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Background: Ensuring fair comparisons of cancer survival statistics across population groups requires careful consideration of differential competing mortality due to other causes, and adjusting for imbalances over groups in other prognostic covariates (e.g. age). This has typically been achieved using comparisons of age-standardised net survival, with age standardisation addressing covariate imbalance, and the net estimates removing differences in competing mortality from other causes. However, these estimates lack ease of interpretability. In this paper, we motivate an alternative non-parametric approach that uses a common rate of other cause mortality across groups to give reference-adjusted estimates of the all-cause and cause-specific crude probability of death in contrast to solely reporting net survival estimates.Methods: We develop the methodology for a non-parametric equivalent of standardised and reference adjusted crude probabilities of death, building on the estimation of non-parametric crude probabilities of death. We illustrate the approach using regional comparisons of survival following a diagnosis of rectal cancer for men in England. We standardise to the covariate distribution and other cause mortality of England as a whole to offer comparability, but with close approximation to the observed all-cause region-specific mortality.Results: The approach gives comparable estimates to observed crude probabilities of death, but allows direct comparison across population groups with different covariate profiles and competing mortality patterns. In our illustrative example, we show that regional variations in survival following a diagnosis of rectal cancer persist even after accounting for the variation in deprivation, age at diagnosis and other cause mortality.Conclusions: The methodological approach of using standardised and reference adjusted metrics offers an appealing approach for future cancer survival comparison studies and routinely published cancer statistics. Our non-parametric estimation approach through the use of weighting offers the ability to estimate comparable survival estimates without the need for statistical modelling. [ABSTRACT FROM AUTHOR]

Background: This paper describes the design and development of a complex multifactorial falls prevention (MFFP) intervention for implementation and testing within the framework of a large UK-based falls prevention randomised controlled trial (RCT).Methods: A complex intervention was developed for inclusion within the Prevention of Falls Injury Trial (PreFIT), a multicentre pragmatic RCT. PreFIT aims to compare the clinical and cost-effectiveness of three alternative primary care falls prevention interventions (advice, exercise and MFFP), on outcomes of fractures and falls. Community-dwelling adults, aged 70 years and older, were recruited from primary care in the National Health Service (NHS), England.Results: Development of the PreFIT MFFP intervention was informed by the existing evidence base and clinical guidelines for the assessment and management of falls in older adults. After piloting and modification, the final MFFP intervention includes seven falls risk factors: a detailed falls history interview with consideration of 'red flags'; assessment of balance and gait; vision; medication screen; cardiac screen; feet and footwear screen and home environment assessment. This complex intervention has been fully manualised with clear, documented assessment and treatment pathways for each risk factor. Each risk factor is assessed in every trial participant referred for MFFP. Referral for assessment is based upon a screening survey to identify those with a history of falling or balance problems. Intervention delivery can be adapted to the local setting.Conclusion: This complex falls prevention intervention is currently being tested within the framework of a large clinical trial. This paper adheres to TIDieR and CONSORT recommendations for the comprehensive and explicit reporting of trial interventions. Results from the PreFIT study will be published in due course. The effectiveness and cost-effectiveness of the PreFIT MFFP intervention, compared to advice and exercise, on the prevention of falls and fractures, will be reported at the conclusion of the trial. [ABSTRACT FROM AUTHOR]

Background: Paramedics make important and increasingly complex decisions at scene about patient care. Patient safety implications of influences on decision making in the pre-hospital setting were previously under-researched. Cutting edge perspectives advocate exploring the whole system rather than individual influences on patient safety. Ethnography (the study of people and cultures) has been acknowledged as a suitable method for identifying health care issues as they occur within the natural context. In this paper we compare multiple methods used in a multi-site, qualitative study that aimed to identify system influences on decision making.Methods: The study was conducted in three NHS Ambulance Trusts in England and involved researchers from each Trust working alongside academic researchers. Exploratory interviews with key informants e.g. managers (n = 16) and document review provided contextual information. Between October 2012 and July 2013 researchers observed 34 paramedic shifts and ten paramedics provided additional accounts via audio-recorded 'digital diaries' (155 events). Three staff focus groups (total n = 21) and three service user focus groups (total n = 23) explored a range of experiences and perceptions. Data collection and analysis was carried out by academic and ambulance service researchers as well as service users. Workshops were held at each site to elicit feedback on the findings and facilitate prioritisation of issues identified.Results: The use of a multi-method qualitative approach allowed cross-validation of important issues for ambulance service staff and service users. A key factor in successful implementation of the study was establishing good working relationships with academic and ambulance service teams. Enrolling at least one research lead at each site facilitated the recruitment process as well as study progress. Active involvement with the study allowed ambulance service researchers and service users to gain a better understanding of the research process. Feedback workshops allowed stakeholders to discuss and prioritise findings as well as identify new research areas.Conclusion: Combining multiple qualitative methods with a collaborative research approach can facilitate exploration of system influences on patient safety in under-researched settings. The paper highlights empirical issues, strengths and limitations for this approach. Feedback workshops were effective for verifying findings and prioritising areas for future intervention and research. [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: The National Institute for Health and Care Excellence (NICE) recommends evidence-based parenting programmes as a first-line intervention for conduct disorders (CD) in children aged 5-11 years. As these are not effective in 25-33% of cases, NICE has requested research into second-line interventions. Child and Adolescent Psychotherapists (CAPTs) address highly complex problems where first-line treatments have failed and there have been small-scale studies of Psychoanalytic Child Psychotherapy (PCP) for CD. A feasibility trial is needed to determine whether a confirmatory trial of manualised PCP (mPCP) versus Treatment as Usual (TaU) for CD is practicable or needs refinement. The aim of this paper is to publish the abridged protocol of this feasibility trial.Methods and Design: TIGA-CUB (Trial on improving Inter-Generational Attachment for Children Undergoing Behaviour problems) is a two-arm, pragmatic, parallel-group, multicentre, individually randomised (1:1) controlled feasibility trial (target n = 60) with blinded outcome assessment (at 4 and 8 months), which aims to develop an optimum practicable protocol for a confirmatory, pragmatic, randomised controlled trial (RCT) (primary outcome: child's behaviour; secondary outcomes: parental reflective functioning and mental health, child and parent quality of life), comparing mPCP and TaU as second-line treatments for children aged 5-11 years with treatment-resistant CD and inter-generational attachment difficulties, and for their primary carers. Child-primary carer dyads will be recruited following a referral to, or re-referral within, National Health Service (NHS) Child and Adolescent Mental Health Services (CAMHS) after an unsuccessful first-line parenting intervention. PCP will be delivered by qualified CAPTs working in routine NHS clinical practice, using a trial-specific PCP manual (a brief version of established PCP clinical practice). Outcomes are: (1) feasibility of recruitment methods, (2) uptake and follow-up rates, (3) therapeutic delivery, treatment retention and attendance, intervention adherence rates, (4) follow-up data collection, and (5) statistical, health economics, process evaluation, and qualitative outcomes.Discussion: TIGA-CUB will provide important information on the feasibility and potential challenges of undertaking a confirmatory RCT to evaluate the effectiveness and cost-effectiveness of mPCP.Trial Registration: Current Controlled Trials, ID: ISRCTN86725795 . Registered on 31 May 2016. [ABSTRACT FROM AUTHOR]

Background: The Adult Social Care Outcomes Toolkit (ASCOT-SCT4) is a multi-attribute utility index designed for the evaluation of long-term social care services. The measure comprises eight attributes that capture aspects of social care-related quality of life. The instrument has previously been validated with a sample of older adults who used home care services in England. This paper aims to demonstrate the instrument's test-retest reliability and provide evidence for its validity in a diverse sample of adults who use publicly-funded, community-based social care in England.Methods: A survey of 770 social care service users was conducted in England. A subsample of 100 services users participated in a follow-up interview between 7 and 21 days after baseline. Spearman rank correlation coefficients between the ASCOT-SCT4 index score and the EQ-5D-3 L, the ICECAP-A or ICECAP-O and overall quality of life were used to assess convergent validity. Data on variables hypothesised to be related to the ASCOT-SCT4 index score, as well as rating of individual attributes, were also collected. Hypothesised relationships were tested using one-way ANOVA or Fisher's exact test. Test-retest reliability was assessed using the intra-class correlation coefficient for the ASCOT-SCT4 index score at baseline and follow-up.Results: There were moderate to strong correlations between the ASCOT-SCT4 index and EQ-5D-3 L, the ICECAP-A or ICECAP-O, and overall quality of life (all correlations ≥ 0.3). The construct validity was further supported by statistically significant hypothesised relationships between the ASCOT-SCT4 index and individual characteristics in univariate and multivariate analysis. There was also further evidence for the construct validity for the revised Food and drink and Dignity items. The test-retest reliability was considered to be good (ICC = 0.783; 95% CI: 0.678-0.857).Conclusions: The ASCOT-SCT4 index has good test-retest reliability for adults with physical or sensory disabilities who use social care services. The index score and the attributes appear to be valid for adults receiving social care for support reasons connected to underlying mental health problems, and physical or sensory disabilities. Further reliability testing with a wider sample of social care users is warranted, as is further exploration of the relationship between the ASCOT-SCT4, ICECAP-A/O and EQ-5D-3 L indices. [ABSTRACT FROM AUTHOR]

Background: We have developed a healthy lifestyles programme (HeLP) for primary school aged children (9-10 years), currently being evaluated in a definitive cluster randomised controlled trial. This paper descriptively presents the baseline characteristics of trial children (BMI, waist circumference, % body fat, diet and physical activity) by gender, cluster level socio-economic status, school size and time of recruitment into the trial.Methods: Schools were recruited from across the South West of England and allocated 1:1 to either intervention (HeLP) or control (usual practice) stratified by the proportion of children eligible for free school meals (FSM, <19%, ≥19%) and school size (one Year 5 class, >1 Year 5 class). The primary outcome is change in body mass index standard deviation score (BMI sds) at 24 months post-randomisation. Secondary outcomes are BMI sds at 18 months, waist circumference and percentage body fat sds at 18 and 24 months, proportion of children classified as underweight, overweight and obese at 18 and 24 months, physical activity (for a sub-sample) and food intake at 18 months.Results: At baseline 11.4% and 13.6% of children were categorised as overweight or obese respectively. A higher percentage of girls than boys (25.3% vs 24.8%) and children from schools in FSM category 2 (28.2% vs 23.2%) were overweight or obese. Children were consuming a mean (range) of 4.15 (0-13) energy dense snacks (EDS) and 3.23 (0-9) healthy snacks (HS) per day with children from schools in FSM category 2 consuming more EDS and negative food markers and less HS and positive food markers. Children spent an average 53.6 min per day (11.9 to 124.8) in MVPA and thirteen hours (779.3 min) per day (11 h to 15 h) doing less than 'light' intensity activity. Less than 5% of children achieved the Departments of Health's recommendation of 60 min of MVPA every day.Conclusion: We have excellent completeness of baseline data for all measures and have achieved compliance to accelerometry not seen before in other large scale studies. Our anthropometric baseline data is representative of local and national data for children this age and reflects the gender and socio-economic variations expected of children this age in relation to physical activity and weight status.Trial Registration: ISRCTN15811706 (1/05/2012). [ABSTRACT FROM AUTHOR]

