Basic versus biofeedback-mediated intensive pelvic floor muscle training for women with urinary incontinence: the OPAL RCT.

BACKGROUND: Urinary incontinence affects one in three women worldwide. Pelvic floor muscle training is an effective treatment. Electromyography biofeedback (providing visual or auditory feedback of internal muscle movement) is an adjunct that may improve outcomes. OBJECTIVES: To determine the clinical effectiveness and cost-effectiveness of biofeedback-mediated intensive pelvic floor muscle training (biofeedback pelvic floor muscle training) compared with basic pelvic floor muscle training for treating female stress urinary incontinence or mixed urinary incontinence. DESIGN: A multicentre, parallel-group randomised controlled trial of the clinical effectiveness and cost-effectiveness of biofeedback pelvic floor muscle training compared with basic pelvic floor muscle training, with a mixed-methods process evaluation and a longitudinal qualitative case study. Group allocation was by web-based application, with minimisation by urinary incontinence type, centre, age and baseline urinary incontinence severity. Participants, therapy providers and researchers were not blinded to group allocation. Six-month pelvic floor muscle assessments were conducted by a blinded assessor. SETTING: This trial was set in UK community and outpatient care settings. PARTICIPANTS: Women aged ≥ 18 years, with new stress urinary incontinence or mixed urinary incontinence. The following women were excluded: those with urgency urinary incontinence alone, those who had received formal instruction in pelvic floor muscle training in the previous year, those unable to contract their pelvic floor muscles, those pregnant or < 6 months postnatal, those with prolapse greater than stage II, those currently having treatment for pelvic cancer, those with cognitive impairment affecting capacity to give informed consent, those with neurological disease, those with a known nickel allergy or sensitivity and those currently participating in other research relating to their urinary incontinence. INTERVENTIONS: Both groups were offered six appointments over 16 weeks to receive biofeedback pelvic floor muscle training or basic pelvic floor muscle training. Home biofeedback units were provided to the biofeedback pelvic floor muscle training group. Behaviour change techniques were built in to both interventions. MAIN OUTCOME MEASURES: The primary outcome was urinary incontinence severity at 24 months (measured using the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form score, range 0-21, with a higher score indicating greater severity). The secondary outcomes were urinary incontinence cure/improvement, other urinary and pelvic floor symptoms, urinary incontinence-specific quality of life, self-efficacy for pelvic floor muscle training, global impression of improvement in urinary incontinence, adherence to the exercise, uptake of other urinary incontinence treatment and pelvic floor muscle function. The primary health economic outcome was incremental cost per quality-adjusted-life-year gained at 24 months. RESULTS: A total of 300 participants were randomised per group. The primary analysis included 225 and 235 participants (biofeedback and basic pelvic floor muscle training, respectively). The mean 24-month International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form score was 8.2 (standard deviation 5.1) for biofeedback pelvic floor muscle training and 8.5 (standard deviation 4.9) for basic pelvic floor muscle training (adjusted mean difference -0.09, 95% confidence interval -0.92 to 0.75; p = 0.84). A total of 48 participants had a non-serious adverse event (34 in the biofeedback pelvic floor muscle training group and 14 in the basic pelvic floor muscle training group), of whom 23 (21 in the biofeedback pelvic floor muscle training group and 2 in the basic pelvic floor muscle training group) had an event related/possibly related to the interventions. In addition, there were eight serious adverse events (six in the biofeedback pelvic floor muscle training group and two in the basic pelvic floor muscle training group), all unrelated to the interventions. At 24 months, biofeedback pelvic floor muscle training was not significantly more expensive than basic pelvic floor muscle training, but neither was it associated with significantly more quality-adjusted life-years. The probability that biofeedback pelvic floor muscle training would be cost-effective was 48% at a £20,000 willingness to pay for a quality-adjusted life-year threshold. The process evaluation confirmed that the biofeedback pelvic floor muscle training group received an intensified intervention and both groups received basic pelvic floor muscle training core components. Women were positive about both interventions, adherence to both interventions was similar and both interventions were facilitated by desire to improve their urinary incontinence and hindered by lack of time. LIMITATIONS: Women unable to contract their muscles were excluded, as biofeedback is recommended for these women. CONCLUSIONS: There was no evidence of a difference between biofeedback pelvic floor muscle training and basic pelvic floor muscle training. FUTURE WORK: Research should investigate other ways to intensify pelvic floor muscle training to improve continence outcomes. TRIAL REGISTRATION: Current Controlled Trial ISRCTN57746448. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 70. See the NIHR Journals Library website for further project information.

