Ethical review in creative industries and other practice-based research

The processes used in Australian universities for reviewing the ethics of research projects are based on the traditions of research and practice from the medical and health sciences. The national guidelines for ethical conduct in research are heavily based on presumptions that the researcher–participant relationship is similar to a doctor–patient relationship. The National Health and Medical Research Council, Australian Research Council and Australian Vice-Chancellors’ Committee have made a laudable effort to fix this problem by releasing the National Statement on Ethical Conduct in Human Research in 2007, to replace the 1999 National Statement on Ethical Conduct in Research Involving Humans. The new statement better encompasses the needs of the humanities, social sciences and creative industries. However, this paper argues that the revised National Statement and ethical review processes within universities still do not fully encompass the definitions of ‘research’ and the requirements, traditions, codes of practice and standards of the humanities, social sciences and creative industries. The paper argues that scholars within these disciplines often lack the language to articulate their modes of practice and risk management strategies to university-level ethics committees. As a consequence, scholars from these disciplines may find their research is delayed or stymied. The paper focuses on creative industries researchers, and explores the issues that they face in managing the ethical review process, particularly when engaging in practice-based research. Although the focus is on the creative industries, the issues are relevant to most fields in the humanities and social sciences.

SNP diversity of Enterococcus faecalis and Enterococcus faecium in a South East Queensland waterway, Australia, and associated antibiotic resistance gene profiles

BACKGROUND: Enterococcus faecalis and Enterococcus faecium are associated with faecal pollution of water, linked to swimmer-associated gastroenteritis and demonstrate a wide range of antibiotic resistance. The Coomera River is a main water source for the Pimpama-Coomera watershed and is located in South East Queensland, Australia, which is used intensively for agriculture and recreational purposes. This study investigated the diversity of E. faecalis and E. faecium using Single Nucleotide Polymorphisms (SNPs) and associated antibiotic resistance profiles. RESULTS: Total enterococcal counts (cfu/ml) for three/six sampling sites were above the United States Environmental Protection Agency (USEPA) recommended level during rainfall periods and fall into categories B and C of the Australian National Health and Medical Research Council (NHMRC) guidelines (with a 1-10% gastrointestinal illness risk). E. faecalis and E. faecium isolates were grouped into 29 and 23 SNP profiles (validated by MLST analysis) respectively. This study showed the high diversity of E. faecalis and E. faecium over a period of two years and both human-related and human-specific SNP profiles were identified. 81.8% of E. faecalis and 70.21% of E. faecium SNP profiles were associated with genotypic and phenotypic antibiotic resistance. Gentamicin resistance was higher in E. faecalis (47% resistant) and harboured the aac(6')-aph(2') gene. Ciprofloxacin resistance was more common in E. faecium (12.7% resistant) and gyrA gene mutations were detected in these isolates. Tetracycline resistance was less common in both species while tet(L) and tet(M) genes were more prevalent. Ampicillin resistance was only found in E. faecium isolates with mutations in the pbp5 gene. Vancomycin resistance was not detected in any of the isolates. We found that antibiotic resistance profiles further sub-divided the SNP profiles of both E. faecalis and E. faecium. CONCLUSIONS: The distribution of E. faecalis and E. faecium genotypes is highly diverse in the Coomera River. The SNP genotyping method is rapid and robust and can be applied to study the diversity of E. faecalis and E. faecium in waterways. It can also be used to test for human-related and human-specific enterococci in water. The resolving power can be increased by including antibiotic-resistant profiles which can be used as a possible source tracking tool. This warrants further investigation.

Validation of de-identified record linkage to ascertain hospital admissions in a cohort study

Background Cohort studies can provide valuable evidence of cause and effect relationships but are subject to loss of participants over time, limiting the validity of findings. Computerised record linkage offers a passive and ongoing method of obtaining health outcomes from existing routinely collected data sources. However, the quality of record linkage is reliant upon the availability and accuracy of common identifying variables. We sought to develop and validate a method for linking a cohort study to a state-wide hospital admissions dataset with limited availability of unique identifying variables. Methods A sample of 2000 participants from a cohort study (n = 41 514) was linked to a state-wide hospitalisations dataset in Victoria, Australia using the national health insurance (Medicare) number and demographic data as identifying variables. Availability of the health insurance number was limited in both datasets; therefore linkage was undertaken both with and without use of this number and agreement tested between both algorithms. Sensitivity was calculated for a sub-sample of 101 participants with a hospital admission confirmed by medical record review. Results Of the 2000 study participants, 85% were found to have a record in the hospitalisations dataset when the national health insurance number and sex were used as linkage variables and 92% when demographic details only were used. When agreement between the two methods was tested the disagreement fraction was 9%, mainly due to "false positive" links when demographic details only were used. A final algorithm that used multiple combinations of identifying variables resulted in a match proportion of 87%. Sensitivity of this final linkage was 95%. Conclusions High quality record linkage of cohort data with a hospitalisations dataset that has limited identifiers can be achieved using combinations of a national health insurance number and demographic data as identifying variables.

