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Abstract Background Large numbers of people are killed or severely injured following injuries each year and these injuries place a large burden on health care resources. The majority of the severely injured are not fully recovered 12-18 months later. Psychological disorders are common post injury and are associated with poorer functional and occupational outcomes. Much of this evidence comes from countries other than the UK, with differing health care and compensation systems. Early interventions can be effective in treating psychological morbidity, hence the scale and nature of the problem and its impact of functioning in the UK must be known before services can be designed to identify and manage psychological morbidity post injury. Methods/Design A longitudinal multi-centre study of 680 injured patients admitted to hospital in four areas across the UK: Nottingham, Leicester/Loughborough, Bristol and Surrey. A stratified sample of injuries will ensure a range of common and less common injuries will be included. Participants will complete a baseline questionnaire about their injury and pre-injury quality of life, and follow-up questionnaires 1, 2, 4, and 12 months post injury. Measures will include health and social care utilisation, perceptions of recovery, physical, psychological, social and occupational functioning and health-related quality of life. A nested qualitative study will explore the experiences of a sample of participants, their carers and service providers to inform service design. Discussion This study will quantify physical, psychological, social and occupational functioning and health and social care utilisation following a range of different types of injury and will assess the impact of psychological disorders on function and health service use. The findings will be used to guide the development of interventions to maximise recovery post injury.

Abstract Background Typical advice on the design and analysis of cluster randomized trials (C-RCTs) focuses on allowance for the clustering at the level of the unit of allocation. However often C-RCTs are also organised spatially as may occur in the fields of Public Health and Primary Care where populations may even overlap. Methods We allowed for spatial effects on the error variance by a multiple membership model. These are a form of hierarchical model in which each lower level unit is a member of more than one higher level unit. Membership may be determined through adjacency or through Euclidean distance of centroids or in other ways such as the proportion of overlapping population. Such models may be estimated for Normal, binary and Poisson responses in Stata (v10 or above) as well as in WinBUGS or MLWin. We used this to analyse a dummy trial and two real, previously published cluster-allocated studies (one allocating general practices within one City and the other allocating general practices within one County) to investigate the extent to which ignoring spatial effects affected the estimate of treatment effect, using different methods for defining membership with Akaike's Information Criterion to determine the "best" model. Results The best fitting model included both a fixed North-South gradient and a random cluster effect for the dummy RCT. For one of the real RCTs the best fitting model included both a random practice effect plus a multiple membership spatial term, while for the other RCT the best fitting model ignored the clustering but included a fixed North-South gradient. Alternative models which fitted only slightly less well all included spatial effects in one form or another, with some variation in parameter estimates (greater when less well fitting models were included). Conclusions These particular results are only illustrative. However, we believe when designing C-RCTs in a primary care setting the possibility of spatial effects should be considered in relation to the intervention and response, as well as any explanatory effect of fixed covariates, together with any implications for sample size and methods for planned analyses.

Abstract Background Burn injuries remain one of the leading causes of injury morbidity and mortality in the World Health Organization's East Mediterranean Region. To provide an overview on the epidemiology of burn injuries in this region, a systematic review was undertaken. Methods Medline, Embase and CINAHL were searched for publications on burns in this region published between 01/01/1997 and 16/4/2007. Data were extracted to a standard spreadsheet and synthesised using a narrative synthesis. No attempt has been made to quantitatively synthesise the data due to the large degree of clinical heterogeneity between study populations. Results Seventy one studies were included in the review, from 12 countries. Burn injuries were found to be one of the leading causes of injury morbidity and mortality. The reported incidence of burns ranged from 112 to 518 per 100,000 per year. Burn victims were more frequently young and approximately one third of the victims were children aged 0-5 years. Hospital mortality ranged from 5 to 37%, but was commonly above 20%. Intentional self-harm burns particularly involving women were common in some countries of the region and were associated with a very high mortality of up to 79%. Conclusion Burn injuries remain an important public health issue in the East Mediterranean Region therefore further research is required to investigate the problem and assess the effectiveness of intervention programmes.

