitive trial. Trial registration: SRCTN registry ISRCTN15900054, protocol version 1.3, March 12, 2018 [ABSTRACT FROM AUTHOR]

Background: The percentages of children in Scotland and England meeting the aerobic physical activity (PA) recommendation differ greatly according to estimates derived from the respective national health surveys. The Scottish Health Survey (SHeS) usually estimates over 70% meeting the recommendation; Health Survey for England (HSE) estimates are usually below 25%. It is plausible that these differences originate from different analysis methods. The HSE monitors the percentage of children in England that undertake 60 min of moderate-to-vigorous PA on each day of the week ('Daily Minimum Method' (DMM)). The SHeS monitors the proportion that undertakes at least seven sessions of moderate-to-vigorous PA, with an average daily duration ≥60 min in Scotland ('Weekly Average Method' (WAM)). We aimed to establish how much this difference in analysis methods influences prevalence estimates.Methods: PA data from 5 to 15 year olds in the 2015 HSE and SHeS were reanalysed (weighted n = 3840 and 965, respectively). Two comparable pairs of estimates were derived: a DMM and WAM estimate from the HSE not including travel to/from school, and WAM estimates from the HSE and the SHeS including travel to/from school. It is not possible to calculate a DMM estimate from the SHeS due to questionnaire design. Results were presented for the total samples, and by sex and age sub-groups.Results: The HSE WAM estimate was 31.7 (95% CI: 30.2-33.3) percentage points higher than the DMM estimate (54.3% (95% CI: 52.6-56.0) and 22.6% (95% CI: 21.2-24.1) respectively). The magnitude of this difference differed by age group but not sex. When comparable WAM estimates were derived from the SHeS and the HSE, the SHeS was 11.8 percentage points higher (73.6% (95% CI: 69.8-77.1) and 61.8% (95% CI: 60.2-63.5) respectively). The magnitude of this difference differed by age group and sex.Conclusions: The results indicate that the difference in the analysis method explains the majority (approximately 30 percentage points) of the difference in the child PA prevalence estimates between Scotland and England (leaving approximately 12 percentage points representing true differences or related to questionnaire differences). These results will help national surveillance determine how to increase comparability between the U.K. home nations. [ABSTRACT FROM AUTHOR]

Background: Health policy in the UK has rapidly diverged since devolution in 1999. However, there is relatively little comparative data available to examine the impact of this natural experiment in the four UK countries. The Quality and Outcomes Framework of the 2004 General Medical Services Contract provides a new and potentially rich source of comparable clinical quality data through which we compare quality of primary medical care for coronary heart disease (CHD), stroke, hypertension and diabetes across the four UK countries.Methods: A cross-sectional analysis was undertaken involving 10,064 general practices in England, Scotland, Wales and Northern Ireland. The main outcome measures were prevalence rates for CHD, stroke, hypertension and diabetes. Achievement on 14 simple process, 3 complex process, 9 intermediate outcome and 5 treatment indicators for the four clinical areas.Results: Prevalence varies by up to 28% between the four UK countries, which is not reflected in resource distribution between countries, and penalises practices in the high prevalence countries (Wales and Scotland). Differences in simple process measures across countries are small. Larger differences are found for complex process, intermediate outcome and treatment measures, most notably for Wales, which has consistently lower quality of care. Scotland has generally higher quality than England and Northern Ireland is most consistently the highest quality.Conclusion: Previously identified weaknesses in Wales related to waiting times appear to reflect a more general quality problem within NHS Wales. Identifying explanations for the observed differences is limited by the lack of comparable data on practice resources and organisation. Maximising the value of cross-jurisdictional comparisons of the ongoing natural experiment of health policy divergence within the UK requires more detailed examination of resource and organisational differences. [ABSTRACT FROM AUTHOR]

Background: New medicines are increasingly being identified as efficacious across multiple indications. The impact of current pricing and reimbursement policies on launch decisions across these indications remains unclear., Objective: This paper, first, maps marketing authorisation and HTA coverage recommendation sequences of multi-indication medicines across Germany, France, England, Scotland, Canada, Australia, and the USA, and, second, evaluates the clinical characteristics, clinical development time and coverage recommendation time of multi-indication medicines, drawing comparisons between the first and subsequent indications of an approved molecule., Methods: Medicine approvals by the Food and Drug Administration between 2009-2019 were screened to identify multi-indication products with approved oncology indications. Data on clinical trial characteristics, clinical performance and HTA outcomes were extracted from publicly available regulatory approval and HTA reports., Results: Relative to subsequent indications, first indications were more likely to receive conditional marketing authorisation, have an orphan designation, have a single arm phase II pivotal trial and lower MCBS score. Subsequent indications had faster HTA coverage recommendation times in England and Canada. While the majority of first indications received HTA coverage recommendations across all settings, the proportion of subsequent indications with HTA coverage recommendations was lower and uptake varied considerably across settings., Conclusions: Discordance in the value of first versus subsequent indications can pose major challenges in systems that define price based on the initial indication. Current pricing and reimbursement systems generate significant fragmentation in the approval and availability of multi-indication products across settings., (© 2023. The Author(s).)

