Liver and cardiometabolic markers and conditions in a cross-sectional study of three Australian communities living with environmental per- and polyfluoroalkyl substances contamination.

BACKGROUND: Per- and polyfluoroalkyl substances (PFAS) have been associated with higher cholesterol and liver function markers in some studies, but the evidence for specific cardiometabolic conditions has been inconclusive. OBJECTIVES: We quantified the associations of single and combined PFAS with cardiometabolic markers and conditions in a cross-sectional study of three Australian communities with PFAS-contaminated water from the historical use of aqueous film-forming foam in firefighting activities, and three comparison communities. METHODS: Participants gave blood samples for measurement of nine PFAS, four lipids, six liver function markers, and completed a survey on sociodemographic characteristics and eight cardiometabolic conditions. We estimated differences in mean biomarker concentrations per doubling in single PFAS concentrations (linear regression) and per interquartile range increase in the PFAS mixture (Bayesian kernel machine regression). We estimated prevalence ratios of biomarker concentrations outside reference limits and self-reported cardiometabolic conditions (Poisson regression). RESULTS: We recruited 881 adults in exposed communities and 801 in comparison communities. We observed higher mean total cholesterol with higher single and mixture PFAS concentrations in blood serum (e.g., 0.18 mmol/L, 95% credible interval -0.06 to 0.42, higher total cholesterol concentrations with an interquartile range increase in all PFAS concentrations in Williamtown, New South Wales), with varying certainty across communities and PFAS. There was less consistency in direction of associations for liver function markers. Serum perfluorooctanoic acid (PFOA) concentrations were positively associated with the prevalence of self-reported hypercholesterolemia in one of three communities, but PFAS concentrations were not associated with self-reported type II diabetes, liver disease, or cardiovascular disease. DISCUSSION: Our study is one of few that has simultaneously quantified the associations of blood PFAS concentrations with multiple biomarkers and cardiometabolic conditions in multiple communities. Our findings for total cholesterol were consistent with previous studies; however, substantial uncertainty in our estimates and the cross-sectional design limit causal inference.

Developing a conceptual framework for implementation science to evaluate a nutrition intervention scaled-up in a real-world setting.

OBJECTIVE: The aim of this paper is to identify and develop a comprehensive conceptual framework using implementation science that can be applied to assess a nutrition intervention in a real-world setting. DESIGN: We conducted a narrative review using electronic databases and a manual search to identify implementation science frameworks, models and theories published in peer-reviewed journals. We performed a qualitative thematic analysis of these publications to generate a framework that could be applied to nutrition implementation science. RESULTS: Based on this review, we developed a comprehensive framework which we have conceptualised as an implementation science process that describes the transition from the use of scientific evidence through to scaling-up with the aim of making an intervention sustainable. The framework consisted of three domains: Domain i - efficacy to effectiveness trials, Domain ii - scaling-up and Domain iii - sustainability. These three domains encompass five components: identifying an 'effective' intervention; scaling-up and implementation fidelity; course corrections during implementation; promoting sustainability of interventions and consideration of a comprehensive methodological paradigm to identify 'effective' interventions and to assess the process and outcome indicators of implementation. The framework was successfully applied to a nutrition implementation program in Bangladesh. CONCLUSIONS: Our conceptual framework built from an implantation science perspective offers a comprehensive approach supported by a foundational and holistic understanding of its key components. This framework provides guidance for implementation researchers, policy-makers and programme managers to identify and review an effective intervention, to scale it up and to sustain it over time.

Factors associated with home visits by volunteer community health workers to implement a home-fortification intervention in Bangladesh: a multilevel analysis.

OBJECTIVE: BRAC, an international development organization based in Bangladesh, engages community health workers called Shasthya Shebikas (SS) to implement home fortification of foods with micronutrient powders (MNP). We identified factors associated with home visits by SS, at different levels of the BRAC programme-delivery hierarchy, to implement home-fortification interventions. DESIGN: We conducted a cross-sectional survey, semi-structured interviews, and collected programme-related data from sub-districts included in the caregiver survey of BRAC's home-fortification programme and performed multilevel logistic regression modelling to investigate factors associated with home visits by SS. SETTINGS: Sixty-eight sub-districts in Bangladesh. PARTICIPANTS: Caregivers of children aged 6-59 months (n 1408) and BRAC's SS (n 201). RESULTS: Households with older children (0·55; 0·42, 0·72; P < 0·001) and located >300 m from the SS's house (0·67; 0·50, 0·89; P = 0·006) were less likely to have been visited by the SS, whereas those with caregivers who had ≥5 years of schooling (1·53; 1·10, 2·12; P = 0·011) were more likely to have been visited by the SS (adjusted OR; 95 % CI). Households in the catchment area of older SS aged >50 years (0·44; 0·21, 0·90; P = 0·025) were less likely to have been visited by the SS, whereas those with SS who received incentives of >800 BDT (3·00; 1·58, 5·58; P = 0·001) were more likely to have been visited by the SS (adjusted OR; 95 % CI). CONCLUSIONS: The number of home visits is a function of the characteristics of SS, factors that characterize the households they serve and characteristics of their organizational context, particularly to implement home fortification of foods with MNP.

