Research

Objectives: To describe associations between birthweight and infant, child and early adult mortality from natural causes in a remote Australian Aboriginal community against a background of rapidly changing mortality due to better health services.Design, participants and setting: Cohort study of 995 people with recorded birthweights who were born between 1956 and 1985 to an Aboriginal mother in a remote Australian Aboriginal community. Participants were followed through to the end of 2006.Main outcome measures: Rates of natural deaths of infants (aged 0 to < 1 year), children (aged 1 to < 15 years) and adults (aged 15 to < 37 years), compared by birth intervals (1956–1965, 1966–1975 and 1976–1985 for infants and children, and 1956–1962 and 1963–1969 for adults) and by birthweight.Results: Birthweights were low, but increased over time. Deaths among infants and children decreased dramatically over time, but deaths among adults did not. Lower birthweights were associated with higher mortality. Adjusted for birth interval, hazard ratios for deaths among infants, children and adults born at weights below their group birthweight medians were 2.30 (95% CI, 1.13–4.70), 1.78 (95% CI, 1.03–3.07) and 3.49 (95% CI, 1.50–8.09), respectively. The associations were significant individually for deaths associated with diarrhoea in infants, with cardiovascular and renal disease in adults, and marginally significant for deaths from pulmonary causes in children and adults.Conclusion: The striking improvements in infant and child survival over time must be applauded. We confirmed a predisposing effect of lower birthweights on deaths in infants and children, and showed, for the first time, an association between lower birthweights and deaths in adults. Together, these factors are probably contributing to the current epidemic of chronic disease in Aboriginal people, an effect that will persist for decades. Similar phenomena are probably operating in developing countries.

Wendy E Hoy FRACP · Jennifer L Nicol BSc(Hons), MSc(Stats)

Objective: To assess the extent to which general practitioners in Australia are engaged in identifying age-related hearing loss and facilitating its management.Design, setting and participants: Cross-sectional analysis of data collected between 1998 and 2000 from the Blue Mountains Hearing Study (BMHS), a representative population-based cohort of people aged ≥ 50 years in two postcode areas west of Sydney. Also analysed were data collected between 2003 and 2008 from random samples of Australian GPs who participated in the Bettering the Evaluation and Care of Health (BEACH) study, a national continuous cross-sectional survey of GP activity.Main outcome measures: Rate of facilitating management and identification of hearing loss in older patients; content of GP–patient encounters with hearing-impaired people; characteristics of participants seeking help from their GP.Results: Of older people in the BMHS with measured (objective) bilateral hearing loss, about a third reported seeking help frovm their GP. BEACH survey data showed that only about 3 per 1000 GP consultations with patients aged ≥ 50 years involved management of age-related hearing loss. For every 100 age-related hearing problems managed, GPs undertook 12 procedural treatments, provided 20 referrals to specialists, and made 29 referrals to allied health professionals.Conclusion: In their routine consultations with patients, GPs have opportunities to identify hearing loss and appropriately refer patients to specialists or allied health professionals. Although GPs are responding to patient presentations for hearing loss, referring around 50% of cases, there appear to be relatively few cases in which hearing loss is identified opportunistically. Levels of identification and management of hearing loss by GPs in Australia are relatively low.

Julie M Schneider BAppSc(Hons), PhD · Bamini Gopinath BTech(Hons), PhD · Catherine M McMahon PhD · Helena C Britt BA, PhD · Christopher M Harrison BPsych(Hons), MSocHlth · Tim Usherwood MD, BS · Stephen R Leeder MD, PhD · Paul Mitchell MD, PhD, FRANZCO

Objective: To compare the clinical effectiveness of single-dose azithromycin treatment with 7 days of amoxycillin treatment among Aboriginal children with acute otitis media (AOM) in rural and remote communities in the Northern Territory. Design, setting and participants: Aboriginal children aged 6 months to 6 years living in 16 rural and remote communities were screened for AOM. Those diagnosed with AOM were randomly allocated to receive either azithromycin (30 mg/kg as a single dose) or amoxycillin (50mg/kg/day in two divided doses for a minimum of 7 days). We used a double-dummy method to ensure blinding. Our study was conducted from 24 March 2003 to 20 July 2005. Main outcome measures: Failure to cure AOM by the end of therapy; nasal carriage of Streptococcus pneumoniae and non-capsular Haemophilus influenzae (NCHi). Results: We followed 306 of 320 children (96%) allocated to the treatment groups. Single-dose azithromycin did not reduce (or increase) the risk of clinical failure (50% failure rate [82/165]) compared with amoxycillin (54% failure rate [83/155]) (risk difference [RD], – 4% [95% CI, – 15% to 7%]; P = 0.504). Compared with amoxycillin, azithromycin significantly reduced the proportion of children with nasal carriage of S. pneumoniae (27% v 63%; RD, – 36% [95% CI, – 47% to – 26%]; P < 0.001) and NCHi (55% v 85%; RD, – 30% [95% CI, – 40% to – 21%]; P < 0.001). Nasal carriage of S. pneumoniae with intermediate or full resistance to penicillin was lower (but not significantly so) in the azithromycin group (10% v 16%), but this group had significantly increased carriage of azithromycin-resistant S. pneumoniae (10% v 3%; RD, 7% [95% CI, 0.1% to 12%]; P = 0.001). Carriage of β-lactamase-producing NCHi was about 5% in both groups. Conclusion: Although azithromycin reduced nasal carriage of S. pneumoniae and NCHi, clinical failure was high in both treatment groups. The possibility of weekly azithromycin treatment in children with persistent AOM should be evaluated. Trial registration: Australian Clinical Trials Registry ACTRN 12609000691246.

