Editorials

Best-practice guidelines mandate a full postmortem examination in these deaths to identify genetic causes and allow potentially life-saving interventions in the victim’s relatives The sudden and unexpected death of an apparently fit, healthy young person has a devastating effect on the family and community. If there is no adequate explanation for the death, the desperate sadness is usually compounded by frustration and fear that another family member may be struck. Yet, there is no uniform process in place in Australia and New Zealand to obtain a proper medical history of the victim, or to examine and investigate the victim’s family. Such a process could provide clues to the diagnosis and also identify previously undiagnosed genetic diseases. The lack of a consistent definition for sudden unexpected death in young people means there are few prevalence data. The best studies of incidence and causes of sudden natural death in 1–40-year-olds have been conducted by two forensic pathology centres in New South Wales.1,2 These suggest an annual incidence of around 20 per million — about 400 deaths per year in Australia. A striking feature was that the postmortem examination identified no specific cause of death in a third. This suggests an arrhythmic death caused by an underlying cardiac channelopathy, such as long-QT syndrome, Brugada syndrome or catecholaminergic polymorphic ventricular tachycardia.3 Clinical and genetic studies have confirmed the presence of these conditions in the Australian and New Zealand populations.4 They are the consequence of inherited dysfunction of cardiac cell channels (for potassium, sodium and calcium), which are involved in generating the cardiac action potential. The mode of death is ventricular tachycardia or fibrillation. The results of the two NSW pathology studies1,2 were surprising, as previous studies on sudden death in young athletes found that the most prominent causes were the structural heart diseases, hypertrophic cardiomyopathy (HCM) and arrhythmogenic right ventricular cardiomyopathy (ARVC). Cardiac channelopathies, HCM and ARVC are all familial, with over 90% of cases inherited in an autosomal dominant fashion, meaning that 50% of first-degree relatives are potentially at risk. There is now good evidence that people with these conditions can benefit from interventions such as β-blockade and cardioverter defibrillators,5 so that identification of affected family members is potentially life-saving. Cardiological and genetic investigation of the relatives of young victims of sudden death can reveal an inherited heart disease in 40% of cases.6,7 To achieve this outcome, there is a need for a coordinated multidisciplinary team approach to the postmortem investigation of sudden deaths, including expert pathology, cardiology, clinical and molecular genetic assessment.8 The TRAGADY (Trans-Tasman Response Against Sudden Death in the Young) initiative was established in 2005, and comprises a group of over 50 highly motivated Australian and New Zealand health professionals, scientists and patient advocates who share the aim of reducing sudden death in the young caused by inherited heart diseases. The group has formulated a mission statement9 and, recognising the inconsistencies in postmortem practice across Australia and New Zealand, its first aim was to create a best-practice guideline for the postmortem investigation of sudden unexpected death in the young. This guideline has now been completed and formally approved by the Royal College of Pathologists of Australasia, and is available on the College website.10 A key message for the general practitioner is that a skilled postmortem examination is imperative after such deaths. There may be pressure from the family to avoid an autopsy, but ascribing such deaths to “heart attack”, for example, when there was some previous chest pain, misses the opportunity to make a proper diagnosis and potentially save the lives of other family members. Similarly, arrhythmic syndromes such as long-QT syndrome have been falsely diagnosed as epilepsy, and the death of any young person with epilepsy should be investigated in detail. Many families have suffered several sudden deaths because of a failure to investigate completely, as described on support group websites, such as that of the Australian Sudden Arrhythmia Death Syndromes Foundation (http://www.sads.org.au). Key points of the TRAGADY best-practice guidelines are summarised in the Box. Key points of best-practice guidelines on postmortem investigation of sudden death of a young person* A full postmortem examination should be completed in all cases of sudden unexpected death in young people (0–40 years). The investigation, ideally led by a pathologist, involves a team approach, including as a minimum: A person designated to liaise with the family; Specialist cardiology involvement with the family when non-cardiac causes are excluded; and Laboratories with molecular genetics, toxicology and metabolic expertise. A detailed antecedent clinical history must be obtained. A detailed and relevant family history must be obtained. Liaison with the family should be established early and be ongoing until a cause of death is ascertained. Skilled macroscopic and microscopic examination of the organs is required, particularly of the heart (especially right ventricular muscle), and the brain. This may require some specimens to be examined by other specialists. Adequate histological material must be obtained for review or, if necessary, referral. Tissue or blood suitable for DNA extraction must be obtained (paraffin-embedded tissue blocks are not suitable). * Devised by TRAGADY (Trans-Tasman Response Against Sudden Death in the Young) and endorsed by the Royal College of Pathologists of Australasia.

Jon R Skinner MD · Johan A Duflou MMed, FRCPA · Christopher Semsarian PhD, FRACP, FCSANZ