Role of home visits by volunteer community health workers: to improve the coverage of micronutrient powders in rural Bangladesh.

OBJECTIVE: We assessed the role of home visits by Shasthya Shebika (SS) - female volunteer community health workers (CHWs) - in improving the distribution of micronutrient powder (MNP), and explored the independent effects of caregiver-provider interaction on coverage variables. DESIGN: We used data from three cross-sectional surveys undertaken at baseline (n 1927), midline (n 1924) and endline (n 1540) as part of an evaluation of a home fortification programme. We defined an exposure group as one that had at least one SS visit to the caregiver's household in the 12 months preceding the survey considering three outcome variables - message (ever heard), contact (ever used) and effective coverage (regular used) of MNP. We performed multiple logistic regressions to explore the determinants of coverage, employed an 'interaction term' and calculated an odds ratio (OR) to assess the modifying effect of SS's home visits on coverage. SETTINGS: Sixty-eight sub-districts from ten districts of Bangladesh. PARTICIPANTS: Children aged 6-59 months and their caregivers. RESULTS: A home visit from an SS positively impacts message coverage at both midline (ratio of OR 1·70; 95 % CI 1·25, 2·32; P < 0·01) and endline (ratio of OR 3·58; 95 % CI 2·22, 5·78; P < 0·001), and contact coverage both at midline (ratio of OR 1·48; 95 % CI 1·06, 2·07; P = 0·021) and endline (ratio of OR 1·74; 95 % CI 1·23, 2·47; P = 0·002). There was no significant effect of a SS's home visit on effective coverage. CONCLUSIONS: The households visited by BRAC's volunteer CHWs have better message and contact coverage among the children aged 6-59 months.

Measuring organizational context in Australian emergency departments and its impact on stroke care and patient outcomes.

BACKGROUND: Emergency departments (ED) are challenging environments but critical for early management of patients with stroke. PURPOSE: To identify how context affects the provision of stroke care in 26 Australian EDs. METHOD: Nurses perceptions of ED context was assessed with the Alberta Context Tool. Medical records were audited for quality of stroke care and patient outcomes. FINDINGS: Collectively, emergency nurses (n = 558) rated context positively with several nurse and hospital characteristics impacting these ratings. Despite these positive ratings, regression analysis showed no significant differences in the quality of stroke care (n = 1591 patients) and death or dependency (n = 1165 patients) for patients in EDs with high or low rated context. DISCUSSION: Future assessments of ED context may need to examine contextual factors beyond the scope of the Alberta Context Tool which may play an important role for the understanding of stroke care and patient outcomes in EDs.

Thrombolysis implementation intervention and clinical outcome: a secondary analysis of a cluster randomized trial.

BACKGROUND: Multiple studies have attempted to increase the rate of intravenous thrombolysis for ischemic stroke using interventions to promote adherence to guidelines. Still, many of them did not measure individual-level impact. This study aimed to make a posthoc comparison of the clinical outcomes of patients in the "Thrombolysis ImPlementation in Stroke (TIPS)" study, which aimed to improve rates of intravenous thrombolysis in Australia. METHODS: A posthoc analysis was conducted using individual-level patient data. Excellent (Three-month post treatment modified Rankin Score 0-2) and poor clinical outcome (Three-month post treatment modified Rankin Score 5-6) and post treatment parenchymal haematoma were the three main outcomes, and a mixed logistic regression model was used to assess the difference between the intervention and control groups. RESULTS: There was a non-significant higher odds of having an excellent clinical outcome of 57% (odds ratio: 1.57; 95% CI: 0.73-3.39) and 33% (odds ratio: 1.33; 95% CI: 0.73-2.44) during the active-and post-intervention period respectively, for the intervention compared to the control group. A non-significant lower odds of having a poor clinical outcome was also found in the intervention, relative to control group of 4% (odds ratio: 0.96; 95% CI: 0.56-2.07) and higher odds of having poor outcome of 44% (odds ratio: 1.44 95% CI: 0.61-3.41) during both active and post-intervention period respectively. Similarly, a non-significant lower odds of parenchymal haematoma was also found for the intervention group during the both active- (odds ratio: 0.53; 95% CI: 0.21-1.32) and post-intervention period (odds ratio: 0.96; 95% CI: 0.36-2.52). CONCLUSION: The TIPS multi-component implementation approach was not effective in reducing the odds of post-treatment severe disability at 90 days, or post-thrombolysis hemorrhage. TRIAL REGISTRATION: Clinical Trial Registration-URL: http://www.anzctr.org.au/ Unique Identifier: ACTRN12613000939796 .