Agreement between self-reported use of in vitro fertilization or ovulation induction, and medical insurance claims in Australian women aged 28–36 years

STUDY QUESTION: What is the self-reported use of in vitro fertilization (IVF) and ovulation induction (OI) in comparison with insurance claims by Australian women aged 28–36 years? SUMMARY ANSWER: The self-reported use of IVF is quite likely to be valid; however, the use of OI is less well reported. WHAT IS KNOWN AND WHAT THIS PAPER ADDS: Population-based research often relies on the self-reported use of IVF and OI because access to medical records can be difficult and the data need to include sufficient personal identifying information for linkage to other data sources. There have been few attempts to explore the reliability of the self-reported use of IVF and OI using the linkage to medical insurance claims for either treatment. STUDY DESIGN: This prospective, population-based, longitudinal study included the cohort of women born during 1973–1978 and participating in the Australian Longitudinal Study on Women's Health (ALSWH) (n = 14247). From 1996 to 2009, participants were surveyed up to five times. PARTICIPANTS AND SETTING: Participants self-reported their use of IVF or OI in two mailed surveys when aged 28–33 and 31–36 years (n = 7280), respectively. This study links self-report survey responses and claims for treatment or medication from the universal national health insurance scheme (i.e. Medicare Australia). MAIN RESULTS AND THE ROLE OF CHANCE: Comparisons between self-reports and claims data were undertaken for all women consenting to the linkage (n = 3375). The self-reported use of IVF was compared with claims for OI for IVF (Kappa, K = 0.83), oocyte collection (K = 0.82), sperm preparation (K = 0.83), intracytoplasmic sperm injection (K = 0.40), fresh embryo transfers (K = 0.82), frozen embryo transfers (K = 0.64) and OI for IVF medication (K = 0.17). The self-reported use of OI was compared with ovulation monitoring (K = 0.52) and OI medication (K = 0.71). BIAS, CONFOUNDING AND OTHER REASONS FOR CAUTION: There is a possibility of selection bias due to the inclusion criteria for participants in this study: (1) completion of the last two surveys in a series of five and (2) consent to the linkage of their responses with Medicare data. GENERALIZABILITY TO OTHER POPULATIONS: The results are relevant to questionnaire-based research studies with infertile women in developed countries. STUDY FUNDING/COMPETING INTEREST(S): ALSWH is funded by the Australian Government Department of Health and Ageing. This research is funded by a National Health and Medical Research Council Centre of Research Excellence grant.

Enabling access to research data in developing countries : designing a policy and practice framework for Malaysia’s Public Research Universities

Members of the World Trade Organisation (WTO) are obliged to implement the Agreement on Trade-related Intellectual Property Rights 1994 (TRIPS) which establishes minimum standards for the protection and enforcement of intellectual property rights. Almost two decades after TRIPS was adopted at the conclusion of the Uruguay Round of trade negotiations, it is widely accepted that intellectual property systems in developing and least-developed countries must be consistent with, and serve, their development needs and objectives. In adopting the Development Agenda in 2007, the World Intellectual Property Organisation (WIPO) emphasised the importance to developing and least-developed countries of being able to obtain access to knowledge and technology and to participate in collaborations and exchanges with research and scientific institutions in other countries. Access to knowledge, information and technology is crucial if creativity and innovation is to be fostered in developing and least-developed countries. It is particularly important that developing and least-developed countries give effect to their TRIPS obligations by implementing intellectual property systems and adopting intellectual property management practices that enable them to benefit from knowledge flows and support their engagement in international research and science collaborations. However, developing and least-developed countries did not participate in the deliberations leading to the adoption in 2004 by Organisation for Economic Co-operation and Development (OECD) member countries of the Ministerial Declaration on Access to Research Data from Public Funding, nor have they formulated policies on access to publicly funded research outputs such as those developed by the National Institutes of Health in the United States, the United Kingdom Research Councils or the Australian National Health and Medical Research Council. These issues are considered from the viewpoint of Malaysia, a developing country whose economy has grown strongly in recent years. Lacking an established policy covering access to the outputs of publicly funded research, data sharing and licensing practices continue to be fragmented. Obtaining access to research data requires arrangements to be negotiated with individual data owners and custodians. Given the potential for restrictions on access to impact negatively on scientific progress and development in Malaysia, measures are required to ensure that access to knowledge and research results is facilitated. This paper proposes a policy framework for Malaysia‘s public research universities that recognises intellectual property rights while enabling the open access to research data that is essential for innovation and development. It also considers how intellectual property rights in research data can be managed in order to give effect to the policy‘s open access objectives.

