StereoTactic radiotherapy for wet Age-Related macular degeneration (STAR): study protocol for a randomised controlled clinical trial.

Background: The standard of care for neovascular age-related macular degeneration (nAMD) involves ongoing intravitreal injections of anti-angiogenic drugs targeting vascular endothelial growth factor (VEGF). The most commonly used anti-VEGF drugs are ranibizumab, bevacizumab and aflibercept. The main objective of the STAR trial is to determine if stereotactic radiotherapy can reduce the number of anti-VEGF injections that patients with nAMD require.

Doing More with Less: Diagnostic Accuracy of CT in Suspected Cauda Equina Syndrome.

Background And Purpose: Cauda equina syndrome typically requires emergent MR imaging to detect compressive lesions on the cauda equina, which may require surgical decompression. While CT is sometimes performed as a complementary imaging technique to evaluate osseous integrity in patients with cauda equina syndrome, the accuracy of CT in detecting significant spinal stenosis and cauda equina impingement is not well-defined in the literature. We hypothesized that percentage thecal sac effacement on CT of the lumbar spine would have high sensitivity and high negative predictive value in evaluating significant spinal stenosis and cauda equina impingement.

Lifestyle and Other Factors Explain One-Half of the Variability in the Serum 25-Hydroxyvitamin D Response to Cholecalciferol Supplementation in Healthy Adults.

Background: Many factors have been associated with serum 25-hydroxyvitamin D [25(OH)D] concentrations in observational studies, with variable consistency. However, less information is available on factors affecting the magnitude of changes in serum 25(OH)D resulting from vitamin D supplementation.

Objective: This study aimed to identify factors associated with the serum 25(OH)D response to supplementation with 1000 IU cholecalciferol/d during the first year of a large, multicenter, randomized, placebo-controlled colorectal adenoma chemoprevention trial.

Intradermal grass pollen immunotherapy increases T2 and IgE responses and worsens respiratory allergic symptoms.

Background: Repeated low-dose grass pollen intradermal allergen injection suppresses allergen-induced cutaneous late-phase responses comparably with conventional subcutaneous and sublingual immunotherapy.

Objective: We sought to evaluate the efficacy and safety of grass pollen intradermal immunotherapy in the treatment of allergic rhinitis.

Methods: We randomly assigned 93 adults with grass pollen-induced allergic rhinitis to receive 7 preseasonal intradermal allergen injections (containing 7 ng of Phl p 5 major allergen) or a histamine control.

Place of death in children and young people with cancer and implications for end of life care: a population-based study in England, 1993-2014.

Background: Efforts to improve end of life care (EoLC) have made tangible impacts on care in adults, including enabling more people to die at their preferred place of death (PoD), usually home or hospices. Little is known how the PoD in children and young people (CYP, ≤24 years) has changed over time, especially in the context of a series of national initiatives for EoLC improvement since the late 1990s. To inform evidence-based policy-making and service development, we evaluated the national trends of PoD and the associated factors in CYP who died with cancer.

Virtual Touch™ Quantification to Diagnose and Monitor Liver Fibrosis in Hepatitis B and Hepatitis C: A NICE Medical Technology Guidance.

Virtual Touch™ Quantification (VTq) is a software application used with Siemens Acuson ultrasound scanners to assess the stiffness of liver tissue. The National Institute for Health and Care Excellence (NICE) Medical Technologies Advisory Committee (MTAC) selected VTq for evaluation and invited the company to submit clinical and economic evidence. King's Technology Evaluation Centre, an External Assessment Centre (EAC) commissioned by NICE, independently assessed the evidence submitted.

Towards a pain free hospital: an in-depth qualitative analysis of the pain experiences of head and neck cancer patients undergoing radiotherapy.

