Study protocol for a randomised controlled trial to evaluate the use of melanoma surveillance photography to the Improve early detection of MelanomA in ultra-hiGh and high-risk patiEnts (the IMAGE trial).

INTRODUCTION: Melanoma surveillance photography (MSP) is a comprehensive surveillance method that comprises two- or three-dimensional total body photography with tagged digital dermoscopy, performed at prescribed intervals. It has the potential to reduce unnecessary biopsies and enhance early detection of melanoma, but it is not yet standard care for all high-risk patients in Australia. This protocol describes a randomised controlled trial (RCT) designed to evaluate the clinical impact and cost-effectiveness of using MSP for the surveillance of individuals at ultra-high or high risk of melanoma from a health system perspective. METHODS AND DESIGN: This is a registry-based, unblinded, multi-site, parallel-arm RCT that will be conducted over 3 years. We aim to recruit 580 participants from three Australian states: Victoria, New South Wales and Queensland, via state cancer registries or direct referral from clinicians. Eligible participants within 24 months of a primary cutaneous melanoma diagnosis will be randomised 1:1 to receive either MSP in addition to their routine clinical surveillance (intervention group) or routine clinical surveillance without MSP (control group). Most participants will continue surveillance with their usual care provider, and the frequency of follow-up visits in both groups will depend on the stage of their primary melanoma and risk factors. The primary outcome measure of the study is the number of unnecessary biopsies (i.e. false positives, being cases where a lesion is biopsied due to suspected melanoma on clinical examination, either with or without MSP, but the resulting histopathology finding is negative for melanoma). Secondary outcomes include the evaluation of health economic outcomes, quality of life and patient acceptability. Two sub-studies will explore the benefit of MSP in high-risk patients prior to a melanoma diagnosis and the diagnostic performance of MSP in the teledermatology setting compared to the en face clinical setting. DISCUSSION: This trial will determine the clinical efficacy, cost-effectiveness and affordability of MSP to facilitate policy decision-making at the national and local levels, across primary and specialist care. TRIAL REGISTRATION: ClinicalTrials.gov NCT04385732 . Registered on May 13, 2020.

High-Level Mobility Assessment Tool Normative Values for Children.

BACKGROUND: Physical therapists need to be able to evaluate high-level gross motor skills of children to determine their capacity to engage in activities such as running, jumping, hopping, and stair climbing. The High-Level Mobility Assessment Tool (HiMAT) has excellent interrater and retest reliability and is less susceptible to a ceiling effect than existing mobility scales in children who are 6 to 17 years old and have traumatic brain injury. OBJECTIVE: The purposes of this study were to develop normative HiMAT score ranges for Australian children and to investigate the relationship between children's HiMAT scores and their age, height, weight, and body mass index (BMI). DESIGN: This study used a cross-sectional design. METHODS: Children included in this study were 5 to 12 years old, had no condition affecting their mobility, could follow 2-stage instructions, and had written informed consent from their parent or guardian. A total 1091 children were assessed at their local school, where their height, weight, and HiMAT score were recorded. The relationships between children's age, height, weight, and BMI were summarized using Spearman rank correlations. Truncated regression models were used to determine the most appropriate predictor variable for developing sex-specific normative ranges. RESULTS: There was a positive correlation between children's HiMAT scores and their age, height, weight, and BMI. Age explained the most variability in HiMAT scores for both boys and girls. LIMITATIONS: The reliability, validity, and responsiveness of the HiMAT have not been tested across a broad range of children with mobility limitations. Normative data reported in this study are for Australian children only. CONCLUSIONS: HiMAT scores for children in this study increased with age, height, weight, and BMI. Age was the most appropriate variable for developing a normative dataset of HiMAT scores for children of primary school age.

Overcoming challenges to data quality in the ASPREE clinical trial.