Urinary incontinence (accidental leakage of urine) is a common and embarrassing problem for women. Pregnancy and childbirth may contribute by leading to less muscle support and bladder control. Pelvic floor exercises and 'biofeedback' equipment (a device that lets women see the muscles working as they exercise) are often used in treatment. There is good evidence that exercises (for the pelvic floor) can help, but less evidence about whether or not adding biofeedback provides better results. This trial compared pelvic floor exercises alone with pelvic floor exercises plus biofeedback. Six hundred women with urinary incontinence participated. Three hundred women were randomly assigned to the exercise group and 300 women were randomised to the exercise plus biofeedback group. Each woman had an equal chance of being in either group. Women were offered six appointments with a therapist over 16 weeks to receive their allocated treatment. After 2 years, there was no difference between the groups in the severity of women's urinary incontinence. Women in both groups varied in how much exercise they managed to do. Some managed to exercise consistently over the 2 years and others less so. There were many factors (other than the treatment received) that affected a woman's ability to exercise. Notably, women viewed the therapists' input very positively. The therapists reported some problems fitting biofeedback into the appointments, but, overall, they delivered both treatments as intended. Women carried out exercises at home and many in the biofeedback pelvic floor muscle training group also used biofeedback at home; however, for both groups, time issues, forgetting and other health problems affected their adherence. There were no serious complications related to either treatment. Overall, exercise plus biofeedback was not significantly more expensive than exercise alone and the quality of life associated with exercise plus biofeedback was not better than the quality of life for exercise alone. In summary, exercises plus biofeedback was no better than exercise alone. The findings do not support using biofeedback routinely as part of pelvic floor exercise treatment for women with urinary incontinence.

Are changes in depressive symptoms, general health and residential area socio-economic status associated with trajectories of waist circumference and body mass index?

OBJECTIVE: This study sought to assess whether changes in depressive symptoms, general health, and area-level socio-economic status (SES) were associated to changes over time in waist circumference and body mass index (BMI). METHODS: A total of 2871 adults (18 years or older), living in Adelaide (South Australia), were observed across three waves of data collection spanning ten years, with clinical measures of waist circumference, height and weight. Participants completed the Centre for Epidemiologic Studies Depression (CES-D) and Short Form 36 health questionnaires (SF-36 general health domain). An area-level SES measure, relative location factor, was derived from hedonic regression models using residential property features but blind to location. Growth curve models with latent variables were fitted to data. RESULTS: Waist circumference, BMI and depressive symptoms increased over time. General health and relative location factor decreased. Worsening general health and depressive symptoms predicted worsening waist circumference and BMI trajectories in covariate-adjusted models. Diminishing relative location factor was negatively associated with waist circumference and BMI trajectories in unadjusted models only. CONCLUSIONS: Worsening depressive symptoms and general health predict increasing adiposity and suggest the development of unhealthful adiposity might be prevented by attention to negative changes in mental health and overall general health.

Assessing Heavy Episodic Drinking: A Random Survey of 18 to 34-Year-Olds in Four Cities in Four Different Continents.

BACKGROUND: Heavy episodic drinking (HED) can have health and social consequences. This study assesses the associations between HED and demographic, socioeconomic, motivation and effects indicators for people aged 18⁻34 years old living in four cities in different regions of the world. METHOD: Multistage random sampling was consistent across the four cities (Ilorin (Nigeria), Wuhan (China), Montevideo (Uruguay) and Moscow (Russia)). The questionnaire was forward/back translated and face-to-face interviewing was undertaken. A total of 6235 interviews were undertaken in 2014. Separate univariable and multivariable modelling was undertaken to determine the best predictors of HED. RESULTS: HED prevalence was 9.0%. The best predictors differed for each city. The higher probability of HED in the final models included beliefs that they have reached adulthood, feeling relaxed as an effect of drinking alcohol, and forgetting problems as an effect of drinking alcohol. Lower probability of HED was associated with not being interested in alcohol as a reason for limiting alcohol, and the belief that drinking alcohol is too expensive or a waste of money. CONCLUSION: Although some indicators were common across the four cities, the variables included in the final models predominantly differed from city to city. The need for country-specific prevention and early intervention programs are warranted.

Effectiveness and cost-effectiveness randomised controlled trial of basic versus biofeedback-mediated intensive pelvic floor muscle training for female stress or mixed urinary incontinence: protocol for the OPAL (optimising pelvic floor exercises to achieve long-term benefits) trial mixed methods longitudinal qualitative case study and process evaluation.

INTRODUCTION: Female urinary incontinence (UI) is common affecting up to 45% of women. Pelvic floor muscle training (PFMT) is the first-line treatment but there is uncertainty whether intensive PFMT is better than basic PFMT for long-term symptomatic improvement. It is also unclear which factors influence women's ability to perform PFMT long term and whether this has impacts on long-term outcomes. OPAL (optimising PFMT to achieve long-term benefits) trial examines the effectiveness and cost-effectiveness of basic PFMT versus biofeedback-mediated PFMT and this evaluation explores women's experiences of treatment and the factors which influence effectiveness. This will provide data aiding interpretation of the trial findings; make recommendations for optimising the treatment protocol; support implementation in practice; and address gaps in the literature around long-term adherence to PFMT for women with stress or mixed UI. METHODS AND ANALYSIS: This evaluation comprises a longitudinal qualitative case study and process evaluation (PE). The case study aims to explore women's experiences of treatment and adherence and the PE will explore factors influencing intervention effectiveness. The case study has a two-tailed design and will recruit 40 women, 20 from each trial group; they will be interviewed four times over 2 years. Process data will be collected from women through questionnaires at four time-points, from health professionals through checklists and interviews and by sampling 100 audio recordings of appointments. Qualitative analysis will use case study methodology (qualitative study) and the framework technique (PE) and will interrogate for similarities and differences between the trial groups regarding barriers and facilitators to adherence. Process data analyses will examine fidelity, engagement and mediating factors using descriptive and interpretative statistics. ETHICS AND DISSEMINATION: Approval from West of Scotland Research Ethics Committee 4 (16/LO/0990). Findings will be published in journals, disseminated at conferences and through the final report. TRIAL REGISTRATION NUMBER: ISRCTN57746448.