Peter S Morris MB BS, PhD, FRACP · Gaudencio Gadil MD · Gabrielle B McCallum BNurs, MPH · Cate A Wilson EN, BPsych(Hons) · Heidi C Smith-Vaughan BAppSci, PhD · Paul Torzillo MB BS, FRACP, JFICM · Amanda J Leach BAgSc(Hons), MAgSc, PhD

Health services research is now a top priority for the National Health and Medical Research Council Health research has many objectives. It can develop fundamental knowledge about human health and what causes ill health, improve means of diagnosing diseases and treating patients, provide evidence for preventive health strategies and interventions, invent new devices and agents to treat and cure disease, and provide the community with better knowledge on how to safeguard their health and wellbeing. It is therefore surprising that the health system has historically been the focus of much less research than has been concentrated on the health of individuals. During the past decade, Australia has increased its research effort into public health and preventive health through National Health and Medical Research Council (NHMRC) funding, from a budget of $10.6 million in 1997 — the last year of the Public Health Research and Development Committee (PHRDC) — to $91.5 million in 2009. (The PHRDC was established by the NHMRC in 1987 in response to the Kerr White Report,1 published in the mid 1980s; in 1997, its role was absorbed, along with that of the then Medical Research Committee, into the newly created NHMRC Research Committee.) But health services research has lagged and in 2009 attracted only $32.4 million (out of a total NHMRC research budget of $706.9 million). Of 3111 applications received by the NHMRC for project grants in 2009, only 134 (0.4%) were categorised by applicants as being for health services research. There is further support for health services and systems research from the health system itself, but little by way of a coordinated approach that recruits the most able researchers. In 2006, the NHMRC made a commitment to increase its support of health services research — in line with the recommendations of the Investment Review of Health and Medical Research review committee chaired by John Grant, which reported in 2004 to the then Minister for Health and Ageing.2 A special advisory group was established by the NHMRC, chaired by Professor Sally Redman of the Sax Institute and the University of Sydney, to set up a framework to influence and support the infusion of evidence from research into improving the health care system and the actions of health professionals, and into public health policy. This committee completed its work in early 2007, and its report was considered by the NHMRC’s Research Committee and Council.3 Both agreed that the NHMRC Partnerships for Better Health initiative be established. In 2008, the NHMRC committed $250 million over 5 years — commencing in 2009 — to support the Partnerships for Better Health initiative, which comprises two key initiatives. The first key initiative is the Partnership Projects scheme, which aims to: provide support for research that addresses the delivery, organisation and funding of programs and services that affect health; and encourage researchers and partner organisations to form alliances to identify research projects, conduct research, interpret their findings, and promote the use of their findings to influence design and evaluation of health and health care policy and practice. As with all NHMRC funding schemes, a rigorous peer-review process was established for this scheme to ensure that only the best research and researchers would be funded. Applications for Partnership Projects were called for on 25 July 2008 and closed on 19 December 2008. This longer than normal application period was considered essential, given that a requirement of applications was that a partnership be established between applicants and organisations involved in health care. One hundred and thirteen applications were received, with a wide range of health bodies partnering health researchers. The applications were reviewed by a panel that consisted of experienced health services researchers (including two from New Zealand), as well as experienced, research-trained state and federal health officers. The 27 successful applications, valued at a total of $21 million, were announced by the Prime Minister on 16 October 2009. They cover a wide range of health services research, including: improving services for people with dual sensory impairment (vision and hearing); improving maternity care services; studies in general practice (including guideline implementation for chronic disease, Indigenous primary care services and diabetic retinopathy monitoring); acute stroke care; sports safety; hepatitis C assessment and treatment in drug users; allied health services in rehabilitation; childhood mental health; system design for the care of pregnant women with diabetes; public health interventions to reduce metabolic syndrome; patient-centred chronic care in Indigenous communities; rural cancer care; and improving hand hygiene in health care settings. A full list of these grants is available at http://www.nhmrc.gov.au/grants/partnerships.htm. The partner organisations, which have committed to work with the researchers with a view to improving health policy and practice, include state health authorities and non-government organisations, as well as community groups, Indigenous community groups and commercial associations. Other partner organisations include: Australian Commission on Safety and Quality in Health Care Sydney South West Area Health Service Australian Football League Hepatitis C Council of NSW Cancer Council Australia Water Quality Research Australia Australian Food and Grocery Council Diabetes Australia Australian Red Cross Blood Service Epilepsy Australia National Stroke Foundation. The second key initiative in the Partnerships for Better Health initiative will be the Partnership Centres for Research Excellence program. This will promote collaboration between researchers and those working in health and the health care system, and will be announced in 2010. A discussion document developed by an international team — Jonathan Lomas (former Director, Canadian Health Services Research Foundation), Sally Davies (Director General, Research and Development, Department of Health, United Kingdom) and Chris Baggoley (Chief Executive Officer, Australian Commission on Safety and Quality in Health Care) — was released for discussion as part of a final consultation process in July 2009.4 The NHMRC Research Committee will consider this feedback in late 2009. To further promote health services research, the NHMRC introduced the Capacity Building Grants in Population Health and Health Services Research program in 2008, which in 2009 was transformed into the Centres of Research Excellence Scheme. This scheme does not require contributions from partner organisations, and aims to support teams of researchers to pursue collaborative research and develop research capacity in health services. The cost to Australia of its health system is more than 9% of its gross domestic product, and exceeded $100 billion per year for the first time last year.5 Although many health professionals do not like to regard health care as an industry, it is the second largest employer of Australians and most of us use its services each year. High-quality research and development is therefore essential for developing a health system that operates on the basis of evidence and ensuring that the health system can be, in the words of the National Health and Hospitals Reform Commission, an “agile, self-improving” system into the future.6

Warwick P Anderson BSc(Hons), PhD · Elim M Papadakis BA(Hons), PhD

Objectives: To explore National Health and Medical Research Council (NHMRC) funding for each National Health Priority Area (NHPA) over time and by grant type, and to quantify the relationship between grants awarded and a range of measures of societal burden of disease (BoD).Design and setting: We conducted a retrospective analysis of NHMRC funding for each NHPA from 2000 to 2008 to assess the strength of correlation between level of NHMRC funding and contribution of each health condition to BoD. Information on mortality, incidence, prevalence, “healthy” years of life lost due to disability (YLD), years of life lost due to premature mortality (YLL) and disability-adjusted life-years (DALYs) was obtained from the 2003 Australian BoD study. Information on health system expenditure for each NHPA was obtained from an Australian Institute of Health and Welfare report.Main outcome measures: Observed versus expected number of grants; amount of funding allocated to each NHPA; relative contribution of each NHPA health condition to BoD.Results: 6099 new and continuing NHMRC grants were linked to NHPAs. Total NHMRC funding by NHPA was strongly correlated with YLL and DALYs, but there was no clear association between the amount of funding per NHPA and YLD or health system expenditure. Based on the proportional contribution of each NHPA health condition to total NHPA-related DALYs, a higher than expected number of grants was allocated to diabetes and cancer research, and a lower than expected number to injury and mental health research.Conclusions: Some of Australia’s NHPAs are better funded than others. The NHMRC could begin to redress this imbalance by allocating research and workforce development funding to less well developed research areas to ensure appropriate resourcing that is commensurate with their contribution to BoD.