BACKGROUND: Large-scale studies risk generating inaccurate and missing data due to the complexity of data collection. Technology has the potential to improve data quality by providing operational support to data collectors. However, this potential is under-explored in community-based trials. The Aspirin in reducing events in the elderly (ASPREE) trial developed a data suite that was specifically designed to support data collectors: the ASPREE Web Accessible Relational Database (AWARD). This paper describes AWARD and the impact of system design on data quality. METHODS: AWARD's operational requirements, conceptual design, key challenges and design solutions for data quality are presented. Impact of design features is assessed through comparison of baseline data collected prior to implementation of key functionality (n = 1000) with data collected post implementation (n = 18,114). Overall data quality is assessed according to data category. RESULTS: At baseline, implementation of user-driven functionality reduced staff error (from 0.3% to 0.01%), out-of-range data entry (from 0.14% to 0.04%) and protocol deviations (from 0.4% to 0.08%). In the longitudinal data set, which contained more than 39 million data values collected within AWARD, 96.6% of data values were entered within specified query range or found to be accurate upon querying. The remaining data were missing (3.4%). Participant non-attendance at scheduled study activity was the most common cause of missing data. Costs associated with cleaning data in ASPREE were lower than expected compared with reports from other trials. CONCLUSIONS: Clinical trials undertake complex operational activity in order to collect data, but technology rarely provides sufficient support. We find the AWARD suite provides proof of principle that designing technology to support data collectors can mitigate known causes of poor data quality and produce higher-quality data. Health information technology (IT) products that support the conduct of scheduled activity in addition to traditional data entry will enhance community-based clinical trials. A standardised framework for reporting data quality would aid comparisons across clinical trials. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number Register, ISRCTN83772183. Registered on 3 March 2005.

Quality of Life for 19,114 participants in the ASPREE (ASPirin in Reducing Events in the Elderly) study and their association with sociodemographic and modifiable lifestyle risk factors.

PURPOSE: To explore the relationship between sociodemographic and lifestyle variables with health-related quality of life (HRQoL) of a large cohort of 'healthy' older individuals. METHODS: The sample included individuals aged 65+ years from Australia (N = 16,703) and the USA (N = 2411) enrolled in the ASPirin in Reducing Events in the Elderly (ASPREE) multicentre placebo-controlled trial study and free of cardiovascular disease, dementia, serious physical disabilities or 'fatal' illnesses. The associations with the physical (PCS) and mental component scores (MCS) of HRQoL (SF-12 questionnaire) were explored using multiple linear regression models from data collected at baseline (2010-2014). RESULTS: The adjusted PCS mean was slightly higher in the USA (49.5 ± 9.1) than Australia (48.2 ± 11.6; p < 0.001), but MCS was similar in both samples (55.7 ± 7.5 and 55.7 ± 9.6, respectively; p = 0.603). Males, younger participants, better educated, more active individuals, or those currently drinking 1-2 alcoholic drinks/day showed a better HRQoL (results more evident for PCS than MCS), while current heavy smokers had the lowest physical HRQoL in both countries. Neither age, walking time, nor alcohol intake was associated with MCS in either cohort. CONCLUSIONS: Baseline HRQoL of ASPREE participants was higher than that reported in population-based studies of older individuals, but the associations between sociodemographic and lifestyle variables were consistent with the published literature. As the cohort ages and develops chronic diseases, ASPREE will be able to document HRQoL changes.

A peer-support lifestyle intervention for preventing type 2 diabetes in India: A cluster-randomized controlled trial of the Kerala Diabetes Prevention Program.