The burden of pancreatic cancer in Australia attributable to smoking.

OBJECTIVE: To estimate the burden of pancreatic cancer in Australia attributable to modifiable exposures, particularly smoking. DESIGN: Prospective pooled cohort study. SETTING, PARTICIPANTS: Seven prospective Australian study cohorts (total sample size, 365 084 adults); participant data linked to national registries to identify cases of pancreatic cancer and deaths. MAIN OUTCOME MEASURES: Associations between exposures and incidence of pancreatic cancer, estimated in a proportional hazards model, adjusted for age, sex, study, and other exposures; future burden of pancreatic cancer avoidable by changes in exposure estimated as population attributable fractions (PAFs) for whole population and for specific population subgroups with a method accounting for competing risk of death. RESULTS: There were 604 incident cases of pancreatic cancer during the first 10 years of follow-up. Current and recent smoking explained 21.7% (95% CI, 13.8-28.9%) and current smoking alone explained 15.3% (95% CI, 8.6-22.6%) of future pancreatic cancer burden. This proportion of the burden would be avoidable over 25 years were current smokers to quit and there were no new smokers. The burden attributable to current smoking is greater for men (23.9%; 95% CI, 13.3-33.3%) than for women (7.2%; 95% CI, -0.4% to 14.2%; P = 0.007) and for those under 65 (19.0%; 95% CI, 8.1-28.6%) than for older people (6.6%; 95% CI, 1.9-11.1%; P = 0.030). There were no independent relationships between body mass index or alcohol consumption and pancreatic cancer. CONCLUSIONS: Strategies that reduce the uptake of smoking and encourage current smokers to quit could substantially reduce the future incidence of pancreatic cancer in Australia, particularly among men.

Increasing gaps in health inequalities related to non-communicable diseases in South Australia; implications towards behavioural risk factor surveillance systems to provide evidence for action.

BACKGROUND: Although Australia is a country cited as having generally low health inequalities among different socioeconomic groups, inequalities have persisted. The aim of this analysis was to highlight how inequalities have evolved over a 13 years period in South Australia (SA). METHODS: Since 2002, over 600 interviews per month have been undertaken with SA residents through a computer assisted telephone survey method (total 77,000+). Major risk factors and chronic diseases have been analyzed providing trends by two socio-economic variables: education and a proxy of income (ability to save). RESULTS: While income and educational gaps are reducing over time in SA, those that remain in the lower socio-economic groups have a generally higher prevalence of risk factors and chronic diseases. The health disparity gap is still relevant, although at a different extent, for all the variables considered in our study, with most appearing to be stable if not increasing over time. CONCLUSIONS: Surveillance can be a good source of information both to show the evolution of problems and to evaluate possible future interventions. Extensive effort is still required to "close the gap" of health inequalities in SA. More precisely targeted and properly implemented interventions are needed.

Burden and trend of diet-related non-communicable diseases in Australia and comparison with 34 OECD countries, 1990-2015: findings from the Global Burden of Disease Study 2015.

BACKGROUND: Diet is a major determining factor for many non-communicable chronic diseases (NCDs). However, evidence on diet-related NCD burden remains limited. We assessed the trends in diet-related NCDs in Australia from 1990 to 2015 and compared the results with other countries of the Organization for Economic Co-operation and Development (OECD). METHODS: We used data and methods from the Global Burden of Disease (GBD) 2015 study to estimate the NCD mortality and disability-adjusted life years (DALYs) attributable to 14 dietary risk factors in Australia and 34 OECD nations. Countries were further ranked from the lowest (first) to highest (35th) burden using an age-standardized population attributable fraction (PAF). RESULTS: In 2015, the estimated number of deaths attributable to dietary risks was 29,414 deaths [95% uncertainty interval (UI) 24,697 - 34,058 or 19.7% of NCD deaths] and 443,385 DALYs (95% UI 377,680-511,388 or 9.5% of NCD DALYs) in Australia. Young (25-49 years) and middle-age (50-69 years) male adults had a higher PAF of diet-related NCD deaths and DALYs than their female counterparts. Diets low in fruits, vegetables, nuts and seeds and whole grains, but high in sodium, were the major contributors to both NCD deaths and DALYs. Overall, 42.3% of cardiovascular deaths were attributable to dietary risk factors. The age-standardized PAF of diet-related NCD mortality and DALYs decreased over the study period by 28.2% (from 27.0% in 1990 to 19.4% in 2015) and 41.0% (from 14.3% in 1990 to 8.4% in 2015), respectively. In 2015, Australia ranked 12th of 35 examined countries in diet-related mortality. A small improvement of rank was recorded compared to the previous 25 years. CONCLUSIONS: Despite a reduction in diet-related NCD burden over 25 years, dietary risks are still the major contributors to a high burden of NCDs in Australia. Interventions targeting NCDs should focus on dietary behaviours of individuals and population groups.

