Helicobacter pylori eradication for primary prevention of peptic ulcer bleeding in older patients prescribed aspirin in primary care (HEAT): a randomised, double-blind, placebo-controlled trial.

BACKGROUND: Peptic ulcers in patients receiving aspirin are associated with Helicobacter pylori infection. We aimed to investigate whether H pylori eradication would protect against aspirin-associated ulcer bleeding. METHODS: We conducted a randomised, double-blind, placebo-controlled trial (Helicobacter Eradication Aspirin Trial [HEAT]) at 1208 primary care centres in the UK, using routinely collected clinical data. Eligible patients were aged 60 years or older who were receiving aspirin at a daily dose of 325 mg or less (with four or more 28-day prescriptions in the past year) and had a positive C13 urea breath test for H pylori at screening. Patients receiving ulcerogenic or gastroprotective medication were excluded. Participants were randomly assigned (1:1) to receive either a combination of oral clarithromycin 500 mg, metronidazole 400 mg, and lansoprazole 30 mg (active eradication), or oral placebo (control), twice daily for 1 week. Participants, their general practitioners and health-care providers, and the research nurses, trial team, adjudication committee, and analysis team were all masked to group allocation throughout the trial. Follow-up was by scrutiny of electronic data in primary and secondary care. The primary outcome was time to hospitalisation or death due to definite or probable peptic ulcer bleeding, and was analysed by Cox proportional hazards methods in the intention-to-treat population. This trial is registered with EudraCT, 2011-003425-96. FINDINGS: Between Sept 14, 2012, and Nov 22, 2017, 30 166 patients had breath testing for H pylori, 5367 had a positive result, and 5352 were randomly assigned to receive active eradication (n=2677) or placebo (n=2675) and were followed up for a median of 5·0 years (IQR 3·9-6·4). Analysis of the primary outcome showed a significant departure from proportional hazards assumptions (p=0·0068), requiring analysis over separate time periods. There was a significant reduction in incidence of the primary outcome in the active eradication group in the first 2·5 years of follow-up compared with the control group (six episodes adjudicated as definite or probable peptic ulcer bleeds, rate 0·92 [95% CI 0·41-2·04] per 1000 person-years vs 17 episodes, rate 2·61 [1·62-4·19] per 1000 person-years; hazard ratio [HR] 0·35 [95% CI 0·14-0·89]; p=0·028). This advantage remained significant after adjusting for the competing risk of death (p=0·028) but was lost with longer follow-up (HR 1·31 [95% CI 0·55-3·11] in the period after the first 2·5 years; p=0·54). Reports of adverse events were actively solicited; taste disturbance was the most common event (787 patients). INTERPRETATION: H pylori eradication protects against aspirin-associated peptic ulcer bleeding, but this might not be sustained in the long term. FUNDING: National Institute for Health and Care Research Health Technology Assessment.

Implementation fidelity of the 'Stay One Step Ahead' home safety intervention: a mixed-methods analysis.

OBJECTIVE: To assess implementation fidelity of the Stay One Step Ahead (SOSA), a complex intervention which was delivered by health visiting teams, children's centres, and family mentors and was aimed at preventing unintentional home injuries in children under 5 in disadvantaged communities. STUDY DESIGN: A mixed-methods evaluation of the implementation fidelity of the SOSA intervention. METHODS: A conceptual framework for implementation fidelity was used to triangulate data from questionnaires and semistructured interviews with parents and practitioners, observations of parent and practitioner contacts, and meeting documents. Quantitative data were analysed using logistic regression and descriptive statistics. Thematic analysis was used for qualitative data. RESULTS: Parents in intervention wards were more likely to receive home safety advice from a practitioner than those living in matched control wards. Monthly safety messages and family mentor home safety activities were delivered with greater fidelity than other intervention components. Content most frequently adapted included the home safety checklist used by health visiting teams, and safety weeks delivered at children's centres. CONCLUSION: Consistent with similarly complex interventions, SOSA was delivered with variable fidelity in a challenging environment. The findings add to the body of evidence on implementation fidelity of home injury prevention programmes, providing important information for future intervention development and delivery.