Abstract Background Regular physical activity reduces the risk of mortality from all causes, with a powerful beneficial effect on risk of falls and hip fractures. However, physical activity levels are low in the older population and previous studies have demonstrated only modest, short-term improvements in activity levels with intervention. Design/Methods Pragmatic 3 arm parallel design cluster controlled trial of class-based exercise (FAME), home-based exercise (OEP) and usual care amongst older people (aged 65 years and over) in primary care. The primary outcome is the achievement of recommended physical activity targets 12 months after cessation of intervention. Secondary outcomes include functional assessments, predictors of exercise adherence, the incidence of falls, fear of falling, quality of life and continuation of physical activity after intervention, over a two-year follow up. An economic evaluation including participant and NHS costs will be embedded in the clinical trial. Discussion The ProAct65 trial will explore and evaluate the potential for increasing physical activity among older people recruited through general practice. The trial will be conducted in a relatively unselected population, and will address problems of selective recruitment, potentially low retention rates, variable quality of interventions and falls risk. Trial Registration Trial Registration: ISRCTN43453770

Abstract Background Regular cycling has been shown to improve health and has a role in tackling the threats posed by obesity and inactivity. Cycle collisions, particularly those involving motorised vehicles, can lead to significant mortality and morbidity and are currently a barrier to wider uptake of cycling. There is evidence that the conspicuity of cyclists is a factor in many injury collisions. Low-cost, easy to use retro-reflective and fluorescent clothing and accessories ('conspicuity aids') are available. Their effectiveness in reducing cycling collisions is unknown. The study is designed to investigate the relationship between the use of conspicuity aids and risk of collision or evasion crashes for utility and commuter cyclists in the UK. Methods/Design A matched case-control study is proposed. Cases are adult commuter and utility cyclists involved in a crash resulting from a collision or attempted evasion of a collision with another road user recruited at a UK emergency department. Controls are commuter and utility cyclists matched by journey purpose, time and day of travel and geographical area recruited at public and private cycle parking sites. Data on the use of conspicuity aids, crash circumstances, demographics, cycling experience, safety equipment use, journey characteristics and route will be collected using self-completed questionnaires and maps. Conditional logistic regression will be used to calculate adjusted odds ratios and 95% confidence intervals of the risk of a crash when using any item of fluorescent or reflective clothing or equipment. Discussion This study will provide information on the effectiveness of conspicuity aids in reducing the risk of injury to cyclists resulting from crashes involving other road users.

Abstract Background Falls in hospitals are common, resulting in injury and anxiety to patients, and large costs to NHS organisations. More than half of all in-patient falls in elderly people in acute care settings occur at the bedside, during transfers or whilst getting up to go to the toilet. In the majority of cases these falls are unwitnessed. There is insufficient evidence underpinning the effectiveness of interventions to guide clinical staff regarding the reduction of falls in the elderly inpatient. New patient monitoring technologies have the potential to offer advances in falls prevention. Bedside sensor equipment can alert staff, not in the immediate vicinity, to a potential problem and avert a fall. However no studies utilizing this assistive technology have demonstrated a significant reduction in falls rates in a randomised controlled trial setting. Methods/Design The research design is an individual patient randomised controlled trial of bedside chair and bed pressure sensors, incorporating a radio-paging alerting mode to alert staff to patients rising from their bed or chair, across five acute elderly care wards in Nottingham University Hospitals NHS Trust. Participants will be randomised to bedside chair and bed sensors or to usual care (without the use of sensors). The primary outcome is the number of bedside in-patient falls. Discussion The REFINE study is the first randomised controlled trial of bedside pressure sensors in elderly inpatients in an acute NHS Trust. We will assess whether falls can be successfully and cost effectively reduced using this technology, and report on its acceptability to both patients and staff. Trial Registration ISRCTN trial number: ISRCTN44972300.

