Considerations on the EU definition of a nanomaterial: Science to support policy making

In recent years, an increasing number of applications and products containing or using nanomaterials have become available. This has raised concerns that some of these materials may introduce new risks for humans or the environment. A clear definition to discriminate nanomaterials from other materials is prerequisite to include provisions for nanomaterials in legislation. In October 2011 the European Commission published the ‘Recommendation on the definition of a nanomaterial’, primarily intended to provide unambiguous criteria to identify materials for which special regulatory provisions might apply, but also to promote consistency on the interpretation of the term ‘nanomaterial’. In this paper, the current status of various regulatory frameworks of the European Union with regard to nanomaterials is described, and major issues relevant for regulation of nanomaterials are discussed. This will contribute to better understanding the implications of the choices policy makers have to make in further regulation of nanomaterials. Potential issues that need to be addressed and areas of research in which science can contribute are indicated. These issues include awareness on situations in which nano-related risks may occur for materials that fall outside the definition, guidance and further development of measurement techniques, and dealing with changes during the life cycle.     

Oxidation of Therapeutic Proteins and Peptides: Structural and Biological Consequences

Oxidation is a common degradation pathway that affects therapeutic proteins and peptides during production, purification, formulation, transportation, storage and handling of solid and liquid preparations. In the present work we review the scientific literature about structural and biological consequences of protein/peptide oxidation. Representative examples are discussed of specific products whose oxidation has been recently studied, including monoclonal antibodies, calcitonin, granulocyte colony-stimulating factor, growth hormone, insulin, interferon alpha and beta, oxytocin and parathyroid hormone. These examples illustrate that oxidation often leads to modifications of higher-order structures, including aggregate induction, and can generate products that are pharmacokinetically different, biologically less active and/or potentially more immunogenic than their native counterpart. It is therefore crucially important during the pharmaceutical development of therapeutic proteins and peptides to comprehensively characterize oxidation products and evaluate the impact of oxidation-induced structural modifications on the biological properties of the drug.     

The Impact of Food Assistance on Dietary Diversity and Food Consumption among People Living with HIV/AIDS

Little is known about the outcomes of food assistance targeted to food insecure people living with HIV/AIDS. Using primary data from Zambia, we estimated the impact of food assistance on the dietary diversity and consumption expenditures of households with HIV infected members receiving antiretroviral therapy. Propensity score matching estimates show that food assistance increased dietary diversity by 9.8 points (23%) mainly through the consumption of food items provided in the ration. Food assistance recipients were 20% points more likely to have acceptable food consumption and 15% points less likely to have poor food consumption than non-recipients. Food assistance also increased food consumption expenditures but had no significant impact on food purchases and total consumption expenditures. Overall, our findings demonstrate that food assistance can be an effective instrument for improving diets and enhancing the food security of people living with HIV/AIDS.     

Rasch analysis of the Patient and Observer Scar Assessment Scale (POSAS) in burn scars

Purpose  

The Patient and Observer Scar Assessment Scale (POSAS) is a questionnaire that was developed to assess scar quality. It consists of two separate six-item scales (Observer Scale and Patient Scale), both of which are scored on a 10-point rating scale. After many years of experience with this scale in burn scar assessment, it is appropriate to examine its psychometric properties using Rasch analysis.     

Gonadal function recovery in very long-term male survivors of childhood cancer

BackgroundAlthough gonadal toxicity has been reported, no data are available on recovery of gonadal function in very long-term survivors of childhood cancer. Inhibin B is a novel reliable serum marker which has been shown to be of value in childhood cancer survivor studies to identify risk groups for impaired gonadal function, but consecutive long-term follow-up studies using serum inhibin B as a marker are not available.ObjectiveTo evaluate possible recovery of gonadal dysfunction over time in adult male survivors of childhood cancer.MethodsIn this retrospective study, adult male long-term childhood cancer survivors (n = 201) who visited our outpatient late effects clinic were included and we used inhibin B as a surrogate marker for gonadal function.ResultsMedian age at diagnosis was 5.9 years (range 0.0–17.5) and discontinuation of treatment was reached at a median age of 8.2 years (range 0.0–20.8). Inhibin B levels were first measured after a median follow-up time of 15.7 years (range 3.0–37.0). Median interval between the first (T1) and second measurement (T2) was 3.3 years (range 0.7–11.3). Median inhibin B level was 127 ng/L (range 5–366) at T1 and 155 ng/L (range 10–507) at T2. The prediction model suggests that inhibin B levels do not normalise in survivors with a very low Inhibin B level at T1.ConclusionsOur results suggest that recovery of gonadal function is possible even long after discontinuation of treatment. However, this recovery does not seem to occur in survivors who already reached critically low inhibin B levels after discontinuation of treatment.     