Background: Around a fifth of children starting school in England are now overweight/obese. There is a paucity of interventions with the aim of obesity prevention in preschool-age children in the UK. Previous research has demonstrated some positive results in changing specific health behaviours, however, positive trends in overall obesity rates are lacking. Preschool settings may provide valuable opportunities to access children and their families not only for promoting healthy lifestyles, but also to develop and evaluate behaviour-change interventions.Methods: This paper presents a cluster randomised feasibility study of a theory based behaviour-change preschool practitioner-led intervention tested in four preschool centres in the North East of England. The primary outcome measures were to test the acceptability and feasibility of the data collection measures and intervention. Secondary measures were collected and reported for extra information. At baseline and post intervention, children's anthropometric, dietary and physical activity measures as well as family 'active' time data were collected. The preschool practitioner-led intervention included family intervention tasks such as 'family goal-setting activities' and 'cooking challenges'. Preschool activities included increasing physical activity and providing activities with the potential to change behaviour with increased knowledge of and acceptance of healthy eating. The process evaluation was an on-going monthly process and was collected in multiple forms such as questionnaires, photographs and verbal feedback.Results: 'Gatekeeper' permission and lower-hierarchal adherence were initially a problem for recruitment and methods acceptance. However, at intervention end the preschool teachers and parents stated they found most intervention methods and activities acceptable, and some positive changes in family health behaviours were reported. However, the preschool centres appeared to have difficulties with enforcing everyday school healthy eating policies.Conclusions: The findings from the current study may have implications for nursery practitioners, nursery settings, Local Educational Authorities and policy makers, and contributes to the body of literature. However, further work with preschool practitioners is required to determine how personal attitudes and school policy application can be supported to implement successfully such an intervention.Trial Registration: ISRCTN12345678 (16/02/17) retrospectively registered. [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]

Background: Lifestyle interventions targeting physical activity, sedentary time and dietary behaviours have the potential to initiate and support behavioural change and result in public health gain. Although men have often been reluctant to engage in such lifestyle programs, many are at high risk of several chronic conditions. We have developed an evidence and theory-based, gender sensitised, health and lifestyle program (European Fans in Training (EuroFIT)), which is designed to attract men through the loyalty they feel to the football club they support. This paper describes the study protocol to evaluate the effectiveness and cost-effectiveness of the EuroFIT program in supporting men to improve their level of physical activity and reduce sedentary behaviour over 12 months.Methods: The EuroFIT study is a pragmatic, two-arm, randomised controlled trial conducted in 15 football clubs in the Netherlands, Norway, Portugal and the UK (England). One-thousand men, aged 30 to 65 years, with a self-reported Body Mass Index (BMI) ≥27 kg/m(2) will be recruited and individually randomised. The primary outcomes are objectively-assessed changes in total physical activity (steps per day) and total sedentary time (minutes per day) at 12 months after baseline assessment. Secondary outcomes are weight, BMI, waist circumference, resting systolic and diastolic blood pressure, cardio-metabolic blood biomarkers, food intake, self-reported physical activity and sedentary time, wellbeing, self-esteem, vitality and quality of life. Cost-effectiveness will be assessed and a process evaluation conducted. The EuroFIT program will be delivered over 12 weekly, 90-minute sessions that combine classroom discussion with graded physical activity in the setting of the football club. Classroom sessions provide participants with a toolbox of behaviour change techniques to initiate and sustain long-term lifestyle changes. The coaches will receive two days of training to enable them to create a positive social environment that supports men in engaging in sustained behaviour change.Discussion: The EuroFIT trial will provide evidence on the effectiveness and cost-effectiveness of the EuroFIT program delivered by football clubs to their male fans, and will offer insight into factors associated with success in making sustained changes to physical activity, sedentary behaviour, and secondary outcomes, such as diet.Trial Registration: Isrctn: 81935608 . Registered 16 June 2015. [ABSTRACT FROM AUTHOR]

Background: There is a political drive in the UK to use assistive technologies such as telehealth and telecare as an innovative and efficient approach to healthcare delivery. However, the success of implementation of such services remains dependent on the ability to engage the wider population to adopt these services. It has been widely acknowledged that low acceptance of technology, forms a key barrier to adoption although findings been mixed. Further, it remains unclear what, if any barriers exist between patients and how these compare to those who have declined or withdrawn from using these technologies. This research aims to address this gap focusing on the UK based Cambridgeshire Community Services Assistive Telehealth and Telecare service, an integrated model of telehealth and telecare.Methods: Qualitative semi-structured interviews were conducted between 1st February 2014 and 1st December 2014, to explore the views and experiences of 'users' and 'non-users' using this service. 'Users' were defined as patients who used the service (N = 28) with 'non-users' defined as either referred patients who had declined the service before allocation (N = 3) or had withdrawn after using the ATT service (N = 9). Data were analysed using the Framework Method.Results: This study revealed that there are a range of barriers and facilitators that impact on the decision to adopt and continue to engage with this type of service. Having a positive attitude and a perceived need that could be met by the ATT equipment were influential factors in the decision to adopt and engage in using the service. Engagement of the service centred on 'usability', 'usefulness of equipment', and 'threat to identity and independence'.Conclusions: The paper described the influential role of referrers in decision-making and the need to engage with such agencies on a strategic level. The findings also revealed that reassurance from the onset was paramount to continued engagement, particularly in older patients who appeared to have more negative feelings towards technology. In addition, there is a clear need for continued product development and innovation to not only increase usability and functionality of equipment but also to motivate other sections of the population who could benefit from such services. Uncovering these factors has important policy implications in how services can improve access and patient support through the application of assistive technology which could in turn reduce unnecessary cost and burden on overstretched health services. [ABSTRACT FROM AUTHOR]

Background: In 2008, the National Institute for Health Research (NIHR) began funding a major 5-year pilot research programme of translational research in England, establishing nine 'Collaborations for Leadership in Applied Health Research and Care' (CLAHRCs). A number of evaluations were carried out to examine whether or not the various collaborations worked as intended and why. In this paper, we examine what the theory of co-production adds to understanding of processes of knowledge creation and translation we observed in one of the CLAHRCs.Methods: A case study of a successful knowledge translation project was identified from our wider realist evaluation of the mechanisms of closer collaboration at play in the CLAHRC. In the project, a computer simulation model of an emergency pathway for acute ischaemic stroke was built to explore if and how the time between the onset and treatment of the condition could be minimised by redesigning the pathway. The aim of the case study was to improve our understanding of the nature and workings of the mechanisms of closer collaboration that were associated with the more successful projects by examining the relevance of the theory of co-production. Qualitative methods of analysis were used to explore the fit between the mechanisms of closer collaboration we observed in the realist evaluation and the principles of co-production we identified from the literature.Results: We found a close fit between the nine mechanisms of closer collaboration at work in the project and the principles of co-production (active agents; equality of partners; reciprocity and mutuality; transformative; and facilitated). The successful style of collaborative working exemplified by the project was consistent with a strong form of co-production.Conclusions: In our view, the theory of co-production provides useful insights into what it is about the qualities of collaborative working that inspire the requisite mechanisms for generating knowledge that is translated into practice. The theory provides a potentially useful basis for future knowledge translation programmes and projects in applied health research in a range of contexts. [ABSTRACT FROM AUTHOR]

Background: Increasingly, it is being suggested that translational gaps might be eradicated or narrowed by bringing research users and producers closer together, a theory that is largely untested. This paper reports a national study to fill a gap in the evidence about the conditions, processes and outcomes related to collaboration and implementation.Methods: A longitudinal realist evaluation using multiple qualitative methods case studies was conducted with three Collaborations for Leadership in Applied Health Research in Care (England). Data were collected over four rounds of theory development, refinement and testing. Over 200 participants were involved in semi-structured interviews, non-participant observations of events and meetings, and stakeholder engagement. A combined inductive and deductive data analysis process was focused on proposition refinement and testing iteratively over data collection rounds.Results: The quality of existing relationships between higher education and local health service, and views about whether implementation was a collaborative act, created a path dependency. Where implementation was perceived to be removed from service and there was a lack of organisational connections, this resulted in a focus on knowledge production and transfer, rather than co-production. The collaborations' architectures were counterproductive because they did not facilitate connectivity and had emphasised professional and epistemic boundaries. More distributed leadership was associated with greater potential for engagement. The creation of boundary spanning roles was the most visible investment in implementation, and credible individuals in these roles resulted in cross-boundary work, in facilitation and in direct impacts. The academic-practice divide played out strongly as a context for motivation to engage, in that 'what's in it for me' resulted in variable levels of engagement along a co-operation-collaboration continuum. Learning within and across collaborations was patchy depending on attention to evaluation.Conclusions: These collaborations did not emerge from a vacuum, and they needed time to learn and develop. Their life cycle started with their position on collaboration, knowledge and implementation. More impactful attempts at collective action in implementation might be determined by the deliberate alignment of a number of features, including foundational relationships, vision, values, structures and processes and views about the nature of the collaboration and implementation. [ABSTRACT FROM AUTHOR]

Background: Screening with the guaiac faecal occult blood test (gFOBt) is associated with improved colorectal cancer (CRC) survival, and is offered biennially to men and women aged 60-74 years in England's national Bowel Cancer Screening Programme (BCSP). Uptake of the gFOBt is low, with only 54 % of the eligible population completing the test. Text-message reminders could improve uptake of gFOBt.Methods/design: This paper describes the protocol for a randomised controlled trial, which will examine the effectiveness of a text-message reminder to promote uptake of gFOBt screening in the BCSP. Individual mobile telephone data from 180 general practices in London with existing mobile-health services will be linked to the national BCSP information system via a secure on-line network. All screening-eligible adults registered with a participating practice will be randomised, to receive either usual care (N = 1600) or usual care plus a text-message reminder to self-complete and return their kit eight weeks after their initial invitation (N = 1600). The primary outcome will be the proportion of individuals who return an adequately completed gFOBt kit within 18 weeks of the initial invitation. Differences in uptake between groups will be evaluated using a logistic regression analysis, adjusting for individual-level and area-level socio-demographic variables.Discussion: This will be the first large-scale randomised trial of a text-message reminder in a national screening programme for CRC. If effective, this study provides a cost-effective means to promote uptake of CRC screening in an organised programme.Trial Registration: Current Controlled Trials ISRCTN70904476 (18/09/2015). [ABSTRACT FROM AUTHOR]