Trends of mortality attributable to child and maternal undernutrition, overweight/obesity and dietary risk factors of non-communicable diseases in sub-Saharan Africa, 1990-2015: findings from the Global Burden of Disease Study 2015.

OBJECTIVE: To assess trends of mortality attributable to child and maternal undernutrition (CMU), overweight/obesity and dietary risks of non-communicable diseases (NCD) in sub-Saharan Africa (SSA) using data from the Global Burden of Disease (GBD) Study 2015. DESIGN: For each risk factor, a systematic review of data was used to compute the exposure level and the effect size. A Bayesian hierarchical meta-regression analysis was used to estimate the exposure level of the risk factors by age, sex, geography and year. The burden of all-cause mortality attributable to CMU, fourteen dietary risk factors (eight diets, five nutrients and fibre intake) and overweight/obesity was estimated. SETTING: Sub-Saharan Africa.ParticipantsAll age groups and both sexes. RESULTS: In 2015, CMU, overweight/obesity and dietary risks of NCD accounted for 826204 (95 % uncertainty interval (UI) 737346, 923789), 266768 (95 % UI 189051, 353096) and 558578 (95 % UI 453433, 680197) deaths, respectively, representing 10·3 % (95 % UI 9·1, 11·6 %), 3·3 % (95 % UI 2·4, 4·4 %) and 7·0 % (95 % UI 5·8, 8·3 %) of all-cause mortality. While the age-standardized proportion of all-cause mortality accounted for by CMU decreased by 55·2 % between 1990 and 2015 in SSA, it increased by 63·3 and 17·2 % for overweight/obesity and dietary risks of NCD, respectively. CONCLUSIONS: The increasing burden of diet- and obesity-related diseases and the reduction of mortality attributable to CMU indicate that SSA is undergoing a rapid nutritional transition. To tackle the impact in SSA, interventions and international development agendas should also target dietary risks associated with NCD and overweight/obesity.

The future burden of lung cancer attributable to current modifiable behaviours: a pooled study of seven Australian cohorts.

Background: Knowledge of preventable disease and differences in disease burden can inform public health action to improve health and health equity. We quantified the future lung cancer burden preventable by behavioural modifications across Australia. Methods: We pooled seven Australian cohort studies (n = 367 058) and linked them to national registries to identify lung cancers and deaths. We estimated population attributable fractions and their 95% confidence intervals (CIs) for modifiable risk factors, using risk estimates from the cohort data and risk factor exposure distribution from contemporary national health surveys. Results: During the first 10-year follow-up, there were 2025 incident lung cancers and 20 349 deaths. Stopping current smoking could prevent 53.7% (95% CI, 50.0-57.2%) of lung cancers over 40 years and 18.3% (11.0-25.1%) in 10 years. The smoking-attributable burden is highest in males, those who smoke <20 cigarettes per day, are <75 years of age, unmarried, of lower educational attainment, live in remote areas or are healthy weight. Increasing physical activity and fruit consumption, if causal, could prevent 15.6% (6.9-23.4%) and 7.5% (1.3-13.3%) of the lung cancer burden, respectively. Jointly, the three behaviour modifications could prevent up to 63.0% (58.0-67.5%) of lung cancers in 40 years, and 31.2% (20.9-40.1%) or 43 300 cancers in 10 years. The preventable burden is highest among those with multiple risk factors. Conclusions: Smoking remains responsible for the highest burden of lung cancer in Australia. The uneven burden distribution distinguishes subgroups that could benefit the most from activities to control the world's deadliest cancer.

Frailty and usage of health care systems: Results from the South Australian Monitoring and Surveillance System (SAMSS).

OBJECTIVES: Little is known about frailty and its impact on health-care systems. Using large-scale population health surveillance data, this study determined the prevalence of frailty, its associated factors, and the impact it places on health care services. STUDY DESIGN: A cross-sectional snapshot of the 2013-2015 South Australian Monitoring and Surveillance System (SAMSS) database was used, focusing on individuals aged ≥65years. Frailty was assessed by the Frailty Index (FI), and classified as robust (scores≤0.1), pre-frail (>0.1 to ≤0.25), and frail (>0.25). RESULTS: 7207 people (53.7% female) were included; mean (SD) age was 74.8 (7.17) years. The mean (SD) FI score was 0.23 (0.11), with a 99% upper limit of 0.53. Over a third (36.3% (95% CI 34.8-37.9)) were classified as frail and over half (53.6% (95% CI 52.0-55.1)) as pre-frail. Frailty was less common in rural areas, and was associated with age, lower education level, and higher socioeconomic disadvantage. After adjustment for confounders, multivariable analyses showed a gradient effect by frailty classification with regard to both hospital- and non-hospital-based services. Frail older adults were more likely to present to hospital Emergency Departments (EDs) than their pre-frail or robust counterparts, yet visited the GP at the same rate as older adults with pre-frailty. CONCLUSION: Frail older adults were higher users of health care services, with the exception of GPs. Knowledge of the health service usage patterns of frail older adults can be used to direct public health policy and plan future GP provision.

