Volume 193 Issue 10

Independent advice continues to be vital for maintaining standards in medical training Many younger doctors may have trouble believing it was only 25 years ago that the assessment of Australian medical schools (for the purpose of medical registration in Australia) changed from assessment by the General Medical Council of the United Kingdom to assessment by a local independent authority. In 1985, the accreditation process was transferred to Australia, and the Australian Medical Council (AMC) was established. The AMC recently marked its first 25 years by publishing its history, Assuring medical standards: the Australian Medical Council 1985–2010.1 The book catalogues many impressive achievements and also describes in detail some significant obstacles in the Council’s progress. Australia now has an almost seamless accreditation process for all phases of medical education (medical student education, postgraduate training and, through the medical colleges, continuing medical education) that is envied by other nations. In addition, the AMC has established a reputation internationally as a leader in the assessment of international medical graduates and for its work in supporting them in preparing for assessment. The release of the AMC history coincides with the most significant change in the regulation of the health professions since laws for registration were first enacted in the mid 19th century.2 It is timely to consider the lessons from the AMC’s experience as we enter this new era of national registration, and to reflect on the importance of independence in setting standards for the profession in the future. Medical education and medical practice are moving into uncertain territory. Several critical issues are likely to engage the AMC and others involved in medical education in the immediate future. First and foremost is securing appropriate clinical training for the rapidly increasing numbers of medical students and graduates, and ensuring sustainable funding for that training through the state and national bodies that have responsibility for the health workforce and clinical training. There is also an urgent need to consolidate state-based standards for early graduate training (the first two postgraduate years) and to align them with those for medical schools and specialty training. The present interest in the ill-defined “competency-based training” is stimulating attempts to define competencies more precisely. If this leads to job redesign and task substitution (as envisaged by the Productivity Commission),3 then that will need to be done in a measured and intelligent manner which does not diminish existing standards of medical care. There is an urgent need to rethink teaching about patient safety throughout medical education.4 If we are ultimately to ensure that preventable harm to patients becomes negligible, then the new science of patient safety must have a high priority in the training and professional development of all doctors.5 The AMC is considering whether this will require strengthening of its accreditation standards. These matters all rest on the underlying responsibility of medical educators to develop good students into competent doctors who will maintain their knowledge, skills and professionalism throughout their careers. Regulation of the medical profession was originally intended to protect the community by defining a legally qualified medical practitioner, but health workforce supply now occupies a pre-eminent place in the new national regulatory structure. Sections 11(3)(d) and 11(4)(a) of the Health Practitioner Regulation National Law Act 2009 (Qld) provide for the Ministerial Council to intervene in an accreditation standard when that standard might impact on the recruitment or supply of medical practitioners. Before the legislation was passed, a caveat was added by way of section 11(4)(b) requiring the Ministerial Council to consider the impact of any such intervention on the quality and safety of health care. While the national law thus incorporates the tension between workforce considerations and standards of medical education, this represents potential future conflict. The concurrent reforms in funding of clinical training have the potential for a more immediate impact on medical education. The need to account for the appropriate expenditure of funds may see a push towards standardisation of clinical training — “one size fits all” thinking — supported by an education model built on “tick box” competencies. Comprehensive, thorough clinical training is essential for developing an effective, flexible and safe medical workforce, and for producing practitioners able to adapt to changes in medical sciences and clinical practice throughout their careers. It would be reassuring for the medical profession if we could confidently predict that the AMC will still be here after the next 25 years, but this is by no means certain. For medicine, it is vital that the AMC commits itself to working closely with the bodies whose responsibilities will influence standards of medical education and medical practice, including the Medical Board of Australia, Australian Health Practitioner Regulation Agency, and Health Workforce Australia. It is equally important, given the policy focus on health workforce reform, that the AMC continues to provide strongly independent, evidence-based advice and guidance on standards of medical training and assessment.

Richard A Smallwood AO, FRACP, FRCP · Ian Frank BA · Theanne Walters BA

The Australian Government’s recent decision not to renew federal funding for the Master of Applied Epidemiology (MAE) program at the Australian National University (ANU) puts the nation’s public health response capacity at serious risk. This program has provided the investigative backbone to the Communicable Diseases Network Australia for nearly 20 years. A charitable view is that its disestablishment came about as an administrative accident — collateral damage when Cabinet decided to terminate the much larger Public Health Education and Research Program (PHERP) after a 20-year funding cycle had reached its promised end. Funding for the MAE was rolled into the PHERP quite recently as an administrative convenience, after being supported through a distinct funding stream for most of its life, but the two are in fact very different types of public health activity. Although other PHERP-funded courses are traditional campus-based degree programs, the MAE puts its intake of outstanding health professionals through intensive field apprenticeships as disease detectives. Over 2 years, trainees undertake brief campus-based training blocks, but, for most of their time, they are placed at health agencies around the nation where they are immersed in disease surveillance and outbreak investigations. They serve as a flying squad to respond at short notice to unusual infectious disease events that present potential threats to the population’s health.1 The program has been a bargain for the government, with a budget under $2 million per year (the cost of about six tertiary hospital beds), which meets trainees’ stipends and supports a small team of academic supervisors. Over two decades, 160 MAE trainees have played central roles in stemming the spread of about 200 epidemics, including severe acute respiratory syndrome (SARS), pandemic (H1N1) 2009 influenza, Hendra virus, food-borne infections, and many others. Their work has generated over 500 academic publications, often of national and global public health significance.2-4 The program was originally modelled on the world-renowned Epidemic Intelligence Service at the Centers for Disease Control and Prevention (CDC) in the United States. The Australian MAE has helped spawn equivalent programs in China, India, Indonesia and Malaysia. In addition to serving as a standing national response team during their 2-year apprenticeship, graduates of the MAE program have gone on to become national, and in some cases international, leaders in public health. The employment distribution of 104 non-Indigenous graduates who completed a survey recently is shown in the Box. The MAE has a particular emphasis on supporting Aboriginal and Torres Strait Islander trainees, recognising that the burden of infectious diseases in Australia falls disproportionately on the Indigenous population. Placements have been made in settings that have allowed Aboriginal trainees to work closely with Aboriginal communities. Twenty-seven Aboriginal MAE graduates have gone on to make a unique contribution to several areas of Aboriginal health and have become role models for Aboriginal health research in Australia.5 Thirteen of these have used their training in this program as a portal of entry to PhD candidacy. A review of the program commissioned jointly by the Australian Government and ANU in February 2010 was unequivocal in recommending that it should continue as a key element of Australia’s disease control activity.6 The MAE program was born as a response to the urgent need, recognised during the early years of the HIV epidemic, for Australia to upgrade its national disease intelligence capacity. It was initiated with assistance from the US CDC, and its first Australian Director was the late Professor Aileen Plant, who would be appalled at its disappearance with no apparent replacement in sight. This will leave Australia vulnerable at a time when increasing population movements, changing climate and other pressures increase the likelihood that we will face new pandemics and the re-emergence of old ones.7 Although Australia is now one of few industrialised nations that has no national centre for disease control, the MAE program at least represented one of the essential elements that such a national organisation would provide.1 Infections respect neither state nor national boundaries, and under Australia’s political structure their control can only be achieved through a consistent, coordinated effort by the federal and jurisdictional governments. The ongoing human resource represented by the MAE trainees is a highly cost-effective insurance policy that we cannot risk losing in the challenging times ahead. Non-Indigenous Master of Applied Epidemiology graduates by current employer and type of work, 1991–2010 Employment classification Institution Epidemiologist Other public health Policy advisor Academic Other research Clinician Laboratory Total Federal government 6 — — — — — — 6 State government 22 9 2 — 1 — 1 35 Research institute 11 — — 3 2 — — 16* International health organisation 7 2 2 — 1 — 1 13† Non-government organisation 2 — 2 — — — — 4 Private enterprise — 1 1 — — 2 — 4 Hospital 1 — — — — 5 — 6 University 4 — — 16 — — — 20 Total 53 12 7 19 4 7 2 104‡ — = zero or not applicable. * Eight of the current jobs are at research institutes that provide services to government in communicable disease surveillance. † Ten of the current jobs are with the World Health Organization. ‡ Twenty-nine students did not complete the survey.

