Using clinical trial data and linked administrative health data to reduce the risk of adverse events associated with the uptake of newly released drugs by older Australians : a model process

Background
The study was undertaken to evaluate the contribution of a process which uses clinical trial data plus linked de-identified administrative health data to forecast potential risk of adverse events associated with the use of newly released drugs by older Australian patients.

Methods
The study uses publicly available data from the clinical trials of a newly released drug to ascertain which patient age groups, gender, comorbidities and co-medications were excluded in the trials. It then uses linked de-identified hospital morbidity and medications dispensing data to investigate the comorbidities and co-medications of patients who suffer from the target morbidity of the new drug and who are the likely target population for the drug. The clinical trial information and the linked morbidity and medication data are compared to assess which patient groups could potentially be at risk of an adverse event associated with use of the new drug.

Results
Applying the model in a retrospective real-world scenario identified that the majority of the sample group of Australian patients aged 65 years and over with the target morbidity of the newly released COX-2-selective NSAID rofecoxib also suffered from a major morbidity excluded in the trials of that drug, indicating a substantial potential risk of adverse events amongst those patients. This risk was borne out in post-release morbidity and mortality associated with use of that drug.

Conclusions
Clinical trial data and linked administrative health data can together support a prospective assessment of patient groups who could be at risk of an adverse event if they are prescribed a newly released drug in the context of their age, gender, comorbidities and/or co-medications. Communication of this independent risk information to prescribers has the potential to reduce adverse events in the period after the release of the new drug, which is when the risk is greatest.

Note: The terms 'adverse drug reaction' and 'adverse drug event' have come to be used interchangeably in the current literature. For consistency, the authors have chosen to use the wider term 'adverse drug event' (ADE).

Using clinical trial data and linked administrative health data to reduce the risk of adverse events associated with the uptake of newly released drugs by older Australians: a model process

BACKGROUND: The study was undertaken to evaluate the contribution of a process which uses clinical trial data plus linked de-identified administrative health data to forecast potential risk of adverse events associated with the use of newly released drugs by older Australian patients. METHODS: The study uses publicly available data from the clinical trials of a newly released drug to ascertain which patient age groups, gender, comorbidities and co-medications were excluded in the trials. It then uses linked de-identified hospital morbidity and medications dispensing data to investigate the comorbidities and co-medications of patients who suffer from the target morbidity of the new drug and who are the likely target population for the drug. The clinical trial information and the linked morbidity and medication data are compared to assess which patient groups could potentially be at risk of an adverse event associated with use of the new drug. RESULTS: Applying the model in a retrospective real-world scenario identified that the majority of the sample group of Australian patients aged 65 years and over with the target morbidity of the newly released COX-2-selective NSAID rofecoxib also suffered from a major morbidity excluded in the trials of that drug, indicating a substantial potential risk of adverse events amongst those patients. This risk was borne out in post-release morbidity and mortality associated with use of that drug. CONCLUSIONS: Clinical trial data and linked administrative health data can together support a prospective assessment of patient groups who could be at risk of an adverse event if they are prescribed a newly released drug in the context of their age, gender, comorbidities and/or co-medications. Communication of this independent risk information to prescribers has the potential to reduce adverse events in the period after the release of the new drug, which is when the risk is greatest.Note: The terms 'adverse drug reaction' and 'adverse drug event' have come to be used interchangeably in the current literature. For consistency, the authors have chosen to use the wider term 'adverse drug event' (ADE).

A pilot study evaluating multiple risk factor interventions by community pharmacists to prevent cardiovascular disease : The PAART CVD pilot project