The burden of cancer attributable to modifiable risk factors: the Australian cancer-PAF cohort consortium.

PURPOSE: To estimate the Australian cancer burden attributable to lifestyle-related risk factors and their combinations using a novel population attributable fraction (PAF) method that accounts for competing risk of death, risk factor interdependence and statistical uncertainty. PARTICIPANTS: 365 173 adults from seven Australian cohort studies. We linked pooled harmonised individual participant cohort data with population-based cancer and death registries to estimate exposure-cancer and exposure-death associations. Current Australian exposure prevalence was estimated from representative external sources. To illustrate the utility of the new PAF method, we calculated fractions of cancers causally related to body fatness or both tobacco and alcohol consumption avoidable in the next 10 years by risk factor modifications, comparing them with fractions produced by traditional PAF methods. FINDINGS TO DATE: Over 10 years of follow-up, we observed 27 483 incident cancers and 22 078 deaths. Of cancers related to body fatness (n=9258), 13% (95% CI 11% to 16%) could be avoided if those currently overweight or obese had body mass index of 18.5-24.9 kg/m2. Of cancers causally related to both tobacco and alcohol (n=4283), current or former smoking explains 13% (11% to 16%) and consuming more than two alcoholic drinks per day explains 6% (5% to 8%). The two factors combined explain 16% (13% to 19%): 26% (21% to 30%) in men and 8% (4% to 11%) in women. Corresponding estimates using the traditional PAF method were 20%, 31% and 10%. Our PAF estimates translate to 74 000 avoidable body fatness-related cancers and 40 000 avoidable tobacco- and alcohol-related cancers in Australia over the next 10 years (2017-2026). Traditional PAF methods not accounting for competing risk of death and interdependence of risk factors may overestimate PAFs and avoidable cancers. FUTURE PLANS: We will rank the most important causal factors and their combinations for a spectrum of cancers and inform cancer control activities.

Identification of Clusters of Foot Pain Location in a Community Sample.

OBJECTIVE: To identify foot pain clusters according to pain location in a community-based sample of the general population. METHODS: This study analyzed data from the North West Adelaide Health Study. Data were obtained between 2004 and 2006, using computer-assisted telephone interviewing, clinical assessment, and self-completed questionnaire. The location of foot pain was assessed using a diagram during the clinical assessment. Hierarchical cluster analysis was undertaken to identify foot pain location clusters, which were then compared in relation to demographics, comorbidities, and podiatry services utilization. RESULTS: There were 558 participants with foot pain (mean age 54.4 years, 57.5% female). Five clusters were identified: 1 with predominantly arch and ball pain (26.8%), 1 with rearfoot pain (20.9%), 1 with heel pain (13.3%), and 2 with predominantly forefoot, toe, and nail pain (28.3% and 10.7%). Each cluster was distinct in age, sex, and comorbidity profile. Of the two clusters with predominantly forefoot, toe, and nail pain, one of them had a higher proportion of men and those classified as obese, had diabetes mellitus, and used podiatry services (30%), while the other was comprised of a higher proportion of women who were overweight and reported less use of podiatry services (17.5%). CONCLUSION: Five clusters of foot pain according to pain location were identified, all with distinct age, sex, and comorbidity profiles. These findings may assist in the identification of individuals at risk for developing foot pain and in the development of targeted preventive strategies and treatments.

Development of an Australian cardiovascular disease mortality risk score using multiple imputation and recalibration from national statistics.

OBJECTIVE: To develop and recalibrate an Australian 5-year cardiovascular disease (CVD) mortality risk score to produce contemporary predictions of risk. METHODS: Data were pooled from six Australian cohort studies (n = 54,829), with baseline data collected between 1989 and 2003. Participants included were aged 40-74 years and free of CVD at baseline. Variables were harmonised across studies and missing data were imputed using multiple imputation. Cox proportional hazards models were used to estimate the risk of CVD mortality associated with factors mutually independently predictive (p < 0.05) and a 5-year risk prediction algorithm was constructed. This algorithm was recalibrated to reflect contemporary national levels of CVD mortality and risk factors using national statistics. RESULTS: Over a mean 16.6 years follow-up, 1375 participants in the six studies died from CVD. The prediction model included age, sex, smoking, diabetes, systolic blood pressure, total and high-density lipoprotein cholesterol (HDLC), a social deprivation score, estimated glomerular filtration rate and its square and interactions of sex with diabetes, HDLC and deprivation score, and of age with systolic blood pressure and smoking. This model discriminated well when applied to a Scottish study population (c-statistic (95% confidence interval): 0.751 (0.709, 0.793)). Recalibration generally increased estimated risks, but well below those predicted by the European SCORE models. CONCLUSIONS: The resulting risk score, which includes markers of both chronic kidney disease and socioeconomic deprivation, is the first CVD mortality risk prediction tool for Australia to be derived using Australian data. The primary model, and the method of recalibration, is applicable elsewhere.

