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).

Spirituality, religion, social support and health among older Australian adults

AIM: To examine the impact of perceived importance of spirituality or religion (ISR) and religious service attendance (RSA) on health and well-being in older Australians. METHODS: A cross-sectional survey of 752 community-dwelling men and women aged 55-85 years from the Hunter Region, New South Wales. RESULTS: Overall, 51% of participants felt spirituality or religion was important in their lives and 24% attended religious services at least 2-3 times a month. In univariate regression analyses, ISR and RSA were associated with increased levels of social support (P < 0.001). However, ISR was also associated with more comorbidities (incidence-rate ratio= 1.2, 95% confidence interval 1.08-1.33). There were no statistically significant associations between ISR or RSA and other measures such as mental and physical health. CONCLUSION: Spirituality and religious involvement have a beneficial impact on older Australians' perceptions of social support, and may enable individuals to better cope with the presence of multiple comorbidities later in life.

The health and economic benefits of reducing intimate partner violence: an Australian example.

BACKGROUND: Intimate partner violence (IPV) has important impacts on the health of women in society. Our aim was to estimate the health and economic benefits of reducing the prevalence of IPV in the 2008 Australian female adult population. METHODS: Simulation models were developed to show the effect of a 5 percentage point absolute feasible reduction target in the prevalence of IPV from current Australian levels (27%). IPV is not measured in national surveys. Levels of psychological distress were used as a proxy for exposure to IPV since psychological conditions represent three-quarters of the disease burden from IPV. Lifetime cohort health benefits for females were estimated as fewer incident cases of violence-related disease and injury; deaths; and Disability Adjusted Life Years (DALYs). Opportunity cost savings were estimated for the health sector, paid and unpaid production and leisure from reduced incidence of IPV-related disease and deaths. Workforce production gains were estimated by comparing surveyed participation and absenteeism rates of females with moderate psychological distress (lifetime IPV exposure) against high or very high distress (current IPV exposure), and valued using the friction cost approach (FCA). The impact of improved health status on unpaid household production and leisure time were modelled from time use survey data. Potential costs associated with interventions to reduce IPV were not considered. Multivariable uncertainty analyses and univariable sensitivity analyses were undertaken. RESULTS: A 5 percentage point absolute reduction in the lifetime prevalence of IPV in the 2008 Australian female population was estimated to produce 6000 fewer incident cases of disease/injury, 74 fewer deaths, 5000 fewer DALYs lost and provide gains of 926,000 working days, 371,000 days of home-based production and 428,000 leisure days. Overall, AUD371 million in opportunity cost savings could be achievable. The greatest economic savings would be home-based production (AUD147 million), followed by leisure time (AUD98 million), workforce production (AUD94 million) and reduced health sector costs (AUD38 million). CONCLUSIONS: This study contributes new knowledge about the economic impact of IPV in females. The findings provide evidence of large potential opportunity cost savings from reducing the prevalence of IPV and reinforce the need to reduce IPV in Australia, and elsewhere.

A longitudinal analysis of changes in job control and mental health

Deteriorating job control has been previously shown to predict poor mental health. The impact of improvement in job control on mental health is less well understood, yet it is of policy significance. We used fixed-effects longitudinal regression models to analyze 10 annual waves of data from a large Australian panel survey (2001-2010) to test within-person associations between change in self-reported job control and corresponding change in mental health as measured by the Mental Component Summary score of Short Form 36. We found evidence of a graded relationship; with each quintile increase in job control experienced by an individual, the person's mental health increased. The biggest improvement was a 1.55-point increase in mental health (95% confidence interval: 1.25, 1.84) for people moving from the lowest (worst) quintile of job control to the highest. Separate analyses of each of the component subscales of job control-decision authority and skill discretion-showed results consistent with those of the main analysis; both were significantly associated with mental health in the same direction, with a stronger association for decision authority. We conclude that as people's level of job control increased, so did their mental health, supporting the value of targeting improvements in job control through policy and practice interventions.

