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ObjectiveTo estimate the effectiveness of standardised self-management kits for children with type 1 diabetes.DesignPragmatic trial with randomisation ratio of two intervention: one control. Qualitative process evaluation.Setting11 diabetes clinics in England and Wales.ParticipantsBetween February 2010 and August 2011, we validly randomised 308 children aged 6–18 years; 201 received the intervention.InterventionWe designed kits to empower children to achieve glycaemic control, notably by recording blood glucose and titrating insulin. The comparator was usual treatment.Outcome measures at 3 and 6 monthsPrimary: Diabetes Pediatric Quality of Life Inventory (PedsQL). Secondary: HbA1c; General PedsQL; EQ-5D; healthcare resource use.ResultsOf the five Diabetes PedsQL dimensions, Worry showed adjusted scores significantly favouring self-management kits at 3 months (mean child-reported difference =+5.87; Standard error[SE]=2.19; 95% confidence interval [CI]) from +1.57 to +10.18; p=0.008); but Treatment Adherence significantly favoured controls at 6 months (mean child-reported difference=−4.68; SE=1.74; 95%CI from −8.10 to −1.25; p=0.008). Intervention children reported significantly worse changes between 3 and 6 months on four of the five Diabetes PedsQL dimensions and on the total score (mean difference=−3.20; SE=1.33; 95% CI from −5.73 to −0.67; p=0.020). There was no evidence of change in HbA1c; only 18% of participants in each group achieved recommended levels at 6 months. No serious adverse reactions attributable to the intervention or its absence were reported.Use of kits was poor. Few children or parents associated blood glucose readings with better glycaemic control. The kits, costing £185, alienated many children and parents.ConclusionsStandardised kits showed no evidence of benefit, inhibited diabetes self-management and increased worry. Future research should study relationships between children and professionals, and seek new methods of helping children and parents to manage diabetes.Trial registration numberNCT17551624.

There are concerns that people seeking sanctuary (asylum seekers and refugees) in Wales, UK, have unmet health needs and face difficulties accessing services, but little collated evidence. This study addressed this gap to inform policy and practice in reducing health inequities. It aimed to: investigate the health, wellbeing and healthcare experiences of adults seeking sanctuary in Wales, including the views of healthcare recipients and providers; and establish what helped or hindered the healthcare experiences of those seeking sanctuary. It is the most comprehensive study of this population in Wales. A mixed-method approach was taken, including a literature search, a cross-sectional survey of 210 adults seeking sanctuary, telephone interviews with 32 health professionals and third sector support workers, and 8 focus groups including 57 people seeking sanctuary and those supporting them. Eight trained volunteer peer researchers, themselves asylum seekers or refugees, administered the surveys. Interviews were digitally recorded, transcribed and analysed using a standard framework. The literature search identified 5 themes that help or hinder people seeking sanctuary to access healthcare. The survey found 79% of respondents attended an initial health assessment on arriving in Wales, with 94% currently registered with Primary healthcare. 64% reported difficulties in accessing health services. Awareness of services was mixed, with 66% having used healthcare in working hours (planned) and 28% out of hours (unplanned). Mainstream health professionals felt they lack capacity to deliver care effectively due to time and other pressures on the healthcare system and the need for appropriate translation/interpretation services. This study triangulates the experiences of people seeking sanctuary with those providing healthcare and general support. Peer researchers maximised sanctuary seekers’ participation. Many of its methods and findings have relevance to other countries in Europe. Key messages Improving health equity is key to realising Wales’ ambition to become a Nation of Sanctuary. Peer Researchers enabled participation by sanctuary seekers and revealed useful findings to steer future policy and practice.

Background: Children's self-management of diabetes in the United Kingdom (UK) is poor. We aimed to estimate the effectiveness and cost-effectiveness of standardised, quality-assured self-management kits for children with type 1 diabetes, and to synthesise HbA1c outcomes with five other contemporaneous UK trials. Methods: The EPIC trial was a pragmatic trial with randomisation ratio of 2 intervention: 1 control in 11 paediatric diabetes clinics in England and Wales, with a qualitative process evaluation. We designed kits to empower children to achieve glycaemic control, notably by recording blood glucose and titrating insulin. Clinic staff offered these kits to children in routine consultations. The comparator was usual treatment. Trial outcome measures at 3 and 6 months: Primary - Diabetes PedsQL. Secondary - HbA1c; General PedsQL; EQ-5D; and healthcare resource use. Trial registration: ISRCTN17551624 We undertook a selective meta-analysis of HbA1c using Cochrane methods of 6 UK children's diabetes education interventions compared with treatment as usual. Findings Trial: Between February 2010 and August 2011 we validly randomised 308 children aged six to 18 years; 201 received the intervention. The process evaluation was conducted up to December 2013. Meta-analysis: 6 trials including 1083 intervention and 935 control. Trial: Of the five dimensions of the Diabetes PedsQL, Worry showed adjusted scores significantly favouring self-management kits at three months (mean child-reported difference = +5.87; standard error [SE] = 2.19; 95% confidence interval [CI] from +1.57 to +10.18; p = 0.008); but Treatment Adherence significantly favoured controls at six months (mean child-reported difference = -4.68; SE = 1.74; 95% CI from -8.10 to -1.25; p = 0.008). Furthermore, intervention children reported significantly worse changes between three and six months on four of the five Diabetes PedsQL dimensions and thus on the total score (mean difference = -3.20; SE = 1.33; 95% CI from -5.73 to -0.67; p = 0.020). Moreover, there was no evidence of change in HbA1c; indeed only 18% of participants in each group achieved recommended levels at 6 months. Clinic staff reported no serious adverse reactions attributable to the intervention or its absence. Children's use of kits was poor. Few children or parents associated blood glucose readings with better glycaemic control. The kits, which cost £185 each, alienated many children and parents. Meta-analysis: When combined in a meta-analysis, five other recent contemporaneous UK trials of various educational interventions also reported no benefit, and little rapport between children, their parents, clinic staff and the interventions. Interpretation: Standardised kits showed no evidence of benefit, inhibited self-management and increased worry. Similar results from five contemporaneous UK trials indicate a serious problem with how children's diabetes education and support is conceptualised and delivered. Future research should study relationships between children and professionals, and seek new methods of helping children and parents to manage diabetes Trial Registration Number: ISRCTN17551624. Funding: National Institute for Health Research. Declaration of Interest: Professor John Gregory has received payments from Pfizer, Bayer and Ipsen for lectures, development of educational presentations and travel/accommodation to attend scientific meetings and advisory board meetings. His employer (Cardiff University) has also received funding from Novo Nordisk to support the development of patient-support materials used in the Development and Evaluation of a Psychosocial Intervention for Children and Teenagers Experiencing Diabetes (DEPICTED) research study. The remaining authors declare no competing interests. Ethical Approval: The Wales Multi-Centre Research Ethics Committee gave approval (08/MRE09/57).

