BACKGROUND It is unknown whether warfarin or aspirin therapy is superior for patients with heart failure who are in sinus rhythm. METHODS We designed this trial to determine whether warfarin (with a target international normalized ratio of 2.0 to 3.5) or aspirin (at a dose of 325 mg per day) is a better treatment for patients in sinus rhythm who have a reduced left ventricular ejection fraction (LVEF). We followed 2305 patients for up to 6 years (mean [±SD], 3.5±1.8). The primary outcome was the time to the first event in a composite end point of ischemic stroke, intracerebral hemorrhage, or death from any cause. RESULTS The rates of the primary outcome were 7.47 events per 100 patient-years in the warfarin group and 7.93 in the aspirin group (hazard ratio with warfarin, 0.93; 95% confidence interval [CI], 0.79 to 1.10; P = 0.40). Thus, there was no significant overall difference between the two treatments. In a time-varying analysis, the hazard ratio changed over time, slightly favoring warfarin over aspirin by the fourth year of follow-up, but this finding was only marginally significant (P = 0.046). Warfarin, as compared with aspirin, was associated with a significant reduction in the rate of ischemic stroke throughout the follow-up period (0.72 events per 100 patient-years vs. 1.36 per 100 patient-years; hazard ratio, 0.52; 95% CI, 0.33 to 0.82; P = 0.005). The rate of major hemorrhage was 1.78 events per 100 patient-years in the warfarin group as compared with 0.87 in the aspirin group (P<0.001). The rates of intracerebral and intracranial hemorrhage did not differ significantly between the two treatment groups (0.27 events per 100 patient-years with warfarin and 0.22 with aspirin, P = 0.82). CONCLUSIONS Among patients with reduced LVEF who were in sinus rhythm, there was no significant overall difference in the primary outcome between treatment with warfarin and treatment with aspirin. A reduced risk of ischemic stroke with warfarin was offset by an increased risk of major hemorrhage. The choice between warfarin and aspirin should be individualized.

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Summary Background RSV causes considerable morbidity and mortality in children. In cystic fibrosis (CF) viral infections are associated with worsening respiratory symptoms and bacterial colonization. Palivizumab is effective in reducing RSV hospitalization in high risk patient groups. Evidence regarding its effectiveness and safety in CF is inconclusive. CF screening in N. Ireland enabled timely palivizumab prophylaxis, becoming routine in 2002. Objectives To determine the effect of palivizumab on RSV‐related hospitalization and compare lung function and bacterial colonization at age 6 years for those born pre‐ and post‐introduction of palivizumab prophylaxis. Methods A retrospective audit was conducted for all patients diagnosed with CF during the period from 1997 to 2007 inclusive. RSV‐related hospitalization, time to Pseudomonas aeruginosa (PA) 1st isolate, lung function and growth parameters were recorded. Comparisons were made for outcomes pre‐ and post‐introduction of routine palivizumab administration in 2002. A cost evaluation was also performed. Results Ninety‐two children were included; 47 pre‐ and 45 post‐palivizumab introduction. The overall RSV‐positive hospitalization rate was 13%. The relative risk of RSV infection in palivizumab non‐recipients versus recipients was 4.78 (95%CI: 1.1–20.7), P = 0.027. Notably, PA 1st isolate was significantly earlier in the palivizumab recipient cohort versus non‐recipient cohort (median 57 vs. 96 months, P < 0.025) with a relative risk of 2.5. Chronic PA infection at 6 years remained low in both groups, with similar lung function and growth parameters. Total costs were calculated at £96,127 ($151,880) for the non‐recipient cohort versus £137,954 ($217,967) for the recipient cohort. Conclusion Palivizumab was effective in reducing RSV‐related hospitalization infection in CF patients. Surprisingly, we found a significantly earlier time to 1st isolate of PA in palivizumab recipients which we could not explain by altered or improved diagnostic tests. Pediatr Pulmonol. 2016;51:379–385. © 2016 Wiley Periodicals, Inc.

Background: Nebulised delivery of different classes of drugs is of fundamental importance in therapeutic regimens relating to both the management of disease progression in cystic fibrosis disease and its associated complications. The aim of this study was to determine if current nebuliser hygiene practices in the home environment by paediatric and adult cystic fibrosis populations are appropriate to ensure appropriate infection control and prevention measures have been addressed. Methods: An Audit Questionnaire Study was completed with adult cystic fibrosis patients ( n=20) or with parents of cystic fibrosis children ( n=24), through a healthcare professional interview on a one-to-one basis, during either a home visit or during patient/parent attendance at cystic fibrosis clinic. Results: Hygienic practices relating to nebuliser care varied, with paediatric carers more likely to clean and disinfect their devices. This study suggests there is much variation and confusion with regard to how to clean and disinfect nebulisers, as well as who is responsible for delivering this advice. Conclusion: The adult cystic fibrosis community in particular needs to be educated on practicalities associated with nebuliser hygiene and the reasons why this is important. Furthermore, to date there is a lack of a universally recommended guideline suitable for all types of cystic fibrosis nebulisers that all relevant pharmaceutical manufacturers advocate.

BackgroundPelvic Organ Prolapse (POP) is estimated to affect 41%–50% of women aged over 40. Findings from the multi-centre randomised controlled “Pelvic Organ Prolapse PhysiotherapY” (POPPY) trial showed that individualised pelvic floor muscle training (PFMT) was effective in reducing symptoms of prolapse, improved quality of life and showed clear potential to be cost-effective. However, provision of PFMT for prolapse continues to vary across the UK, with limited numbers of women’s health physiotherapists specialising in its delivery. Implementation of this robust evidence from the POPPY trial will require attention to different models of delivery (e.g. staff skill mix) to fit with differing care environments.MethodsA Realist Evaluation (RE) of implementation and outcomes of PFMT delivery in contrasting NHS settings will be conducted using multiple case study sites. Involving substantial local stakeholder engagement will permit a detailed exploration of how local sites make decisions on how to deliver PFMT and how these lead to service change. The RE will track how implementation is working; identify what influences outcomes; and, guided by the RE-AIM framework, will collect robust outcomes data. This will require mixed methods data collection and analysis.Qualitative data will be collected at four time-points across each site to understand local contexts and decisions regarding options for intervention delivery and to monitor implementation, uptake, adherence and outcomes. Patient outcome data will be collected at baseline, six months and one year follow-up for 120 women. Primary outcome will be the Pelvic Organ Prolapse Symptom Score (POP-SS). An economic evaluation will assess the costs and benefits associated with different delivery models taking account of further health care resource use by the women. Cost data will be combined with the primary outcome in a cost effectiveness analysis, and the EQ-5D-5L data in a cost utility analysis for each of the different models of delivery.DiscussionStudy of the implementation of varying models of service delivery of PFMT across contrasting sites combined with outcomes data and a cost effectiveness analysis will provide insight into the implementation and value of different models of PFMT service delivery and the cost benefits to the NHS in the longer term.