The health profile of people living with Parkinson's Disease managed in a comprehensive care setting

Background: Globally there are few reports of the impairments, disabilities and medications used in people living with idiopathic Parkinson’s disease. Caregiver characteristics and caregiver burden have seldom been reported. We examined the health status in a large cohort of people living with Parkinson’s disease and their caregivers managed in a comprehensive health care setting.

Methods/Design: A prospective, cross sectional analysis of impairments, disabilities and Parkinson’s disease medication use was conducted in a sample of 100 people with Parkinson’s disease rated I-IV on the modified Hoehn & Yahr scale. Participants were recruited from the Victorian Comprehensive Parkinson Program in Melbourne, Australia. Their caregivers were invited to provide their views on the burden of care, services provided and support received.

Results: The severity of impairments and disabilities was strongly associated with disease duration (mean of 5.5 years). Those with long standing disease or more severe disease also used more Parkinson’s disease medications and participated in fewer social roles than people who were newly diagnosed or mildly affected. The severity of impairments was strongly correlated with limitations in performing activities of daily living. Limitations in performing daily activities were also found to be a significant contributing factor for health-related quality of life (PDQ-39 SI β=0.55, p=0.000; EQ-5D SI β=0.43, p=0.001). People with Parkinson’s disease lived at home with relatives. The average caregiver was a spouse or child providing approximately 3.5 hours of care per day, with the capacity to provide 9.4 hours per day and had provided care for four years. Additional support was high (63%) for 2.5 hours per day.

Conclusion: The comprehensive care setting of this cohort describes a relatively benign condition despite a wide range of disease duration and severity. This report provides a baseline with which to compare other delivery models.

Views of women and health professionals on mHealth lifestyle interventions in pregnancy: a qualitative investigation

BACKGROUND: Evidence suggests that women are failing to meet guidelines for nutrition, physical activity, and weight gain during pregnancy. Interventions to promote a healthy lifestyle in pregnancy demonstrate mixed results and many are time and resource intensive. mHealth-delivered interventions offer an opportunity to provide trusted source information in a timely and cost-effective manner. Studies regarding women's and health professionals' views of mHealth in antenatal care are limited.

OBJECTIVE: This study aimed to explore women's and health professionals' views regarding mHealth information sources and interventions to assist women to eat well, be physically active, and gain healthy amounts of weight in pregnancy.

METHODS: A descriptive qualitative research approach employed focus groups and in-depth interviews with 15 pregnant or postpartum women and 12 in-depth interviews with health professionals including two from each category: obstetricians, general practitioners, midwives, dietitians, physiotherapists, and community pharmacists. All interviews were transcribed verbatim and thematically analyzed.

RESULTS: Women uniformly embraced the concept of mHealth information sources and interventions in antenatal care and saw them as central to information acquisition and ideally incorporated into future antenatal care processes. Health professionals exhibited varied views perceiving mHealth as an inevitable, often parallel, service rather than one integrated into the care model. Four key themes emerged: engagement, risk perception, responsibility, and functionality. Women saw their ability to access mHealth elements as a way to self-manage or control information acquisition that was unavailable in traditional care models and information sources. The emergence of technology was perceived by some health professionals to have shifted control of information from trusted sources, such as health professionals and health organizations, to nontrusted sources. Some health professionals were concerned about the medicolegal risks of mHealth (incorrect or harmful information and privacy concerns), while others acknowledged that mHealth was feasible if inherent risks were addressed. Across both groups, there was uncertainty as to who should be responsible for ensuring high-quality mHealth. The absence of a key pregnancy or women's advocacy group, lack of health funds for technologies, and the perceived inability of maternity hospitals to embrace technology were seen to be key barriers to provision. Women consistently identified the functionality of mHealth as adding value to antenatal care models. For some health professionals, lack of familiarity with and fear of mHealth limited their engagement with and comprehension of the capacity of new technologies to support antenatal care.