BACKGROUND: The major efficacy trials on diabetes prevention have used resource-intensive approaches to identify high-risk individuals and deliver lifestyle interventions. Such strategies are not feasible for wider implementation in low- and middle-income countries (LMICs). We aimed to evaluate the effectiveness of a peer-support lifestyle intervention in preventing type 2 diabetes among high-risk individuals identified on the basis of a simple diabetes risk score. METHODS AND FINDINGS: The Kerala Diabetes Prevention Program was a cluster-randomized controlled trial conducted in 60 polling areas (clusters) of Neyyattinkara taluk (subdistrict) in Trivandrum district, Kerala state, India. Participants (age 30-60 years) were those with an Indian Diabetes Risk Score (IDRS) ≥60 and were free of diabetes on an oral glucose tolerance test (OGTT). A total of 1,007 participants (47.2% female) were enrolled (507 in the control group and 500 in the intervention group). Participants from intervention clusters participated in a 12-month community-based peer-support program comprising 15 group sessions (12 of which were led by trained lay peer leaders) and a range of community activities to support lifestyle change. Participants from control clusters received an education booklet with lifestyle change advice. The primary outcome was the incidence of diabetes at 24 months, diagnosed by an annual OGTT. Secondary outcomes were behavioral, clinical, and biochemical characteristics and health-related quality of life (HRQoL). A total of 964 (95.7%) participants were followed up at 24 months. Baseline characteristics of clusters and participants were similar between the study groups. After a median follow-up of 24 months, diabetes developed in 17.1% (79/463) of control participants and 14.9% (68/456) of intervention participants (relative risk [RR] 0.88, 95% CI 0.66-1.16, p = 0.36). At 24 months, compared with the control group, intervention participants had a greater reduction in IDRS score (mean difference: -1.50 points, p = 0.022) and alcohol use (RR 0.77, p = 0.018) and a greater increase in fruit and vegetable intake (≥5 servings/day) (RR 1.83, p = 0.008) and physical functioning score of the HRQoL scale (mean difference: 3.9 score, p = 0.016). The cost of delivering the peer-support intervention was US$22.5 per participant. There were no adverse events related to the intervention. We did not adjust for multiple comparisons, which may have increased the overall type I error rate. CONCLUSIONS: A low-cost community-based peer-support lifestyle intervention resulted in a nonsignificant reduction in diabetes incidence in this high-risk population at 24 months. However, there were significant improvements in some cardiovascular risk factors and physical functioning score of the HRQoL scale. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Registry ACTRN12611000262909.

Risk factor management in a contemporary Australian population at increased cardiovascular disease risk.

BACKGROUND: Effective management of cardiovascular and chronic kidney disease risk factors offers longer, healthier lives and savings in healthcare. AIM: To examine risk factor management in participants of the SCReening Evaluation of the Evolution of New Heart Failure study, a self-selected population at increased cardiovascular disease risk recruited from members of a health insurance fund in Melbourne and Shepparton, Australia. METHODS: Inclusion criteria were age ≥ 60 years with one or more self-reported ischaemic or other heart diseases, irregular or rapid heart rhythm, cerebrovascular disease, renal impairment or treatment for hypertension or diabetes for ≥2 years. Exclusion criteria were known heart failure or cardiac abnormality on echocardiography or other imaging. Medical history, clinical examination, full blood examination and biochemistry (without lipids and glycated haemoglobin (HbA1c)) were performed for 3847 participants on enrolment, and blood pressure, lipids and HbA1c were measured 1-2 years after enrolment for 3203 participants. RESULTS: Despite 99% of 3294 participants with hypertension receiving antihypertensive medication, half had blood pressures >140/90 mmHg. Approximately 77% of participants were overweight or obese, with one third being obese. Additionally, 74% of participants at high cardiovascular disease risk had low-density lipoprotein cholesterol levels ≥2 mmol/L, one third of diabetic participants had HbA1c >7%, 22% had an estimated glomerular filtration rate < 60 mL/min/1.73m2 , and substantial proportions had under-utilisation of antiplatelet therapy and anticoagulation for atrial fibrillation and were physically inactive. CONCLUSIONS: This population demonstrated substantial potential to reduce cardiovascular and renal morbidity and mortality and healthcare costs through more effective management of modifiable risk factors.

SCReening Evaluation of the Evolution of New Heart Failure Study (SCREEN-HF): early detection of chronic heart failure in the workplace.

