Division, Brigham and Women's Hospital, Boston, MA
Anemia in Chronic Kidney Disease
The first step of a population survey is establishing research and management goals and identifying the role that a population abundance estimate will have in reaching those goals (Hayes weight loss zoloft buy astralean 40 mcg mastercard, Ober and Sherwin weight loss prescription drugs buy astralean 40 mcg free shipping, 2009) weight loss unintentional cheap 40 mcg astralean amex. Having a clear understanding of the reason for the population survey will guide assessors in choosing the appropriate assessment method weight loss pills for 16 year old astralean 40 mcg overnight delivery, planning the assessment and evaluating the results weight loss 50 lbs purchase 40 mcg astralean amex. Be prepared Whether the goal is a one-time measure of population size to determine the sampling effort required or the establishment of a population abundance baseline for comparison with future assessments weight loss pills korea 40 mcg astralean mastercard, it is critical that surveyors are well prepared for abundance estimation. Surveyors should be trained in population abundance assessment techniques and know the assumptions implicit to the methods they are using. Potential sampling errors can often be mitigated if the sources of error are identified at the fieldwork planning stage. Standardize methods For any survey technique, it is critical that assessors describe their methods clearly and standardize them across assessments for comparison among replicates and/or with future assessments. For example, many bat species exhibit synchronized seasonal birth pulses (Kunz and Pierson, 1994). Repeated counts of the same population must be made at the same time of year if population size comparisons are to be made across time. Observer training and the use of specified equipment and observation stations are also important in standardizing population assessment protocols. Understand sources of variance There are numerous sources of variance in population abundance data. It is important for the surveyors to understand their methodology and how to minimize variance in their data resulting from factors other than changes in the trait of concern. Multiple assessments should be made to reduce the effects of natural variance (Mills, 2007; Williams, Nichols and Conroy, 2002). Colony size does not necessarily equal population size In addition to these general recommendations for conducting bat population assessments, readers should also be aware of two considerations specific to bat roost surveys. First, a bat colony is not always the same as a bat population, and it is important for researchers to understand the population structure of the bats they are studying. Although roosting colonies are often considered to be isolated populations, there are cases where individuals transfer regularly among colonies (Horn and Kunz, 2008). A census of the population must therefore include all interbreeding colonies, if it is to yield reliable population abundance data (Kunz et al. Similarly, many roosting colonies contain multiple species of bats, and the total colony size should not be assumed to be equally divided among co-roosting species (Figure 3. Species-specific population abundance assessment at the colony depends on how effectively observers can identify the co-roosting bat species. Population abundance surveys coupled with species composition sampling revealed that Pteropus vampyrus individuals outnumbered Acerodon jubatus individuals in a ratio of 6:1 Source: Mildenstein, in preparation can sometimes be counted directly at a roost site, it is unlikely that all individuals can be identified to species. The species composition at the roost site can be estimated by sampling areas within the roost and identifying the proportion of the sampled bats that belong to each species. Species-specific population abundance estimates can be made by multiplying the total colony count by the estimated species proportions. Sensitivity of roost sites to disturbance A second important survey consideration specific to bat population measurement is the long-term importance of roost sites to bats. Bat colonies can be extremely sensitive to disturbance at the roost, especially when hibernating (Tuttle, 1979; 2003) or when pups are present (Mann, Steidl and Dalton, 2002). Because many species show high fidelity to roost sites (Lewis, 1995), disturbance that leads to abandoning the roost can be devastating (Kunz et al. Although wildlife research often aims to support conservation, some bat study activities have disturbed roosting colonies and resulted in population declines (examples in Kunz et al. Therefore, veterinarians and biologists should plan their bat research activities with care to avoid disturbing the bats they hope to protect. At the onset of a disease survey, knowing the size of the study population can help gauge the sampling effort required. Some sampling protocols specify a minimum portion of the target population that should be sampled. In these cases, researchers will need to know the total population size to determine how many bats they will need to capture and sample for the study. For example, a sampling protocol suggests that a minimum of 10 percent of the total bat population should be sampled; if researchers count 1 000 individuals at the roost, they will aim to capture 100 individuals (0. When the approximate rate of disease infection occurrence in a bat population is known, the size of the target population can be used to determine the sampling effort required for the study to be able to detect the disease. For example, if the rate of infection for a certain virus tends to be about 1 percent in bat populations, and the study population is assessed at 5 000 bats, only about 50 bats (0. Assuming uniform capture probability, researchers would have to catch and test at least 100 bats to detect a single infected individual. The scope of inference of a study is the population to which the research results from the sampled population can be extended. As a simplistic example, if bats were randomly captured and sampled for disease at the mouth of a cave, the results of the research could be inferred to apply to the entire population within the cave. However, if only a certain segment of the bat population emerged from that particular cave entrance. Thus, knowledge of the population guides disease research design and helps provide a context for the results of disease study. In other words, the power of a disease surveillance study is the likelihood that, by design, it will discover disease in a population if the disease is there. Conversely, if a surveillance protocol specifies a goal of a certain power for the study, and the approximate effect size is also known, the required sample size can be calculated using the population abundance (Mills, 2007; Williams, Nichols and Conroy, 2002). Tracking changes over time Bat population size provides a context for the results of disease research on bats. Routine population assessments should be included in any long-term study of bats as hosts to Bat population abundance assessment and monitoring 43 disease to inform researchers and managers about the population trajectory of the hosts. Changes in or movements of bat populations are likely to have an impact on the diseases the bats carry. It is prudent for disease studies to include efforts for tracking the populations that are hosts to diseases of concern. In designing the disease investigation protocol, the size of the study population can help determine the number of individuals that must be sampled for disease. In longer-term disease monitoring programmes, tracking changes in disease presence can be informed by tracking changes in the host population, including fluctuations in bat population size and distribution. The size of a bat population can be censused by counting individuals directly