BackgroundNumbers of asylum seekers and refugees living in Wales have increased sharply. Many are liable to have unmet health needs and difficulty accessing services. We investigated the experience of, and access to, unplanned and emergency health services by asylum seekers, refugees and those refused asylum living in Wales.MethodWe surveyed 210 asylum seekers, refused asylum seekers and refugees and conducted eight focus groups with 57 participants (with interpreters present when necessary) to explore experiences. We used descriptive statistics to analyse survey data and framework analyses to analyse interview data.ResultsSurvey data showed awareness of unscheduled health services was mixed. Best known was the 999 ambulance service (72% reportedly had heard of and could contact this outside daytime hours). NHS111 was familiar to 36% but just a quarter (26%) had heard of and could contact GP out-of-hours services. Fewer than half of respondents (44%) knew of the Emergency Department. 26% reported using a health service out-of-hours. Focus group respondents with little English reported difficulty explaining their health needs, particularly in emergencies and when seeking telephone help through 999 and 111 calls. Others said they used emergency services if they did not know how to access routine and out-of-hours care or if they felt their efforts to see a GP did not resolve their problem.ConclusionLanguage barriers and poor knowledge of UK health systems mean asylum seekers, refused asylum seekers and refugees use emergency health services to meet needs which could be seen and treated in routine primary services. Language barriers using phone lines may also result in paramedic attendance or conveyance to Emergency Departments because health needs are not clearly identified. Better information and support may help this population access services which match their needs and support their health more effectively.

BackgroundThe numbers of asylum seekers and refugees in Wales have recently increased sharply, but we know little of their health experiences.AimTo investigate asylum seekers’ and refugees’ experiences of health care, especially what helped or hindered.MethodEight volunteer peer researchers were recruited from asylum-seeking and refugee communities; and trained to run the quantitative survey. They worked in small groups with support from team members. The Statistical Package for Social Sciences (SPSS) was used to describe, analyse, and present results.ResultsThe 210 responders included 90 known refugees, 89 known asylum seekers, and 11 known to have been refused asylum. Although 79% of responders reported attending an initial health assessment on arriving in Wales, and 94% reported that they were currently registered with a GP, only 36% found it easy or very easy to make an appointment with their GPs. Awareness of services was mixed: best known was the 999 service, with 77% reporting that they knew how to access it. Sixty-six per cent reported using health care in working hours, and 28% reported use out of hours. Key influences on these statistics included knowledge of the NHS and how to navigate it, language barriers, and cultural factors.ConclusionThis study provides valuable insight into asylum seekers’ and refugees’ experiences of health care. Together with our complementary qualitative study it suggests that a compassionate approach to providing care, building on existing good practice, and with additional resources for training and support services, can reduce healthcare inequalities for asylum seekers and refugees.

The authors respond to the article by H. F. Coelho, P. H. Canter, and E. Ernst (2007), which reviewed the current status of mindfulness-based cognitive therapy (MBCT). First, they clarify the randomization procedures in the 2 main MBCT trials. Second, they report posttreatment and follow-up data to show that trial participants allocated to "treatment as usual" did not become worse. Third, they discuss which experimental designs are better for identification of the active component of treatment. Finally, they report reanalyses of the 2 main MBCT trials with multilevel modeling that corrected for intragroup correlations. These analyses reinforce the original findings: For patients with 3 or more previous episodes, MBCT significantly reduced the risk of a further episode of depression and significantly decreased mean scores on the Beck Depression Inventory (A. T. Beck, C. H. Ward, M. Mendelson, J. Mock, and J. Erbaugh, 1961) after treatment.

Background Few robust studies have tested whether enhancing housing also improves health. Aim To evaluate the effectiveness of installing ventilation systems, and central heating where necessary, in the homes of children with moderate or severe asthma. Design and setting Pragmatic randomised controlled trial (RCT) in homes within Wrexham County Borough, Wales, UK. Method A pragmatic RCT was carried out, of a tailored package of housing improvements providing adequate ventilation and temperature, following inspection by a housing officer. One hundred and ninety-two children with asthma aged 5 to 14 years, identified from general practice registers, were randomised to receive this package, either immediately or a year after recruitment. At baseline, and after 4 and 12 months, parents reported their child's asthma-specific and generic quality of life, and days off school. Results The package improved parent-reported asthma-specific quality of life significantly at both 4 and 12 months. At 12 months, this showed an adjusted mean difference between groups of 7.1 points (95% confidence interval [CI] = 2.8 to 11.4, P = 0.001): a moderate standardised effect size of 0.42. The generic quality-of-life scale showed reported physical problems were significantly reduced at 4 months, but not quite at 12 months, when the mean difference was 4.5 (95% CI = -0.2 to 9.1, P = 0.061). The improvement in psychosocial quality of life at 12 months was not significant, with a mean difference of 2.2 (95% CI = -1.9 to 6.4, P = 0.292). Parent-reported school attendance improved, but not significantly Conclusion This novel and pragmatic trial, with integrated economic evaluation, found that tailored improvement of the housing of children with moderate to severe asthma significantly increases parent-reported asthma-related quality of life and reduces physical problems. Collaborative housing initiatives have potential to improve health.

Background Accidental needle-stick injuries (NSIs) are a hazard for health-care workers and for the general public. Objectives To estimate the presentation rate of NSIs to general medical practices, their relation to practice characteristics, and review practice policies for managing NSIs. Method Descriptive study using logistic regression analysis. Results Annual rates of 2.73 (95% CI 2.08, 3.50) occupational NSIs per 100 clinical practice staff and 2.14 (95% CI 1.39, 3.13) nonoccupational NSIs per 100 000 practice population were recorded. Stepwise logistic regressions showed that chance of a practice reporting at least one occupational NSI in previous five years was best predicted by being a single-handed practice (decreased odds). In contrast, the chance of a practice reporting at least one non-occupational NSI was best predicted by being a rural practice (increased odds). About one in five practices possessed no written policy on managing NSIs. Stepwise logistic regressions showed that the chance of a practice owning a NSI policy was best predicted by being located in an LHB area with a coastline (increased odds). Conclusion NSIs are an important public health issue in Wales. We have tried to address the lack of guidance by developing new guidelines in Wales.

Introduction Drug overdose is the most frequent cause of death among people who misuse illegal drugs. People who inject these drugs are 14–17 times more likely to die than their non-drug using peers. Various strategies to reduce drug-related deaths have failed to meet target reductions. Research into community-based interventions for preventing drug overdose deaths is promising. This review seeks to identify published studies describing community-based interventions and to evaluate their effectiveness at reducing drug overdose deaths. Methods and analysis We will systematically search key electronic databases using a search strategy which groups terms into four facets: (1) Overdose event, (2) Drug classification, (3) Intervention and (4) Setting. Searches will be limited where possible to international literature published in English between 1998 and 2014. Data will be extracted by two independent reviewers using a predefined table adapted from the Cochrane Collaboration handbook. The quality of included studies will be evaluated using the Cochrane Collaboration's tool for assessing risk of bias. We will conduct a meta-analysis for variables which can be compared across studies, using statistical methods to control for heterogeneity where appropriate. Where clinical or statistical heterogeneity prevents a valid numerical synthesis, we will employ a narrative synthesis to describe community-based interventions, their delivery and use and how effectively they prevent fatal overdoses. Ethics and dissemination We will publish findings from this systematic review in a peer-reviewed scientific journal and present results at national and international conferences. It will be disseminated electronically and in print. Trial registration number PROSPERO CRD42015017833.

Background The incidence of incisional hernias (IHs) following midline abdominal incisions is difficult to estimate. Furthermore recent analyses have reported inconsistent findings on the superiority of absorbable versus non-absorbable sutures. Objective To estimate the mean IH rate following midline laparotomy from the published literature, to identify variables that predict IH rates and to analyse whether the type of suture (absorbable versus non-absorbable) affects IH rates. Methods We undertook a systematic review according to PRISMA guidelines. We sought randomised trials and observational studies including patients undergoing midline incisions with standard suture closure. Papers describing two or more arms suitable for inclusion had data abstracted independently for each arm. Results Fifty-six papers, describing 83 separate groups comprising 14 618 patients, met the inclusion criteria. The prevalence of IHs after midline incision was 12.8% (range: 0 to 35.6%) at a weighted mean of 23.7 months. The estimated risk of undergoing IH repair after midline laparotomy was 5.2%. Two meta-regression analyses (A and B) each identified seven characteristics associated with increased IH rate: one patient variable (higher age), two surgical variables (surgery for AAA and either surgery for obesity surgery (model A) or using an upper midline incision (model B)), two inclusion criteria (including patients with previous laparotomies and those with previous IHs), and two circumstantial variables (later year of publication and specifying an exact significance level). There was no significant difference in IH rate between absorbable and non-absorbable sutures either alone or in conjunction with either regression analysis. Conclusions The IH rate estimated by pooling the published literature is 12.8% after about two years. Seven factors account for the large variation in IH rates across groups. However there is no evidence that suture type has an intrinsic effect on IH rates.

