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Registry-based trials have emerged as a potentially cost-saving study methodology. Early estimates of cost savings, however, conflated the benefits associated with registry utilisation and those associated with other aspects of pragmatic trial designs, which might not all be as broadly applicable. In this study, we sought to build a practical tool that investigators could use across disciplines to estimate the ranges of potential cost differences associated with implementing registry-based trials versus standard clinical trials.
We built simulation Markov models to compare unique costs associated with data acquisition, cleaning, and linkage under a registry-based trial design versus a standard clinical trial. We conducted one-way, two-way, and probabilistic sensitivity analyses, varying study characteristics over broad ranges, to determine thresholds at which investigators might optimally select each trial design.
Registry-based trials were more cost effective than standard clinical trials 98.6% of the time. Data-related cost savings ranged from $4300 to $600,000 with variation in study characteristics. Cost differences were most reactive to the number of patients in a study, the number of data elements per patient available in a registry, and the speed with which research coordinators could manually abstract data. Registry incorporation resulted in cost savings when as few as 3768 independent data elements were available and when manual data abstraction took as little as 3.4 seconds per data field.
Registries offer important resources for investigators. When available, their broad incorporation may help the scientific community reduce the costs of clinical investigation. We offer here a practical tool for investigators to assess potential costs savings.
This paper takes a holistic approach to the data for rural hinterlands in the Black Sea region in the fourth century BCE to reveal pan-Black Sea patterning, importantly including the southern coast and the territory of ancient Sinope. During a period of dynamic mobility and prosperity, the rural hinterlands of Greek settlements around the Black Sea expanded in ways that demonstrate significant regional commonalities in terms of increased settlement, intensified agricultural infrastructure, new connections via road and path networks and the inclusion of dependent territories beyond the traditional chora. Decisions to expand rural territory and intensify agricultural production were taken at the local level, but this patterning demonstrates that such developments were also a response to the dynamics of Black Sea economic and political networks. The associated increased density of occupation and connectivity in these rural hinterlands made them key facilitators of social networks, creating stronger ties between Greek settlements and other local communities, and ultimately enmeshing a more diverse group of people within Black Sea networks.
The eastern bettong Bettongia gaimardi, a potoroid marsupial, has been extinct on the Australian mainland since the 1920s. Sixty adult bettongs were reintroduced from the island of Tasmania to two predator-free fenced reserves on mainland Australia. We examined baseline health parameters (body weight, haematology and biochemistry, parasites and infectious disease exposure) in a subset of 30 (13 male, 17 female) individuals at translocation and again at 12–24 months post-reintroduction. The mean body weight increased significantly post-reintroduction but there were no significant differences in body weight between the two reintroduction sites or between the sexes in response to reintroduction. Differences were evident in multiple haematological and biochemical variables post-reintroduction but there were few differences between the two reintroduced populations or between the sexes in response to reintroduction. Ectoparasite assemblages differed, with five of 13 species failing to persist, and an additional four species were identified post-reintroduction. None of the bettongs had detectable antibodies to the alphaherpesviruses Macropodid herpesvirus 1 and 2 post-reintroduction, including one individual that was seropositive at translocation. Similarly, the novel gammaherpesvirus potoroid herpesvirus 1 was not detected by polymerase chain reaction (PCR) in any of the bettongs post-reintroduction, including one individual that was PCR-positive at translocation. None of the bettongs had detectable antibodies to Toxoplasma gondii either at translocation or post-reintroduction. Our data demonstrate changing baseline health parameters in eastern bettongs following reintroduction to the Australian mainland are suggestive of improved health in the reintroduced populations, and provide additional metrics for assessing the response of macropodoids to reintroduction.
This paper presents the results of an analysis of the realization of word-final /k/ in a sample of read and casual speech by 28 female pupils from a single-sex Glaswegian high school. Girls differed in age, socioeconomic background, and ethnicity. Ejectives were the most usual variant for /k/ in both speech styles, occurring in the speech of every pupil in our sample. Our narrow auditory analysis revealed a continuum of ejective production, from weak to intense stops. Results from multinomial logistic regression show that ejective production is promoted by phonetic, linguistic and interactional factors: ejectives were used more in read speech, when /k/ occurred in the /-ŋk/ cluster (e.g. tank), and when the relevant word was either at the end of a clause or sentence, or in turn-final position. At the same time, significant interactions between style, and position in turn, and the social factors of age and ethnicity, show that the use of ejectives by these girls is subject to a fine degree of sociolinguistic control, alongside interactional factors. Finally, cautious comparison of these data with recordings made in 1997 suggests that these results may also reflect a sound change in progress, given the very substantial real-time increase in ejective realizations of /k/ in Glasgow over the past fourteen years.