Background: There is insufficient evidence for the efficacy of comprehensive multiple risk factor interventions by pharmacists in the primary prevention of cardiovascular disease (CVD). Given the proven benefits of pharmacist interventions for individual risk factors, it is essential that evidence for a comprehensive approach to care be generated so that pharmacists remain key members of the health care team for individuals at risk of initial onset of CVD. Objective: To establish the feasibility of an intervention delivered by community pharmacists to reduce the risk of primary onset of CVD.
Methods: A single-cohort intervention study was undertaken in 2008-2009. Twelve community pharmacists from 10 pharmacies who were trained to provide lifestyle and medicine management support to reduce CVD risk recruited 70 at-risk participants aged 50-74 years who were free from diabetes or CVD. Participants received a baseline assessment to establish CVD risk and health behaviors. An assessment report provided to patients and pharmacists was used to collaboratively establish treatment goals and, over 5 sessions, implement treatment strategies. Follow-up assessment at 6 months measured changes in baseline parameters. The primary outcome was the average change to overall 5-year risk of CVD onset.
Results: Sixty-seven participants were included in the analysis. The mean participant age was 60 years and 73% were female. We observed a 25% (95% CI 17 to 33) proportional risk reduction in overall CVD risk. Significant reductions also occurred in mean blood pressure (-11/-5 mm Hg) and waist circumference (-1.3 cm), with trends toward improvement for most other observed risk factors.
Conclusions: Findings support previous evidence of positive cardiovascular health outcomes following pharmacist intervention in other patient groups; we recommend generating randomized controlled trial evidence for a primary prevention population.

An analytical model on the propagation of modern email worms

Email worms propagate across networks by taking advantage of email relationships. Modeling the propagation of email worms can help predict their potential damages and develop countermeasures. We propose a novel analytical model on the propagation process of modern reinfection email worms. It relies on probabilistic analysis, and thus can provide a steady and reliable assessment on the propagation dynamics. Additionally, by introducing virtual users to represent the repetitious spreading process, the proposed model overcomes the computational challenge caused by reinfection processes. To demonstrate the benefits of our model, we conduct a series of experimental evaluation. The results show that our novel approach achieves a greater accuracy and is more suitable for modeling modern email worms than previous models.

Responses to racism : a taxonomy of coping styles used by aboriginal Australians

The author takes up the challenge from social psychologists to explore the coping responses of those who experience racism. Previous attempts to provide taxonomies of responses to racism-discrimination-oppression are reviewed. An analysis of data derived from semistructured interviews conducted with 34 Indigenous Australians that explored experiences of racism and emotional and behavioral responses is reported, and a taxonomy of coping made up of 3 broad categories is presented. The defining feature of these categories is the purpose of the responses contained therein: to defend the self, to control or contain the reaction, or to confront the racism. It is argued that this may be a more useful way to understand responses to racism than taxonomies previously proposed.

Selected approaches and frameworks to carry out genomic data provision and analysis on the cloud

While High Performance Computing clouds allow researchers to process large amounts of genomic data, complex resource and software configuration tasks must be carried out beforehand. The current trend exposes applications and data as services, simplifying access to clouds. This paper examines commonly used cloud-based genomic analysis services, introduces the approach of exposing data as services and proposes two new solutions (HPCaaS and Uncinus) which aim to automate service development, deployment process and data provision. By comparing and contrasting these solutions, we identify key mechanisms of service creation, execution and data access required to support non-computing specialists employing clouds.

How calls from carers, friends and family members of someone affected by cancer differ from those made by people diagnosed with cancer; analysis of 4 years of South Australian Cancer Council Helpline data

PURPOSE: The purpose of this study is to determine how people diagnosed with cancer who call the Cancer Council Helpline in South Australia differ from carers/family/friends (caregivers) who call. METHOD: Descriptive, retrospective audit of calls from people who contacted Cancer Council Helpline in South Australia between 16 April 2009 and 16 April 2013 who were diagnosed with cancer (n&nbsp;=&nbsp;5766) or were the caregivers (n&nbsp;=&nbsp;5174) of a person with cancer. RESULTS: Caregivers were more likely to be female (p&nbsp;<&nbsp;0.001); younger in age (p&nbsp;<&nbsp;0.001); call regarding cancer that was metastasised/widespread/advanced, terminal or at an unknown stage (p&nbsp;<&nbsp;0.001) and phone requesting general cancer information or emotional support (p&nbsp;<&nbsp;0.001). This group was more distressed (p&nbsp;<&nbsp;0.001) but less likely (p&nbsp;=&nbsp;0.02) to be offered and/or accept referrals to counselling than people diagnosed with cancer who called. Follow-up care was required by 63.5&nbsp;% of caregivers and 73.1&nbsp;% of people with cancer according to distress management guidelines; 8.5 and 15.3&nbsp;%, respectively, accepted referrals to internal services. The most frequently discussed topic for both groups was emotional/psychological concerns. There were no differences in remoteness of residence or call length between groups. CONCLUSIONS: Caregivers represented different demographic groups than people diagnosed with cancer who called this helpline. The two groups phoned for different issues, at different stages of disease progression, displayed different levels of distress and, therefore, may benefit from services being tailored to meet their unique needs. These results also demonstrate the capacity of helplines to complement other health services and confirm that callers to cancer helplines exhibit high levels of distress.