Progressive reduction in trauma mortality and morbidity demands both peer-group and state registry evaluations, with ensuing recommendations implemented by a responsive state government trauma committee Between 1992 and 2005, the Consultative Committee on Road Traffic Fatalities in Victoria (CCRTF) conducted several studies evaluating trauma care delivery and management in consecutive victims of road traffic accidents who had received medical treatment but subsequently died.1-4 These studies found that, between 1992 and 1997, combined preventable/potentially preventable (P + PP) death rates* among patients who died after road accidents were unaltered (* respectively, survival prospects with optimal treatment assessed as ≥ 75%, and as 25%–74%).1,5 Similarly, the frequency of errors and deficiencies contributing to death was unchanged. In 1997, recommendations were made to reduce identified problems6 and, in response, the Victorian Government established a Ministerial Task Force on Trauma and Emergency Services to implement a statewide integrated trauma system to expedite early definitive care.7 Previously, while there had been one adult major trauma service (MTS) in Victoria (The Alfred Hospital), most patients were taken to their nearest public hospital, where P + PP death rates were two to three times higher than at the MTS.3 The statewide integrated trauma system, developed in stages from 2000, has a four-tiered structure, with public hospitals assigned to different service levels according to the complexity of care they provide.7 Implementation of the statewide trauma system involved the development of two additional MTSs in Melbourne (a second adult hospital managing a sufficient caseload of seriously injured patients, and a paediatric hospital) and the designation of 11 metropolitan hospitals, 9 regional hospitals and numerous primary injury services in small rural communities. Under the integrated system, major trauma patients are identified at the scene of injury according to specified anatomical, physiological and mechanistic criteria and transported to an MTS, provided that the anticipated transport time from the scene of injury will not exceed 30 minutes.7 Longer times are accepted for patients who are managed and transported by Advanced Trauma Life Support helicopter crews. Otherwise, the patient is triaged to the nearest designated hospital and, after resuscitation, stabilisation and communication with the hospital, transferred to an MTS if appropriate. Early communication with the hospital from the scene of injury facilitates immediate patient reception by a trauma team. The team is comprised of at least one emergency medicine consultant and surgical and anaesthetic registrars, with a consultant general surgeon attending within 20–30 minutes for time-critical patients. Directors of trauma services are accountable for improved management in the hospital through coordination, audit and feedback. The Victorian State Trauma Registry, established in 2001, monitors and reports on progress to the State Trauma Committee, which is responsible to the Minister for Health.8 In a recent study, the CCRTF compared management and outcomes of 245 consecutive road traffic fatality cases before (1997–1998) and 193 consecutive cases after (2002–2004) the implementation of the integrated trauma system.4 The proportion of these trauma patients with TRISS (Trauma and Injury Severity Score)9 survival prospects of ≥ 75% who subsequently died fell from 31% before to 22% after the introduction of the new trauma system. The proportion of major road trauma victims admitted to MTSs increased from 34% to 62%. More patients were attended by Advanced Trauma Life Support road and helicopter paramedics, with increased time spent by paramedics at the scene of injury and increased transport times. The per-patient number of deficiencies and errors contributing to death was significantly reduced overall, particularly in the emergency department. P + PP death rates fell from 36% to 28% (preventable deaths from 5% to 3%, and potentially preventable deaths from 31% to 25%). While P + PP death rates remained markedly lower at MTSs than at other hospitals, P + PP death rates before hospital arrival and within each of the four hospital groups did not significantly change. The overall reduction in P + PP mortality can largely be attributed to increased admissions to MTSs. Recently, the Victorian State Trauma Registry estimated that there was a 37% reduction in the likelihood of death among hospitalised major trauma patients in 2002–2006 compared with 2001–2002.8 This finding, supported by research by Cameron and colleagues reported in this issue of the Journal (→ A statewide system of trauma care in Victoria: effect on patient survival),10 is further evidence of overall improvement following introduction of the new trauma system. In response to the lack of improvement within each hospital group, the CCRTF established an interactive strategy with the trauma services. Based on the most recent CCRTF findings, consensus recommendations to counter ongoing system and clinical deficiencies were developed jointly with each trauma service.11 Persisting deficiencies in the Victorian system include the lack of Trauma Director/Coordinator appointments at many hospitals; failure to ensure compliance with protocols and guidelines; delays in communication and referral; insufficient intensive-care beds; and problems with coordination, audit and feedback.11 In addition, funding for independent peer-group review of trauma mortality has ceased. Panel studies (involving multidisciplinary peer-group evaluation of patient management), trauma registry data and population-based research indicate that mortality and morbidity are reduced following the introduction of integrated trauma systems and that continuing improvements can be achieved.12-15 Statewide trauma systems operate in all jurisdictions in Australia except for Tasmania, the Northern Territory and Western Australia (where one is pending). Independent peer-group review is currently limited to New South Wales, where some fatalities, pre-hospital care and interhospital transfer cases are evaluated. NSW and Queensland have state trauma committees. Key system weaknesses recognised by the state trauma committees of the Royal Australasian College of Surgeons include MTS caseload dilution in NSW following the development of 12 MTSs; lack of consultant staff attendance for the early management of severe trauma and critical decision making in NSW and South Australia; insufficient surgical and intensive-care beds in the Australian Capital Territory; and deficiencies in theatre access and lack of intensive-care beds and funding in Queensland. Although the initiation of statewide trauma systems in Australia has been a major advance, it is still awaited in three jurisdictions. The number of MTSs designated should allow sufficient caseload of severe injury at each MTS.16 Future quality improvement requires identification of ongoing deficiencies so that targeted countermeasures can be introduced and their effectiveness assessed. Identifying such deficiencies depends on continuing analysis of trauma registry data, complemented by independent peer review of preventable mortality to clarify factors contributing to death. Effective oversight by a state trauma committee is mandatory to ensure an adequate response to the findings of the audit process and to implement corrective actions. Meetings between audit personnel and hospital staff would further facilitate quality improvement. The creation of a national trauma council would help to coordinate and develop standardised quality assurance and improvement in trauma care delivery across all Australian states and territories. Finally, quality improvement remains dependent on the commitment of consultant staff to direct all phases of trauma care.

Francis T McDermott MD, FRACS, FRCS(Eng) · Stephen M Cordner FRCPath, FRCPA, DipCrim