Exploring improvements in patient logistics in Dutch hospitals with a survey

ABSTRACT: BACKGROUND: Research showed that promising approaches such as benchmarking, operations research, lean management and six sigma, could be adopted to improve patient logistics in healthcare. To our knowledge, little research has been conducted to obtain an overview on the use, combination and effects of approaches to improve patient logistics in hospitals. We therefore examined the approaches and tools used to improve patient logistics in Dutch hospitals, the reported effects of these approaches on performance, the applied support structure and the methods used to evaluate the effects. METHODS: A survey among experts on patient logistics in 94 Dutch hospitals. The results were analysed using cross tables. RESULTS: Forty-eight percent of all hospitals participated. Ninety-eight percent reported to have used multiple approaches, 39% of them used five or more approaches. Care pathways were the preferred approach by 43% of the hospitals, followed by business process re-engineering and lean six sigma (both 13%). Flowcharts were the most commonly used tool, they were used on a regular basis by 94% of the hospitals. Less than 10% of the hospitals used data envelopment analysis and critical path analysis on a regular basis. Most hospitals (68%) relied on external support for process analyses and education on patient logistics, only 24% had permanent internal training programs on patient logistics. Approximately 50% of the hospitals that evaluated the effects of approaches on efficiency, throughput times and financial results, reported that they had accomplished their goals. Goal accomplishment in general hospitals ranged from 63% to 67%, in academic teaching hospitals from 0% to 50%, and in teaching hospitals from 25% to 44%. More than 86% performed an evaluation, 53% performed a post-intervention measurement. CONCLUSIONS: Patient logistics appeared to be a rather new subject as most hospitals had not selected a single approach, they relied on external support and they did not have permanent training programs. Hospitals used a combination of approaches and tools, about half of the hospitals reported goal accomplishment and no approach seemed to outperform the others. To make improvement efforts more successful, research should be conducted into the selection and application of approaches, their contingency factors, and goal-setting procedures.     

Effectiveness of a peer-led HIV prevention intervention in secondary schools in Rwanda: results from a non-randomized controlled trial

ABSTRACT: BACKGROUND: While the HIV epidemic is levelling off in sub-Saharan Africa, it remains at an unacceptably high level. Young people aged 15-24 years remain particularly vulnerable, resulting in a regional HIV prevalence of 1.4% in young men and 3.3% in young women. This study assesses the effectiveness of a peer-led HIV prevention intervention in secondary schools in Rwanda on young people's sexual behavior, HIV knowledge and attitudes. METHODS: In a non-randomized longitudinal controlled trial, fourteen schools were selected in two neighboring districts: Bugesera (intervention) and Rwamagana (control). Students (n = 1950) in eight intervention and six control schools participated in three surveys (baseline, six and twelve months in the intervention). Analysis was done using linear and logistic regression using generalized estimation equations adjusted for propensity score. RESULTS: The overall retention rate was 72%. Time trends in sexual risk behavior (being sexually active, sex in last six months, condom use at last sex) were not significantly different in students from intervention and control schools, nor was the intervention associated with increased knowledge, perceived severity or perceived susceptibility. It did significantly reduce reported stigma. CONCLUSIONS: Analyzing this and other interventions, we identified several reasons for the observed limited effectiveness of peer education: 1) intervention activities (spreading information) are not tuned to objectives (changing behavior); 2) young people prefer receiving HIV information from other sources than peers; 3) outcome indicators are not adequate and the context of the relationship in which sex occurs. Effectiveness of peer education may increase through integration in holistic interventions and redefining peer educators' role as focal points for sensitization and referral to experts and services. Finally, we argue that a narrow focus on sexual risks will never significantly turn the tide.     

Plasma Cholecystokinin and Gallbladder Responses to Increasing Doses of Bombesin in Celiac Disease

Impaired postprandial gallbladder emptying inceliac disease has been attributed to an absence ofappropriate cholecystokinin release. To determine if aflat jejunal mucosa in celiac patients is related to a reduced cholecystokinin-secretingcapacity, increasing doses of bombesin were infused intosix patients with celiac disease and a flat jejunalmucosa (group A), in seven celiac patients with a normal jejunal mucosa while on a gluten-free diet(group B), and in seven healthy controls (group C).Bombesin induced significant (P < 0.05) increments ofplasma CCK to a maximum value of 1.0 ± 0.3 pM in group A, to 1.5 ± 0.3 pM in group B, andto 1.2 ± 0.3 pM in group C (NS between groups),that were accompanied by significant (P < 0.05)gallbladder emptying responses of 70 ± 4% ingroup A, 47 ± 10% in group B and 65 5% in group C.Dose-response relationships were not different betweengroups. We conclude that there is no major impairment ofgallbladder responsiveness to bombesin or ofcholecystokinin-secreting capacity in patients with a flat jejunal mucosadue to celiac disease.