Robert M Douglas MD, FRACP, FAFPHM · Fiona J Stanley MD, MSc, FAFPHM · A Rob Moodie MB BS, MPH, FAFPHM · Anthony I Adams MB BS, MPH, FAFPHM · John M Kaldor PhD

The inaugural Australian Otitis Media (OMOZ) workshop, Darwin, 25–26 May 2010, was well timed. The workshop — held in the same month that the Australian Senate tabled its report, Hear us: inquiry into hearing health in Australia1 — brought together 70 of Australia’s leading otitis media (OM) researchers. The workshop reinforced that OM is a major concern in Australia, identified important research advances, and highlighted future research areas and strategies for long-term interventions. As emphasised in the Senate report, findings from conferences on hearing health should be made publicly available. The purpose of our report, therefore, is to share the main findings from the OMOZ workshop with the broader community of OM researchers, health care professionals and policy leaders. Why otitis media mattersOM, or inflammation of the middle ear, is a prevalent and costly disease. The associated fluid accumulation behind the tympanic membrane can lead to pain, tympanic membrane perforation, and hearing impairment. The prevalence of OM in Australian Indigenous children (about 80% by 12 months of age) is among the highest in the world.2 Tympanic membrane perforation rates among Indigenous children (20%) exceed the threshold of 4% that the World Health Organization considers a “massive public health problem requiring immediate action”.3 Conductive hearing loss in Indigenous Australians has been associated with language and speech development delay, poor educational and employment outcomes, and a heightened risk of criminal activity.1 In 2008, the estimated costs of treating OM in Australia ranged from $100 million to $400 million.4 Clinically important advances in otitis media researchDelegates gained insight into important advances from laboratory-based research, environmental and epidemiological studies, intervention programs and clinical trials. It was highlighted that a multidisciplinary approach is required to better understand, prevent and manage OM. Laboratory-based researchResearchers from the University of Western Australia (UWA) and Telethon Institute for Child Health Research (TICHR), Perth, WA, reported that bacteria (particularly non-typeable Haemophilus influenzae and Streptococcus pneumoniae) and respiratory viruses are more commonly found in the nasopharynx of OM-prone children than in healthy children. They also reported that bacteria persist in the middle ear of OM-prone children, both in biofilms and within cells. Such persistence may contribute to the chronic and recurrent nature of OM. Researchers from WA, Queensland and the Northern Territory highlighted the importance of investigating the interactions between bacteria and viruses in the pathogenesis of OM. Delegates acknowledged that further research is needed to determine the clinical significance of Haemophilus haemolyticus, Alloiococcus otitidis and polyoma viruses in OM. Associate Professor Peter Richmond (School of Paediatrics and Child Health, UWA) noted that children vaccinated with pneumococcal conjugate vaccine were protected from life-threatening disease, but cautioned that children who have normal antibody responses may still experience OM. He reasoned that more appropriate assays are required to adequately assess antibody function. Professor Jennelle Kyd (Deputy Vice-Chancellor [Academic and Research], Central Queensland University [CQU], Rockhampton, Qld) emphasised that evaluation of vaccine effectiveness should include measurements of mucosal immunity. Researchers from CQU and the University of Newcastle in New South Wales are using cell culture models to further our understanding of the interactions between external risk factors (eg, cigarette smoke), otopathogens and host immunity. Researchers from CQU have also developed animal models to enhance our understanding of OM pathogenesis, support OM vaccine development and optimise antigen delivery. A study of 1000 non-Indigenous families in WA led by Dr Sarra Jamieson (Division of Genetics and Health, TICHR) demonstrated that immunological genotypes were associated with OM susceptibility. Together, this led to the conclusion that further immunological studies in other populations and settings are warranted. Environmental studies, intervention programs and clinical trialsAssociate Professor Deborah Lehmann (Division of Population Sciences, TICHR) stressed that crowding at home is the strongest predictor of nasopharyngeal carriage of otopathogens in Indigenous children, whereas daycare attendance is the strongest predictor in non-Indigenous children. Delegates agreed with previous assertions that “reducing overcrowding is the key to fighting the disease”.5 Lehmann reported that exposure to environmental tobacco smoke increases the risk of OM 1.6-fold, and that reducing exposure to tobacco smoke could reduce the risk of OM by up to 27%. The link between hygiene and OM generated much discussion. Delegates agreed that further evidence is required to optimise hygiene education and practices in order to improve ear and general health. Such evidence may be forthcoming from an ongoing intervention study (promoting regular ear screening, frequent hand washing and reduced smoke exposure) of Indigenous children in WA. Debra Fernando (Sax Institute, Sydney, NSW) described the Study of Environment on Aboriginal Resilience and Child Health, which is examining ear disease, mental health, housing and environmental factors in urban Indigenous children from NSW. Preliminary findings indicate that over a third of the cohort had some middle ear abnormality detected by otoscopy. Associate Professor Chris Perry (School of Health and Rehabilitation Sciences, University of Queensland, Brisbane, Qld) updated delegates on the Deadly Ears program that involves a team of ear, nose and throat surgeons, audiologists, speech pathologists, nurses and Indigenous health workers. They provide screening, surgery, rehabilitation and educational services to remote Indigenous communities in Queensland. Associate Professor Amanda Leach (Child Health Division, Menzies School of Health Research [Menzies], Darwin, NT) described the PREV-IX_COMBO randomised controlled trial (ACTRN12610000544077; NCT01174849) that will compare the effect of two new pneumococcal conjugate vaccines (Prevenar13 [Wyeth] and Synflorix [GlaxoSmithKline]) and a combination schedule of these vaccines on immunogenicity, nasopharyngeal carriage and OM prevalence in Indigenous infants. Associate Professor Ross Andrews (Child Health Division, Menzies) noted that recruitment for the PneuMum study (NCT00714064) — assessing the effect of maternal pneumococcal vaccination on early-onset OM in Indigenous infants — is nearing completion. As highlighted by Associate Professor Peter Morris (Child Health Division, Menzies), trials such as PREV-IX_COMBO and PneuMum provide data for evidence-based guidelines that can be used to change policy and practice and, ultimately, to improve health outcomes. Research priorities and recommendationsThe OMOZ workshop enabled delegates to identify specific research priorities and recommendations, particularly those involving interagency participation, that could help reduce the burden of OM in Australia (Box). Research prioritiesFurther research into interventions to reduce ear disease in Indigenous communities is urgently required. The manner in which studies are conducted is critical if research is to be sustainable and meaningful to Indigenous communities. Involvement of Indigenous people in research will allow important questions to be addressed and promote research skills within Indigenous communities. Research into ear health in urban Indigenous children is urgently required. Further studies are required to determine whether the incidence of OM can be reduced by modifying risk factors such as hygiene practices, breastfeeding duration, cigarette smoke exposure and household crowding. Diagnostic accuracy is required to ensure appropriate treatment. Laboratory and clinical protocols should be standardised for accurate interpretation and comparison of research findings. Bacterial and viral density and diversity studies are required to help explain the vast difference in risk of OM between Indigenous and non-Indigenous children. RecommendationsResearch that strengthens the evidence for action (and the anticipated health benefits) must be clearly communicated to health care providers, policy leaders and the broader community. OM with tympanic membrane perforation for greater than 2 weeks’ duration must be considered a chronic disease. To reduce the unacceptably high levels of OM in Indigenous children, broader initiatives are required. Interagency collaboration should focus on promoting an agreed set of short-, medium- and long-term strategies. An ear health and hearing taskforce led by Indigenous Australians (supported by researchers, policymakers, clinicians and public health workers) is needed. This taskforce should inform government agencies about options for improving ear health and hearing in Indigenous Australians until the problem of OM is solved. Long-term funding is crucial to enable the conduct of long-term research and intervention studies that are required to address the large and complex problem of OM in both Indigenous and non-Indigenous children. As OM in Indigenous children is often asymptomatic, health care professionals should be encouraged to examine Indigenous children’s ears regularly. Immunisation data from the Australian Childhood Immunisation Register should be made available to facilitate evaluation of vaccine impact through data linkage. An OM research advisory board should be established to communicate research findings that have the greatest potential to influence policy and practice. Researchers should use the EarInfoNet website (http://www.healthinfonet.ecu.edu.au/other-health-conditions/ear) to share research findings with the community, promote standardisation of research methods, raise awareness of research expertise within Australia, and foster collaboration among researchers. We are listening — are you?The inaugural OMOZ workshop was timely and highly successful. It highlighted that OM is a major but unrecognised public health issue in Australia. Researchers are aware of the complexity of the condition, the gaps in knowledge about the pathogens and their interaction with the host, the difficulty of accurate diagnosis, and the challenges of prevention and appropriate treatments. However, they are optimistic that with enhanced awareness and stronger collaborative efforts with health care providers, policy leaders and the community, the burden of OM in Australia can be reduced. We all need to listen ... and take action. Keys to reducing the burden of otitis media (OM) in Australia Prevention — known risk factors for OM must be addressed. The costs and benefits of reducing the risk of severe disease should be quantified. Intervention — defined and evaluable interventions to prevent and treat OM are required. We must establish how, where and when to intervene. Treatment — children at high risk of severe OM should be identified early and treatment options should be enhanced. Investigation — ongoing laboratory research is essential to understand host–pathogen interactions and to develop and evaluate OM treatments and vaccines. Participation — involvement of Indigenous people in prioritisation, implementation and transfer of research is critical to sustainable improvements in ear health. Communication — research findings should be conveyed to the broader community, particularly health care service providers and policy leaders.