Cost-effectiveness of England's national 'Safe At Home' scheme for reducing hospital admissions for unintentional injury in children aged under 5.

BACKGROUND: Injuries in children aged under 5 years most commonly occur in the home and disproportionately affect those living in the most disadvantaged communities. The 'Safe at Home' (SAH) national home safety equipment scheme, which ran in England between 2009 and 2011, has been shown to reduce injury-related hospital admissions, but there is little evidence of cost-effectiveness. MATERIALS AND METHODS: Cost-effectiveness analysis from a health and local government perspective. Measures were the incremental cost-effectiveness ratio per hospital admission averted (ICER) and cost-offset ratio (COR), comparing SAH expenditure to savings in admission expenditure. The study period was split into three periods: T1 (years 0-2, implementation); T2 (years 3-4) and T3 (years 5-6). Analyses were conducted for T2 versus T1 and T3 versus T1. RESULTS: Total cost of SAH was £9 518 066. 202 223 hospital admissions in the children occurred during T1-3, costing £3 320 000. Comparing T3 to T1 SAH reduced admission expenditure by £924 per month per local authority and monthly admission rates by 0.5 per local authority per month compared with control areas. ICER per admission averted was £4209 for T3 versus T1, with a COR of £0.29, suggesting that 29p was returned in savings on admission expenditure for every pound spent on SAH. CONCLUSION: SAH was effective at reducing hospital admissions due to injury and did result in some cost recovery when taking into admissions only. Further analysis of its cost-effectiveness, including emergency healthcare, primary care attendances and wider societal costs, is likely to improve the return on investment further.

Effectiveness of systematically delivered evidence-based home safety promotion to improve child home safety practices: a controlled before-and-after study.

OBJECTIVE: Evaluate the effectiveness of systematically delivered evidence-based home safety promotion for improving child home safety practices. DESIGN: Controlled before-and-after study. SETTING: Nine electoral wards in Nottingham, UK. PARTICIPANTS: 361 families with children aged 2-7 months at recruitment living in four intervention wards with high health, education and social need; and 401 in five matched control wards. INTERVENTION: Evidence-based home safety promotion delivered by health visiting teams, family mentors and children's centres including 24 monthly safety messages; home safety activity sessions; quarterly 'safety weeks'; home safety checklists. OUTCOMES: Primary: composite measure comprising having a working smoke alarm, storing poisons out of reach and having a stairgate. Secondary: other home safety practices; medically attended injuries. Parents completed questionnaires at 12 and 24 months after recruitment plus optional three monthly injury questionnaires. RESULTS: At 24 months there was no significant difference between groups in the primary outcome (55.8% vs 48.8%; OR 1.58, 95% CI 0.98 to 2.55) or medically attended injury rates (incidence rate ratio 0.89, 95% CI 0.51 to 1.56), but intervention families were more likely to store poisons safely (OR 1.81, 95% CI 1.06 to 3.07), have a fire escape plan (OR 1.81, 95% CI 1.06 to 3.08), use a fireguard or have no fire (OR 3.17, 95% CI 1.63 to 6.16) and perform more safety practices (ß 0.46, 95% CI 0.13 to 0.79). CONCLUSIONS: Systematic evidence-based home safety promotion in areas with substantial need increases adoption of some safety practices. Funders should consider commissioning evidence-based multicomponent child home safety interventions. TRIAL REGISTRATION NUMBER: ISRCTN31210493.

'It is designed for everybody to find their own level and to improve themselves'; views of older people and instructors of the Falls Management Exercise (FaME) programme.