Background: Clinically effective and cost-effective methods for managing problematic sexual behaviour in adolescents are urgently needed. Adolescents who show problematic sexual behaviour have a range of negative psychosocial outcomes, and they and their parents can experience stigma, hostility and rejection from their community. Multisystemic therapy (MST) shows some evidence for helping to reduce adolescent sexual reoffending and is one of the few promising interventions available to young people who show problematic sexual behaviour. This paper describes the protocol for Services for Teens Engaging in Problem Sexual Behaviour (STEPS-B), a feasibility trial of MST for problem sexual behaviour (MST-PSB) in antisocial adolescents at high risk of out-of-home placement due to problematic sexual behaviour.Methods/design: Eighty participants and their families recruited from five London boroughs will be randomized to MST-PSB or management as usual with follow-up to 20 months post-randomization. The primary outcome is out-of-home placement at 20 months. Secondary outcomes include sexual and non-sexual offending rates and antisocial behaviours, participant well-being, educational outcomes and total service and criminal justice sector costs. Feasibility outcomes include mapping the clinical service pathways needed to recruit adolescents displaying problematic sexual behaviour, acceptability of a randomized controlled trial to the key systems involved in managing these adolescents, and acceptability of the research protocol to young people and their families. Data will be gathered from police computer records, the National Pupil Database and interviews and self-report measures administered to adolescents and parents and will be analysed on an intention-to-treat basis.Discussion: The STEPS-B feasibility trial aims to inform policymakers, commissioners of services and professionals about the potential for implementing MST-PSB as an intervention for adolescents showing problem sexual behaviour. Should MST-PSB show potential, STEPS-B will determine what would be necessary to implement the programme more fully and at a scale that would warrant a full trial.Trial Registration: ISRCTN28441235 (registered 25 January 2012). [ABSTRACT FROM AUTHOR]

Background: Social prescribing is a way of addressing the 'non-medical' needs (e.g. loneliness, debt, housing problems) that can affect people's health and well-being. Connector schemes (e.g. delivered by care navigators or link workers) have become a key component to social prescribing's delivery. Those in this role support patients by either (a) signposting them to relevant local assets (e.g. groups, organisations, charities, activities, events) or (b) taking time to assist them in identifying and prioritising their 'non-medical' needs and connecting them to relevant local assets. To understand how such connector schemes work, for whom, why and in what circumstances, we conducted a realist review.Method: A search of electronic databases was supplemented with Google alerts and reference checking to locate grey literature. In addition, we sent a Freedom of Information request to all Clinical Commissioning Groups in England to identify any further evaluations of social prescribing connector schemes. Included studies were from the UK and focused on connector schemes for adult patients (18+ years) related to primary care.Results: Our searches resulted in 118 included documents, from which data were extracted to produce context-mechanism-outcome configurations (CMOCs). These CMOCs underpinned our emerging programme theory that centred on the essential role of 'buy-in' and connections. This was refined further by turning to existing theories on (a) social capital and (b) patient activation.Conclusion: Our realist review highlights how connector roles, especially link workers, represent a vehicle for accruing social capital (e.g. trust, sense of belonging, practical support). We propose that this then gives patients the confidence, motivation, connections, knowledge and skills to manage their own well-being, thereby reducing their reliance on GPs. We also emphasise within the programme theory situations that could result in unintended consequences (e.g. increased demand on GPs). [ABSTRACT FROM AUTHOR]

Background: Systematic reviews suggest that multi-component interventions are effective in reducing bullying victimisation and perpetration. We are undertaking a phase III randomised trial of the INCLUSIVE multi-component intervention. This trial aims to assess the effectiveness and cost-effectiveness of the INCLUSIVE intervention in reducing aggression and bullying victimisation in English secondary schools. This paper updates the original trial protocol published in 2014 (Trials 15:381, 2014) and presents the changes in the process evaluation protocol and the secondary outcome data collection.Methods: The methods are summarised as follows.Design: cluster randomised trial.Participants: 40 state secondary schools. Outcomes assessed among the cohort of students at the end of year 7 (n = 6667) at baseline.Intervention: INCLUSIVE is a multi-component school intervention including a social and emotional learning curriculum, changes to school environment (an action group comprising staff and students reviews local data on needs to review rules and policies and determine other local actions) and staff training in restorative practice. The intervention will be delivered by schools supported in the first two years by educational facilitators independent of the research team, with a third intervention year involving no external facilitation but all other elements. Comparator: normal practice.Outcomes: Primary: Two primary outcomes at student level assessed at baseline and at 36 months: 1. Aggressive behaviours in school: Edinburgh Study of Youth Transitions and Crime school misbehaviour subscale (ESYTC) 2. Bullying and victimisation: Gatehouse Bullying Scale (GBS) Secondary outcomes assessed at baseline, 24 and 36 months will include measures relating to the economic evaluation, psychosocial outcomes in students and staff and school-level truancy and exclusion rates.Sample Size: 20 schools per arm will provide 90% power to identify an effect size of 0.25 SD with a 5% significance level. Randomisation: eligible consenting schools were randomised stratified for single-sex versus mixed-sex schools, school-level deprivation and measures of school attainment.Discussion: The trial involves independent research and intervention teams and is supervised by a Trial Steering Committee and a Data Monitoring Committee.Trial Registration: Current Controlled Trials, ISRCTN10751359 . Registered on 11 March 2014. [ABSTRACT FROM AUTHOR]

Background: Child maltreatment is a significant public health problem. Group Family Nurse Partnership (gFNP) is a new intervention for young, expectant mothers implemented successfully in pilot studies. This study was designed to determine the effectiveness and cost-effectiveness of gFNP in reducing risk factors for maltreatment with a potentially vulnerable population.Methods: A multi-site, randomized controlled, parallel-arm trial and prospective economic evaluation was conducted, with allocation via remote randomization (minimization by site, maternal age group) to gFNP or usual care. Participants were expectant mothers aged below 20 years with at least one live birth, or aged 20-24 years with no live births and with low educational qualifications. Data from maternal interviews at baseline and when infants were 2, 6 and 12 months, and video-recording at 12 months, were collected by researchers blind to allocation. Cost information came from weekly logs completed by gFNP family nurses and other service delivery data reported by participants. Primary outcomes measured at 12 months were parenting attitudes (Adult-Adolescent Parenting Index, AAPI-2) and maternal sensitivity (CARE Index). The economic evaluation was conducted from a UK NHS and personal social services perspective with cost-effectiveness expressed in terms of incremental cost per quality-adjusted life year (QALY) gained. The main analyses were intention-to-treat with additional complier average causal effects (CACE) analyses.Results: Between August 2013 and September 2014, 492 names of potential participants were received of whom 319 were eligible and 166 agreed to take part, 99 randomly assigned to receive gFNP and 67 to usual care. There were no between-arm differences in AAPI-2 total (7 · 5/10 in both, SE 0.1), difference adjusted for baseline, site and maternal age group 0 · 06 (95% CI - 0 · 15 to 0 · 28, p = 0 · 59) or CARE Index (intervention 4 · 0 (SE 0 · 3); control 4 · 7 (SE 0 · 4); difference adjusted for site and maternal age group - 0 · 68 (95% CI - 1 · 62 to 0 · 16, p = 0 · 25) scores. The probability that gFNP is cost-effective based on the QALY measure did not exceed 3%.Conclusions: The trial did not support gFNP as a means of reducing the risk of child maltreatment in this population but slow recruitment adversely affected group size and consequently delivery of the intervention.Trial Registration: ISRCTN78814904 . Registered on 17 May 2013. [ABSTRACT FROM AUTHOR]

Background: Childhood unintentional injury represents an important global health problem. Many unintentional injuries experienced by children aged under 5 years occur within the home and are preventable. The aim of this study was to explore the approaches used by parents of children under five in order to help prevent unintentional injuries in the home and the factors which influence their use. Understanding how parents approach risk-management in the home has important implications for injury practitioners.Methods: A multi-centre qualitative study using semi-structured interviews. A thematic approach was used to analyse the data. Sixty five parents of children aged under 5 years, from four study areas were interviewed: Bristol, Newcastle, Norwich and Nottingham.Results: Three main injury prevention strategies used by parents were: a) Environmental such as removal of hazards, and use of safety equipment; b) parental supervision; and c) teaching, for example, teaching children about safety and use of rules and routine. Strategies were often used in combination due to their individual limitations. Parental assessment of injury risk, use of strategy and perceived effectiveness were fluid processes dependent on a child's character, developmental age and the prior experiences of both parent and child. Some parents were more proactive in their approach to home safety while others only reacted if their child demonstrated an interest in a particular object or activity perceived as being an injury risk.Conclusion: Parents' injury prevention practices encompass a range of strategies that are fluid in line with the child's age and stage of development; however, parents report that they still find it challenging to decide which strategy to use and when. [ABSTRACT FROM AUTHOR]

Background: Health services research is expected to involve service users as active partners in the research process, but few examples report how this has been achieved in practice in trials. We implemented a model to involve service users in a multi-centre randomised controlled trial in pre-hospital emergency care. We used the generic Standard Operating Procedure (SOP) from our Clinical Trials Unit (CTU) as the basis for creating a model to fit the context and population of the SAFER 2 trial.Methods: In our model, we planned to involve service users at all stages in the trial through decision-making forums at 3 levels: 1) strategic; 2) site (e.g. Wales; London; East Midlands); 3) local. We linked with charities and community groups to recruit people with experience of our study population. We collected notes of meetings alongside other documentary evidence such as attendance records and study documentation to track how we implemented our model.Results: We involved service users at strategic, site and local level. We also added additional strategic level forums (Task and Finish Groups and Writing Days) where we included service users. Service user involvement varied in frequency and type across meetings, research stages and locations but stabilised and increased as the trial progressed.Conclusion: Involving service users in the SAFER 2 trial showed how it is feasible and achievable for patients, carers and potential patients sharing the demographic characteristics of our study population to collaborate in a multi-centre trial at the level which suited their health, location, skills and expertise. A standard model of involvement can be tailored by adopting a flexible approach to take account of the context and complexities of a multi-site trial.Trial Registration: Current Controlled Trials ISRCTN60481756. Registered: 13 March 2009. [ABSTRACT FROM AUTHOR]