Rebecca J Mitchell MA(Psych), MOHS, PhD · Rod J McClure PhD, FAFPHM · Jake Olivier PhD · Wendy L Watson BSc(Hons), MA, PhD

Objective: To measure the level of functional health literacy (FHL) in an Australian population, and to explore the level of risk associated with level of FHL.Design, setting and participants: Cross-sectional, random population survey administered to 2824 South Australians aged ≥ 15 years, September – October 2008.Main outcome measures: Newest Vital Sign as a measure of FHL, self-reported general health status, and use of health services.Results: 24% of respondents were at risk of limited FHL, and 21% had a high likelihood of inadequate FHL; this increased with age (≥ 65 years, 50% v 25–44 years, 11%). In multiple logistic regression models, a high likelihood of inadequate FHL was significantly more common among those with lower education (left school ≤ 15 years of age, odds ratio [OR], 8.1; 95% CI, 4.8–13.6); with lower annual income (< $20 000, OR, 4.1; 95% CI, 2.3–7.4); who were born in countries other than Australia, New Zealand, the United Kingdom and Ireland; and with poorer health status (OR, 1.6; 95% CI, 1.2–2.2). Inadequate FHL was significantly less common among females (OR, 0.6; 95% CI, 0.5–0.8). People with inadequate or at-risk FHL were significantly more likely to report having diabetes, cardiac disease or stroke, and significantly less likely to have recently attended a doctor. Respondents aged ≥ 65 years with inadequate FHL were more likely to have been admitted to hospital (OR, 2.2; 95% CI, 1.1–4.5).Conclusion: Many Australians are likely to have limited health literacy, and this is a risk to effective health care delivery and health improvement across the community.

Robert J Adams MD, FRACP · Sarah L Appleton BSc · Catherine L Hill MD, BS, FRACP · Mark Dodd BEc · Christopher Findlay BEc, MEc, PhD · David H Wilson MPH, PhD

Objective: To describe the patterns of screening for hepatitis C virus (HCV) infection in methadone-maintained pregnant women and their infants.Design, setting and patients: Retrospective review of medical records from one rural and two metropolitan hospitals in New South Wales for pregnant women on methadone maintenance treatment and infants born to these women between 1 January 2000 and 31 December 2006, as well as records for pregnant women who were not on methadone treatment.Main outcome measures: Rates of anti-HCV antibody and HCV RNA testing for pregnant women and their infants, and ages at which infants attended follow-up appointments.Results: Of 295 pregnant women on methadone maintenance treatment, 288 were tested for anti-HCV antibodies (98%), compared with 1995 of 9987 women who were not on methadone treatment (20%) (P < 0.001). Seropositive results were obtained for 243 women in the methadone group (84%) and 54 in the non-methadone group (3%) (P < 0.001), of whom 44 (18%) and 17 (31%), respectively, were subsequently tested for HCV RNA (P = 0.03). HCV RNA test results were positive for 31 (70%) and 10 (59%) seropositive women in the methadone and non-methadone groups, respectively (P = 0.39). Of infants of HCV-seropositive methadone-maintained mothers, 27% of those for whom we had follow-up attendance data received HCV screening, and one of these infants tested positive for anti-HCV antibodies and HCV RNA.Conclusions: Screening for HCV infection in the high-risk population of pregnant women on methadone maintenance treatment and their infants is inadequate. This could lead to significant underdetection of active HCV infection in this high-risk population, and their infants. Current screening guidelines may therefore need to be revised.

Anthony J W Liu,* MB BS, FRACP, MPH · Ethan I An,* BMedSc, MB BS(Hons) · Henry G Murray MB ChB, MRCOG, FRACOG · Emma Tetstall BSc(Hons), MB BS(Hons) · Marcel J Leroi FRACP, FRCPA, MMed(ClinEpi) · Ralph K H Nanan Dr med Habil (Germany), FRACP

Objectives: To compare the use of evidence-based pharmacological and invasive treatments and 12-month mortality rates between patients with and without diabetes who present with acute myocardial infarction (MI), and to explore the relationship between these treatments and late clinical outcomes.Design and setting: Prospective, nationwide multicentre registry: the Acute Coronary Syndrome Prospective Audit (ACACIA).Patients: Patients presenting to 24 metropolitan and 15 non-metropolitan hospitals with acute coronary syndrome (ACS) and a final discharge diagnosis of acute MI between November 2005 and July 2007.Main outcome measure: All-cause mortality at 12 months.Results: Nearly a quarter of 1744 patients with a final diagnosis of acute MI had a history of diabetes on presentation. Patients with diabetes were older, with a greater prevalence of comorbidities than non-diabetic patients, and were less likely to be treated at discharge with evidence-based medications (aspirin, clopidogrel, a statin and/or a β-blocker) or to receive early invasive procedures. After adjusting for baseline characteristics and therapeutic interventions, diabetes at presentation was independently associated with a higher mortality at 12 months after MI (hazard ratio, 1.79; 95% CI, 1.18–2.72; P = 0.007). Early invasive management and discharge prescription of guideline-recommended medications were associated with a significantly reduced hazard of mortality at 12 months.Conclusion: Patients with diabetes have a higher risk than non-diabetic patients of late mortality following an acute MI, yet receive fewer guideline-recommended medications and early invasive procedures. Increased application of proven pharmacotherapies and an early invasive management strategy in patients with diabetes presenting with ACS might improve their outcomes.Study protocol number (sanofi-aventis): PML-0051.