Classification tree analysis of postal questionnaire data to identify risk of excessive gestational weight gain

OBJECTIVE: overweight/obese weight status during pregnancy increases risk of a range of adverse health outcomes for mother and child. Whereas identification of those who are overweight/obese pre-pregnancy and in early pregnancy is straightforward, prediction of who will experience excessive gestational weight gain (EGWG), and thus be at greater risk of becoming overweight or obese during pregnancy is more challenging. The present study sought to better identify those at risk of EGWG by exploring pre-pregnancy BMI as well as a range of psychosocial risk factors identified as risk factors in prior research. METHODS: 225 pregnant women completed self-reported via postal survey measures of height, weight, and psychosocial variables at 16-18 weeks gestation, and reported their weight again at 32-34 weeks to calculate GWG. Classification and regression tree analysis (CART) was used to find subgroups in the data with increased risk of EGWG based on their pre-pregnancy BMI and psychosocial risk factor scores at Time 1. FINDINGS: CART confirmed that self-reported BMI status was a strong predictor of EGWG risk for women who were overweight/obese pre-pregnancy. Normal weight women with low motivation to maintain a healthy diet and who reported lower levels of partner support were also at considerable risk of EGWG. IMPLICATIONS FOR PRACTICE: present findings offer support for inclusion of psychosocial measures (in addition to BMI) in early antenatal visits to detect risk of EGWG. However, these findings also underscore the need for further consideration of effect modifiers that place women at increased or decreased risk of EGWG. Proposed additional constructs are discussed to direct further theory-driven research.

Using digital data and bibliometric analysis for researching doctoral education

As more digital data become publicly available new opportunities for researchers in education are arising. Researchers may be unaware of the existence and usefulness of such data even though these are freely available. In this article the use of one such source of information is described and its potential for research into research education discussed. We sought to exploit the research potential of the existing, yet dispersed, collection of online Australian thesis records to inform their research into the development of the PhD in Australia. Having created a searchable and reliable database from the available records, bibliometric analyses enabled us to map knowledge production and research capability in institutional and disciplinary settings from 1949 to 2003 as indicated by PhD theses. This is in contrast to the more familiar use of data based on student load or completion rates, and complements that data by focusing on research output as opposed to student throughput.

Manual on application of molecular tools in aquaculture and inland fisheries management. Part I : laboratory protocols, data management and analysis

The aim of this manual is to provide a comprehensive practical tool for the generation and analysis of genetic data for subsequent application in aquatic resources management in relation to genetic stock identification in inland fisheries and aquaculture. The material only covers general background on genetics in relation to aquaculture and fisheries resource management, the techniques and relevant methods of data analysis that are commonly used to address questions relating to genetic resource characterisation and population genetic analyses. No attempt is made to include applications of genetic improvement techniques e.g. selective breeding or producing genetically modified organisms (GMOs). The manual includes two ‘stand-alone’ parts, of which this is the second volume: Part 1 &ndash; Conceptual basis of population genetic approaches: will provide a basic foundation on genetics in general, and concepts of population genetics. Issues on the choices of molecular markers and project design are also discussed. Part 2 &ndash; Laboratory protocols, data management and analysis: will provide step-by-step protocols of the most commonly used molecular genetic techniques utilised in population genetics and systematic studies. In addition, a brief discussion and explanation of how these data are managed and analysed is also included. This manual is expected to enable NACA member country personnel to be trained to undertake molecular genetic studies in their own institutions, and as such is aimed at middle and higher level technical grades. The manual can also provide useful teaching material for specialised advanced level university courses in the region and postgraduate students. The manual has gone through two development/improvement stages. The initial material was tested at a regional workshop and at the second stage feedback from participants was used to improve the contents.