Background: January 2016 saw the publication of proposed revisions to the UK's lower risk drinking guidelines but no sustained promotional activity. This paper aims to explore the impact of publishing guidelines without sustained promotional activity on reported guideline exposure and determinants of behaviour (capability, opportunity and motivation) proposed by the COM-B model.Methods: Data were collected by a monthly repeat cross-sectional survey of adults (18+) resident in England over 15 months between November 2015 and January 2017 from a total of 16,779 drinkers, as part of the Alcohol Toolkit Study. Trends and associated 95% confidence intervals were described in the proportion of reported exposure to guidelines in the past month and measures of the capability, opportunity and motivation to consume alcohol within drinking guidelines.Results: There was a rise in reported exposure to drinking guidelines in January 2016 (57.6-80.6%) which did not reoccur in January 2017. Following the increase in January 2016, reported exposure reduced slowly but remained significantly higher than in December 2015. In February 2016, there was an increase in measures of capability (31.1% reported tracking units of alcohol consumption and 87.8% considered it easier to drink safely) and opportunity (84.0% perceived their lifestyle as conducive to drinking within guidelines). This change was not maintained in subsequent months. Other measures showed marginal changes between January and February 2016 with no evidence of change in subsequent months.Conclusions: Following the publication of revised drinking guideline in January 2016, there was a transient increase in exposure to guidelines, and capability and opportunity to drink within the guidelines that diminished over time. The transience and size of the changes indicate that behaviour change is unlikely. Well-designed, theory-based promotional campaigns may be required for drinking guidelines to be an effective public health intervention. [ABSTRACT FROM AUTHOR]

Background: Systematic reviews have identified effective strategies for increasing postal response rates to questionnaires; however, most studies have isolated single techniques, testing the effect of each one individually. Despite providing insight into explanatory mechanisms, this approach lacks ecological validity, given that multiple techniques are often combined in routine practice.Methods: We used a two-armed parallel randomised controlled trial (n = 2702), nested within a cross-sectional health survey study, to evaluate whether using a pragmatic combination of behavioural science and evidenced-based techniques (e.g., personalisation, social norms messaging) in a study invitation letter increased response to the survey, when compared with a standard invitation letter. Participants and outcome assessors were blinded to group assignment. We tested this in a sample of women testing positive for human papillomavirus (HPV) at cervical cancer screening in England.Results: Overall, 646 participants responded to the survey (response rate [RR] = 23.9%). Logistic regression revealed higher odds of response in the intervention arm (n = 357/1353, RR = 26.4%) compared with the control arm (n = 289/1349, RR = 21.4%), while adjusting for age, deprivation, clinical site, and clinical test result (aOR = 1.30, 95% CI: 1.09-1.55).Conclusion: Applying easy-to-implement behavioural science and evidence-based methods to routine invitation letters improved postal response to a health-related survey, whilst adjusting for demographic characteristics. Our findings provide support for the pragmatic adoption of combined techniques in routine research to increase response to postal surveys.Trial Registration: ISRCTN, ISRCTN15113095 . Registered 7 May 2019 - retrospectively registered. [ABSTRACT FROM AUTHOR]

Background: Early mobilisation leads to a two-fold increase in the adjusted odds of discharge by 30-days compared to late mobilisation. Whether this association varies by patient characteristics identified as reasons for delayed mobilisation is unknown.Methods: Audit data was linked to hospitalisation records for 133,319 patients 60 years or older surgically treated for hip fracture in England or Wales between 2014 and 2016. Adjusted proportional odds regression models tested whether the cumulative incidences of discharge differed between those mobilised early and those mobilised late for subgroups defined by dementia, delirium, hypotension, prefracture ambulation, and prefracture residence, accounting for the competing risk of death.Results: Overall, 34,253 patients presented with dementia, 9818 with delirium, and 10,123 with hypotension. Prefracture, 100,983 were ambulant outdoors, 30,834 were ambulant indoors only, 107,144 were admitted from home, and 23,588 from residential care. 1502 had incomplete data for ambulation and 2587 for prefracture residence. 10, 8, 8, 12, and 12% fewer patients with dementia, delirium, hypotension, ambulant indoors only prefracture, or admitted from residential care mobilised early when compared to those who presented without dementia, delirium, hypotension, with outdoor ambulation prefracture, or admitted from home. The adjusted odds ratios of discharge by 30-days postoperatively among those who mobilised early compared with those who mobilised late were 1.71 (95% CI 1.62-1.81) for those with dementia, 2.06 (95% CI 1.98-2.15) without dementia, 1.56 (95% CI 1.41-1.73) with delirium, 2.00 (95% CI 1.93-2.07) without delirium, 1.83 (95% CI, 1.66-2.02) with hypotension, 1.95 (95% CI, 1.89-2.02) without hypotension, 2.00 (95% CI 1.92-2.08) with outdoor ambulation prefracture, 1.80 (95% CI 1.70-1.91) with indoor ambulation only prefracture, 2.30 (95% CI 2.19-2.41) admitted from home, and 1.64 (95% CI 1.51-1.77) admitted from residential care, accounting for the competing risk of death.Conclusion: Irrespective of dementia, delirium, hypotension, prefracture ambulation or residence, early compared to late mobilisation increased the likelihood of hospital discharge by 30-days postoperatively. However, fewer patients with dementia, delirium, or hypotension, poorer prefracture ambulation, or from residential care mobilised early. There is a need reduce this care gap by ensuring sufficient resource to enable all patients to benefit from early mobilisation. [ABSTRACT FROM AUTHOR]

Background: Increasing demand on emergency healthcare systems has prompted introduction of new healthcare service models including the provision of GP services in or alongside emergency departments. In England this led to a policy proposal and £100million (US$130million) of funding for all emergency departments to have co-located GP services. However, there is a lack of evidence for whether such service models are effective and safe. We examined diagnostic errors reported in patient safety incident reports to develop theories to explain how and why they occurred to inform potential priority areas for improvement and inform qualitative data collection at case study sites to further refine the theories.Methods: We used a mixed-methods design using exploratory descriptive analysis to identify the most frequent and harmful sources of diagnostic error and thematic analysis, incorporating realist methodology to refine theories from an earlier rapid realist review, to describe how and why the events occurred and could be mitigated, to inform improvement recommendations. We used two UK data sources: Coroners' reports to prevent future deaths (30.7.13-14.08.18) and National Reporting and Learning System (NRLS) patient safety incident reports (03.01.05-30.11.15).Results: Nine Coroners' reports (from 1347 community and hospital reports, 2013-2018) and 217 NRLS reports (from 13 million, 2005-2015) were identified describing diagnostic error related to GP services in or alongside emergency departments. Initial theories to describe potential priority areas for improvement included: difficulty identifying appropriate patients for the GP service; under-investigation and misinterpretation of diagnostic tests; and inadequate communication and referral pathways between the emergency and GP services. High-risk presentations included: musculoskeletal injury, chest pain, headache, calf pain and sick children.Conclusion: Initial theories include the following topics as potential priority areas for improvement interventions and evaluation to minimise the risk of diagnostic errors when GPs work in or alongside emergency departments: a standardised initial assessment with streaming guidance based on local service provision; clinical decision support for high-risk conditions; and standardised computer systems, communication and referral pathways between emergency and GP services. These theories require refinement and testing with qualitative data collection from case study (hospital) sites. [ABSTRACT FROM AUTHOR]

Background: Many health visiting services in England use the Promotional Guide system with mothers and fathers, an intervention to support their transition to parenthood, but there is little known about its use and effectiveness, especially with fathers. The aim of this study was to test the feasibility and acceptability of the Promotional Guide system with first-time fathers and pilot potential outcome measures to assess their mental health and wellbeing.Methods: A mixed methods prospective observational cohort study. Expectant first-time fathers were recruited from four London (UK) local authority boroughs. Data were collected through online pre and post intervention questionnaires, and semi-structured telephone interviews. Quantitative data were analysed using descriptive statistics and qualitative data were analysed using framework analysis.Results: Eighty-six fathers were interested in participating; 7 did not meet inclusion criteria and 79 were invited to complete the baseline questionnaire. Questionnaires completed by 45 men at both timepoints were included in the final analysis. Mean and standard deviations were calculated for all outcomes, showing a slight deterioration in the scores across all measures in the postnatal period compared to the antenatal. Ten of these men were also interviewed. Six major categories were identified: 1) Experience of health visitor contact, 2) Experience of Promotional Guides, 3) Experience of perinatal health services, 4) Experience of fatherhood, 5) Fathers' mental health and wellbeing, and 6) Experience of the research process. While antenatal and postnatal outcomes were collected from 45 first-time fathers, none had received the intervention in its entirety. This study identified major gaps in the implementation of the Promotional Guide system with fathers.Conclusion: This study assessed recruitment of first-time fathers, time to complete recruitment, and retention rates and identified outcome measures that could be used in a future definitive study. While it wasn't possible to examine the potential changes following the use of the Promotional Guide system, the study reported on the changes in the fathers' 'states' in the antenatal and postnatal period. It provided a narrative on whether first-time fathers found it acceptable to be asked about their mental health and wellbeing, highlighted their specific needs during their transition to fatherhood, and how they wanted to be supported. It also identified barriers to implementation of the Promotional Guide system by health visitors, which need to be addressed prior to any future research into this intervention. These findings have a number of implications for researchers, health professionals, health service managers, commissioners, policy makers and parents. [ABSTRACT FROM AUTHOR]

Background: Previous research has shown the benefits of arts and cultural engagement for physical, mental and social wellbeing. This engagement is socially and geographically patterned. Yet it remains unclear whether place-based attributes are associated with engagement behaviour independent of individual factors. Therefore, the aim of this cross-sectional study was to robustly disentangle associations between geographical deprivation and arts engagement from the individual socio-demographic factors that tend to correlate with residential locations.Methods: Two different samples drawn from two representative surveys of adults living in England were compared - Understanding Society Wave 2 (2010/12) (N = 14,782) and Taking Part survey (2010/11) (N = 4575). Propensity score matching (PSM) was applied to investigate the association between neighbourhood deprivation (20% most deprived vs 20% least deprived) and arts engagement (arts participation, cultural attendance and museums and heritage engagement).Results: Higher levels of neighbourhood deprivation were associated with lower arts, culture and heritage engagement independent of individuals' demographic backgrounds, socio-economic characteristics and regional locations. When exploring subcategories of deprivation, similar results were obtained across deprivation domains. Results were also consistent when using more distinct categories of deprivation (i.e. 10% most deprived vs 10% least deprived) and when comparing people living in the 20% most deprived neighbourhoods with those living in the 40% medium-deprived areas.Conclusion: This study is the first to apply a robust PSM technique to examine the association between neighbourhood deprivation and arts engagement using two nationally-representative samples. Results show that neighbourhood deprivation may act as a barrier that could prevent people from engaging in the arts, which in turn may exacerbate social and health inequalities. This highlights the importance of place-based schemes that focus on increasing individual motivation and capacity to engage in arts and cultural activities, especially in areas of high deprivation. [ABSTRACT FROM AUTHOR]