Background Morton’s neuroma is a common foot condition affecting health-related quality of life. Though its management frequently includes steroid injections, evidence of cost-effectiveness is sparse. So, we aimed to evaluate whether steroid injection is cost-effective in treating Morton’s neuroma compared with anaesthetic injection alone. Methods We undertook incremental cost-effectiveness and cost-utility analyses from the perspective of the National Health Service, alongside a patient-blinded pragmatic randomised trial in hospital-based orthopaedic outpatient clinics in Edinburgh, UK. Of the original randomised sample of 131 participants with Morton’s neuroma (including 67 controls), economic analysis focused on 109 (including 55 controls). Both groups received injections guided by ultrasound. We estimated the incremental cost per point improvement in the area under the curve of the Foot Health Thermometer (FHT-AUC) until three months after injection. We also conducted cost-utility analyses using European Quality of life-5 Dimensions–3 Levels (EQ-5D-3L), enhanced by the Foot Health Thermometer (FHT), to estimate utility and thus quality-adjusted life years (QALYs). Results The unit cost of an ultrasound-guided steroid injection was £149. Over the three months of follow-up, the mean cost of National Health Service resources was £280 for intervention participants and £202 for control participants – a difference of £79 [bootstrapped 95% confidence interval (CI): £18 to £152]. The corresponding estimated incremental cost-effectiveness ratio was £32 per point improvement in the FHT-AUC (bootstrapped 95% CI: £7 to £100). If decision makers value improvement of one point at £100 (the upper limit of this CI), there is 97.5% probability that steroid injection is cost-effective. As EQ-5D-3L seems unresponsive to changes in foot health, we based secondary cost-utility analysis on the FHT-enhanced EQ-5D. This estimated the corresponding incremental cost-effectiveness ratio as £6,400 per QALY. Over the recommended UK threshold, ranging from £20,000 to £30,000 per QALY, there is 80%-85% probability that steroid injection is cost-effective. Conclusions Steroid injections are effective and cost-effective in relieving foot pain measured by the FHT for three months. However, cost-utility analysis was initially inconclusive because the EQ-5D-3L is less responsive than the FHT to changes in foot health. By using the FHT to enhance the EQ-5D, we inferred that injections yield good value in cost per QALY. Trial registration Current Controlled Trials ISRCTN13668166

Objectives. To assess whether risk-communication interventions are associated with changes in patient knowledge, attitudes, and behaviors, and to identify aspects of these interventions that modify these effects. Design. Systematic review. Data sources. 96 studies from the period 1985-1996 retrieved by electronic searching of eight databases, hand searching of four journals, contacting key authors, and reference list searching. Main outcome measures. The effect size of the principal outcome was identified from each study. Outcomes measuring behavioral change were preferred; if these were not available, knowledge, anxiety, or risk perceptions were used, according to the focus of the study. Data were available to calculate the principal effect sizes for 82 of the studies. Analysis. Meta-regression. Results. The methodologic qualities of the studies varied. Nevertheless, risk-communication interventions generally had positive (beneficial) effects. Interventions addressing treatment choices were associated with larger effects than were those in other contexts, such as prevention or screening. Interventions using individual risk estimates were associated with larger effects than were those using more general risk information. Two design variables were identified as effect modifiers: randomized controlled trials were associated with smaller effects than other designs, and dichotomous outcomes were associated with larger effects than continuous outcomes. Conclusions. Risk communication interventions may be most productive if they include individual risk estimates in the discussion between professional and patient. Patient decisions about treatment appear more amenable to change by these interventions than attendance for screening or modification of risky behavior. Key words: risk communication; prevention interventions; patient behavioral changes; systematic review. (Med Decis Making 2000;20:290-297)

Background: Morton neuroma is a common cause of neuralgia affecting the web spaces of the toes. Corticosteroid injections are commonly administered as a first-line therapy, but the evidence for their effectiveness is weak. Our primary research aim was to determine whether corticosteroid injection is an effective treatment for Morton neuroma compared with an anesthetic injection as a placebo control. Methods: We performed a pragmatic, patient-blinded randomized trial set within hospital orthopaedic outpatient clinics in Edinburgh, United Kingdom. One hundred and thirty-one participants with Morton neuroma (mean age, fifty-three years; 111 [85%] female) were randomized to receive either corticosteroid and anesthetic (1 mL methylprednisolone [40 mg] and 1 mL 2% lignocaine) or anesthetic alone (2 mL 1% lignocaine). An ultrasonographic image was obtained before treatment, and injections were performed with the needle placed under ultrasonographic guidance. The primary outcome was the difference in patient global assessment of foot health between the two groups at three months after injection. This was measured with use of a 100-unit visual analog scale (VAS) anchored by “best imaginable health state” and “worst imaginable health state.” Results: Compared with the control group, global assessment of foot health in the corticosteroid group was significantly better at three months (mean difference, 14.1 scale points [95% confidence interval, 5.5 to 22.8 points]; p = 0.002). The difference between the groups was also significant at one month. Significant and nonsignificant improvements associated with the corticosteroid injection were observed for measures of pain, function, and patient global assessment of general health at one and three months after injection. The size of the neuroma as determined by ultrasonography did not significantly influence the treatment effect. Conclusions: Corticosteroid injections for Morton neuroma can be of symptomatic benefit for at least three months. Level of Evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Objective To identify and estimate the effectiveness of interventions to provide analgesia for patients with femoral fracture in the emergency pre-hospital setting. Methods We searched the Cochrane Library, CINAHL, HMIC, Medline, PubMed, Scopus, Web of Science, grey literature and citations of included studies. We included randomised trials and observational studies that included pain score measurements. We carried out a meta-analysis using Review Manager. Results We identified 858 studies and assessed 36 full articles for eligibility. Ten studies met the inclusion criteria, including 478 patients. Five studies were randomised controlled trials, comparing outcomes between: fascia iliaca compartment block (FICB) with standard care; femoral nerve block with standard care; Transcutaneous Electrical Nerve Stimulation (TENS) with placebo; auricular acupressure with sham acupressure; and simple splints with traction splints. Two cohort studies included comparisons of pain scores with and without FICB. Three uncontrolled observational studies reported effects of FICB. Meta-analysis of four randomised studies with 227 patients showed that, compared with control, proactive interventions reduced pain scores by 1.9 standard deviations (95% CI from 1.1 to 2.7; p Conclusions Current published research suggests that interventions to enhance the provision of analgesia for femoral fracture in emergency pre-hospital care reduce pain scores significantly more than standard care. However, as only five randomised studies are available with a range of diverse interventions, further research is warranted.