An Internet-Based Intervention Augmented With a Diet and Physical Activity Consultation to Decrease the Risk of Dementia in At-Risk Adults in a Primary Care Setting: Pragmatic Randomized Controlled Trial.

BACKGROUND: There is a need to develop interventions to reduce the risk of dementia in the community by addressing lifestyle factors and chronic diseases over the adult life course. OBJECTIVE: This study aims to evaluate a multidomain dementia risk reduction intervention, Body Brain Life in General Practice (BBL-GP), targeting at-risk adults in primary care. METHODS: A pragmatic, parallel, three-arm randomized trial involving 125 adults aged 18 years or older (86/125, 68.8% female) with a BMI of ≥25 kg/m2 or a chronic health condition recruited from general practices was conducted. The arms included (1) BBL-GP, a web-based intervention augmented with an in-person diet and physical activity consultation; (2) a single clinician-led group, Lifestyle Modification Program (LMP); and (3) a web-based control. The primary outcome was the Australian National University Alzheimer Disease Risk Index Short Form (ANU-ADRI-SF). RESULTS: Baseline assessments were conducted on 128 participants. A total of 125 participants were randomized to 3 groups (BBL-GP=42, LMP=41, and control=42). At immediate, week 18, week 36, and week 62 follow-ups, the completion rates were 43% (18/42), 57% (24/42), 48% (20/42), and 48% (20/42), respectively, for the BBL-GP group; 71% (29/41), 68% (28/41), 68% (28/41), and 51% (21/41), respectively, for the LMP group; and 62% (26/42), 69% (29/42), 60% (25/42), and 60% (25/42), respectively, for the control group. The primary outcome of the ANU-ADRI-SF score was lower for the BBL-GP group than the control group at all follow-ups. These comparisons were all significant at the 5% level for estimates adjusted for baseline differences (immediate: difference in means -3.86, 95% CI -6.81 to -0.90, P=.01; week 18: difference in means -4.05, 95% CI -6.81 to -1.28, P<.001; week 36: difference in means -4.99, 95% CI -8.04 to -1.94, P<.001; and week 62: difference in means -4.62, 95% CI -7.62 to -1.62, P<.001). CONCLUSIONS: A web-based multidomain dementia risk reduction program augmented with allied health consultations administered within the general practice context can reduce dementia risk exposure for at least 15 months. This study was limited by a small sample size, and replication on a larger sample with longer follow-up will strengthen the results. TRIAL REGISTRATION: Australian clinical trials registration number (ACTRN): 12616000868482; https://anzctr.org.au/ACTRN12616000868482.aspx.

A multi-center randomized controlled trial to reduce unmet needs, depression, and anxiety among hematological cancer patients and their support persons.

Purpose: Individuals diagnosed with a high-grade hematological malignancy are at high risk for psychosocial distress. This study aimed to examine the effectiveness of a web-based information tool and nurse delivered telephone support in reducing: (i) unmet information needs; (ii) depression; and (iii) anxiety, among hematological cancer patients and their support persons (SPs).Methods: Patients with a new diagnosis of acute myeloid leukemia, acute lymphoblastic leukemia, Burkitt lymphoma, or lymphoblastic lymphoma and their SPs were enrolled in a prospective multi-site randomized trial. Participants received either access to an online information tool and telephone support from a hematology nurse, or usual care. Outcome data were collected 2, 4, 8, and 12 weeks post-recruitment. The primary endpoint was unmet information needs.Results: Data from 60 patients and 15 SPs were included in the analysis. There were no statistically significant differences in unmet information needs, depression or anxiety between intervention and control groups for patients. Patients in both groups demonstrated a decrease in information needs over the intervention period. Post hoc analyses revealed that patients who did not achieve remission with the first cycle of treatment experienced increased anxiety from 4 weeks until the end of the study (p = 0.008).Conclusions: A web-based information tool and nurse delivered telephone support did not reduce unmet information needs, depression or anxiety among hematological cancer patients, however this finding is inconclusive given the low power of the study.Implications for Psychosocial Providers or Policy: Patients who do not achieve remission are at high risk of anxiety, and may benefit from targeted psychological intervention.

