Ustekinumab for the treatment of moderate to severe psoriasis

This paper presents a summary of the evidence review group (ERG) report into the clinical effectiveness and cost-effectiveness of ustekinumab for the treatment of moderate to severe psoriasis based upon a review of the manufacturer's submission to the National Institute for Health and Clinical Excellence (NICE) as part of the single technology appraisal (STA) process. The submission's main evidence came from three randomised controlled trials (RCTs), of reasonable methodological quality and measuring a range of clinically relevant outcomes. Higher proportions of participants treated with ustekinumab (45 mg and 90 mg) than with placebo or etanercept achieved an improvement on the Psoriasis Area and Severity Index (PASI) of at least 75% (PASI 75) after 12 weeks. There were also statistically significant differences in favour of ustekinumab over placebo for PASI 50 and PASI 90 results, and for ustekinumab over etanercept for PASI 90 results. A weight-based subgroup dosing analysis for each trial was presented, but the methodology was poorly described and no statistical analysis to support the chosen weight threshold was presented. The manufacturer carried out a mixed treatment comparison (MTC); however, the appropriateness of some of the methodological aspects of the MTC is uncertain. The incidence of adverse events was similar between groups at 12 weeks and withdrawals due to adverse events were low and less frequent in the ustekinumab than in the placebo or etanercept groups; however, statistical comparisons were not reported. The manufacturer's economic model of treatments for psoriasis compared ustekinumab with other biological therapies. The model used a reasonable approach; however, it is not clear whether the clinical effectiveness estimates from the subgroup analysis, used in the base-case analysis, were methodologically appropriate. The base-case incremental cost-effectiveness ratio for ustekinumab versus supportive care was 29,587 pounds per quality-adjusted life-year (QALY). In one-way sensitivity analysis the model was most sensitive to the number of hospital days associated with supportive care, the cost estimate for intermittent etanercept 25 mg and the utility scores used. In the ERG's scenario analysis the model was most sensitive to the price of ustekinumab 90 mg, the proportion of patients with baseline weight > 100 kg and the relative risk of intermittent versus continuous etanercept 25 mg. In the ERG's probabilistic sensitivity analysis ustekinumab had the highest probability of being cost-effective at conventional NICE thresholds, assuming the same price for the 45-mg and 90-mg doses; however, doubling the price of ustekinumab 90 mg resulted in ustekinumab no longer dominating the comparators. In conclusion, the clinical effectiveness and cost-effectiveness of ustekinumab in relation to other drugs in this class is uncertain. Provisional NICE guidance issued as a result of the STA states that ustekinumab is recommended as a treatment option for adults with plaque psoriasis when a number of criteria are met. Final guidance is anticipated in September 2009.

Entecavir for the treatment of chronic hepatitis B infection

This paper presents a summary of the evidence review group (ERG) report into the clinical and cost-effectiveness of entecavir for the treatment of chronic hepatitis B (CHB) in adults based upon a review of the manufacturer's submission to the National Institute for Health and Clinical Excellence (NICE) as part of the single technology appraisal (STA) process. The submission's evidence came from five randomised controlled trials (RCTs), of good methodological quality and measuring a range of clinically relevant outcomes, comparing entecavir with lamivudine. After 1 year of treatment entecavir was statistically superior to lamivudine in terms of the proportion of patients achieving hepatitis B virus (HBV) DNA suppression, alanine aminotransferase (ALT) normalisation and histological improvement, but not in terms of the proportion of patients achieving hepatitis B e antigen (HBeAg) seroconversion. The incidence of adverse or serious adverse events was similar for both treatments. The results of the manufacturer's mixed treatment comparison (MTC) model to compare entecavir with the comparator drugs in nucleoside-naive patients were considered to be uncertain because of concerns over its conduct and reporting. For the economic evaluation the manufacturer constructed two Markov state transition models, one in HBeAg-positive and one in HBeAg-negative patients. The modelling approach was considered reasonable subject to some uncertainties and concerns over some of the structural assumptions. In HBeAg-positive patients the base-case incremental cost-effectiveness ratios (ICER) for entecavir compared with lamivudine and pegylated interferon alpha-2a were 14,329 pounds and 8403 pounds per quality-adjusted life-year (QALY) respectively. Entecavir was dominated by telbivudine. In HBeAg-negative patients the base-case ICERs for entecavir compared with lamivudine, pegylated interferon alpha-2a and telbivudine were 13,208 pounds, 7511 pounds and 6907 pounds per QALY respectively. In HBeAg-positive lamivudine-refractory patients entecavir dominated adefovir added to lamivudine. In one-way deterministic sensitivity analysis on all key input parameters for entecavir compared with lamivudine in nucleoside-naive patients, ICERs generally remained under 30,000 pounds per QALY. In probabilistic sensitivity analysis in nucleoside-naive HBeAg-positive patients the probability of the ICER for entecavir being below 20,000 pounds per QALY was 57%, 82% and 45% compared with lamivudine, pegylated interferon alpha-2a and telbivudine respectively. In nucleoside-naive HBeAg-negative patients the probabilities were 90%, 100% and 96% respectively. The manufacturer's lifetime treatment scenario for HBeAg-negative patients and the ERG's 20-year treatment scenario for HBeAg-positive patients increased the ICERs, particularly in the latter case. Amending the HBeAg-negative model so that patients with compensated cirrhosis would also receive lifetime treatment gave probabilities of entecavir being cost-effective at a willingness to pay of 20,000 pounds and 30,000 pounds of 4% and 40% respectively. The NICE guidance issued in August 2008 as a result of the STA states that entecavir is recommended as an option for the treatment of people with chronic HBeAg-positive or HBeAg-negative hepatitis B in whom antiviral treatment is indicated.