The freshwater bivalve Corbicula australis as a sentinel species for metal toxicity assessment: An in situ case study integrating chemical and biomarker analyses.

A weight of evidence approach in environmental assessment includes the use of biomonitor organisms to measure biologically available contaminant concentrations and lethal and sublethal responses in an exposure, dose, and response framework. Corbicula australis was assessed as a test species for metal toxicity using in situ river sediment exposures at 4 locations in the Molonglo River (New South Wales, Australia), which has a legacy of sediment metal contamination, following 8 decades of mining in its upper reaches. A sediment metal contamination gradient was evident from 12.5 km to 47 km downstream of the mine, as follows: zinc (851-130 mg/kg) > lead (104-7 mg/kg) > copper (31-5 mg/kg) > cadmium (2-0.3 mg/kg). Exposed C. australis accumulated the following metals in tissue: zinc (1358-236 µg/g) > copper (24-20 µg/g) > cadmium (4.7-0.7 µg/g) = lead (4.2-1.8 µg/g). Biomarker responses showed increased sublethal impairment with increased tissue metal concentrations. Total antioxidant capacity was mildly impaired, with corresponding increased lipid peroxidation and lysosomal membrane destabilization at the higher tissue metal concentrations. Corbicula australis proved to be an effective biomonitor organism for sediment metal assessment, as it is able to accumulate metals relative to sediment concentrations and showed a pattern of increased sublethal impairment with increased tissue metal concentration. It is recommended as a suitable species for incorporation into local freshwater monitoring and assessment programs. Environ Toxicol Chem 2017;36:709-719. © 2016 SETAC.

Soy Isoflavone Intake and Sleep Parameters over 5 Years among Chinese Adults: Longitudinal Analysis from the Jiangsu Nutrition Study.

BACKGROUND: Soy isoflavone is beneficial for menopausal/postmenopausal symptoms, including sleep complaints. However, little is known about its longitudinal association with sleep in the general population. OBJECTIVE: Our aim was to investigate the association between soy isoflavone intake and sleep duration and daytime falling asleep among Chinese adults. DESIGN: A longitudinal analysis was performed. Soy isoflavone intake was assessed by food frequency questionnaire. Sleep duration was self-reported at two time points. Occurrence of daytime falling asleep was determined at follow-up. Short and long sleep were defined as sleep <7 h/day or ≥9 h/day, respectively. PARTICIPANTS/SETTING: Adults aged 20 years and older from the Jiangsu Nutrition Study (2002-2007) with complete isoflavone intake and sleep duration data at both time points (n=1,474) were analyzed (follow-up, n=1,492). MAIN OUTCOME MEASURES: We measured sleep duration in 2002 and 2007 and daytime falling asleep occurrence in 2007. STATISTICAL ANALYSES PERFORMED: Mixed-effects logistic regression was performed for repeated measures between isoflavone intake and sleep duration. Logistic regression was performed for daytime falling asleep at follow-up. Demographic, anthropometric, and social factors were adjusted in the analyses. RESULTS: The prevalence of long sleep duration was 18.9% in 2002 and 12.6% in 2007, and the prevalence of daytime falling asleep was 5.3%. Compared with the lowest quartile of isoflavone intake, the highest quartile was associated with a lower risk of long sleep duration (odds ratio=0.66; 95% CI 0.48 to 0.90; P for trend=0.018) over 5 years. Compared with persistent low intake of isoflavone (less than median intake of isoflavone at two time points), persistent high intake was associated with a reduced risk of daytime falling asleep in women (odds ratio=0.20; 95% CI 0.06 to 0.68), but not men. No consistent association between soy isoflavone intake and short sleep duration was found. CONCLUSIONS: Soy isoflavone intake was associated with a low risk of long sleep duration in both sexes and a low risk of daytime falling asleep in women but not men.

The impact of dietary risk factors on the burden of non-communicable diseases in Ethiopia: findings from the Global Burden of Disease study 2013.