Traumatic brain injury (TBI) is one of the leading causes of morbidity and mortality in youth worldwide. Though much remains to be learned, research focused on pediatric TBI has flourished in the last two decades. The current chapter will emphasize recent scientific literature relevant to understanding the consequences of moderate to severe TBI and the role of neuropsychological assessment in particular in characterizing and managing these difficulties. Epidemiological, pathophysiological, and intervention data will be highlighted as well. Outcomes and clinical care after uncomplicated mild TBI in children can be expected to differ from more severe injury; comprehensive reviews of this literature are available elsewhere [1, 2].
In the USA, more than one million children and adolescents sustain TBI each year. Among children aged 0 to 14 years, TBI accounts for approximately 2700 annual deaths, 37,000 hospitalizations, and 435,000 emergency department visits . Not surprisingly given such frequency, the associated financial costs are considerable. Annual hospitalization charges alone exceed $1 billion . Rates and costs of all childhood TBI are undoubtedly much larger, as many milder injuries go unreported entirely or are treated in outpatient settings and remain unaccounted for in hospital-based estimates.
The incidence of TBI varies by severity, with mild TBI comprising 80 to 90% of all treated cases. Throughout childhood, boys are at considerably greater risk for TBI than girls.
The recent drive within the UK National Health Service to improve psychosocial care for people with mental illness is both understandable and welcome: evidence-based psychological and social interventions are extremely important in managing psychiatric illness. Nevertheless, the accompanying downgrading of medical aspects of care has resulted in services that often are better suited to offering non-specific psychosocial support, rather than thorough, broad-based diagnostic assessment leading to specific treatments to optimise well-being and functioning. In part, these changes have been politically driven, but they could not have occurred without the collusion, or at least the acquiescence, of psychiatrists. This creeping devaluation of medicine disadvantages patients and is very damaging to both the standing and the understanding of psychiatry in the minds of the public, fellow professionals and the medical students who will be responsible for the specialty's future. On the 200th birthday of psychiatry, it is fitting to reconsider the specialty's core values and renew efforts to use psychiatric skills for the maximum benefit of patients
To compare the effects of hospital cleaning agents and germicides on the survival of epidemic Clostridium difficile strains.
We compared the activity of and effects of exposure to 5 cleaning agents and/or germicides (3 containing chlorine, 1 containing only detergent, and 1 containing hydrogen peroxide) on vegetative and spore forms of epidemic and non-epidemic C. difficile strains (3 of each). We carried out in vitro exposure experiments using a human fecal emulsion to mimic conditions found in situ.
Cleaning agent and germicide exposure experiments yielded very different results for C. difficile vegetative cells, compared with those for spores. Working-strength concentrations of all of the agents inhibited the growth of C. difficile in culture. However, when used at recommended working concentrations, only chlorine-based germicides were able to inactivate C. difficile spores. C. difficile epidemic strains had a greater sporulation rate than nonepidemic strains. The mean sporulation rate, expressed as the proportion of a cell population that is in spore form, was 13% for all strains not exposed to any cleaning agent or germicide, and it was significantly increased by exposure to cleaning agents or germicides containing detergent alone (34%), a combination of detergent and hypochlorite (24%), or hydrogen peroxide (33%). By contrast, the mean sporulation rate did not change substantially after exposure to germicides containing either a combination of detergent and dichloroisocyanurate (9%) or dichloroisocyanurate alone (15%).
These results highlight differences in the activity of cleaning agents and germicides against C. difficile spores and the potential for some of these products to promote sporulation.
The Roy Castle Fag Ends Community Stop Smoking Service (RCFE) is commissioned by three primary care trusts (PCTs) to provide the adult smoking-cessation service across Liverpool. The service is not theoretically driven but there are several principles governing RCFE, which maintain the client-led, person-centred philosophy. Unique aspects are that the service is provided by trained lay advisors with a nonmedical background and there is no waiting list — clients can self-refer by calling a helpline or walking into a meeting. At RCFE, clients control their own quit attempt as well as self-regulating attendance at meetings and discharge from the service. Relapsed clients are also welcomed back without fear of criticism or the need for an appointment. Possible reasons for the success of RCFE include the client-led methodology, the community approach that removes doctor–patient barriers that may exist, and the nature of the group meetings, which allows interaction between clients who are at different stages of the quit process. Introducing some of the RCFE principles into other stop-smoking services may help to increase the overall smoking-cessation rate in England.