BACKGROUND: Older adults are at increased risk of falls due to ageing, decreased muscle strength and impaired balance. Clinical trials have demonstrated the efficacy and effectiveness of the Falls Management Exercise (FaME) programme in improving functioning and preventing falls. However, programme completion is often low, impacting the potential benefits of FaME. OBJECTIVE: To explore the barriers and facilitators for participation and completion of the FaME programme from an instructor and participant perspective. METHODS: Semi-structured interviews were conducted with 20 FaME users and seven Postural Stability Instructors from the East Midlands region of England, UK. Interviews were conducted using a topic guide and explored their views of the programme, intended benefits, reasons for participating, instructor's approach and venue facilities. Data were transcribed verbatim and analysed using thematic analysis. Written informed consent was obtained from all participants and instructors. RESULTS: Common themes identified by participants and instructors for adherence related to perceived health benefits, psychological well-being, intervention characteristics, cost, instructors' qualities, opportunity to socialise, venue accessibility and facilities. Further factors such as maintaining independence, discipline, relationship with peers and caring responsibilities influenced participants' engagement with the programme. Instructor factors such as progression were also reported as important predictors. CONCLUSIONS: Instructor and participant factors influence uptake, attendance and adherence of FaME. The findings from this study can inform the development and improvement of additional falls-prevention programmes. It can also guide marketing strategies to promote uptake of exercise-based falls-prevention programmes among older adults.

Mental health and other factors associated with work productivity after injury in the UK: multicentre cohort study.

INTRODUCTION: Mental health conditions are a major contributor to productivity loss and are common after injury. This study quantifies postinjury productivity loss and its association with preinjury and postinjury mental health, injury, demographic, health, social and other factors. METHODS: Multicentre, longitudinal study recruiting hospitalised employed individuals aged 16-69 years with unintentional injuries, followed up at 1, 2, 4 and 12 months. Participants completed questionnaires on injury, demographic factors, health (including mental health), social factors, other factors and on-the-job productivity upon return to work (RTW). ORs were estimated for above median productivity loss using random effects logistic regression. RESULTS: 217 adults had made an RTW at 2, 4 or 12 months after injury: 29% at 2 months, 66% at 4 months and 83% at 12 months. Productivity loss reduced over time: 3.3% of working time at 2 months, 1.7% at 4 months, 1% at 12 months. Significantly higher productivity loss was associated with preinjury psychiatric conditions (OR 21.40, 95% CI 3.50 to 130.78) and post-traumatic stress avoidance symptoms at 1 month (OR for 1-unit increase in score 1.15, 95% CI 1.07 to 1.22). Significantly lower productivity loss was associated with male gender (OR 0.32, 95% CI 0.14 to 0.74), upper and lower limb injuries (vs other body regions, OR 0.15, 95% CI 0.03 to 0.81) and sports injuries (vs home, OR 0.18, 95% CI 0.04 to 0.78). Preinjury psychiatric conditions and gender remained significant in analysis of multiply imputed data. CONCLUSIONS: Unintentional injury results in substantial productivity loss. Females, those with preinjury psychiatric conditions and those with post-traumatic stress avoidance symptoms experience greater productivity loss and may require additional support to enable successful RTW.

Earlier diagnosis of lung cancer in a randomised trial of an autoantibody blood test followed by imaging.

The EarlyCDT-Lung test is a high-specificity blood-based autoantibody biomarker that could contribute to predicting lung cancer risk. We report on the results of a phase IV biomarker evaluation of whether using the EarlyCDT-Lung test and any subsequent computed tomography (CT) scanning to identify those at high risk of lung cancer reduces the incidence of patients with stage III/IV/unspecified lung cancer at diagnosis compared with the standard clinical practice at the time the study began.The Early Diagnosis of Lung Cancer Scotland (ECLS) trial was a randomised controlled trial of 12 208 participants at risk of developing lung cancer in Scotland in the UK. The intervention arm received the EarlyCDT-Lung test and, if test-positive, low-dose CT scanning 6-monthly for up to 2 years. EarlyCDT-Lung test-negative and control arm participants received standard clinical care. Outcomes were assessed at 2 years post-randomisation using validated data on cancer occurrence, cancer staging, mortality and comorbidities.At 2 years, 127 lung cancers were detected in the study population (1.0%). In the intervention arm, 33 out of 56 (58.9%) lung cancers were diagnosed at stage III/IV compared with 52 out of 71 (73.2%) in the control arm. The hazard ratio for stage III/IV presentation was 0.64 (95% CI 0.41-0.99). There were nonsignificant differences in lung cancer and all-cause mortality after 2 years.ECLS compared EarlyCDT-Lung plus CT screening to standard clinical care (symptomatic presentation) and was not designed to assess the incremental contribution of the EarlyCDT-Lung test. The observation of a stage shift towards earlier-stage lung cancer diagnosis merits further investigations to evaluate whether the EarlyCDT-Lung test adds anything to the emerging standard of low-dose CT.

