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In this pragmatic trial, patients with asthma who required first-line controller therapy or were already using an inhaled glucocorticoid and needed additional therapy received a leukotriene-receptor antagonist (LTRA) or an inhaled glucocorticoid as first-line treatment or an LTRA or a long-acting beta 2 -agonist as an add-on. Results of double-blind, randomized, controlled trials provide, appropriately, the bedrock of evidence in determining the efficacy of therapeutic interventions. Proof of efficacy in the trial setting of optimized adherence and follow-up for selective patient populations does not, however, guarantee that a particular therapy will be effective in the diverse patient populations seen in clinical practice. 1 – 3 In the case of asthma, for example, the eligibility criteria in most such trials exclude an estimated 95% of patients with a current diagnosis of asthma, including smokers and those who have “insufficient” bronchodilator reversibility or impaired pulmonary function. 4 , 5 Moreover, the design of . . .

•Stroke is a common cause of mortality especially in the acute phase of stroke onset.•A raised modified early warning score is an accurate indicator of in-patient mortality.•Raised modified early warning score is also accurate predictor of mortality at 7 days, 30 days and 1 year.•There is a linear relationship between increased modified early warning score and increased mortality. An accurate prediction tool may facilitate optimal management of patients with acute stroke from an early stage. We evaluated the association between admission modified early warning score (MEWS) and mortality in patients with acute stroke. Data from the Anglia Stroke Clinical Network Evaluation Study (ASCNES) were analysed. We evaluated the association between admission MEWS and four outcomes; in-patient, 7-day, 30-day and 1-year mortality. Logistic regression models were used to calculate the odds of all mortality timeframes, whereas Cox proportional hazards models were used to calculate mortality at 1 year. Five univariate and multivariate models were constructed, adjusting for confounders. Patients with a moderate (2−3) or high (≥4) scores were compared to patients with a low score (0–1). The study population consisted of 2006 patients. A total of 1196 patients had low MEWS, 666 had moderate MEWS and 144 had a high MEWS. A high MEWS was associated with increased mortality as an in-patient (OR 4.93, 95 % CI: 2.88–8.42), at 7 days (OR 7.53, 95 % CI: 4.24–13.38), at 30 days (OR 5.74, 95 % CI: 3.38–9.76) and 1-year (HR 2.52, 95 % CI 1.88–3.39). At 1 year, model 5 had a 1.02 OR (95 % CI 0.83–1.24) with moderate MEWS and 2.52 (95 % CI 1.88–3.39) with high MEWS. Elevated MEWS on admission is a potential marker for acute-stroke mortality and may therefore be a useful risk prediction tool, able to guide clinicians attempting to prognosticate outcomes for patients with acute-stroke.

Background Stroke is the third leading cause of death in developed countries and the leading cause of long-term disability worldwide. A series of national stroke audits in the UK highlighted the differences in stroke care between hospitals. The study aims to describe variation in outcomes following stroke and to identify the characteristics of services that are associated with better outcomes, after accounting for case mix differences and individual prognostic factors. Methods/Design We will conduct a cohort study in eight acute NHS trusts within East of England, with at least one year of follow-up after stroke. The study population will be a systematically selected representative sample of patients admitted with stroke during the study period, recruited within each hospital. We will collect individual patient data on prognostic characteristics, health care received, outcomes and costs of care and we will also record relevant characteristics of each provider organisation. The determinants of one year outcome including patient reported outcome will be assessed statistically with proportional hazards regression models. Self (or proxy) completed EuroQol (EQ-5D) questionnaires will measure quality of life at baseline and follow-up for cost utility analyses. Discussion This study will provide observational data about health service factors associated with variations in patient outcomes and health care costs following hospital admission for acute stroke. This will form the basis for future RCTs by identifying promising health service interventions, assessing the feasibility of recruiting and following up trial patients, and provide evidence about frequency and variances in outcomes, and intra-cluster correlation of outcomes, for sample size calculations. The results will inform clinicians, public, service providers, commissioners and policy makers to drive further improvement in health services which will bring direct benefit to the patients.