Teacher practice: a spotlight on the use of feedback and conferencing in the first year of schooling

With the prevalence of statements that refer to a need to “bridge”, “narrow” or “close” gaps in achievement it would appear that Government bodies have an appreciation for the fact that students need not be victims of circumstance. In addition to this, research has suggested that certain skills, such as the acquisition of phonemic awareness, need to be acquired in the early years to ensure that children do not fall behind their peers. Use of feedback is one way in which teachers have attempted to positively influence student outcomes. There are authors, however, who have suggested that not all forms of feedback are necessarily effective. In light of these perspectives, this study sought to investigate whether the incorporation of student/teacher conferences into a pre-existing program could be seen to support the development of phonemic awareness skills of students in their first year of schooling.

Effect of nutritional supplements on wound healing in home-nursed elderly: a randomized trial

 Objective: The objective was to determine whether provision of oral nutritional supplements, delivered by community nurses, could improve nutritional status and wound healing in home-nursed elderly. Methods: This was a double-blind, randomized trial in 50 elderly patients referred for wound management. Patients received 237 mL/d of 4 or 8 kJ/mL of an oral nutritional supplement for 4 wk. Nutritional status was measured with the Subjective Global Assessment and the Mini-Mental State Examination questionnaire to determine cognitive function and wound characteristics to assess healing. Differences between variables were examined with the Mann-Whitney or Student's t test for comparing two groups, one-way analysis of variance when there was more than two groups, and chi-square analysis for comparing two categorical variables. Associations between variables were examined with Pearson's correlation and regression analysis. Results: At baseline, 34% subjects were moderately malnourished and 8% were severely malnourished. In both groups, there was significantly greater improvement in Mini-Mental State Examination scores at week 4 (95% confidence interval -2.0 to -0.001, P = 0.04) and a greater decrease in the wound effusion score (95% confidence interval -2.0 to 0.0, P = 0.045). Median length of stay did not differ between groups (P > 0.05). Conclusions: Malnutrition is common in elderly patients who are nursed at home for wound management. Provision of energy- and protein-dense oral supplements by community nurses is effective in improving some indices of wound healing and cognitive function in this group. Although further study is needed to determine the effect on length of stay, the nutritional needs of this vulnerable group should not be overlooked. © 2005 Elsevier Inc. All rights reserved.

Atmospheric quality and distribution of heavy metals in Argentina employing Tillandsia capillaris as a biomonitor.

The atmospheric quality and distribution of heavy metals were evaluated throughout a wide region of Argentina. In addition, the biomonitor performance of Tillandsia capillaris Ruiz & Pav. f. capillaris was studied in relation to the accumulation of heavy metals and to its physiologic response to air pollutants. A sampling area of 50,000 km2 was selected in the central region of the Argentine Republic. This area was subdivided into grids of 25 x 25 km. Pools of T. capillaris, where present, were collected at each intersection point. From each pool three sub-samples were analyzed independently. Furthermore, five replicates were collected at 20% of the points in order to analyze the variability within the site. The content of Co, Cu, Fe, Ni, Mn, Pb and Zn was determined by Atomic Absorption Spectrometry. Chemical-physiological parameters were also determined to detect symptoms of foliar damage. Chlorophylls, phaeophytins, hydroperoxy conjugated dienes, malondialdehyde and sulfur were quantified in T. capillaris. Some of these parameters were used to calculate a foliar damage index. Data sets were evaluated by one-way ANOVA, correlation analysis, principal component analysis and mapping. Geographical distribution patterns were obtained for the different metals reflecting the contribution of natural and anthropogenic emission sources. According to our results it can be inferred that Fe, Mn and Co probably originated in the soil. For Pb, the highest values were found in the mountainous area, which can be attributed to the presence of Pb in the granitic rocks. Ni showed mainly an anthropogenic origin, with higher values found in places next to industrial centers. For Zn the highest values were in areas of agricultural development. The same was observed for Cu, whose presence could be related to the employment of pesticides. The foliar damage index distribution map showed that the central and southeastern zones were the ones where the major damage in the bioindicator was found. The central zone coincides with the city of Córdoba whereas the southeastern area is strictly agricultural, so the high values found there could be related to the use of pesticides.