Evidence generated from a realist synthesis of trials on educational weight loss interventions in type 2 diabetes mellitus.

BACKGROUND: Obesity and diabetes are major public health problems. Current approaches to weight loss show varying success. Complex community-based interventions work through several interconnected stages. An individual's actions in response to an intervention depend on many known and unknown factors, which vary among individuals. AIM: To conduct a realist synthesis to identify in which context, for whom, in what circumstances, and how weight loss interventions work in obese or overweight individuals with type 2 diabetes. METHODS: A total of 49 trials identified during a systematic review were subsequently analysed using realist methodology. This iterative process involved hypothesis generation about how participants within a particular context respond to an intervention's resources producing the outcomes. We used established behaviour change theory to look for repeating themes. Theory and 'mechanisms' were tested against the literature on what is shown to be effective. Where established theory was lacking, we discussed issues during discussion groups with individuals living with the condition to generate our own programme theories. RESULTS: Mechanisms that were repeatedly identified included high-frequency contact with those delivering the intervention, social support, education increasing awareness of diabetes-related modifiable risk factors, motivational interviewing and counselling, goal-setting, self-monitoring and feedback and meal replacements. The central theme underlying successful mechanisms was personalising each intervention component to the participants' gender, culture and family setting. CONCLUSION: This is the first comprehensive realist synthesis in this field. Our findings suggest that, for weight loss interventions to be successful in those with diabetes, they must be personalized to the individual and their specific context.

'Real world' effectiveness of the Falls Management Exercise (FaME) programme: an implementation study.

BACKGROUND: Falls incidence increases with age alongside declines in strength and balance. Clinical trials show that the Falls Management Exercise (FaME) programme improves strength and balance, which can reduce falls and improve physical functioning. OBJECTIVE: To determine if the clinical trial efficacy of FaME translates into effectiveness in non-research settings. DESIGN AND SETTING: An implementation study of FaME in 10 local authorities across the East Midlands region of England. SUBJECTS: Adults aged 65 and over enrolled on a FaME programme. METHOD: Anonymised outcome data collected by the FaME providers were compared at baseline, end of programme and 6 months follow-up using univariate and multivariate analyses. RESULTS: For 348 adults enrolled in programmes and analysed, the mean age was 76.8, 73% were female and 143 (41%) completed ≥75% of classes. Overall confidence in balance, fear of falling, functional reach and timed-up-and-go (all P < 0.001), and turn 180° (P = 0.008) improved significantly at programme completion versus baseline, but improvements were not maintained 6 months later. Falls risk (FRAT score) and total minutes of physical activity did not change significantly though minutes of strength and balance activity increased by 55% at programme completion and was maintained at 6 months. The falls incidence rate ratio (IRR) was non-significantly lower at programme completion (IRR 0.76, 95% Confidence Interval (CI) 0.48,1.21) and follow-up (IRR 0.82 95% CI 0.48,1.39) versus baseline. CONCLUSIONS: There is modest translation of FaME efficacy into effectiveness, but not all effects persist after completion. Strategies to aid adherence and exercise maintenance are important to maximise benefits.

A study of mapping usual care and unmet need for vocational rehabilitation and psychological support following major trauma in five health districts in the UK.