Joseph Hung FRACP, FACC, FCSANZ · David B Brieger PhD, FRACP, FCSANZ · John V Amerena FRACP, FACC, FCSANZ · Steven G Coverdale MB ChB, FRACP · James M Rankin MB BS, FRACP · Carolyn M Astley RN, BN(Hons) · Ashish Soman MB BS, MRCP(UK) · Derek P Chew MB BS, MPH, FRACP

Objective: To develop a tool to allow Australian hospitals to monitor the range of hospital-acquired diagnoses coded in routine data in support of quality improvement efforts.Design and setting: Secondary analysis of abstracted inpatient records for all episodes in acute care hospitals in Victoria for the financial year 2005–06 (n = 2.032 million) to develop a classification system for hospital-acquired diagnoses; each record contains up to 40 diagnosis fields coded with the ICD-10-AM (International Classification of Diseases, 10th revision, Australian modification).Main outcome measure: The Classification of Hospital Acquired Diagnoses (CHADx) was developed by: analysing codes with a “complications” flag to identify high-volume code groups; assessing their salience through an iterative review by health information managers, patient safety researchers and clinicians; and developing principles to reduce double counting arising from coding standards.Results: The dataset included 126 940 inpatient episodes with any hospital-acquired diagnosis (complication rate, 6.25%). Records had a mean of three flagged diagnoses; including unflagged obstetric and neonatal codes, 514 371 diagnoses were available for analysis. Of these, 2.9% (14 898) were removed as comorbidities rather than complications, and another 118 640 were removed as redundant codes, leaving 380 833 diagnoses for grouping into CHADx classes. We used 4345 unique codes to characterise hospital-acquired conditions; in the final CHADx these were grouped into 144 detailed subclasses and 17 “roll-up” groups.Conclusions: Monitoring quality improvement requires timely hospital-onset data, regardless of causation or “preventability” of each complication. The CHADx uses routinely abstracted hospital diagnosis and condition-onset information about in-hospital complications. Use of this classification will allow hospitals to track monthly performance for any of the CHADx indicators, or to evaluate specific quality improvement projects.

Terri J Jackson PhD · Jude L Michel BHlthInfoManagement(Hons) · Rosemary F Roberts MPH, MBA · Christine M Jorm MD, PhD, FANZCA · John G Wakefield FRACMA, FACRRM, FRACGP

Objective: To identify individual and household factors associated with violence among Australian Indigenous women with dependent children.Design and participants: Univariate and multivariable analysis of data from the 2002 National Aboriginal and Torres Strait Islander Social Survey, stratified by area.Main outcome measure: Self-reported experience of being a victim of violence in the previous year.Results: One in four Indigenous women living with dependent children younger than 15 years reported being victims of violence in the previous year; this corresponds to an estimated 24 221 Indigenous mothers (95% CI, 21 507–26 935) nationwide. Violence was more prevalent in regional areas and cities than remote areas. In remote areas, mothers who had been removed from their natural families during childhood had nearly threefold greater odds of being victims of violence (odds ratio [OR], 2.90; 95% CI, 1.82–4.61); in non-remote areas, the odds were 72% greater (OR, 1.72; 95% CI, 1.23–2.39). Older maternal age (≥ 45 years) was associated with lower odds of experiencing violence in both non-remote areas (OR, 0.39; 95% CI, 0.25–0.60) and remote areas (OR, 0.46; 95% CI, 0.30–0.70). Women with partners residing in the household faced lower odds of violence in both non-remote areas (OR, 0.54; 95% CI, 0.41–0.72) and remote areas (OR, 0.46; 95% CI, 0.32–0.67).Conclusions: The prevalence of violence against Indigenous mothers with young children is alarmingly high across remote and non-remote areas. This study identified distinctive characteristics of victims, but further research is needed to assess potential risk factors, such as history of removal from natural family.

Kyllie Cripps BA(Hons), PhD · Catherine M Bennett PhD, MAppEpid · Lyle C Gurrin PhD · David M Studdert LLB, ScD

Objective: To compare the clinical effectiveness of point-of-care testing (PoCT) with that of pathology laboratory testing, as measured by patients’ adherence to medication.Design: Multicentre, cluster randomised controlled trial using non-inferiority analysis. Medication adherence was assessed twice (in April 2006 and January 2007) by a self-administered questionnaire using the five-item Medication Adherence Report Scale (MARS-5).Setting: 53 Australian general practices in urban, rural and remote areas across three Australian states, September 2005 to February 2007.Participants: 4968 patients with established type 1 or type 2 diabetes, established hyperlipidaemia, or requiring anticoagulant therapy were recruited to the study. Of these, 4381 were included in the analysis (2585 in the intervention group and 1796 in the control group).Intervention: The intervention group (3010 patients in 30 practices) had blood and urine samples tested using PoCT devices within their general practices. The control group (1958 patients in 23 practices) had samples tested by their usual pathology laboratories.Main outcome measures: The proportion of questionnaire responses indicating medication adherence overall and by condition.Results: PoCT was non-inferior to pathology laboratory testing in relation to the proportion of questionnaire responses indicating medication adherence (39.3% v 37.0%) (difference, 2.3% [90% CL, – 0.1%, 4.6%]; P < 0.001). Non-inferiority could also be concluded separately for patients with diabetes (38.5% v 37.3%) (difference, 1.2% [90% CL, – 2.5%, 5.0%]; P = 0.01); hyperlipidaemia (38.3% v 37.3%) (difference, 1.0% [90% CL, – 1.5%, 3.5%]; P < 0.001) and for patients requiring anticoagulant therapy (44.5% v 41.4%) (difference, 3.1% [90% CL, – 2.1%, 8.3%]; P = 0.01).Conclusions: Having access to immediate test results through PoCT is associated with the same or better medication adherence compared with having test results provided by a pathology laboratory. PoCT used in general practice can provide general practitioners and patients with timely and complete clinical information, facilitating important self-management behaviours such as medication adherence.Trial registration: Australian Clinical Trials Registry ACTRN 12605000272695.