Objective The aim of the present study was to determine whether asymptomatic heart failure (HF) in the workplace is subject to the health worker effect, making screening using conventional risk factors combined with a cardiac biomarker, namely N-terminal pro B-type natriuretic peptide (NT-proBNP), as useful as in the general population. Methods Between June 2007 and December 2009 a 'well' population deemed at high risk for development of HF was identified through health insurance records. Blood was collected from volunteer participants for analysis of urea, electrolytes and creatinine, a full blood count and NT-proBNP. An echocardiogram was performed on selected participants based on high NT-proBNP concentrations. Results The mean left ventricular ejection fraction (LVEF) was significantly reduced in participants with the highest compared with the lowest NT-proBNP quintile. In multivariate analysis, log-transformed NT-proBNP was independently associated with impaired LVEF and with moderate to severe diastolic dysfunction after adjustment for age, sex, coronary artery disease, diabetes, hypertension and obesity. Conclusions A large burden of asymptomatic left ventricular dysfunction (AVLD) was observed in subjects aged 60 and over with plasma NT-proBNP in the top quintile that was independent of conventional risk factors and work status. HWE does not appear to operate in AVLD. NT-proBNP testing in a population with HF risk factors may cost-effectively identify those at greatest risk of developing HF in a working population and facilitate early diagnosis, treatment and maintenance of work capacity. What is known about the topic? Chronic heart failure (CHF) has several causes, the most common being hypertension and coronary ischaemia. CHF is a major health problem of increasing prevalence that severely impacts quality of life, shortens lives and reduces worker productivity. It is often not diagnosed early enough to take full advantage of ameliorating medication. What does this paper add? Population screening for CHF is not currently advocated. This may be because conventional risk factors must be used in combination and there is no useful biomarker available. Yet evidence (SOLVD (Studies of Left Ventricular Dysfunction trials) recommends early diagnosis. We believe the work place is an area of potential screening where there is little supporting evidence. This paper provides evidence that the biomarker NT-proBNP is a useful new tool that improves cost-effectiveness of screening in a selected population. Specifically, the paper recommends CHF screening in the population with the highest potential health gain (i.e. the working population) by the sector with the highest economic gain (i.e. employers). What are the implications for practitioners? The paper presents important health screening recommendations for medical and health and safety practitioners within a selected population of workers. We feel practitioners should consider screening for incipient heart failure, particularly within Australia's working population, to save lives, provide economic benefit and extend working longevity.

The extra resource burden of in-hospital falls: a cost of falls study.

OBJECTIVE: To quantify the additional hospital length of stay (LOS) and costs associated with in-hospital falls and fall injuries in acute hospitals in Australia. DESIGN, SETTING AND PARTICIPANTS: A multisite prospective cohort study conducted during 2011-2013 in the control wards of a falls prevention trial (6-PACK). The trial included all admissions to 12 acute medical and surgical wards of six Australian hospitals. In-hospital falls data were collected from medical record reviews, daily verbal reports by ward nurse unit managers, and hospital incident reporting and administrative databases. Clinical costing data were linked for three of the six participating hospitals to calculate patient-level costs. OUTCOME MEASURES: Hospital LOS and costs associated with in-hospital falls and fall injuries for each patient admission. RESULTS: We found that 966 of a total of 27 026 hospital admissions (3.6%) involved at least one fall, and 313 (1.2%) at least one fall injury, a total of 1330 falls and 418 fall injuries. After adjustment for age, sex, cognitive impairment, admission type, comorbidity and clustering by hospital, patients who had an in-hospital fall had a mean increase in LOS of 8 days (95% CI, 5.8-10.4; P < 0.001) compared with non-fallers, and incurred mean additional hospital costs of $6669 (95% CI, $3888-$9450; P < 0.001). Patients with a fall-related injury had a mean increase in LOS of 4 days (95% CI, 1.8-6.6; P = 0.001) compared with those who fell without injury, and there was also a tendency to additional hospital costs (mean, $4727; 95% CI, -$568 to $10 022; P = 0.080). CONCLUSION: Patients who experience an in-hospital fall have significantly longer hospital stays and higher costs. Programs need to target the prevention of all falls, not just the reduction of fall-related injuries.

Cluster randomised controlled trial of a peer-led lifestyle intervention program: study protocol for the Kerala diabetes prevention program.