Lea-Ann S Kirkham PhD · Selma P Wiertsema PhD · Heidi C Smith-Vaughan PhD · Ruth B Thornton BSc(Hons) · Robyn L Marsh BSc(Hons) · Deborah Lehmann MB BS, MSc · Amanda J Leach BAgSc(Hons), MAgSc, PhD · Peter S Morris MB BS, FRACP, PhD · Peter C Richmond MB BS, FRACP

Objective: To document presenting symptoms, investigations and management for Australian patients with oesophageal adenocarcinoma (OAC), gastro-oesophageal junction adenocarcinoma (GOJAC) and oesophageal squamous cell carcinoma (OSCC).Design, setting and participants: Cross-sectional study of a population-based sample of 1100 Australian patients aged 18–79 years with histologically confirmed oesophageal cancer diagnosed in 2002–2005, using data from cancer registries and treatment centres, supplemented with clinical information collected through medical record review in 2006–2007 and mortality information collected in 2008.Main outcome measures: Prevalence of primary symptoms, and staging investigations and treatment modalities used.Results: The primary presenting symptom was dysphagia, which was self-reported by 41%, 39% and 48% of patients with OAC, GOJAC and OSCC, respectively. Less common symptoms were reflux, chest pain, bleeding and weight loss. All patients underwent endoscopy, most had a staging computed tomography scan (OAC 93%, GOJAC 95% and OSCC 93%), and about half had positron emission tomography scans (OAC 51%, GOJAC 44% and OSCC 42%). Pretreatment tumour stage was reported in 25% of records, and could be derived from results of investigations in a further 23%, but the remaining half lacked sufficient information to ascribe a pretreatment stage. Curative treatments were attempted for 60% of OAC, 88% of GOJAC and 65% of OSCC patients. Surgery was performed on 52% of OAC, 83% of GOJAC and 41% of OSCC patients. About two-thirds of surgical patients received additional therapies.Conclusions: With anticipated increases in oesophageal cancer incidence, the resources required to diagnose and manage patients with oesphageal cancer are also likely to rise. Our data provide a baseline from which to plan for the future care of patients with cancers of the oesophagus.

Bernard M Smithers MB BS, FRACS, FRCS · Paul P Fahey BSc, MMedStat · Tracie Corish RN · David C Gotley MD, FRACS · Gregory L Falk FRACS, FACS · Garett S Smith MS, FRACS · George K Kiroff MB BS, MS, FRACS · Andrew D Clouston MB BS, PhD, FRCPA · David I Watson MD, FRACS · David C Whiteman MB BS,PhD, FAFPHM

Objectives: To explore the perceived impact of medicolegal concerns on how Australian doctors practise medicine and to compare doctors who have experienced a medicolegal matter with those who have not.Design and setting: Cross-sectional survey (posted in September 2007, with reminder 4 weeks later) of Australian doctors from all major specialty groups, trainees and a sample of general practitioners who were insured with a medical insurance company.Participants: 2999 respondents of 8360 who were sent the survey.Main outcome measures: Perceived practice changes due to concerns about medicolegal issues, beliefs about medicolegal issues, and the influence of medicolegal issues on both career choices and how doctors relate to their patients.Results: Respondents reported changes in practice behaviour due to medicolegal concerns, with 43% of doctors stating that they referred patients more than usual, 55% stating that they ordered tests more than usual, and 11% stating that they prescribed medications more than usual. Respondents also reported improved communication of risk (66%), increased disclosure of uncertainty (44%), developed better systems for tracking results (48%) and better methods for identifying non-attenders (39%) and for auditing clinical practice (35%). Concerns about medicolegal issues led to 33% considering giving up medicine, 32% considering reducing their working hours and 40% considering retiring early. These proportions were all significantly greater for doctors who had previously experienced a medicolegal matter compared with those who had not.Conclusions: This Australian study, like international studies, confirms that doctors’ concerns about medicolegal issues impact on their practice in a variety of ways. There is a greater perceived impact on those doctors who have previously experienced a medicolegal matter.

Louise M Nash MB BS(Hons), BA, FRANZCP · Merrilyn M Walton BA, MSW, PhD · Michele G Daly BSc(Hons), MSc · Patrick J Kelly BMath(Hons), PhD · Garry Walter BMedSc, PhD, FRANZCP · Elizabeth H van Ekert BA, DipEd, MMedHum · Simon M Willcock MB BS, PhD · Christopher C Tennant MD, MPH, FRANZCP

Objectives: To compare survival among the subgroup of children with acute lymphoblastic leukaemia (ALL) who were treated at Princess Margaret Hospital for Children (PMH) in Perth, Western Australia, over 25 years under 15 consecutive protocols of the Children’s Cancer Group (CCG) with survival for the entire cohort of children in multiple centres treated under CCG protocols in that period; and to highlight the benefits of membership of a large cooperative research group conducting multicentre randomised controlled trials.Design, participants and setting: Retrospective review of the outcomes of all 311 children with newly diagnosed ALL treated at PMH between 1983 and 2008.Main outcome measures: 4-year event-free survival; and 10-year overall survival.Results: Four-year event-free survival for the entire PMH cohort increased from 66% (SE, 6%) for 1983–1987 to 88% (SE, 6%) for 2002–2005, while overall survival over the same period improved from 78% (SE, 5%) to 94% (SE, 4%). Comparisons of outcomes of children treated at PMH with those of the entire CCG cohort, protocol by protocol, revealed similar outcomes.Conclusion: Outcomes of children treated at PMH over the 25-year period are equivalent to those of the larger CCG cohort.

Hannah Forward MB BS(Hons) · Guicheng C Zheng PhD · Catherine H Cole MB BS, FRACP, FRCPA

Objective: To examine cancer incidence and mortality in Indigenous Queenslanders.Design, setting and patients: Assessment of indirectly standardised incidence and mortality ratios for Indigenous Australians in Queensland diagnosed with cancer from 1997 to 2006, compared with the total Queensland population.Main outcome measures: Standardised incidence and mortality ratios.Results: Compared with the total Queensland population, Indigenous Queenslanders had a lower overall incidence of cancer (standardised incidence ratio, 0.79; 95% CI, 0.75–0.82), but a higher incidence of some of the more fatal cancer types. Overall cancer mortality was higher (standardised mortality ratio, 1.36; 95% CI, 1.28–1.45) and similar to rates for Indigenous people in other Australian states.Conclusion: Cancer rates for Indigenous Queenslanders, a mostly urbanised population, are similar to rates for Indigenous Australians mostly living in remote areas.

Suzanne P Moore BHSc(Nursing), MPH, PhD · Peter K O’Rourke BSc(Hons) BA(Hons), PhD · Kylie-Ann Mallitt BSc(Hons) · Gail Garvey BEd, MEd · Adèle C Green MB BS, MSc, PhD · Michael D Coory MB BS, PhD, FAFPHM · Patricia C Valery MD, MPH, PhD

Objective: Design and setting: With the use of data obtained from Australian Bureau of Statistics’ catalogues and World Advertising Research Centre reports, three alternative series of annual totals of PCC of alcohol for the past 20 years (1990–91 to 2008–09) were estimated based on different assumptions about the alcohol content of wine. For the “old” series, the alcohol content of wine was assumed to have been stable over time. For the “new” series, the alcohol content of wine was assumed to have increased once in 2004–05 and then to have remained stable to 2008–09. For the “adjusted” series, the alcohol content of wine was assumed to have gradually increased over time, beginning in 1998–99. Linear trend analysis was applied to identify significant trends.Main outcomes measure: National trend in annual PCC of alcohol 1990–91 to 2008–09.Results: The new and adjusted series of annual totals of PCC of alcohol showed increasing trends; the old series was stable.Conclusions: Until recently, official national annual totals of PCC of alcohol were underestimated and led to the mistaken impression that levels of alcohol consumption had been stable since the early 1990s. In fact, Australia’s total PCC has been increasing significantly over time because of a gradual increase in the alcohol content and market share of wine and is now at one of its highest points since 1991–92. This new information is consistent with evidence of increasing alcohol-related harm and highlights the need for timely and accurate data on alcohol sales and harms across Australia.