Abstract Background Medication errors are an important cause of morbidity and mortality in primary care. The aims of this study are to determine the effectiveness, cost effectiveness and acceptability of a pharmacist-led information-technology-based complex intervention compared with simple feedback in reducing proportions of patients at risk from potentially hazardous prescribing and medicines management in general (family) practice. Methods Research subject group: "At-risk" patients registered with computerised general practices in two geographical regions in England. Design: Parallel group pragmatic cluster randomised trial. Interventions: Practices will be randomised to either: (i) Computer-generated feedback; or (ii) Pharmacist-led intervention comprising of computer-generated feedback, educational outreach and dedicated support. Primary outcome measures: The proportion of patients in each practice at six and 12 months post intervention: - with a computer-recorded history of peptic ulcer being prescribed non-selective non-steroidal anti-inflammatory drugs - with a computer-recorded diagnosis of asthma being prescribed beta-blockers - aged 75 years and older receiving long-term prescriptions for angiotensin converting enzyme inhibitors or loop diuretics without a recorded assessment of renal function and electrolytes in the preceding 15 months. Secondary outcome measures; These relate to a number of other examples of potentially hazardous prescribing and medicines management. Economic analysis: An economic evaluation will be done of the cost per error avoided, from the perspective of the UK National Health Service (NHS), comparing the pharmacist-led intervention with simple feedback. Qualitative analysis: A qualitative study will be conducted to explore the views and experiences of health care professionals and NHS managers concerning the interventions, and investigate possible reasons why the interventions prove effective, or conversely prove ineffective. Sample size: 34 practices in each of the two treatment arms would provide at least 80% power (two-tailed alpha of 0.05) to demonstrate a 50% reduction in error rates for each of the three primary outcome measures in the pharmacist-led intervention arm compared with a 11% reduction in the simple feedback arm. Discussion At the time of submission of this article, 72 general practices have been recruited (36 in each arm of the trial) and the interventions have been delivered. Analysis has not yet been undertaken. Trial registration Current controlled trials ISRCTN21785299

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. [ABSTRACT FROM AUTHOR]

Abstract Background Each year in the UK 2000 children attend emergency departments and 500 are admitted to hospital following a bath water scald. The long term effects can include disability, disfigurement or psychological harm and repeated skin grafts may be required as the child grows. The costs of treating a severe scald are estimated at 250,000 GBP. Children living in the most deprived wards are at greatest risk of thermal injuries; hospital admission rates are three times that for children living in the least deprived wards. Domestic hot water, which is usually stored at around 60 degrees Celsius, can result in a second-degree burn after 3 seconds and a third-degree burn after 5 seconds. Educational strategies to encourage testing of tap water temperature and reduction of hot water thermostat settings have largely proved unsuccessful. Legislation in the USA mandating pre-setting hot water heater thermostats at 49 degrees Celsius was effective in reducing scald injuries, suggesting passive measures may have a greater impact. Thermostatic mixer valves (TMVs), recently developed for the domestic market, fitted across the hot and cold water supply pipes of the bath, allow delivery of water set at a fixed temperature from the hot bath tap. These valves therefore offer the potential to reduce scald injuries. Design/Methods A pragmatic, randomised controlled trial to assess the effectiveness of TMVs in reducing bath hot tap water temperatures in the homes of families with young children in rented social housing. Two parallel arms include an intervention group and a control group where the intervention will be deferred. The intervention will consist of fitting a TMV (set at 44 degrees Celsius) by a qualified plumber and provision of educational materials. The control arm will not receive a TMV or the educational materials for the study duration but will be offered the intervention after collection of follow-up data 12 months post randomisation. The primary outcome measure will be the bath hot tap water temperature. Fifteen families per arm are required to detect a reduction in the mean bath hot tap water temperature from 60.4 degrees Celsius (SD 9.1) in the control group to 46 degrees Celsius in the intervention group, with 90% power and a 5% significance level (2 sided). Secondary outcome measures including acceptability will require a sample size of 120 participants. Discussion Whilst TMVs have the potential to reduce scald injuries, to date there have been no randomised controlled trials assessing their effectiveness, acceptability and cost effectiveness. Trial Registration ISRCTN21179067

Abstract Background Globally and nationally large numbers of people are injured each year, yet there is little information on the impact of these injuries on people's lives, on society and on health and social care services. Measurement of the burden of injuries is needed at a global, national and regional level to be able to inform injured people of the likely duration of impairment; to guide policy makers in investing in preventative measures; to facilitate the evaluation and cost effectiveness of interventions and to contribute to international efforts to more accurately assess the global burden of injuries. Methods/Design A prospective, longitudinal multi-centre study of 1333 injured individuals, atttending Emergency Departments or admitted to hospital in four UK areas: Swansea, Surrey, Bristol and Nottingham. Specified quotas of patients with defined injuries covering the whole spectrum will be recruited. Participants (or a proxy) will complete a baseline questionnaire regarding their injury and pre-injury quality of life. Follow up occurs at 1, 4, and 12 months post injury or until return to normal function within 12 months, with measures of health service utilisation, impairment, disability, and health related quality of life. National estimates of the burden of injuries will be calculated by extrapolation from the sample population to national and regional computerised hospital in-patient, emergency department and mortality data. Discussion This study will provide more detailed data on the national burden of injuries than has previously been available in any country and will contribute to international collaborative efforts to more accurately assess the global burden of injuries. The results will be used to advise policy makers on prioritisation of preventive measures, support the evaluation of interventions, and provide guidance on the likely impact and degree of impairment and disability following specific injuries.

