FOXP3+ regulatory T-cell counts correlate with histological response in Crohn's colitis treated with infliximab

Crohn's disease is a chronic inflammatory bowel disease of unknown aetiology. Mucosal inflammatory dysregulation is likely important, with increased production of pro-inflammatory cytokines, including tumour necrosis factor alpha (TNFα). The chimeric monoclonal antibody, infliximab, inhibits TNFα and promotes intestinal mucosal healing. Despite this, many patients still require surgical intervention. Patients who have undergone colonic resection post-infliximab therapy, show markedly variable morphological response to treatment. FOXP3+ CD4+ regulatory T-cells have been shown to have a protective role in autoimmune/inflammatory diseases and their sequestration to the bowel is found in those treated with infliximab. We examined the immunohistochemical profile of lymphoid aggregates in tissue sections from post-infliximab Crohn's colitis resection specimens, classified as morphological responders or non-responders, defined in relation to the absence/presence of mucosal ulceration and active inflammation, and a control group. Results indicated no significant diffences in CD68-positive cell counts but increased FOXP3-positive (P = 0.02) and CD4-positive (P = 0.05) cell counts in responders versus non-responders. Untreated control scores were similar to non-responders. Although based on small study numbers, our results suggest an association between upregulation of FOXP3+/CD4+ regulatory T-cells and morphological response to infliximab therapy. This represents a possible quantitative methodology for monitoring therapeutic response to infliximab therapy, based on immunohistochemical evaluation of endoscopic biopsy specimens.

Control of the Australian life insurance industry: an example of regulatory externalities within the Australian financial sector 1870-1945

The regulatory environment in which the Australian life insurance industry operates has its antecedents in two major periods of legislative intervention. The first established the principle of ‘freedom with disclosure’ in the 1870s, which has since formed the basis of the regulatory approach. In the 1940s, the second refined the concept in the context of a general recognition of an interventionist approach to financial markets. It is suggested that regulation of the life insurance market in Australia came about not in response to problems associated with market failure but in reaction to external influences not directly related to conditions in the Australian life insurance industry. This was impacted not only on the timing of intervention but on the approach taken as well.

Profiles of poor performers in medical practice : models for prevention and intervention

Recent research on evidence-based medical practice has highlighted trends and patterns among medically qualified poor performers, and has produced a profile of risky performers in the profession. Drawing on empirically derived examples from medical practitioners based on reviews of recent government-ordered inquiries of hospitals in Australia, behaviours and practices that increase the risk of poor performance are identified. These findings permit development of a preventive approach to intervene before the problematic performance generates complaints to regulatory bodies. Preventive risk assessment measures to serve the interests of patients and the public are reviewed. These findings will be of interest to individual practitioners, and to those who regulate the profession, such as medical associations, medical councils and medical defense unions.

Changes in injury-related hospital emergency department presentations associated with the imposition of regulatory versus voluntary licensing conditions on licensed venues in two cities

Introduction and Aims
Regulatory and collaborative intervention strategies have been developed to reduce the harms associated with alcohol consumption on licensed venues around the world, but there remains little research evidence regarding their comparative effectiveness. This paper describes concurrent changes in the number of night-time injury-related hospital emergency department presentations in two cities that implemented either a collaborative voluntary approach to reducing harms associated with licensed premises (Geelong) or a regulatory approach (Newcastle).

Design and Methods
This paper reports findings from Dealing with Alcohol-Related problems in the Night-Time Economy project. Data were drawn from injury-specific International Classification of Disease, 10th Revision codes for injuries (S and T codes) presenting during high-alcohol risk times (midnight—5.59 am, Saturday and Sunday mornings) at the emergency departments in Geelong Hospital and Newcastle (John Hunter Hospital and the Calvary Mater Hospital), before and after the introduction of licensing conditions between the years of 2005 and 2011. Time-series, seasonal autoregressive integrated moving average analyses were conducted on the data obtained from patients' medical records.

Results
Significant reductions in injury-related presentations during high-alcohol risk times were found for Newcastle since the imposition of regulatory licensing conditions (344 attendances per year, P < 0.001). None of the interventions deployed in Geelong (e.g. identification scanners, police operations, radio networks or closed-circuit television) were associated with reductions in emergency department presentations.

