Assessment of Needs for Plasma for Fractionation in Europe

In the early 1990s, a series of outbreaks of hepatitis C (HCV) infections clustering among recipients of certain lots of plasma-derived medicinal products (PDMP) alarmed regulatory authorities, manufacturers and the public alike. Also, a few episodes of Hepatitis A (HAV) infections occurred in haemophiliacs receiving solvent-detergent-treated factor VIII concentrates. Thus, several measures were brought into effect to reestablish the safety of the incriminated products and to further increase the margin of safety of PDMP in general. Therefore, intramuscular immunoglobulins had to be free of HCV RNA as shown by nucleic acid amplification technology (NAT) in the final products. Furthermore, the manufacturing process of PDMP had to be validated for both viral inactivation and elimination. Finally, HCV-NAT was to be standardised and implemented as a validated test of plasma pool samples.In 1994, a joint meeting of EPFA, EAPPI and Regulatory Authorities was held in Brussels to outline the state of the art and to delineate the actions to be taken. Five years later, in 1999, the incidence rates of HIV, HBV and HCV in unpaid blood donors have been minimized, especially in European countries. With probabilities for window period donations as low as 0.6 in 1 million for both HIV and HCV and 2.1 in 1 million for HBV in Switzerland, labile blood products have reached extreme, but not absolute safety. The introduction of HCV-NAT roughly doubles this safety resulting in a 1 in 3 million probability of a window donation.Concomittantly, extensive viral validation studies document effective inactivation and removal of viruses in PDMP. The demonstrated margins of safety, expressed as logarithmical reduction factors (LRF), range from 4 to over 20 log(10), depending on product, virus, and inactivation procedure used. Further progress to even safer PDMP shall be acomplished by consolidating the GMP processes, abandoning of obsolete requirements and harmonising national regulations within Europe. Before introducing new measures for additional agents such as HAV or Parvovirus B 19, gains and risks and even potential new threats have to be carefully assessed. Alternative efforts for the safeguard of patients, e.g. vaccination for HAV, need to be balanced against the risks of changing established and validated manufacturing procedures of PDMP with long-lasting safety records.     

对完善我国公立医院绩效分配模式的思考

公立医院绩效分配模式的完善是公立医院改革的重点和难点。在全国推行绩效工资的宏观背景下,探讨绩效分配模式具有十分重要的现实意义。公立医院绩效的内涵可以总结为经济运行绩效、患者绩效和社会绩效。一个完善的绩效分配方式的理想目标是三者的统筹兼顾,但现实中,我国的医院差异很大,应在充分考虑各种影响因素的基础上,因地制宜地选择顺应卫生体制改革要求的绩效分配模式,以公益性和公平性为目标,寻求各方利益的平衡点,实现由原来的工资奖金分配制度向绩效工资改革的平稳过渡。

     

Web-Based Surveillance of Public Information Needs for Informing Preconception Interventions

Background

The risk of adverse pregnancy outcomes can be minimized through the adoption of healthy lifestyles before pregnancy by women of childbearing age. Initiatives for promotion of preconception health may be difficult to implement. Internet can be used to build tailored health interventions through identification of the public''s information needs. To this aim, we developed a semi-automatic web-based system for monitoring Google searches, web pages and activity on social networks, regarding preconception health.

Methods

Based on the American College of Obstetricians and Gynecologists guidelines and on the actual search behaviors of Italian Internet users, we defined a set of keywords targeting preconception care topics. Using these keywords, we analyzed the usage of Google search engine and identified web pages containing preconception care recommendations. We also monitored how the selected web pages were shared on social networks. We analyzed discrepancies between searched and published information and the sharing pattern of the topics.

Results

We identified 1,807 Google search queries which generated a total of 1,995,030 searches during the study period. Less than 10% of the reviewed pages contained preconception care information and in 42.8% information was consistent with ACOG guidelines. Facebook was the most used social network for sharing. Nutrition, Chronic Diseases and Infectious Diseases were the most published and searched topics. Regarding Genetic Risk and Folic Acid, a high search volume was not associated to a high web page production, while Medication pages were more frequently published than searched. Vaccinations elicited high sharing although web page production was low; this effect was quite variable in time.