Early identification of outbreaks allows carers and public health agencies to reduce the burden of this disease Recently, serious outbreaks of foodborne gastroenteritis occurring in aged-care facilities (ACFs) have captured public and media attention. Gastroenteritis will occur in settings where people gather, even when standards of care and food hygiene are very high. Some infections are inevitable due to the susceptibility of the population and the highly infectious and persistent nature of enteric pathogens. Early recognition of an outbreak and identification of the responsible organism enable interventions that can reduce the impact of disease. While gastroenteritis normally has a mild clinical course, hospitalisation and death as a result of gastroenteritis are more common among elderly people, particularly those who live in ACFs.1 The relative contribution of gastroenteritis to deaths among elderly residents of ACFs is difficult to establish. Death certificates rarely record this common condition as a contributing cause, and many residents have severe underlying illnesses that are more directly related to their death. In May 2007, the deaths of five elderly residents of a Victorian ACF were referred to the state coroner for investigation as to whether an outbreak of Salmonella Typhimurium 44 was related to their deaths. Recently, similarly serious outbreaks of Salmonella Typhimurium 135 and Clostridium perfringens have occurred among ACF residents in South Australia and New South Wales, respectively. Reassuringly, the incidence of gastroenteritis in elderly people is considerably lower than the incidence in younger people.2 Each year in Australia, an estimated 17.2 million cases of gastroenteritis (0.9 episodes per person per year) affect all age groups.2 While most episodes are mild, more severe cases result in an estimated 3.4 million visits to general practitioners annually.2 People over the age of 65 years who live in the community have the lowest incidence of gastroenteritis of any age group, and are five times less likely to experience gastroenteritis than children aged 0–4 years.2 A recent study of residents of six Australian ACFs found that the incidence of gastroenteritis was about 0.1 episodes per resident per year, making it less common than respiratory infections, urinary tract infections, and skin and soft tissue infections (Judy Forrest, Managing Director, Bug Control (Aust) Pty Ltd, personal communication). These findings are consistent with surveillance of nosocomial infections in long-term care settings internationally.3 When it does occur in ACFs, gastroenteritis commonly manifests as outbreaks in which two or more residents, along with facility staff, may be affected. In Australia, recorded outbreaks in ACFs comprise about 50% of all outbreaks of gastroenteritis (Katie Fullerton, Coordinating Epidemiologist, OzFoodNet, personal communication). A single case of gastroenteritis in an elderly resident of an ACF may signal the beginning of an outbreak, making it important for clinicians to have a low threshold for testing faecal specimens. Although testing to identify specific causes rarely benefits the individual patient, early recognition of the pathogen can guide public health investigations and infection control measures in the facility to minimise the spread and consequences of a potential outbreak. The spread of gastroenteritis in ACFs may be from person to person, foodborne, or a combination of both. The identification of some pathogens may require specialised laboratory testing, so it is important that clinicians seek advice from a laboratory microbiologist on optimal specimen collection procedures and appropriate tests. Once a diagnosis is made in two epidemiologically linked cases, further diagnostic testing is rarely required. If a foodborne pathogen such as Salmonella, C. perfringens, or shiga toxin-producing Escherichia coli is isolated from the faeces of an elderly resident of an ACF, there is an urgent need for public health authorities to search for other related cases and investigate food sources. If norovirus is identified, the focus should be on strict and heightened infection control within the facility. Norovirus is a challenge to control.4 The global spread of novel strains of the virus resulted in many gastroenteritis outbreaks in Australia in 2006 and 2007.5,6 More outbreaks than normal were observed in a wide range of settings, particularly ACFs, hospitals and childcare centres. Norovirus is highly infectious7 and difficult to control, even when intensive infection control measures are implemented.4 Outbreaks of infection with the virus cause major difficulties not only for the aged-care sector, but also for acute health care, tourism and the international cruise ship industries.4,8 Each year, Australian health departments issue advice to ACFs regarding prevention of common infections, such as gastrointestinal and respiratory infections, in addition to the numerous state and territory and national guidelines for the sector. Australia has a robust system of aged care, including provision of a safe food supply. Of the reported gastroenteritis outbreaks in these facilities, only a small number are the result of contaminated food.9 As of 5 October 2008, a new national food standard (Standard 3.3.1) requires organisations that prepare food for vulnerable populations (including elderly people) to implement risk-based food safety plans (http://www.foodstandards.gov.au/thecode). These changes need to be incorporated into state and territory food laws in order to take effect. The proportion of Australia’s population that may be considered elderly will dramatically increase in coming decades, resulting in more people requiring the services of ACFs.10 It is clear that gastroenteritis is an important issue for elderly people and ACF managers. To minimise the risk to residents, facility managers and clinicians need to be aware that organisms causing gastroenteritis often result in outbreaks and that faecal specimens of ill residents should be tested. Early identification of outbreaks allows carers and public health agencies to reduce the burden of this disease.

Martyn D Kirk BAppSci, MAppEpid · Leslee Roberts BMed, MAppEpid, PhD · John Horvath MB BS, FRACP, AO