at the roost or as they leave the roost, or estimated using partial counts, capture-recapture data or indices of abundance. Each of the population abundance assessment methods described here has advantages and disadvantages (Table 3. The distribution, abundance and vulnerability to population reduction of the grey-headed flying fox Pteropus poliocephalus in New South Wales. On the importance of articulating assumptions when conducting acoustic studies of habitat use by bats. The conservation status of the spectacled flying fox Pteropus conspicillatus in Australia. Temporal variation in activity of bats and the design of echolocation-monitoring studies. Habitat structure, wing morphology, and the vertical stratification of Malaysian fruit bats. Variation in the size at birth and post-natal growth of the insectivorous bat Pipistrellus subflavus (Chiroptera: Vespertilionidae). Monitoring trends in bat populations of the United States and territories: Problems and prospects. Methods for assessing colony size, population size, and relative abundance of bats. Development of Mariana fruit bat survey protocols for Mariana Islands Surveys final report. Bat Count 2002 final report: Results and management recommendations from a pilot study of bat surveys, manager training, and public awareness and education. Acoustic identification of 12 species of echolocating bats by discriminant function analysis and artificial neural networks. Oryx 15(2): 148-152 46 Investigating the role of bats in emerging zoonoses Rodrigues, L. Monitoring trends in bat populations of the United States and territories: Problems and prospects, pp. Analysis and management of animal populations: modeling, estimation, and decision making. Fauna of the United States: A preliminary survey of faunal relations in national parks. Wildlife disease surveillance is critically important for epidemiological investigations of the human and animal diseases that may be linked to free-ranging animal reservoirs, such as West Nile virus encephalitis, avian influenza, Ebola, Nipah and Hendra viruses, and hantavirus (Field et al. Because of the complexity of wildlife-human or wildlife-livestock-human disease transmission, a multi-disciplinary scientific approach to studying disease dynamics and emergence is often necessary (Daszak et al. Principles of human and veterinary medicine, epidemiology, ecology, microbiology and molecular biology are all important for understanding the ecology and emergence of infectious agents from wild animal reservoirs. When an aetiological agent in a disease outbreak has been identified as originating in wildlife, studying the ecology of the host and any potential vectors, including their interactions with people and/or domestic animals, is critical to assessing the risk of repeated spill-over. Studies of infectious agents in free-ranging wildlife are replete with challenges. For pathogens that cause acute infection in an animal, direct detection may be very difficult, but serology can offer an effective means of screening a population for exposure, assuming that antibodies persist over time. Population distribution and abundance are also key elements for the study of pathogens in wildlife. There are significant challenges to obtaining any or all of this information from freeranging wildlife. Statistical analyses may indicate the need to sample a certain number of individual animals to achieve statistical significance. Animals often live in difficult environmental conditions (remote, inaccessible, extreme in climate), or they may be solitary or scarce, making it difficult to achieve large numbers of samples. Wildlife study needs technical skill in locating and safely capturing and handling the target species, which may require specialized equipment, including tranquillizers or other anaesthetic techniques. Sampling wild animals can present physical risks to the scientist, such as being bitten, scratched, kicked or crushed. There are also risks to the animal, and animal welfare must be considered when designing wildlife studies that include capture, restraint and the collection of biological samples. Maintenance of a cold chain is one of the most important considerations when working with wildlife in remote settings (Figure 4. Longitudinal studies are particularly useful for understanding temporal or seasonal patterns of infection in animal populations. Wildlife capture is often opportunistic, and the animals captured rarely represent a truly random sample. Factors associated with trap placement, including position, height and even time of capture, may select for certain individuals or even certain species. For instance, canopy nets or harp traps are often used to capture insectivorous bats, and it has been shown that different species forage at different heights within a tropical forest (Hodgkison et al. Nets may also inherently select for particular individuals, such as slower or weaker animals that are unable to manoeuvre away from a net, or careless individuals that are less wary of obstacles. Pteropid fruit bats roost in trees, in colonies of structured and segregated populations based on age, sex and social dominance. A mist net placed in a location that is convenient for the scientist may therefore result in a biased selection based on age or sex. Recapture bias may also occur if traps are used in the same location over a long trapping period. Another challenge inherent to wildlife disease studies arises when trying to capture rare, solitary or nomadic animals, which may yield low sample numbers. Biases are often unavoidable and must simply be acknowledged as limitations of the study. Sick versus healthy animals When the research objectives include detecting a pathogen that may occur at low incidence, it is sometimes advantageous to bias the study deliberately, by sampling animals that are more likely to be infected, such as sick or injured individuals. Rabies and other lyssaviruses, including Australian bat lyssavirus, can be shed asymptomatically by bats, but also cause neurological disease in infected bats. Studies of Australian bat lyssavirus targeting sick and injured bats have achieved higher detection rates than those that sample healthy populations (McCall et al. Many zoonotic viruses with bat reservoir hosts, such as Hendra, Nipah and Marburg viruses do not appear to cause any clinical disease in infected bats (Halpin et al. Mist nets can be used to capture large or small bats in open spaces near roost or feeding sites. Canopy nets can be hung from tree branches at various elevations, for sampling bat species that forage at specific heights (Hodgkison et al. They are designed to capture echo-locating bats that might otherwise evade mist nets (Figure 4. Harp traps are most effective when placed at the openings of caves or in flyways that are heavily travelled by bats. An advantage of harp traps is that bats flying into the strings slide down the trap into a collecting bag (Figure 4. There is none of the entanglement that occurs with mist nets, and harp traps can capture a large number of bats in a short period. Although giant harp traps have been designed for the capture of large Pteropodid bats, mist nets are far more practical and more widely used. Regardless of which technique is used, it is important that field personnel monitor the nets or traps regularly to prevent bat injury or death, which can occur as a result of extensive struggling, entanglement, predation or exposure to the elements. It is recommended that mist nets are actively monitored throughout the trapping session and that bats are extracted from the net as soon as possible after capture. Scientists capturing bats for disease surveillance must consider the safety of both the field personnel and the bats being sampled. Depending on the pathogen under study and the questions being asked, effective surveillance can often be achieved through non-lethal means that use safe and effective capture and release methods.