Conclusion

Our study represent a resource to prioritize communication on specific topics on the web, to address misconceptions, and to tailor interventions to specific populations.     

北方军人消化性溃疡流行病学调查

目的：了解消化性溃疡（PU）在我军区部队中的发病情况以及相关危险因素,为进一步预防和治疗研究提供基础。方法：通过整群抽样的方法,运用统一的自填问卷,调查研究对象PU的发病情况和暴露因素以及其它影响因素。结果：军人PU相关症状发生率（Sc≥5）为8.41%（618/7345,95%CI=7.77%~9.03%）。多因素分析发现,兵龄、消化性溃疡的家族史、NSAID用药史、精神紧张、脾气易怒与PU症状积分（Sc≥5）发生率显著相关,其他因素（年龄、BMI、文化程度、出生地、吸烟、饮酒、刺激食物、饮食规律）与PU症状的发生率未见明显关系。结论：北方部队PU症状的发生率低于南方部队,兵龄、消化性溃疡的家族史、NSAID用药史、精神紧张、脾气易怒可能是军人消化性溃疡的危险因素。     

Assessment of enterovirus contamination in mussel samples from Morocco

Summary In Morocco, shellfish sanitary quality analysis does not currently include enteric virus detection. Enteroviruses are classically detected by cell culture, but molecular methods such as RT-PCR are now broadly used alone or associated to cell culture. RT-PCR has the advantage of requiring less time and budget than cell culture. Bivalve mussels, being filter-feeders tend to accumulate viruses in contaminated seawater. In order to assess mussel contamination by enteroviruses, we screened samples of two origins, an aquaculture system and an area where wild mussels grow. Domestic sewage samples from an outlet near the above wild mussels growing area were also analysed. Viruses were concentrated from mussel meat by direct glycine elution and PEG 8000 precipitation. Total RNA was then extracted from the PEG precipitate by the guanidine thiocyanate method and used in RT-PCR. Enterovirus genomes were detected in 10% of wild shellfish samples, whilst none was present in the aquaculture samples. Since organisms harvested in both growing areas are used for human consumption, the enterovirus contamination observed in this study may highlight a potential public health risk and illustrate the importance of including routine virological analysis of shellfish in Morocco.     

Epidemiological observations on lungworm, Dictyocaulus arnfieldi, in donkeys from Morocco

Regular monthly examination of lungs of donkeys, with a total of 423 in a year, revealed that in Morocco Dictyocaulus arnfieldi infection is present throughout the year with an annual incidence of 47.8% (range 30 to 62.2%). The monthly mean number of worms per animal varied from 19.4 to 69.6 (annual average 39.5) with a maximum of 1000 worms in a donkey. October, February and June are the months when peaks of infections were observed. The ratio of worms in lungs to larvae per g in faeces (L.P.G.) ratio varied from 1:0.57 to 1:1.33 (average 1:0.97) and although this relation was significant, cases with high worm burden and no larvae in faeces were observed.     

Epidemic Surveillance Using an Electronic Medical Record: An Empiric Approach to Performance Improvement

Backgrounds

Electronic medical records (EMR) form a rich repository of information that could benefit public health. We asked how structured and free-text narrative EMR data should be combined to improve epidemic surveillance for acute respiratory infections (ARI).

Methods

Eight previously characterized ARI case detection algorithms (CDA) were applied to historical EMR entries to create authentic time series of daily ARI case counts (background). An epidemic model simulated influenza cases (injection). From the time of the injection, cluster-detection statistics were applied daily on paired background+injection (combined) and background-only time series. This cycle was then repeated with the injection shifted to each week of the evaluation year. We computed: a) the time from injection to the first statistical alarm uniquely found in the combined dataset (Detection Delay); b) how often alarms originated in the background-only dataset (false-alarm rate, or FAR); and c) the number of cases found within these false alarms (Caseload). For each CDA, we plotted the Detection Delay as a function of FAR or Caseload, over a broad range of alarm thresholds.