Angela Gialamas BHSc · Lisa N Yelland BMathCompSc(Hons) · Philip Ryan MB BS · Kristyn Willson BSc(Hons) · Caroline O Laurence BA(Hons), MHSM, PhD · Tanya K Bubner BSocSc(HumServ), GradDipHlthServMan · Philip Tideman MB BS, FRACP · Justin J Beilby MB BS, MD, FRACGP

Objective: To describe the processes and costs of engaging practice nurses (PNs) to establish a cluster randomised controlled trial (RCT) to study type 2 diabetes in general practice.Design, setting and participants: Descriptive study of the processes and costs of engaging PNs from 59 general practices in Victoria that were participating in the Patient Engagement And Coaching for Health (PEACH) study, prior to practices being randomly assigned in the cluster RCT.Main outcome measures: Estimated direct research costs and personnel costs for establishing a general practice-based research project involving PNs (eg, costs for approaching Victorian Divisions of General Practice and the Australian Practice Nurses Association; practice and patient recruitment; research project establishment at general practices; and PNs’ training, support and engagement during the study establishment period).Results: The estimated cost to establish our PN-led general practice-based cluster RCT was over $110 000, with an average cost of $2000 per practice. Direct research and personnel costs were considerably higher than anticipated. Lack of research skills among PNs required intensive hands-on support from the research team.Conclusions: It is feasible to undertake a PN-led, general practice-based clinical trial in diabetes care. Future research funding needs to account for recruitment costs, including the need to build PN research capacity, and to overcome the inherent difficulties of engaging practices in complex intervention trials in primary care.Trial registration: International Standard Randomised Controlled Trial Number Register ISRCTN50662837.

Irene D Blackberry BMed, PhD · John S Furler FRACGP, GradDipPubHlth, PhD · Doris Young MB BS, MD, FRACGP · James D Best FRCPath, FRCP

Objective: To investigate the issues that confront women when addressing overweight and obesity before conception.Design: Questionnaire-based study of 412 unselected women in early pregnancy.Setting and participants: 255 women who attended a public, antenatal “first visit” clinic at a major urban obstetric hospital in Brisbane and 157 women who presented to a private obstetrician in Brisbane for a routine ultrasound scan during a 6-week period in 2006 were surveyed.Main outcome measures: Preconception health activities, prepregnancy body mass index (BMI), self-reported weight category, attempts to lose weight before pregnancy, and weight loss advice received before pregnancy.Results: Folic acid supplementation was reported by 56% of participants, and 53% attended a preconception health check. Of women who provided details of height and prepregnancy weight, 30% were overweight or obese before pregnancy. However, 23 of 65 women with a BMI in the overweight range categorised themselves as normal weight (36%), and only 8 of 50 women with a BMI in the obese range categorised themselves as obese (16%). As BMI increased, more women reported trying to lose weight (P < 0.001) and reported receiving advice regarding weight loss (P < 0.001). Prepregnancy weight loss was reported by 52 of 115 overweight and obese women (45%).Conclusions: Potential barriers to addressing overweight and obesity before pregnancy include poor uptake of routine prepregnancy health activities, inaccurate self-categorisation of weight, unsuccessful weight loss attempts and inadequate advice regarding prepregnancy weight loss.

Leonie K Callaway MB BS(Hons), FRACP, PhD · Michael J O’Callaghan FRACP · H David McIntyre FRACP

Objective: To determine if regular weight measurement throughout pregnancy can reduce excessive gestational weight gain.Design: A randomised controlled trial.Setting: A tertiary obstetric hospital in Melbourne, between July 2007 and May 2008.Participants: 236 pregnant women recruited at ≤ 14 weeks’ gestation.Intervention: Women allocated to the intervention group were given a personalised weight measurement card, advised of their optimal gestational weight gain (based on their body mass index at the time of recruitment and the United States Institute of Medicine guidelines), and instructed to record their weight at 16, 20, 24, 28, 30, 32 and 34 weeks’ gestation. The control group were weighed at recruitment, but were not given instructions about regular weight measurement. All participants were blinded to the purpose of the study.Main outcome measure: Weight gain from recruitment to follow-up at 36 weeks’ gestation.Results: In the study population, there was a trend to less weight gain in the intervention group. The women in the intervention group experienced a mean (SD) per-week weight gain of 0.44 (0.173) kg compared with those in the control group, who gained 0.46 (0.156) kg/week (mean difference, 0.02 kg/week; 95% CI, − 0.02 to 0.07 kg/week). The intervention significantly reduced gestational weight gain in the group of women who were overweight but not obese at recruitment: those in the intervention group (20 women) gained a mean (SD) of 0.42 (0.153) kg/week and the control group (18 women) gained 0.54 (0.123) kg/week (mean difference, 0.12 kg/week; 95% CI, 0.03 to 0.22 kg/week; P = 0.01).Conclusion: Regular weight measurement in pregnancy was not found to be effective in reducing weight gain, except among women who were overweight but not obese before pregnancy.Trial registration: Australian Clinical Trials Registry ACTRN12607000272493

Kirby Jeffries · Alexis Shub MB BS, FRANZCOG, PhD · Susan P Walker MB BS, FRANZCOG, MD · Richard Hiscock FANZCA, GradDipMedStat · Michael Permezel MB BS, FRCP, FRANZCOG

Objective: To document the types of, and mortality from, Staphylococcus aureus bacteraemia in Australia and New Zealand, and determine factors associated with mortality.Design and setting: Prospective observational study in 27 independent or hospital pathology laboratories in Australia (24) and New Zealand (3), employing a web-based database to prospectively record demographic features, selected risk factors, principal antibiotic treatment and mortality data on all patients with positive blood cultures for S. aureus from June 2007 to May 2008.Main outcome measure: 30-day all-cause mortality.Results: 1994 episodes of S. aureus bacteraemia were identified, and complete 30-day follow-up data were available for 1865. Most episodes had their onset in the community (60.8%; 95% CI, 58.7%–63.0%). Methicillin-resistant S. aureus (MRSA) caused 450 episodes (24.1%; 95% CI, 22.2%–25.9%), and 123 of these (27.3%) had a susceptibility profile consistent with community-associated MRSA. All-cause mortality at 30 days was 20.6% (95% CI, 18.8%–22.5%). On univariate analysis, increased mortality was significantly associated with older age, European ethnicity, MRSA infection, infections not originating from a medical device, sepsis syndrome, pneumonia/empyema, and treatment with a glycopeptide or other non-β-lactam antibiotic. On multivariable analysis, independent predictors of mortality were age, sepsis syndrome, pneumonia/empyema, device-associated infection with a secondary focus, left-sided endocarditis, and treatment with a glycopeptide such as vancomycin, but not MRSA infection.Conclusions: S. aureus bacteraemia is a common infection in both the community and hospitals in Australia and New Zealand, and is associated with appreciable mortality. Invasive MRSA infection may be more life-threatening, partly because of the inferior efficacy of the standard treatment, vancomycin. National web-based surveillance of S. aureus bacteraemia and its outcomes is not only important but also easily achievable.