Objective: To see whether there is a relation between grommet insertion operation and tonsillectomy rates, otolaryngology services, and deprivation scores in Scotland. Design: Analysis of routine 1990 NHS data on grommet insertions and tonsillectomies in Scottish children aged 0-15 years compared with data on general practitioner and otolaryngology services and Carstairs deprivation scores. Setting: All 15 Scottish health boards. Subjects--All children aged 0-15 (1 021 933). Results: Tonsillectomy was more common than grommet insertion operations in Scotland (6182:4850). Health boards with high grommet insertion rates were more likely to have low tonsillectomy rates (Spearman9s rank correlation -0.59; 95% confidence interval -0.87 to -0.03). Grommet insertion rates varied fourfold (from 2.4/1000 to 9.2/1000) and tonsillectomy rates twofold (from 3.6/1000 to 8.0/1000) across Scottish health boards. Variation between health boards had changed over the 15 years 1975-90. Variation in grommet insertion rates did not reflect variation in the supply of otolaryngology consultants (Spearman9s rank correlation -0.25). There was a non-significant tendency for high general practitioner referral rates to be associated with high grommet insertion rates, low tonsillectomy rates, and less deprived areas (Spearman9s rank correlation coefficients 0.50, -0.53, and -0.43). Deprivation (measured by Carstairs scoring for each health board) was associated with higher tonsillectomy rates (Spearman9s rank correlation 0.41; 95% confidence interval -0.22 to 0.80) and significantly lower grommet insertion rates (-0.73; -0.92 to -0.28). Conclusion--Social factors as well as differences in disease prevalence and medical practice need to be considered when studying variation in childhood grommet insertion and tonsillectomy rates.

Background There has been little rigorous economic analysis of the relationship between asthma and improved housing. Aim To evaluate the cost-effectiveness of installing ventilation systems, and central heating if necessary, in homes of children with ‘moderate’ or ‘severe’ asthma. Design and setting An incremental cost-effectiveness analysis alongside a pragmatic randomised controlled trial of a tailored package of housing modifications designed to improve ventilation and household heating in homes within Wrexham County Borough, Wales, UK. Method A total of 177 children aged between 5 and 14 years, identified from general practice registers, were studied. Parents reported on the quality of life of their children over a 12-month period. General practices reported on health-service resources used by those children, and their asthma-related prescriptions, over the same period. Results The tailored package shifted 17% of children in the intervention group from ‘severe’ to ‘moderate’ asthma, compared with a 3% shift in the control group. The mean cost of these modifications was £1718 per child treated or £12300 per child shifted from ‘severe’ to ‘moderate’. Healthcare costs over 12 months following randomisation did not differ significantly between intervention and control groups. Bootstrapping gave an incremental cost-effectiveness ratio (ICER) of £234 per point improvement on the 100-point PedsQL™ asthma-specific scale, with 95% confidence interval (CI) = £140 to £590. The ICER fell to £165 (95% CI = £84 to £424) for children with ‘severe’ asthma. Conclusion This novel and pragmatic trial, with integrated economic evaluation, reported that tailored improvement of the housing of children with moderate to severe asthma is likely to be a cost-effective use of public resources. This is a rare example of evidence for collaboration between local government and the NHS.

Background Depression is often a chronic relapsing condition, with relapse rates of 50-80% in those who have been depressed before. This is particularly problematic for those who become suicidal when depressed since habitual recurrence of suicidal thoughts increases likelihood of further acute suicidal episodes. Therefore the question how to prevent relapse is of particular urgency in this group. Methods/Design This trial compares Mindfulness-Based Cognitive Therapy (MBCT), a novel form of treatment combining mindfulness meditation and cognitive therapy for depression, with both Cognitive Psycho-Education (CPE), an equally plausible cognitive treatment but without meditation, and treatment as usual (TAU). It will test whether MBCT reduces the risk of relapse in recurrently depressed patients and the incidence of suicidal symptoms in those with a history of suicidality who do relapse. It recruits participants, screens them by telephone for main inclusion and exclusion criteria and, if they are eligible, invites them to a pre-treatment session to assess eligibility in more detail. This trial allocates eligible participants at random between MBCT and TAU, CPE and TAU, and TAU alone in a ratio of 2:2:1, stratified by presence of suicidal ideation or behaviour and current anti-depressant use. We aim to recruit sufficient participants to allow for retention of 300 following attrition. We deliver both active treatments in groups meeting for two hours every week for eight weeks. We shall estimate effects on rates of relapse and suicidal symptoms over 12 months following treatment and assess clinical status immediately after treatment, and three, six, nine and twelve months thereafter. Discussion This will be the first trial of MBCT to investigate whether MCBT is effective in preventing relapse to depression when compared with a control psychological treatment of equal plausibility; and to explore the use of MBCT for the most severe recurrent depression - that in people who become suicidal when depressed. Trial Registration Current Controlled Trials: ISRCTN97185214.

A flexible, generalized method of treatment allocation is proposed. The method uses a set of controlling parameters that enables the generic algorithm to produce a family of possible outcomes ranging from simple randomization to deterministic allocation. The method controls balance at stratum level, stratification level and overall without detriment to the predictability of the method. The paper lists the desirable characteristics of allocation methods and shows that the proposed method fulfils the majority and is easy to use in the clinical context, once the coding has been established. An explanation of the method for 2, 3 and 4 treatment group allocations is given. Simulations demonstrate the flexibility of the method. Copyright © 2011 John Wiley & Sons, Ltd.

Background Cancer follow-up places a significant burden on hospital outpatient clinics. There are increasing calls to develop alternative models of provision. Aim To undertake a systematic review of qualitative studies examining patients' and healthcare professionals' views about cancer follow-up. Design of study Systematic review. Setting Primary and secondary care. Method Comprehensive literature searches included: 19 electronic databases, online trial registries, conference proceedings, and bibliographies of included studies. Eligible studies included qualitative studies examining patients' and healthcare professionals' views of cancer follow-up. Studies of patients with any type of cancer, considered free of active disease, or no longer receiving active treatment were included. Findings were synthesised using thematic analysis. Results Nineteen studies were included; seven were linked to randomised controlled trials. Eight studies examined the views of healthcare professionals (four of which included GPs) and 16 examined the views of patients. Twelve descriptive themes were identified, from which 12 perceived implications for practice were derived. Most themes related to conventional follow-up in secondary care. Some views concerning other models of care were based on participants' ideas, rather than experiences. Conclusion Patients' main concern is recurrent disease, and they find regular follow-up, expertise of specialists, and quick access to tests reassuring. Information regarding the effectiveness of follow-up is not given to patients who also have unmet information needs, which would help them to cope and be more involved. Continuity of care, unhurried consultations, and psychosocial support are important, but sometimes lacking in secondary care. GPs are thought to be unwilling and to have insufficient time and expertise to conduct follow-up.

Aim. This paper is a report of a systematic review of the effectiveness and costeffectiveness of nurse-led follow-up for patients with cancer. Background. As cancer survivorship increases, conventional follow-up puts a major burden on outpatient services. Nurse-led follow-up is a promising alternative. Data sources. Searches were conducted covering a period from inception to February 2007 of 19 electronic databases, seven online trial registries, five conference proceedings reference lists of previous reviews and included studies. Review methods. Standard systematic review methodology was used. Comparative studies and economic evaluations of nurse-led vs. physician-led follow-up were eligible. Studies comparing different types of nurse-led follow-up were excluded. Any cancer was considered; any outcome measure included. Results. Four randomised controlled trials were identified, two including cost analyses. There were no statistically significant differences in survival, recurrence or psychological morbidity. One study showed better HRQL measures for nurse-led follow-up, but one showed no difference, two showed a statistically significant difference for patient satisfaction, but two did not. Patients with lung cancer were more satisfied with nurse-led telephone follow-up and more were able to die at home. Patients with breast cancer thought patient-initiated follow-up convenient, but found conventional follow-up more reassuring. One study showed the cost of nurse-led follow-up to be less than that of physician-led follow-up, but no statistical comparison was made. Conclusion. Patients appeared satisfied with nurse-led follow-up. Patient-initiated or telephone follow-up could be practical alternatives to conventional care. However, well-conducted research is needed before equivalence to physician-led follow-up can be assured in terms of survival, recurrence, patient well-being and cost-effectiveness.

