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Background: Chronic Rhinosinusitis (CRS) affects approximately 1 in 10 UK adults and impacts quality of life quality of life significantly. Response to treatment may be driven by individual CRS endotypes and therefore work to delineate biomarker clusters that may separate responders from non-responders is needed. The ongoing MACRO three-arm parallel-group trial randomises adult CRS patients to endoscopic sinus surgery, macrolide therapy or placebo. Aim: This study aims to correlate CRS endotypes with clinical parameters from the ongoing MACRO trial, including olfactory function and outcomes in terms of response to treatment using core biomarkers sets. Methods: Adult CRS patients enrolled into the MACRO trial will be recruited from participating UK otorhinolaryngology departments. Nasal tissue samples and swabs will be obtained in theatre or clinic from patients randomised to all three trial arms. Nasal tissue will be analysed with multiplex electrochemiluminescence for 32 cytokines including IL-5, IL-13, IgE and periostin. Bacterial swabs will be analysed using illumina miSeq 16S amplicon sequencing. Mean expression for each biomarker will be reported for treatment responder and non-responder groups. Correlation of biomarkers with MACRO trial outcome data such as endoscopic evaluation scores and quality-of-life improvement scores will be reported. Discussion: Defining clear endotypes in CRS will contribute to refining patient pathways for the efficient use of clinical resources. This work may lay the groundwork for future studies to predict which patients might respond to medical or surgical therapy. [ABSTRACT FROM AUTHOR]

This study assesses postoperative quality-of-life outcomes via the Glasgow Benefit Inventory (GBI) in patients undergoing transnasal endoscopic pituitary surgery for pituitary adenoma. This was a retrospective cohort study in a UK tertiary referral centre. 145 patients who had undergone transnasal endoscopic pituitary surgery for pituitary adenoma over a 6-year period at one institution completed the GBI with at least 3 months' follow up. Patients with prior radiotherapy were excluded. The GBI is a patient-reported outcome measure that assesses post-intervention outcomes in three domains: 'general' functioning, 'social support' and 'physical' functioning. Pre- and post-operative visual loss scores were additionally assessed via a 1–5 Likert scale. GBI scores were assessed alongside these visual loss scores, clinical and surgical parameters and demographics. Mean age was 59.5 years (range 20–87 years) and mean follow up was 36 months. A total of 46 of 145 (31.7%) patients had secreting tumours. The most common primary symptom was visual loss. Mean total score for all patients was positive (+8.4); with 'general' domain score the most positive (+10.5). All patient groups had overall positive, 'general' and 'social support' domain scores. Patients with Cushing's disease reported significantly higher mean total scores (+29.6) than all other groups. Acromegaly (+7.9) and non-functioning adenoma (NFA) groups (+5.2) reported lower mean total scores. 'Physical' domain mean scores were negative for acromegaly and NFA groups. There was statistical significance between a pre- to post-operative improvement in visual score and mean total GBI score (p = 0.02) and mean 'general' domain GBI score (p = 0.02). These findings can aid preoperative counselling of patients undergoing this surgery. Those with NFA and no anticipated improvement to visual loss symptoms may be advised of possible worsened physical outcomes and of the option to delay the surgery until symptoms are present. [ABSTRACT FROM AUTHOR]

Background: Urethral stricture is a common cause of difficulty passing urine in men with prevalence of 0.5 %; about 62,000 men in the UK. The stricture is usually sited in the bulbar part of the urethra causing symptoms such as reduced urine flow. Initial treatment is typically by endoscopic urethrotomy but recurrence occurs in about 60% of men within 2 years. The best treatment for men with recurrent bulbar stricture is uncertain. Repeat endoscopic urethrotomy opens the narrowing but it usually scars up again within 2 years requiring repeated procedures. The alternative of open urethroplasty involves surgically reconstructing the urethra, which may need an oral mucosal graft. It is a specialist procedure with a longer recovery period but may give lower risk of recurrence. In the absence of firm evidence as to which is best, individual men have to trade off the invasiveness and possible benefit of each option. Their preference will be influenced by individual social circumstances, availability of local expertise and clinician guidance. The open urethroplasty versus endoscopic urethrotomy (OPEN) trial aims to better guide the choice of treatment for men with recurrent urethral strictures by comparing benefit over 2 years in terms of symptom control and need for further treatment.Methods/design: OPEN is a pragmatic, UK multicentre, randomised trial. Men with recurrent bulbar urethral strictures (at least one previous treatment) will be randomised to undergo endoscopic urethrotomy or open urethroplasty. Participants will be followed for 24 months after randomisation, measuring symptoms, flow rate, the need for re-intervention, health-related quality of life, and costs. The primary clinical outcome is the difference in symptom control over 24 months measured by the area under the curve (AUC) of a validated score. The trial has been powered at 90% with a type I error rate of 5% to detect a 0.1 difference in AUC measured on a 0-1 scale. The analysis will be based on all participants as randomised (intention-to-treat). The primary economic outcome is the incremental cost per quality-adjusted life year. A qualitative study will assess willingness to be randomised and hence ability to recruit to the trial.Discussion: The OPEN Trial seeks to clarify relative benefit of the current options for surgical treatment of recurrent bulbar urethral stricture which differ in their invasiveness and resources required. Our feasibility study identified that participation would be limited by patient preference and differing recruitment styles of general and specialist urologists. We formulated and implemented effective strategies to address these issues in particular by inviting participation as close as possible to diagnosis. In addition re-calculation of sample size as recruitment progressed allowed more efficient design given the limited target population and funding constraints. Recruitment is now to target.Trial Registration: ISRCTN98009168 Date of registration: 29 November 2012. [ABSTRACT FROM AUTHOR]