OBJECTIVE: To identify where and how trauma survivors' rehabilitation needs are met after trauma, to map rehabilitation across five UK major trauma networks, and to compare with recommended pathways. DESIGN: Qualitative study (interviews, focus groups, workshops) using soft-systems methodology to map usual care across trauma networks and explore service gaps. Publicly available documents were consulted. CATWOE (Customers, Actors, Transformation, Worldview, Owners, Environment) was used as an analytic framework to explore the relationship between stakeholders in the pathway. SETTING: Five major trauma networks across the UK. SUBJECTS: 106 key rehabilitation stakeholders (service providers, trauma survivors) were recruited to interviews (n = 46), focus groups (n = 4 groups, 17 participants) and workshops (n = 5 workshops, 43 participants). INTERVENTIONS: None. RESULTS: Mapping of rehabilitation pathways identified several issues: (1) lack of vocational/psychological support particularly for musculoskeletal injuries; (2) inconsistent service provision in areas located further from major trauma centres; (3) lack of communication between acute and community care; (4) long waiting lists (up to 12 months) for community rehabilitation; (5) most well-established pathways were neurologically focused. CONCLUSIONS: The trauma rehabilitation pathway is complex and varies across the UK with few, if any patients following the recommended pathway. Services have developed piecemeal to address specific issues, but rarely meet the needs of individuals with multiple impairments post-trauma, with a lack of vocational rehabilitation and psychological support for this population.

Evaluation of the effectiveness, implementation and cost-effectiveness of the Stay One Step Ahead home safety promotion intervention for pre-school children: a study protocol.

BACKGROUND: Unintentional injuries in children under the age of 5 years commonly occur in the home and disproportionately affect those living in disadvantaged circumstances. Targeted home safety promotion should be offered to families most at risk but there is a paucity of standardised evidence-based resources available for use across family-support practitioners. OBJECTIVE: To assess the effectiveness, implementation and cost-effectiveness of a 2-year home safety programme (Stay One Step Ahead) developed by parents, practitioners and researchers, and delivered by a range of family support providers in inner-city localities, compared with usual care in matched control localities. METHODS: Parents of children aged 0 to 7 months will be recruited to a controlled before and after observational study. The primary outcome is home safety assessed by the proportion of families with a fitted and working smoke alarm, safety gate on stairs (where applicable) and poisons stored out of reach, assessed using parent-administered questionnaires at baseline, 12 and 24 months.Secondary outcomes include: the impact on other parent-reported safety behaviours, medically-attended injuries, self-efficacy for home safety and knowledge of child development and injury risk using questionnaires and emergency department attendance data; implementation (reach, acceptability, barriers, facilitators) of home safety promotion assessed through interviews and observations; and cost-effectiveness using medically-attended injury costs ascertained from healthcare records. CONCLUSION: If shown to be effective and cost-effective this study will provide a practical resource to underpin national guidance. The study could inform public health prevention strategies to reduce home injury in children most at risk, while delivering cost savings to health and care services. TRIAL REGISTRATION NUMBER: ISRCTN31210493; Pre result.

PHysical activity Implementation Study In Community-dwelling AduLts (PHISICAL): study protocol.

BACKGROUND: Falls in older people are a leading causes of unintentional injury. Due to an ageing population, injuries are likely to increase unless more is done to reduce older people's falls risk. In clinical trials, the Falls Management Exercise (FaME) programme has reduced the rate of falls and falls-related injuries in community-dwelling older adults. However, the commissioning of FaME is inconsistent across England, potentially due to a lack of evidence that FaME can be delivered effectively in a 'real world' setting. The PHysical activity Implementation Study In Community-dwelling AduLts (PHISICAL) study is designed to study the implementation of FaME in a range of different settings in England. METHODS: The PHISICAL study will use a mixed-methods, triangulation, multilevel design to explore the implementation of FaME. Framework analysis of semistructured interviews with up to 90 stakeholders (exercise programme users, service providers, referrers and commissioners) and observational data from locally led communities of practice will identify the factors that influence FaME's implementation. Quantitative, anonymised, routine service data from up to 650 exercise programme users, including measures of falls and physical activity, will allow assessment of whether the benefits of FaME reported in clinical trials translate to the 'real world' setting. CONCLUSION: The findings from this study will be used to develop a toolkit of resources and guidance to inform the commissioning and delivery of future FaME programmes. This study has the potential to inform public health prevention strategies, and in doing so may reduce the number of falls in the older population while delivering cost savings to health and social care services.