Objective: To evaluate clinical and cost effectiveness of implementing evidence-based guidelines for the prevention of stroke. Design: Cluster-randomised trial Setting: Three primary care organisations in the North of England covering a population of 400 000. Participants: Seventy six primary care teams in four clusters: North, South & West, City I and City II. Intervention: Guidelines for the management of patients with atrial fibrillation and transient ischaemic attack (TIA) were developed and implemented using a multifaceted approach including evidence-based recommendations, audit and feedback, interactive educational sessions, patient prompts and outreach visits. Outcomes: Identification and appropriate treatment of patients with atrial fibrillation or TIA, and cost effectiveness. Results: Implementation led to 36% increase (95% CI 4% to 78%) in diagnosis of atrial fibrillation, and improved treatment of TIA (odds ratio of complying with guidelines 1.8; 95% CI 1.1 to 2.8). Combined analysis of atrial fibrillation and TIA estimates that compliance was significantly greater (OR 1.46 95% CI 1.10 to 1.94) in the condition for which practices had received the implementation programme. The development and implementation of guidelines cost less than £1500 per practice. The estimated costs per quality-adjusted life year gained by patients with atrial fibrillation or TIA were both less than £2000, very much less than the usual criterion for cost effectiveness. Conclusions: Implementation of evidence-based guidelines improved the quality of primary care for atrial fibrillation and TIA. The intervention was feasible and very cost effective. Key components of the model include contextual analysis, strong professional support, clear recommendations based on robust evidence, simplicity of adoption, good communication and use of established networks and opinion leaders.

Background Osteoporosis creates brittle bones susceptible to fracture, with resulting high levels of morbidity and mortality. Poor access to bone densitometry services for the residents of North Wales led to the Welsh Assembly Government offering capital to purchase a dual-energy X-ray absorptiometry (DXA) scanner, used to diagnose osteoporosis, for the region. The commissioning question for the six Local Health Boards across North Wales was where to site the new scanner. This decision needed to reflect current inequalities in access to services and concerns over inappropriate prescribing relative to Welsh norms. Methods Epidemiological, corporate and comparative healthcare needs assessments were performed. In addition, two cross-sectional surveys were conducted to determine the views of general practices and users of bone densitometry services resident in North Wales. An option appraisal and sensitivity analysis of 13 costed options for DXA scanning was conducted. Results We estimated that only 31% of the people in North Wales who met national guidelines were receiving DXA scans. There was definite inequity of access to the current service provided by area of residence. There was also evidence of inequity of access by age and sex. The most suitable option identified in the option appraisal was a bone densitometry service based in the central location of Llandudno. Conclusion The assessment identified significant unmet need for DXA scanning. A recommendation was made to improve access through the introduction of a new bone densitometry service based at Llandudno. This would double scanning provision provided and reduce travel costs and time for many North Wales residents. This recommendation was adopted by a joint commissioning group established by the six Local Health Boards in North Wales at the end of 2004 – evidence based commissioning in practice.

Introduction Drug overdose is the most frequent cause of death among people who misuse illegal drugs. People who inject these drugs are 14–17 times more likely to die than their non-drug using peers. Various strategies to reduce drug-related deaths have failed to meet target reductions. Research into community-based interventions for preventing drug overdose deaths is promising. This review seeks to identify published studies describing community-based interventions and to evaluate their effectiveness at reducing drug overdose deaths. Methods and analysis We will systematically search key electronic databases using a search strategy which groups terms into four facets: (1) Overdose event, (2) Drug classification, (3) Intervention and (4) Setting. Searches will be limited where possible to international literature published in English between 1998 and 2014. Data will be extracted by two independent reviewers using a predefined table adapted from the Cochrane Collaboration handbook. The quality of included studies will be evaluated using the Cochrane Collaboration9s tool for assessing risk of bias. We will conduct a meta-analysis for variables which can be compared across studies, using statistical methods to control for heterogeneity where appropriate. Where clinical or statistical heterogeneity prevents a valid numerical synthesis, we will employ a narrative synthesis to describe community-based interventions, their delivery and use and how effectively they prevent fatal overdoses. Ethics and dissemination We will publish findings from this systematic review in a peer-reviewed scientific journal and present results at national and international conferences. It will be disseminated electronically and in print. Trial registration number PROSPERO CRD42015017833.

There is little rigorous evidence to underpin clinical guidelines for palliative care. However, research in palliative care is difficult, especially with dying patients. Consent is a major issue, since staff do not wish to invite dying patients to participate in trials. We, therefore, conducted a feasibility study in two units within the North West Wales NHS Trust. We explored two novel approaches to research in palliative care -cluster randomisation and randomised consent. All patients admitted to the two units during the study were asked for permission to use their data for research. We allocated the two units, at random, to use cluster randomisation or randomised consent for three months, and then to crossover to the other design. Of 24 patients dying during cluster-randomised phases, 13 gave consent on admission to use their data and were, thus, eligible to enter the trial; however, defined eligibility criteria reduced these to six active participants. Of 29 patients dying during randomised consent phases, seven gave consent on admission to use their data; although two were eligible for randomisation, neither entered the trial. We judge that cluster randomisation is the more effective design for research with dying patients. Computer simulation, based on data from 1500 dying patients on the Welsh Integrated Care Pathway, shows that crossover cluster trials need much smaller samples than simple cluster trials. Furthermore, this study has shown that crossover cluster trials are entirely feasible. We recommend a ‘definitive’ trial to test the crossover design more widely.

OBJECTIVES: Interest has been growing in the use of the theory of planned behaviour (TBP) in health services research. The sample sizes range from less than 50 to more than 750 in published TPB studies without sample size calculations. We estimate the sample size for a multi-stage random survey of prescribing intention and actual prescribing for asthma in British general practice. To our knowledge, this is the first systematic attempt to determine sample size for a TPB survey. METHODS: We use two different approaches: reported values of regression models' goodness-of-fit (the lambda method) and zero-order correlations (the variance inflation factor or VIF method). Intra-cluster correlation coefficient (ICC) is estimated and a socioeconomic variable is used for stratification. We perform sensitivity analysis to estimate the effects of our decisions on final sample size. RESULTS: The VIF method is more sensitive to the requirements of a TPB study. Given a correlation of .25 between intention and behaviour, and of .4 between intention and perceived behavioural control, the proposed sample size is 148. We estimate the ICC for asthma prescribing to be around 0.07. If 10 general practitioners were sampled per cluster, the sample size would be 242. CONCLUSIONS: It is feasible to perform sophisticated sample size calculations for a TPB study. The VIF is the appropriate method. Our approach can be used with adjustments in other settings and for other regression models.

Objective: To evaluate the reliability and responsiveness to change of an audit tool to assess adherence to evidence of effectiveness in the speech and language therapy (SLT) management of poststroke dysphagia. Design: The tool was used to review SLT practice as part of a randomized study of different education strategies. Medical records were audited before and after delivery of the trial intervention. Setting: Seventeen SLT departments in the north-west of England participated in the study. Subjects: The assessment tool was used to assess the medical records of 753 patients before and 717 patients after delivery of the trial intervention across the 17 departments. A target of 10 records per department per month was sought, using systematic sampling with a random start. Analysis: Inter- and intra-rater reliability were explored, together with the tool's internal consistency and responsiveness to change. Results: The assessment tool had high face validity, although internal consistency was low ( ra=0.37). Composite scores on the tool were however responsive to differences between SLT departments. Both inter- and intra-rater reliability ranged from ‘substantial’ to ‘near perfect’ across all items. Conclusions: The audit tool has high face validity and measurement reliability. The use of a composite adherence score should, however, proceed with caution as internal consistency is low.

