Can We Compare the Health-Related Quality of Life of Childhood Cancer Survivors Following Photon and Proton Radiation Therapy? A Systematic Review.

Paediatric cancer patients have a risk of late side effects after curative treatment. Proton radiation therapy (PRT) has the potential to reduce the incidence and severity of toxicities produced by conventional photon radiation therapy (XRT), which may improve the health-related quality of life (HRQoL) in children. This systematic review aimed to identify the evidence of HRQoL outcomes in childhood cancer survivors following XRT and PRT.

Data integrity in regulated bioanalysis: a summary from the European Bioanalysis Forum Workshop in collaboration with the MHRA.

In this conference report, we summarize the main findings and messages from a workshop on 'Data Integrity'. The workshop was held at the 11th European Bioanalysis Forum Open (EBF) Symposium in Barcelona (21-23 November 2018), in collaboration with the Medicines and Health products Regulatory Agency to provide insight and understanding of regulatory data integrity expectations. The workshop highlighted the importance of engaging with software developers to address the gap between industry's data integrity needs and current system software capabilities.

Exploring the availability and impact of antenatal point-of-care ultrasound services in rural and remote communities: A scoping review.

Background: There are global disparities in the provision of maternal health care, with women from rural communities and under-resourced countries expecting poorer access to healthcare services. This potentially compounds the existing higher burden of maternal and neonatal morbidity within these populations. In this setting, point-of-care ultrasound (PoCUS) has the potential to improve outcomes while mitigating challenges and barriers associated with the introduction of new medical technology.

'Real-world' compensatory behaviour with low nicotine concentration e-liquid: subjective effects and nicotine, acrolein and formaldehyde exposure.

Aims: To compare the effects of (i) high versus low nicotine concentration e-liquid, (ii) fixed versus adjustable power and (iii) the interaction between the two on: (a) vaping behaviour, (b) subjective effects, (c) nicotine intake and (d) exposure to acrolein and formaldehyde in e-cigarette users vaping in their everyday setting.

Design: Counterbalanced, repeated measures with four conditions: (i) low nicotine (6 mg/ml)/fixed power; (ii) low nicotine/adjustable power; (iii) high nicotine (18 mg/ml)/fixed power; and (iv) high nicotine/adjustable power.

Setting: London and the South East, England.

Collaborative Method Performance Study of the Measurement of Nicotine, Its Metabolites, and Total Nicotine Equivalents in Human Urine.

Biomarkers of tobacco exposure have a central role in studies of tobacco use and nicotine intake. The most significant exposure markers are nicotine itself and its metabolites in urine. Therefore, it is important to evaluate the performance of laboratories conducting these biomarker measurements.

Factors Influencing the Relationship Between the Dose of Amlodipine Required for Blood Pressure Control and Change in Blood Pressure in Hypertensive Cats.

Background: Hypertension is a common problem in elderly cats. In most cats, systolic blood pressure (SBP) of <160 mmHg is achieved in response to amlodipine besylate at either 0.625 or 1.

E-cigarette puffing patterns associated with high and low nicotine e-liquid strength: effects on toxicant and carcinogen exposure.

Background: Contrary to intuition, use of lower strength nicotine e-liquids might not offer reduced health risk if compensatory puffing behaviour occurs. Compensatory puffing (e.g.

Self-titration by experienced e-cigarette users: blood nicotine delivery and subjective effects.

Rationale: Self-titration is well documented in the tobacco literature. The extent to which e-cigarette users (vapers) self-titrate is unknown.

Objective: This study explored the effects of high and low nicotine strength liquid on puffing topography, nicotine delivery and subjective effects in experienced vapers.

The structures of hexadecylamine films adsorbed on iron-oxide surfaces in dodecane and hexadecane.

Molecular-dynamics simulations are used to gain insights on recent sum-frequency spectroscopy and polarised neutron reflectometry measurements of the structure of hexadecylamine films adsorbed on iron-oxide surfaces in dodecane and hexadecane. Simulations were carried out under quiescent and high-shear conditions. Mass-density profiles, molecular-height and molecular-orientation probability distribution functions, and in-layer radial distribution functions were calculated.

Bioanalysis for plasma protein binding studies in drug discovery and drug development: views and recommendations of the European Bioanalysis Forum.

Plasma protein binding (PPB) is an important parameter for a drug's efficacy and safety that needs to be investigated during each drug-development program. Even though regulatory guidance exists to study the extent of PPB before initiating clinical studies, there are no detailed instructions on how to perform and validate such studies. To explore how PPB studies involving bioanalysis are currently executed in the industry, the European Bioanalysis Forum (EBF) has conducted three surveys among their member companies: PPB studies in drug discovery (Part I); in vitro PPB studies in drug development (Part II); and in vivo PPB studies in drug development.

Structure and friction of stearic acid and oleic acid films adsorbed on iron oxide surfaces in squalane.

The structure and friction of fatty acid surfactant films adsorbed on iron oxide surfaces lubricated by squalane are examined using large-scale molecular dynamics simulations. The structures of stearic acid and oleic acid films under static and shear conditions, and at various surface coverages, are described in detail, and the effects of unsaturation in the tail group are highlighted. At high surface coverage, the measured properties of stearic acid and oleic acid films are seen to be very similar.