BACKGROUND: The burden of non-communicable diseases (NCDs) has increased in sub-Saharan countries, including Ethiopia. The contribution of dietary behaviours to the NCD burden in Ethiopia has not been evaluated. This study, therefore, aimed to assess diet-related burden of disease in Ethiopia between 1990 and 2013. METHOD: We used the 2013 Global Burden of Disease (GBD) data to estimate deaths, years of life lost (YLLs) and disability-adjusted life years (DALYs) related to eight food types, five nutrients and fibre intake. Dietary exposure was estimated using a Bayesian hierarchical meta-regression. The effect size of each diet-disease pair was obtained based on meta-analyses of prospective observational studies and randomized controlled trials. A comparative risk assessment approach was used to quantify the proportion of NCD burden associated with dietary risk factors. RESULTS: In 2013, dietary factors were responsible for 60,402 deaths (95% Uncertainty Interval [UI]: 44,943-74,898) in Ethiopia-almost a quarter (23.0%) of all NCD deaths. Nearly nine in every ten diet-related deaths (88.0%) were from cardiovascular diseases (CVD) and 44.0% of all CVD deaths were related to poor diet. Suboptimal diet accounted for 1,353,407 DALYs (95% UI: 1,010,433-1,672,828) and 1,291,703 YLLs (95% UI: 961,915-1,599,985). Low intake of fruits and vegetables and high intake of sodium were the most important dietary factors. The proportion of NCD deaths associated with low fruit consumption slightly increased (11.3% in 1990 and 11.9% in 2013). In these years, the rate of burden of disease related to poor diet slightly decreased; however, their contribution to NCDs remained stable. CONCLUSIONS: Dietary behaviour contributes significantly to the NCD burden in Ethiopia. Intakes of diet low in fruits and vegetables and high in sodium are the leading dietary risks. To effectively mitigate the oncoming NCD burden in Ethiopia, multisectoral interventions are required; and nutrition policies and dietary guidelines should be developed.

Achieving Good Outcomes for Asthma Living (GOAL): mixed methods feasibility and pilot cluster randomised controlled trial of a practical intervention for eliciting, setting and achieving goals for adults with asthma.

BACKGROUND: Despite being a core component of self-management, goal setting is rarely used in routine care. We piloted a primary care, nurse-led intervention called Achieving Good Outcomes for Asthma Living (GOAL) for adults with asthma. Patients were invited to identify and prioritise their goals in preparation for discussing and negotiating an action/coping plan with the nurse at a routine asthma review. METHODS: The 18-month mixed methods feasibility cluster pilot trial stratified and then randomised practices to deliver usual care (UC) or a goal-setting intervention (GOAL). Practice asthma nurses and adult patients with active asthma were invited to participate. The primary outcome was asthma-specific quality of life. Semi-structured interviews with a purposive patient sample (n = 14) and 10 participating nurses explored GOAL perception. The constructs of normalisation process theory (NPT) were used to analyse and interpret data. RESULTS: Ten practices participated (five in each arm), exceeding our target of eight. However, only 48 patients (target 80) were recruited (18 in GOAL practices). At 6 months post-intervention, the difference in mean asthma-related quality of life (mAQLQ) between intervention and control was 0.1 (GOAL 6.20: SD 0.76 (CI 5.76-6.65) versus UC 6.1: SD 0.81 (CI 5.63-6.57)), less than the minimal clinically important difference (MCID) of 0.5. However, change from baseline was stronger in the intervention group: at 6 months the change in the emotions sub-score was 0.8 for intervention versus 0.2 for control. Costs were higher in the intervention group by £22.17. Routine review with goal setting was considered more holistic, enhancing rapport and enabling patients to become active rather than passive participants in healthcare. However, time was a major barrier for nurses, who admitted to screening out patient goals they believed were unrelated to asthma. CONCLUSIONS: The difference in AQLQ score from baseline is larger in the intervention arm than the control, indicating the intervention may have impact if appropriately strengthened. The GOAL intervention changed the review dynamic and was well received by patients, but necessitated additional time, which was problematic in the confines of the traditional nurse appointment. Modification to recruitment methods and further development of the intervention are needed before proceeding to a definitive cluster randomised controlled trial. TRIAL REGISTRATION: ISRCTN18912042 . Registered on 26 June 2012.

Unpaid Informal Caregivers in South Australia: Population Characteristics, Prevalence and Age-Period-Cohort Effects 1994-2014.

BACKGROUND: The ongoing need for an availability of informal carers is taking on greater relevance as the global burden of disease transitions from acute fatal diseases to long term morbidity. Growing evidence suggests that extra burden on family carers may further impact on their health and ability to provide care. Important as it is to monitor the prevalence of those conditions which influence the burden of disease, it is also important to monitor the prevalence and health profiles of those who provide the informal care. The aim of this study was to demonstrate the prevalence and demographics of adult carers aged 15 and over in the state of South Australia over 20 years between 1994 and 2014. METHODS: Data from nine representative, cross-sectional population surveys, conducted in South Australia, Australia were used, (total N = 26,788 and n = 1,504 carers). The adjusted prevalence estimate of carers and their demographic characteristics were determined. So as to examine whether there were any generational effects on the prevalence of carers, an Age-Period Cohort (APC) analysis was undertaken. RESULTS: The prevalence estimates of carers increased during the two decades from 3.7% in 1994 to 6.7% by 2014. Large increases in the proportion of retired carers, those aged 70 years and over, those carers employed, and those with higher educational qualifications were observed. There were also larger proportions of respondents with a country of birth other than Australia, UK, Ireland and European counties. The APC analysis illustrated an increasing prevalence rate over each decade for carers aged 20-80 years, especially for those over the age of 60 years. CONCLUSIONS: The results illustrate changing carer characteristics and carer prevalence estimates in South Australia as new generations of carers take on the caring role. There is a need to include questions regarding informal carers within ongoing mainstream population surveys, particularly at state levels, so as to plan for their future health care and home support.