The draft Good Medical Practice code of professional conduct is now available for public comment and consultation Over the past few years, all medical boards in Australia have issued guidance to doctors about expected standards of medical practice. Most of these documents were adapted from Good Medical Practice, a code of conduct first issued by the General Medical Council of the United Kingdom in 1995.1 Given their shared origin, the various medical board guidelines have much in common, but they are not identical. On behalf of state and territory medical boards, the Australian Medical Council (AMC), through an expert working group, is developing good practice guidelines for the entire nation. This project is now well developed, and a draft Australian Good Medical Practice code2 is currently the subject of a consultation process with the medical profession and the community. The project deserves the attention of the medical profession. Indeed, the profession’s input is critical, principally to ensure that the proposed standards are realistic and consistent with current good practice. In addition, experience tells us that codes of practice are more likely to be followed when those affected have contributed to their development. A number of questions are likely to cross the minds of doctors. Why do we need a code of practice? Doesn’t the Australian Medical Association (AMA) issue a Code of Ethics?3 Who is drafting the new Code? Why is the community involved? Is this project related to the Council of Australian Governments (COAG) decision to introduce uniform national registration for all health professionals? Is the new Code to be enforceable, and by whom? The project began before the COAG decision, but the timing now makes it highly likely that the Australian Good Medical Practice code will be adopted as a starting point by the proposed national medical board. A national registration system will need national standards. These standards must reflect the considered views of both the medical profession and the community served by the profession. In effect, the national Code will amount to a declaration to the new national board from the profession and the community about the standards of medical practice expected in Australia. It is not intended to supplant the AMA Code of Ethics. Rather, it extends the principle-based AMA Code into an explicit statement to the community and the profession about standards of practice. The draft Code covers issues in detail, including providing good care, working with patients, working with other health professionals, minimising patient risk, ensuring the health of doctors, and doctors’ performance in teaching, supervising and conducting research (Box). The Code aims to define clear, nationally consistent standards of practice. To develop these, the AMC established an expert working group with strong clinical representation, and including the perspectives of junior doctors and medical students, medical regulators and educators, medical and health administrators, consumers and community groups, medical profession advocates, rural and Indigenous practitioners, and international medical graduates. This working group reviewed the codes of each of the state and territory medical boards, comparable initiatives in the UK, New Zealand, Canada and the United States, the professional standards documents of the specialist colleges, guidelines from the National Health and Medical Research Council (NHMRC) and the AMA Code of Ethics. How will the Australian Good Medical Practice code be used? Firstly, it will give all doctors and the broader community a clear understanding of what is expected of medical practitioners in Australia. Secondly, it is expected to be used in the assessment of complaints about doctors and allegations of unprofessional conduct. Currently, the legislation establishing state medical boards and defining their powers gives the existing codes slightly different status in different states, but in all cases the boards use their codes in assessing practitioners’ conduct. Practitioners who depart from the standards set out in these codes may need to justify their conduct. Serious or persistent failures to meet the standards may have consequences for a doctor’s registration. The legislation governing the new national medical board has not yet been written. However, as a number of boards currently have the power to regulate standards of medical practice and issue codes of practice to guide practitioners, it is likely that the national board will have these powers, and that the national Code will be applied in the same way. This Code is important for all practitioners, so please have your say. The Australian Government Department of Health and Ageing has funded a comprehensive national process, seeking involvement and feedback from the profession and the community across Australia through face-to-face meetings, an online survey and written submissions. The consultation process is open until 28 November. More information is available at <http://goodmedicalpractice.org.au>. Outline of the draft Australian Good Medical Practice code of professional conduct, August 2008 Providing good patient care is the core of good medical practice requires doctors to maintain high levels of competence and professional conduct includes assessment, planning of management and ensuring effective care involves shared decision making between patient and doctor Working with patients requires relationships based on openness, trust and good communication Working with other health care professionals requires respect for colleagues, teamwork and willingness to share information and resources Working within the health care system doctors have a responsibility to contribute to the effectiveness and efficiency of the health care system Minimising patient risk requires doctors to understand what to do if patient care is compromised and the importance of reporting and responding to adverse events Maintaining good standards of medical practice requires doctors to participate in relevant continuing professional development and credentialling, and to practise within their accepted scope of practice Professional behaviour doctors’ standard of behaviour must justify the respect and trust of the community Ensuring doctors’ health maintain own health and wellbeing and look after the health of colleagues Teaching, supervising and assessing important to the care of patients now and in the future Undertaking research vital in improving health of individuals and the population researchers carry particular responsibilities.

on behalf of the Australian Medical Council Code of Professional Conduct Working Group

The humanities offer tools for wise application of biomedical knowledge and promotion of humane medical care Writing in the New York Times, columnist David Brooks recently described a “distinct brand of social misfits” in “fields like law, medicine or politics, where a person’s identity is defined by career rank”.1 He fears that their childhoods may have been spent in domestic “achievatrons” that ensured their academic success but compromised their interpersonal skills. Brooks believes that American society produces a disproportionate number of people with a “rank-link imbalance”, which he described as “the social skills required to improve their social rank, but none of the social skills that lead to genuine bonding”. These people have opinions about everything and “treat their conversational partners the way the Nazis treated Poland. They crush initial resistance, and the onslaught of accumulated narcissism is finally too much to bear”.1 It is hard to know whether Australia has a disproportionate number of “misfits” in law, medicine or politics, but if this is the case, Brooks suggests that they are the people most likely to force their way to the top of their career ladder and make life miserable for the rest of us. One way of producing doctors (or lawyers or politicians) with a capacity for genuine bonding might be to broaden their education.2 However, physician and writer Rafael Campo argues that “no one has proven that injecting the humanities in any form into medical settings translates to more humane physicians or better cared-for patients”.3 Campo’s use of the word “injecting” is telling; it conveys a sense of the humanities as something foreign to medicine. To appreciate whether the humanities are indeed foreign to medicine, try to imagine a health care facility in which no ethical issues are explored, no lessons have been learnt from the past, no cultural awareness is displayed, no written words (other than technical communications) appear, and no books, films, television programs, plays or concerts are discussed by patients or staff. Imagine that there are no artworks, no music and no other aesthetically pleasing elements. Although some of our hospitals are admittedly run down, the products of the arts and humanities are nevertheless all around us. Two recent Australian examples illustrate why we need to draw on the humanities in health care. The first is the front cover of the 19 May 2008 issue of this Journal, which depicts the phrase “Sorry, the first step” spelt out in candles in front of Parliament House.4 Many doctors are indeed sorry that biomedical solutions to Indigenous health problems have been confounded by ignorance concerning Indigenous history and culture.5 Fortunately, the Indigenous Health Curriculum Framework prepared for the Committee of Deans of Australian Medical Schools gives priority to topics such as culture, self and diversity, Indigenous history and society, and models of health service delivery.6 All of these areas draw on knowledge and insights from the humanities. The arts also offer teaching resources that provide for better cultural understanding. Recent examples include the film Ten canoes, which imaginatively recreates the world of the Yolngu people; Kate Grenville’s novel The secret river, and Doris (Garimara) Pilkington’s book Follow the rabbit-proof fence and its subsequent film adaptation; and plays Murras, Coordah and The keepers, which explore the impact of government policies of forced removal. Such resources communicate and educate by being emotionally engaging. The second example relates to quality and safety in health care. Among the competencies outlined in the National Patient Safety Education Framework are communication skills, teamwork, leadership, honesty and respect.7 The intellectual foundations for these competencies lie in the medical humanities, in particular psychology, sociology, philosophy and ethics as applied to medical practice. Biomedicine puts at our disposal the tools for safe, effective health care; the humanities explore their wise application in practice. Certain educational approaches accommodate the humanities better than others.8 Problem-based learning and its variants engage students’ emotions by giving each patient a story. However, problem-based learning is easily subverted by ignoring or parodying the human, experiential features of clinical problems. Privileging biomedical subjects over the humanities quickly alerts students to what counts as knowledge.3 A good medical curriculum provides time and resources for emotional engagement, reflection, and independent, self-directed learning — qualities that characterise what is best about the study of the humanities.9 The human experience of illness is most powerfully conveyed to students by those who have first-hand knowledge. It can be supplemented by poems, novels and films that faithfully represent that experience: Iris, A beautiful mind and The sea inside (which explore dementia, schizophrenia and quadriplegia, respectively) are recent examples. The Medical Humanities website of New York University provides an extensive database of resources on literature, arts and medicine.10 In the United States, the Accreditation Council for Graduate Medical Education has identified compassionate patient care and professionalism among six required competencies for residents, which training programs must assess.11 It has been suggested that the humanities, and specifically bioethics, could contribute to resident education.12 However, it has been argued that time and effort would be better spent in humanising the US health care system itself.13 The humanities cannot make people behave well. The late John Eisenberg, Director of the Agency for Healthcare Research and Quality in the US, has shown that doctors respond to many different influences.14 Well intentioned educational interventions will not produce more humane doctors if their role models’ behaviour suggests that it is better to do well than to do good. Medical facilities are moral worlds15 in which humane behaviour is elicited by being treated humanely,16 both in medical schools and in clinical settings.17 The humanities provide insight into why people (including patients, doctors and politicians) behave as they do and have done in the past. Equipping students with such insight is a necessary but not a sufficient strategy in the never-ending battle with the rank-link misfits.