Lung cancer screening: does pulmonary nodule detection affect a range of smoking behaviours?

BACKGROUND: Lung cancer screening can reduce lung cancer mortality by 20%. Screen-detected abnormalities may provide teachable moments for smoking cessation. This study assesses impact of pulmonary nodule detection on smoking behaviours within the first UK trial of a novel auto-antibody test, followed by chest x-ray and serial CT scanning for early detection of lung cancer (Early Cancer Detection Test-Lung Cancer Scotland Study). METHODS: Test-positive participants completed questionnaires on smoking behaviours at baseline, 1, 3 and 6 months. Logistic regression compared outcomes between nodule (n = 95) and normal CT groups (n = 174) at 3 and 6 months follow-up. RESULTS: No significant differences were found between the nodule and normal CT groups for any smoking behaviours and odds ratios comparing the nodule and normal CT groups did not vary significantly between 3 and 6 months. There was some evidence the nodule group were more likely to report significant others wanted them to stop smoking than the normal CT group (OR across 3- and 6-month time points: 3.04, 95% CI: 0.95, 9.73; P = 0.06). CONCLUSION: Pulmonary nodule detection during lung cancer screening has little impact on smoking behaviours. Further work should explore whether lung cancer screening can impact on perceived social pressure and promote smoking cessation.

Use it or lose it: a qualitative study of the maintenance of physical activity in older adults.

BACKGROUND: Lack of physical activity (PA) is a recognised global public health problem, which is increasing in prevalence with a detrimental impact on the pattern of disease worldwide. In the UK, older adults comprise the most sedentary group, with only 57% of males and 52% of females aged 65-74 years and 43% of males and 21% of females aged 75-84 years meeting PA recommendations. PA confers multiple health benefits including increased stamina, muscle, bone and joint strength, increased independence and reduced risk of falls in old age. Despite benefits experienced during time-limited PA programmes, increased PA is not always continued. This study aimed to provide a better understanding of PA maintenance behaviours in older people. METHODS: Face to face semi-structured interviews were conducted with adults who completed one of two strength and balance exercise programmes as part of the ProAct65+ trial: group (FaME) and home based (OTAGO) exercises. Five GP practices in Nottingham and Derby were recruited and invited people aged 65 years and older who met eligibility criteria. Interviews were conducted in participants' homes. Interviews explored PA levels pre and post intervention, perceived health benefits, facilitators, barriers and use of technology for PA maintenance. The interviews were transcribed verbatim and analysed using framework analysis and the software NVivo10. RESULTS: Fifteen participants from each intervention group were interviewed. The FaME group consisted of 10 females and 5 males, age range of 70-88 years. The OTAGO group consisted of 12 females and 3 males aged 72-95 years. Important themes identified were physical, social, psychological and environmental facilitators and barriers. These included increased physical autonomy, enjoyment, positive evaluation of the activity and physical benefits, importance of social interaction, positive feedback, development of behaviour considered normal or habitual, motivation and self-efficacy. Some participants used technologies not included in the original interventions, like pedometers and smart phones to motivate themselves. CONCLUSIONS: A range of modifiable factors influence continued participation in PA at the end of exercise programmes. The findings from this study will inform the commissioning and quality improvement of future PA programmes and development of an intervention to enhance continuation of PA after exercise interventions in older adults.

Determinants of motivation to quit in smokers screened for the early detection of lung cancer: a qualitative study.