Background: The workplace has been identified as an ideal setting for health interventions. However, few UK-based workplace intervention studies have been published. Fewer still focus on the practicalities and implications when running an intervention within the workplace setting. The objective of this paper was to qualitatively determine the perceived behaviour changes of participants in a free fruit at work intervention. Understanding the dynamics of a workplace intervention and establishing any limitations of conducting an intervention in a workplace setting were also explored.Methods: Twenty-three face-to-face interviews were conducted with individuals receiving free fruit at work for 18 weeks (74 % female). The worksite was the offices of a regional local government in the North East of England. Analysis was guided theoretically by Grounded Theory research and the data were subjected to content analysis. The transcripts were read repeatedly and cross-compared to develop a coding framework and derive dominant themes.Results: Topics explored included: the workplace food environment; the effect of the intervention on participants and on other related health behaviours; the effect of the intervention on others; participant's fruit consumption; reasons for not taking part in the intervention; expectations and sustainability post-intervention; and how to make the workplace healthier. Five emergent themes included: the office relationship with food; desk based eating; males and peer support; guilt around consumption of unhealthy foods; and the type of workplace influencing the acceptability of future interventions.Conclusion: Exploring the perceptions of participants offered valued insights into the dynamics of a free fruit workplace intervention. Findings suggest that access and availability are both barriers and facilitators to encouraging healthy eating in the workplace. [ABSTRACT FROM AUTHOR]

Background: Active for life year 5 (AFLY5) is a school-based intervention, based on social cognitive theory, which aims to promote healthy levels of physical activity and healthy eating by improving a child's self-efficacy to make healthy choices, their knowledge of how to make such choices and prompting parents to support their children to make healthy choices. Previously published results showed no effect on the three primary outcomes and beneficial effects on three of nine secondary outcomes (time spent screen-viewing at weekends, consumption of snacks and of high energy drinks). This paper aims to determine the effect of the intervention on potential mediators.Methods: We conducted a cluster RCT of a school-based intervention, with allocation concealed by use of a remote system. The study was undertaken in the South West of England between 2011 and 2013. Participants were school children who were age 8-9 years at baseline assessment and 9-10 years during the intervention. Potential mediators were assessed at the end of the intervention. The intervention consisted of teacher training, provision of all materials required for lessons and homeworks and written materials for school newsletters and parents. The ten potential mediators were child-reported self-efficacy for physical activity and fruit and vegetable consumption, perceived parental logistic support and modelling for their child's physical activity, parental efforts to limit their child's sedentary behaviour and modelling of healthy fruit and vegetable consumption, together with a knowledge assessment.Results: We successfully recruited 60 schools with over 2,221 children; valid data for the 10 mediators were available for 87 % to 96 % of participants. Three of the ten potential mediators were greater in the intervention, compared with the control group: fruit and vegetable self-efficacy 2.2 units (95 % CI: 0.7 to 3.8), assessed on a scale 26 to 130; child-reported maternal limitation of sedentary behaviour 0.5 (0.1 to 0.8), scale 4 to 16; and knowledge 0.5 (0.2, 0.7) scale 0 to 9. Reported maternal limitation of sedentary behaviour and the child's knowledge explained 23 % of the effect of the intervention on reducing time spent on sedentary behaviour at the weekend. There was no effect on other mediators.Conclusions: Our findings suggest that the effect of the AFLY5 intervention on reducing screen-viewing at weekends was partially mediated by an effect on mothers limiting their child's time spent sedentary and on increasing the child's knowledge about healthy behaviour. However, overall our findings suggest that theory driven interventions, like AFLY5, can fail to influence most potential mediators and this may explain the failure of the intervention to improve most primary and secondary outcomes.Trial Registration: Current Controlled Trials ISRCTN50133740. Registered 17/03/2011. [ABSTRACT FROM AUTHOR]

Background: Videoconferencing has been proposed as a way of improving access to healthcare for older adults in care homes. Despite this, effective uptake of videoconferencing remains varied. This study evaluates a videoconferencing service for care home staff seeking support from healthcare professionals for the care of residents. The aim was to explore factors affecting the uptake and sustainability of videoconferencing in care homes, to establish what works for whom, in which circumstances and respects. The findings informed recommendations for commissioners and strategic managers on how best to implement videoconferencing for remote healthcare provision in care homes for older adults.Methods: Realist evaluation was used to develop, refine and test theories around the uptake and maintenance of videoconferencing in three care homes across Yorkshire and the Humber, England. The care homes were selected using maximum variation sampling regarding the extent to which they used videoconferencing. A developmental inquiry framework and realist interviews were used to identify Context, Mechanism and Outcome Configurations (CMOCs) regarding uptake and sustainability of the service. Participants included care home residents (aged > 65) and staff, relatives and strategic managers of care home chains. The interviews were an iterative process conducted alongside data analysis. Transcripts of audio recordings were entered into NVIVO 12, initially coded into themes, then hypotheses developed, refined and tested.Results: Outcomes were generated in relation to two main contextual factors, these were: (1) communication culture in the home and (2) the prior knowledge and experience that staff have of videoconferencing. The key facilitators identified were aspects of leadership, social links within the home and psychological safety which promoted shared learning and confidence in using the technology.Conclusions: Videoconferencing is a valuable tool, but successful implementation and sustainability are dependent on care home culture and staff training to promote confidence through positive and supported experiences. [ABSTRACT FROM AUTHOR]

Background: Navafenterol (AZD8871) is a novel, long-acting, dual-pharmacology (muscarinic receptor antagonist and β2-adrenoceptor agonist) molecule in development for chronic obstructive pulmonary disease and asthma.Methods: These two phase I, randomised, single-blind, multiple-ascending-dose studies evaluated inhaled navafenterol and placebo (3:1 ratio) in healthy, male, non-Japanese (study A; NCT02814656) and Japanese (study B; NCT03159442) volunteers. In each study, volunteers were dosed in three cohorts, allowing gradual dose escalation from 300 μg to 600 μg to 900 μg. The primary objective was to investigate the safety and tolerability of navafenterol at steady state. Pharmacokinetics were also assessed.Results: Twenty-four volunteers completed each study (navafenterol, n = 6; placebo, n = 2 in each cohort). There were no deaths, serious adverse events (AEs) or treatment-emergent AEs (TEAEs) leading to discontinuation of navafenterol. The most frequent TEAEs were vessel puncture-site bruise (placebo, n = 2; navafenterol 900 μg; n = 3) in study A and diarrhoea (placebo, n = 1; navafenterol 300 μg, n = 2; navafenterol 900 μg, n = 3) in study B. No dose-response relationship was observed for TEAEs. There was a dose-dependent increase in mean heart rate on day 16 in both studies. The pharmacokinetics of navafenterol were similar between non-Japanese and Japanese volunteers.Conclusions: Multiple ascending doses of navafenterol were well-tolerated and the safety and pharmacokinetics of navafenterol were similar in non-Japanese and Japanese volunteers. The findings support navafenterol clinical development.Trial Registration: ClinicalTrials.gov ; Nos.: NCT02814656 and NCT03159442; URL: www.clinicaltrials.gov . [ABSTRACT FROM AUTHOR]

Background: Navafenterol (AZD8871) is an inhaled long-acting dual-pharmacology muscarinic antagonist/β2-adrenoceptor agonist (MABA) in development for the treatment of obstructive airways diseases. The safety, tolerability, pharmacodynamics, and pharmacokinetics of navafenterol were investigated in patients with mild asthma.Methods: This was a randomised, single-blind, placebo-controlled, single-ascending-dose study. Patients were randomly assigned to one of two cohorts which evaluated escalating doses of navafenterol (50-2100 μg) in an alternating manner over three treatment periods. The primary pharmacodynamic endpoint was the change from pre-dose baseline in trough forced expiratory volume in 1 s (FEV1) for each treatment period.Results: Sixteen patients were randomised; 15 completed treatment. Data from all 16 patients were analysed. The maximum tolerated dose was not identified, and all doses of navafenterol were well tolerated. The most frequently reported treatment-emergent adverse events (TEAEs) were headache (n = 10, 62.5%) and nasopharyngitis (n = 7, 43.8%). No TEAEs were serious, fatal, or led to discontinuation, and no dose dependency was identified. Navafenterol demonstrated a dose-ordered bronchodilatory response with a rapid onset of action (within 5 min post-dose). Doses ≥200 μg resulted in improvements in trough FEV1 (mean change from baseline range 0.186-0.463 L) with sustained bronchodilation for 24-36 h. Plasma concentrations increased in a dose-proportional manner, peaking ~ 1 h post-dose, with a derived terminal elimination half-life of 15.96-23.10 h.Conclusions: In this study navafenterol was generally well tolerated with a rapid onset of action which was sustained over 36 h.Trial Registration: ClinicalTrials.gov; No.: NCT02573155. [ABSTRACT FROM AUTHOR]

Background: Navafenterol (AZD8871) is a dual-pharmacology muscarinic antagonist β2-agonist (MABA) molecule in development for the treatment of chronic obstructive pulmonary disease (COPD). The pharmacodynamics, safety and tolerability of single doses of navafenterol were investigated in patients with moderate to severe COPD.Methods: This was a randomized, five-way complete cross-over study. Patients received single doses of navafenterol 400 μg, navafenterol 1800 μg and placebo (all double-blind) and indacaterol 150 μg and tiotropium 18 μg (both open-label active comparators). The primary pharmacodynamic endpoint was change from baseline in trough forced expiratory volume in 1 s (FEV1) on day 2. Safety and tolerability were monitored throughout.Results: Thirty-eight patients were randomized and 28 (73.7%) completed the study. Navafenterol 400 μg and 1800 μg demonstrated statistically significant improvements vs placebo in change from baseline in trough FEV1 (least squares mean [95% confidence interval]: 0.111 [0.059, 0.163] L and 0.210 [0.156, 0.264] L, respectively, both P < .0001). The changes were significantly greater with navafenterol 1800 μg vs the active comparators (least squares mean treatment difference: 0.065-0.069 L, both P < .05). The frequency of treatment-emergent adverse events was similar for placebo and the active comparators (range 34.4-37.5%), slightly higher for navafenterol 400 μg (52.9%), and lowest for navafenterol 1800 μg (22.6%).Conclusions: Both doses of navafenterol demonstrated sustained bronchodilation over 24 h. Navafenterol was well tolerated and no safety concerns were raised.Trial Registry: ClinicalTrials.gov ; No.: NCT02573155 ; URL: www.clinicaltrials.gov . Registered 9th October, 2015. [ABSTRACT FROM AUTHOR]