J Jill Gordon MPsychMed, PhD, FRACGP

Combined with appropriate lifestyle modification and statin therapy, raising HDL levels may be an important strategy to reduce cardiovascular risk In the past two decades, we have made significant advances in the management of cardiovascular disease (CVD), with a dramatic reduction in cardiovascular events occurring in parallel with the widespread use of statins to lower low-density lipoprotein (LDL) cholesterol levels. Nevertheless, despite intensive use of statin therapy, a significant patient cohort remains at high risk of cardiovascular events, paving the way for new strategies to reduce their residual cardiovascular risk. One attractive target for such strategies is high-density lipoprotein (HDL) cholesterol. There is strong epidemiological evidence demonstrating the inverse relationship between the incidence of cardiovascular events in normal populations and serum HDL levels. Based on data from the Framingham Heart Study, the risk of myocardial infarction increases about 25% per 0.13 mmol/L decrement in serum HDL below median values.1 HDL levels are also predictive of coronary events in patients with known CVD across a range of LDL levels, as demonstrated in the Treating to New Targets trial, in which nearly 10 000 patients with established CVD were treated with statins.2 HDL levels were inversely predictive of time to first major cardiovascular event across the spectrum of LDL levels, including patients with treated LDL levels below 1.8 mmol/L, highlighting the predictive value of HDL levels independent of LDL levels. The atheroprotective effects of HDL have been attributed to its ability to mediate “reverse cholesterol transport”, where cholesterol in peripheral tissues is transferred via plasma to the liver for either recycling or excretion. More recently, the antioxidant and anti-inflammatory properties of HDL have been explored. In particular, intravenous preparations of HDL have been shown to dramatically reduce acute vascular inflammation in animal models, improve endothelial function (an important surrogate of cardiovascular risk), and promote atheroma regression and stabilisation in human studies.3 Moreover, because of the heterogeneity of human HDL, an appreciation of function as well as absolute concentration is becoming increasingly important. For example, HDL from subjects with diabetes has been shown to be less effective in its cholesterol-effluxing and anti-inflammatory capacity.4 Lifestyle modifications in the form of regular exercise, smoking cessation, weight loss and moderate alcohol consumption have each been shown to individually raise HDL levels by 5%–10%.5 Although statins are currently the cornerstone of lipid-modifying therapy, they raise HDL levels by only 5%–10%.6 On the other hand, fibrates have been shown to raise HDL levels by 10%–15%.7 Fibrates regulate HDL metabolism as ligands and activators of the nuclear transcription factor peroxisome proliferator-activated receptor-α.8 The benefits of using fibrates to raise HDL levels have been suggested by a number of randomised trials. For example, the Veterans Affairs High-Density Lipoprotein Intervention Trial (VA-HIT) included 2531 patients with CVD, with an LDL level ≤ 3.6 mmol/L, HDL level ≤ 1.0 mmol/L, and triglycerides ≤ 3.4 mmol/L; patients were randomly assigned to receive treatment with gemfibrozil or placebo. At 5 years, the combined primary endpoint of cardiac death and non-fatal myocardial infarction occurred less often in the gemfibrozil-treated group, and the reduction in this endpoint correlated strongly with both serum HDL levels and degree of weight loss, but was independent of changes in LDL cholesterol or triglycerides concentration.7,9 Nicotinic acid is another effective HDL-raising drug, with an ability to raise levels by up to 30%. The HDL-Atherosclerosis Treatment Study (HATS) reported the effects of combined therapy with a statin and niacin on 160 patients with CVD, with an HDL level < 0.9 mmol/L and LDL level < 3.75 mmol/L.10 Compared with placebo, patients receiving simvastatin plus niacin were significantly less likely to experience a cardiovascular event. Furthermore, the magnitude of the reduction of clinical events with drug therapy was greater than that observed in studies of statins alone, suggesting that raising HDL levels provides additional protection beyond that attributable to simply lowering LDL levels.10 The side-effect profile remains problematic with this drug class, though development of extended-release preparations may overcome these issues. Most recently, a novel class of HDL-raising medications, the cholesteryl ester transfer protein (CETP) inhibitors, which prevent the transfer of cholesteryl ester from HDL to triglyceride-rich lipoproteins in exchange for triglyceride, have been tested in large clinical trials. In particular, the CETP inhibitor torcetrapib was evaluated in the multicentre randomised Investigation of Lipid Level Management to Understand its Impact in Atherosclerotic Events (ILLUMINATE) trial, which compared torcetrapib with placebo in more than 15 000 patients receiving atorvastatin.11 A significant increase in HDL levels (72%) and an additional decline in LDL levels (25%) below baseline after 12 months of torcetrapib therapy were seen. However, the trial was prematurely terminated due to a significant increase in cardiovascular events in the treatment arm; an “off target” effect on the aldosterone receptor leading to blood pressure elevations was postulated as a potential mechanism for this.11 Despite the setback experienced with torcetrapib, further studies are underway to develop more target-specific CETP inhibitors. Intravenous reconstituted HDL preparations and apolipoprotein A-I mimetic compounds are also in development. In the future, these compounds may be used to regress atheroma or suppress the arterial inflammation that is the hallmark of the acute coronary syndromes. Thus, raising HDL levels, in combination with optimising LDL cholesterol levels, blood pressure and glycaemic control, as well as appropriate lifestyle modification, represent important strategies for reducing residual cardiovascular risk. Such measures should see further improvements in clinical outcomes for patients with CVD.