BACKGROUND: The promotion of smoking cessation within lung cancer screening could lead to benefits for smoking-related disease and improve cost-effectiveness of screening. Little is known about how smokers respond to lung cancer screening and how this impacts smoking behaviour. We aimed to understand how lung cancer screening influences individual motivations about smoking, including in those who have stopped smoking since screening. METHODS: Thirty one long-term smokers aged 51-74 took part in semi-structured interviews about smoking. They had been screened with the EarlyCDT-Lung Test (13 positive result; 18 negative) as part of the Early Cancer Detection Test Lung Cancer Scotland Study. They were purposively sampled for interview based on their self-reported post-screening smoking behaviour. Eleven participants had stopped smoking since screening. Verbatim interview transcripts were analysed using thematic analysis. RESULTS: Two key overarching themes were interpretations of screening test results and emotional responses to those interpretations. Participants' understanding of the risk implied by their test result was often inaccurate, for example a negative result interpreted as an 'all-clear' from lung cancer and a positive result as meaning lung cancer would definitely develop. Those interpretations led to emotional responses (fear, shock, worry, relief, indifference) influencing motivations about smoking. Other themes included a wake-up call causing changes in perceived risk of smoking-related disease, a feeling that now is the time to stop smoking and family influences. There was no clear pattern in smoking motivations in those who received positive or negative test results. Of those who had stopped smoking, some cited screening experiences as the sole motivation, some cited screening along with other coinciding factors, and others cited non-screening reasons. Cues to change were experienced at different stages of the screening process. Some participants indicated they underwent screening to try and stop smoking, while others expressed little or no desire to stop. CONCLUSIONS: We observed complex and individualised motivations about smoking following lung cancer screening. To be most effective, smoking cessation support in this context should explore understanding of screening test results and may need to be highly tailored to individual emotional responses to screening.

Injury among children and young people with and without attention-deficit hyperactivity disorder in the community: The risk of fractures, thermal injuries, and poisonings.

BACKGROUND: Injuries commonly cause morbidity and mortality in children and young people (CYP). Attention-deficit hyperactivity disorder (ADHD) is the commonest neurobehavioural disorder in CYP and is associated with increased injury risk. However, large, population-based estimates of the risk of specific injuries are lacking. We aimed to provide estimates of the risk of fractures, thermal injuries, and poisonings in CYP with and without ADHD. METHODS: In this population-based cohort study, we used primary and secondary care medical records from England from the Clinical Practice Research Datalink. There were 15,126 CYP with ADHD frequency-matched to 263,724 without, aged 3-17 years at diagnosis. The risk of (a) fractures, (b) thermal injuries, and (c) poisonings in CYP with ADHD was compared with those without. RESULTS: The absolute rate of injury per thousand person-years at risk in CYP with versus without ADHD was fracture 28.9 (95% CI [27.5, 30.3]) versus 18.7 (95% CI [18.5, 19.0]), long bone fracture 17.7 (95% CI [16.7, 18.8]) versus 11.8 (95% CI [11.6, 12.0]), thermal injuries 4.4 (95% CI [3.9, 4.9]) versus 2.2 (95% CI [2.1, 2.3]), and poisonings 6.3 (95% CI [5.7, 6.9]) versus 1.9 (95% CI [1.9, 2.0]). Adjusting for age, sex, geographical region, deprivation, and calendar year, CYP with ADHD had 25% increase in risk of fracture (hazard ratio [HR] = 1.25; 95% CI [1.19, 1.31]), 21% increase in risk of long bone fracture (HR = 1.21; 95% CI [1.13, 1.28]), double the risk of thermal injury (HR = 2.00; 95% CI [1.76, 2.27]), and almost four times the risk of poisoning (HR = 3.72; 95% CI [3.32, 4.17]). CONCLUSIONS: CYP with ADHD are at greater risk of fracture, thermal injury, and poisoning compared with those without. Paediatricians and health care professionals should provide injury prevention advice at diagnosis and reviews.

Detection in blood of autoantibodies to tumour antigens as a case-finding method in lung cancer using the EarlyCDT®-Lung Test (ECLS): study protocol for a randomized controlled trial.