Background: The recent emergence of strains belonging to the meningococcal serogroup W (MenW) sequence type-11 clonal complex and descending from the South American sub-lineage (MenW:cc11/SA) has caused significant shifts in the epidemiology of meningococcal disease worldwide. Although MenW:cc11/SA is deemed highly transmissible and invasive, its epidemiological characteristics have not yet been quantified.Methods: We designed a mathematical model of MenW transmission, carriage, and infection to analyze the recent epidemiology of invasive disease caused by MenW:cc11/SA strains and by other MenW strains in England and in France. We confronted that model with age-stratified incidence data to estimate the transmissibility and the invasiveness of MenW:cc11/SA in England, using the data in France as a validation cohort.Results: During the epidemiological years 2010/2011-2014/2015 in England, the transmissibility of MenW:cc11/SA relative to that of other MenW strains was estimated at 1.20 (95% confidence interval, 1.15 to 1.26). The relative invasiveness of MenW:cc11/SA was also found to exceed unity and to increase with age, with estimates ranging from 4.0 (1.6 to 9.7) in children aged 0-4 years to 20 (6 to 34) in adults aged ≥ 25 years. In France, the model calibrated in England correctly reproduced the early increase of MenW:cc11/SA disease during 2012/2013-2016/2017. Most recent surveillance data, however, indicated a decline in MenW:cc11/SA disease. In both countries, our results suggested that the transmission of MenW:cc11/SA carriage possibly started several months before the first reported case of MenW:cc11/SA disease.Discussion: Our results confirm earlier suggestions about the transmission and the pathogenic potential of MenW:cc11/SA. The main limitation of our study was the lack of age-specific MenW carriage data to confront our model predictions with. Furthermore, the lesser model fit to the most recent data in France suggests that the predictive accuracy of our model might be limited to 5-6 years.Conclusions: Our study provides the first estimates of the transmissibility and of the invasiveness of MenW:cc11/SA. Such estimates may be useful to anticipate changes in the epidemiology of MenW and to adapt vaccination strategies. Our results also point to silent, prolonged transmission of MenW:cc11/SA carriage, with potentially important implications for epidemic preparedness. [ABSTRACT FROM AUTHOR]

Background: Much of the food available from takeaways, pubs and restaurants particularly that sold by independent outlets, is unhealthy and its consumption is increasing. These food outlets are therefore important potential targets for interventions to improve diet and thus prevent diet related chronic diseases. Local authorities in England have been charged with delivering interventions to increase the provision of healthy food choices in independent outlets, but prior research shows that few such interventions have been rigorously developed or evaluated. We aimed to learn from the experiences of professionals delivering interventions in independent food outlets in England to identify the operational challenges and their suggestions for best practice.Methods: We used one-to-one semi-structured qualitative interviews to explore the views and experiences of professionals who were either employees of, or contracted by, a local authority to deliver interventions to increase the provision of healthier food choices in independent food outlets. Purposive sampling was used to recruit a sample which included men and women, from a range of professional roles, across different areas of England. Interviews were informed by a topic guide, and proceeded until no new themes emerged. Interviews were recorded, transcribed verbatim and analysed using the Framework method.Results: We conducted 11 individual interviews. Participants focussed on independent takeaways and their unhealthy food offerings, and highlighted the advantages and disadvantages of intervention delivery methods, their evaluation and impact. The main barriers to implementation of interventions in independent takeaways were identified as limited funding and the difficulties of engaging the food outlet owner/manager. Engagement was thought to be facilitated by delivering intensive, interactive and tailored interventions, clear and specific information, and incentives, whilst accounting for practical, primarily financial, constraints of food businesses. Alternative intervention approaches, targeting suppliers or customers, were suggested.Conclusions: Participants emphasised independent takeaways as particularly challenging, but worthwhile intervention targets. Participants perceived that interventions need to take account of the potentially challenging operating environment, particularly the primacy of the profit motive. Upstream interventions, engaging suppliers, as well as those that drive consumer demand, may be worth exploring. Rigorous, evidence-informed development and evaluation of such interventions is needed. [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: Stroke telemedicine can reduce healthcare inequities by increasing access to specialists. Successful telemedicine networks require specialists adapting clinical practice to provide remote consultations. Variation in experiences of specialists between different countries is unknown. To support future implementation, we compared perceptions of Australian and United Kingdom specialists providing remote acute stroke consultations.Methods: Specialist participants were identified using purposive sampling from two new services: Australia's Victorian Stroke Telemedicine Program (n = 6; 2010-13) and the United Kingdom's Cumbria and Lancashire telestroke network (n = 5; 2010-2012). Semi-structured interviews were conducted pre- and post-implementation, recorded and transcribed verbatim. Deductive thematic and content analysis (NVivo) was undertaken by two independent coders using Normalisation Process Theory to explore integration of telemedicine into practice. Agreement between coders was M = 91%, SD = 9 and weighted average κ = 0.70.Results: Cross-cultural similarities and differences were found. In both countries, specialists described old and new consulting practices, the purpose and value of telemedicine systems, and concerns regarding confidence in the assessment and diagnostic skills of unknown colleagues requesting telemedicine support. Australian specialists discussed how remote consultations impacted on usual roles and suggested future improvements, while United Kingdom specialists discussed system governance, policy and procedures.Conclusion: Australian and United Kingdom specialists reported telemedicine required changes in work practice and development of new skills. Both groups described potential for improvements in stroke telemedicine systems with Australian specialists more focused on role change and the United Kingdom on system governance issues. Future research should examine if cross-cultural variation reflects different models of care and extends to other networks. [ABSTRACT FROM AUTHOR]

Background: Loneliness is associated with poor health outcomes at all ages, including shorter life expectancy and greater risk of developing depression. People with mental health problems are particularly vulnerable to loneliness and, for those with anxiety or depression, loneliness is associated with poorer outcomes. Interventions which support people to utilise existing networks and access new social contact are advocated in policy but there is little evidence regarding their effectiveness. People with mental health problems have potential to benefit from interventions to reduce loneliness, but evidence is needed regarding their feasibility, acceptability and outcomes. An intervention to reduce loneliness for people with anxiety or depression treated in secondary mental health services was developed for this study, which will test the feasibility and acceptability of delivering and evaluating it through a randomised controlled trial.Methods: In this feasibility trial, 40 participants with anxiety or depression will be recruited through two secondary mental health services in London and randomised to an intervention (n = 30) or control group (n = 10). The control group will receive standard care and written information about local community resources. The coproduced intervention, developed in this study, includes up to ten sessions with a 'Community Navigator' over a 6-month period. Community Navigators will work with people individually to increase involvement in social activities, with the aim of reducing feelings of loneliness. Data will be collected at baseline and at 6-month follow-up - the end of the intervention period. The acceptability of the intervention and feasibility of participant recruitment and retention will be assessed. Potential primary and secondary outcomes for a future definitive trial will be completed to assess response and completeness, including measures of loneliness, depression and anxiety. Qualitative interviews with participants, staff and other stakeholders will explore experiences of Community Navigator support, the mechanisms by which it may have its effects and suggestions for improving the programme.Discussion: Our trial will provide preliminary evidence of the feasibility and acceptability of Community Navigator support and of trial procedures for testing this. The results will inform a future definitive randomised controlled trial of this intervention.Trial Registration: ISRCTN10771821 . Registered on 3 April 2017. [ABSTRACT FROM AUTHOR]

Background: Late access to antenatal care increases risks of adverse outcomes including maternal and perinatal mortality. There is evidence that BMI influences patient engagement with health services, such as cancer screening services and delayed access to treatment; this association has not been fully explored in the context of antenatal care. This study investigated the association between the stage of pregnancy women access antenatal care, BMI, and other socio-demographic factors.Methods: Retrospective analysis of routine hospital data from 34 NHS maternity units in England, UK, including 619,502 singleton births between 1989 and 2007. Analyses used logistic regression to investigate the association between maternal BMI categories and stage of pregnancy women accessed antenatal care. Adjusted odds ratios (aORs) and 95% confidence intervals (CIs) were used to estimate associations, adjusting for maternal age, ethnic group, parity, Index of Multiple Deprivation score and employment status. The primary outcome was late access to antenatal care (>13+6 weeks). Secondary outcomes were trimester of access, and the association between late access and other socio-demographic variables.Results: Women with an overweight or obese BMI accessed antenatal care later than women with a recommended BMI (aOR 1.11, 95%CI 1.09-1.12; aOR 1.04, 95%CI 1.02-1.06 respectively), and underweight women accessed care earlier (aOR 0.77, 95%CI 0.74-0.81). Women with obesity were 42% more likely to access care in the third trimester compared with women with a recommended BMI. Additional significant socio-demographic associations with late access included women from minority ethnic groups, teenagers, unemployment and deprivation. The greatest association was observed among Black/Black British women accessing care in the third trimester (aOR 5.07, 95% CI 4.76, 5.40).Conclusions: There are significant and complex socio-demographic inequalities associated with the stage of pregnancy women access maternity care, particularly for women with obesity accessing care very late in their pregnancy, and among BME groups, teenagers, deprived and unemployed women. These populations are at increased risk of adverse maternal and fetal outcomes and require support to address inequalities in access to antenatal care. Interventions to facilitate earlier access to care should address the complex and inter-related nature of these inequalities to improve pregnancy outcomes among high-risk groups. [ABSTRACT FROM AUTHOR]