Nurse-Initiated Acute Stroke Care in Emergency Departments: The Triage, Treatment, and Transfer Implementation Cluster Randomized Controlled Trial.

Background and Purpose- We aimed to evaluate the effectiveness of an intervention to improve triage, treatment, and transfer for patients with acute stroke admitted to the emergency department (ED). Methods- A pragmatic, blinded, multicenter, parallel group, cluster randomized controlled trial was conducted between July 2013 and September 2016 in 26 Australian EDs with stroke units and tPA (tissue-type plasminogen activator) protocols. Hospitals, stratified by state and tPA volume, were randomized 1:1 to intervention or usual care by an independent statistician. Eligible ED patients had acute stroke <48 hours from symptom onset and were admitted to the stroke unit via ED. Our nurse-initiated T3 intervention targeted (1) Triage to Australasian Triage Scale category 1 or 2; (2) Treatment: tPA eligibility screening and appropriate administration; clinical protocols for managing fever, hyperglycemia, and swallowing; (3) prompt (<4 hours) stroke unit Transfer. It was implemented using (1) workshops to identify barriers and solutions; (2) face-to-face, online, and written education; (3) national and local clinical opinion leaders; and (4) email, telephone, and site visit follow-up. Outcomes were assessed at the patient level. Primary outcome: 90-day death or dependency (modified Rankin Scale score of ≥2); secondary outcomes: functional dependency (Barthel Index ≥95), health status (Short Form [36] Health Survey), and ED quality of care (Australasian Triage Scale; monitoring and management of tPA, fever, hyperglycemia, swallowing; prompt transfer). Intention-to-treat analysis adjusted for preintervention outcomes and ED clustering. Patients, outcome assessors, and statisticians were masked to group allocation. Results- Twenty-six EDs (13 intervention and 13 control) recruited 2242 patients (645 preintervention and 1597 postintervention). There were no statistically significant differences at follow-up for 90-day modified Rankin Scale (intervention: n=400 [53.5%]; control n=266 [48.7%]; P=0.24) or secondary outcomes. Conclusions- This evidence-based, theory-informed implementation trial, previously effective in stroke units, did not change patient outcomes or clinician behavior in the complex ED environment. Implementation trials are warranted to evaluate alternative approaches for improving ED stroke care. Clinical Trial Registration- URL: http://www.anzctr.org.au. Unique identifier: ACTRN12614000939695.

Functional Measures of Sarcopenia: Prevalence, and Associations with Functional Disability in 10,892 Adults Aged 65 Years and Over from Six Lower- and Middle-Income Countries.

Identification of sarcopenia in lower- and middle-income countries (LMICs) is limited by access to technologies that assess muscle mass. We investigated associations between two functional measures of sarcopenia, grip strength and gait speed (GS), with functional disability in adults from six LMICs. Data were extracted from the World Health Organization (WHO) Study on global AGEing and adult health Wave 1 (2007-2010) for adults (≥ 65 years) from China, Mexico, Ghana, India, Russia and South Africa (n = 10,892, 52.8% women). We calculated country-specific prevalence of low grip strength, slow GS (≤ 0.8 m/s), and both measures combined. Using multivariable negative binomial regression, we separately assessed associations between low grip strength, slow GS, and both measures combined, with the WHO Disability Assessment Schedule 2.0, accounting for selected socioeconomic factors. In women, low grip strength ranged from 7 in South Africa to 51% in India; in men, it ranged from 17 in Russia to 51% in Mexico. Country-specific proportions of slow GS ranged from 77 in Russia, to 33% in China. The concomitant presence of both was the lowest in South Africa and the highest in India (12.3% vs. 33%). Independent of age, those with both low grip strength and slow GS had between 1.2- and 1.5-fold worse functional disability scores, independent of comorbidities, low education, and low wealth (all country-dependent). Low grip strength, slow GS, and the combination of both, were all associated with higher levels of functional disability, thus indicating these objective measures offer a reasonably robust estimate for potential poor health outcomes.

Evaluating recruitment strategies for AUSPICE, a large Australian community-based randomised controlled trial.

