Effectiveness and cost-effectiveness of basic versus biofeedback-mediated intensive pelvic floor muscle training for female stress or mixed urinary incontinence: protocol for the OPAL randomised trial.

INTRODUCTION: Accidental urine leakage is a distressing problem that affects around one in three women. The main types of urinary incontinence (UI) are stress, urgency and mixed, with stress being most common. Current UK guidelines recommend that women with UI are offered at least 3 months of pelvic floor muscle training (PFMT). There is evidence that PFMT is effective in treating UI, however it is not clear how intensively women have to exercise to give the maximum sustained improvement in symptoms, and how we enable women to achieve this. Biofeedback is an adjunct to PFMT that may help women exercise more intensively for longer, and thus may improve continence outcomes when compared with PFMT alone. A Cochrane review was inconclusive about the benefit of biofeedback, indicating the need for further evidence. METHODS AND ANALYSIS: This multicentre randomised controlled trial will compare the effectiveness and cost-effectiveness of PFMT versus biofeedback-mediated PFMT for women with stress UI or mixed UI. The primary outcome is UI severity at 24 months after randomisation. The primary economic outcome measure is incremental cost per quality-adjusted life-year at 24 months. Six hundred women from UK community, outpatient and primary care settings will be randomised and followed up via questionnaires, diaries and pelvic floor assessment. All participants are offered six PFMT appointments over 16 weeks. The use of clinic and home biofeedback is added to PFMT for participants in the biofeedback group. Group allocation could not be masked from participants and healthcare staff. An intention-to-treat analysis of the primary outcome will estimate the mean difference between the trial groups at 24 months using a general linear mixed model adjusting for minimisation covariates and other important prognostic covariates, including the baseline score. ETHICS AND DISSEMINATION: Approval granted by the West of Scotland Research Ethics Committee 4 (16/LO/0990). Written informed consent will be obtained from participants by the local research team. Serious adverse events will be reported to the data monitoring and ethics committee, the ethics committee and trial centres as required. A Standard Protocol Items: Recommendations for Interventional Trials checklist and figure are available for this protocol. The results will be published in international journals and included in the relevant Cochrane review. TRIAL REGISTRATION NUMBER: ISRCTN57746448; Pre-results.

Risk factors and predictors of mortality for proximal humeral fractures.

BACKGROUND: Risk factors for mortality after proximal humeral fracture, including socioeconomic status, are poorly defined. This retrospective review of prospectively collected data defines the epidemiology and predictors of mortality in association with proximal humeral fractures. METHODS: Patients who sustained proximal humeral fractures were identified from fragility fracture and trauma databases between May 2001 and September 2012. RESULTS: In total, 1880 patients with a mean age of 69 years and a male to female ratio of 2 : 3 were identified. Socioeconomic distribution is skewed towards the lowest and highest quintiles. Low-energy mechanisms caused 88% of fractures. Men sustain fractures when they are aged 10 years younger and via higher-energy mechanisms. In total, 536 patients (29%) died within the study period with a 1-year mortality of 9.8%, rising to 28.2% at 5 years. Female gender, increasing age, pathological fracture and increased number of co-morbidities were independent variables for increased mortality. CONCLUSIONS: The present study, which was conducted over an 11-year period, is the first to combine the epidemiology and risk factors for mortality with socioeconomic rank. One-year mortality risk is twice that of the background matched population. Patient counselling with respect to increased mortality should be considered, especially in higher-risk elderly females with multiple co-morbidities.

A case of craniocervical abscess with sinus thrombosis in Lemierre's syndrome.

A 74-year old gentleman with a cranio-cervical abscess failed to improve after incision and drainage and standard intravenous antibiotic therapy. Imaging demonstrated thrombosis of the internal jugular vein, sigmoid sinus and transverse sinus; and microbiological analysis isolated Fusobacterium nucleatum. The diagnosis of Lemierre's syndrome was confirmed, and he was effectively treated with appropriate antibiotics and anti-coagulation.