BACKGROUND: India currently has more than 60 million people with Type 2 Diabetes Mellitus (T2DM) and this is predicted to increase by nearly two-thirds by 2030. While management of those with T2DM is important, preventing or delaying the onset of the disease, especially in those individuals at 'high risk' of developing T2DM, is urgently needed, particularly in resource-constrained settings. This paper describes the protocol for a cluster randomised controlled trial of a peer-led lifestyle intervention program to prevent diabetes in Kerala, India. METHODS/DESIGN: A total of 60 polling booths are randomised to the intervention arm or control arm in rural Kerala, India. Data collection is conducted in two steps. Step 1 (Home screening): Participants aged 30-60 years are administered a screening questionnaire. Those having no history of T2DM and other chronic illnesses with an Indian Diabetes Risk Score value of ≥60 are invited to attend a mobile clinic (Step 2). At the mobile clinic, participants complete questionnaires, undergo physical measurements, and provide blood samples for biochemical analysis. Participants identified with T2DM at Step 2 are excluded from further study participation. Participants in the control arm are provided with a health education booklet containing information on symptoms, complications, and risk factors of T2DM with the recommended levels for primary prevention. Participants in the intervention arm receive: (1) eleven peer-led small group sessions to motivate, guide and support in planning, initiation and maintenance of lifestyle changes; (2) two diabetes prevention education sessions led by experts to raise awareness on T2DM risk factors, prevention and management; (3) a participant handbook containing information primarily on peer support and its role in assisting with lifestyle modification; (4) a participant workbook to guide self-monitoring of lifestyle behaviours, goal setting and goal review; (5) the health education booklet that is given to the control arm. Follow-up assessments are conducted at 12 and 24 months. The primary outcome is incidence of T2DM. Secondary outcomes include behavioural, psychosocial, clinical, and biochemical measures. An economic evaluation is planned. DISCUSSION: Results from this trial will contribute to improved policy and practice regarding lifestyle intervention programs to prevent diabetes in India and other resource-constrained settings. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Registry: ACTRN12611000262909.

In-hospital falls and fall-related injuries: a protocol for a cost of fall study.

BACKGROUND: In-hospital falls are common and pose significant economic burden on the healthcare system. To date, few studies have quantified the additional cost of hospitalisation associated with an in-hospital fall or fall-related injury. The aim of this study is to determine the additional length of stay and hospitalisation costs associated with in-hospital falls and fall-related injuries, from the acute hospital perspective. METHODS AND DESIGN: A multisite prospective study will be conducted as part of a larger falls-prevention clinical trial-the 6-PACK project. This study will involve 12 acute medical and surgical wards from six hospitals across Australia. Patient and admission characteristics, outcome and hospitalisation cost data will be prospectively collected on approximately 15 000 patients during the 15-month study period. A review of all in-hospital fall events will be conducted using a multimodal method (medical record review and daily verbal report from the nurse unit manager, triangulated with falls recorded in the hospital incident reporting and administrative database), to ensure complete case ascertainment. Hospital clinical costing data will be used to calculate patient-level hospitalisation costs incurred by a patient during their inpatient stay. Additional hospital and hospital resource utilisation costs attributable to in-hospital falls and fall-related injuries will be calculated using linear regression modelling, adjusting for a priori-defined potential confounding factors. DISCUSSION: This protocol provides the detailed statement of the planned analysis. The results from this study will be used to support healthcare planning, policy making and allocation of funding relating to falls prevention within acute hospitals.

Cluster randomized controlled trial of a peer support program for people with diabetes: study protocol for the Australasian Peers for Progress study.

BACKGROUND: Well managed diabetes requires active self-management in order to ensure optimal glycaemic control and appropriate use of available clinical services and other supports. Peer supporters can assist people with their daily diabetes self-management activities, provide emotional and social support, assist and encourage clinical care and be available when needed. METHODS: A national database of Australians diagnosed with type 2 diabetes is being used to invite people in pre-determined locations to participate in community-based peer support groups. Peer supporters are self-identified from these communities. All consenting participants receive diabetes self-management education and education manual prior to randomization by community to a peer support intervention or usual care. This multi-faceted intervention comprises four interconnected components for delivering support to the participants. (1) Trained supporters lead 12 monthly group meetings. Participants are assisted to set goals to improve diabetes self-management, discuss with and encourage each other to strengthen linkages with local clinical services (including allied health services) as well as provide social and emotional support. (2) Support through regular supporter-participant or participant-participant contact, between monthly sessions, is also promoted in order to maintain motivation and encourage self-improvement and confidence in diabetes self-management. (3) Participants receive a workbook containing diabetes information, resources and community support services, key diabetes management behaviors and monthly goal setting activity sheets. (4) Finally, a password protected website contains further resources for the participants. Supporters are mentored and assisted throughout the intervention by other supporters and the research team through attendance at a weekly teleconference. Data, including a self-administered lifestyle survey, anthropometric and biomedical measures are collected on all participants at baseline, 6 and 12 months. The primary outcome is change in cardiovascular disease risk using the UKPDS risk equation. Secondary outcomes include biomedical, quality of life, psychosocial functioning, and other lifestyle measures. An economic evaluation will determine whether the program is cost effective. DISCUSSION: This manuscript presents the protocol for a cluster randomized controlled trial of group-based peer support for people with type 2 diabetes in a community setting. Results from this trial will contribute evidence about the effectiveness of peer support in achieving effective self-management of diabetes. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ANZCTR); ACTRN12609000469213.