Tanya N Chikritzhs PhD · Steve J Allsop PhD · A Rob Moodie MB BS, MPH · Wayne D Hall PhD

The Victorian Department of Health reviewed its Hospital in the Home (HIH) program in 2009, for the first time in a decade. Annual reimbursements to all Victorian hospitals for HIH care had reached $110 million. Nearly all Victorian hospitals have an HIH program. Collectively, these units recorded 32 462 inpatient admissions in 2008–09, representing 2.5% of all inpatient admissions, 5.3% of multiday admissions and 5% of all bed-days in Victoria. If HIH were a single entity, it would be a 500-bed hospital. Treatment of many patients with acute community- and hospital-acquired infections or venous thromboembolism has moved into HIH. There is still capacity for growth in clinical conditions that can be appropriately managed at home. The review found evidence of gaming by hospitals through deliberate blurring of boundaries between acute HIH care and postacute care. The Victorian HIH program is a remarkable success that has significantly expanded the overall capacity of the hospital system, with lower capital resources. It suggests HIH with access to equivalent hospital remuneration is necessary for a successful HIH policy. Hospitals should invest in HIH medical leadership and supervision to expand their HIH services, including teaching. HIH is a challenge to the traditional vision of a hospital. Greater community awareness of HIH could assist in its continued growth.

Michael Montalto MB BS, PhD, FRACGP

Objectives: To review the literature on different models of clinical governance and to explore their relevance to Australian primary health care, and their potential contributions on quality and safety.Data sources: 25 electronic databases, scanning reference lists of articles and consultation with experts in the field. We searched publications in English after 1999, but a search of the German language literature for a specific model type was also undertaken. The grey literature was explored through a hand search of the medical trade press and websites of relevant national and international clearing houses and professional or industry bodies. 11 software packages commonly used in Australian general practice were reviewed for any potential contribution to clinical governance.Study selection: 19 high-quality studies that assessed outcomes were included.Data extraction: All abstracts were screened by one researcher, and 10% were screened by a second researcher to crosscheck screening quality. Studies were reviewed and coded by four reviewers, with all studies being rated using standard critical appraisal tools such as the Strengthening the Reporting of Observational Studies in Epidemiology checklist. Two researchers reviewed the Australian general practice software. Interviews were conducted with 16 informants representing service, regional primary health care, national and international perspectives.Data synthesis: Most evidence supports governance models which use targeted, peer-led feedback on the clinician’s own practice. Strategies most used in clinical governance models were audit, performance against indicators, and peer-led reflection on evidence or performance.Conclusions: The evidence base for clinical governance is fragmented, and focuses mainly on process rather than outcomes. Few publications address models that enhance safety, efficiency, sustainability and the economics of primary health care. Locally relevant clinical indicators, the use of computerised medical record systems, regional primary health care organisations that have the capacity to support the uptake of clinical governance at the practice level, and learning from the Aboriginal community-controlled sector will help integrate clinical governance into primary care.

Christine B Phillips MA, MPH, FRACGP · Christopher M Pearce MFM, PhD, FRACGP · Sally Hall RN · Joanne Travaglia BSocWk, PhD · Simon de Lusignan MB BS, MSc, MD(Res) · Tom Love MPH, MSc, PhD · Marjan Kljakovic MB BS, PhD

Objective: To identify the financial costs and benefits associated with teaching in private general practice.Design: Cost–benefit analysis of teaching in private general practice across three levels of training — undergraduate medical training, prevocational training and general practice vocational training — using data from a 2007 survey of general practitioners in South Australia.Setting and participants: GPs and practices teaching in association with the Adelaide to Outback GP Training Program or the Discipline of General Practice at the University of Adelaide.Main outcome measure: Net financial outcome per week.Results: The net financial outcome of teaching varied across the training levels. Practices incurred a net financial cost from teaching medical students that was statistically significantly different from zero. With respect to vocational training and teaching junior doctors, there were small net financial benefits to practices, although the mean estimates were not statistically significantly different from zero.Conclusions: This study shows a net financial cost for practices teaching medical students, while at the prevocational and vocational training levels, adequate levels of subsidies and income generated by the trainees help offset the costs of teaching. Our results suggest that a review of subsidies for undergraduate teaching is necessary, particularly as the demand for teaching practices will increase substantially over the next 5 years.

Caroline O Laurence BA(Hons), MHSM, PhD · Linda E Black BA(Psych), DipAppPsych, MAPS · Jonathan Karnon BSc(Hons), MSc, PhD · Nancy E Briggs BSc, MSc, PhD

We report the first Australian case of treatment of infant botulism with a human botulinum antitoxin developed in the United States by the California Department of Public Health. Our patient’s clinical improvement was rapid, and although the product is expensive, cost-analysis supports the economical viability of its use. In future cases of suspected infant botulism, we recommend that Australian clinicians promptly obtain and administer this antitoxin to their patient. Clinical recordA 5-month-old girl who was fully breastfed presented to the emergency department at a tertiary children’s hospital with poor feeding and lethargy. She was afebrile and mildly dehydrated, with a poor suck and a weak cry. Laboratory testing revealed a normal full blood examination and mild derangement of electrolytes consistent with dehydration. Blood cultures were sterile, and cerebrospinal fluid examination was normal. Formal neurological examination revealed bilateral ptosis, low muscle tone, globally reduced muscle strength and no gag reflex. Deep tendon reflexes were absent, and pupillary reflexes were preserved. Nerve conduction velocities and electromyography were normal. Further history revealed no recent ingestion of honey and no passage of bowel motions for 10 days. She had not received oral polio vaccine and had no history of overseas travel. The patient was transferred to the hospital’s paediatric intensive care unit (PICU), where we established a working diagnosis of infant botulism, pending confirmatory investigations. The patient was electively intubated and ventilated on Day 3 of her hospital admission. Faecal fluid was obtained per rectum for a mouse toxin bioassay. We telephoned the California Department of Public Health’s Infant Botulism Treatment and Prevention Program (IBTPP) in the United States to purchase BabyBIG (botulism immune globulin [intravenous human]) (Massachusetts Public Health Biologic Laboratories and Cangene Corporation, Boston, Mass, USA), which we received 48 hours later. A single infusion of BabyBIG was administered on Day 7 of the child’s admission to hospital, with no adverse consequences. The product cost US$43 500. The diagnosis of infant botulism was confirmed by the mouse bioassay, with growth of toxin B-producing Clostridium botulinum from faeces. The child was extubated on Day 10 of her PICU admission, discharged from the PICU on Day 16, and discharged home on full enteral feeds on Day 24. Follow-up physiotherapy showed gross motor delay with postural weakness, which had resolved by 2 months after discharge. DiscussionThis is the first case of infant botulism in Australia in which BabyBIG has been used (personal communication, Dr Stephen Arnon, Chief, IBTPP, California Department of Public Health, 21 March 2009). While an uncommon disease, Australia has had about one case per year since 1999.1 Infant botulism arises from ingestion of C. botulinum spores and growth of the organism in the gastrointestinal tract, producing botulinum toxin, which binds irreversibly to receptors at the neuromuscular junction, producing flaccid paralysis. Ingestion of honey is a classic risk factor, although frequently no specific source of the infection is found. Intensive supportive care is required until muscular function recovers — a process which takes weeks to months, usually with extended hospitalisation and artificial ventilation. BabyBIG was developed by the California Department of Public Health and registered with the US Food and Drug Administration (FDA).2 The product is derived from serum donations from individuals immunised with pentavalent botulinum toxoid, a vaccine developed by the US military. Purification and preparation of the product is in line with FDA licensing requirements for processing human plasma, including screening of donors and testing plasma for transmissible diseases. The product comes as a lyophilised powder of immunoglobulin G, stabilised with 5% sucrose and 1% human albumin, and contains neutralising antibodies against botulinum toxins A and B. The product has a half-life of about 28 days, and a single infusion is calculated to neutralise all absorbed botulinum toxin for at least 6 months. BabyBIG was initially assessed in a randomised, double-blind, placebo-controlled trial conducted between 1993 and 1997.3 The trial involved 129 Californian infants with botulism, treated on Days 0–3 of hospital admission, and showed significant decreases in duration of ventilation (by 2.6 weeks [P = 0.01]), length of PICU stay (by 3.2 weeks [P < 0.001]), length of hospital stay (from 5.7 weeks down to 2.6 weeks, [P < 0.001]), and mean hospital costs per patient (of US$88 600 [P < 0.0001]). Subsequent open-label, US-wide use of the product on 382 infants showed similar results in the 366 infants who received BabyBIG within 7 days of admission.3 The product was initially only available to infants in North America, but since 2003 has been exported internationally on a case-by-case basis. A subsequent review has shown that only 5% (32) of 681 cases treated with BabyBIG since 2003 have been misdiagnoses, with no adverse events occurring as a consequence of the infusion in any infants.4 Although the cost of the treatment is substantial, evidence has shown the intervention to be economically sound. In our case, a conservative estimate of costs saved just from reduced requirement for intensive care ranged from A$28 000 to A$117 600, based on an estimate of A$4000 per intensive care day. The social and emotional benefits of early discharge and recovery to the child and her family are obvious. In cases of suspected infant botulism, we recommend that Australian intensive care physicians and paediatricians promptly obtain and administer BabyBIG to their patient. All experience to date encourages pre-emptive treatment without waiting for confirmation by diagnostic testing. Despite long distances in sourcing the product, with good communication, this process can provide a timely, safe, effective and cost-saving treatment for infant botulism.

