Search

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]