Problem: Rapid referral and management of patients with transient ischaemic attacks is a key component in the national strategy for stroke prevention. However, patients with transient ischaemic attacks are poorly identified and undertreated. Design and setting: Before and after evaluation of quality improvement programme with controlled comparison in three primary care trusts reflecting diverse populations and organisational structures in an urban district in the North of England. Key measures for improvement: The proportion of patients receiving antiplatelet drugs and safe driving advice on referral to a speciality clinic, and the numbers of referrals, adjusted for age, to the specialist clinic before and after the improvement programme. Strategies for change: Interviews with patient and professionals to identify gaps and barriers to good practice; development of evidence based guidelines for the management of patients with transient ischaemic attacks; interactive multidisciplinary workshops for each primary care trust with feedback of individual audit results of referral practice; outreach visits to teams who were unable to attend the workshops; referral templates and desktop summaries to provide reminders of the guidelines to clinicians; incorporation of standards into professional contracts. Effects of change: A significant improvement occurred in identification and referral of patients with transient ischaemic attacks to specialist clinics, with a 41% increase in referrals from trained practices compared with control practices. There were also significant improvements in the early treatment and safety advice provided to patients before referral. Lessons learnt: A strategic approach to effective quality improvement across a diverse health community is feasible and achievable. Careful planning with patient and professional involvement to develop a tailored and multifaceted quality improvement programme to implement evidence based practice can work in very different primary care settings. Key components of the effectiveness of the model include contextual analysis, strong professional support, clear recommendations based on robust evidence, simplicity of adoption, good communication, and use of established networks and opinion leaders.

Objective: To evaluate the clinical and cost effectiveness of two training strategies to promote the use of research evidence in speech and language therapy (SLT) management of poststroke dysphagia. Design: Pragmatic, cluster randomized trial. Setting: Seventeen SLT departments in north-west England. Participants: Two SLTs from each department received training and cascaded information across their department. Process of care was measured from the notes of 708 patients with acute poststroke dysphagia across eight departments allocated to training strategy A, and 762 patients across nine departments in strategy B. Interventions: Strategy A: training on the critical appraisal of published research papers and practice guidelines. Strategy B: strategy A plus training on management of change in clinical practice. Main outcome measures: Pre-and post-training adherence to practice guidelines in poststroke dysphagia management, based on a review of case notes. Incremental cost of increased adherence to clinical guidelines. Results: Departments' practice differed in adherence to guidelines. Departments changed following training ( F=2.22, df 16, 1436, p=0.004). The effect of training strategy on clinical practice was not significant. Strategy B departments engaged in more activities relating to research use following training than strategy A. Total costs of training averaged £2001, t2892, $3886 (SD £502, t726, $975) for strategy A and £3366, t4866, $6537 (SD £2121, t3066, $4119) for strategy B. Conclusions: Training in research implementation in addition to critical appraisal and guideline introduction is associated with increased dissemination activities and awareness of research information, but not with changes in clinical practice within six months of training. The department in which SLTs work influences their use of research. The process of poststroke dysphagia management can be measured using a tool developed from practice guidelines.

Background Spinal pain is common and costly to health services and society. Management guidelines have encouraged primary care referral for spinal manipulation, but the evidence base is weak. More economic evaluations alongside pragmatic trials have been recommended. Objective Our aim was to assess the cost-utility of a practice-based osteopathy clinic for subacute spinal pain. Methods A cost-utility analysis was performed alongside a pragmatic single-centre randomized controlled trial in a primary care osteopathy clinic accepting referrals from 14 neighbouring practices in North West Wales. Patients with back pain of 2-12 weeks duration were randomly allocated to treatment with osteopathy plus usual GP care or usual GP care alone. Costs were measured from a National Health Service (NHS) perspective. All primary and secondary health care interventions recorded in GP notes were collected for the study period. We calculated quality adjusted life year (QALY) gains based on EQ-5D responses from patients in the trial, and then cost per QALY ratios. Confidence intervals (CIs) were estimated using non-parametric bootstrapping. Results Osteopathy plus usual GP care was more effective but resulted in more health care costs than usual GP care alone. The point estimate of the incremental cost per QALY ratio was 3560 pounds (80% CI 542 pounds-77,100 pounds). Sensitivity analysis examining spine-related costs alone and total costs excluding outliers resulted in lower cost per QALY ratios. Conclusion A primary care osteopathy clinic may be a cost-effective addition to usual GP care, but this conclusion was subject to considerable random error. Rigorous multi-centre studies are needed to assess the generalizability of this approach.

Background Although guidelines for the care of the dying patient exist the evidence base to support the guidelines is poor. Some of the factors contributing to this include failure to recruit to trials, protective healthcare professionals and subsequent attrition from trials due to the death of the patients. Recent studies report favourably on the use of cluster randomisation as an appropriate methodology for use in this patient group. Methods/design A feasibility study, exploring two types of randomisation as appropriate methodology for trials involving dying patients. Cluster randomisation and randomised consent will be utilised following a crossover design at two sites, one oncology ward and one Macmillan unit within the Northwest Wales NHS Trust. All patients commencing on the Integrated Care Pathway (ICP) for the Last Days of Life will be eligible for inclusion in the study. Using the hypothesis that it is not necessary to prescribe an anti-emetic medication when setting up a syringe driver for the dying patient, the study will evaluate different models of research methodology. Discussion The identification of the most appropriate methodology for use in studies concerning this patient group will inform the development of future clinical studies. Furthermore, the outcomes of this feasibility study will inform the development, of a proposal seeking funding for Wales-wide trials in palliative care. The identification of an appropriate methodology will provide a starting point for the establishment of a robust evidence base for the care of the dying patient.

This article explores the meaning of ‘evidence-based fertility treatment’ and reviews the relevance of evidence-based health care to the proposed National Service Framework (NSF) for Infertility Services. It summarizes the principles of systematic literature reviewing and proposes an agenda for those developing the NSF. This agenda is illustrated by data from a preliminary review by the authors. The main strength of the proposed NSF lies in the National Evidence-Based Clinical Guidelines but the main weakness lies in the lack of rigorous positive evidence underpinning these guidelines. The NSF team will have to appraise, enhance, extend and synthesize these reviews. The lack of an NSF would threaten the future effectiveness and cost-effectiveness of infertility services in the UK.

Objective: To evaluate the effectiveness of a tailored and multifaceted approach to the implementation of nationally recommended and evidence-based guidelines in primary care within existing systems and resources. Methods: A non-randomised Latin square to compare guideline implementation in two neighbouring health districts covering 180 general practices. Evidence-based guidelines for the treatment of patients with asthma and angina were implemented actively in one district and passively disseminated in the other district. Outcome measures for asthma were smoking status and inhaler technique. For angina the outcome measures were: smoking status; blood pressure; aspirin prescribed, contraindicated or self-medicated; beta-blocker prescribed or contraindicated; routine hospital admission; prescribed drugs; self-reported change. Results: There were improvements in all outcome criteria between baseline and follow-up audits, regardless of whether the guideline was actively implemented or passively disseminated. The estimated increase in the proportion of records complying with guidelines was 4% [95% confidence intervals (CI): 0, 8] and was higher in intervention than in control practices. Using only records not compliant at baseline, the corresponding difference was 15% (95% CI: 7, 24). The only significant improvement associated with active implementation was smoking status in angina patients. Both prescribing and hospital admission monthly totals changed during the period of the trial, but there was no significant difference between the pattern of changes in intervention and control districts. A significantly greater proportion of health professionals saw the intervention guideline compared with the control (75% versus 25%). There was a significant correlation between self-reported change and interventions steps ( P < 0.05). Conclusions: Increases in quality markers occurred irrespective of the multifaceted implementation efforts. Some of this increase was due to the method of data collection. Nevertheless, national initiatives may have more influence than local implementation initiatives.