Sanjay Patel MB BS, FRACP

All topical ophthalmic agents should be considered potentially potent systemically Many Australians are prescribed topical ophthalmic medications for chronic conditions such as glaucoma, ocular inflammation, infection and allergy. Despite their overall safety, these agents have the potential to cause significant systemic side effects and to have serious interactions with oral medications. In many cases, these effects may go unreported by the patient or misdiagnosed by the medical community. There is a need for improved prescribing practices in both the ophthalmic and general medical communities, with increased awareness of the full range of therapeutic agents being taken by the patient. With the recent passage of legislation allowing optometrists prescribing rights under the Pharmaceutical Benefits Scheme (PBS) (National Health Amendment [Pharmaceutical Benefits] Act 2007 [Cwlth]), it is timely to remind all health care practitioners of the potential hazards of topical ophthalmic medications. Pharmacokinetics make ocular drug delivery more akin to intravenous than to oral administration.1 Topically administered medications gain access to the highly vascular nasal mucosa and are variably absorbed, avoiding first-pass hepatic metabolism.2,3 One drop of timolol 0.5% solution in each eye approximates a 10 mg oral dose for treating systemic hypertension or angina.2 All topical agents should be considered as potentially potent systemically. A retrospective analysis of de-identified PBS billing data from Medicare Australia revealed that, between 1999 and 2004, 20 000 Australians per year had been exposed to co-supply of topical and systemic β-blockers.4 This combination has been linked with adverse respiratory and cardiovascular events, as well as reduced topical ocular hypotensive efficacy.5 The scale of this as a Quality Use of Medicines issue is larger than was anticipated. Multiple factors may be responsible: an assumption that topical therapy is systemically “homoeopathic”; the fact that many patients may not mention eye drops when asked about their drug history; and the fact that patients may not remember their full list of medications. Topical medications usually constitute first-line therapy for glaucoma. Parasympathomimetics (pilocarpine derivatives) have been in use for 140 years, topical β-blockers for 30 years, and, more recently, carbonic anhydrase inhibitors, α2-agonists and prostaglandin analogues have emerged. While the overall safety of these agents is recognised, there is a potential for serious side effects in a small proportion of people. As well as their own direct effects systemically, topical agents may have significant additive or interactive effects with systemic medications. Topical β-blockers may precipitate or aggravate bronchospasm, congestive heart failure, bradyarrhythmias, sinus arrest, a variety of central nervous system effects and dyslipidaemias.6-8 In this issue of the Journal, Schweitzer and colleagues (page 406)9 describe a case involving two episodes of melancholic depression in a patient who had been prescribed β-blocker antiglaucoma agents. Taking these medications has been rated as the most significant risk factor for falls in glaucoma patients.10 Parasympathomimetics locally provoke brow ache and/or headache, miosis and myopia, and, with systemic absorption, carry the risk of bradycardia, hypotension, bronchospasm,7 gastrointestinal symptoms and urinary frequency. Topical α2-agonists have been associated with central nervous system depression and with profound hypotension in children.11 Topical carbonic anhydrase inhibitors do not seem to produce the metabolic side effects of their oral counterparts, but may be associated with an idiosyncratic bone marrow suppression and sulphonamide allergy.6 To date, topical prostaglandin analogues have not been associated with cardiovascular or respiratory side effects, adding support to their use as first-line antiglaucoma agents.6 However, their use has been associated with headache, flu-like symptoms and myalgias in up to 10% of patients, with case reports of neurological referral and investigation.11,12 Co-prescription of systemic and topical β-blockers can reduce heart rate in patients with glaucoma.5 Simultaneous administration of topical timolol and systemic verapamil has been associated with severe bradycardia.7 Co-administration of topical α2-agonists with oral monoamine oxidase inhibitors carries a risk of hypertensive crisis and is contraindicated.3 Salicylates have been shown to cause accumulation of systemically administered carbonic anhydrase inhibitors; this is also theoretically possible with topical carbonic anhydrase inhibitors.3 Topical steroid drops are key to the management of ocular allergy and inflammatory disease. While they are well tolerated systemically, their ocular side effects are potentially blinding: potentiation of infection, cataract and glaucoma. Commonly perceived as a “safe” alternative, fluorometholone has been associated with all these ocular side effects, albeit less frequently.13 Topical chloramphenicol is commonly prescribed to treat infective conjunctivitis, and is used perioperatively with ocular surgery. Although bacteriostatic rather than bactericidal in action, its broad spectrum of activity and lack of systemic use make it an ideal first-line ocular topical agent. Its potential to induce life-threatening aplastic anaemia remains controversial: the risk has been estimated to be about 1 in 150 000, at worst,14 but it is likely to be much lower.15 Whether the rare occurrence of this condition is by a dose-dependent or a dose-independent (idiosyncratic) mechanism,14,15 prescribers need to be cautious when prescribing for patients with a personal or family history of blood abnormalities. Concern about this risk has been enough to marginalise the use of chloramphenicol in the United States. Additionally, chloramphenicol should only be prescribed when conjunctivitis is likely to be bacterial in origin and for clinically appropriate time periods.16 We believe prescribing practice can be improved with simple steps: (i) take a full drug history, and specifically ask about eye drops; (ii) physicians must remember to ask whether the patient’s optometrist has prescribed any medication, and should be aware of the newer combination preparations (Combigan [Allergan], Cosopt [Merck, Sharp and Dohme], DuoTrav [Alcon], Xalacom [Pfizer]), all of which contain the β-blocker timolol; (iii) ophthalmologists (and now optometrists) should be aware of a patient’s concurrent systemic health and medication status before commencing any topical agents, particularly β-blockers. The eye is not an isolated organ but may be influenced by systemic diseases and therapies. Further, recent publications1,4,8 highlight the converse — topical therapies for the eye may have significant systemic effects and/or interactions with systemic medications. It is important to be alert to possible systemic side effects and interactions between systemic and topical agents and to investigate and modify treatment regimens appropriately. Limit the use of topical steroids, and use them only with adequate supervision. Remind all patients using topical medications to follow the “double DOT” procedure (Don’t Open eyes Technique and Digital Occlusion of the Tear duct), which involves closing the eyes and applying digital pressure over the lacrimal sac for 1–2 minutes after drop administration (Box 1, Box 2). This reduces systemic absorption by two-thirds, thereby significantly widening the safety margin of all agents.17,18 Recent legislative changes across Australia allow practitioners who are not medically trained to prescribe topical medications, although, at present, legislation varies from state to state. These changes underline the importance of general practitioners and physicians recognising the potential systemic effects of these topical ophthalmic medications and being alert to interactions with other medications. Improved communication between all health care practitioners and ophthalmologists will be vital for patient safety. 1 Lacrimal drainage system 2 The “double DOT” procedure* for reducing systemic absorption of topical ophthalmic medications * Don’t Open eyes Technique and Digital Occlusion of the Tear duct.