Summary: The purpose of the study was to estimate the cost-effectiveness of balloon kyphoplasty compared to nonsurgical management and vertebroplasty for the treatment of hospitalised osteoporotic vertebral compression fractures in the UK. A cost-effectiveness model was constructed and used for analysis. Balloon kyphoplasty may be cost-effective compared to relevant alternatives. Introduction: The objective of this study was to estimate the cost-effectiveness of balloon kyphoplasty (BKP) for the treatment of patients hospitalised with acute osteoporotic vertebral compression fracture (OVCF) compared to percutaneous vertebroplasty (PVP) and nonsurgical management (NSM) in the UK. Methods: A Markov simulation model was developed to evaluate treatment with BKP, NSM and PVP in patients with symptomatic OVCF. Data on health-related quality of life (HRQoL) with acute OVCF were derived from the FREE and VERTOS II randomised clinical trials (RCTs) and normalised to the NSM arm in the FREE trial. Estimated differences in mortality among the treatments and costs for NSM were obtained from the literature whereas procedure costs for BKP and PVP were obtained from three National Health Service hospitals. It was assumed that BKP and PVP reduced hospital length of stay by 6 days compared to NSM. Results: The incremental cost-effectiveness ratio was estimated at Great Britain Pound Sterling (GBP) 2,706 per quality-adjusted life year (QALY) and GBP 15,982 per QALY compared to NSM and PVP, respectively. Sensitivity analysis showed that the cost-effectiveness of BKP vs. NSM was robust when mortality and HRQoL benefits with BKP were varied. The cost-effectiveness of BKP compared to PVP was particularly sensitive to changes in the mortality benefit. Conclusion: BKP may be a cost-effective strategy for the treatment of patients hospitalised with acute OVCF in the UK compared to NSM and PVP. Additional RCT data on the benefits of BKP and PVP compared to simulated sham surgery and further data on the mortality benefits with BKP compared to NSM and PVP would reduce uncertainty. [ABSTRACT FROM AUTHOR]

The article examines the Islet transplantation as a treatment option for patients with type 1 diabetes. Currently, the transplantation of islets of Langerhans is targeted for people with severe glycaemic lability, hypoglycaemia unawareness and recurrent hypoglycaemia. It explains that type 1 diabetes is due to the autoimmune damage of insulin producing beta cells in the pancreatic islets of Langerhans. Some benefits of islet transplantation include minimal invasive and low morbidity. Reasons why islet transplantation has not become a mainstream treatment include shortage of donor organs for islet isolation, high costs of isolation procedures and the need for lifelong use of immunosuppressive agents.

Balloon kyphoplasty (BKP) is a procedure used to treat vertebral compression fractures (VCFs). We developed a cost-effectiveness model to evaluate BKP in United Kingsdom patients with hospitalised VCFs and estimated the cost-effectiveness of BKP compared to non-surgical management. The results indicate that BKP provides a cost-effective alternative for treating these patients. VCFs of osteoporotic patients are associated with chronic pain, a reduction in health-related quality of life (QoL) and high healthcare costs. BKP is a minimally invasive procedure that has resulted in pain relief, vertebral body height-restoration, decreased kyphosis and improved physical functioning in patients with symptomatic VCFs. BKP was shown to improve health-related QoL in a 12-month interim analysis of a randomised phase-III trial. The objectives of this study were to develop a Markov cost-effectiveness model to evaluate BKP in patients with painful hospitalised VCFs and to estimate the cost-effectiveness of BKP compared with non-surgical management in a UK setting. It was assumed that QoL-benefits found at 12 months linearly approached zero during another 2 years, and that patients receiving BKP warranted six fewer hospital bed days compared with patients given non-surgical management. The procedure was associated with quality-adjusted life-years (QALY)-gains of 0.17 and cost/QALY-gains at £8,800. The results were sensitive to assumptions about avoided length of hospital-stay and persistence of kyphoplasty-related QoL-benefits. In conclusion, the results indicate that BKP provides a cost-effective alternative for treating patients with hospitalised VCFs in a UK-setting. [ABSTRACT FROM AUTHOR]

Background The prevalence of percutaneous endoscopic gastrostomy (PEG) feeding of children in the UK has increased. This study explored how gastrostomy feeding affects the daily lives of children and their families, from the parents' perspectives and developed a conceptual framework for assessing the impact of feeding on family life. Methods A semi-structured interview approach was used to obtain the parents' views regarding the impact of feeding on daily lives; both of the children and their family. The study was a cross-sectional qualitative design employing purposive sampling. Twenty-four interviews were conducted and data were analysed descriptively and thematically. Results Difficulties arising from PEG feeding included vomiting (71%), diarrhoea (33%), infection of the PEG site (46%) and leakage (54%). The key issues that emerged included delayed and disturbed sleep, restricted ability to go out, difficulties finding a place to feed, childcare problems, negative attitudes of others towards feeding and family divisions. Parents primarily raised key issues regarding the impact of PEG feeding on themselves or the family rather than on the child. Conclusions An assessment framework has been developed, based on the parents perceptions, for use in assessing the impact of feeding upon family life and identifying the support required for parents of children receiving PEG feeding. Provision of adequate support is likely to require a network of healthcare professionals, social care and support groups, all working together to meet identified needs. [ABSTRACT FROM AUTHOR]