The high costs of getting ethical and site-specific approvals for multi-centre research.

BACKGROUND: Multi-centre studies generally cost more than single-centre studies because of larger sample sizes and the need for multiple ethical approvals. Multi-centre studies include clinical trials, clinical quality registries, observational studies and implementation studies. We examined the costs of two large Australian multi-centre studies in obtaining ethical and site-specific approvals. METHODS: We collected data on staff time spent on approvals and expressed the overall cost as a percent of the total budget. RESULTS: The total costs of gaining approval were 38 % of the budget for a study of 50 centres (mean cost AUD $6960 per site) and 2$2300 per site). Seventy-five and 90 % of time was spent on repeated tasks, respectively, and many time-consuming tasks, such as reformatting documents, did nothing to improve the study design or participant safety. CONCLUSIONS: Improvements have been made to the ethical approval application system, but more gains could be made without increasing risks of harm to research participants. We propose that ethical review bodies and individual sites publish statistics on how long they take to process approvals which could then be nationally benchmarked

The association of cold weather and all-cause and cause-specific mortality in the island of Ireland between 1984 and 2007

This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.This article has been made available through the Brunel Open Access Publishing Fund.Background This study aimed to assess the relationship between cold temperature and daily mortality in the Republic of Ireland (ROI) and Northern Ireland (NI), and to explore any differences in the population responses between the two jurisdictions. Methods A time-stratified case-crossover approach was used to examine this relationship in two adult national populations, between 1984 and 2007. Daily mortality risk was examined in association with exposure to daily maximum temperatures on the same day and up to 6 weeks preceding death, during the winter (December-February) and cold period (October-March), using distributed lag models. Model stratification by age and gender assessed for modification of the cold weather-mortality relationship. Results In the ROI, the impact of cold weather in winter persisted up to 35 days, with a cumulative mortality increase for all-causes of 6.4% (95%CI=4.8%-7.9%) in relation to every 1oC drop in daily maximum temperature, similar increases for cardiovascular disease (CVD) and stroke, and twice as much for respiratory causes. In NI, these associations were less pronounced for CVD causes, and overall extended up to 28 days. Effects of cold weather on mortality increased with age in both jurisdictions, and some suggestive gender differences were observed. Conclusions The study findings indicated strong cold weather-mortality associations in the island of Ireland; these effects were less persistent, and for CVD mortality, smaller in NI than in the ROI. Together with suggestive differences in associations by age and gender between the two Irish jurisdictions, the findings suggest potential contribution of underlying societal differences, and require further exploration. The evidence provided here will hope to contribute to the current efforts to modify fuel policy and reduce winter mortality in Ireland

Assessment of Heat-Related Health Impacts in Brisbane, Australia: Comparison of Different Heatwave Definitions

Background: There is no global definition of a heatwave because local acclimatisation and adaptation influence the impact of extreme heat. Even at a local level there can be multiple heatwave definitions, based on varying temperature levels or time periods. We investigated the relationship between heatwaves and health outcomes using ten different heatwave definitions in Brisbane, Australia. ---------- Methodology/Principal Findings: We used daily data on climate, air pollution, and emergency hospital admissions in Brisbane between January 1996 and December 2005; and mortality between January 1996 and November 2004. Case-crossover analyses were used to assess the relationship between each of the ten heatwave definitions and health outcomes. During heatwaves there was a statistically significant increase in emergency hospital admissions for all ten definitions, with odds ratios ranging from 1.03 to 1.18. A statistically significant increase in the odds ratios of mortality was also found for eight definitions. The size of the heat-related impact varied between definitions.---------- Conclusions/Significance Even a small change in the heatwave definition had an appreciable effect on the estimated health impact. It is important to identify an appropriate definition of heatwave locally and to understand its health effects in order to develop appropriate public health intervention strategies to prevent and mitigate the impact of heatwaves