Investigation of decision making issues in the use of current clinical information systems

Clinical information systems have become important tools in contemporary clinical patient care. However, there is a question of whether the current clinical information systems are able to effectively support clinicians in decision making processes. We conducted a survey to identify some of the decision making issues related to the use of existing clinical information systems. The survey was conducted among the end users of the cardiac surgery unit, quality and safety unit, intensive care unit and clinical costing unit at The Prince Charles Hospital (TPCH). Based on the survey results and reviewed literature, it was identified that support from the current information systems for decision-making is limited. Also, survey results showed that the majority of respondents considered lack in data integration to be one of the major issues followed by other issues such as limited access to various databases, lack of time and lack in efficient reporting and analysis tools. Furthermore, respondents pointed out that data quality is an issue and the three major data quality issues being faced are lack of data completeness, lack in consistency and lack in data accuracy. Conclusion: Current clinical information systems support for the decision-making processes in Cardiac Surgery in this institution is limited and this could be addressed by integrating isolated clinical information systems.

Smoking status as a moderator of the association between food insecurity and decreased fruit and vegetable consumption

Food insecurity is the inadequate access to, or availability of, sufficient amounts of nutritious, culturally-appropriate and safe foods, or the inability to acquire such foods by socially acceptable means. Food insecurity has been shown to be associated with poor dietary intakes and poor health status. Recently, evidence has emerged suggesting increased rates of food insecurity among those with substance abuse problems, including those who smoke. This cross-sectional study investigates the potential moderating effect of smoking on the association between food insecurity and fruit and vegetable intakes among the Australian population, using regression analyses. Participants were adults 18 years and older participating in the 2004/05 National Health Survey (n = 19,500). Those from food insecure households were up to two-times more likely to report inadequate fruit and vegetable intakes compared to those who were food secure. Those who smoked were nearly six times more likely to report being food insecure, and up to three-times more likely to report inadequate fruit and vegetable intakes, compared to their non-smoking counterparts. Further analyses revealed a marked decline in the strength of the association between food insecurity and fruit consumption with the addition of smoking status into a regression model. These findings have important implications for the development of policy and interventions to address food insecurity, suggesting that those from food insecure households are less likely to comply with national dietary recommendations, and that this may in part be moderated by smoking status.

Associations exist between food insecurity, poor diet, chronic illness and obesity among an Australian population

Food insecurity is the limited availability of, or access to, sufficient amounts of nutritious, culturally-appropriate and safe foods, or the inability to access such foods by socially-acceptable means. Evidence from the United States and Canada suggests that food insecurity may be associated with poor dietary intakes, obesity, and chronic disease including depression and diabetes, thus constituting a significant public health issue. Currently, no existing studies have investigated the dietary and health factors associated with food insecurity among the general Australian population. The current study investigated the potential associations between food insecurity, diet and health among Australian adults (18 years and over) participating in the cross-sectional National Health Survey (n = 19,500). Data were analysed by logistic regression adjusting for sociodemographic covariates. Those from food insecure households were 50% less likely to consume the recommended number of servings of fruit, 60% more likely to report poor health and experienced a 6-fold increase in the risk of severe depressive disorders, compared to their food secure counterparts. Furthermore, food insecurity was associated with a 50% increase in the risk of being diagnosed with ‘high sugar levels’. Finally, women from food insecure households were 30% more likely to be obese compared to their food secure counterparts. These findings suggest that food insecurity may play an important role in preventing adherence with national dietary recommendations, and may increase the risk of obesity and chronic illness. This has important implications for both clinical practice, and the development of interventions and policy to address food insecurity.