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The nature of the treatment precluded blinding of subjects and their treating clinicians to the actual treatment received by the subjects weight loss zone order astralean 40 mcg without prescription. The protocol specified that an interim analysis was to be performed on the first 315 patients with a minimum follow up of 18 months weight loss breastfeeding safe 40 mcg astralean. An interim analysis was provided on the first 315 patients as of the database cutoff weight loss 05 kg per week buy discount astralean 40 mcg on line, September 5 weight loss pills metabolism buy astralean 40 mcg online, 2014 weight loss pills ebay cheap 40 mcg astralean with visa. The study analysis as of the interim database cut-off date compared data between 210 Optune subjects and 105 control subjects weight loss pills new cheap astralean 40 mcg free shipping. Received maximal debulking surgery and radiotherapy concomitant with temozolomide (45-70 Grays (Gy)): 1. Patients may enroll in the study if received Gliadel wafers before entering the trial 2. Any additional treatments received prior to enrollment will be considered an exclusion 3. Significant co-morbidities at baseline which would prevent maintenance temozolomide treatment: 1. Implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, or documented clinically significant arrhythmias f. Evidence of increased intracranial pressure (midline shift > 5 mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness) h. Treatment Arm At treatment initiation, patients were seen at an outpatient clinic. During this period, baseline examinations were performed and Optune treatment was initiated. The investigator also instructed the subjects on the operation of the Optune System and battery replacement. Once the subjects were trained in operating the device, they were released to continue treatment at home. Optune treatment was discontinued in the case of clinical disease progression, if a device-related serious adverse event occurred, or after 24 months or second progression whichever occurred first. Follow-up During treatment, all patients were seen once every month at an outpatient clinic where they underwent medical follow up and routing laboratory exams. The pre-specified interim analysis was performed on the first 315 patients enrolled after the 315th patient had 18 months of follow up (database cutoff September 5, 2014). A final analysis was performed on the entire 700 patient trial cohort (data available for 695 patients as of the database cutoff December 29, 2014). The analysis was performed by the treatment group to which the patient was randomized. Protocol Deviations Major protocol deviations were defined as deviations that have the potential to influence the primary and secondary efficacy endpoints of the study. There were a total of 13 major protocol deviations in the interim analysis and a total of 24 major protocol violations at the final analysis. In the interim analysis dataset, 2 patients received experimental chemotherapies as part of other clinical trials together with their standard of care temozolomide (1 in each treatment arm). In the final analysis dataset, 2 patients received experimental chemotherapies as part of other clinical trials together with their standard of care temozolomide (1 in each treatment arm). This deviation was termed "crossover" although no official crossover was allowed in the protocol, and Optune therapy was given without sponsor or investigator consent. Demographics and Baseline Characteristics Baseline characteristics were well balanced between treatment groups in both the interim and final analyses. The median number of Optune cycles was 9 because some patients were treated beyond progression as defined in the protocol. Thirteen percent of patients in both groups had biopsy only performed at diagnosis. The median number of Optune cycles was 6 because some patients were treated beyond progression as defined in the protocol. Therefore, the trial met its primary endpoint at the final analysis as well as at the interim analysis. An increase of almost 5 months as seen here is highly significant clinically (log-rank p = 0. An increase of 3 months as seen here is highly significant both statistically (log-rank p=0. An increase of almost 3 months as seen here is highly significant statistically and clinically (log-rank p=0. Financial Disclosure the Financial Disclosure by Clinical Investigators regulation (21 C. Part 54) requires applicants who submit a marketing application to include certain information concerning the compensation to , and financial interests and arrangements of, any clinical investigator conducting clinical studies covered by the regulation. None of the clinical investigators had disclosable financial interests/arrangements as defined in sections 54. The information provided does not raise any questions about the reliability of the data. The trial met its pre-specified thresholds for statistical significance at both the interim and final analyses. Quality of life, cognitive function and functional status were all maintained throughout treatment with the device based on an assessment of the interim analysis cohort of 315 patients. These include headaches, seizures, focal signs and symptoms, cognitive changes, emotional disorders, and many more. This risk is minor compared to the side effects of other oncology therapies, can be easily treated using topical ointments and resolves once treatment is discontinued. Other less common risks include headaches, insomnia and soft psychiatric symptoms. The magnitude of the observed benefit and the statistical significance of the results was clinically meaningful in order to justify early stopping of the study based on interim results in only 315 of the 695 enrolled patients. Importantly, similar results were confirmed in the final analysis which included available data at the time of database lock for all 695 enrolled subjects. Overall Conclusions Newly diagnosed glioblastoma is a difficult to treat, deadly disease, where treatment of the disease has seen little progress in the past 20 years. Optune treatment exhibits negligible toxicity and superior outcome measures compared to the best available treatments today. Hazards to Health from Use of the Device: See Indications, Contraindications, Warnings, Precautions, and Adverse Events in the device labeling. The m easurem ent of entiate the site of central nervous system tumor markers in blood has proved useful metastases (beta-glucurфnidвse, carcinoin defining certain system ic cancers. Beta-glucuronidase Beta-glucuronidase, a widely distrib uted enzyme which hydrolyzes the betaglycosidic bond betw een glucuronic acid and a variety of other substances (includ ing steroids, aromatic compounds, and sugar derivatives), has particularly high activity in epithelial tissue, reproductive organs, and leukocy tes. In the course of malignant transformation in many body tissues, such as breast, the activity of beta-glucuronidase in creases. In the pres ence of metastases to the leptomeninges from a system ic carcinom a (lung car cinoma, breast carcinoma, and malignant melanoma), the activity of beta-glucuronidase increases. Eight of nine patients with unequivocal clinical and cytological evidence of leptom eningeal carcinoma secondary to breast carcinoma had betaglucuronidase levels above 80 mU per L and as high as 220 mU per L. Seven of 12 patients with verified leptom eningeal metastases from lung carcinoma had simi lar elevations of beta-glucuronidase with a range from 90 mU per L to 260 mU per L. Three of six p atien ts with m alignant melanoma also had similar increases, and the three other patients had levels be tween 45 and 60 mU per L. In the case of meningeal metastases from systemic lym phoma, only two of eight patients had beta-glucuronidase activities above 45 mU per