Background: Treatment for head and neck cancer can frequently be a painful experience with implications for patients in terms of quality of life, nutrition and ultimately treatment outcomes. Pain may arise for a number of reasons in this patient group including the influence of localised tissue damage from radiotherapy, the effects of chemotherapeutic agents as well as the disease process itself. Early identification of cancer pain, through screening and early analgesic and pain management are thought to be the most appropriate approaches to the problem.

Randomized controlled trials: who fails run-in?

Background: Early identification of participants at risk of run-in failure (RIF) may present opportunities to improve trial efficiency and generalizability.

Methods: We conducted a partial factorial-design, randomized, controlled trial of calcium and vitamin D to prevent colorectal adenoma recurrence at 11 centers in the United States. At baseline, participants completed two self-administered questionnaires (SAQs) and a questionnaire administered by staff.

Armband activity monitor data do not correlate with reported pain scores in patients receiving vertebroplasty.

Background: Prior research on the efficacy of vertebroplasty has focused primarily on subjective, patient-reported outcomes.

Objective: To apply an armband activity monitor (SenseWear by BodyMedia Inc, USA) to patients presenting for consideration for vertebroplasty and to determine the correlation between patient-reported outcomes and quantitative activity metrics at baseline and 30 days after presentation.

Materials And Methods: Nineteen patients were enrolled (15 receiving vertebroplasty, 4 not receiving vertebroplasty).

A distributional approach to obtain adjusted comparisons of proportions of a population at risk.

Background: Dichotomisation of continuous data has statistical drawbacks such as loss of power but may be useful in epidemiological research to define high risk individuals.

Methods: We extend a methodology for the presentation of comparison of proportions derived from a comparison of means for a continuous outcome to reflect the relationship between a continuous outcome and covariates in a linear (mixed) model without losing statistical power. The so called "distributional method" is described and using perinatal data for illustration, results from the distributional method are compared to those of logistic regression and to quantile regression for three different outcomes.

Congenital diaphragmatic hernia-influence of fetoscopic tracheal occlusion on outcomes and predictors of survival.

Unlabelled: The morbidity of infants with congenital diaphragmatic hernia (CDH) who had undergone foetal endoscopic tracheal occlusion (FETO) to those who had not was compared and predictors of survival regardless of antenatal intervention were identified. FETO was undertaken on the basis of the lung to head ratio or the position of the liver. A retrospective review of the records of 78 CDH infants was undertaken to determine the lung-head ratio (LHR) at referral and prior to birth, maximum oxygen saturation in the labour suite and neonatal outcomes.

Multicentre prospective survey of SeHCAT provision and practice in the UK.

Objective: A clinical diagnosis of bile acid malabsorption (BAM) can be confirmed using SeHCAT (tauroselcholic ((75)selenium) acid), a radiolabelled synthetic bile acid. However, while BAM can be the cause of chronic diarrhoea, it is often overlooked as a potential diagnosis. Therefore, we investigated the use of SeHCAT for diagnosis of BAM in UK hospitals.

Paclitaxel-coated balloon fistuloplasty versus plain balloon fistuloplasty only to preserve the patency of arteriovenous fistulae used for haemodialysis (PAVE): study protocol for a randomised controlled trial.

Background: The initial therapy for a stenosis in an arteriovenous fistula used for haemodialysis is radiological balloon dilatation or angioplasty. The benefit of angioplasty is often short-lived, intervention-free survival is reported to be 40-50 % at 1 year. Previous small studies and observational data suggest that paclitaxel-coated balloons may be of benefit in improving outcomes after fistuloplasty of stenotic arteriovenous fistulae.

Improving Online Teaching by Using Established Best Classroom Teaching Practices.

This pilot study explored the effectiveness of an online workshop provided to faculty teaching one course in a large online RN-to-baccalaureate nursing (BSN) program. This exploration helped to fill a gap in knowledge related to implementing best classroom teaching practices into distance education for online nursing students. Focus groups with purposeful sampling (three focus groups: two faculty focus groups with a total of 11 faculty and one student focus group with a total of six students) were used to assess the effectiveness of the workshop and faculty and student perceptions of the seven best classroom teaching practices.