Assessing food insecurity : current underestimations in Australia, alternative measures and reflections on their use

Food insecurity is the limited access to, or availability of, nutritious, culturally-appropriate and safe foods, or the inability to access these foods by socially acceptable means. In Australia, the monitoring of food insecurity is limited to the use of a single item, included in the three-yearly National Health Survey (NHS). The current research comprised a) a review of the literature and available tools to measure food security, b) piloting and adaptation of the more comprehensive 16-item United States Department of Agriculture (USDA) Food Security Survey Module (FSSM), and c) a cross-sectional study comparing this more comprehensive tool, and it’s 10- and 6- item short forms, with the current single-item used in the NHS, among a sample of households in disadvantaged urban-areas of Brisbane, Australia. Findings have shown that internationally the 16-item USDA-FSSM is the most widely used tool for the measurement of food insecurity. Furthermore, of the validated tools that exist to measure food insecurity, sensitivity and reliability decline as the number of questions in a tool decreases. Among an Australian sample, the current single-measure utilised in the NHS yielded a significantly lower prevalence for food insecurity compared to the 16-item USDA-FSSM and it’s two shorter forms respectively (four and two percentage points lower respectively). These findings suggest that the current prevalence of food insecurity (estimated at 6% in the most recent NHS) may have been underestimated, and have important implications for the development of an effective means of monitoring food security within the context of a developed country.

Research data finder : an institutional metadata repository

QUT’s new metadata repository (data registry), Research Data Finder, has been designed to promote the visibility and discoverability of QUT research datasets. Funded by the Australian National Data Service (ANDS), it will provide a qualitative snapshot of research data outputs created or collected by members of the QUT research community that are available via open or mediated access. As a fully integrated metadata repository Research Data Finder aligns with institutional sources of truth, such as QUT’s research administrative system, ResearchMaster, as well as QUT’s Academic Profiles system to provide high quality data descriptions that increase awareness of, and access to, shareable research data. In addition, the repository and its workflows are designed to foster smoother data management practices, enhance opportunities for collaboration and research, promote cross-disciplinary research and maximize existing research datasets. The metadata schema used in Research Data Finder is the Registry Interchange Format - Collections and Services (RIF-CS), developed by ANDS in 2009. This comprehensive schema is potentially complex for researchers; unlike metadata for publications, which are often made publicly available with the official publication, metadata for datasets are not typically available and need to be created. Research Data Finder uses a hybrid self-deposit and mediated deposit system. In addition to automated ingests from ResearchMaster (research project information) and Academic Profiles system (researcher information), shareable data is identified at a number of key “trigger points” in the research cycle. These include: research grant proposals; ethics applications; Data Management Plans; Liaison Librarian data interviews; and thesis submissions. These ingested records can be supplemented with related metadata including links to related publications, such as those in QUT ePrints. Records deposited in Research Data Finder are harvested by ANDS and made available to a national and international audience via Research Data Australia, ANDS’ discovery service for Australian research data. Researcher and research group metadata records are also harvested by the National Library of Australia (NLA) and these records are then published in Trove (the NLA’s digital information portal). By contributing records to the national infrastructure, QUT data will become more visible. Within Australia and internationally, many funding bodies have already mandated the open access of publications produced from publicly funded research projects, such as those supported by the Australian Research Council (ARC), or the National Health and Medical Research Council (NHMRC). QUT will be well placed to respond to the rapidly evolving climate of research data management. This project is supported by the Australian National Data Service (ANDS). ANDS is supported by the Australian Government through the National Collaborative Research Infrastructure Strategy Program and the Education Investment Fund (EIF) Super Science Initiative.

eHealth in Australia and elsewhere : a comparison and lessons for the near future

Meticulous planning and preparation do not always guarantee that eHealth programs unfold as predicted. eHealth entails interdependent social interactions which are difficult to predict without past experience or reference to lessons learned. Judicious insight into past case studies and eventualities, therefore, is essential towards building a successful eHealth solution. Australia’s eHealth program is at a crucial stage where appropriate policy considerations and operational changes are in order. In this paper, we present an initial exploration of prominent eHealth initiatives of other countries to identify similarities, differences and to seek lessons towards making Australia’s eHealth initiative a better journey.