OBJECTIVES: To examine the effectiveness of different strategies for recruiting participants for a large Australian randomised controlled trial (RCT), the Australian Study for the Prevention through Immunisation of Cardiovascular Events (AUSPICE). DESIGN, SETTING, PARTICIPANTS: Men and women aged 55-60 years with at least two cardiovascular risk factors (hypertension, hypercholesterolaemia, overweight/obesity) were recruited for a multicentre placebo-controlled RCT assessing the effectiveness of 23-valent pneumococcal polysaccharide vaccine (23vPPV) for preventing cardiovascular events. METHODS: Invitations were mailed by the Australian Department of Human Services to people in the Medicare database aged 55-60 years; reminders were sent 2 weeks later. Invitees could respond in hard copy or electronically. Direct recruitment was supplemented by asking invitees to extend the invitation to friends and family (snowball sampling) and by Facebook advertising. MAIN OUTCOME: Proportions of invitees completing screening questionnaire and recruited for participation in the RCT. RESULTS: 21 526 of 154 992 invited people (14%) responded by completing the screening questionnaire, of whom 4725 people were eligible and recruited for the study. Despite the minimal study burden (one questionnaire, one clinic visit), the overall participation rate was 3%, or an estimated 10% of eligible persons. Only 16% of eventual participants had responded within 2 weeks of the initial invitation letter (early responders); early and late responders did not differ in their demographic or medical characteristics. Socio-economic disadvantage did not markedly influence response rates. Facebook advertising and snowball sampling did not increase recruitment. CONCLUSIONS: Trial participation rates are low, and multiple concurrent methods are needed to maximise recruitment. Social media strategies may not be successful in older age groups. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12615000536561.

Geographical variations in self-rated health and functional limitations among older Chinese in eight WHO-SAGE provinces.

BACKGROUND: The proportion of population ageing in China will grow significantly in the next few decades but the pace of population ageing and social change vary considerably across regions. Notably, Eastern coastal areas are economically more advanced compared to the Western region. These economic disparities could result in differing adverse health outcomes. METHODS: We investigate geographical variations in self-rated overall health and functional limitations in a national representative sample of Chinese aged 50 years and older (n = 13,175) using the WHO Study on global AGEing and adult health (WHO SAGE). We used multivariable logistic regression to investigate urban-rural inequalities across regions, adjusting for sociodemographic and health covariates. Two main outcomes were self-rated overall health and functional limitations based on the WHO Disability Assessment Schedule 2.0 for a range of daily activities. RESULTS: The largest urban-rural differences in adverse health outcomes were in Shandong (AORs for urban versus rural of 6.32 [95% Confidence Interval 4.53-8.82] for poor or very poor self-rated overall health and 5.14 [CI 3.55-7.44] for functional limitations), followed by Jilin (AORs 2.71 [CI 2.04-3.61] and 4.72 [CI 3.43-6.49]), and Hubei (AORs 2.36 [CI 1.82-3.07] and 4.11 [CI 2.80-6.04]), respectively. Covariates significantly associated with both adverse health outcomes were older age, poor income, no health insurance, and increasing number of chronic diseases. CONCLUSION: Our study reveals substantial disparities between urban and rural areas observed in both the well-developed areas (eg Shandong) and also the lower end of the economic spectrum (eg Hubei and Jilin). Targeted economic development policy and systematic health prevention and healthcare policies could be beneficial in improving health in later life whilst minimising geographical inequalities.

Increasing the capacity of policy agencies to use research findings: a stepped-wedge trial.

BACKGROUND: This paper describes the trial of a novel intervention, Supporting Policy In health with evidence from Research: an Intervention Trial (SPIRIT). It examines (1) the feasibility of delivering this kind of programme in practice; (2) its acceptability to participants; (3) the impact of the programme on the capacity of policy agencies to engage with research; and (4) the engagement with and use of research by policy agencies. METHODS: SPIRIT was a multifaceted, highly tailored, stepped-wedge, cluster-randomised, trial involving six health policy agencies in Sydney, Australia. Agencies were randomly allocated to one of three start dates to receive the 1-year intervention programme. SPIRIT included audit, feedback and goal setting; a leadership programme; staff training; the opportunity to test systems to facilitate research use in policies; and exchange with researchers. Outcome measures were collected at each agency every 6 months for 30 months. RESULTS: Participation in SPIRIT was associated with significant increases in research use capacity at staff and agency levels. Staff reported increased confidence in research use skills, and agency leaders reported more extensive systems and structures in place to support research use. Self-report data suggested there was also an increase in tactical research use among agency staff. Given the relatively small numbers of participating agencies and the complexity of their contexts, findings suggest it is possible to effect change in the way policy agencies approach the use of research. This is supported by the responses on the other trial measures; while these were not statistically significant, on 18 of the 20 different measures used, the changes observed were consistent with the hypothesised intervention effect (that is, positive impacts). CONCLUSIONS: As an early test of an innovative approach, SPIRIT has demonstrated that it is possible to increase research engagement and use in policy agencies. While more work is needed to establish the replicability and generalisability of these findings, this trial suggests that building staff skills and organisational structures may be effective in increasing evidence use.