L, but these patients were diag nosed early in their course, before major signs of neurological dysfunction were present. Only one of 20 patients with intraparenchym al b rain m etastases had beta-glucuronidase activity above 80 mU per L; in this patient, there was a clinical suspicion of concomitant leptomeningeal m etastases, n e v e r cytologically or pathologically confirmed. None of nine patients with purely epidural metastases from a system ic carcinom a had betaglucuronidase above 80 mU per L. It is less commonly elevated in m eningeal metastases from lymphomas or leukemias, although when present is diagnostically helpful. It is infrequently detected in intraparenchymal or epidural metastases and not consistently elevated in the few primary brain tumors studied. It is grossly elevated in acute and moderately ele vated in subacute and chronic infections of the meninges. Originally de scribed in 1965, it was believed at first to be an antigen specific for cancer of the colon. Subsequently, the antigen has been found in serum in association with other malignancies of both endodermal and non-endodermal origin. As a serum marker, then, it has had limited value in the early diagnosis of cancer. In th e course of malignant transformation, elevated levels of lactic dehydrogenase can be recovered in the fluid medium that bathes neoplastic tissues. In the brain, lactic dehydrogenase is omnipresent and has an isoenzyme pat tern with a predominance of the electrophoretically fast-moving isoenzyme frac tions 1 and 2. Studies on brain tissue homogenates have indicated that neoplas tic change in brain results in a shift in the isoenzyme pattern from a predomi nance of fractions 1 and 2 to a predomi nance of fractions 4 and 5. It has two subunits, alpha and beta, which can be detected by radio immunoassay methods. These highly radio-sensitive midline childhood tumors are usually lo cated in the suprasellar and posterior third ventricular regions in areas relatively inaccesible to surgery. It is composed of a polypeptide chain of pro tein and carbohydrate and is synthesized by the yolk sac, liver, and gastrointestinal tract of the fetus. It may reappear in the serum of adults in association with normal restorative processes. C reatine phosphokinase is found in high concen trations in human brain and is distributed fairly uniformly throughout the central nervous system tissue. Aspar tate transaminase has been elevated in some patients with metastatic epidural spinal cord compression. It increases in a variety of primary and m etastatic tum ors (in clu d in g leukem ic in filtratio n of th e leptomeninges) and is independent of cell counts or protein concentrations. T h eir functions have not b e e n fully specified, but they appear to be involved in m ediating central effects of certain neurotransmitters and modulators. In patients with pituitary tumors without suprasellar ex tension, hormone levels are also normal with the exception of some patients with prolactin-secreting tumors or acromeg aly. C erebrospinal fluid prolactin concen trations are normal in patients with the empty sella syndrome. Effective treatrilent of tumors results in a fall from previously elevated levels, and serial determinations are useful in determ ining efficacy of treatment. It is also elevated in some tumors, such as m edulloblastom a and dysgerminoma, for reasons that remain unclear. In human brain tumors, however, sterol syn th e sis is in c re ased, and in c re ased amounts of desmosterol and cholesterol appear. Patients without brain tumors have either no detectable desmos terol or low concentrations (less than 0. T here is evidence, however, that they are related to metabo lism, structure, and function of the nucleic acids. Their metabolism appears to be re lated to cellular growth and proliferation, and therefore they have been the subject of numerous investigations of urine and sera o f p atie n ts with m alig n an cies. By con trast, a group of patients with malignant brain tumors had increased levels (pu trescine 546 ± 89 and spermidine 285 ± 40 pmoles per ml in glioblastomas and 561 ± 164 and 331 ± 101 pmoles per ml, respec tively, in medulloblastomas). Systematic study of metastatic brain tumors or metastases to the leptomeninges has not been reported. Increased levels may reflect elevated serum levels and diffusion across an intact blood-brain barrier. The potential advantages of tum or m arker m easurem ents over ex fo liated cytology are th e follow ing. Tumor markers may also be produced by primary brain tumors, as in the case of peri-third ventricular germ cell tumors in children. Serial sam ples, both before and after non-surgical trea tm e n t, in d icate resp o n se of the neoplasm to treatm ent. Moreover, there is a suggestion in the lit erature that these markers may precede, in som e in sta n ces, b o th n eu ro lo g ic symptoms and signs and neuroradiologic discovery. Computerized tomography scanning now allows for im proved as sessm ent of tum or recurrence and re sponse of tumor to treatment. Lumbar puncture in patients with brain tumors and increased intracranial pressure has significant risk. These measurements will probably also assume adjunctive roles in managing patients with prim ary brain tumors. However, the po tential of these markers in assessing early metastatic disease and in helping to de fine the role of the blood-brain barrier vis-a-vis effective systemic chemotherapy for brain tumors remains a fertile area for continued investigation. T h e p ro b a b le c a u se o f in c re a s e d polyam ine levels in physiological fluids. The isocitric dehydrogenase of the cerebrospinal fluid in various cancerous and noncancerous conditions. Wisco, PhD, University of California, Los Angeles, David Geffen School of Medicine Scientific Reviewer, Richard Hargreaves, PhD, Merck and Co. Barrett, PhD, Chair, Drexel University College of Medicine David Brautigan, PhD, University of Virginia, School of Medicine Cherie L. Divi, PhD, National Cancer Institute, National Institutes of Health Marnie Halpern, PhD, Carnegie Institution of Washington Tony E. This is all possible because of basic research in surprisingly diverse areas of science ranging from studies examining the makeup of atoms and the fertilization of sea urchin eggs to those looking at bone replacement in the skeletons of rats. It is often difficult, however, to discriminate cancer from the normal tissue of the surrounding areas. This can be done in both humans and in animal models and provides early insight into the likely effectiveness of the experimental drug, as well as valuable information on the appropriate dose to test in clinical trials.
The close phylogenetic relationship between Hendra and Nipah viruses is consistent with a common progenitor virus weight loss pills that start with l generic astralean 40 mcg with amex. Epidemiological investigations into the 1994 equine morbillivirus outbreaks in Queensland weight loss after mirena removal buy astralean 40 mcg otc, Australia weight loss for men generic astralean 40 mcg. Neutralization assays for differential henipavirus serology using Bio-Plex Protein Array Systems weight loss 7 day juice fast purchase astralean 40 mcg on line. Full length genome sequence of Tioman virus weight loss pills natural purchase astralean 40 mcg otc, a novel paramyxovirus in the genus Rubulavirus weight loss pills garcinia cambogia cheap astralean 40 mcg, isolated from fruit bats in Malaysia. A fatal case of Hendra virus infection in a horse in north Queensland: clinical and epidemiological features. Comparison of the deduced matrix and fusion protein sequences of equine morbillivirus with cognate genes of the Paramyxoviridae. Characterization of Mapeura virus: structure, proteins and nucleotide sequence of the gene encoding nucleocapsid protein. Serological evidence of infection with Nipah virus in bats (order Chiroptera) in peninsular