John D Turnidge FRACP, FRCPA, MASM · Despina Kotsanas BSc(Hons), MClinEpi · Wendy Munckhof FRACP, FRCPA, PhD · Sally Roberts MB ChB, FRACP, FRCPA · Catherine M Bennett BSc(Hons), MAppEpid, PhD · Graeme R Nimmo MPH, FRCPA, FASM · Geoffrey W Coombs BApplSci(Med Sci), PostGradDipMedSci · Ronan J Murray MRCPI, FRACP, FRCPA · Benjamin Howden MB BS, FRACP, FRCPA · Paul D R Johnson MB BS, PhD, FRACP · Kate Dowling BSc, GradDip(AppStats) · on behalf of the Australia New Zealand Cooperative on Outcomes in Staphylococcal Sepsis

Objective: To determine whether the availability of patients’ own medications (POM) in emergency departments (EDs) results in decreased prescribing errors of patients’ usual medications on admission.Design, participants and setting: Observational study of patients presenting by ambulance to the ED of Austin Hospital, a Melbourne metropolitan teaching hospital, between 13 and 31 March 2006. Patients were enrolled if they were brought to the ED by ambulance, aged 18 years or older, taking four or more regular medications, admitted to hospital, and not referred to a pharmacist before the admission medication chart was written. ED pharmacists determined patients’ regular medications and details of medications brought in by ambulance. Admission medication charts were assessed and discrepancies were recorded as prescribing errors if a change was made after a pharmacist discussed the discrepancy with the prescriber.Main outcome measures: Percentage of medications correctly prescribed when POM were brought in to the ED compared with when they were not; the nature and frequency of prescribing errors on admission.Results: 100 patients were enrolled; they were taking 4–17 regular medications (mean, 8.0; SD, 3.7). Among the 428 POM that were brought to the ED, 56 errors occurred (13.1%); and among the 372 regular medications taken by patients for whom POM were not brought in, 95 errors occurred (25.5%) (difference in percentages, 12.4%; 95% CI, 6.7%–18.0%; P < 0.001). The most prevalent prescribing errors were omissions (40.4%), and most errors (72.8%) were classified as of “moderate” clinical significance.Conclusions: When POM were brought to the ED by paramedics, significantly fewer errors occurred on admission medication charts. An intervention program to encourage paramedics to bring POM to the ED is indicated.

Esther W Chan BPharm(Hons), MClinPharm · Simone E Taylor PharmD, GCCRM · Jennifer L Marriott BPharm, PhD, GCHE · Bill Barger AssDipHthSci, MICACert

Objective: To examine the initial impact of the National Bowel Cancer Screening Program (NBCSP), which was launched in May 2006 and offers faecal occult blood testing to Australians aged 55 or 65 years.Design and setting: Review of data on colorectal cancer (CRC) cases diagnosed between May 2006 and June 2008 from a prospective database used at 19 Australian hospitals, linked and analysed by BioGrid Australia.Main outcome measures: Number of CRC cases detected through the NBCSP or symptomatic presentation, and differences by sex, stage at diagnosis, tumour location and level of socioeconomic disadvantage.Results: 1628 cases of CRC were identified; 1268 had information on the patients’ test status as part of the NBCSP, and 40 of these (3.2%) were recorded as being detected by the NBCSP. Of 75 CRC cases in patients aged 55 or 65 at diagnosis, 22 were NBCSP-detected. Overall, there was no difference in NBCSP-detected cases by sex. The distribution of tumour locations was similar between NBCSP-detected cases and symptomatic cases, but NBCSP-detected cancers were diagnosed at an earlier stage than symptomatic cancers (stage I, 40% v 14%; stage IV, 3% v 15%, respectively). Of patients diagnosed through the NBCSP, 63% were from areas of least socioeconomic disadvantage (deciles 8–10) and 18% were from the most disadvantaged areas (deciles 1–4) (P = 0.0375).Conclusion: Initiation of the Australian NBCSP has had a measurable impact on CRC stage at diagnosis, and an improvement in survival would be anticipated. The lower uptake among people from disadvantaged areas is of concern.

Sumitra S Ananda MB BS, FRACP · Stephen J McLaughlin MB BS, FRACS, FRCS · Frank Chen MB BS, FRACS · Ian P Hayes MB BS, FRACS, FRCS · Andrew A Hunter MB BS, FRACS · Iain J Skinner MB BS, FRACS · Malcolm C A Steel MB BS, FRACS · Ian T Jones MB BS, FRACS, FRCS · Ian A Hastie MB BS, FRACS · Nicholas A Rieger MB BS, FRACS · Susan Shedda MB BS, FRACS, MPH · Daniel J Compston BHIthInfoManagement · Peter Gibbs MB BS, FRACP, MD

Objective: To describe cardiovascular disease (CVD) risk management in Indigenous primary health care.Design, setting and participants: Review of 1165 randomly selected case records of Indigenous Australian adults, aged ≥ 18 years, regularly attending eight health services in diverse settings in New South Wales, Queensland and Central Australia, October 2007 – May 2008.Main outcome measure: Adherence to CVD risk screening and management guidelines, especially with respect to overall or absolute CVD risk.Results: More than half the people in the sample (53%) were not adequately screened for CVD risk according to national recommendations. Underscreening was significantly associated with younger age, less frequent attendance, and lower uptake of the Medicare Health Assessment. Of the sample, 9% had established CVD, and 29% of those aged ≥ 30 years were classified as high risk according to the 2004 National Heart Foundation of Australia (NHFA) adjusted Framingham equation. Of those with CVD, 40% (95% CI, 30%–50%) were not prescribed a combination of blood pressure (BP) medicines, statins and antiplatelet agents, and 56% (95% CI, 49%–62%) of high-risk individuals without CVD were not prescribed BP medicines and statins. For high-risk individuals not prescribed BP medicines or statins, 74% (95% CI, 64%–84%) and 30% (95% CI, 23%–39%) respectively, did not meet 2004 NHFA criteria for prescribing of these medications, and of those already prescribed BP medicines or statins, 41% (95% CI, 36%–47%) and 59% (95% CI, 52%–66%) did not meet respective guideline targets.Conclusions: These management gaps are similar to those found in non-Indigenous health care settings, suggesting deficiencies across the health system. Prescribing guidelines which exclude many high-risk individuals contribute to suboptimal management. Guideline reform and improved health service capacity could substantially improve Indigenous vascular health.