Meryta L A May MB BS, FRACP, FRCPA · Michael A Corkeron MB BS, FANZCA, FCICM · Mark Stretton MB BS, FRACP

Clinical record We report the case of a 20-year-old man who suffered an artefactual elevation of creatinine after consuming a creatine water supplement. Before this event, the patient was regularly seen in our clinic to monitor progression of a secondary paroxysmal nocturnal haemoglobinuria clone complicating childhood aplastic anaemia, for which he was previously treated with immunosuppression. Aside from his asymptomatic, stable, moderate thrombocytopenia (platelet count, 50–60 × 109/L), there had never been evidence of haemolysis or thrombosis. The patient took no regular prescription medications and had previously documented normal renal function (Table). Blood tests performed 1 day before the patient’s admission to hospital showed a significantly elevated creatinine level of 196 μmol/L (reference range, 40–120 μmol/L), with an estimated glomerular filtration rate of 38 mL/min, calculated using the MDRD (modification of diet in renal disease) formula.1 The patient reported no recent systemic illnesses or symptoms. However, on specific questioning, he reported using a creatine water supplement at 1.0–2.5 L/day for the previous 2–3 months — an intake greater than that recommended in the product packaging information (3 g creatine in 500 mL of water daily). Physical examination was unremarkable and fluid status was clinically euvolaemic. The patient was admitted to hospital for investigation of apparent acute renal dysfunction. Repeat blood tests confirmed a disproportionately elevated creatinine level of 206 μmol/L relative to the urea level, which was normal (6.9 mmol/L; reference range, 2.1–7.1 mmol/L). All electrolyte levels were within normal limits, including a potassium level of 4.1 mmol/L. A full blood count examination demonstrated stable thrombocytopenia with a platelet count of 58 × 109/L. Other parameters, including glycated haemoglobin level, white cell count and neutrophil count, fell within their reference ranges. Results of further directed investigations did not show any significant abnormalities to account for the apparent renal impairment. These included a total protein level of 82 g/L, an albumin level of 47 g/L, and a creatine kinase level of 331 U/L. Although above the reference range, at this level the creatine kinase would not be associated with elevated creatinine. Also within reference range were the patient’s levels of negative antinuclear antibodies, extractable nuclear antigens, anti-double-stranded DNA, antinuclear cytoplasmic antibodies, antiglomerular basement membrane antibody, antistreptolysin serology, HIV, and hepatitis B and C serology. Midstream urine analysis was unremarkable, being within the reference range for cells, casts, protein and myoglobin. Renal tract ultrasound with Doppler studies showed normal-sized kidneys with no evidence of renal artery or vein thrombosis, or obstruction. The patient was initially treated with intravenous normal saline and cessation of the creatine water supplement. Further blood tests performed 2.5 hours later showed a reduction in his creatinine level to 152 μmol/L; and those performed 17 hours later showed that the level had normalised to 81 μmol/L. In view of the rapid return to a normal creatinine level, a renal biopsy was not performed. The patient was clinically well throughout his hospital stay and, since discharge, has experienced normal renal function. Patient’s renal function tests Time of test Creatinine (μmol/L)* eGFR (mL/min)† Urea (mmol/L)‡ 1 month before supplement use 79 > 90 8.1 At admission to hospital 206 36 6.9 2.5 hours after admission to hospital 152 51 7.1 17 hours after admission to hospital 81 > 90 4.3 1 week after ending supplement use 96 87 7.1 eFGR = estimated glomerular filtration rate, calculated using the MDRD (modification of diet in renal disease) formula. * Reference range (RR), 73–108 μmol/L. † RR, > 60 mL/min. ‡ RR, 2.1–7.1 mmol/L. Creatine supplements are commonly used by professional and amateur athletes to help enhance their sporting performance.2 Creatine is typically sold in powder form to limit spontaneous hydrolysis to creatinine. Recently, creatine monohydrate suspended in water (Creatine Water AsthNon3000, Immuno-Biological Laboratories Co, Takasaki-Shi, Gunma, Japan) has become commercially available in Australia. The manufacturing process attempts to stabilise creatine in liquid for prolonged periods of time. Our patient’s disproportionately elevated creatinine level compared with a urea level within reference range, lack of evidence for organic renal abnormality, and rapid normalisation of creatinine level once he stopped using the creatine supplement suggest that artefactual elevation of creatinine secondary to consumption of creatine water was responsible for the abnormal biochemical test results seen. We investigated this hypothesis further by analysing a previously unopened bottle of the creatine water product that the patient had been using. The product information stated that a 500 mL bottle contains water, sorbitol 5 g, creatine monohydrate 3 g and sodium 0.27 mg. We analysed the fluid on the hospital’s laboratory analyser (UniCel DxC-800 Synchron, Beckman-Coulter, Brea, Calif, USA) using the Jaffé method and obtained a creatinine concentration of 21 000 μmol/L. To determine whether the drink actually contained creatinine or if this concentration was an artefact of the creatine present in the supplement, we then analysed it using high-performance liquid chromatography. This analysis showed a creatine concentration of 46.5 mmol/L, which was about the same as that stated on the product label, and a creatinine concentration of 20 000 μmol/L, which was similar to that from the hospital’s laboratory analyser. Further testing also found that creatine itself caused minimal cross-reactivity; a separately produced creatine solution with a concentration of 55.6 mmol/L recorded a creatinine concentration of only 80 μmol/L (Jaffé method). Given the creatine level we found in the supplement was consistent with that reported in the manufacturer’s product information, it appears that the creatine was not spontaneously converting to creatinine after bottling. This suggests that a substantial amount of creatinine was produced during the manufacturing process. When our patient consumed the creatine water, he would have directly absorbed this creatinine, which was subsequently measured in blood tests as an artefactually elevated creatinine level in the absence of renal abnormality.3 There are many case reports describing renal impairment attributed to creatine supplements. Pritchard and Kalra4 reported a 25-year-old man with focal segmental glomerulosclerosis and deteriorating renal function attributed to creatine supplements. Thorsteindottir et al2 and Koshy et al5 described cases of acute interstitial nephritis in previously healthy young men taking creatine supplements. In contrast to our case, both these patients were symptomatic, had proteinuria, and had renal biopsies that confirmed organic abnormality. Willis and colleagues6 reported a series of four patients with HIV referred for investigation of elevated creatinine level, in whom no kidney disease was identified, and whose creatinine levels improved when they stopped consuming creatine or protein supplements. Willis and colleagues proposed that the elevated creatinine level may have been the result of endogenous metabolism of creatine to creatinine. Several prospective studies have demonstrated that creatine supplements may produce mild elevations of creatinine in the absence of kidney injury in healthy patients as well as those with pre-existing renal impairment;3,7,8 this is generally attributed to conversion of creatine to creatinine in vivo. Our case is novel in that the creatinine appears to have been consumed directly, rather than being the result of increased endogenous production from creatine. In relatively asymptomatic patients with elevated creatinine levels for whom investigations do not identify evidence of organic renal disease, a full nutritional supplement history should be obtained. Our case provides evidence that creatine monohydrate water supplements may contain creatinine contamination that can cause artefactual elevation of creatinine levels on routine laboratory testing. Lessons from practice History of non-prescription medication and supplement use is important in assessing patients with acute renal impairment. Creatine water supplements may contain significant quantities of creatinine that can cause an artificial elevation of blood creatinine levels on routine laboratory analysis. Disproportionately elevated creatinine levels compared with urea levels should raise suspicion of artefactual elevation.