BACKGROUND: Lung cancer is the most common cause of cancer related death worldwide. The majority of cases are detected at a late stage when prognosis is poor. The EarlyCDT®-Lung Test detects autoantibodies to abnormal cell surface proteins in the earliest stages of the disease which may allow tumour detection at an earlier stage thus altering prognosis. The primary research question is: Does using the EarlyCDT®-Lung Test to identify those at high risk of lung cancer, followed by X-ray and computed tomography (CT) scanning, reduce the incidence of patients with late-stage lung cancer (III & IV) or unclassified presentation (U) at diagnosis, compared to standard practice? METHODS: A randomised controlled trial of 12 000 participants in areas of Scotland targeting general practices serving patients in the most deprived quintile of the Scottish Index of Multiple Deprivation. Adults aged 50-75 who are at high risk of lung cancer and healthy enough to undergo potentially curative therapy (Performance Status 0-2) are eligible to participate. The intervention is the EarlyCDT®-Lung Test, followed by X-ray and CT in those with a positive result. The comparator is standard clinical practice in the UK. The primary outcome is the difference, after 24 months, between the rates of patients with stage III, IV or unclassified lung cancer at diagnosis. The secondary outcomes include: all-cause mortality; disease specific mortality; a range of morbidity outcomes; cost-effectiveness and measures examining the psychological and behavioural consequences of screening. Participants with a positive test result but for whom the CT scan does not lead to a lung cancer diagnosis will be offered 6 monthly thoracic CTs for 24 months. An initial chest X-ray will be used to determine the speed and the need for contrast in the first screening CT. Participants who are found to have lung cancer will be followed-up to assess both time to diagnosis and stage of disease at diagnosis. DISCUSSION: The study will determine the clinical and cost effectiveness of EarlyCDT®-Lung Test for early lung cancer detection and assess its suitability for a large-scale, accredited screening service. The study will also assess the potential psychological and behavioural harms arising from false positive or false negative results, as well as the potential benefits to patients of true negative EarlyCDT lung test results. A cost-effectiveness model of lung cancer screening based on the results of the EarlyCDT Lung Test study will be developed. TRIAL REGISTRATION: NCT01925625 . August 19, 2013.

The Community In-reach Rehabilitation and Care Transition (CIRACT) clinical and cost-effectiveness randomisation controlled trial in older people admitted to hospital as an acute medical emergency.

Objective: To compare the clinical and cost-effectiveness of a Community In-reach Rehabilitation and Care Transition (CIRACT) service with the traditional hospital-based rehabilitation (THB-Rehab) service. Design: Pragmatic randomised controlled trial with an integral health economic study. Settings: Large UK teaching hospital, with community follow-up. Subjects: Frail older people aged 70 years and older admitted to hospital as an acute medical emergency. Measurements: Primary outcome: hospital length of stay; secondary outcomes: readmission, day 91-super spell bed days, functional ability, co-morbidity and health-related quality of life; cost-effectiveness analysis. Results: A total of 250 participants were randomised. There was no significant difference in length of stay between the CIRACT and THB-Rehab service (median 8 versus 9 days; geometric mean 7.8 versus 8.7 days, mean ratio 0.90, 95% confidence interval (CI) 0.74­1.10). Of the participants who were discharged from hospital, 17% and 13% were readmitted within 28 days from the CIRACT and THB-Rehab services, respectively (risk difference 3.8%, 95% CI −5.8% to 13.4%). There were no other significant differences in any of the other secondary outcomes between the two groups. The mean costs (including NHS and personal social service) of the CIRACT and THB-Rehab service were £3,744 and £3,603, respectively (mean cost difference £144; 95% CI −1,645 to 1,934). Conclusion: The CIRACT service does not reduce major hospital length of stay nor reduce short-term readmission rates, compared to the standard THB-Rehab service; however, a modest (<2.3 days) effect cannot be excluded. Further studies are necessary powered with larger sample sizes and cluster randomisation. Trial registration: ISRCTN 94393315, 25th April 2013