Alginates for Protection Against Pepsin-Acid Induced Aerodigestive Epithelial Barrier Disruption.

Objective: Gastroesophageal reflux disease (GERD) and laryngopharyngeal reflux (LPR) are chronic conditions caused by backflow of gastric and duodenal contents into the esophagus and proximal aerodigestive tract, respectively. Mucosal barrier dysfunction resultant from the synergistic actions of chemical injury and the mucosal inflammatory response during reflux contributes to symptom perception. Alginates effectively treat symptoms of mild to moderate GERD and have recently shown benefit for LPR.

Using specialist screening practitioners (SSPs) to increase uptake of bowel scope (flexible sigmoidoscopy) screening: results of a feasibility single-stage phase II randomised trial.

Objective: To determine the feasibility of specialist screening practitioners (SSPs) offering patient navigation (PN) to facilitate uptake of bowel scope screening (BSS) among patients who do not confirm or attend their appointment.

Design: A single-stage phase II trial.

Setting: South Tyneside District Hospital, Tyne and Wear, England, UK.

Cost-effectiveness of habit-based advice for weight control versus usual care in general practice in the Ten Top Tips (10TT) trial: economic evaluation based on a randomised controlled trial.

Objective: Ten Top Tips (10TT) is a primary care-led behavioural intervention which aims to help adults reduce and manage their weight by following 10 weight loss tips. The intervention promotes habit formation to encourage long-term behavioural changes. The aim of this study was to estimate the cost-effectiveness of 10TT in general practice from the perspective of the UK National Health Service.

The economic costs of intrapartum care in Tower Hamlets: A comparison between the cost of birth in a freestanding midwifery unit and hospital for women at low risk of obstetric complications.

Objective: to compare the economic costs of intrapartum maternity care in an inner city area for 'low risk' women opting to give birth in a freestanding midwifery unit compared with those who chose birth in hospital.

Design: micro-costing of health service resources used in the intrapartum care of mothers and their babies during the period between admission and discharge, data extracted from clinical notes.

Setting: the Barkantine Birth Centre, a freestanding midwifery unit and the Royal London Hospital's consultant-led obstetric unit, both run by the former Barts and the London NHS Trust in Tower Hamlets, a deprived inner city borough in east London, England, 2007-2010.

The mesially impacted mandibular third molar: The incidence and consequences of distal cervical caries in the mandibular second molar.

Aims: Distal Cervical Caries (DCC) of the mandibular second molar (Md2M) is primarily related to retained mesially impacted third molars (Md3M). Treatment of this condition indicates the removal of the Md3M and the restoration of the Md2M and, on occasions, the loss of the Md2M. The aim of this study was to determine the incidence, treatment outcomes for patients, and calculate costs related to Md2M DCC.

Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): a randomised controlled trial with cost-effectiveness analysis.

Background: Carotid artery stenting (CAS) is an alternative to carotid endarterectomy (CEA) for the treatment of carotid stenosis, but safety and long-term efficacy were uncertain.

Objective: To compare the risks, benefits and cost-effectiveness of CAS versus CEA for symptomatic carotid stenosis.

Design: International, multicentre, randomised controlled, open, prospective clinical trial.

Cost-utility analysis of stenting versus endarterectomy in the International Carotid Stenting Study.

Background: The International Carotid Stenting Study was a multicenter randomized trial in which patients with symptomatic carotid artery stenosis were randomly allocated to treatment by carotid stenting or endarterectomy. Economic evidence comparing these treatments is limited and inconsistent.

Aims: We compared the cost-effectiveness of stenting versus endarterectomy using International Carotid Stenting Study data.

A randomised trial of granulocyte-macrophage colony-stimulating factor for neonatal sepsis: childhood outcomes at 5 years.

Objective: We performed a randomised trial in very preterm, small for gestational age (SGA) babies to determine if prophylaxis with granulocyte macrophage colony stimulating factor (GM-CSF) improves outcomes (the PROGRAMS trial). GM-CSF was associated with improved neonatal neutrophil counts, but no change in other neonatal or 2-year outcomes. As subtle benefits in outcome may not be ascertainable until school age we performed an outcome study at 5 years.

A comparative phase 1 clinical trial to identify anti-infective mechanisms of vitamin D in people with HIV infection.

Objectives: To determine if there is a biological mechanism that explains the association between HIV disease progression and increased mortality with low circulating vitamin D levels; specifically, to determine if restoring vitamin D levels induced T-cell functional changes important for antiviral immunity.

Design: This was a pilot, open-label, three-arm prospective phase 1 study.

Methods: We recruited 28 patients with low plasma vitamin D (<50 nmol/l 25-hydroxyvitamin D3), comprising 17 HIV+ patients (11 on HAART, six treatment-naive) and 11 healthy controls, who received a single dose of 200 000 IU oral cholecalciferol.