Health resource utilisation costs in acute patients with persistent midline cervical tenderness following road trauma.

INTRODUCTION: The costs associated with patients discharged with isolated clinician-elicited persistent midline tenderness and negative computed tomography (CT) findings have not been reported. Our aim was to determine the association of acute and post-acute patient and injury characteristics with health resource costs in such patients following road trauma. METHODS: In a prospective cohort study, road trauma patients presenting with isolated persistent midline cervical tenderness and negative CT, who underwent additional acute imaging with MRI, were recruited. Patients were reviewed in the outpatient spine clinic following discharge, and were followed up at 6 and 12 months post-trauma. Multivariate linear regression was used to assess the association of injury mechanism, clinical assessment, socioeconomic factors and outcome findings with health resource costs generated in the acute hospital and post-acute periods. RESULTS: There were 64 patients recruited, of whom 24 (38%) had cervical spine injury detected on MRI. Of these, 2 patients were managed operatively, 6 were treated in cervical collars and 16 had the cervical spine cleared and were discharged. At 12 months, there were 25 patients (44%) with residual neck pain, and 22 (39%) with neck-related disability. The mean total cost was AUD $10,153 (SD=10,791) and the median was $4015 (IQR: 3044-6709). Transient neurologic deficit, which fully resolved early in the emergency department, was independently associated with higher marginal mean acute costs (represented in the analysis by the ß coefficient) by $3521 (95% CI: 50-6880). Low education standard (ß coefficient: $5988, 95% CI: 822-13,317), neck pain at 6 months (ß coefficient: $4017, 95% CI: 426-9254) and history of transient neurologic deficit (ß coefficient: $8471, 95% CI: 1766-18,334) were associated with increased post-acute costs. CONCLUSION: In a homogeneous group of road trauma patients with non fracture-related persistent midline cervical tenderness, health resource costs varied considerably. As long term morbidity is common in this population, a history of resolved neurologic deficit may require greater intervention to mitigate costs. Additionally, adequate communication between acute and community care providers is essential in order to expedite the recovery process through early return to normal daily activities.

Acetabular rim lesions: arthroscopic assessment and clinical relevance.

PURPOSE: The purpose of this study was to investigate whether acetabular morphology may influence both pathogenesis and prognosis of the acetabular rim lesions and to propose a new system to classify labral tears. METHODS: We assessed radiographic and arthroscopic findings in 81 patients (40 male and 41 female patients, 86 hips) aged from 16 to 74 years (median, 31 years) who underwent hip arthroscopy. RESULTS: Acetabular rim lesions were associated with four different hip morphologies. Eleven (32 %) of 34 patients with severe rim lesions underwent hip arthroplasty for progressive symptoms, whereas no patient with early rim lesion reported significant progression of symptoms. The strategy of treatment was changed in 33 % of the patients undergoing arthroscopy before undertaking peri-acetabular osteotomy. CONCLUSIONS: Hip arthroscopy avoids more invasive procedures in patients with early acetabular rim lesions.

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

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

Comparing the responsiveness of functional outcome assessment measures for trauma registries.