David P Peiris MB BS, FRACGP, MIPH · Anushka A Patel MB BS, PhD, FRACP · Alan Cass MB BS, FRACP, PhD · Michael P Howard RN, MHN, MPH · Maria L Tchan BN, MPH · John P Brady BScApp · Joanne De Vries DipPHC · Bernadette A Rickards RN, MPH · Della J Yarnold MB · Noel E Hayman MB BS, MPH, FAFPHM · Alex D Brown BMed, MPH, FCSANZ

Objective: To investigate trends in the incidence of adenocarcinoma (AC) of the oesophagus in New South Wales, factors associated with a diagnosis of AC, and factors associated with survival of patients with AC.Design and setting: We examined all cases of invasive oesophageal cancer recorded in the NSW Central Cancer Registry from 1972 to 2005. The Accessibility/Remoteness Index of Australia was used to assess geographical remoteness and the Index of Relative Socio-Economic Disadvantage to assess socioeconomic status.Main outcome measures: Incidence of AC; factors associated with diagnosis of AC and survival of patients with AC.Results: The overall incidence of oesophageal AC in NSW increased in both males and females (annual percentage change, 4.2% [95% CL, 2.7%, 5.8%] in males [1988–2005] and 4.3% [95% CL, 1.8%, 7.0%] in females [1983–2005]). A diagnosis of AC was significantly associated with being male (adjusted odds ratio [AOR], 4.37 [95% CL, 3.84, 4.98]; P < 0.001); a younger age at diagnosis (P trend < 0.001); having distant rather than localised disease spread (AOR, 2.12 [95% CL, 1.82, 2.48]; P < 0.001); higher socioeconomic status (P trend < 0.001); and living in an inner regional area (AOR, 1.26 [95% CL, 1.11, 1.43]; P < 0.001) or outer regional area (AOR, 1.19 [95% CL, 1.00, 1.41]; P = 0.05) compared with a major city. Early diagnosis of AC was associated with substantial improvement in survival outcomes: patients with metastatic disease at diagnosis had a three times greater risk of dying than those with localised AC at diagnosis.Conclusion: The incidence of AC is increasing in NSW. Possible contributing factors include increasing obesity, which is associated with increased incidence of gastro-oesophageal reflux disease. Survival may be improved by diagnosis at an earlier stage and changes in modifiable risk factors (eg, smoking, diet, exercise).

Efty P Stavrou PhD · Heather J McElroy MMedStat · Deborah F Baker MPH · Garett Smith BMed, MS, FRACS · James F Bishop MMed, MD, FRACP

Objective: To describe demographic and clinical characteristics of patients residing in Victoria who were diagnosed with multidrug-resistant tuberculosis (MDR-TB) during the period 1 January 1998 to 31 December 2007.Design, setting and patients: Retrospective review of Victorian Department of Health data on laboratory-confirmed cases of MDR-TB for the period 1998–2007.Main outcome measures: Age, sex, country of birth, time between arrival in Australia and notification of TB, residency status, site of disease, and treatment period and outcome.Results: From 1998 to 2007, 31 patients who resided in Victoria were diagnosed with MDR-TB. The median age of patients was 27 years, most patients were born overseas, and more than half were full-time students. The median time between arrival in Australia and notification of TB was 2 years, and 24 patients were notified to the Department within 5 years of arrival. Twenty patients had pulmonary disease; in 12 of these patients, sputum was smear-positive for acid-fast bacilli. The median treatment period for patients who completed treatment was 22 months.Conclusions: The number of patients diagnosed with MDR-TB per year increased during the period 1998–2007. If sustained, this increase will have important implications for public health policy and planning.

Caroline J Lavender BA, BSc(Hons) · Lynne K Brown DipAppSci · Paul D R Johnson MB BS, PhD, FRACP

Objective: To examine the effect of the level of patient copayment on the rate of purchase of inhaled corticosteroids (ICS) by patients with obstructive lung disease.Design and setting: Cross-sectional study of records of all prescriptions for ICS dispensed to general and concessional beneficiaries aged 15 years or over in the period January 2003 to December 2006. Data were obtained from the Pharmaceutical Benefits Scheme, which subsidises medication costs for all Australians.Main outcome measures: The number of prescriptions for ICS dispensed to government concession card holders compared with the number dispensed to general beneficiaries, expressed as a rate ratio.Results: ICS prescriptions were dispensed to over 1.6 million people during the study period. Concession card holders were dispensed ICS prescriptions at a higher rate than general beneficiaries, both overall (43.7 v 9.1 ICS prescriptions per 100 person-years) and in all population subgroups. After adjusting for age, sex, remoteness category and socioeconomic status, people holding a concession card were dispensed over 2.5 times the number of ICS prescriptions (alone or in combination with a long-acting β2-agonist) compared with general beneficiaries. Similar patterns were seen after adjusting for differences between the two groups in the prevalence of obstructive lung disease.Conclusions: As the patient copayment for general beneficiaries is over six times higher than for concession card holders, our findings imply that cost is a barrier to the purchase of ICS prescriptions for obstructive lung disease, independent of socioeconomic status.