Malaysia. Recurrent zoonotic transmission of Nipah virus into humans, Bangladesh, 2001-2007. Characterization of a paramyxovirus isolated from the brain of a piglet in Mexico. Case-control study of risk factors for human infection with a novel zoonotic paramyxovirus, Nipah virus, during a 1998-1999 outbreak of severe encephalitis in Malaysia. Isolation of a new parainfluenza virus from a frugivorous bat, Rousettus leschenaulti, collected at Poona, India. An apparently new virus (family Paramyxoviridae) infectious for pigs, humans and fruit bats. Pulau virus; a new member of the Nelson Bay orthoreovirus species isolated from fruit bats in Malaysia. Identification and phylogenetic comparison of Salem virus, a novel paramyxovirus of horses. Investigation of a second focus of equine morbillivirus infection in coastal Queensland. Isolation and molecular characterisation of a novel cytopathogenic paramyxovirus from tree shrews. A longitudinal study of the prevalence of Nipah virus in Pteropus lylei bats in Thailand: Evidence for seasonal preference in disease transmission. A novel P/V/C gene in a new member of the Paramyxoviridae family, which causes lethal infection in humans, horses, and other animals. The exceptionally large genome of Hendra virus: support for creation of a new genus within the family Paramyxoviridae. Negative findings from serological studies of equine morbillivirus in the Queensland horse population. With the notable exception of fewer than ten recent cases, rabies is fatal in humans. The M protein links the inner nucleocapsid and the outer membranebound G protein (Finke and Conzelmann, 2005). Lacking relevant proof-reading ability during replication, most viral variation arises via the survival of mutations, known as genetic drift. Currently, 12 putative viral species or genotypes reside in the genus Lyssavirus (Table 5. These have been grouped into phylogroups based on pathogenicity and immunogenicity (Badrane et al. Bats are considered the major hosts for all lyssaviruses except Mokola, and perpetuate a wide diversity of viral antigenic variants in those genotypes that have been adequately studied. Genotype 1 rabies virus is the type species of the genus, and the most significant lyssavirus in terms of public health and veterinary impacts. Vampire bat-variant rabies virus in Latin America causes a significant number of human deaths each year, and there are very rare cases due to other bat lyssavirus genotypes elsewhere (Table 5. History and impact Compared with the long history of rabies virus in carnivores and humans, recognition of bat lyssaviruses is comparatively recent and with the notable exception of rabies virus in Latin American vampire bats, particularly Desmondus rotundus bat lyssaviruses rarely cause rabies in humans and other animals. Allusions to bat-borne rabies first appeared in the 1500s in a description by Spanish conquistadores in Latin America of human and livestock deaths following bat bites, but the association was not confirmed until 1921 by Haupt dn Rehaaq in Brazil (Kuzmin and Rupprecht, 2007; Freuling et al. Reports of human deaths in the United States of America following bites by insectivorous bats in the 1950s led to the recognition of bat rabies among insectivorous bats in North America (Kuzmin and Rupprecht, 2007; Constantine, 2009). Bat-associated rabies in the United States causes about one to four human deaths each year and rare disease occurrences in other animals. Surveys of African mammals led to the recognition of Lagos bat virus (1956), Mokola virus (1968) and Shimoni bat virus (2009) (Kuzmin et al. African bat lyssaviruses appear to be rare causes of disease in domestic animals or humans. However, carnivore-variant rabies is relatively common in Africa, differentiation of bat lyssaviruses from carnivore rabies virus requires genotype-specific tests, and there is little systematic surveillance in Africa. The actual impact of bat lyssaviruses in Africa is therefore likely to be masked by the far greater impact of carnivore-variant rabies virus (Struthers, 1991). There have been two human deaths attributed to bites from bats, the last in 1998, and no detection in animals other than bats (Barrett, 2004). A series of bat surveys between 1990 and 2002 led to the discovery of single isolates of Aravan virus, Khujand virus, Irkut virus and West Caucasian bat virus in insectivorous bats of Central Asia and Eastern Europe. Bat lyssaviruses appear to have no significant impact on bat populations, particularly compared with the devastating impact of the recently emerged fungal white-nose syndrome (Frick et al. Epidemiology and disease ecology Lyssaviruses have been detected in most of the bat species that have been appropriately surveyed, and should be presumed to be present in all bat species globally. Many countries have little to no surveillance of bats, and epidemiological and disease ecology data are very limited for the African and Eurasian lyssaviruses. The absence of isolates from bats in India and Southeast Asia probably reflects a lack of surveillance rather than an absence of lyssaviruses. Within each bat lyssavirus genotype for which there are adequate isolates there are bat species-specific virus variants or biotypes that are maintained by particular bat species within geographically discrete areas. In contrast to dog-variant rabies virus, which is present on all continents except Australia and Antarctica, the distribution of each genotype of bat lyssavirus appears to be limited to specific bat species within a single continent (Table 5. The considerable differences between the ecology of bats and that of carnivores need to be considered when extrapolating from the larger body of knowledge about carnivore rabies epidemiology. Lyssaviruses are found across diverse bat species, whether they are insectivorous, frugivorous or haematophagous; hibernate and/or migrate or do not; are solitary or roost in colonies of a few individuals to millions of bats of single or mixed species; and (in contrast to most carnivores) bear young (usually one at a time) once or twice per year. The extent to which these factors influence and interact in the disease ecology of bats is unclear and may be specific to the relationship between each bat species and each virus variant. Presumably, as for carnivore-variant rabies, transmission between bats is by transfer of infectious saliva through biting and licking. Aerosol transmission in caves may play a role in bat rabies epidemiology, particularly among bats that roost in caves in large, high-density colonies (Constantine, 2009). Transmission between solitary bat species and arboreal flying foxes in Australia presumably depends on direct bite contact. When adequately sampled, bats from nearly all of the more than 40 bat species present in the United States of America are found to be infected with many distinct variants of rabies virus (Streicker et al. Enzootic cases occur in every state except Hawaii (Blanton, Palmer and Rupprecht, 2010). Most isolations of rabies virus in bats of the Americas come from relatively few species of the genera Desmodus, Eptesicus, Lasionycteris, Lasiurus, Myotis and Tadarida. Paradoxically, among the bats submitted to diagnostic testing at state laboratories, studies have shown higher infection rates in solitary bats and those living in small groups than in colonial species (Blanton, Palmer and Rupprecht, 2010). The occurrence of bat rabies in the Americas is comparatively high, with 1 625 laboratory-diagnosed cases Significant zoonotic diseases identified in bats 85 among the 27 915 bats examined during 2009 in the United States alone (Blanton, Palmer and Rupprecht, 2010). In Europe, a total of 889 lyssavirus-infected bats had been detected by 2010 (Freuling and Muller, 2010), with isolates from only ten of the 45 known bat species (Freuling et al. European insectivorous bats roost in large colonies, some migrate over