Kathryn A Jackson MB BS(Hons), BSc · Kacey M O’Rourke MB BS(Hons), BAppSc · Adrian Kark MB ChB, FRACP · Glen A Kennedy MB BS(Hons), FRACP, FRCPA

To the Editor: The benefits of bicycle helmet use have been the subject of recent discussion, with calls from some experts to review laws mandating the wearing of helmets.1 The objective of this brief report is to summarise long-term trends in cyclist head injuries seen at an inner-city major trauma centre and determine the odds of any skull fracture or intracranial bleed associated with not wearing a helmet. This was a retrospective study conducted at the Royal Prince Alfred Hospital (RPAH, Sydney, New South Wales), covering several local government areas that have the highest bicycle-use rates in NSW,2 where the law for mandatory helmet wearing was enacted in 1991. Patient data were obtained through the hospital trauma registry, which contains data on all patients admitted to the hospital with trauma. These data included information on helmet use routinely abstracted from ambulance and medical notes. Inclusion criteria were cyclists admitted from 1991 to 2009, who were over 16 years of age and involved in an incident on a public road. We excluded patients transferred from other hospitals. Head Abbreviated Injury Scale (AIS) scores (AIS 1990, 1998 and 2005 versions3) were used, with a head AIS score ≥ 3 indicating severe head injury, such as significant intracranial bleeding or depressed or comminuted skull fracture. Injuries with an AIS score of 2 included isolated concussion and simple skull fractures. To investigate the association between helmet use and head injury, we reviewed the medical charts of all cyclists admitted with trauma from 2008 to June 2010. We compared mechanism of injury (fall off bike without collision versus collision with another vehicle or object), anatomical injury (skull fracture or intracranial bleed), helmet use and the type of road where the incident occurred (state or regional roads versus local roads), according to NSW Roads and Traffic Authority classifications. Data were analysed using Stata software, version 10.1 (StataCorp, College Station, Tex, USA). Percentages were calculated with 95% confidence intervals, and categorical data were compared using χ2 tests. Mean ages were compared using the Student t test, and a logistic regression model was used to obtain odds ratios for any skull fracture or intracranial bleed associated with not using a helmet, after adjusting for mechanism of injury and road type. The study was approved by the Sydney South West Area Health Service RPAH Ethics Review Committee (RPAH Zone). There were 979 patients who met our inclusion criteria. The long-term trend in the number of cyclists sustaining severe head injuries remained low (range, 0–3 per year) (Box 1). Cyclists as a percentage of total admissions for trauma increased from 1.3% in 2005 (29/2258 [95% CI, 0.9%–1.8%]) to 3.9% in 2009 (122/3104 [95% CI, 3.3%–4.7%]). Trends in helmet use and severe head injury are summarised in Box 2. Severe head injury rates as a percentage of total cyclists admitted decreased from 10.3% (3/29 [95% CI, 3.6%–26.4%]) in 2005 to 2.5% (3/122 [95% CI, 0.8%–7.0%]) in 2009, a relative reduction of 76%. Helmet use in admitted cyclists from 1991 to 2009 ranged from 85% to 100%. Information was available about the location of the fall and helmet use for 287 of the 313 cyclists identified from 2008–2010 (Box 3). Their mean age was 36 years (95% CI, 34–37 years) and 81% were men. Non-helmet wearers had five times higher odds of intracranial bleeding or skull fracture compared with helmet wearers after adjusting for road type and mechanism of injury (odds ratio, 5.3 [95% CI, 1.7–17.1]; P = 0.005). The increase in admissions for bicycle injury is consistent with recently reported population trends.4 In addition, the number of cyclists sustaining severe head injuries has remained consistently low over the long term, with an apparent decline in the rate of severe head injuries in admitted patients since 2005. The odds reduction for skull fractures and intracranial bleeds in those wearing helmets is within the range reported in a Cochrane review of helmet use.5 The benefits of helmet use need to be placed in the context of lifetime costs of severe traumatic brain injury, estimated to be around $4.8 million per incident case.6 It is the opinion of the trauma service at RPAH, based on these findings, that mandatory bicycle helmet laws be maintained, and enforced as part of overall road safety strategies. 1 Trends in cyclist admissions and head injuries in admitted cyclists, RPAH, Sydney, New South Wales, 1991–2009 AIS = Abbreviated Injury Scale. RPAH = Royal Prince Alfred Hospital. 2 Trends in bicycle helmet use and severe head injury as a percentage of total cyclist trauma admissions, RPAH, Sydney, New South Wales, 1991–2009 AIS = Abbreviated Injury Scale. RPAH = Royal Prince Alfred Hospital. 3 Head injury in helmet and non-helmet users among 287 cyclists admitted to Royal Prince Alfred Hospital with trauma, 2008 to June 2010 Helmet (n = 241) No helmet (n = 46) Significance† Age, years (95% CI) 36 (34–38 years) 33 (29–37 years) P = 0.14 Men (%; 95% CI) 196 (81%; 76%–86%) 39 (85%; 71%–92%) P = 0.60 Fall off bicycle* (%; 95% CI) 83 (34%; 29%–41%) 13 (28%; 17%–43%) P = 0.75 State/regional road (%; 95% CI) 63 (26%; 21%–32%) 11 (24%; 14%–38%) P = 0.75 Skull fracture or intracranial bleed (%; 95% CI) 8 (3%; 2%–6%) 6 (13%; 6%–36%) P = 0.005 * Without direct collision with another vehicle, object or person. † Two-tailed P < 0.05 significant.

Michael M Dinh · Susan Roncal · Timothy C Green · Elizabeth Leonard · Amanda Stack · Chris Byrne · Jeffrey Petchell

To the Editor: It is incorrect for Chong and colleagues to state that “during the financial year 2006–07, 32 777 people were admitted to hospital in Australia due to road crashes”. It is also wrong for them to claim “it is often not clear how many of these road crashes are traffic crashes, and how many are non-traffic crashes”.1 Henley and Harrison report that there were 52 066 people seriously (but not fatally) injured due to land transport injury in 2006–07, and 32 777 of these (63.0%) occurred in traffic (on-road) accidents.2 A further 13 639 (26.2%) land transport injury cases in that year were explicitly described as non-traffic (off-road) accidents. The National Injury Surveillance Unit of the Australian Institute of Health and Welfare regularly publishes transport injury-specific analyses, including reports on land transport injuries (both traffic and non-traffic), rail-related transport injuries and transport injuries involving Indigenous Australians. The most recent of these reports is Henley and Harrison’s.2 In addition to the statistics mentioned above, they also report that the national age-standardised rate of non-traffic transport injuries was 66.5 per 100 000 population. In the previous year, this rate was 67.2 per 100 000 population.3 The next report in this series, to be published shortly, will include analysis of national trends in the rate of non-traffic transport injuries over the period 2000–01 to 2007–08.

Clare E Bradley · James E Harrison · Geoffrey I Henley

In reply: We acknowledge our error in reporting Henley and Harrison’s findings,1 and commend Bradley and colleagues for providing information about traffic and non-traffic transport injuries separately. We are also pleased that the National Injury Surveillance Unit will soon publish a report including analysis of trends in non-traffic transport injuries, extending our analyses beyond New South Wales. This is consistent with our conclusion that more needs to be done to understand non-traffic crashes.2 We defend our claim that the statistics in many reports and articles often do not clearly distinguish between traffic and non-traffic crashes and injuries.

Shanley S S Chong · Wei Du · Julie Hatfield

To the Editor: An editorial by Stewart alludes to the problem of silent multiple comparisons when interpreting P values from cancer cluster investigations.1 Visible multiplicities such as occur with pre-specified subgroup analyses or sequential monitoring of trials are difficult enough, but at least in these circumstances we know how many multiple comparisons are under consideration. More difficult are silent multiplicities such as occur with cluster investigations (and also with publication bias2 or reporting bias3) where we do not know how many multiple comparisons should be considered. The P value is intended to be an objective measure of the play of chance, and this is (arguably) the case when applied to a pre-specified primary hypothesis in a randomised trial. But this is not the case for cluster investigations, in which the number of multiple comparisons can never be known with any certainty. Statisticians analysing data from a cluster could obtain any P value they wanted by calibrating it against an arbitrary number of multiple comparisons. Where does this leave scientific reasoning in cluster investigations? All cases of cancer have causes; the key question in a cluster investigation is whether the cases have a common cause related to the neighbourhood or workplace from which the cluster was reported. Only rarely is an obvious common cause identified, and a decision to take some action (eg, evacuate the workplace) needs to be based on expert opinion. For the ABC cluster, no obvious common cause was identified. However, the expert panel was concerned that the women with breast cancer were relatively young and were long-term employees at the site, suggesting that there might be an unidentified common cause related to the site.4 This concern, based on expert opinion, is (arguably) enough evidence to evacuate the site. Investigation of cancer clusters is a difficult task. If a common cause cannot be identified, then there is no objective evidence on which to obtain agreement among experts about the importance of the cluster. Specifically, we need to be very clear that, for cluster investigations, a P value (even when adjusted for multiple comparisons) does not provide an objective measure of whether the cluster is due to chance. In the end, an expert group has to make a decision in the presence of uncertainty. When communicating the results to the public, the uncertainty should be acknowledged — as should the fact that experts sometimes disagree.