The purpose of the study was to investigate the effects of introducing a critical care outreach service on in-hospital mortality and length of stay in a general acute hospital. A pragmatic ward-randomised trial design was used, with intervention introduced to all wards in sequence. No blinding was possible. Sixteen adult wards in an 800-bed general hospital in the north of England. All admissions to the 16 surgical, medical and elderly care wards during 32-week study period were included (7450 patients in total, of whom 2903 were eligible for the primary comparison). Essential elements of the Critical Care Outreach service introduced during the study were a nurse-led team of nurses and doctors experienced in critical care, a 24-h service, emphasis on education, support and practical help for ward staff. The main outcome measures were in-hospital mortality and length of stay. Outreach intervention reduced in-hospital mortality compared with control (two-level odds ratio: 0.52 (95% CI 0.32–0.85). A possible increased length of stay associated with outreach was not fully supported by confirmatory and sensitivity analyses. The study suggests outreach reduces mortality in general hospital wards. It may also increase length of stay, but our findings on this are equivocal.

Introduction Many patients with ulcerative colitis (UC) present with acute exacerbations needing hospital admission. Treatment includes intravenous steroids but up to 40% of patients do not respond and require emergency colectomy. Mortality following emergency colectomy has fallen, but 10% of patients still die within 3 months of surgery. Infliximab and ciclosporin, both immunosuppressive drugs, offer hope for treating steroid-resistant UC as there is evidence of their short-term effectiveness. As there is little long-term evidence, this pragmatic randomised trial, known as Comparison Of iNfliximab and ciclosporin in STeroid Resistant Ulcerative Colitis: a Trial (CONSTRUCT), aims to compare the clinical and cost-effectiveness of infliximab and ciclosporin for steroid-resistant UC. Methods and analysis Between May 2010 and February 2013, 52 UK centres recruited 270 patients admitted with acute severe UC who failed to respond to intravenous steroids but did not need surgery. We allocated them at random in equal proportions between infliximab and ciclosporin.The primary clinical outcome measure is quality-adjusted survival, that is survival weighted by Crohn's and Colitis Questionnaire (CCQ) participants’ scores, analysed by Cox regression. Secondary outcome measures include: the CCQ—an extension of the validated but community-focused UK Inflammatory Bowel Disease Questionnaire (IBDQ) to include patients with acute severe colitis and stoma; two general quality of life measures—EQ-5D and SF-12; mortality; survival weighted by EQ-5D; emergency and planned colectomies; readmissions; incidence of adverse events including malignancies, serious infections and renal disorders; disease activity; National Health Service (NHS) costs and patient-borne costs. Interviews investigate participants’ views on therapies for acute severe UC and healthcare professionals’ views on the two drugs and their administration. Ethics and dissemination The Research Ethics Committee for Wales has given ethical approval (Ref. 08/MRE09/42); each participating Trust or Health Board has given NHS Reseach & Development approval. We plan to present trial findings at international and national conferences and publish in high-impact peer-reviewed journals. Trial registration number ISRCTN: 22663589; EudraCT number: 2008-001968-36

Objectives Endoscopic ultrasound (EUS) is recommended for staging gastro-oesophageal cancers but has never been rigorously evaluated. This trial assessed whether EUS, when added to usual staging tests: changes treatment; improves survival and quality of life; and uses resources cost-effectively. Methods We conducted a pragmatic randomised trial in eight centres. As 80% of participants came from two centres, we combined the other centres for analysis. Patients diagnosed with gastro-oesophageal cancer received a standard staging protocol, after which the multi-disciplinary team agreed a provisional management plan. In principle the choice lay between endoscopic mucosal resection, immediate surgery, neoadjuvant chemotherapy followed by surgery, or multi-modal treatment (ie chemotherapy and radiotherapy). We then randomised consenting patients without metastases by telephone to receive EUS or not. Thereafter we recorded changes in the management plan, in the use of healthcare resources and in participant-reported outcomes. In particular we focused on three facets of quality of life: generic (measured by the EQ5D), cancer-related (FACT general scale and subscales) and condition-specific (FACT additional concerns scale). We then followed participants at defined intervals till the end of the trial—that is for between one and 3.5 years. Findings We randomised 223 patients, of whom 213 yielded enough data for primary analysis. At the end of the trial 45% of EUS participants and 32% of the non-EUS participants were alive. EUS improved survival adjusted for generic quality of life with an HR of 0.69 (95% CI 0.49 to 0.98); and both its components—survival and EQ5D scores; the benefits of EUS were significantly greater for those with poor initial quality of life, but there was no difference between centres. Similarly, there was a significant interaction between initial quality of life and the effect of EUS on all the FACT scales; again sicker patients benefitted more from EUS. However, there was no significant difference between EUS and non-EUS groups in mean FACT scores adjusted for covariates. Both management plans and final treatment varied between centres. Although EUS changed the management plan for several participants, differences between groups in actual treatment and the proportion of tumours completely resected were not significant. In both groups, two thirds of initial treatment plans were for chemotherapy followed by surgery, but 40% of participants received multi-modal or palliative treatment. Conclusion EUS has a beneficial effect on survival and generic quality of life, especially for participants initially in poorer health.

Background. Low response rates to surveys are a problem in general practice. There is evidence that offering GPs incentives improves response rates to postal questionnaires. However, there is less evidence about the most effective form of incentive. Objective. Our trial aimed to maximize response to a postal questionnaire and to test the most effective form of incentive. Methods. The study involved a randomized controlled trial of a postal survey Results. The incentive of a lottery for six bottles of champagne generated a response rate of 79%. Furthermore, one chance of six bottles generated 9% more responses than six chances of one bottle. Conclusions. This study has established that, among incentives for postal questionnaires, one big prize improves the yield more than many small prizes despite the lower odds of winning. It has also confirmed that offering a modest incentive to GPs generates good response rates for postal questionnaires.

The concentrations of high density lipoprotein (HDL) subfractions in 100 healthy male subjects were compared with 100 newly presenting patients with myocardial infarction (MI) within 12 h of the onset of chest pain. A subfraction of HDL enriched in apolipoprotein E (apo E), separated by heparin-Sepharose affinity chromotography, was present in lower concentrations (P < 0.001) in the plasma of the coronary patients than in the control subjects. This finding was confirmed by a lower content (P < 0.02) of apo E, measured by ELISA, in the total HDL fraction isolated from the coronary patients. Gradient gel electrophoresis of the total HDL demonstrated that the coronary patients had a significantly decreased concentration of the large HDL particles, HDL2b, of mean diameter 10.57 nm and a higher concentration of the smaller-sized HDL3, especially HDL3c, of mean diameter 7.62 nm. The coronary patients had a lower concentration of HDL cholesterol than the control subjects, attributable to the HDL2 fraction, with no difference in HDL2a between the two groups. There was no difference in the concentration of plasma cholesterol or triglyceride. The distribution of apo E phenotypes was similar in the two groups. HDL2b produced the highest discriminant power between the two groups, followed by apo E-rich HDL, HDL2 and HDL3c Plasma cholesterol correlated strongly with apo E-rich HDL for control subjects but not for MI survivors. This study demonstrates that the inverse relationship between HDL cholesterol and coronary risk shown in epidemiological studies is attributable to the large, apo E-containing HDL subspecies which under some circumstances are implicated in cholesterol removal by reverse cholesterol transport. This study also suggests that the concentration of the large, ago E-containing HDL may provide a sensitive predictor for subjects at risk of developing coronary heart disease.