large distances, and roost sites may contain colonies of different species, allowing horizontal spread within and among species. Flying foxes roost in trees, in large camps of thousands to hundreds of thousands. Camps often contain one or more species, and black, grey-headed and little red flying foxes migrate for distances ranging from hundreds to thousands of kilometres in search of fruit, blossoms and leaves. It remains unclear whether all four species act as maintenance hosts or one or more species maintain the virus with frequent spill-over to other flying foxes. These bats are solitary, roost in tree hollows and are rarely encountered, and little is known about the epidemiology of this distinct variant. Clinical disease due to lyssavirus infection is believed to be fatal in all mammals. The moderate to high sero-prevalence in healthy bats around the globe suggests either clinical recovery or subclinical resolution of infection (so-called "abortive" infection), where an early adequate immune response clears infection prior to the onset of clinical signs. An apparently normal animal may excrete virus for several days prior to developing clinical signs. Human, livestock, wildlife and environmental pespectives the disease ecology of bat lyssaviruses in humans and other animals reflects the interactions of many factors that influence contact between bats and other species, including those that influence bat, human and other animal behaviour and the effect of lyssavirus encephalitis on bat behaviour. On very rare occasions bat lyssaviruses are transmitted to humans via organ transplants or laboratory exposure. Experimental evidence has demonstrated the potential for aerosol transmission within bat caves (Constantine, 2009). Secondary transmission via an infected animal other than a maintenance host species is well documented for carnivore-variant rabies. Transmission of bat rabies virus from affected cats to humans has been documented (Badilla et al. The vampire bat population of Latin America is believed to have increased substantially following European introduction of large prey, notably livestock such as cattle (Hughes, Orciari and Rupprecht, 2005; Kuzmin and Rupprecht, 2007). Vampire bats feed during the night and can feed repeatedly on sleeping people and other animals without waking them. Blood feeding leads to high levels of bat-bite exposure and fatal disease in humans and livestock, particularly cattle. Given the remoteness of localities in regions such as Amazonia, the regularity of prior outbreaks, the increased environmental intrusion for mining and timber resources, the rapid conversion of rain forest to livestock and agricultural pursuits, and the lack of adequate laboratory-based surveillance, more than 500 human cases a year may occur in the Americas related to bat lyssaviruses, primarily owing to highly adaptive populations of vampire bats (Schneider et al. Vampires are not cold-tolerant, and the distribution of vampire bats in Latin America is partially limited by minimum temperatures (Greenhall and Schmidt, 1988). Higher global temperatures arising from climate change will increase the potential range of vampire bats and the distribution and impact of bat rabies (Hughes, Orciari and Rupprecht, 2005). From 1946 to 2009, at least 57 of 250 cases of human rabies in the United States of America were attributed to bat rabies variants (Messenger et al. Of the bat-variant cases, the majority (at least 30) were associated with a single variant, known as the Ln/Ps variant, found among silver-haired (Lasionycteris noctivagans) and eastern tricoloured (Perimyotis subflavus) bats. Of the remaining bat-variant cases, at least 13 were attributed to a rabies virus variant associated with Mexican free-tailed bats (Tadarida brasiliensis), two to a variant associated with big brown bats (Eptesicus fuscus), and two to a variant associated with Myotis spp. The variants associated with six cases prior to 1970 and four cases from 2004 to 2009 remain unknown. Intriguingly, the silver-haired and eastern tricoloured bat species associated with the variant causing most human cases in the United States of America are far less common near human dwellings than are more colonial bat species, such as Eptesicus or Myotis. In addition, in many human cases a bite or other exposure to a bat may not initially be reported, although subsequent investigation usually reveals that the infected person has had contact with or proximity to a bat. Most microchiropteran bats have small but extremely sharp teeth, and blood or a wound does not have to be evident for a bite to transmit infection. The histories of human bat rabies cases in the United States suggest that people may not seek medical care following bat contact because they do not realize the risks, do not appreciate the significance of a comparatively small wound, or are unaware that exposure has occurred. Many European bats lead generally secluded lives, and human contact with sick or injured bats is uncommon. Education and vaccination of bat rehabilitation workers can minimize the risk to public health. In Australia, people most frequently come into contact with bats when they attempt to rescue sick, injured or orphaned flying foxes. Loss of habitat through agriculture and urbanization has contributed to the urbanization of the four common species of flying foxes. They are frequently injured or trapped on powerlines, barbed wire and fruit tree netting, and are comparatively large (300 to 900 g) and obvious, bringing them into contact with humans. The vast majority of lyssavirus infections in livestock are the result of spill-over of carnivore rabies variants. Bat lyssavirus spill-over is most frequent with genotype 1 bat rabies viruses in the Americas, resulting in dead-end spill-over infections of cattle, cats, foxes and other mammals (Kuzmin and Rupprecht, 2007). The factors driving emergence of a variant associated with big brown (Eptesicus fuscus) and Myotis bats as a self-sustaining epizootic in skunks in Arizona, United States of America are unclear (Leslie et al. Spill-overs of Lagos bat and Mokola viruses have been detected in cats, dogs and wild carnivores (Kuzmin and Rupprecht, 2007; Markotter et al. The evolution of lyssaviruses in bats or carnivores has been the subject of considerable debate (Holmes et al. It remains unclear whether lyssavirus genotypes evolved first in bats or carnivores. It as been proposed that genotype 1 rabies virus was introduced to American bats by terrestrial animals during European colonization. Control and prevention Vaccination programmes to control lyssavirus infection in maintenance host species are the most effective means of controlling spill-over infection to humans and other animals. Animal control, parental and oral vaccination programmes have been successful in eradicating or controlling carnivore rabies in dogs and wildlife, including foxes, raccoons and skunks (Rupprecht et al. Vaccination of free-living bats is not feasible, and in the absence of effective control strategies for eradicating lyssaviruses in bats, it is necessary to manage spill-over of bat lyssaviruses to humans and other animals. The impact of vampire bat rabies on livestock can be minimized by the prophylactic vaccination of cattle. The unique blood-feeding behaviour of vampire bats, and their sensitivity to anticoagulants also allow the local suppression of vampire bat populations by poisoning. Anticoagulant gel can be applied to the coats of Judas bats and spread through the colony through communal grooming, or anticoagulant can be administered topically to recent wounds or intramuscularly to cattle, to be transferred to vampire bats during blood feeding (Kuzmin and Rupprecht, 2007).