Reconstructing the incidence of human immunodeficiency virus (HIV) in Hong Kong by using data from HIV positive tests and diagnoses of acquired immune deficiency syndrome

The human immunodeficiency virus&ndash;acquired immune deficiency syndrome (HIV&ndash;AIDS) epidemic in Hong Kong has been under surveillance in the form of voluntary reporting since 1984. However, there has been little discussion or research on the reconstruction of the HIV incidence curve. This paper is the first to use a modified back-projection method to estimate the incidence of HIV in Hong Kong on the basis of the number of positive HIV tests only. The model proposed has several advantages over the original back-projection method based on AIDS data only. First, not all HIV-infected individuals will develop AIDS by the time of analysis, but some of them may undertake an HIV test; therefore, the HIV data set contains more information than the AIDS data set. Second, the HIV diagnosis curve usually has a smoother pattern than the AIDS diagnosis curve, as it is not affected by redefinition of AIDS. Third, the time to positive HIV diagnosis is unlikely to be affected by treatment effects, as it is unlikely that an individual receives medication before the diagnosis of HIV. Fourth, the induction period from HIV infection to the first HIV positive test is usually shorter than the incubation period which is from HIV infection to diagnosis of AIDS. With a shorter induction period, more information becomes available for estimating the HIV incidence curve. Finally, this method requires the number of positive HIV diagnoses only, which is readily available from HIV&ndash;AIDS surveillance systems in many countries. It is estimated that, in Hong Kong, the cumulative number of HIV infections during the period 1979&ndash;2000 is about 2600, whereas an estimate based only on AIDS data seems to give an underestimate.

The Early Prevention of Obesity in CHildren (EPOCH) collaboration : an individual patient data prospective meta-analysis

Background
Efforts to prevent the development of overweight and obesity have increasingly focused early in the life course as we recognise that both metabolic and behavioural patterns are often established within the first few years of life. Randomised controlled trials (RCTs) of interventions are even more powerful when, with forethought, they are synthesised into an individual patient data (IPD) prospective meta-analysis (PMA). An IPD PMA is a unique research design where several trials are identified for inclusion in an analysis before any of the individual trial results become known and the data are provided for each randomised patient. This methodology minimises the publication and selection bias often associated with a retrospective meta-analysis by allowing hypotheses, analysis methods and selection criteria to be specified a priori.

Methods/Design
The Early Prevention of Obesity in CHildren (EPOCH) Collaboration was formed in 2009. The main objective of the EPOCH Collaboration is to determine if early intervention for childhood obesity impacts on body mass index (BMI) z scores at age 18-24 months. Additional research questions will focus on whether early intervention has an impact on children's dietary quality, TV viewing time, duration of breastfeeding and parenting styles. This protocol includes the hypotheses, inclusion criteria and outcome measures to be used in the IPD PMA. The sample size of the combined dataset at final outcome assessment (approximately 1800 infants) will allow greater precision when exploring differences in the effect of early intervention with respect to pre-specified participant- and intervention-level characteristics.

Discussion
Finalisation of the data collection procedures and analysis plans will be complete by the end of 2010. Data collection and analysis will occur during 2011-2012 and results should be available by 2013.

Can qualitative content analysis be adapted for use by social informaticians to study social media discourse? A position paper

IS research on social media (e.g. Facebook, Twitter, blogs) has so far used user surveys or quantitative content analysis (QuantCA) research methods almost exclusively. There is considerable potential for social informatics research to use qualitative content analysis (QualCA) to explore social media discourse and its appropriation by people “in situ”. This paper presents the position that QualCA offers researchers the flexibility to identify emergent research questions and units of analysis which they may not have preconceived. This is likely to be important for IS research because of the infancy and evolving nature of social media discourse. The paper puts forward suggestions on how the QualCA research method can be adapted for this type of research.