Sex differences in patients having grommet operations in Scotland were analysed to provide further evidence on whether girls should be managed differently from boys. In children treated at less than one year, 64% were boys, but this proportion declined with age and, after the age of 13 years, became less than 50%. The median age at treatment and the repeat operation rate were similar for both sexes. Different management according to the sex of the patient does therefore not appear to be justified.

Objective To describe interventions to prevent and treat overdoses in the pre-hospital setting and review their effectiveness. Design This review was undertaken in three stages: 1: systematic overview—systematic literature search for all reports of interventions to treat and prevent overdose in the pre-hospital setting; 2: systematic review—we selected comparative studies from the overview results and undertook qualitative synthesis; 3: we identified studies suitable for meta-analysis. Setting We looked for interventions providing overdose reversal and/or prevention treatment in the prehospital emergency setting. UK opiate overdoses are amongst the highest in Europe. People who suffer a non-fatal poisoning are at high risk of death within the following year. For every death there are approximately 7 “near misses”. Naloxone is administered to reverse overdose. Participants Drug users who overdose or are at risk of further overdose. Main Outcome Measure Prevention of fatal overdose. Results (1) Systematic overview—39 references described interventions in six categories: 1. take-home naloxone administered by peers to an overdose patient, following training; 2. CPR training for bystanders witnessing an overdose; 3. alternative routes of naloxone administration by health professionals(intranasal, subcutaneous, intramuscular, intravenous); 4. police attendance protocols to encourage 999 calls by peers witnessing overdose; 5. supervised injection facilities; 6. psychosocial/educational interventions. (2) Systematic review—15 studies were included. Populations, interventions, methods and outcome were heterogeneous but 10/15 contained at least one comparative result. Quality assessment scores identified 3/15 reasonable quality studies (1 RCT) but most were poor quality. Evidence of effectiveness was weak but suggested death rates may be reduced by: take-home naloxone; bystander CPR; treatment for addiction; naloxone implants. Inter-study results were not comparable. (3) Meta-analysis—we could not identify comparable results across such diverse studies. Meta-analysis of effectiveness was therefore not possible. Conclusion There is little evidence of effectiveness for interventions identified in this review, including alternative pathways for naloxone administration, although naloxone is an effective treatment to reverse opiate overdose. Rigorous evaluation is needed to assess clinical and cost effectiveness, adverse event rates and effects on drug-taking behaviour of such approaches.

Background Osteoporosis creates brittle bones susceptible to fracture, with resulting high levels of morbidity and mortality. Poor access to bone densitometry services for the residents of North Wales led to the Welsh Assembly Government offering capital to purchase a dual-energy X-ray absorptiometry (DXA) scanner, used to diagnose osteoporosis, for the region. The commissioning question for the six Local Health Boards across North Wales was where to site the new scanner. This decision needed to reflect current inequalities in access to services and concerns over inappropriate prescribing relative to Welsh norms.

Objective: To compare the workloads of general practitioners and nurses and costs of patient care for nurse telephone triage and standard management of requests for same day appointments in routine primary care. Design: Multiple interrupted time series using sequential introduction of experimental triage system in different sites with repeated measures taken one week in every month for 12 months. Setting: Three primary care sites in York. Participants: 4685 patients: 1233 in standard management, 3452 in the triage system. All patients requesting same day appointments during study weeks were included in the trial. Main outcome measures: Type of consultation (telephone, appointment, or visit), time taken for consultation, presenting complaints, use of services during the month after same day contact, and costs of drugs and same day, follow up, and emergency care. Results: The triage system reduced appointments with general practitioner by 29-44%. Compared with standard management, the triage system had a relative risk (95% confidence interval) of 0.85 (0.72 to 1.00) for home visits, 2.41 (2.08 to 2.80) for telephone care, and 3.79 (3.21 to 4.48) for nurse care. Mean overall time in the triage system was 1.70 minutes longer, but mean general practitioner time was reduced by 2.45 minutes. Routine appointments and nursing time increased, as did out of hours and accident and emergency attendance. Costs did not differ significantly between standard management and triage: mean difference £1.48 more per patient for triage (95% confidence interval −0.19 to 3.15). Conclusions: Triage reduced the number of same day appointments with general practitioners but resulted in busier routine surgeries, increased nursing time, and a small but significant increase in out of hours and accident and emergency attendance. Consequently, triage does not reduce overall costs per patient for managing same day appointments. What is already known on this topic Nurse telephone triage is used to manage the increasing demand for same day appointments in general practice Evidence that nurse telephone triage is effective is limited What this study adds Triage resulted in 29-44% fewer same day appointments with general practitioners than standard management Nursing and overall time increased in the triage group as 40% of patients were managed by nurses Triage was not less costly than standard management because of increased costs for nursing, follow up, out of hours, and accident and emergency care

A woman's successive offspring tend to have similar birthweights. We use data from the Medical Birth Registry of Norway to describe weight and perinatal mortality of second births given the weight of the mother's first birth. Mean weights among second births differ by as much as 1000 grams, depending on the weight of the first. Furthermore, the survival of the second baby at any given weight is strongly affected by its weight relative to the first baby's weight. A baby may be average size compared to the whole population, but small compared to its sibling; such a baby has the increased mortality that goes with being relatively small. For example, an infant of 3250 grams is relatively large if the mother's previous baby was 2250 grams, but relatively small if the previous birth weighed 4250 grams. In the first case, the mortality risk of the 3250-gram baby is 2.2 per thousand, while in the second case, risk for the same weight infant is 9.0, or four times higher. Implications of these observations for the more general analysis of birthweight and perinatal mortality are discussed.

Background Deaths from opiate overdose in the UK are among the highest in Europe. Drug related deaths in Wales are not reducing. Naloxone is administered to reverse overdose by paramedics and in emergency departments. Aim To describe interventions to treat overdoses in the pre-hospital setting and review their effectiveness. Method 1—systematic literature search; 2—selection of comparative studies for qualitative synthesis; 3—meta-analysis of suitable studies. Results 39 references described interventions in six categories: 1) take-home naloxone administered by peers to an overdose patient, following training; 2) CPR training for bystanders witnessing an overdose; 3) routes of naloxone administration by health professionals; 4) police attendance protocols to encourage 999 calls by peers witnessing an overdose; 5) supervised injection facilities; 6) psychosocial/educational interventions. Fifteen studies were included in the systematic review. Populations, interventions, methods and outcome were heterogeneous. Evidence of effectiveness was weak but suggested death rates may be reduced by: take-home naloxone; bystander CPR; treatment for addiction; naloxone implants. Many studies were of poor quality. Inter-study results were not comparable. Meta-analysis of effectiveness was not possible. Discussion Naloxone is an effective treatment for the reversal of opiate overdose. Yet there is little evidence of effectiveness for interventions identified in this review, including issuing trained drug users with naloxone to treat peers. Roll out of take-home naloxone in Wales should be rigorously evaluated to assess clinical and cost effectiveness, adverse event rates and effects on drug-taking behaviour.