Criteria for the audit of radiotherapy outcomes may be easier to define in the context of an individual clinic and implement through internal audit [20 weight loss pills that start with l order astralean 40 mcg visa. It is generally considered that the findings of the audit and its results are confidential between the auditing organization and the audited centre weight loss using essential oils cheap astralean 40 mcg otc. In general weight loss pills khloe astralean 40 mcg low price, quality audits can review the overall radiotherapy practice through a comprehensive audit weight loss pills at target cheap 40 mcg astralean otc, or selected parts of the practice that are important to achieve the desired treatment outcome weight loss 9 weeks order astralean 40 mcg line, through a partial audit weight loss pills images buy 40 mcg astralean fast delivery. Audits can be external or internal, depending on whether the auditing organization is external to the audited centre or is part of the centre. Audits can be proactive or reactive, depending on whether the interest of the audited centre rests in continual improvement of its practices or the audit is invited as a reaction to specific problems or issues, such as suspected or reported radiotherapy incidents. The different types and levels of radiotherapy audits are discussed briefly below. A comprehensive audit in radiotherapy involves the entire clinical pathway of the patient, including all interrelated steps of radiotherapy. Typically, a comprehensive audit entails a review of infrastructure as well as of patient related and equipment related procedures, including radiation safety and patient protection. The audit of clinical outcomes may or may not be included in comprehensive audit systems. As mentioned above, the audit of radiation treatment outcomes may be difficult to accomplish and the approach may vary between the various auditing systems, but the audit of outcomes should at least assess whether procedures to measure the outcomes are in place within the audited centre and the outcomes are regularly monitored. A partial audit has a limited extent, and only selected important areas of the radiotherapy process are reviewed and assessed. An example of an audit focusing on resources would be a review of staffing levels and their professional qualifications. A dosimetry audit verifying the correctness of beam calibration in external beam radiotherapy [20. Audits may also measure the degree of compliance with particular clinical guidelines or protocols. Overall, a partial audit is useful in examining individual areas of the radiotherapy practice and defining targets to achieve in these areas which, when 311 achieved, would contribute to the overall improvement of quality in the centre. Partial audits may be performed remotely or through on-site review; sometimes they use surveys and questionnaires. Internal and external audits normally have different interests and scopes, and they can complement each other. For example, an internal audit may be used as preparation for an external audit or to monitor the implementation of the external audit recommendations. Also, the internal audit rather than the external audit, especially in the international context, would be more suitable for reviewing radiotherapy outcomes in the audited centre. This is mostly because the current clinical outcome data reflect the treatment of patients at the audited centre a few years earlier, not at the time of the audit. The infrastructure and processes may have changed over the years, and the current practices at the time of the audit will be reflected in future outcomes. The relationship between the current outcomes and past practices may be difficult to assess by external auditors and they may not be able to formulate useful recommendations. Therefore, the external audit, in particular that by the international auditing body, should be considered an assessment or a snapshot of practices at the time of the audit. Consequently, such an audit would typically focus on infrastructure, including equipment, facilities and human resources, radiotherapy processes, and possibly research and training activities. An internal audit is usually carried out by an audit team from within the centre, but outside the radiotherapy department, and typically reviews compliance with hospital procedures and protocols. For example, internal audits may systematically review different topical areas through a series of partial audits as per the internal audit programme, and the external audit may assess the complete clinical pathway in a comprehensive manner. Appropriate data collection forms can be developed for a specific part of the practice in order to collect data for analysis over a defined period of time. Using such data, the audit can then assess the effectiveness of the practice, draw conclusions and outline recommendations for improvement, where appropriate. Normally, internal audits are carried out on a regular basis, with a typical frequency of 12 months or less. External audits are generally independent and are carried out by organizations external to the audited centre. A programme of routine internal audits complemented by less frequent external audits is considered a practical and effective tool for quality improvement. A reactive audit can be associated with incident monitoring, which consists of reporting and analysing 312 clinical cases where there is concern regarding an adverse event or possibly adverse outcomes. Specifying the objectives of the audit is important for the audit preparation, the auditing process, its outcome and acceptance; therefore, the audit objectives have to be clearly defined. The time frame and programme of the quality audit also have an impact and must be carefully planned by the institution organizing an audit. As the audit is a collaborative process involving the staff of the audited centre and the audit team, both groups have their roles and responsibilities assigned. A local team should be identified to interact with the auditors, representing appropriate professional groups, who will prepare the documentation necessary for the audit, inform relevant staff of the upcoming audit and arrange for practical aspects of the audit. Staff in the audited area should be aware of the audit, its objectives, its programme and the expected level of their engagement. Staff should feel comfortable with the audit process in order to fully engage with it. The quality audit should be an open and collaborative review of the radiotherapy practice, including any difficulties involved, with the intention of recognizing, understanding and addressing them. The local team should make available records and findings of previous external and internal audits, as appropriate, for the audit team to review. It may be necessary to collect some additional data sets or prepare statistics for review by the auditors, depending on the audit requirements. In addition, a broader perspective, wisdom and good judgement would help to properly address issues that may arise in the audit and to carry out the audit activities in a tactful and sensitive manner. The audit team should communicate the audit rules to the local team and should follow the pre-agreed programme of the audit. Typically, the audit starts with the entry briefing to introduce to the staff of the audited centre the auditors and the audit objectives, programme and logistics. For example, a comprehensive clinical audit will review the overall performance of the radiotherapy centre following the patient pathway. This will include diagnosis, decision to treat, treatment prescription, planning and preparation, delivery of the treatment and follow-up. The relevant services, departments, equipment and staff will be involved in the audit activities as per the audit programme. It is important that the audit team has access to all relevant areas within the centre and speaks with staff members involved in the radiotherapy process. An exit briefing should take place at the conclusion of the audit to inform the staff of the audited centre about the audit