In-depth study of homogeneity in DBS using two different techniques: results from the EBF DBS-microsampling consortium.

Background: At the start of their work, the European Bioanalysis Forum dried blood spots microsampling consortium did not form a dedicated team to investigate the spot homogeneity. However, two teams performed experiments that produced results relating to sample homogeneity.

Results: The data, which were produced via two different approaches (a radiolabeled and a nonradiolabeled approach), are highly complementary and demonstrate clear effects on sample inhomogeneity due to the substrate type, compound and hematocrit levels.

Recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs by Global CRO Council for Bioanalysis (GCC).

An open letter written by the Global CRO Council for Bioanalysis (GCC) describing the GCC survey results on stability data from co-administered and co-formulated drugs was sent to multiple regulatory authorities on 14 December 2011. This letter and further discussions at different GCC meetings led to subsequent recommendations on this topic of widespread interest within the bioanalytical community over the past 2 years.

Serum cotinine and prognosis in breast cancer.

Various studies have suggested that women who smoke have a worse prognosis if they develop breast cancer. Cotinine levels have been measured in sera from 511 patients with stage I and II breast cancer diagnosed between 1975 and 1980, all of whom had complete follow-up. Although the known prognostic factors, axillary nodal status, tumour size and grade were found to be significant, there was no relationship between serum cotinine and metastasis-free survival.

Cotinine-assessed second-hand smoke exposure and risk of cardiovascular disease in older adults.

Objectives: To examine whether second-hand smoke (SHS) exposure measured by serum cotinine is associated with increased coronary heart disease (CHD) and stroke risk among contemporary older British adults.

Design: Prospective population-based study with self-reported medical history and health behaviours. Fasting blood samples were analysed for serum cotinine and cardiovascular disease (CVD) risk markers.

Interlaboratory comparability of serum cotinine measurements at smoker and nonsmoker concentration levels: a round-robin study.

Introduction: Cotinine, the primary proximate metabolite of nicotine, is commonly measured as an index of exposure to tobacco in both active users of tobacco and nonsmokers with possible exposure to secondhand smoke (SHS). A number of laboratories have implemented analyses for measuring serum cotinine in recent years, but there have been few interlaboratory comparisons of the results. Among nonsmokers exposed to SHS, the concentration of cotinine in blood can be quite low, and extensive variability in these measurements has been reported in the past.

Secondhand smoke (SHS) exposure is associated with circulating markers of inflammation and endothelial function in adult men and women.

Aims: Secondhand smoke (SHS) exposure is associated with elevated CHD risks. Yet the pathways through which this may operate have not been investigated in epidemiologic studies with objective SHS exposure measures and a wide range of CHD risk factors associated with active smoking. Therefore we investigate associations between SHS exposure and CHD risk factors, to clarify how SHS exposure may raise risk of CHD.

Changes in environmental tobacco smoke (ETS) exposure over a 20-year period: cross-sectional and longitudinal analyses.

Aims: To examine long-term changes in environmental tobacco smoke (ETS) exposure in British men between 1978 and 2000, using serum cotinine.

Design: Prospective cohort: British Regional Heart Study.

Setting: General practices in 24 towns in England, Wales and Scotland.

Relative bioavailability and pharmacokinetics of two oral formulations of docosahexaenoic acid/eicosapentaenoic acid after multiple-dose administration in healthy volunteers.

Objectives: To assess the comparative pharmacokinetic profile and bioavailability of docosahexaenoic acid (DHA)/eicosapentaenoic acid (EPA) after multiple-dose administration of a new oral formulation (test formulation) and a commercially available reference formulation in healthy subjects.

Methods: Forty-eight healthy subjects received a 28-day oral treatment with DHA/EPA in the form of either the test or the reference product according to an open-label, randomized, parallel-group design. Both formulations were given t.

Screening for medium chain acyl-CoA dehydrogenase deficiency using electrospray ionisation tandem mass spectrometry.

Objective: To establish criteria for the diagnosis of medium chain acyl-CoA dehydrogenase (MCAD) deficiency in the UK population using a method in which carnitine species eluted from blood spots are butylated and analysed by electrospray ionisation tandem mass spectrometry (ESI-MS/MS).

Design: Four groups were studied: (1) 35 children, aged 4 days to 16.2 years, with proven MCAD deficiency (mostly homozygous for the A985G mutation, none receiving carnitine supplements); (2) 2168 control children; (3) 482 neonates; and (4) 15 MCAD heterozygotes.

Distribution and characterization of angiotensin-converting enzyme-like activity in tissues of the blue crab Callinectes sapidus.

Angiotensin-converting enzyme-like activity (ACELA) was determined in tissue homogenates of the blue crab, Callinectes sapidus, using the synthetic substrate hippuryl-histidyl-leucine (Hip-His-Leu) and the specific inhibitor, captopril. ACELA was highest in gill homogenates followed by the hepatopancreas and hemolymph with specific activities of 1.69, 0.

One aid or two?--more visits please!

A prospective trial of hearing aid provision was undertaken to define factors which might be used to allow hearing aids to be fitted optimally. Patients referred for the provision of a hearing aid were studied prospectively at each of five visits when they were questioned by means of a proforma. Fifty-six patients completed the trial and gave adequate responses for analysis.