Avatars of Eurocentrism in the critique of the liberal peace

Recent scholarly critiques of the so-called liberal peace raise important political and ethical challenges to practices of postwar intervention in the global South. However, their conceptual and analytic approaches have tended to reproduce rather than challenge the intellectual Eurocentrism underpinning the liberal peace. Eurocentric features of the critiques include the methodological bypassing of target subjects in research, the analytic bypassing of subjects through frameworks of governmentality, the assumed ontological split between the ‘liberal’ and the ‘local’, and a nostalgia for the liberal subject and the liberal social contract as alternative bases for politics. These collectively produce a ‘paradox of liberalism’ that sees the liberal peace as oppressive but also the only true source of emancipation. However, the article suggests that a repoliticization of colonial difference offers an alternative ‘decolonizing’ approach to critical analysis through repositioning the analytic gaze. Three alternative research strategies for critical analysis are briefly developed

Chronic migraine, comorbidity and socioeconomic deprivation: cross-sectional analysis of a large nationally representative primary care database

Background: Chronic migraine is common but there is limited knowledge on associated comorbidities. Objectives: To examine mental and physical comorbidities in chronic migraine and the influence of socioeconomic status in a large, nationally representative dataset. Design: Analysis of cross-sectional primary healthcare data from 1,468,404 adults in Scotland. Chronic migraine, 31 other physical conditions, and seven mental health conditions we examined. Prevalence rates were standardized by age groups, sex, and socioeconomic deprivation, and adjusted odds ratio (aOR) and 95% confidence intervals (CI) calculated for those with chronic migraine compared with those without. Results: Chronic migraine patients had more conditions, with the biggest difference found for five or more conditions (chronic migraine 11.7% vs. controls 4.9%; aOR 3.00; 95% CI 2.78–3.22). Twenty-five of the 31 physical conditions were significantly more prevalent in the chronic migraine group. The biggest difference was for chronic pain (aOR 4.33; 95% CI 4.12–4.55). For mental health conditions, the biggest differences were for anxiety (aOR 2.95; 95% CI 2.76–31.5) and depression (aOR 2.94; 95% CI 2.81–3.08). Increasing deprivation was associated with more severe and complex comorbidity (five or more conditions), and with more combined mental and physical comorbidity in the chronic migraine group. Conclusions: In a large nationally representative sample in primary care, comorbidity was most common in those with chronic migraine compared with standardized controls, and this was exacerbated by living in areas of higher deprivation

Socioeconomic differentials in the immediate mortality effects of the national Irish smoking ban

This article has been made available through the Brunel Open Access Publishing Fund.Background: Consistent evidence has demonstrated that smoking ban policies save lives, but impacts on health inequalities are uncertain as few studies have assessed post-ban effects by socioeconomic status (SES) and findings have been inconsistent. The aim of this study was to assess the effects of the national Irish smoking ban on ischemic heart disease (IHD), stroke, and chronic obstructive pulmonary disease (COPD) mortality by discrete and composite SES indicators to determine impacts on inequalities. Methods: Census data were used to assign frequencies of structural and material SES indicators to 34 local authorities across Ireland with a 2000–2010 study period. Discrete indicators were jointly analysed through principal component analysis to generate a composite index, with sensitivity analyses conducted by varying the included indicators. Poisson regression with interrupted time-series analysis was conducted to examine monthly age and gender-standardised mortality rates in the Irish population, ages ≥35 years, stratified by tertiles of SES indicators. All models were adjusted for time trend, season, influenza, and smoking prevalence. Results: Post-ban mortality reductions by structural SES indicators were concentrated in the most deprived tertile for all causes of death, while reductions by material SES indicators were more equitable across SES tertiles. The composite indices mirrored the results of the discrete indicators, demonstrating that post-ban mortality decreases were either greater or similar in the most deprived when compared to the least deprived for all causes of death. Conclusions: Overall findings indicated that the national Irish smoking ban reduced inequalities in smoking-related mortality. Due to the higher rates of smoking-related mortality in the most deprived group, even equitable reductions across SES tertiles resulted in decreases in inequalities. The choice of SES indicator was influential in the measurement of effects, underscoring that a differentiated analytical approach aided in understanding the complexities in which structural and material factors influence mortality