A cross-sectional study of agreement between the Hospital Anxiety and Depression Scale and patient- and radiation oncologist-reported single-item assessment of depression and anxiety.

OBJECTIVE: To describe among radiation oncology patients: (1) the proportion likely to be experiencing symptoms of depression and anxiety as identified by (a) the Hospital Anxiety and Depression Scale (HADS; standardised tool), (b) patient-reported single items (ultrashort tool), and (c) radiation oncologist-reported single items (clinician judgement); (2) preferences for being offered psychological support; and (3) agreement between single-item measures and the HADS. METHODS: Adult cancer patients (n = 152; consent rate 58%) receiving radiotherapy completed a touchscreen tablet survey assessing symptoms of anxiety and depression (HADS and a single-item tool) and support preferences. Each participant's treating radiation oncologist completed a survey assessing his or her perception of whether the patient was anxious or depressed. RESULTS: Prevalence estimates for likely depression (6.9-18%) and anxiety (17-33%) overlapped across the 3 measures. Overall, only 9.9% of patients (95% CI, 5.6%-16%) wanted to be offered psychological support. For depression, agreement between the HADS and ultrashort tool was fair (κ = 0.37, P < 0.0001); agreement between the HADS and clinician judgement was slight (κ = 0.14, P < 0.05). For anxiety, agreement between the HADS and clinician judgement was not significantly greater than chance alone (κ = 0.04, P = 0.33), and agreement between the HADS and ultrashort tool was moderate (κ = 0.49, P < 0.0001). CONCLUSIONS: These findings highlight the important role that oncology consultations play in interpreting assessment tool results and responding to individual patient's history and preferences for psychological support.

Smoking cessation intervention delivered by social service organisations for a diverse population of Australian disadvantaged smokers: A pragmatic randomised controlled trial.

OBJECTIVES: There remains a need to identify effective smoking cessation interventions in severely disadvantaged populations. This trial aimed to examine the effectiveness of an intervention (Call it Quits) developed to promote smoking cessation and delivered by community social service case-workers. METHODS: Call it Quits was a pragmatic, parallel randomised trial of a case-worker delivered smoking cessation intervention conducted in a non-government community social service organisation in New South Wales (NSW), Australia. Adult smokers requiring financial assistance were randomly assigned to the five-session Call it Quits intervention or usual care control group. Of the 618 eligible individuals, 300 were randomised to the intervention group, of whom 187 (62%) consented and 318 were randomised to the control group, of whom 244 (77%) consented, resulting in 431 participants. The primary outcome measure was self-reported continuous abstinence up to 6-month follow-up with biochemical verification. Primary analysis was performed using all the available data from participants under the assumption the data is missing completely at random, followed by sensitivity analyses. RESULTS: No statistically significant differences in the primary outcome were found (1.4% in the control group versus 1.0% in the intervention group, OR = 0.77, p = 0.828). CONCLUSIONS: A multi-component smoking cessation intervention delivering motivational interviewing-based counselling and free NRT by a trained case-worker within a community social service setting was not effective at achieving abstinence in a highly disadvantaged sample of smokers but increased attempts to stop and led to a reduction in number of cigarettes smoked daily.

Examining variation across treatment clinics in cancer patients' psychological outcomes: results of a cross sectional survey.

PURPOSE: The majority of research on psychological outcomes for cancer patients has focussed on the role of individual characteristics, and disease and treatment factors. There has been very little exploration of the potential contribution of the treatment clinic to these outcomes. This study explored whether there is variation among clinics in cancer patients' psychological outcomes. METHODS: Cancer outpatients were recruited from 22 medical oncology and haematology clinics in Australia. Participants completed a pen and paper survey including the Hospital Anxiety and Depression Scale (HADS), as well as sociodemographic, disease and treatment characteristics. RESULTS: Of those eligible to participate, 4233 (82%) consented and 2811 (81% of consenters) returned the completed survey. There was no statistically significant variation in HADS depression scores across clinics. Some difference in anxiety scores derived from the HADS questionnaire between clinics (p = 0.03) was found with the percentage of between-clinic variation estimated to be 1.11%. However, once all demographic, disease and treatment predictors were adjusted for there was no statistical differences between clinics (percent of between-clinic variation = 0.53%; p = 0.1415). CONCLUSIONS: Psychological outcomes were not found to vary between clinics. Other sources of variation including patient characteristics may over-ride between-clinic variability, if it exists.