CONCLUSIONS: Women exhibited positive views regarding mHealth for the promotion of a healthy lifestyle in antenatal care. Conversely, health professionals expressed a much wider variation in attitudes and were more able to identify potential risks and barriers to development and implementation. This study contributes to the understanding of the opportunities and challenges in developing mHealth lifestyle interventions in antenatal care.

The essential role of social theory in qualitative public health research

OBJECTIVE: To define the role of social theory and examine how research studies using qualitative methods can use social theory to generalize their results beyond the setting of the study or to other social groups. APPROACH: The assumptions underlying public health research using qualitative methods derive from a range of social theories that include conflict theory, structural functionalism, symbolic interactionism, the sociology of knowledge and feminism. Depending on the research problem, these and other social theories provide conceptual tools and models for constructing a suitable research framework, and for collecting and analysing data. In combination with the substantive health literature, the theoretical literature provides the conceptual bridge that links the conclusions of the study to other social groups and settings. CONCLUSION: While descriptive studies using qualitative research methods can generate important insights into social experience, the use of social theory in the construction and conduct of research enables researchers to extrapolate their findings to settings and groups broader than the ones in which the research was conducted.

Mental health following acquisition of disability in adulthood-the impact of wealth

BACKGROUND: Acquisition of a disability in adulthood has been associated with a reduction in mental health. We tested the hypothesis that low wealth prior to disability acquisition is associated with a greater deterioration in mental health than for people with high wealth. METHODS: We assess whether level of wealth prior to disability acquisition modifies this association using 12 waves of data (2001-2012) from the Household, Income and Labour Dynamics in Australia survey-a population-based cohort study of working-age Australians. Eligible participants reported at least two consecutive waves of disability preceded by at least two consecutive waves without disability (1977 participants, 13,518 observations). Fixed-effects linear regression was conducted with a product term between wealth prior to disability (in tertiles) and disability acquisition with the mental health component score of the SF-36 as the outcome. RESULTS: In models adjusted for time-varying confounders, there was evidence of negative effect measure modification by prior wealth of the association between disability acquisition and mental health (interaction term for lowest wealth tertile: -2.2 points, 95% CI -3.1 points, -1.2, p<0.001); low wealth was associated with a greater decline in mental health following disability acquisition (-3.3 points, 95% CI -4.0, -2.5) than high wealth (-1.1 points, 95% CI -1.7, -0.5). CONCLUSION: The findings suggest that low wealth prior to disability acquisition in adulthood results in a greater deterioration in mental health than among those with high wealth.

What is needed to make research on the psychosocial work environment and health more meaningful? Reflections and missed opportunities in IPD debates

We identify issues that have been overlooked in the debates about the work of the IPD-Work Consortium. These include the need for objective cut-points for psychosocial work stress exposures and better conceptual models of how psychosocial work exposures, health behaviors, obesity, and enduring health conditions are related.

Perspectives of clinical handover processes: a multi-site survey across different health professionals