Achieving target recruitment in randomized controlled trials (RCTs) is challenging. This paper compares our experience of recruiting for an RCT with the predictions made in our proposal. Participating UK primary care practices searched their computer databases to identify patients (12 years and over) with asthma who may be poorly controlled. Postal invitations were sent to all patients identified. Respondees were prescreened by phone, to assess their asthma control and establish their mobile phone suitability. Potentially eligible patients were booked for a trial recruitment visit. We recruited 288 patients (2.4% of those invited) across 32 practices, with a total list size of 311,926 patients. This compares to our predicted recruitment of 312 patients from a population of 72,000 patients in six to eight practices. In addition to the recognized problem of poor response rates, the major challenges were insufficiently discriminating computer searches and incompatibilities between mobile phone handsets, networks and the asthma application. Our data have implications for clinicians, managers, and researchers in primary care. Researchers in this area may wish to consider our data when designing their recruitment strategies. Improved coding of asthma morbidity data in clinical practice would ease identification of poorly controlled patients, both for clinical interventions and recruitment to trials. If telehealth is to become mainstream, there needs to be standardization of applications, operating platforms, and network capabilities.

Background The usefulness of time-limited consecutive data collection compared to continuous consecutive data collection in conditions which show seasonal variations is unclear. The objective of this study is to assess whether one month of admission data can be representative of data collected over two years in the same hospitals. Methods We compared the baseline characteristics and discharge outcomes of stroke patients admitted in the first month (October 2009) of the Anglia Stroke Clinical Network Evaluation Study (ASCNES) with the routinely collected data over 2 years between September 2008 and April 2011 from the same 8 hospital trusts in the Anglia Stroke & Heart Clinical Network (AS&HCN) as well as seasonal cohorts from the same period. Results We included a total of 8715 stroke patients (October 2009 cohort of ASCNES (n = 308), full AS&HCN cohort (n = 8407 excluding October 2009)) as well as cohorts from different seasons. All cohorts had a similar median age. No significant differences were observed for pre-stroke residence, pre-stroke modified Rankin, weekend vs. weekday admission, time of admission, patients with atrial fibrillation, type of stroke, admission systolic blood pressure, use of thrombolysis (rTPA), in-patient mortality and discharge destination. There were statistically significant differences between cohorts with regard to Oxfordshire Community Stroke Project Classification. Conclusions Stroke patients admitted in one month had largely indistinguishable characteristics and discharge outcomes to those admitted to the same trusts in three separate seasons and also over two years in this cohort.

Nursing home placement after stroke indicates a poor outcome but numbers placed vary between hospitals. The aim of this study is to determine whether between-hospital variations in new nursing home placements post-stroke are reliant solely on case-mix differences or whether service heterogeneity plays a role. A prospective, multi-center cohort study of acute stroke patients admitted to eight National Health Service acute hospitals within the Anglia Stroke and Heart Clinical Network between 2009 and 2011 was conducted. We modeled the association between hospitals (as a fixed-effect) and rates of new discharges to nursing homes using multiple logistic regression, adjusting for important patient risk factors. Descriptive and graphical data analyses were undertaken to explore the role of hospital characteristics. Of 1335 stroke admissions, 135 (10%) were discharged to a nursing home but rates varied considerably from 6% to 19% between hospitals. The hospital with the highest adjusted odds ratio of nursing home discharges (OR 4.26; 95% CI 1.69 to 10.73), was the only hospital that did not provide rehabilitation beds in the stroke unit. Increasing hospital size appeared to be related to an increased odds of nursing home placement, although attenuated by the number of hospital stroke admissions. Our results highlight the potential influence of hospital characteristics on this important outcome, independently of patient-level factors.

Background : Information is lacking on the relative effectiveness and cost effectiveness — in a real-life primary-care setting — of leukotriene receptor antagonists (LTRAs) and long-acting β2 adrenergic receptor agonists (β2 agonists) as add-on therapy for patients whose asthma symptoms are not controlled on low-dose inhaled corticosteroids (ICS). Objective : To estimate the cost effectiveness of LTRAs compared with longacting β2 agonists as add-on therapy for patients whose asthma symptoms are not controlled on low-dose ICS. Methods : An economic evaluation was conducted alongside a 2-year, pragmatic, randomized controlled trial set in 53 primary-care practices in the UK. Patients aged 1280 years with asthma insufficiently controlled with ICS (n = 361) were randomly assigned to add-on LTRAs (n = 176) or long-acting β2 agonists (n = 185). The main outcome measures were the incremental cost per point improvement in the Mini Asthma Quality of Life Questionnaire (MiniAQLQ), per point improvement in the Asthma Control Questionnaire (ACQ) and per QALY gained from perspectives of the UK NHS and society. Results : Over 2 years, the societal cost per patient receiving LTRAs was £1157 versus £952 for long-acting b2 agonists, a (significant, adjusted) increase of d214 (95%CI 2, 411) [year 2005 values]. Patients receiving LTRAs experienced a non-significant incremental gain of 0.009 QALYs (95% CI −0.077, 0.103). The incremental cost per QALY gained from the societal (NHS) perspective was £22 589 (£11 919). Uncertainty around this point estimate suggested that, given a maximum willingness to pay of £30 000 per QALY gained, the probability that LTRAs are a cost-effective alternative to long-acting β2 agonists as add-on therapy was approximately 52% from both societal and NHS perspectives. Conclusions : On balance, these results marginally favour the repositioning of LTRAs as a cost-effective alternative to long-acting β2 agonists as add-on therapy to ICS for asthma. However, there is much uncertainty surrounding the incremental cost effectiveness because of similarity of clinical benefit and broad confidence intervals for differences in healthcare costs. Trial registration : UK National Research Register N0547145240; Controlled Clinical Trials ISRCTN99132811.