findings, conclusions and recommendations. The auditors should invite comments, encourage open discussion and clarify any points raised. They must ensure that the audit findings, conclusions and recommendations are based on the facts, substantiated by accurate records of the audit documentation. To complete the audit, the auditors have to produce a report to the audited centre. However, the auditors have no authority to enforce actions or requirements on the basis of the audit findings. It is up to the audited centre to follow up on the audit recommendations and to take up any relevant actions. Following the receipt of the audit report, the audited centre should analyse the findings and decide on how to act upon the audit recommendations. It will be necessary to develop a concept for the management of the implementation of the audit recommendations, dedicate the appropriate time, allocate resources, assign responsibilities, and monitor and document the improvements. In particular, items that need to be changed should be classified and a timetable for implementing the changes drafted following a careful analysis of the resources needed. Apart from 314 infrastructure improvements involving direct investments, there may be other changes required, for example, work reorganization, with possible implications such as increased workload, greater responsibilities, and on some occasions a change of status or a reassignment of staff members to different tasks. Any obstacles and barriers in the process of improvement should be analysed and carefully addressed. There may be various reasons and difficulties, such as inadequate communication, as well as organizational issues, for example insufficient information and feedback. Other problems may be related to the lack of an overall plan for the audit, or the auditors may make unrealistic recommendations or address issues of lesser importance to the audited centre. Mostly, difficulties with implementing the audit recommendations are related to a lack of resources [20. An important part of post-audit activities by the audited centre is the process of implementing changes and maintaining improvements. In order to achieve this, the centre should have in place a system for monitoring the quality of its practices, for example by regular internal audits of the various important areas of work. Also, an incident reporting system should be introduced in order to learn from incidents and near misses, identify gaps and improve internal procedures. The input from research and scientific developments cannot be underestimated in the process of improving the practices. The engagement of the centre in supporting staff development and motivation is also an important factor contributing to sustainable improvement of radiotherapy practices. Dosimetry audit It has been over forty years since audits of radiation dose were introduced for radiotherapy centres [20. There are two audit systems existing in parallel, based on on-site visits and remote audits, often called postal dose audits. In contrast, postal dose audit systems may provide cost effective audits for hundreds or thousands of radiotherapy facilities [20. Generally, postal dose audit programmes verify a few selected dose points or beam parameters. Dosimetry audits are useful for confirming good dosimetry practices, but they can also discover problems and errors and bring these to the attention of the clinical physicists involved. Follow-up of errors and discrepancies provides support in finding the reasons for deviations and helps to resolve them. They also contribute to reducing uncertainties and to increasing consistency in radiotherapy results. At the same time, satisfactory audit results provide confidence to clinicians that the dosimetry supporting their practice is correct and outcomes for patients will not be affected by deficient physics practices. It is required for any new radiotherapy facility to receive an external dosimetry audit before patient treatment starts. The scope of dosimetry audits and their complexity should be adjusted to the complexity of radiotherapy technology as this may increase the potential benefits to the patient. However, the basic beam calibration audit should be made mandatory for all radiotherapy facilities; if the beam calibration is incorrect, all patients treated with this beam will receive incorrect doses, no matter how well the treatment prescription is made. It is estimated that, at present, only about two thirds of radiotherapy centres around the world have access to regular dosimetry audits [20. Comprehensive clinical audit Accurate beam dosimetry and high quality of treatment planning are essential in the radiation treatment of cancer, but they cannot ensure the required patient outcome will be achieved without a correspondingly high level of clinical practice. It consists of a review of radiotherapy infrastructure as well as of patient related and equipment related procedures, including radiation safety and patient 317 protection aspects, as appropriate. Staffing levels and professional training programmes for radiation oncologists, medical physicists and radiotherapists can also be reviewed. The objective of comprehensive clinical audits is to review the quality of all aspects of the practice of radiotherapy in a cancer centre with a view to improving quality. The audit reviews and provides an assessment of the ability of a centre to maintain its radiotherapy practices at the level corresponding to the best clinical practices in the specific economic circumstances. The methodology incorporated in both sets of guidelines can be applied in a wide range of economic and cultural settings. A few aspects of comprehensive clinical audits need to be highlighted in order to facilitate quality improvement in the audited centre: (a) (b) (c) Clinical audits should promote the development and usage of internationally recognized, evidence based standards of radiotherapy practices taking into account the available resources. They should encourage the exchange of knowledge, experience and know-how to help achieve adequate standards of performance. They should foster an environment of good professional relationships and a multidisciplinary approach to patient care. A detailed set of checklists is available to assist the audit team throughout the audit and to structure the audit report. These checklists are also made available to the radiotherapy centre prior to the audit so that its staff can become familiar with the auditing methodology and the details of audit procedures. Throughout the audit, the team reviews the working practices and procedures of the centre; interviews staff; checks and evaluates clinical and technical procedures, protocols and documentation; and performs practical dose measurements. Radiation treatments for typical anatomical sites treated in the centre are assessed for randomly selected patient files and treatment records. The audit findings, recommendations and conclusions are formulated taking into account the criteria of evidence based good radiotherapy practices. The audit report specifies areas for improvement of practices in the audited centre and advice for further developments. Some audited centres have been recognized as operating at a high level of competence. The audit findings and recommendations help the audited centres to define targets and bring improvements to ensure optimal patient care and achieve the desired treatment outcome. Every day around the world, many teenagers, young children and even infants are diagnosed with cancer. Cancer in children is an important health care problem, not only for the individual patient and medical staff, but also for families, teachers, friends and society as a whole. Most childhood cancers are curable; using the best treatment options, more than 80% of children with cancer may survive to adulthood.
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