AIMS AND OBJECTIVES: To examine the perspectives of health professionals of different disciplines about clinical handover. BACKGROUND: Ineffective handovers can cause major problems relating to the lack of delivery of appropriate care. DESIGN: A prospective, cross-sectional design was conducted using a survey about clinical handover practices. METHODS: Health professionals employed in public metropolitan hospitals, public rural hospitals and community health centres were involved. The sample comprised doctors, nurses and allied health professionals, including physiotherapists, social workers, pharmacists, dieticians and midwives employed in Western Australia, New South Wales, South Australia and the Australian Capital Territory. The survey sought information about health professionals' experiences about clinical handover; their perceived effectiveness of clinical handover; involvement of patients and family members; health professionals' ability to confirm understanding and to clarify clinical information; role modelling behaviour of health professionals; training needs; adverse events encountered and possibilities for improvements. RESULTS: In all, 707 health professionals participated (response rate = 14%). Represented professions were nursing (60%), medicine (22%) and allied health (18%). Many health professionals reported being aware of adverse events where they noticed poor handover was a significant cause. Differences existed between health professions in terms of how effectively they gave handover, perceived effectiveness of bedside handover vs. nonbedside handover, patient and family involvement in handover, respondents' confirmation of understanding handover from their perspective, their observation of senior health professionals giving feedback to junior health professionals, awareness of adverse events and severity of adverse events relating to poor handovers. CONCLUSIONS: Complex barriers impeded the conduct of effective handovers, including insufficient opportunities for training, lack of role modelling, and lack of confidence and understanding about handover processes. RELEVANCE TO CLINICAL PRACTICE: Greater focus should be placed on creating opportunities for senior health professionals to act as role models. Sophisticated approaches should be implemented in training and education.

Individual, occupational, and workplace correlates of occupational health and safety vulnerability in a sample of Canadian workers

Objective: To describe OH&S vulnerability across a diverse sample of Canadian workers.
Methods: A survey was administered to 1,835 workers employed more than 15 hrs/week in workplaces with at least five employees. Adjusted logistic models were fitted for three specific and one overall measure of workplace vulnerability developed based on hazard exposure and access to protective OH&S policies and procedures, awareness of employment rights and responsibilities, and workplace empowerment.
Results: More than one third of the sample experienced some OH&S vulnerability. The type and magnitude of vulnerability varied by labor market sub-group. Younger workers and those in smaller workplaces experienced signficantly higher odds of multiple types of vulnerability. Temporary workers reported elevated odds of overall, awareness- and empowerment-related vulnerability, while respondents born outside of Canada had significantly higher odds of awareness vulnerability.
Conclusion: Knowing how labor market sub-groups experience different types of vulnerability can inform better-tailored primary prevention interventions.

Is being childless detrimental to a woman's health and well-being across her life course?

BACKGROUND: Childlessness is a growing phenomenon. Previous research examining health and well-being differentials between women with and without children has produced conflicting results. Most of this research has been conducted in the United States or parts of Europe. There has been limited research in Australia that has examined the health and well-being of women with and without children across the life course. The aim of the current study was to examine the association between motherhood status and general physical and mental health and well-being over a 10-year time period. METHODS: Using 10 waves of data from the Household, Income and Labour Dynamics in Australia study, longitudinal linear mixed models with time varying variables (both dependent and independent) were constructed to assess the effect of childlessness on health and well-being based on the Short Form-36 Health Survey Version 1 (n=52,381 observations). FINDINGS: Findings suggest that childless women experience poorer physical and mental health and well-being during the peak reproductive years; however, this trend is reversed for women aged 65 years or more. Although never-married, childless women experienced better health and well-being compared with mothers, this was not the case for childless women who were divorced, separated, or widowed or in a relationship. CONCLUSION: The findings support the notion that whether or not a woman has children does have consequences for her health and well-being; however, this differs across the life course.

A path model of psychosocial and health behaviour change predictors of excessive gestational weight gain