Two experiments were conducted to understand the influence
of estrogen exposure on cardiovascular responses to acute
stress measured by impedance cardiography. Study 1 compared
stress responses of 29 postmenopausal women who used postmenopausal
hormone replacement therapy (HRT) and 29 who did not use
HRT. Women who did not use HRT had higher systolic blood
pressure and pulse pressure responses to the tasks relative
to HRT users. Study 2 compared stress responses of 38 healthy
postmenopausal women not initially on HRT who were randomly
assigned to transdermal estradiol or placebo treatment
for 6–8 weeks. HRT assignment did not influence substantially
women's cardiovascular responses to stress. Characteristics
correlated with HRT use, not HRT itself, or differences
in type, duration, and dosage may account for the discrepancy
The detailed composition, pH, and the properties of rennet clotting, coagulum development and syneresis at pH 6·4 were estimated in milks from 4 Friesian cows during the first 9 weeks of lactation. The concentrations of casein, fat, citrate, Ca, Mg, Pi and Na decreased significantly during early lactation whilst the pH and concentration of lactose increased. Levels of whey protein and K and the casein:fat ratio were unaltered. Considerable variation occurred in the relative proportions of α-, β- and κ-casein. These changes in composition were associated with decreasing coagulum strength and an increased rate of whey drainage although rennet clotting time (RCT) did not follow a significant trend. RCT was positively related to levels of Na and whey protein but negatively correlated with Pi, K and lactose. There were significant positive correlations between coagulum strength and casein, fat, non-protein nitrogen, Pi, Ca, Mg and citrate. The correlation with α-casein was stronger than that with β- or κ-casein. Syneresis time was positively related to fat, Ca and coagulum strength, but negatively related to the concentration of lactose.
Bovine, caprine, ovine and human milks have been clarified by addition of Triton X-100 and EDTA followed by a short incubation. Generally, addition of 4·2% Triton X–100 and 5·4% EDTA was sufficient and with skim-milk samples no dilution was necessary. With whole milks some dilution and greater amounts of Triton X-100 or longer incubation times or higher temperatures were required. These factors were interrelated to some extent and the optimum conditions will be determined by convenience and any particular requirements of the experiment. The attainment of optically transparent milk samples greatly facilitates colorimetric measurements; as examples we have shown that total protein may be estimated by the biuret reaction, NH2 groups measured with 2,4,6-trinitrobenzene sulphonic acid and SH groups by reaction with 5, 5′-dithiobis(2-nitrobenzoic acid). Acid phosphatase activity in bovine milk was followed colorimetrically by reaction with p-nitrophenyl phosphate to demonstrate the suitability of the clarification procedure in the measurement of enzymic reactions.
The chemical composition and rennet coagulation properties at pH 6·4 of milks from 2 commercial herds of Friesian cows were monitored during the change from winter diet to spring grazing. There was considerable variation both in composition and in coagulation properties during this period. There were significant trends for increasing concentrations of casein, Na and lactose, and decreasing concentrations of fat, citrate, K and Mg following the change. Many correlations occurred between concentrations of components, some of which may have physiological significance. Coagulum strength increased after the change to spring grazing and was related to the concentrations of casein, citrate and some of the minerals. Syneresis time did not follow any trend during this period, but was significantly related to concentrations of fat, Na and K. Rennet clotting time did not follow a significant trend immediately after the dietary change, but tended to increase as the summer progressed; it was significantly related to concentrations of Ca, Pi Na and K, as well as to the original pH of the milk. When the concentration of lactose in milk was adjusted, variations in lactose concentration did not affect the coagulation properties of milk.
A quantitative method for rapid routine analysis of individual free fatty acids (FFA) in milk was developed. Lipid was extracted from milk in ether and FFA were recovered by shaking the extract with anion exchange resin Amberlyst 26. The resin-bound FFA were methylated directly and the individual acids quantified, using internal standards, by gas-liquid chromatography. The properties of the resin were measured. The validity of the method was established by extraction of FFA mixtures and milk. Individual acids were, on average, found to be within 6% of the actual concentration present in the mixture. An average coefficient of variation of 4·3% was achieved for the major individual fatty acids on repeated extraction of a single milk sample.
The detailed chemical composition of 25 milks from different breeds of cow, sheep and goat were related to their properties of rennet clotting, coagulum development and syneresis at pH 6·4. Experiments in which concentrations of fat and whey proteins in milk were manipulated, and in which milks were homogenized at different pressures, were also carried out and the effects observed were related to the above processes.
The composition of milks varied widely and many relations between concentrations of components could be related to their known modes of secretion from the alveolus or to their structural functions in the colloidal phase of milk. Rennet clotting was related to total Ca concentration and also to the proportions of αs- and β-caseins present. Coagulum strength was strongly related to total casein concentration in milk but was unaffected by total fat content or by casein/fat ratios. Syneresis was inversely related to fat content of milk and little affected by coagulum strength. Homogenization retarded syneresis, probably by altering coagulum structure and modifying entrapment of fat globules within the coagulum.
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