Rosario D Ampon BSc, MAppStat · Helen K Reddel MB BS, FRACP, PhD · Patricia K Correll BN, MPH, GradDipAppEpi · Leanne M Poulos BMedSc(Hons), MPH(Hons) · Guy B Marks PhD, FRACP, FAFPHM

Objective: To investigate the long-term effectiveness of a general practice monitoring system with respiratory expert recommendations for general practitioners’ management of patients with chronic obstructive pulmonary disease (COPD), compared with usual care. Design, settings and participants: A multicentre randomised controlled trial of patients with COPD, clustered by general practices; 200 participants were recruited to maintain at least 75 participants per group for analysis. The trial took place from July 2005 to February 2008 in the south-western region of the Netherlands.Intervention: Ongoing half-yearly monitoring of COPD patients with respiratory expert recommendations for the GP was compared with usual care.Main outcome measures: Primary outcome — Chronic Respiratory Questionnaire (CRQ) score; secondary outcomes — CRQ domain scores, generic health-related quality of life (Short-Form 12 and EuroQol-5D), breathlessness (Modified Medical Research Council score), exacerbations, and decline in forced expiratory volume in 1 second. A detailed process evaluation was performed along with the trial.Results: Data from 170 participants were analysed. Based on repeated measurement analyses, the additional gain in CRQ score during follow-up was 0.004 points for monitoring compared with usual care (95% CI, − 0.172 to 0.180). Also, no important differences between monitoring and the usual care group were found for secondary outcomes. Half the monitoring visits resulted in disease management recommendations by a respiratory expert, and 46% of these recommendations were implemented by the GPs. Patient adherence to lifestyle recommendations was low.Conclusion: An expert-supported monitoring system for patients with COPD was not clinically effective. As patients had a pre-existing entry in the monitoring system, the population may be well regulated, with reduced room for improvement.Trial registration: www.clinicaltrials.gov NCT00542061.

Lisette van den Bemt MSc · Tjard R J Schermer PhD · Ivo J M Smeele MD, PhD · Leandra J M Boonman-de Winter MSc · Ton van Boxem MD, PhD · Joke Denis · Joke G Grootens-Stekelenburg · Richard P T M Grol PhD · Chris van Weel MD, FRCGP, FRACGP

Objective: To assess whether knowledge of insurance implications influenced uptake of genetic testing by participants in a research study of the causes of colorectal cancer.Design, setting and participants: Analysis of uptake of genetic testing by participants in the population-based Victorian Colorectal Cancer Family Study during two periods: from 1999 to 2003, when participants were not informed of any potential effect of genetic testing conducted during the study on their eligibility for new insurance policies; and from 2003 to 2006, when the protocol was changed to provide participants with information on the potential effect of genetic testing on insurance eligibility.Main outcome measure: Uptake of genetic testing for germline mutations in DNA mismatch repair (MMR) genes at a family cancer clinic.Results: The proportion of participants who declined genetic testing among those informed of insurance implications was more than double the proportion among those without this knowledge (29/59 [49%] v 9/47 [19%]; P = 0.002). This difference could not be explained statistically by adjusting for measured putative predictors.Conclusion: Identification of people with a mutation in an MMR gene has clinical importance, and such screening may be a cost-effective way to reduce the burden of colorectal cancer in the community. If people are choosing not to obtain genetic information because of how it will affect their eligibility for insurance, reforms to existing insurance practices are indicated.

Louise A Keogh BSc, MA, PhD · Christine M van Vliet BSc, MB BS, MPH · David M Studdert LLB, ScD · Judith A Maskiell BSc(Nursing), GradDip(BusMgt) · Finlay A Macrae FRACP, FRCP, MD · D James St John MB BS, MD, FRCP · Clara L Gaff BSc, FHGSA(GenCounsel), PhD · Mary Anne Young GradDip(FamilyTherapy), FHGSA(GenCounsel), MHSc(GenCouns) · Melissa C Southey BSc, PhD, GradDipLaw · Graham G Giles BSc, MSc, PhD · Doreen A Rosenthal BA, PhD · John L Hopper BSc, MSc, PhD · Mark A Jenkins BSc, PhD

Objective: To determine the adequacy of consent documentation related to descriptions of intended procedures, associated risks and treatment alternatives, and to analyse trends in the adequacy of consent documentation in a specialty surgical unit.Design, patients and setting: Retrospective reviews of consent forms for all patients on the Urology Unit waiting list of the Repatriation General Hospital, Adelaide on three occasions. Reviews were undertaken during 2005, 2007 and 2008, with a minimum of 12 months between reviews.Results: 1280 consent documents were evaluated. No trend in the studied criteria of adequacy of documentation was observed during the study period. Overall, 18.5% of consent forms described procedures using plain language. In 15.3% of consent forms, a significant component of the procedure was described using only an acronym, without further explanation. In 6.6% of consent forms, procedure descriptions contained only acronyms, abbreviations or technical terminology, with no plain language word. The purpose of the operation was conveyed in 10.1% of consent forms. Relevant risks were provided in 4.1%. Any indication of the magnitude of procedural risks was provided in only four of 1280 forms. No consent form provided information about alternative treatments.Conclusions: We believe these findings are broadly representative of current hospital practice and that the community should consider whether an acronym or technical terminology is appropriate for documenting consent. If not, can minimum practice standards be defined, and should any emerging recommendations be mandated?

Mark T Siddins MB BS(Hons), MS, FRACS(Urol) · Elizabeth M Klinken BM BS, BSc · Lee R Vocale BM BS, BSc

Objective: To evaluate the difference in time taken for ethics and site governance approval for multicentre clinical trials using two different systems of ethics review.Design: We evaluated the times to final ethics and governance approval for two international, multicentre clinical trials of treatment for metastatic colorectal cancer: the MAX trial, using a non-centralised ethics review system, and the CO.20 trial, using the new New South Wales centralised ethics review system.Main outcome measure: Time from trial submission to overall study approval.Results: The median time taken to obtain ethics approval for the MAX trial at 16 NSW sites was 100 days (range, 36–161 days). The median time to obtain central ethics approval for the CO.20 trial at 14 NSW sites was 77 days, with an additional 60 days (range 20–79 days) required to obtain site-specific research governance approval.Conclusions: Any difference in time to approval between the review systems was outweighed by the overall time taken. However, the time spent by both the coordinating centre and local sites in collation, submission and correspondence was greatly reduced, and the centralised process allowed for standardised documentation at all study sites.

Sian C Hicks BSc(Hons), PhD · Rebecca E James BA/BSc, GradDipEd, MScMed · Nicole Wong RN, BN, BSc(Hons) · Niall C Tebbutt BM BCh, PhD, FRACP · Kate Wilson BA, MPH