Background : Information is lacking on the relative effectiveness and cost effectiveness — in a primary-care setting — of leukotriene receptor antagonists (LTRAs) as an alternative to inhaled corticosteroids (ICS) for initial asthma controller therapy. Objective : To compare the cost effectiveness of LTRAs versus ICS for patients initiating asthma controller therapy. Methods : An economic evaluation was conducted alongside a 2-year, pragmatic, randomized controlled trial set in 53 primary-care practices in the UK. Patients aged 1280 years with asthma and symptoms requiring regular antiinflammatory therapy (n = 326) were randomly assigned to LTRAs (n = 162) or ICS (n = 164). The main outcome measures were the incremental costs per point improvement in the Mini Asthma Quality of Life Questionnaire, per point improvement in the Asthma Control Questionnaire and per QALY gained from the UK NHS and societal perspectives. Results : Over 2 years, resource use was similar between the two treatment groups, but the cost to society per patient was significantly higher for the LTRA group, at £711 versus £433 for the ICS group (adjusted difference £204; 95% CI 74, 308) [year 2005 values]. Cost differences were driven primarily by differences in prescription drug costs, particularly study drug costs. There was a nonsignificant (imputed, adjusted) difference between treatment groups, favouring ICS, in QALYs gained at 2 years of −0.073 (95% CI −0.143, 0.010). Therapy with LTRAs was, on average, a dominated strategy, and, at a threshold for willingness to pay of £30 000 per QALY gained, the probability of LTRAs being cost effective compared with ICS was approximately 3% from both societal and NHS perspectives. Conclusions : There is a very low probability of LTRAs being cost effective in the UK, at 2005 values, compared with ICS for initial asthma controller therapy. Trial registration : UK National Research Register N0547145240; Controlled Clinical Trials ISRCTN99132811.

Background: Information is lacking on the relative effectiveness and cost effectiveness - in a primary-care setting - of leukotriene receptor antagonists (LTRAs) as an alternative to inhaled corticosteroids (ICS) for initial asthma controller therapy. Objective: To compare the cost effectiveness of LTRAs versus ICS for patients initiating asthma controller therapy. Methods: An economic evaluation was conducted alongside a 2-year, pragmatic, randomized controlled trial set in 53 primary-care practices in the UK. Patients aged 1280 years with asthma and symptoms requiring regular antiinflammatory therapy (n = 326) were randomly assigned to LTRAs (n = 162) or ICS (n = 164). The main outcome measures were the incremental costs per point improvement in the Mini Asthma Quality of Life Questionnaire, per point improvement in the Asthma Control Questionnaire and per QALY gained from the UK NHS and societal perspectives. Results: Over 2 years, resource use was similar between the two treatment groups, but the cost to society per patient was significantly higher for the LTRA group, at £711 versus £433 for the ICS group (adjusted difference £204; 95% CI 74, 308) [year 2005 values]. Cost differences were driven primarily by differences in prescription drug costs, particularly study drug costs. There was a nonsignificant (imputed, adjusted) difference between treatment groups, favouring ICS, in QALYs gained at 2 years of -0.073 (95% CI -0.143, 0.010). Therapy with LTRAs was, on average, a dominated strategy, and, at a threshold for willingness to pay of £30 000 per QALY gained, the probability of LTRAs being cost effective compared with ICS was approximately 3% from both societal and NHS perspectives. Conclusions: There is a very low probability of LTRAs being cost effective in the UK, at 2005 values, compared with ICS for initial asthma controller therapy. Trial registration: UK National Research Register N0547145240; Controlled Clinical Trials ISRCTN99132811.