Michael D Coory

To the Editor: We read with interest the report by Sitas and colleagues about the Australian Broadcasting Corporation (ABC) breast cancer cluster investigation.1 After publication of the final report on the ABC cancer cluster,2 the Public Health Unit of Sydney South West Area Health Service undertook a similar investigation. In May 2007, our Public Health Unit was contacted by an occupational health representative after reports of five recent cases of breast cancer among women working in two departments at a Sydney hospital between 2002 and 2006. Four of these cases were confirmed, and all four women had offices in the same area of the hospital. Based on the assumption that women employed in these two departments between 2001 and 2006 (a total of 69 women) were the population “at risk”, we found that there was an excess of observed cases over expected cases (standardised incidence ratio [SIR], 15.1 [95% CI, 4.1–38.8]; P < 0.001). There were no known hazards affecting these women that would not be present elsewhere in the hospital, so an expert panel recommended a hospital-wide epidemiological investigation and environmental survey. The case definition was any woman diagnosed with invasive breast cancer while working at the hospital between 1 January 1998 and 31 August 2007. To ascertain cases, we wrote a letter to all current employees and issued a media release. A dedicated telephone hotline received 147 calls from 19 July to 31 August 2007. We confirmed 24 cases meeting the case definition. These women had a mean age of 51 years at diagnosis, had worked at the hospital for a median of 11 years, were not clustered by work location or type, and had similar risk factors for developing breast cancer to women in the New South Wales population as a whole. From employment records and NSW cancer statistics, we calculated that 23 cases of invasive breast cancer would be expected based on the age structure and size of the female workforce at the hospital over the study period. The observed number of cases was not significantly different from the expected number (SIR, 1.1 [95% CI, 0.7–1.6]; P = 0.44).3 In the environmental survey, no unusual hazards were identified. Breast cancer is the most common invasive cancer diagnosed in Australian women.4 In most cases, potential “clusters” are probably a chance occurrence, even when the number of cases is statistically significantly higher than expected, with no plausible explanation identified.5 Our investigation found no excess of cases of breast cancer in women employed at the hospital over the study period. Guidelines6 are helpful in defining a consistent approach to cluster investigation, but such investigations are resource intensive. Careful initial analysis of information is important to determine whether further investigation of a reported cluster is warranted. In our study, we concluded that a broader investigation was justified.

Catherine Francis · Trish F Mannes · Leena Gupta · Stephen J Conaty

To the Editor: Flitcroft and colleagues’ discussion of the National Bowel Cancer Screening Program provides a useful reminder of how political, institutional and financial issues can affect evidence-based policy.1 Bowel cancer is second to prostate cancer as the biggest cause of cancer death in Australian men, and men are more likely than women to be diagnosed with bowel cancer. There are no indications, however, that the screening program has sought to engage men as a target group. Men and women think about and act on their health in different ways and respond differently to messages, sources of information and modes of information delivery.2 Men are less likely than women to undergo preventive screening and are more likely to seek treatment at a later stage in a disease. A report for the Australian Government noted that, before receiving the Bowel Cancer Screening Pilot Program material, men were less likely to have been aware of preventive or pre-emptive behaviours “unless their GP had actually raised the subject with them, or a close friend had suffered, bringing the issue to a more personal level”.3 Further evidence indicated that fewer than one-third of men participated in the screening from mid 2006 to mid 2007, despite men aged 55 and 65 years being more likely than women to return positive results; among men aged 55 years, only 28% chose to participate.4 Participation rates during the 2-year screening period ending August 2008 were estimated to be 39.2% for men and 46.7% for women.5 Despite the considerable evidence that the “doing of health” is a highly sex-dependent activity, a population-based, “one size fits all” approach appears to have been adopted. Adding further insult to injury, men were blamed for their lower participation rate and for failing to understand “that screening for cancer saves lives”.6 A disappointing response to a free breast cancer screening initiative, on the other hand, prompted an investigation into the relationship between the wording of the screening invitation letter and the level of screening attendance.7 With around one in 19 men predicted to develop bowel cancer before the age of 75 years, men’s under-representation in bowel cancer screening is a serious problem. There is a need for more attention to be given to men’s attitudes and beliefs about risk and prevention, with a view to developing specific approaches to increase men’s participation in screening.8 It should not be too much to expect that Australia’s first National Men’s Health Policy, and an updated National Women’s Health Policy, will result in sex being taken into account in the design and implementation of national health initiatives.

Margo H Saunders · Anita Peerson

To the Editor: Flitcroft and colleagues’ historical report of bowel cancer screening in Australia is helpful to those new to this internationally accepted life-saving practice.1 One inaccuracy needs correcting. Lung cancer is the leading cause of cancer death in Australia — not prostate or breast cancer. Flitcroft et al appear to have quoted the Australian Institute of Health and Welfare data for new diagnoses, not cancer deaths.2 This error reflects the general lack of community focus or interest in the more than 7000 Australians who die each year from smoking-related lung cancer.3 An update is also warranted. Since submission of their article, once-only flexible sigmoidoscopy screening has joined faecal occult blood test (FOBT) screening in having randomised controlled trial evidence. Results of a recent British study point to the necessity of looking for this occult disease with flexible colorectal endoscopy.4 The study showed a massive 43% reduction in colorectal cancer mortality and a 50% reduction in incidence of invasive rectal cancer, owing to early flexible sigmoidoscopic diagnosis of colonic polyposis followed by polypectomy performed at subsequent colonoscopy. These techniques save thousands of lives worldwide each year. Flitcroft et al state that “A staged roll-out is a sensible approach”, but many of us who perform colonoscopic polypectomies on a weekly basis strongly disagree. Which is better — to be on a waiting list for a colonoscopy with a positive FOBT result, or to be ignorant of the possibility of a growing cancer in the colon? It is time to give people the opportunity of FOBT with or without further investigations. Flitcroft et al rightly point out that the National Health and Medical Research Council recommended that we should have at least biennial FOBT screening for individuals over 50 years of age.5 Australians have been very tardy in terms of adopting this recommendation. We don’t need an “age-specific cost-effectiveness analysis”. The argument should be about introducing flexible sigmoidoscopy. Like Semmelweis and hand washing back in 1847, history will judge our current generation harshly for ignoring the original life-saving FOBT research that was published in 19936 and allowing thousands of Australians to die unnecessarily from bowel cancer since then. It is time for us to take our heads out of the sand and introduce a proper national bowel cancer screening program. Thank you to Flitcroft and colleagues for helping us take another step in this direction.

Guy R Hingston

To the Editor: As public health professionals, we strongly support Givney’s call for the creation of an Australian national authority for disease prevention and control.1 This proposal is by no means a new one,2 but its relevance has, if anything, increased with time. Such an authority would structure and coordinate responses to emerging disease threats, as well as ensure that Australia has the national public health infrastructure required to coordinate the increasingly complex strategies needed for disease surveillance more generally. Human papillomavirus (HPV) surveillance is a recent case in point. Between 2007 and 2009, Australia delivered what remains the world’s most widely targeted HPV vaccination program, offering free vaccination with quadrivalent HPV vaccine to all girls and women aged 12 to 26 years. Australia’s excellent cancer registries will be able to accurately monitor the anticipated decline in cervical cancer incidence, but it will not occur for decades. In the meantime, we need to track more immediate vaccine impacts, such as the incidence of genital warts, incident Pap smear abnormalities and type-specific HPV infection. Specialist groups are initiating their own studies in these areas, with funding from a combination of government and industry sources, but there is no coordinated system for bringing together the key components of surveillance, and for ensuring that they are properly funded and analysed. The surveillance requirements for an HPV vaccination program are complex because of the multiple outcomes of vaccination, varying time scales over which these outcomes are expected, and the range of stakeholders involved in the fields of immunisation, cancer control and sexual health. No clear ownership or responsibility for comprehensive surveillance is apparent in Australia. In the United States, the Centers for Disease Control and Prevention have taken responsibility for coordinating HPV surveillance,3 and in the United Kingdom efforts are led by the Health Protection Agency, with planning and funding for comprehensive surveillance having been established at the outset of the immunisation program. The creation of an independent, well resourced body that is expert in disease control and prevention will ensure that Australia is best placed to respond to emerging disease threats as well as able to obtain maximum value from the implementation of prevention strategies.