Predictive value of serum testosterone for type 2 diabetes risk assessment in men.

BACKGROUND: Effective prevention of type 2 diabetes (T2D) requires early identification of high-risk individuals who might benefit from intervention. We sought to determine whether low serum testosterone, a novel risk factor for T2D in men, adds clinically meaningful information beyond current T2D risk models. METHODS: The Men Androgen Inflammation Lifestyle Environment and Stress (MAILES) study population consists of 2563 community-dwelling men aged 35-80 years in Adelaide, Australia. Of the MAILES participants, 2038 (80.0 %) provided information at baseline (2002-2006) and follow-up (2007-2010). After excluding participants with diabetes (n = 317), underweight (n = 5), and unknown BMI status (n = 11) at baseline; and unknown diabetes status (n = 50) at follow-up; 1655 participants were followed for 5 years. T2D at baseline and follow-up was defined by self-reported diabetes, or fasting plasma glucose (FPG) ≥7.0 mmol/L (126.1 mg/dL), or glycated haemoglobin (HbA1c) ≥6.5 %, or diabetes medications. Risk models were tested using logistic regression models. Sensitivity, specificity, positive predictive values (PPV) were used to identify the optimal cut-off point for low serum testosterone for incident T2D and the area under the receiver operating characteristic (AROC) curve was used to summarise the predictive power of the model. 15.5 % of men had at least one missing predictor variable; addressed through multiple imputation. RESULTS: The incidence rate of T2D was 8.9 % (147/1655) over a median follow-up of 4.95 years (interquartile range: 4.35-5.00). Serum testosterone level predicted incident T2D (relative risk 0.96 [95 % CI: 0.92,1.00], P = 0.032) independent of current risk models including the AUSDRISK, but did not improve corresponding AROC statistics. A cut-off point of <16 nmol/L for low serum testosterone, which classified about 43 % of men, returned equal sensitivity (61.3 % [95 % CI: 52.6,69.4]) and specificity (58.3 % [95 % CI: 55.6,60.9) for predicting T2D risk, with a PPV of 12.9 % (95 % CI: 10.4,15.8). CONCLUSIONS: Low serum testosterone predicts an increased risk of developing T2D in men over 5 years independent of current T2D risk models applicable for use in routine clinical practice. Screening for low serum testosterone in addition to risk factors from current T2D risk assessment models or tools, including the AUSDRISK, would identify a large subgroup of distinct men who might benefit from targeted preventive interventions.

Bias of health estimates obtained from chronic disease and risk factor surveillance systems using telephone population surveys in Australia: results from a representative face-to-face survey in Australia from 2010 to 2013.

BACKGROUND: Emerging communication technologies have had an impact on population-based telephone surveys worldwide. Our objective was to examine the potential biases of health estimates in South Australia, a state of Australia, obtained via current landline telephone survey methodologies and to report on the impact of mobile-only household on household surveys. METHODS: Data from an annual multi-stage, systematic, clustered area, face-to-face population survey, Health Omnibus Survey (approximately 3000 interviews annually), included questions about telephone ownership to assess the population that were non-contactable by current telephone sampling methods (2006 to 2013). Univariable analyses (2010 to 2013) and trend analyses were conducted for sociodemographic and health indicator variables in relation to telephone status. Relative coverage biases (RCB) of two hypothetical telephone samples was undertaken by examining the prevalence estimates of health status and health risk behaviours (2010 to 2013): directory-listed numbers, consisting mainly of landline telephone numbers and a small proportion of mobile telephone numbers; and a random digit dialling (RDD) sample of landline telephone numbers which excludes mobile-only households. RESULTS: Telephone (landline and mobile) coverage in South Australia is very high (97%). Mobile telephone ownership increased slightly (7.4%), rising from 89.7% in 2006 to 96.3% in 2013; mobile-only households increased by 431% over the eight year period from 5.2% in 2006 to 27.6% in 2013. Only half of the households have either a mobile or landline number listed in the telephone directory. There were small differences in the prevalence estimates for current asthma, arthritis, diabetes and obesity between the hypothetical telephone samples and the overall sample. However, prevalence estimate for diabetes was slightly underestimated (RCB value of -0.077) in 2013. Mixed RCB results were found for having a mental health condition for both telephone samples. Current smoking prevalence was lower for both hypothetical telephone samples in absolute differences and RCB values: -0.136 to -0.191 for RDD landline samples and -0.129 to -0.313 for directory-listed samples. CONCLUSION: These findings suggest landline-based sampling frames used in Australia, when appropriately weighted, produce reliable representative estimates for some health indicators but not for all. Researchers need to be aware of their limitations and potential biased estimates.