BACKGROUND: Measuring long-term disability and functional outcomes after major trauma is not standardized across trauma registries. An ideal measure would be responsive to change but not have significant ceiling effects. The aim of this study was to compare the responsiveness of the Glasgow Outcome Scale (GOS), GOS-Extended (GOSE), Functional Independence Measure (FIM), and modified FIM in major trauma patients, with and without significant head injuries. METHODS: Patients admitted to two adult Level I trauma centers in Victoria, Australia, who survived to discharge from hospital, were aged 15 years to 80 years with a blunt mechanism of injury, and had an estimated Injury Severity Score >15 on admission, were recruited for this prospective study. The instruments were administered at baseline (hospital discharge) and by telephone interview 6 months after injury. Measures of responsiveness, including effect sizes, were calculated. Bootstrapping techniques, and floor and ceiling effects, were used to compare the measures. RESULTS: Two hundred forty-three patients participated, of which 234 patients (96%) completed the study. The GOSE and GOS were the most responsive instruments in this major trauma population with effect sizes of 5.3 and 4.4, respectively. The GOSE had the lowest ceiling effect (17%). CONCLUSIONS: The GOSE was the instrument with greatest responsiveness and the lowest ceiling effect in a major trauma population with and without significant head injuries and is recommended for use by trauma registries for monitoring functional outcomes and benchmarking care. The results of this study do not support the use of the modified FIM for this purpose.

The spatial distribution of esophageal and gastric cancer in Caspian region of Iran: an ecological analysis of diet and socio-economic influences.

Recent studies have suggested a systematic geographic pattern of esophageal cancer (EC) and gastric cancer (GC) incidence in the Caspian region of Iran. The aims of this study were to investigate the association between these cancers and the region's dietary and socioeconomic risk factors and to map EC and GC after adjustment for the risk factors and the removal of random and geographic variations from area specific age standardised incidence ratios (SIRs). We obtained cancer data from the Babol cancer registry from 2001 to 2005, socioeconomic indices from the Statistical Centre of Iran, and dietary patterns from the control group in a case control study conducted in the study region. Regression models were fitted to identify significant covariates, and clusters of elevated rates were identified. We found evidence of systematic clustering for EC and GC in men and women and both sexes combined. EC and GC SIRs were lower in urban areas, and were also lower in areas of high income. EC SIRs were lower in areas with higher proportions of people having unrestricted food choice and higher in areas with higher proportions of people with restricted food choice. EC and GC were associated with aggregated risk factors, including income, urbanisation, and dietary patterns. These variables represent the influence of improved lifestyle which has coincided with a decrease in upper gastrointestinal cancer frequency over recent decades but which has not necessarily been uniform throughout the region.

Risk of cardiovascular disease and diabetes in a working population with sedentary occupations.

OBJECTIVE: To assess the prevalence of risk factors and risk for cardiovascular disease and Type 2 diabetes in employees with sedentary occupations enrolled in a workplace health-promotion program. METHODS: Participants (n = 762) were recruited from ten Melbourne workplaces, participating in a physical activity program. Demographic, behavioral, biomedical, and physical measurements were collected. RESULTS: The majority of employees were not meeting recommended guidelines for physical activity (62%), fruit intake (70%), vegetable intake (86%), body mass index (58%), or waist circumference (53%). Most had intermediate (53%) or high (7%) risk of developing Type 2 diabetes. CONCLUSIONS: The majority of Australian adults in sedentary occupations were not meeting guidelines for a number of chronic disease risk factors and a substantial proportion were unaware of their increased risk. This study supports the potential of chronic disease risk factor detection and intervention programs in the workplace.

A randomized controlled trial of an interactive voice response telephone system and specialist nurse support for childhood asthma management.

OBJECTIVES: To evaluate the effects of an automated interactive voice response system (IVR) and Specialist Nurse Support to reduce health care utilization and improve health-related quality of life in children with asthma. STUDY DESIGN: A randomized controlled trial in 121 children with doctor-diagnosed asthma and an acute presentation with asthma in the previous 12 months aged between 3 and 16 years. Children were randomized to one of three groups for a 6-month intervention receiving asthma education and management support from a Specialist Nurse by telephone or e-mail (N = 41), from IVR (N = 39), or receiving usual care (control group; N = 41). Outcomes included health care utilization and use of oral steroid rescue. Health-related quality of life (HRQOL) data using the Pediatric Asthma Quality of Life Questionnaire and Pediatric Quality of Life Inventory were collected at baseline and at the end of the study. RESULTS: There was no statistically significant benefit identified for either the IVR or the Nurse Support interventions for health care utilization, use of oral steroid rescue, or HRQOL compared with controls. Relative to controls, the incremental costs were -A$225.73 (95% confidence interval [CI]: -A$840, A$391) per child for the Nurse Support intervention and -A$451.45 (-A$1075, A$173) per child for IVR. The results were most sensitive to the frequency of admissions to hospital. CONCLUSION: This study suggested that both IVR and Nurse Support interventions may be cost-saving from a health system perspective, with IVR providing the greatest benefit and this pilot study provides a strong basis for developing larger trials with longer follow-up.