Differences in Use of Government Subsidised Mental Health Services by Men and Women with Psychological Distress: A Study of 229,628 Australians Aged 45 Years and Over.

This study examined factors associated with use of government subsidised mental health services by 229,628 men and women from the Sax Institute's 45 and Up Study. Logistical regression models assessed use of mental health services by gender and according to level of psychological distress. Approximately equal proportion of men and women had high psychological distress scores (approximately 7%) but only 7% of these men and 11% of these women used services. Use was associated with predisposing (younger age and higher education), enabling (private health insurance) and need factors (higher psychological distress scores). Associations were similar for men and women except urban area of residence, separated/divorced marital status, and smoking were associated with service use for women but not men. Results suggest some inequity in the use of services by those with higher levels of need and further efforts may be required to reach people with higher need but lower service use.

Health-related quality of life for immediate versus delayed androgen-deprivation therapy in patients with asymptomatic, non-curable prostate cancer (TROG 03.06 and VCOG PR 01-03 [TOAD]): a randomised, multicentre, non-blinded, phase 3 trial.

BACKGROUND: Androgen-deprivation therapy in patients with prostate cancer who have relapsed with rising prostate-specific antigen concentration only (PSA-only relapse), or with non-curable but asymptomatic disease at diagnosis, could adversely affect quality of life at a time when the disease itself does not. We aimed to compare the effect of immediate versus delayed androgen-deprivation therapy on health-related quality of life over 5 years in men enrolled in the TOAD (Timing of Androgen Deprivation) trial. METHODS: This randomised, multicentre, open-label, phase 3 trial done in 29 public and private cancer centres across Australia, New Zealand, and Canada compared immediate with delayed androgen-deprivation therapy in men with PSA-only relapse after definitive treatment, or de-novo non-curable disease. Patients were randomly assigned (1:1) with a database-embedded, dynamically balanced algorithm to immediate androgen-deprivation therapy (immediate therapy group) or to delayed androgen-deprivation therapy (delayed therapy group). Any type of androgen-deprivation therapy was permitted, as were intermittent or continuous schedules. The European Organisation for Research and Treatment of Cancer (EORTC) quality-of-life questionnaires QLQ-C30 and PR25 were completed before randomisation, every 6 months for 2 years, and annually for a further 3 years. The primary outcome of the trial, reported previously, was overall survival, with global health-related quality of life at 2 years as a secondary endpoint. Here we report prespecified secondary objectives of the quality-of-life endpoint. Analysis was by intention to treat. Statistical significance was set at p=0·0036. The trial was registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12606000301561, and ClinicalTrials.gov, number NCT00110162. FINDINGS: Between Sept 3, 2004, and July 13, 2012, 293 men were recruited and randomly assigned; 151 to the delayed therapy group and 142 to the immediate therapy group. There was no difference between the two groups in global health-related quality of life over 2 years from randomisation. There were no statistically significant differences in global quality of life, physical functioning, role functioning, or emotional functioning, fatigue, dyspnoea, insomnia, or feeling less masculine over the entire 5 years after randomisation. Sexual activity was lower in the immediate therapy group than in the delayed group at 6 and 12 months (at 6 months mean score 29·20 [95% CI 24·59-33·80] in the delayed group vs 10·40 [6·87-13·93] in the immediate group, difference 18·80 [95% CI 13·00-24·59], p<0·0001; at 12 months 28·63 [24·07-33·18] vs 13·76 [9·94-17·59], 14·86 [8·95-20·78], p<0·0001), with the differences exceeding the clinically significant threshold of 10 points until beyond 2 years. The immediate therapy group also had more hormone-treatment-related symptoms at 6 and 12 months (at 6 months mean score 8·48 [95% CI 6·89-10·07] in the delayed group vs 15·97 [13·92-18·02] in the immediate group, difference -7·49 [-10·06 to -4·93], p<0·0001; at 12 months 9·32 [7·59-11·05] vs 17·07 [14·75-19·39], -7·75 [-10·62 to -4·89], p<0·0001), but with differences below the threshold of clinical significance. For the individual symptoms, hot flushes were clinically significantly higher in the immediate group (adjusted proportion 0·31 for delayed therapy vs 0·55 for immediate therapy, adjusted odds ratio 2·87 [1·96-4·21], p<0·0001) over the 5-year period, as were nipple or breast symptoms (0·06 vs 0·14, 2·64 [1·61-4·34], p=0·00013). INTERPRETATION: Immediate use of androgen-deprivation therapy was associated with early detriments in specific hormone-treatment-related symptoms, but with no other demonstrable effect on overall functioning or health-related quality of life. This evidence can be used to help decision making about treatment initiation for men at this disease stage. FUNDING: Australian National Health and Medical Research Council and Cancer Councils, The Royal Australian and New Zealand College of Radiologists, Mayne Pharma Australia, Tolmar Australia.