Background: The perspectives and experiences of trial staff are increasingly being investigated as these can be used to improve recruitment, adherence to trial protocols and support given to future staff. We interviewed staff working on a type 1 diabetes trial in order to aid interpretation of trial findings, inform recommendations for the rollout of the treatments investigated and provide recommendations for the conduct of future trials. However, our interviews uncovered aspects of trial work erstwhile unrecognised or underreported in the trials literature, and it is these which form the focus of this paper., Methods: In-depth interviews were conducted with (n = 18) staff, recruited from seven centres, who were involved in recruitment and trial delivery. Data were analysed thematically., Results: Alongside logistical and practical issues which made trial work challenging, staff often talked spontaneously and at length about how trial work had affected them emotionally. Staff not only described the emotional stresses arising from having to meet recruitment targets and from balancing research roles with clinical responsibilities, they also discussed having to emotionally manage patients and their colleagues. The emotional aspects of trial work particularly came to the fore when staff notified patients about their treatment allocation. On such occasions, staff described having to employ emotional strategies to pre-empt and manage potential patient disappointment and anger. Staff also described having to manage their own emotions when patients withdrew from the trial or were not randomised to the treatment arm which, in their clinical judgment, would have been in their best interests. To help address the emotional challenges they encountered, staff highlighted a need for more practical, emotional and specialist psychological support., Conclusions: More attention should be paid to the emotional aspects of trial work to help ensure trial staff are adequately supported. Such support could comprise: increased training for staff to improve their own and patients' understandings of randomization, role-play to develop techniques to manage patient anger and disappointment, sharing of good practice, formalised team support with psychological input and access to specialist psychological support to troubleshoot complex emotional and ethical issues.

Background: Obtaining the necessary approvals and permission for clinical research requires successful negotiation of the ethical and R&D layers of the NHS. Differences in structure and governance frameworks feature between the constituent nations of the UK (England, Scotland, Wales and Northern Ireland), which adds complexity to cross-national studies. Difficulties in carrying out research in the NHS in the UK due to bureaucratic and time-consuming governance processes have led to the development of a new system of application and co-ordination from 2009. This paper illustrates how this new system fails to be consistent and streamlined and is unlikely to become so unless changes are made to the implementation and management of the governance processes., Methods: We present a case study of the research governance process at the survey stage of an investigation into the use, preferences and need for information by people making choices or decisions about health care. The method involved home-based, face-to-face interviewing in a questionnaire survey in relation to decisions about lymphoma treatment, Down's syndrome screening in pregnancy, and caring for people with dementia., Results: Our experience of the ethics stage was very positive, noting an efficient process of application and a speedy decision, both in relation to the initial application and to subsequent substantial amendments. By contrast, the R&D stages were very slow, most with unexplained delays, but some offering contradictory advice and exhibiting a lack of clear guidance and training for NHS staff. The R&D arrangements in Scotland were far quicker and more likely to be successful than in England. Overall, the delays were so severe that substantial parts of the research could not be delivered as planned within the funding timescale., Conclusions: If high-quality research in the NHS, particularly in England, is to be delivered in a timely and cost-effective way, R&D processes for gaining research governance approval need improvement. Attention is needed in process implementation and management, particularly in relation to staff training, as well as clarity in guidance and communication within and between organisations.

Background: Scotland's overall health record is comparatively poor for a Western European country, particularly amongst people of working age. A number of previous studies have explored why this might be the case by comparing mortality in Scotland with England and Wales. A study in the 1980s showed that the higher prevalence of deprivation in Scotland accounted for Scotland's excess mortality risk. However, more recent studies suggest that deprivation now explains less of this excess. This has led to the suggestion that there is a yet unidentified "Scottish effect" contributing to Scotland's mortality excess. Recent research has also suggested that there could be an unidentified effect influencing Scotland's higher rate of heart disease. This paper explores whether there is also an unexplained Scottish excess, relative to England, in self reports of poor health., Methods: Data came from the individual Sample of Anonymised Records, a 3% random sample of the 2001 UK census. Using logistic regression models, self reports of health (limiting illness and general health) from the working age populations (aged 25 to 64) of Scotland and England were compared. Account was taken of people's country of birth. Stratified analysis by employment status allowed further exploration of Scotland's excess., Results: People born and living in Scotland reported higher levels of poor general health and limiting illness compared to people born and living in England. Adjustment for socioeconomic position and employment status largely explained the higher rates. In the stratified analysis a Scottish excess was seen only amongst the economically inactive born and living in Scotland. For those in employment, people born and living in Scotland actually had slightly lower odds of reporting poor general health and limiting illness than people born and living in England., Conclusion: This analysis suggests that higher rates of poor self reported health in Scotland can be explained by differences in employment and socioeconomic position and so there is unlikely to be an unidentified "Scottish effect" for self reports of health. Scotland's excess of poor general health and limiting illness amongst the economically inactive is probably attributable to its economic and employment history.