Results

CDAs that combined text analyses seeking ARI symptoms in clinical notes with provider-assigned diagnostic codes in order to maximize the precision rather than the sensitivity of case-detection lowered Detection Delay at any given FAR or Caseload.

Conclusion

An empiric approach can guide the integration of EMR data into case-detection methods that improve both the timeliness and efficiency of epidemic detection.     

Epidemiological Surveillance of Serratia marcescens Infections by Bacteriocin Typing

During 10 months, 155 isolates of Serratia marcescens were cultured from 105 patients, of whom 49 were considered to have significant infection. The 155 isolates were typed by bacteriocin sensitivity, and 137 (88.4%) were assigned to 37 provisional bacteriocin groups; 18 isolates were nontypable. No major outbreaks of nosocomial infection were demonstrable; however, there were four chronologically separate minor episodes of cross-infection that involved two or three patients per room or unit, respectively.     

An Assessment of Welfare Conditions in Wildlife Markets across Morocco

The welfare of wild-caught animals in markets has generally been overlooked by both wildlife trade and welfare studies, despite the potential negative impacts on the animals. Morocco is a member of the World Organisation for Animal Health and has proposed draft legislation prohibiting mistreatment or abuse of animals in captivity. There is still, however, a bustling wild animal trade, and vendor compliance with industry-standard best practices is lacking. This study provides insight into the conditions of 2113 wild-caught animals in markets in six of the largest cities in Morocco by scoring their welfare based on four of the Farm Animal Welfare Committee Five Freedoms: freedom from hunger and thirst, freedom from discomfort, freedom to express normal behavior, and freedom from distress. Over 88% of animals were housed in situations that broke all four of the freedoms measured, and only 9 animals were in situations that broke none. Access to water, sun/heat exposure, and ability to hide from stressors were particularly poor. We urge the Moroccan government to fulfill its commitment to establish welfare laws and devote resources to their application.     

Genomic and Epidemiological Surveillance of Zika Virus in the Amazon Region

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Challenges and Research Needs for Risk Assessment of Pesticides for Registration in Africa

Risk assessment is necessary for registration and risk management of new pesticides. The aim of this article is to discuss challenges that risk assessors in Africa face when conducting risk assessment of pesticides. Risk assessment requires toxicity assessment, environmental fate studies, and the use of models for occupational, dietary, residential, and environmental exposure assessments. Toxicity studies are very costly with the result that toxicity data used to register pesticides in Africa are often sourced from northern hemisphere countries. Assessors also often use exposure modeling results from the northern hemisphere. This is not an ideal approach as occupational exposure is influenced by agricultural practices, climatic conditions, and other factors. Furthermore, residential exposure models require time-location-activity information, exposure factors, and toxicokinetic rate constants for particular pesticides. Dietary exposure assessment needs accurate and comprehensive local food consumption data. Authorities in African countries should therefore generate the required data, despite these being very costly and tedious. Authorities should also provide guidance on the type of models and standard scenarios for estimating predicted environmental concentrations in various environmental compartments. It is recommended that higher educational institutions in Africa should incorporate risk assessment in general and pesticide toxicity and exposure models in particular in their curricula.     

Validity of Epidemiological Data in Risk Assessment Applications

Data from epidemiological studies might be seen as superior to data from animal bioassays for risk assessment purposes. Because humans are the population of interest, use of epidemiological data avoids interspecies extrapolation. However, one must not assume that an epidemiological study is necessarily valid at face value. We describe issues of validity that arise in the conduct and interpretation of epidemiological research and that affect the utility of epidemiological data in risk assessment. These issues include choice of study design, size and representativeness of the study sample, measurement of exposures and outcomes, control of confounding and specification of statistical model for analysis of data, all of which affect the accuracy and validity of study results.     