Ivan Goldberg MB BS, FRANZCO, FRACS · Gregory Moloney MB BS · Peter McCluskey MB BS, FRANZCO

The future viability of general surgery may depend on combining subspecialty elective surgery with full-scope acute practice in both public and private settings Subspecialisation in surgery is an irresistible and irreversible force. It improves standards of patient care1 but tends to be accompanied by an erosion of competence in the broad scope of the major specialty. For example, many major hospitals in Australia have had difficulty retaining subspecialty breast surgeons on the on-call roster because these surgeons feel that their competence to manage the full range of general surgical emergencies has been diminished by their day-to-day practice involving primarily the breast and axilla and rarely the abdomen. Nevertheless, the community needs surgeons willing and able to provide acute surgical care in the major specialties, including general surgery. Is it possible to have a model of care that satisfies both of these apparently divergent scopes of practice? A century ago, there was a single broad field of surgery. During the 20th century, specialties within surgery developed, many of these arising from general surgery, which continues to be the largest specialty. The Royal Australasian College of Surgeons (RACS) currently recognises nine specialty disciplines, by training and examination: general surgery; orthopaedic surgery; otolaryngology, head and neck surgery; plastic and reconstructive surgery; cardiothoracic surgery; neurosurgery; paediatric surgery; urology; and vascular surgery.2 Recognition as a surgical specialty has required definition of a discrete area of knowledge and skills, and a group of practitioners dedicated to the practice, teaching and advancement of the specialty. Subspecialisation within each specialty continues this development, driven by surgeons’ motivation to increase their knowledge and improve patient care. However, it may also have professional and personal benefits for the surgeon, including a more regulated lifestyle and enhanced prestige and remuneration. Examples of subspecialisation within the specialty of general surgery are breast, endocrine, upper gastrointestinal, hepato-pancreatico-biliary, and colorectal surgery. Of particular concern is that general surgery — comprising the largest specialty group of surgeons and those most likely to be required to treat emergencies — is now attracting proportionally fewer applicants for training. In 2007, general surgery offered 51% of available training posts but attracted only 30% of applications.2 Until recently, a third of trainees transferred to another specialty during their training. Although it is hoped that the new Surgical Education and Training (SET) program3 will bring improvements for all surgical specialties, attraction to and retention in general surgery training is likely to be a continuing challenge. Despite the best efforts of the RACS and public hospitals, the number of training positions in general surgery of sufficient quality to meet accreditation standards has increased only gradually from 266 in 2004 to 304 in 2008.2 These factors at the supply end, combined with the fact that 40% of active general surgeons are aged over 60,2 are creating serious workforce pressures. Very few surgeons remain on the on-call roster after age 60. The situation seen in Australia is similar in other developed countries and is particularly concerning in the United States, where Fischer has warned of the impending disappearance of the general surgeon.4 General surgical specialists have been trained to a competent level in the full range of the specialty, including trauma and the acute abdomen. However, as subspecialisation develops, surgeons may become de-skilled in the requirements of emergency surgery. Thirty years ago, general surgeons practised the full range of the specialty, taking pride in the breadth and depth of their knowledge and skills. This has changed significantly. In a 2003 survey,5 the practice patterns of members of General Surgeons Australia were: general surgery with subspecialty, 45% general surgery with more than 90% subspecialty, 23% “general” general surgery, 18% subspecialty only, 14% Nevertheless, 83% felt an obligation to stay on emergency rosters out of duty to the community, trainees and professional colleagues. But for how long will this goodwill continue? Emergency work is demanding, and reliance on a diminishing pool of “general” general surgeons will not be sustainable. Indeed, the future viability of the specialty of general surgery may depend on the development of a model of practice that combines subspecialty elective surgery and full-scope acute practice in both public and private settings. What is required to encourage surgeons to continue to work on emergency rosters? First, we need a review of these rosters. The tradition of ongoing responsibility for the care of patients taken in during an on-call period being maintained by visiting surgeons — who make up most of the workforce and who are in private practice outside the public hospital for most of their working week — should be reconsidered. The Australian Medical Association has promulgated safe-hours principles,6 and these depend, in part, on the acceptance of safe-handover principles.7 The RACS supports both these professional workplace ideals.8 Rosters have been successfully trialled where a consultant-led surgical team is on call exclusively for emergencies, with no scheduled elective duties, for a defined time period such as 24 hours, or longer. At the end of this time, the team completely hands over care of patients with unresolved problems to the next team.9 Second, we need a review of the efficient use of operating theatres for emergency and elective surgery. Lack of access to beds and operating theatres for elective surgery is a continuing source of frustration for patients, surgeons and trainees, and may be solved by separating the services.10 This can be achieved by establishing a separate hospital for elective surgery, at least for surgery of minor or moderate complexity, or by effective quarantining of services within a major hospital complex. Third, surgeons need to maintain competence in emergency surgery relevant to their major surgical specialty. It is possible to identify the requirements of emergency surgery as a defined scope of practice within each of the nine major specialties. This set of knowledge and skills could be formalised in a curriculum for continuing professional development and delivered in an adult learning format, including online modules and hands-on technical skills laboratories. Surgeons would then have the confidence to continue to serve on on-call emergency rosters, thereby acting as mentors and role models for trainee surgeons, while also continuing to practise a subspecialty interest in elective surgical practice. Finally, hospitals should value their surgeons and provide appropriate incentives and conditions of service, including adequate remuneration and tangible support for continuing professional development. This will require cultural and organisational reform, but hospitals could then reasonably expect surgeons to provide emergency services as a condition of their employment. My emphasis here has been on general surgery, where the problems are so obvious. However, service issues also apply to other surgical specialties with developed and developing subspecialisation (notably orthopaedics and otolaryngology) and are also relevant to other medical specialties. Problems particularly occur in the public sector; while provision of acute care in the private sector is also problematic, motivations and incentives in private sector settings appear to be more effective in maintaining services. In rural and remote areas, the provision of elective and emergency services is also threatened by workforce pressures beyond the issue of subspecialisation. The RACS has recently responded to concerns about the increasing difficulties in providing adequate emergency and trauma care by publishing a position statement outlining guidelines for the sustainability of emergency surgery services.10 To continue to provide emergency surgical care to the Australian community, it is apparent that models of coexistence must be found, and that solutions will include effective rostering and practice models, the certainty of availability of facilities for care, and the appropriate valuation of surgeons, as well as ongoing support for the maintenance of professional competence.

