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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).

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 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.

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.

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.

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.

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.

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

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.

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.