Background: Dupuytren's contractures are fibrous cords under the skin of the palm of the hand. The contractures are painless but cause one or more fingers to curl into the palm, resulting in loss of function. Standard treatment within the NHS is surgery to remove (fasciectomy) or divide (fasciotomy) the contractures, and the treatment offered is frequently determined by surgeon preference. This study aims to determine the feasibility of conducting a large, multicentre randomised controlled trial to assess the clinical and cost-effectiveness of needle fasciotomy versus limited fasciectomy for the treatment of Dupuytren's contracture.Methods/design: HAND-1 is a parallel, two-arm, multicentre, randomised feasibility trial. Eligible patients aged 18 years or over who have one or more fingers with a Dupuytren's contracture of more than 30° in the metacarpophalangeal (MCP) and/or proximal interphalangeal (PIP) joints, well-defined cord(s) causing contracture, and have not undergone previous surgery for Dupuytren's on the same hand will be randomised (1:1) to treatment with either needle fasciotomy or limited fasciectomy. Participants will be followed-up for up to 6 months post surgery. Feasibility outcomes include number of patients screened, consented and randomised, adherence with treatment, completion of follow-up and identification of an appropriate patient-reported outcome measure (PROM) to use as primary outcome for a main trial. Embedded qualitative research, incorporating a QuinteT Recruitment Intervention, will focus on understanding and optimising the recruitment process, and exploring patients' experiences of trial participation and the interventions.Discussion: This study will assess whether a large multicentre trial comparing the clinical and cost-effectiveness of needle fasciotomy and limited fasciectomy for the treatment of Dupuytren's contractures is feasible, and if so will provide data to inform its design and successful conduct.Trial Registration: International Standard Registered Clinical/soCial sTudy Number: ISRCTN11164292 . Registered on 28 August 2015. [ABSTRACT FROM AUTHOR]

Background: National guidance recommends pregnant women are offered membrane sweeping at term to reduce induction of labour. Local audit suggested this was not being undertaken routinely across two maternity units in the West Midlands, UK between March and November 2012.Methods: Bespoke training session for midwifery teams (nine community and one antenatal clinic) was developed to address identified barriers to encourage offer of membrane sweeping, together with an information leaflet for women and appointment of a champion within each team. The timing of training session on membrane sweeping to ten midwifery teams was randomly allocated using a stepped wedge cluster randomised design. All women who gave birth in the Trusts after 39 + 3/40 weeks gestation within the study time period were eligible. Relevant anonymised data were extracted from maternity notes for three months before and after training. Data were analysed using a generalised linear mixed model, allowing for clustering and adjusting for temporal effects. Primary outcomes were number of women offered and accepting membrane sweeping and average number of sweeps per woman. Sub-group comparisons were undertaken for adherence to Trust guidance and potential influence of pre-specified maternal characteristics. Data included whether sweeping was offered but declined and no record of membrane sweeping.Results: Training was given to all teams as planned. Analyses included data from 2787 of the 2864 (97%) eligible low-risk women over 39 + 4 weeks pregnant. Characteristics of the women were similar before and after training. No evidence of difference in proportion of women being offered and accepting membrane sweeping (44.4% before training versus 46.8% after training (adjusted relative risk [aRR] = 0.90, 95% confidence interval [CI] = 0.71-1.13), nor in average number of sweeps per woman (0.603 versus 0.627, aRR = 0.83, 95% CI = 0.67-1.01). No differences in any secondary outcomes nor influence of maternal characteristics were demonstrated. The midwives evaluated training positively.Conclusions: This stepped wedge cluster trial enabled randomised evaluation within a natural roll-out and demonstrates the importance of robust evaluation in circumstances in which it is rarely undertaken. While the midwives evaluated the training positively, it did not appear to change practice.Trials Registration: ISRCTN14300475 . Registered on 23 August 2016. [ABSTRACT FROM AUTHOR]

Background: Atopic eczema (AE) is a common skin problem that impairs quality of life and is associated with the development of other atopic diseases including asthma, food allergy and allergic rhinitis. AE treatment is a significant cost burden for health care providers. The purpose of the trial is to investigate whether daily application of emollients for the first year of life can prevent AE developing in high-risk infants (first-degree relative with asthma, AE or allergic rhinitis).Methods: This is a protocol for a pragmatic, two-arm, randomised controlled, multicentre trial. Up to 1400 term infants at high risk of developing AE will be recruited through the community, primary and secondary care in England. Participating families will be randomised in a 1:1 ratio to receive general infant skin-care advice, or general skin-care advice plus emollients with advice to apply daily to the infant for the first year of life. Families will not be blinded to treatment allocation. The primary outcome will be a blinded assessment of AE at 24 months of age using the UK Working Party Diagnostic Criteria for Atopic Eczema. Secondary outcomes are other definitions of AE, time to AE onset, severity of AE (EASI and POEM), presence of other allergic diseases including food allergy, asthma and hay fever, allergic sensitisation, quality of life, cost-effectiveness and safety of the emollients. Subgroup analyses are planned for the primary outcome according to filaggrin genotype and the number of first-degree relatives with AE and other atopic diseases. Families will be followed up by online and postal questionnaire at 3, 6, 12 and 18 months with a face-to-face visit at 24 months. Long-term follow-up until 60 months will be via annual questionnaires.Discussion: This trial will demonstrate whether skin-barrier enhancement through daily emollient for the first year of life can prevent AE from developing in high-risk infants. If effective, this simple and cheap intervention has the potential to result in significant cost savings for health care providers throughout the world by preventing AE and possibly other associated allergic diseases.Trial Registration: ISRCTN registry; ID: ISRCTN21528841 . Registered on 25 July 2014. [ABSTRACT FROM AUTHOR]

Background: NHS specialist chronic fatigue syndrome (CFS/ME) services in England treat approximately 8000 adult patients each year. Variation in therapy programmes and treatment outcomes across services has not been described.Methods: We described treatments provided by 11 CFS/ME specialist services and we measured changes in patient-reported fatigue (Chalder, Checklist Individual Strength), function (SF-36 physical subscale, Work & Social Adjustment Scale), anxiety and depression (Hospital Anxiety & Depression Scale), pain (visual analogue rating), sleep (Epworth, Jenkins), and overall health (Clinical Global Impression) 1 year after the start of treatment, plus questions about impact of CFS/ME on employment, education/training and domestic tasks/unpaid work. A subset of these outcome measures was collected from former patients 2-5 years after assessment at 7 of the 11 specialist services.Results: Baseline data at clinical assessment were available for 952 patients, of whom 440 (46.2%) provided 1-year follow-up data. Treatment data were available for 435/440 (98.9%) of these patients, of whom 175 (40.2%) had been discharged at time of follow-up. Therapy programmes varied substantially in mode of delivery (individual or group) and number of sessions. Overall change in health 1 year after first attending specialist services was 'very much' or 'much better' for 27.5% (115/418) of patients, 'a little better' for 36.6% (153/418), 'no change' for 15.8% (66/418), 'a little worse' for 12.2% (51/418), and 'worse' or 'very much worse' for 7.9% (33/418). Among former patients who provided 2- to 5-year follow-up (30.4% (385/1265)), these proportions were 30.4% (117/385), 27.5% (106/385), 11.4% (44/385), 13.5% (52/385), and 17.1% (66/385), respectively. 85.4% (327/383) of former patients responded "Yes" to "Do you think that you are still suffering from CFS/ME?" 8.9% (34/383) were "Uncertain", and 5.7% (22/383) responded "No".Conclusions: This multi-centre NHS study has shown that, although one third of patients reported substantial overall improvement in their health, CFS/ME is a long term condition that persists for the majority of adult patients even after receiving specialist treatment. [ABSTRACT FROM AUTHOR]

Background: Patient and public involvement (PPI) is framed as positive for individuals, the health system, public health, as well as for communities and society as a whole. We investigated whether preferences for PPI differed between two countries with Beveridge type health systems-Sweden and England. We measured willingness to be involved in individual treatment decisions and in decisions about the organization and provision of local health and social care services.Methods: This was a comparative cross-sectional study of the general population's preferences. Together, the two samples included 3125 respondents; 1625 in England and 1500 in Sweden. Country differences were analysed in a multinomial regression model controlling for gender, age and educational attainment.Results: Overall, 68% of respondents wanted a passive patient role and 44% wanted to be involved in local decisions about organization and provision of services. In comparison with in Sweden, they were in England less likely to want a health professional such as a GP or consultant to make decisions about their treatment and also more likely to want to make their own decisions. They were also less likely to want to be involved in local service development decisions. An increased likelihood of wanting to be involved in organizational decision-making was associated with individuals wanting to make their own treatment decisions. Women were less likely to want health professionals to make decisions and more likely to want to be involved in organizational decisions.Conclusions: An effective health system that ensures public health must integrate an effective approach to PPI both in individual treatment decisions and shaping local health and social care priorities. To be effective, involvement activities must take in to account the variation in the desire for involvement and the implications that this has for equity. More work is needed to understand the relationship between the desire to be involved and actually being involved, but both appear related to judgements of the impact of involvement on health care decisions. [ABSTRACT FROM AUTHOR]

Background: Research into relational care in hospitals will be facilitated by a focus on staff-patient interactions. The Quality of Interactions Schedule (QuIS) uses independent observers to measure the number of staff-patient interactions within a healthcare context, and to rate these interactions as 'positive social'; 'positive care'; 'neutral'; 'negative protective'; or 'negative restrictive'. QuIS was developed as a research instrument in long term care settings and has since been used for quality improvement in acute care. Prior to this study, its use had not been standardised, and reliability and validity in acute care had not been established.Methods: In 2014 and 2015 a three - phase study was undertaken to develop and test protocols for the use of QuIS across three acute wards within one NHS trust in England. The phases were: (1) A pilot of 16 h observation which developed implementation strategies for QuIS in this context; (2) training two observers and undertaking 16 h of paired observation to inform the development of training protocols; (3) training four nurses and two lay volunteers according to a finalised protocol followed by 36 h of paired observations to test inter-rater agreement. Additionally, patients were asked to rate interactions and to complete a shortened version of the Patient Evaluation of Emotional Care during Hospitalisation (PEECH) questionnaire.Results: Protocols were developed for the use of QuIS in acute care. Patients experienced an average of 6.7 interactions/patient/h (n = 447 interactions). There was close agreement between observers in relation to the number of interactions observed (Intraclass correlation coefficient (ICC) = 0.97) and moderate to substantial agreement on the quality of interactions (absolute agreement 73%, kappa 0.53 to 0.62 depending on weighting scheme). There was 79% agreement (weighted kappa 0.40: P < 0.001; indicating fair agreement) between patients and observers over whether interactions were positive, negative or neutral.Conclusions: Observers using clear QuIS protocols can achieve levels of agreement that are acceptable for the use of QuIS as a research instrument. There is fair agreement between observers and patients' rating of interactions. Further research is needed to explore the relationship between QuIS measures and reported patient experience. [ABSTRACT FROM AUTHOR]