An evidence-informed strategy to prevent osteoporosis in Australia

Osteoporosis imposes a tremendous burden on Australia : 1.2 million Australians have osteoporosis and 6.3 million have Osteopenia. In the 2007-08 financial year, 82000 Australians suffered fragility fractures, of Which >17000 were hip fractures. In the 2000-01 financial year, direct costs were estimated at $1.9 billion per year and an additional $5.6 billion on indirect costs. Osteoporosis was designated a National Health Priority Area in 2002; however, implementation of national plans has not yet matched the rhetoric in terms of urgency. Building healthy bones throughout life, the Osteoporosis Australia strategy to prevent osteoporosis throughout the life cycle, presents an evidence-informed set of recommendations for consumers, health care professionals and policymakers. The strategy was adopted by consensus at the Osteoporosis Australia Summit in Sydney, 20 October 2011. Primary objectives throughout the life cycle are: to maximise peak bone mass during childhood and adolescence to prevent premature bone loss and improve or maintain muscle mass, strength and functional capacity in healthy adults to prevent and treat osteoporosis in order to minimise the risk of suffering fragility fractures, and reduce falls risk, in older people. The recommendations focus on three affordable and important interventions to ensure people have adequate calcium intake, vitamin D levels and appropriate, physical activity throughout their lives. Recommendations relevant to all stages of life include: daily dietary calcium intakes should be consistent with Australian and New Zealand guidelines serum levels of vitamin D in the general population should be above 50 nmol/L in winter or early spring for optimal bone health regular weight-bearing physical activity, Muscle strengthening exercises and challenging balance/ mobility activities should be conducted in a safe environment.

On the time spent preparing grant proposals : an observational study of Australian researchers

Objective: To estimate the time spent by the researchers for preparing grant proposals, and to examine whether spending more time increase the chances of success. Design: Observational study. Setting: The National Health and Medical Research Council (NHMRC) of Australia. Participants: Researchers who submitted one or more NHMRC Project Grant proposals in March 2012. Main outcome measures: Total researcher time spent preparing proposals; funding success as predicted by the time spent. Results: The NHMRC received 3727 proposals of which 3570 were reviewed and 731 (21%) were funded. Among our 285 participants who submitted 632 proposals, 21% were successful. Preparing a new proposal took an average of 38 working days of researcher time and a resubmitted proposal took 28 working days, an overall average of 34 days per proposal. An estimated 550 working years of researchers' time (95% CI 513 to 589) was spent preparing the 3727 proposals, which translates into annual salary costs of AU$66 million. More time spent preparing a proposal did not increase the chances of success for the lead researcher (prevalence ratio (PR) of success for 10 day increase=0.91, 95% credible interval 0.78 to 1.04) or other researchers (PR=0.89, 95% CI 0.67 to 1.17). Conclusions: Considerable time is spent preparing NHMRC Project Grant proposals. As success rates are historically 20–25%, much of this time has no immediate benefit to either the researcher or society, and there are large opportunity costs in lost research output. The application process could be shortened so that only information relevant for peer review, not administration, is collected. This would have little impact on the quality of peer review and the time saved could be reinvested into research.

Evidence based healthcare planning in developing countries : an informatics perspective

Most of the national Health Information Systems (HIS) in resource limited developing countries do not serve the purpose of management support and thus the service is adversely affected. While emphasising the importance of timely and accurate health information in decision making in healthcare planning, this paper explains that Health Management Information System Failure is commonly seen in developing countries as well as the developed countries. It is suggested that the possibility of applying principles of Health Informatics and the technology of Decision Support Systems should be seriously considered to improve the situation. A brief scientific explanation of the evolution of these two disciplines is included.

Australian dispensing doctors' prescribing : quantitative and qualitative analysis

Objective: To evaluate the prescribing practices of Australian dispensing doctors (DDs) and to explore their interpretations of the findings. Design, participants and setting: Sequential explanatory mixed methods. The quantitative phase comprised analysis of Pharmaceutical Benefits Scheme (PBS) claims data of DDs and non-DDs, 1 July 2005 30 June 2007. The qualitative phase involved semi-structured interviews with DDs in rural and remote general practice across Australian states, August 2009 February 2010. Main outcome measures: The number of PBS prescriptions per 1000 patients and use of Regulation 24 of the National Health (Pharmaceutical Benefits) Regulations 1960 (r. 24); DDs' interpretation of the findings. Results: 72 DDs' and 1080 non-DDs' PBS claims data were analysed quantitatively. DDs issued fewer prescriptions per 1000 patients (9452 v 15057; P = 0.003), even with a similar proportion of concessional patients and patients aged >65 years in their populations. DDs issued significantly more r. 24 prescriptions per 1000 prescriptions than non-DDs (314 v 67; P=0.008). Interviews with 22 DDs explained that the fewer prescriptions were due to perceived expectation from their peers regarding prescribing norms and the need to generate less administrative paperwork in small practices. Conclusions: Contrary to overseas findings, we found no evidence that Australian DDs overprescribed because of their additional dispensing role. MJA 2011; 195: 172-175