The Role of Individual Variables, Organizational Variables and Moral Intensity Dimensions in Libyan Management Accountants’ Ethical Decision Making

This study investigates the association of a broad set of variables with the ethical decision making of management accountants in Libya. Adopting a cross-sectional methodology, a questionnaire including four different ethical scenarios was used to gather data from 229 participants. For each scenario, ethical decision making was examined in terms of the recognition, judgment and intention stages of Rest’s model. A significant relationship was found between ethical recognition and ethical judgment and also between ethical judgment and ethical intention, but ethical recognition did not significantly predict ethical intention—thus providing support for Rest’s model. Organizational variables, age and educational level yielded few significant results. The lack of significance for codes of ethics might reflect their relative lack of development in Libya, in which case Libyan companies should pay attention to their content and how they are supported, especially in the light of the under-development of the accounting profession in Libya. Few significant results were also found for gender, but where they were found, males showed more ethical characteristics than females. This unusual result reinforces the dangers of gender stereotyping in business. Personal moral philosophy and moral intensity dimensions were generally found to be significant predictors of the three stages of ethical decision making studied. One implication of this is to give more attention to ethics in accounting education, making the connections between accounting practice and (in Libya) Islam. Overall, this study not only adds to the available empirical evidence on factors affecting ethical decision making, notably examining three stages of Rest’s model, but also offers rare insights into the ethical views of practising management accountants and provides a benchmark for future studies of ethical decision making in Muslim majority countries and other parts of the developing world

Variation in hospital cleaning practice and process in Australian hospitals: A structured mapping exercise

Background The purpose of this paper is to highlight the range of cleaning practices and processes in 11 Australian hospitals and to discuss the challenges this variation poses to the implementation of clinical trials or changes to hospital cleaning practices. Methods A cross-sectional study design was used to determine cleaning practices and processes in hospitals participating in the ‘Researching Effective Approaches to Cleaning in Hospitals’ (REACH) study. A standardised template and approach was used to collect information. Data collection activities included structured on-site discussions, a review of hospital practices and a document review of policy and procedural documents related to cleaning. Results Variations in the auditing process used to evaluate environmental cleanliness, cleaning practices, product use, training and communication pathways available to cleaning staff were identified. There was also variation in workforce structure and responsibilities for cleaning. Conclusion This paper is the first to describe the differences in cleaning practices between Australian hospitals. The variations identified present a number of challenges for the conduct of research and have important implications for both monitoring of and standards for cleanliness. These challenges include implementing a practice change or cleaning study where hospitals have different processes, practices and structures

Contribution of respiratory tract infections to child deaths: a data linkage study

Background: Respiratory tract infections (RTIs) are an important cause of death in children, and often contribute to the terminal decline in children with chronic conditions. RTIs are often underrecorded as the underlying cause of death; therefore the overall contribution of RTIs to child deaths and the potential preventability of RTI-related deaths have not been adequately quantified. Methods: We analysed deaths in children resident in England who died of non-injury causes aged 28 days to 18 years between 2001 and 2010 using death certificates linked to a longitudinal hospital admission database. We defined deaths as RTI-related if RTIs or other respiratory conditions were recorded on death certificates or linked hospital records up to 30 days before death. We examined trends in mortality by age group, year and season (winter or summer) and determined the winter excess of RTI-related deaths using rate differencing techniques. We estimated the proportion of RTI-related deaths in children with chronic conditions. Results: 22.4% (5039/22509) of child deaths were RTI-related. RTI-related deaths declined by 2.3% per year in infants aged 28 to 364 days between 2001 and 2010. No decline was observed for older children. On average there were 161 winter excess RTI-related deaths annually, accounting for 32% of all RTI-related deaths. 89.0% of children with RTI-related deaths had at least one chronic condition; neurological conditions were the most prevalent. Conclusions: RTI-related deaths have not declined in the last decade except in infants. Targeted strategies to prevent the winter excess of RTIs and to treat RTIs in children, particularly children with chronic conditions, may reduce RTI-related deaths