Housing strategies that improve indigenous health outcomes

Housing is a key social determinant of health. The relationship between housing outcomes and health outcomes is bi-directional: housing affects healthoutcomes, and health affects housing outcomes. There are clear links between the quality and location of housing and health outcomes. The impacts of housing on health vary between geographic and climatic locations and contexts. There is a wide range of housing interventions that positively impact Indigenous health. One way of categorisingthese is: infrastructure improvements; addressing behavioural factors; and adjustments to policy environments.

A tale of two expropriations: Newcrestia and Agrizania

A comparison will be made between the decision of the High Court of Australia in Newcrest Mining (WA) Ltd v The Commonwealth1 (“Newcrest”) and the decisions of the South African Courts in the Agri South Africa line of cases.2 Although the mineral law systems of the two countries differ insofar as historical development and content,3 the simplified facts of the Newcrest and Agri SA decisions and principles of expropriation law are similar enough to draw an interesting comparison between the respective cases. Both cases dealt with the issue of whether the mineral rights/mining rights of private holders were expropriated by legislation which prohibited mining in one way or another. A comparison between the cases shows the approaches towards the issues and what exactly constitutes deprivation and/or acquisition of property for purposes of expropriation and whether deprivation and/or acquisition actually took place.The differences between the mineral law systems of Australia and South Africa (before the enactment of the Mineral and Petroleum Resources Development Act 28 of 2002 (hereafter “MPRDA”)) and the protection afforded against the resumption/expropriation of mineral rights or mining rights will be set as background information for a better understanding of the respective decisions. The facts of the two cases will first be set out and simplified for comparative purposes before the respective decisions are discussed. At the end, a comparison will be made between the decisions and a conclusion reached about the similarity of principles and the correctness of the respective decisions.

Parents' food choice motives and their associations with children's food preferences

Objective The objective was to investigate parents' motives for selecting foods for their children and the associations between these motives and children's food preferences. Design Cross-sectional survey. A modified version of the Food Choice Questionnaire was used to assess parents' food choice motives. Parents also reported children's liking/disliking of 176 food and beverage items on 5-point Likert scales. Patterns of food choice motives were examined with exploratory principal component analysis. Associations between motives and children's food preferences were assessed with linear regression while one-way and two-way ANOVA were used to test for sociodemographic differences. Setting Two Australian cities. Subjects Parents (n 371) of 2-5-year-old children. Results Health, nutrition and taste were key motivators for parents, whereas price, political concerns and advertising were among the motives considered least important. The more parents' food choice for their children was driven by what their children wanted, the less children liked vegetables (β =-0·27, P<0·01), fruit (β=-0·19, P<0·01) and cereals (β=-0·28, P<0·01) and the higher the number of untried foods (r=0·17, P<0·01). The reverse was found for parents' focus on natural/ethical motives (vegetables β=0·17, P<0·01; fruit β=0·17, P<0·01; cereals β=0·14, P=0·01). Health and nutrition motives bordered on statistical significance as predictors of children's fruit and vegetable preferences. Conclusions Although parents appear well intentioned in their motives for selecting children's foods, there are gaps to be addressed in the nature of such motives (e.g. selecting foods in line with the child's desires) or the translation of health motives into healthy food choices.