Discussion and Conclusions
The data suggest that mandatory interventions based on trading hours restrictions were associated with reduced emergency department injury presentations in high-alcohol hours than voluntary interventions. [Miller P, Curtis A, Palmer D, Busija L, Tindall J, Droste N, Gillham K, Coomber K, Wiggers J. Changes in injury-related hospital emergency department presentations associated with the imposition of regulatory versus voluntary licensing conditions on licensed venues in two cities. Drug Alcohol Rev 2014]*

Long-term ethylene oxide exposure trends in US hospitals : relationship with OSHA regulatory and enforcement actions

We assessed long-term trends in ethylene oxide (EtO) worker exposures for the purposes of exposure surveillance and evaluation of the impacts of the Occupational Safety and Health Administration (OSHA) 1984 and 1988 EtO standards. We obtained exposure data from a large commercial vendor and processor of EtO passive dosimeters. Personal samples (87 582 workshift [8-hr] and 46 097 short-term [15-min] samples) from 2265 US hospitals were analyzed for time trends from 1984 through 2001 and compared with OSHA enforcement data. Exposures declined steadily for the first several years after the OSHA standards were set. Workshift exposures continued to taper off and have remained low and constant through 2001. However, since 1996, the probability of exceeding the short-term excursion limit has increased. This trend coincides with a decline in enforcement of the EtO standard. Results indicate the need for renewed intervention efforts to preserve gains made following the passage and implementation of the 1984 and 1988 EtO standards.

Regulatory Objectives for Contemporary Electronic Communications : Talking Business or Talking Culture?

The common mantra in telecommunications regulatory fora (be it national, regional or international) now goes along the lines of 'deregulation-good; regulation-bad' and competition is said to be the ultimate answer to basically every question. A generalised dictum like this is in itself suspicious and even more so, when it refers to a sector such as telecommunications, which has a history of heavy regulation and has been the very epitome of state intervention. In the contemporary environment of vibrant communications, subcribing to a purely 'black-or-white' aproach may be, to put it mildly, unsafe. Before answering the question of appropriate regulatory model for communications markets, it is essential to figure out what goals are to be pursued in order to consider what kind of measures could bring about their attainment. In the words of Robert Bork, 'only when the issue of goals has been settled is it possible to frame a coherent body of substantive rules'. Against this backdrop, the present paper looks into the goals and objectives of telecommunications regulation, their complexity and inherent tension between commercial and public interests.

The evaluation and development of the lead authority partnership scheme as a central intervention strategy for health and safety enforcement by local authorities

The research comprises a suite of studies that examines and develops the Lead Authority Partnership Scheme (LAPS) as a central intervention strategy for health and safety by local authority (LA) enforcers. Partnership working is a regulatory concept that in recent years has become more popular but there has been little research conducted to investigate, explore and evaluate its practical application. The study reviewed two contrasting approaches to partnership working between LAs and businesses, both of which were intended to secure improvements in the consistency of enforcement by the regulators and in the health and safety management systems of the participating businesses. The first was a well-established and highly prescriptive approach that required a substantial resource commitment on the part of the LA responsible for conducting a safety management review (SMR) of the business. As a result of his evaluation of the existing ‘full SMR’ scheme, the author developed a second, more flexible approach to partnership working. The research framework was based upon a primarily qualitative methodology intended to investigate and explore the impact of the new flexible arrangements for partnership working. The findings from this study of the flexible development of the scheme were compared and contrasted with those from studies of the established ‘full SMR’ scheme. A substantial degree of triangulation was applied in an attempt to strengthen validity and broaden applicability of the research findings. Key informant interviews, participant observation, document/archive reviews, questionnaires and surveys all their particular part to play in the overall study. The findings from this research revealed that LAPS failed to deliver consistency of LA enforcement across multiple-outlet businesses and the LA enforced business sectors. Improvement was however apparent in the safety management systems of the businesses participating in LAPS. Trust between LA inspector and safety professional was key to the success of the partnerships as was the commitment of these key individuals. Competition for precious LA resources, the priority afforded to food safety over health and safety, the perceived high resource demands of LAPS, and the structure and culture of LAs were identified as significant barriers to LA participation. Flexible approaches, whilst addressing the resource issues, introduced some fresh concerns relating to credibility and delivery. Over and above the stated aims of the scheme, LAs and businesses had their own reasons for participation, notably the personal development of individuals and kudos for the organisation. The research has explored the wider implications for partnership working with the overall conclusion it is most appropriately seen as a strategic level element within a broader structured intervention strategy.

Regulatory governance of ‘training markets’, ‘market failure’, and ‘quasi’ markets: historical dimensions of the post-initial training market in the Netherlands

This article examines regulatory governance of the post-initial training market in The Netherlands. From an historical perspective on policy formation processes, it examines market formation in terms of social, economic, and cultural factors in the development of provision and demand for post-initial training; the roles of stakeholders in the longterm construction of regulatory governance of the market; regulation of and public providers; policy responses to market failure; and tripartite division of responsibilities between the state, social partners, commercial and publicly-funded providers. Historical description and analysis examine policy narratives of key stakeholders with reference to: a) influence of societal stakeholders on regulatory decision-making; b) state regulation of the post-initial training market; c) public intervention regulating the market to prevent market failure; d) market deregulation, competition, employability and individual responsibility; and, e) regulatory governance to prevent ‘allocative failure’ by the market in non-delivery of post-initial training to specific target groups, particularly the low-qualified. Dominant policy narratives have resulted in limited state regulation of the supply-side, a tripartite system of regulatory governance by the state, social partners and commercial providers as regulatory actors. Current policy discourses address interventions on the demand-side to redistribute structures of opportunity throughout the life courses of individuals. Further empirical research from a comparative historical perspective is required to deepen contemporary understandings of regulatory governance of markets and the commodification of adult learning in knowledge societies and information economies. (DIPF/Orig.)