Monetary costs of agitation in older adults with Alzheimer's disease in the UK: prospective cohort study.

Objective: While nearly half of all people with Alzheimer's disease (AD) have agitation symptoms every month, little is known about the costs of agitation in AD. We calculated the monetary costs associated with agitation in older adults with AD in the UK from a National Health Service and personal social services perspective.

Design: Prospective cohort study.

Non-pharmacological interventions for agitation in dementia: systematic review of randomised controlled trials.

Background: Agitation in dementia is common, persistent and distressing and can lead to care breakdown. Medication is often ineffective and harmful.

Aims: To systematically review randomised controlled trial evidence regarding non-pharmacological interventions.

Understanding quality improvement at scale in general practice: a qualitative evaluation of a COPD improvement programme.

Background: A growing body of knowledge exists to guide efforts to improve the organisation and delivery of health care, most of which is based on work carried out in hospitals. It is uncertain how transferable this knowledge is to primary care.

Aim: To understand the enablers and constraints to implementing a large-scale quality improvement programme in general practice, designed to improve care for people with chronic obstructive pulmonary disease.

A systematic review of the clinical effectiveness and cost-effectiveness of sensory, psychological and behavioural interventions for managing agitation in older adults with dementia.

Background: Agitation is common, persistent and distressing in dementia and is linked with care breakdown. Psychotropic medication is often ineffective or harmful, but the evidence regarding non-pharmacological interventions is unclear.

Objectives: We systematically reviewed and synthesised the evidence for clinical effectiveness and cost-effectiveness of non-pharmacological interventions for reducing agitation in dementia, considering dementia severity, the setting, the person with whom the intervention is implemented, whether the effects are immediate or longer term, and cost-effectiveness.

Economic evaluation of policy initiatives in the organisation and delivery of healthcare: a case study of gastroenterology endoscopy services.

Background: Complex clinical interventions are increasingly subject to evaluation by randomised trial linked to economic evaluation. However evaluations of policy initiatives tend to eschew experimental designs in favour of interpretative perspectives which rarely allow the economic evaluation methods used in clinical trials. As evidence of the cost effectiveness of such initiatives is critical in informing policy, it is important to explore whether conventional economic evaluation methods apply to experimental evaluations of policy initiatives.

A cross-sectional randomised study of fracture risk in people with HIV infection in the probono 1 study.

Objective: To determine comparative fracture risk in HIV patients compared with uninfected controls.

Design: A randomised cross-sectional study assessing bone mineral density (BMD), fracture history and risk factors in the 2 groups.

Setting: Hospital Outpatients.

A randomised trial of granulocyte-macrophage colony-stimulating factor for neonatal sepsis: outcomes at 2 years.

Objective: The authors performed a randomised trial in very preterm small-for-gestational age (SGA) babies to determine if prophylaxis with granulocyte-macrophage colony-stimulating factor (GM-CSF) improves outcomes (the PROGRAMS trial). Despite increased neutrophil counts following GM-CSF, the authors reported no significant difference in neonatal sepsis-free survival.

Patients And Methods: 280 babies born <31 weeks of gestation and SGA were entered into the trial.

Cost effectiveness of alternative planned places of birth in woman at low risk of complications: evidence from the Birthplace in England national prospective cohort study.

Objectives: To estimate the cost effectiveness of alternative planned places of birth.

Design: Economic evaluation with individual level data from the Birthplace national prospective cohort study.

Setting: 142 of 147 trusts providing home birth services, 53 of 56 freestanding midwifery units, 43 of 51 alongside midwifery units, and a random sample of 36 of 180 obstetric units, stratified by unit size and geographical region, in England, over varying periods of time within the study period 1 April 2008 to 30 April 2010.

Cost-effectiveness of therapeutic hypothermia to treat neonatal encephalopathy.

Objective: To estimate the cost-effectiveness (CE) of total body hypothermia plus intensive care versus intensive care alone to treat neonatal encephalopathy.

Methods: Decision analytic modeling was used to synthesize mortality and morbidity data from three randomized controlled trials, the Total Body Hypothermia for Neonatal Encephalopathy Trial (TOBY), National Institute of Child Health and Human Development (NICHD), and CoolCap trials. Cost data inputs were informed by TOBY, the sole source of prospectively collected resource utilization data for encephalopathic infants.

Cost-effectiveness of heptavalent conjugate pneumococcal vaccine (Prevenar) in Germany: considering a high-risk population and herd immunity effects.

In Germany, the seven-valent conjugate vaccine Prevenar is recommended for use in children at high risk of pneumococcal disease. Recent data suggest that giving conjugate vaccine to all children may lead to a decline in pneumococcal disease in unvaccinated adults, a phenomenon known as herd immunity. This analysis evaluated the cost and economic consequences in Germany of vaccinating (1) children at high risk, (2) all children when considering only benefits for vaccinated individuals and (3) all children when also considering herd immunity benefits.