Mortality Reduction for Fever, Hyperglycemia, and Swallowing Nurse-Initiated Stroke Intervention: QASC Trial (Quality in Acute Stroke Care) Follow-Up.

BACKGROUND AND PURPOSE: Implementation of nurse-initiated protocols to manage fever, hyperglycemia, and swallowing dysfunction decreased death and disability 90 days poststroke in the QASC trial (Quality in Acute Stroke Care) conducted in 19 Australian acute stroke units (2005-2010). We now examine long-term all-cause mortality. METHODS: Mortality was ascertained using Australia's National Death Index. Cox proportional hazards regression compared time to death adjusting for correlation within stroke units using the cluster sandwich (Huber-White estimator) method. Primary analyses included treatment group only unadjusted for covariates. Secondary analysis adjusted for age, sex, marital status, education, and stroke severity using multiple imputation for missing covariates. RESULTS: One thousand and seventy-six participants (intervention n=600; control n=476) were followed for a median of 4.1 years (minimum 0.3 to maximum 70 months), of whom 264 (24.5%) had died. Baseline demographic and clinical characteristics were generally well balanced by group. The QASC intervention group had improved long-term survival (>20%), but this was only statistically significant in adjusted analyses (unadjusted hazard ratio [HR], 0.79; 95% confidence interval [CI], 0.58-1.07; P=0.13; adjusted HR, 0.77; 95% CI, 0.59-0.99; P=0.045). Older age (75-84 years; HR, 4.9; 95% CI, 2.8-8.7; P<0.001) and increasing stroke severity (HR, 1.5; 95% CI, 1.3-1.9; P<0.001) were associated with increased mortality, while being married (HR, 0.70; 95% CI, 0.49-0.99; P=0.042) was associated with increased likelihood of survival. Cardiovascular disease (including stroke) was listed either as the primary or secondary cause of death in 80% (211/264) of all deaths. CONCLUSIONS: Our results demonstrate the potential long-term and sustained benefit of nurse-initiated multidisciplinary protocols for management of fever, hyperglycemia, and swallowing dysfunction. These protocols should be a routine part of acute stroke care. CLINICAL TRIAL REGISTRATION: URL: http://www.anzctr.org.au. Unique identifier: ACTRN12608000563369.

Improving adherence to colorectal cancer surveillance guidelines: results of a randomised controlled trial.

BACKGROUND: Colorectal cancer (CRC) survivors are at increased risk of developing the disease again. Surveillance guidelines are aimed at maximising the early detection of recurring or new cancers and pre-cancerous polyps. The frequency and type of surveillance recommended depends on the type of treatment for the initial CRC, the extent of colonoscopic investigation prior to treatment and the results of previous surveillance tests. This paper aimed to test the effect of a paper-based educational intervention to improve adherence to colonoscopy following treatment for colorectal cancer. METHODS: People with a diagnosis of colorectal cancer within the last 10 months, aged ≥18 and English speaking were recruited through a population-based cancer registry in Australia. Participants were randomly allocated to either the intervention or control. Participants completed an interview at baseline. Self-reported participation in colonoscopy was obtained at 12 month followup by survey. Those allocated to the control received a generic pamphlet on colorectal cancer treatment; while intervention participants received a letter which provided specific information about guideline recommendations for surveillance colonoscopy. Rates of guideline adherence were compared between groups. The guideline recommendations for the timing of surveillance colonoscopy changed part way through the study. This change occurred after all intervention materials had been sent, but prior to all participants completing the 12 month follow up. Post hoc analyses were conducted to assess adherence to the new guidelines. RESULTS: Of the 767 participants, 604 (79%) had had surgery, had stage I - III disease and completed the baseline interview within 12 months of diagnosis (intervention = 305; control = 299). There was no significant difference between those adherent to surveillance colonoscopy guidelines, in the control (67, 27%) and intervention groups (80, 31%) at followup (difference = 4.3% (95%CI:-3.7%, 12%), χ 2(1df) = 1.09, P = 0.296). Overall, 246 (49%) participants were adherent to the new guidelines, compared to 147 (29%) adherent to the old guidelines. CONCLUSIONS: Results indicate the paper-based educational intervention is not effective in improving adherence to colorectal cancer surveillance guidelines for colonoscopy. TRIAL REGISTRATION NUMBER: ACTRN12609000628246 Registration date: 28/07/2009.