Abstract Falls in older people are a major public health concern in terms of morbidity, mortality and cost. Previous studies suggest that multifactorial interventions can reduce falls, and many geriatric day hospitals are now offering falls intervention programmes. However, no studies have investigated whether these programmes, based in the day hospital are effective, nor whether they can be successfully applied to high-risk older people screened in primary care. The hypothesis is that a multidisciplinary falls assessment and intervention at Day hospitals can reduce the incidence of falls in older people identified within primary care as being at high risk of falling. This will be tested by a pragmatic parallel-group randomised controlled trial in which the participants, identified as at high risk of falling, will be randomised into either the intervention Day hospital arm or to a control (current practice) arm. Those participants preferring not to enter the full randomised study will be offered the opportunity to complete brief diaries only at monthly intervals. This data will be used to validate the screening questionnaire. Three day hospitals (2 Nottingham, 1 Derby) will provide the interventions, and the University of Nottingham's Departments of Primary Care, the Division of Rehabilitation and Ageing Unit, and the Trent Institute for Health Service Research will provide the methodological and statistical expertise. Four hundred subjects will be randomised into the two arms. The primary outcome measure will be the rate of falls over one year. Secondary outcome measures will include the proportion of people experiencing at least one fall, the proportion of people experiencing recurrent falls (>1), injuries, fear of falling, quality of life, institutionalisation rates, and use of health services. Cost-effectiveness analyses will be performed to inform health commissioners about resource allocation issues. The importance of this trial is that the results may be applicable to any UK day hospital setting. Sites General practices across Nottinghamshire and Derbyshire. Day hospitals: Derbyshire Royal Infirmary (Southern Derbyshire Acute Hospitals NHS Trust) Sherwood Day Service (Nottingham City Hospital Trust) Leengate Day Hospital (Queen's Medical Centre Nottingham University Hospital NHS Trust)

Background: Traumatic injuries are common amongst working-age adults. Survivors often experience physical and psychological problems, reduced quality of life and difficulty returning to work. Vocational rehabilitation improves work outcomes for a range of conditions but evidence of effectiveness for those with traumatic injuries is lacking. This study assesses feasibility of delivering a vocational rehabilitation intervention to enhance return to work and improve quality of life and wellbeing in people with at least moderate trauma to inform design of a definitive randomised controlled trial (RCT). Methods: Non-randomised, single-arm, multi-centre mixed-methods feasibility study with nested case studies and qualitative study. The case studies comprise interviews, observations of clinical contacts and review of clinical records. The qualitative study comprises interviews and/or focus groups. Participants will be recruited from two UK major trauma centres. Participants will comprise 40 patients aged 16–69 with an injury severity score of > 8 who will receive the intervention and complete questionnaires. Interviews will be conducted with 10 patients and their occupational therapists (OTs), clinical psychologists (CPs), employers and commissioners of rehabilitation services. Fidelity will be assessed in up to six patients by observations of OT and CP—patient contacts, review of patient records and intervention case report forms. OT and CP training will be evaluated using questionnaires and competence to deliver the intervention assessed using a team objective structured clinical examination and written task. Patients participating in and those declining participation in the study will be invited to take part in interviews/focus groups to explore barriers and facilitators to recruitment and retention. Outcomes include recruitment and retention rates, intervention fidelity, OT and CP competence to deliver the intervention, experiences of delivering or receiving the intervention and factors likely to influence definitive trial delivery. Discussion: Effective vocational rehabilitation interventions to enhance return to work amongst trauma patients are urgently needed because return to work is often delayed, with detrimental effects on health, financial stability, healthcare resource use and wider society. This protocol describes a feasibility study delivering a complex intervention to enhance return to work in those with at least moderate trauma. Trial registration: ISRCTN: 74668529. Prospectively registered on 23 January 20 [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Rationale, aims, and objectives: High response rates to research questionnaires can help to ensure results are more representative of the population studied and provide increased statistical power, on which the study may have been predicated. Improving speed and quality of response can reduce costs. Method: We conducted a randomized study within a trial (SWAT) to assess questionnaire response rates, reminders sent, and data completeness with unconditional compared with conditional monetary incentives. Eligible individuals were mailed a series of psychological questionnaires as a follow‐up to a baseline host trial questionnaire. Half received a £5 gift voucher with questionnaires (unconditional), and half were promised the voucher after returning questionnaires (conditional). Results: Of 1079 individuals, response rates to the first follow‐up questionnaire were 94.2% and 91.7% in the unconditional and conditional monetary incentive groups, respectively (OR 1.78; 95% CI, 0.85‐3.72). There were significantly greater odds of returning repeat questionnaires in the unconditional group at 6 months (OR 2.97; 95% CI, 1.01‐8.71;.047) but not at 12 months (OR 1.12; 95% CI, 0.44‐2.85). Incentive condition had no impact at any time point on the proportion of sent questionnaires that needed reminders. Odds of incomplete questionnaires were significantly greater at 3 months in the unconditional compared with the conditional incentive group (OR 2.45; 95% CI, 1.32‐4.55;.004). Conclusions: Unconditional monetary incentives can produce a transitory greater likelihood of mailed questionnaire response in a clinical trial participant group, consistent with the direction of effect in other settings. However, this could have been a chance finding. The use of multiple strategies to promote response may have created a ceiling effect. This strategy has potential to reduce administrative and postage costs, weighed against the cost of incentives used, but could risk compromising the completeness of data. [ABSTRACT FROM AUTHOR]