Epidemiological Assessment of Hormesis in Studies with Low-Level Exposure

Despite its resurgence within toxicology and, specifically, risk assessment, the concept of hormesis remains peripheral to current epidemiological practice. In this paper we examine some reasons for this, focusing on applications within occupational and environmental epidemiology. Unclear in the existing literature is whether hormesis pertains to a single biological mechanism or response, or the aggregate effect of all correlates of exposure. Although J-shaped and U-shaped relationships between risk factors and disease endpoints have been identified epidemiologically, it is unclear whether such patterns reflect biological hormesis or a combination of factors resulting in a hormetic-looking relationship. Given the potential importance of assessing hormetic responses in epidemiological studies, we identify and discuss key limitations of epidemiology in validly detecting and interpreting hormesis. For example, most observational occupational and environmental studies lack the ability to determine the dose received by each individual, and therefore poor surrogates of exposure are frequently used, potentially introducing considerable systematic and random error. Further, because exposure is not randomly assigned to humans, the potential for confounding is great. Finally, using a simple simulation to assess the impact of ignoring hormesis in the analysis of epidemiological data containing mild hormesis, we demonstrate a resulting “hormetic bias,” in which relative risks at exposure levels above the hormetic region are systematically overestimated.     

Sentinel Hospital-Based Surveillance for Assessment of Burden of Rotavirus Gastroenteritis in Children in Pakistan

Objectives

To determine the burden and molecular epidemiology of rotavirus gastroenteritis in children hospitalized with severe acute watery diarrhea in Pakistan prior to introduction of rotavirus vaccine.

Methods

A cross-sectional study was carried out over a period of two years from 2006 – 2008 at five sentinel hospitals in the cities of Karachi, Lahore, Rawalpindi, and Peshawar. Stool samples collected from children under five years of age hospitalized with severe acute watery diarrhea were tested for rotavirus antigen via enzyme immunoassay (EIA) (IDEA REF K6020 Oxoid Ltd (Ely), Cambridge, United Kingdom). A subset of EIA positive stool samples were further processed for genotyping.

Results

6679 children were enrolled and stool specimens of 2039 (30.5%) were positive for rotavirus. Rotavirus positivity ranged from 16.3% to 39.4% in the 5 hospitals with highest positivity in Lahore. 1241 (61%) of all rotavirus cases were in infants under one year of age. Among the strains examined for G-serotypes, the occurrence of G1, G2, G9 and G4 strains was found to be 28%, 24%, 14% and 13%, respectively. Among P-types, the most commonly occurring strains were P6 (31.5%) followed by P8 (20%) and P4 (12%). Prevalent rotavirus genotype in hospitalized children of severe diarrhea were G1P[8] 11.6% (69/593), followed by G2P[4] 10.4% (62/593), and G4P[6] 10.1% (60/593).

Conclusions

Approximately one third of children hospitalized with severe gastroenteritis in urban centers in Pakistan have rotavirus. Introduction of rotavirus vaccine in Pakistan''s national immunization program could prevent many severe episodes and diarrheal deaths.     

Maintenance of Weight Loss: A Needs Assessment

This study identified facilitators and obstacles to maintenance of weight loss following a very-low-calorie-diet and behavior modification program. A survey was mailed to a random sample of 178 program completers and received a 61% response rate; the most frequent follow-up period was more than 2 years. Twenty-nine percent reported weighing the same (within 10 lbs) or less than the end of their participation in the treatment program (maintainers), while 71% reported their present weight was a mean of 65% higher than their initial weight loss (regainers). Maintainers were significantly more likely to report engaging in regular aerobic exercise, attending a maintenance support group, and confidence in their ability to manage their weight in the future, while regainers were more likely to report stress and motivation as frequent weight management obstacles. Respondents consistently identified the need for low/no cost ongoing support. Maintainers and relapsers reported similar challenges in managing their weight, yet with different results, suggesting the need to identify subgroups for which different post-treatment support options could be applied.