The economic implications of treating atherothrombotic disease in Australia, from the government perspective.

BACKGROUND: The management of atherothrombotic disease is responsible for a large proportion of direct medical costs in most countries, imposing a substantial financial burden on health care payers. There is limited knowledge about direct per-person medical costs using a "bottom-up" approach. OBJECTIVE: This study was designed to estimate the per-person direct medical costs incurred by communitybased subjects in Australia who have or are at high risk for atherothrombotic disease. The perspective was a governmental one, at the federal level for pharmaceuticals and at the state level for hospitalizations. METHODS: One-year follow-up data were obtained for Australian participants in the international REACH (Reduction of Atherothrombosis for Continued Health) Registry who were aged >or=45 years and had either established atherothrombotic disease (coronary artery disease, cerebrovascular disease, or peripheral artery disease [PAD]) or >or=3 risk factors for atherothrombotic disease. Information was extracted on the use of cardiovascular medications, hospitalizations, general practice visits, clinical pathology and imaging studies, and use of rehabilitation services. Bottom-up costing was undertaken by assigning unit costs to each health care item, based on Australian government reimbursement data for 2006-2007. Costs were estimated in Australian dollars. RESULTS: Data for 2873 Australian participants in the REACH Registry were included in the analysis. Mean (SD) annual pharmaceutical costs per person were A$1388 (A$645). Mean ambulatory care costs per person were A$704 (A$492), and mean hospitalization costs were A$10,711 (A$10,494). Compared with participants with >or=3 risk factors (adjusted for age and sex), participants with 2 to 3 affected vascular territories incurred A$160 more in mean pharmaceutical costs (95% CI, 78 to 256) and A$181 more in ambulatory care costs (95% CI, 107 to 252). Mean ambulatory care costs were A$132 greater among participants with PAD only relative to those with >or=3 risk factors (95% CI, 19 to 272). Hospital costs were not significantly increased with an increasing number of affected vascular territories. The greatest difference in direct hospital costs (A$943) was between participants with PAD relative to those with >or=3 risk factors (95% CI, -564 to 3545). CONCLUSIONS: From the government perspective, management of atherothrombotic disease in Australia was costly during the period studied, particularly among those with PAD only or disease affecting 2 to 3 vascular territories. Hospitalization accounted for the majority of health care expenditure associated with atherothrombotic disease, although the number of hospitalized participants was relatively small.

Inequalities in cardiovascular disease mortality: the role of behavioural, physiological and social risk factors.

BACKGROUND: While the relationship between socio-economic disadvantage and cardiovascular disease (CVD) is well established, the role that traditional cardiovascular risk factors play in this association remains unclear. The authors examined the association between education attainment and CVD mortality and the extent to which behavioural, social and physiological factors explained this relationship. METHODS: Adults (n=38,355) aged 40-69 years living in Melbourne, Australia were recruited in 1990-1994. Subjects with baseline CVD risk factor data ascertained through questionnaire and physical measurement were followed for an average of 9.4 years with CVD deaths verified by review of medical records and autopsy reports. RESULTS: CVD mortality was higher for those with primary education only, compared with those who had completed tertiary education, with an HR of 1.66 (95% CI 1.10 to 2.49) after adjustment for age, country of birth and gender. Those from the lowest educated group had a more adverse cardiovascular risk factor profile compared with the highest educated group, and adjustment for these risk factors reduced the HR to 1.18 (95% CI 0.78 to 1.77). In analysis of individual risk factors, smoking and waist circumference explained most of the difference in CVD mortality between the highest and lowest education groups. CONCLUSIONS: Most of the excess CVD mortality in lower socio-economic groups can be explained by known risk factors, particularly smoking and overweight. While targeting cardiovascular risk factors should not divert efforts from addressing the underlying determinants of health inequalities, it is essential that known risk factors are addressed effectively among lower socio-economic groups.