Background: Current methods of measuring the population burden of injuries rely on many assumptions and limited data available to the global burden of diseases (GBD) studies. The aim of this study was to compare the population burden of injuries using different approaches from the UK Burden of Injury (UKBOI) and GBD studies. Methods and Findings: The UKBOI was a prospective cohort of 1,517 injured individuals that collected patient-reported outcomes. Extrapolated outcome data were combined with multiple sources of morbidity and mortality data to derive population metrics of the burden of injury in the UK. Participants were injured patients recruited from hospitals in four UK cities and towns: Swansea, Nottingham, Bristol, and Guildford, between September 2005 and April 2007. Patient-reported changes in quality of life using the EQ-5D at baseline, 1, 4, and 12 months after injury provided disability weights used to calculate the years lived with disability (YLDs) component of disability adjusted life years (DALYs). DALYs were calculated for the UK and extrapolated to global estimates using both UKBOI and GBD disability weights. Estimated numbers (and rates per 100,000) for UK population extrapolations were 750,999 (1,240) for hospital admissions, 7,982,947 (13,339) for emergency department (ED) attendances, and 22,185 (36.8) for injury-related deaths in 2005. Nonadmitted ED-treated injuries accounted for 67% of YLDs. Estimates for UK DALYs amounted to 1,771,486 (82% due to YLDs), compared with 669,822 (52% due to YLDs) using the GBD approach. Extrapolating patient-derived disability weights to GBD estimates would increase injury-related DALYs 2.6-fold. Conclusions: The use of disability weights derived from patient experiences combined with additional morbidity data on ED-treated patients and inpatients suggests that the absolute burden of injury is higher than previously estimated. These findings have substantial implications for improving measurement of the national and global burden of injury. Please see later in the article for the Editors' Summary., Introduction Quantifying the burden placed on society is an essential component of the public health response to conditions, supporting development of policy, priority setting, and monitoring of interventions [1,2]. The [...]

Background: In England, there is a discrepancy between the prevalence of attention-deficit/hyperactivity disorder (ADHD) ascertained from medical records and community surveys. There is also a lack of data on variation in recorded prevalence by deprivation and geographical region; information that is important for service development and commissioning.Methods: Cohort study using data from the Clinical Practice Research Datalink comprising 5196 children and young people aged 3-17 years with ADHD and 490 016 without, in 2012.Results: In 2012, the recorded prevalence of ADHD was 1.06% (95% CI 1.03 to 1.09). Prevalence in the most deprived areas was double that of the least deprived areas (prevalence rate ratio 2.58 (95% CI 2.36 to 2.83)), with a linear trend from least to most deprived areas across all regions in England.Conclusions: The low prevalence of ADHD in medical records may indicate considerable underdiagnosis. Higher rates in more disadvantaged areas indicate greater need for services in those areas. [ABSTRACT FROM AUTHOR]