Julia M L Brotherton · John Kaldor · Marion Saville

To the Editor: Givney’s recent letter restated the case for a national centre for disease control.1 His arguments for national planning, and particularly for a non-politicised approach to coordination and modification of responses to public health threats based on evidence, will be welcomed by many. A clear example of the validity of his case is provided by the recent pandemic (H1N1) 2009 influenza. In hindsight, despite certain risk groups being severely affected,2 the 2009 influenza season was generally mild.3,4 However, the public health response, based on the agreed pre-pandemic plans, was personnel-intensive and long-lasting.5 Crucially, there was a need for a well trained, flexible epidemiological workforce to rapidly analyse data to inform any response. Here, we highlight the contributions of Master of Applied Epidemiology (MAE) staff and students to this component of the response. The MAE program has operated as Australia’s only field-based epidemiology training program since 1991. MAE staff and students were enlisted to the response within days of the pandemic alert, as they constitute the only readily available epidemiological capacity in Australia. A survey conducted in February 2010 indicated that between April and December 2009, 18 students and five MAE staff members contributed 1159 person-days (3.2 person-years) to the response at local, state and national levels and internationally in New Zealand and with the World Health Organization. Contributions included establishing and evaluating surveillance systems, data analysis and reporting, training and supervision, rapid assessment and longer-term research projects. Areas covered included: border screening; investigation of clusters of cases related to air arrivals; school, prison and household transmission studies; analysis of state and national data; and establishment of a hospital-based sentinel surveillance system. Research findings have been disseminated widely via government reports, seminars, conference presentations and peer-reviewed publications. During the pandemic, the MAE program provided epidemiological “surge capacity”. This vital technical input to higher-level analysis allowed policy responses to changing evidence, a contribution that needs to be maintained and strengthened if Australia is to respond appropriately to future emerging disease threats. A logical home for a field epidemiology training program such as the MAE would be a national centre for disease control, with strong linkages to one or more academic institutions. We therefore echo Givney’s call for the establishment of an Australian centre, providing independent, evidence-based advice to governments, and incorporating a strong commitment to workforce capacity building and sustainability.

Paul M Kelly · Kamalini Lokuge · Hassan Vally · Alexander S Cameron

CorrectionMissing authors: In “Pathways to the diagnosis of epithelialovarian cancer in Australia” in the 20 September 2010 issue of the Journal (Med J Aust 2010; 193: 326-330), two study groups were omitted from the list of authors. The Australian Cancer Study (Ovarian Cancer) and the Australian Ovarian Cancer Study Group should have been listed as the final two authors, as shown here.

Susan J Jordan MB BS, FRACGP, PhD · Jane E Francis MA, MPH · Anne E Nelson PhD · Helen M Zorbas MB BS, FASBP · Karen A Luxford BSc(Hons), PhD · Penelope M Webb MA, DPhil

CorrectionIncorrect competing interests statement: In “Febrile convulsions after 2010 seasonal trivalent influenza vaccine: implications for vaccinesafety surveillance in Australia” in the 1 November 2010 issue of the Journal (Med J Aust 2010; 193: 492-493), there was an error in the competing interests statement. The sentence relating to Jim Buttery should have read “Murdoch Childrens Research Institute has received payment from CSL for Jim Buttery participating in data safety monitoring boards for influenza vaccine studies and trials, and a grant from CSL for a Guillain–Barré syndrome surveillance study”.

Michael S Gold · Paul Effler · Heath Kelly · Peter C Richmond · Jim P Buttery

Gordon Kerridge was born into humble circumstances in Sydney on 7 April 1920. Watching his younger brother suffer from infantile paralysis (polio) gave him his vocation of becoming an orthopaedic surgeon. He was dux of Fort Street High School and was awarded a scholarship to attend the University of Sydney, from which he graduated in 1943. After military service, Gordon was recruited to the Royal Newcastle Hospital by the pioneering medical administrator Dr Chris McCaffery, who had a vision of a community hospital treating patients according to need. There he joined a group of enthusiastic young doctors who established a reputation for the hospital of clinical excellence, high-quality training, continual innovation, and relentless questioning of existing medical and organisational dogma. Gordon was a superb surgeon, pioneering many new operations and techniques. A gifted and inspiring teacher, he had the ability to explain complex issues simply. He was an early participant in setting up orthopaedic training schemes in Singapore, Indonesia and Fiji. He was elected President of the Australian Orthopaedic Association in 1979 and was later awarded the Association’s highest award, the L O Betts medal, of which he was particularly proud. In the 1950s, Gordon helped establish the Hunter Orthopaedic School, where children of sound mind but with profound physical disability could receive a normal education. Throughout the 1960s, he was a tireless advocate for road safety, educating the community through talks and slideshows and lobbying the industry and politicians. He worked closely with the Minister for Transport to win community support for legislation to make the wearing of seatbelts compulsory in 1971. Gordon was closely involved in the establishment of the University of Newcastle’s Medical School. Above all, he taught his students the art of being a good doctor — how to think, how to solve problems, and how to maintain an ethical and compassionate approach. His teaching was peppered with good stories and bad jokes. His surgical abilities were surpassed only by the quality of his relationships with people. His empathy and rapport with patients and families was extraordinary; he always had time for a word or a joke to share with the cleaner, the ward clerk, the nurse or the orderly. After retiring from operating in 1986, he established a consulting practice, which he enjoyed for the rest of his life. A proud and passionate citizen of Newcastle, Gordon served the community in numerous ways. He was an enthusiastic patron of Waratahs Rugby Union Club and Norths Rugby League Club, and was involved in the scouting movement. In 1978, he was made a Member of the Order of Australia for services to the community. The later years of his life were difficult. A number of illnesses in the family were distressing; Newcastle lost some of its identity as Australia deindustrialised; the ethos of medicine drifted away from his ideals; and much of the heritage and principles associated with his beloved Royal Newcastle Hospital were lost due to reorganisation, a geographical move, and health politics. Although privately disappointed and frustrated, he remained active in medicine and in the community. He recovered after a fractured hip and decided to retire, but died suddenly on 21 August 2008, shortly after closing his rooms. Gordon is survived by his wife Cath and their large family. Four of his six children are involved in the health care field.

Ross K Kerridge · Roland Hicks

Surgical safety checks According to a US study, routine adoption of safety practices used by aircrew may help reduce surgical mortality. In 2006, a training program focusing on checklists and team-work was implemented at 74 surgical facilities in the Veterans Health Administration. Theatre staff (anaesthetists, nurses, technicians and surgeons) all attended the training together, which included strategies such as routine preoperative briefings and postoperative debriefings, challenging each other when identifying safety risks, recognising red flags and stepping back to reassess a situation. The training also facilitated more open communication in theatre and encouraged all team members to speak up if they had a safety concern. Facilities participating in the program experienced an 18% reduction in annual patient mortality (RR, 0.82; 95% CI, 0.76-0.91; P = 0.01) compared with a 7% decrease among the 34 facilities that had not yet undergone training (RR, 0.93; 95% CI, 0.80-1.06; P = 0.59). JAMA 2010; 304: 1693-1700 Say cheese Is it possible to tell the difference between a fake smile and one that comes from the heart? A 72-year-old man with acute cerebral ischaemia and left facial hemiparesis was unable to fully smile on command, but during emotional encounters he was able to overcome the facial paralysis. This is believed to be because the nerve tracts affecting voluntary facial movement originate from the motor cortex, while those affecting involuntary movement during emotion probably arise from a medial brain region with input from the limbic system. N Engl J Med 2010; 363: e25 Dental bugs and cardiovascular events Bacteria associated with chronic periodontal disease have been implicated as contributing to cardiovascular disease, but can their release during invasive dental procedures actually trigger a cardiovascular event? After analysing Medicaid data for 32 000 cases of myocardial infarction or stroke, UK researchers have shown a small but significant increase in these events within a month after invasive dental procedures such as tooth extractions (incidence ratio, 1.50; 95% CI, 1.09-2.06). Fortunately, no events occurred on the actual day of the procedure and the risk was found to gradually subside to baseline after about 6 months. The authors state that these “short-lived adverse effects are . . . likely to be outweighed by long-term benefits of invasive dental treatment to vascular health”. Ann Intern Med 2010; 153: 499-506 Is smaller better? Results of a WA study have challenged concerns that medical students posted to small remote locations (with populations < 20 000) may be disadvantaged in their learning opportunities. After a year-long rural clerkship, students returning from small communities had significantly higher end-of-year grades compared with their city counterparts and reported greater levels of satisfaction with their learning experience. The potential disadvantages of smaller populations, such as smaller case loads and fewer or no specialists available for teaching, appeared to be outweighed by benefits such as lack of competition for cases, continuity of care, and an increased sense of belonging to the health care community. Rural Remote Health [internet] 2010; 10: 1470 Fish oil supplements and postnatal depression Women taking fish oil supplements during pregnancy do not reduce their risk of postnatal depression, nor are they more likely to have smarter children, according to a large Australian study. The trial randomly assigned 2399 pregnant women (with or without a history of depression) to take either docosahexaenoic acid (DHA)-rich fish oil capsules or matched vegetable oil capsules. At 6 weeks and 6 months postpartum, depressive symptoms did not differ significantly between the two groups (9.67% v 11.19%, P = 0.09), nor did the mean cognitive composite scores of their children at 18 months of age. However, taking the fish oil supplement was associated with half the risk of preterm birth, confirming findings of previous studies. JAMA 2010; 304: 1675-1683 doi: 10.1001/jama.2010.1507

Alison Williams