Background: The provision of patient information leaflets regarding telehealth has been perceived by potential consumers as a strategy to promote awareness and adoption of telehealth services. However, such leaflets need to be designed carefully if adoption and awareness among potential users is to be promoted. Therefore, the aims of this study were: first, to see how telehealth was portrayed in some of the existing telehealth leaflets (THLs). Second, to explore patients' perceptions of the existing THLs and their engagement with the concept and how THLs can be optimised.Methods: A two-step approach was employed to address the aims of this study. The first phase involved the use of discourse analysis to compare 12 electronically and publically available THLs, with the existing THL guidance "Involve Yorkshire and Humber". The second phase involved conducting 14 semi-structured interviews with potential telehealth users/patients to gauge their perception and engagement with the concept, using the two leaflets that were mostly matching with the guidance used. Six interviews were audio-recorded and eight had detailed jotted notes. The interviews were transcribed and thematically analysed to identify key themes.Results: The discourse analysis showed certain gaps and variations within the screened leaflets when addressing the following aspects: cost of the telehealth service, confidentiality, patients' choices in addition to equipment use and technical support. Analysis of the interviews revealed patients' need for having clear and sufficient information about the telehealth service within the THLs; in addition to, patients' preference for the use of simpler terminologies for telehealth description and the provision of clear simple texts with pictorial presentations. The interviews also revealed certain limitations against adoption of telehealth by the participants, such as: lack of privacy and confidentiality of information, fear of technology breakdown and equipment failure, loss of face-to-face contact with healthcare professionals and being too dependent on the telehealth service.Conclusion: The current study showed a great variation among the screened THLs and highlighted certain gaps within the content and presentation of these leaflets. However, the study also highlighted certain key issues to be considered when designing THLs in the future to enhance telehealth uptake and use by patients. [ABSTRACT FROM AUTHOR]

Background: Accurate calculation of hospital length of stay (LOS) from the English Hospital Episode Statistics (HES) is important for a wide range of audit and research purposes. The two methodologies which are commonly used to achieve this differ in their accuracy and complexity. We compare these methods and make recommendations on when each is most appropriate.Methods: We calculated LOS using continuous inpatient spells (CIPS), which link care spanning across multiple hospitals, and spells, which do not, for six conditions with short (dyspepsia or other stomach function, ENT infection), medium (dehydration and gastroenteritis, perforated or bleeding ulcer), and long (stroke, fractured proximal femur) average LOS. We examined how inter-area comparisons (i.e. benchmarking) and temporal trends differed. We defined a classification system for spells and explored the causes of differences.Results: Stroke LOS was 16.5 days using CIPS but 24% (95% CI: 23, 24) lower, at 12.6 days, using spells. Smaller differences existed for shorter-LOS conditions including dehydration and gastroenteritis (4.5 vs. 4.2 days) and ENT infection (0.9 vs. 0.8 days). Typical patient pathways differed markedly between areas and have evolved over time. One area had the third shortest stroke LOS (out of 151) using spells but the fourth longest using CIPS. These issues were most profound for stroke and fractured proximal femur, as patients were frequently transferred to a separate hospital for rehabilitation, however important disparities also existed for conditions with simpler secondary care pathways (e.g. ENT infections, dehydration and gastroenteritis).Conclusions: Spell-based LOS is widely used by researchers and national reporting organisations, including the Health and Social Care Information Centre, however it can substantially underestimate the time patients spend in hospital. A widespread shift to a CIPS methodology is required to improve the quality of LOS estimates and the robustness of research and benchmarking findings. This is vital when investigating clinical areas with typically long, complex patient pathways. Researchers should ensure that their LOS calculation methodology is fully described and explicitly acknowledge weaknesses when appropriate. [ABSTRACT FROM AUTHOR]

Background: Extended brief interventions (EBIs) are effective in targeting alcohol misuse in the general population. However, little is known of the effects of EBI in adults with intellectual (also known as learning) disabilities. In this feasibility trial we compared EBI with usual care for alcohol misuse in adults with mild to moderate Intellectual Disability (ID).Methods: The study took place in three community ID networks of services in England. Participants aged 18-65 years with reported alcohol problems, a score ≥8 on the Alcohol Use Disorder Identification Test (AUDIT), and IQ <70 (+/5%CI) were recruited and were randomly allocated to either EBI (five weekly sessions and one follow-up at 8 weeks) and usual care or usual care alone. Research assistants were blind to arm allocation. Research assessments took place at baseline, 2 and 3 months. The primary outcome was reduction in alcohol consumption measured by the AUDIT. Preliminary health economic analysis was performed to investigate the costs of delivering EBI and the feasibility of a cost-effectiveness analysis in a full trial. The trial is closed.Results: Participants were recruited from January 2014 to August 2015. Thirty individuals were randomised (15 in each arm) and provided primary outcome data. In regard to harmful drinking, at baseline, all the participants exceeded the relevant threshold. At 8 weeks, the proportion of participants with harmful drinking had decreased to 60% for both groups, and at 12 weeks it had decreased by 66°7% and 46°7% for the intervention and the control groups, respectively. The unit cost for the delivery of EBI is £430.Conclusions: Recruitment to this trial has been proven challenging as prevalence of alcohol misuse in the targeted population was lower than anticipated. EBI may provide an effective low-intensity treatment for this population. Participants' and carers' feedback on their experience was overall positive. Further work needs to be undertaken to ascertain the group of participants that should be participating in a future definitive trial.Trial Registration: Psychological Intervention Alcohol Misuse Learning Disability; isrctn.com, identifier: ISRCTN58783633 . Registered on 17 December 2013. [ABSTRACT FROM AUTHOR]

Background: Mobile devices may facilitate depression screening in the waiting area of antenatal clinics. This can present implementation challenges, of which we focused on survey layout and technology deployment.Methods: We assessed the feasibility of using tablet computers to administer a socio-demographic survey, the Whooley questions and the Edinburgh Postnatal Depression Scale (EPDS) to 530 pregnant women attending National Health Service (NHS) antenatal clinics across England. We randomised participants to one of two layout versions of these surveys: (i) a scrolling layout where each survey was presented on a single screen; or (ii) a paging layout where only one question appeared on the screen at any given time.Results: Overall, 85.10% of eligible pregnant women agreed to take part. Of these, 90.95% completed the study procedures. Approximately 23% of participants answered Yes to at least one Whooley question, and approximately 13% of them scored 10 points of more on the EPDS. We observed no association between survey layout and the responses given to the Whooley questions, the median EPDS scores, the number of participants at increased risk of self-harm, and the number of participants asking for technical assistance. However, we observed a difference in the number of participants at each EPDS scoring interval (p = 0.008), which provide an indication of a woman's risk of depression. A scrolling layout resulted in faster completion times (median = 4 min 46 s) than a paging layout (median = 5 min 33 s) (p = 0.024). However, the clinical significance of this difference (47.5 s) is yet to be determined.Conclusions: Tablet computers can be used for depression screening in the waiting area of antenatal clinics. This requires the careful consideration of clinical workflows, and technology-related issues such as connectivity and security. An association between survey layout and EPDS scoring intervals needs to be explored further to determine if it corresponds to a survey layout effect. Future research needs to evaluate the effect of this type of antenatal depression screening on clinical outcomes and clinic workflows.Trial Registration: This study was registered in ClinicalTrials.gov under the identifier NCT02516982 on 20 July 2015. [ABSTRACT FROM AUTHOR]

Background: As life expectancy increases and the number of older people, particularly those aged 85 years and over, expands there is an increase in demand for long-term care. A large proportion of people in a care home setting spend most of their time sedentary, and this is one of the leading preventable causes of death. Encouraging residents to engage in more physical activity could deliver benefits in terms of physical and psychological health, and quality of life. This study is the final stage of a programme of research to develop and preliminarily test an evidence-based intervention designed to enhance opportunities for movement amongst care home residents, thereby increasing levels of physical activity.Methods/design: This is a cluster randomised feasibility trial, aiming to recruit at least 8-12 residents at each of 12 residential care homes across Yorkshire, UK. Care homes will be randomly allocated on a 1:1 basis to receive either the intervention alongside usual care, or to continue to provide usual care alone. Assessment will be undertaken with participating residents at baseline (prior to care home randomisation) and at 3, 6, and 9 months post-randomisation. Data relating to changes in physical activity, physical function, level of cognitive impairment, mood, perceived health and wellbeing, and quality of life will be collected. Data at the level of the home will also be collected and will include staff experience of care, and changes in the numbers and types of adverse events residents experience (for example, hospital admissions, falls). Details of National Health Service (NHS) usage will be collected to inform the economic analysis. An embedded process evaluation will obtain information to test out the theory of change underpinning the intervention and its acceptability to staff and residents.Discussion: This feasibility trial with embedded process evaluation and collection of health economic data will allow us to undertake detailed feasibility work to inform a future large-scale trial. It will provide valuable information to inform research procedures in this important but challenging area.Trial Registration: ISRCTN registry, ISRCTN16076575 . Registered on 25 June 2015. [ABSTRACT FROM AUTHOR]

Background: The estimated number of cigarette smokers in the world is 1.3 billion, expected to rise to 1.7 billion by 2025, with 10 million smokers living in the U.K. Smoking is the leading, preventable death-cause worldwide, being responsible for almost 650,000 deaths in the E.U. annually. A combination of pharmacological interventions, including nicotine replacement therapy, bupropion and varenicline, and behavioural support is the most effective approach to smoking cessation. However, even the best methods have high relapse rates of approximately 75% within 6 months. Electronic (or "e-") cigarettes use battery power to disperse a solution that usually contains propylene glycol or glycerine, water, flavouring and nicotine. E-cigarettes have become the most popular smoking cessation aid in England, however, information on their effects on cardiovascular function is limited and contradictory. As e-cigarettes are not solely nicotine-based products, existing research exploring the effects of nicotine on the cardio-vasculature provides only limited information, while their extensive uptake urges the need of evidence to inform the general public, smokers and policy-makers.Methods: This is a pragmatic, 3-group, randomised, assessor-blinded, single-centre trial exploring the cardiovascular physiological effects of the use of e-cigarettes (nicotine-free and nicotine-inclusive, assessed separately) combined with behavioural support as a smoking cessation method in comparison to the combination of NRT and behavioural support. The primary outcome will be macro-vascular function, determined by a Flow Mediated Dilatation ultrasound assessment, 6 months following participants' "quit date".Discussion: Participants will be assessed at baseline, 3 days following their self-determined "quit date", at intervention end (3 months) and 6 months following their "quite date". Findings are expected to give an indication of the cardiovascular effects of e-cigarettes both in the short- and in the medium-term period, informing the general public, policy holders and researchers, helping to define the future role of e-cigarettes as a smoking cessation aid.Trial Registration: Clinicaltrials.gov NCT03061253 . Registered 17th February 2017. [ABSTRACT FROM AUTHOR]