Stakeholder knowledge of threatened coastal species; the case of beach-goers and the Hooded Plover Thinornis rubricollis

One way of measuring pre-existing knowledge of a threatened species and its circumstances is to measure the degree of surprise expressed by stakeholders in relation to factual statements regarding the species. Beach-goers (n = 684) were surveyed in regard to their knowledge of the beach-dwelling, threatened, Hooded Plover Thinornis rubricollis, a coastal obligate in south eastern Australia. Principle components analysis revealed that respondents’ degree of knowledge could be categorized as involving ‘chick (flightless young) ecology’ and ‘human impacts’ (threatening processes). Respondents were more surprised by aspects of chick ecology than by threatening processes (F1,514 = 460.446, p < 0.001). Prior knowledge of the species was associated with less surprise at factual statements. Therefore, priorities for further education should focus on linking threats with chick ecology, particularly because an understanding that chicks are not stationary within fenced areas is critical to the interpretation and effectiveness of current signage used to mitigate human impacts.

In-store music and aroma influences on shopper behavior and satisfaction

Retail markets are increasingly competitive and retailers continuously look to differentiate their retail offering. One way to differentiate is by providing a pleasant and exciting shopping ambience. This paper experimentally tests the effects of music (volume high or low) and aroma (vanilla scent present/absent) on young fashion shoppers in a real retail setting. Results show that volume of music and the presence of a vanilla aroma both have a significant impact on shoppers' emotions and satisfaction levels. Additional analysis reveals that the arousal induced by music and aroma results in increased pleasure levels, which in turn positively influences shopper behaviors, including time and money spend, approach behavior, and satisfaction with the shopping experience. Direct effects of arousal on behaviors as well as an interaction effect between music and aroma on pleasure and time spent in the store are also present. The paper contributes to the better understanding of shoppers' emotions and shopper behaviors in response to in-store atmospherics and offers retailers practical insights into how to create competitive advantage by customizing the atmosphere in their stores.

Evaluating young adult voter decision-making involvement within a compulsory political system

Purpose - This study aims to specifically focus on the lower-involvement young adult voters within the Australian compulsory voting context. It explores voters’ political decision-making by considering the influence of the consumer behaviour theory of involvement. Design/methodology/approach - A thematic analysis was conducted to analyse the interviews within the two research questions: information seeking and decision-making. Findings - Key themes within information seeking are the reach of the information available, the frequency of the information presented, the creativity of the message and one-way versus two-way communication. Key themes within evaluation are promise keeping/trust, achievements or performance and policies. Lower-involvement decision-making has the potential to be a habitual, limited evaluation decision. However, issues of trust, performance and policies may encourage evaluation, thereby reducing the chances of habitually voting for the same party as before. Practical implications - This new area of research has implications for the application of marketing for organisations and political marketing theory. Considering voting decision-making as a lower-involvement decision has implications for assisting the creation and adaptation of strategies to focus on this group of the population. Originality/value - The compulsory voting environment creates a unique situation to study lower-involvement decision-making, as these young adults are less likely to opt out of the voting process. Previous research in political marketing has not specifically explored the application of involvement to young adult voting within a compulsory voting environment.

Utilisation of intensive foraging zones by female Australian fur seals

Within a heterogeneous environment, animals must efficiently locate and utilise foraging patches. One way animals can achieve this is by increasing residency times in areas where foraging success is highest (area-restricted search). For air-breathing diving predators, increased patch residency times can be achieved by altering both surface movements and diving patterns. The current study aimed to spatially identify the areas where female Australian fur seals allocated the most foraging effort, while simultaneously determining the behavioural changes that occur when they increase their foraging intensity. To achieve this, foraging behaviour was successfully recorded with a FastLoc GPS logger and dive behaviour recorder from 29 individual females provisioning pups. Females travelled an average of 118 ± 50 km from their colony during foraging trips that lasted 7.3 ± 3.4 days. Comparison of two methods for calculating foraging intensity (first-passage time and first-passage time modified to include diving behaviour) determined that, due to extended surface intervals where individuals did not travel, inclusion of diving behaviour into foraging analyses was important for this species. Foraging intensity 'hot spots' were found to exist in a mosaic of patches within the Bass Basin, primarily to the south-west of the colony. However, the composition of benthic habitat being targeted remains unclear. When increasing their foraging intensity, individuals tended to perform dives around 148 s or greater, with descent/ascent rates of approximately 1.9 m•s-1 or greater and reduced postdive durations. This suggests individuals were maximising their time within the benthic foraging zone. Furthermore, individuals increased tortuosity and decreased travel speeds while at the surface to maximise their time within a foraging location. These results suggest Australian fur seals will modify both surface movements and diving behaviour to maximise their time within a foraging patch.