Weight loss and attrition in overweight and obese young women during a 36- week internet-based lifestyle intervention

Background: Young women are at high risk of weight gain yet few studies have examined the long-term effectiveness of weight loss programs in this group. This study aimed to investigate the effects of a self-directed internet-based lifestyle program on body weight in young women.

Methods: Overweight or obese young women (BMI 33.4 ± 0.3 kg/m2, age 27.8 ± 0.3 years) were initially randomized to General lifestyle advice (G) or Structured lifestyle advice (S) via in-person and website support for 12 weeks (Phase I). After Phase I, all participants were supported through a self-directed internet-based program for 36 weeks (Phase II). The internet-based program included a structured hypocaloric diet, physical activity program, self-monitoring tools, peer group forum and monthly emails. Body weight, energy intake and physical activity were measured at week 0, week 12, week 24 and week 48. Adherence to self-regulatory behaviors was measured at week 48. Mixed model analyses were conducted to determine changes in body weight, energy intake and physical activity.

Results: A total of 203 overweight or obese young women commenced Phase I and 130 commenced Phase II. In Phase I, S group had significantly greater weight loss than G group (4.2 ± 0.6 kg vs 0.6 ± 0.3 kg, P<0.001). In Phase II, both groups had significant weight loss over time without significant group differences (-0.8 ± 1.1kg vs -0.8 ± 0.6, P>0.05). Forty-one percent (53/130) of the participants who commenced Phase II completed the internet-based intervention. Dropouts had a higher baseline BMI, were more likely to be married or in a de facto relationship, and more likely to have at least one child.

Conclusions: A self-directed internet-based program could be effective in providing support in maintaining weight loss on a structured lifestyle program in young women over 36 weeks. Further research is required to maintain engagement in young women who were married/in a de facto relationship or have children.

Examining the approaches to diminish judicial intervention in statutory adjudication in Australia

In Australia, statutory construction adjudication is a fast payment dispute resolution process designed to keep the cash flowing down the hierarchical contractual chain in construction projects. Its rapid, highly regulatory and temporarily binding nature have led to it being often described as a ‘quick and dirty’ process that delivers ‘rough and ready’ justice. Adjudicators often have to grapple with complex legal issues related to jurisdictional facts and interpretation of contract provisions, though the majority of them are not legally trained. This has often led to a poor quality of adjudication outcome for large and complex payment claims which has, in turn, led to a mounting dissatisfaction due to the many judicial challenges to adjudicators’ determinations seen in recent years. The evolving tension between the object of the security of payment legislation and excessive involvement of the courts has often been the subject of comment by the judiciary. This paper aims to examine the legislative and judicial approaches to support the object of the security of payment legislation to ease cash flow. The paper adopts a desktop study approach whereby evidence is gathered from three primary sources – judicial decisions, academic publications and governmental reports. The paper concludes that there is a need to adopt other measures which can provide more convenient relief to aggrieved parties to an adjudication process, such that the adjudication process is kept away from the courts as far as is possible. Specifically, it is proposed that a well-designed expanded legislative review scheme of allegedly flawed adjudication, based on that provided in the Western Australian legislation, might stand as a promising remedy to eliminate the evolving tension.

Reducing the global burden of depression : population level analysis of intervention cost-effectiveness in 14 world regions

International evidence on the cost and effects of interventions for reducing the global burden of depression remain scarce. Aims: To estimate the population-level cost-effectiveness of evidence-based depression interventions and their contribution towards reducing current burden. Method: Primary-care-based depression interventions were modelled at the level of whole populations in 14 epidemiological subregions of the world. Total population-level costs (in international dollars or I$) and effectiveness (disability adjusted life years (DALYs) averted) were combined to form average and incremental cost-effectiveness ratios. Results: Evaluated interventions have the potential to reduce the current burden of depression by 10–30%. Pharmacotherapy with older antidepressant drugs, with or without proactive collaborative care, are currently more cost-effective strategies than those using newer antidepressants, particularly in lower-income subregions. Conclusions: Even in resource-poor regions, each DALYaverted by efficient depression treatments in primary care costs less than 1 year of average per capita income, making such interventions a cost-effective use of health resources. However, current levels of burden can only be reduced significantlyif there is a substantialincrease substantial increase intreatment coverage.