Intraoperative assessment of ossicular fixation.

Determining the degree of ossicular fixation is a difficult task, with the final assessment often being made with manual palpation during exploratory tympanotomy. A more objective method to evaluate ossicular fixation would be valuable. In this paper we describe a new method which makes use of a magnet and coil to measure ossicular motion through the ear canal with an elevated tympanic membrane.

Variation in adverse drug reactions listed in product information for antidepressants and anticonvulsants, between the USA and Europe: a comparison review of paired regulatory documents.

Objective: To compare consistency of adverse drug reaction (ADR) data in publicly available product information documents for brand drugs, between the USA and Europe. To assess the usefulness of information for prescribers and patients.

Design: A comparison review of product information documents for antidepressants and anticonvulsants concurrently marketed by the same pharmaceutical company in the USA and Europe.

Randomized Trial of Introduction of Allergenic Foods in Breast-Fed Infants.

Background: The age at which allergenic foods should be introduced into the diet of breast-fed infants is uncertain. We evaluated whether the early introduction of allergenic foods in the diet of breast-fed infants would protect against the development of food allergy.

Methods: We recruited, from the general population, 1303 exclusively breast-fed infants who were 3 months of age and randomly assigned them to the early introduction of six allergenic foods (peanut, cooked egg, cow's milk, sesame, whitefish, and wheat; early-introduction group) or to the current practice recommended in the United Kingdom of exclusive breast-feeding to approximately 6 months of age (standard-introduction group).

A Qualitative Analysis of Post-operative Nutritional Barriers and Useful Dietary Services Reported by Bariatric Surgical Patients.

Background: Outcomes studies show many bariatric patients fail to lose optimal weight or regain significant weight post-surgery. One reason for weight regain may be difficulty adhering to the postoperative diet.

Methods: Cross-sectional survey methodology collected text data on perceived postoperative nutritional barriers and helpful dietary services reported by bariatric patients.

A Multicenter Prospective Study to Investigate the Diagnostic Accuracy of the SeHCAT Test in Measuring Bile Acid Malabsorption: Research Protocol.

Background: Bile acid malabsorption (BAM) is one possible explanation for chronic diarrhea. BAM may be idiopathic, or result from ileal resection or inflammation including Crohn's disease, or may be secondary to other conditions, including cholecystectomy, peptic ulcer surgery, and chronic pancreatitis. No "gold standard" exists for clinical diagnosis of BAM, but response to treatment with a bile acid sequestrant (BAS) is often accepted as confirmation.

Prediction of infant extubation outcomes using the tension-time index.

Objective: The tension-time index of the diaphragm (TTdi) is a composite assessment of the load on and the capacity of the diaphragm. TTmus is a non-invasive tension-time index of the respiratory muscles. Our aim was to determine whether TTdi or TTmus predicted extubation outcome and performed better than respiratory muscle strength (Pimax, Pdimax), respiratory drive (P0.

Outcome of seizures in the general population after 25 years: a prospective follow-up, observational cohort study.

Objectives: We investigated long-term (to 25 years) seizure prognosis and survival in people with newly diagnosed epilepsy in the community. We explored whether prognosis is different in those with epilepsy (>2 unprovoked seizures) and those with a single seizure at presentation.

Methods: This is a prospective observational cohort study of people with newly diagnosed seizures.

Work of breathing during CPAP and heated humidified high-flow nasal cannula.

Objective: To determine whether continuous positive airway pressure (CPAP) compared with heated humidified, high-flow nasal cannula (HHFNC) in infants with evolving or established bronchopulmonary dysplasia (BPD) reduced the work of breathing (WOB) and thoracoabdominal asynchrony (TAA) and improved oxygen saturation (SaO2).

Design: Randomised crossover study.

Setting: Tertiary neonatal unit.