Effects of visual contact with zoo visitors on black-capped capuchin welfare

Previous research has suggested that the presence of zoo visitors may be stressful for various primate species, and visual contact with visitors may be the sensory stimuli that mediate visitor effects. We studied a group of black-capped capuchins, Cebus apella, in a controlled experiment, randomly imposing two treatments: customised one-way vision screens on the exhibit viewing windows to reduce visual contact with visitors; and unmodified viewing windows that allow full visual contact with visitors. We sampled capuchin behaviour including intra-group aggression and other social interactions, vigilance and abnormal behaviours. To provide a measure of physiological stress, we also analysed capuchin faecal samples for glucocorticoid metabolite (FGM) concentration. When the view of visitors was obscured, we found marked reductions in capuchin aggression (from 14.5 bouts to 4.6 bouts per weekend, P= 0.004) and FGM concentration (from 620 to 410. ng/g, P= 0.008) among all adults, as well as reductions in abnormal behaviour (P = 0.01) in two individuals. The capuchins also avoided the visitor viewing area (P = 0.003) in the unmodified viewing window treatment. These results suggest that reducing the capuchins' ability to view visitors improved their welfare. However we also found a reduction in the number of visitors when visual contact was reduced (from an average of 23 visitors per scan to 15, P = 0.008), suggesting that the visitor experience may have been compromised by the lack of interaction with the capuchins. These results highlight a possible dilemma for the zoo industry between enhancing animal welfare in primates and providing for visitor experience.

Expressions of shame in investigative interviews with Australian Aboriginal children

This study inspected a sample of 70 interview transcripts with Australian Aboriginal children to gain a sense of how frequently verbal shame responses were occurring in investigative interviews regarding alleged sexual abuse. Transcripts were examined to determine how children articulated shame, how interviewers reacted to these responses, and how shame related to children's accounts. Examination of frequencies revealed that verbal shame responses occurred in just over one-quarter of the interviews. One-way analyses of variance indicated that children who expressed shame within the interview spoke the same amount as children who did not express shame, however, they required more interviewer prompts before a disclosure was made. Interviews where children expressed shame also included a greater number of interviewer reminders compared to interviews without shame responses. Results emphasize the importance of interviewer awareness of shame, and also point to the value of reassurance, patience, and persistence with non-leading narrative prompting when interviewing children who express shame during discussions of sexual abuse.

High impulsivity as a risk factor for the development of internalizing disorders in detained juvenile offenders

Background : Whilst impulsivity is most commonly linked to the development of internalizing disorders, high levels of impulsivity, anxiety, and depression have been found in detained juvenile offenders. We therefore sought to determine whether impulsivity is associated with the development of self-reported anxiety or depression in a sample of detained juvenile offenders.

Methods : 323 male juvenile offenders and 86 typically developing controls, aged 15–17 were assessed. The Schedule for Affective Disorder and Schizophrenia for School-Age Children Present and Lifetime (SADS-PL) was used to assess psychiatric diagnoses, the Barratt Impulsivity Scale (BIS-11) was used to measure impulsivity, and the Screen for Child Anxiety Related Emotional Disorders (SCARED) and the Birleson Depression Self-Rating Scale (DSRS) were used to assess self-reported anxiety and depression respectively.

Results : Compared to controls, juvenile offenders had significantly higher scores on the BIS-11 total, as well as on the motor and nonplanning subscales (all p values <0.001), as well as higher DSRS (p < 0.001) and SCARED (p < 0.05) scores. Within the juvenile offender group, scores on the SCARED correlated positively with BIS-11 total, attention subscale, motor subscale, and total DSRS (all p values <0.01). DSRS scores correlated positively with BIS-11 total, attention subscale, nonplanning subscale, and total SCARED scores (all p values <0.01). Participants were then categorized low, middle or high impulsivity according to scores on the BIS-11. One-way ANOVAs demonstrated a significant difference between these tertiles on DSRS [F(2,320) = 4.862, p < 0.05] and SCARED total scores [F(2,320) = 3.581, p < 0.05]. Specifically, post-hoc analyses found that the high impulsivity tertile scored significant higher than the remaining tertiles on both DSRS (16.1 ± 0.3 vs. 14.0 ± 0.6, p < 0.05) and SCARED (23.3 ± 0.9 vs. 18.4 ± 1.4, p < 0.05) scores. Using multiple linear regression, BIS-11 attention scores, number of months served in custody, age, and BIS-11 nonplanning scores predicted higher levels of anxiety, whilst only BIS-11 attention and nonplanning scores predicted higher levels of depression.

Conclusions : In detained juvenile offenders, high impulsivity may be an important risk factor not only for the externalizing disorders, but also for anxiety and depression. Results of this study, therefore, suggest that specific facets of impulsivity may represent one mechanism underlying the emergence of anxiety and depression in this population.