This study aimed to evaluate a conceptual model of psychosocial, behaviour change, and behavioural predictors of excessive gestational weight gain (GWG). Background: Excessive GWG can place women and their babies at risk of poor health outcomes, including obesity. Models of psychosocial and behaviour change predictors of excessive GWG have not been extensively explored; understanding the mechanisms leading to excess GWG will provide crucial evidence towards the development of effective interventions. Method: Two hundred and eighty-eight pregnant women (≤18 weeks gestation) were recruited to a prospective study. Demographic, psychosocial, health behaviour change, and behavioural factors were assessed at 17 (Time 1, T1) and 33 weeks (Time 2, T2) gestation. Pre-pregnancy and final pregnancy weight were obtained and women were classified with/without excessive GWG. Logistic regressions refined the list of predictors of excessive GWG; variables with p < .1 were included in a path analysis. Results: Age, family income, T2 depression, T2 pregnancy-specific coping, T1 buttocks dissatisfaction, T2 GWG-specific self-efficacy, T1 dietary readiness, T1 dietary importance, and T1 vegetable intake predicted excessive GWG in the logistic regressions and were included in the path model. The baseline path model demonstrated poor fit. Once statistically and theoretically plausible paths were added, adequate model fit was achieved (χ² = 21.61(9), p < .05; RMSEA = .07; CFI = .93); this revised model explained 19.5% of the variance in excessive GWG. Women with high T1 buttocks dissatisfaction were more likely to exhibit low levels of dietary readiness. Women with low dietary readiness were more likely to have a lower vegetable intake, which predicted excessive GWG. Women with higher T2 depressive symptoms were more likely to report lower GWG self-efficacy and gain excessively. Conclusion: Future behavioural GWG trials should consider combining psychosocial and health behaviour change factors to optimise GWG.

Assessing mediators between discrimination, health behaviours and physical health outcomes: a representative cross-sectional study

PURPOSE: Discrimination is a social determinant of health; however, the pathways linking discrimination to ill-health are under-researched. This study investigated the mediators through which discrimination affects health behaviours and physical health outcomes, as well as assessed whether sex moderated these mechanisms. METHODS: Data from a representative survey (n = 1023) of undergraduate students enrolled in a Brazilian university in 2012 were used. Structural equation models were applied to assess the following mediation mechanisms--(1) discrimination influences self-rated health and body mass index via anxiety/depression; (2) discrimination affects behaviours (alcohol consumption, problem drinking, smoking, fruit/vegetable consumption, and physical activity) through discomfort associated with discriminatory experiences. The potential of sex to act as an effect-modifying variable was also explored in each of the postulated pathways. RESULTS: The effect of discrimination on self-rated poor health was totally (100.0%) mediated by anxiety/depression, while body mass index was not correlated with discrimination. Self-reported discrimination was associated with some behaviours via discomfort. Particularly, discomfort partially mediated the positive association between discrimination, leisure time physical activity (43.3%), and fruit/vegetable consumption (52.2%). Sex modified the association between discrimination, discomfort and physical activity in that such mechanism (more discrimination → more discomfort → more physical activity) was statistically significant in the entire sample and among females, but not among males. CONCLUSIONS: This is one of the first studies to demonstrate that discrimination is associated with physical health outcomes and behaviours via distinct pathways. Future investigations should further explicate the mediational pathways between discrimination and key health outcomes.

Effect of nativity and duration of residence on chronic health conditions among Asian immigrants in Australia: a longitudinal investigation

This study examined the effect of Asian nativity and duration of residence in Australia on the odds of reporting a chronic health condition (cancer, respiratory problems, cardiovascular disease (CVD) and diabetes mellitus). Data were from waves 3, 7 and 9 of the Household Income and Labour Dynamics in Australia (HILDA) longitudinal survey, and multi-level group-mean-centred logistic regression models were used for the analysis. After covariate adjustment, Asian immigrants were less likely to report cancer and respiratory problem compared with native-born Australians. While there was no significant difference in reporting CVD, they were more likely to report diabetes than native-born people. Asian immigrants maintained their health advantage with respect to cancer regardless of duration of residence. However, after 20 years of stay, Asian immigrants lost their earlier advantage and were not significantly different from native-born people in terms of reporting a respiratory problem. In contrast, Asian immigrants were not measurably different from native-born Australians in reporting diabetes if their length of stay in Australia was less than 20 years, but became disadvantaged after staying for 20 years or longer. There was no measurable difference in the odds of reporting CVD between Asian immigrants and native-born Australians for any duration of residence. On the whole this study found that health advantage, existence of healthy immigrant effect and subsequent erosion of it with increasing duration of residence among Asian immigrants depends upon the chronic health condition.