Ian R Gough MD, FRACS

Now that we can predict risk accurately, we need to reconsider screening strategies The recent completion of the Human Genome Project offered great promise that medical genetics would have a population-based impact on the prevention and treatment of inherited conditions. A common inherited condition, hereditary haemochromatosis, was initially touted as a “poster child” for population genetic screening. Most cases are due to homozygosity for a single mutation of the HFE gene, leading to iron overload. Hereditary haemochromatosis is considered an ideal candidate for population genetic screening as genetic susceptibility is common, testing is inexpensive, and iron studies can detect early stages of the disease.1 Most importantly, venesection is a simple and effective way to both prevent and manage the potential sequelae of iron overload,2 which include severe fatigue, arthritis, impotence, cirrhosis, diabetes, and cardiomyopathy.3 However, even for an inherited condition as apparently straightforward as haemochromatosis, justifying population genetic screening has proven more complicated than initially expected.4 After the gene linked with hereditary haemochromatosis was identified in 1996,5 a flurry of publications called for the consideration of population genetic screening, as it was thought that most people who were homozygous for the C282Y mutation would eventually develop the disease. Although more than 90% of cases are due to C282Y homozygosity,3 there is now good evidence that not all those who are homozygous will progress through all stages of the disease. These stages comprise genetic predisposition without abnormality; iron overload (raised serum ferritin in the presence of a raised fasting transferrin saturation) without symptoms; iron overload with haemochromatosis-associated symptoms, such as arthritis and fatigue; and iron overload with organ damage, particularly cirrhosis.6 Although most of those who are homozygous appear to develop raised serum ferritin and raised transferrin saturation by the fifth decade of life,7 until now there have been few reliable data on the number of homozygous individuals who develop disease as a result of iron overload. Population estimates of the prevalence of non-specific signs and symptoms of haemochromatosis (eg, arthritis and fatigue) and disease due to documented iron overload (eg, cirrhosis) in C282Y homozygous individuals have been hindered by either the failure to clinically assess individuals before knowledge of their genetic status or an inability to account for the long lead time of preclinical iron-overload status. A cross-sectional population study of participants aged 20–80 years suggested that disease attributable to haemochromatosis occurs in fewer than 1% of those who are homozygous, regardless of sex.8 However, this study did not conduct clinical examinations or liver biopsies, and a quarter of the homozygous patients were excluded on the basis that they had been previously diagnosed. This exclusion would be expected to reduce the estimate of clinical penetrance of C282Y homozygosity. Furthermore, the study included homozygous patients of ages at which disease would not be expected to have developed. Until recently, there had been only two longitudinal studies of hereditary haemochromatosis designed to accurately estimate the proportion of homozygous patients who will develop disease secondary to iron overload.9,10 However, with a combined total of 23 patients, they were substantially underpowered to assess disease prevalence. In the largest longitudinal prospective study to date, my colleagues and I assessed 203 homozygous individuals among a healthy population of 31 192, followed up over 12 years.11 Data were collected by physicians who were blinded to genotype, and liver biopsies were performed as clinically indicated (serum ferritin > 1000 μg/L, unexplained hepatomegaly or raised serum aminotransferase levels).12 We found that homozygous individuals with a serum ferritin level higher than 1000 μg/L were at increased risk of haemochromatosis-associated signs and symptoms, when compared with either those who were homozygous with a serum ferritin level of 1000 μg/L or less, or individuals with other HFE genotypes. In particular, homozygous men with a serum ferritin level higher than 1000 μg/L reported greater fatigue, use of arthritis medication and history of liver disease than men without the C282Y mutation. We also assessed the proportion of homozygous individuals with disease that was directly attributable to iron overload using the combined definition of documented iron overload13 and one or more of the following: cirrhosis, liver fibrosis, hepatocellular carcinoma, raised aminotransferase concentration, physician-diagnosed symptomatic hereditary haemochromatosis, and arthropathy of the second and third metacarpophalangeal joints. Iron overload-related disease developed in 28% of homozygous men, but only 1% of homozygous women.11 Our study is important because it enables us, for the first time, to make accurate predictions about the proportion of those at genetic risk of haemochromatosis who will develop symptoms that could otherwise be prevented. Furthermore, we confirmed that homozygous individuals with a serum ferritin level higher than 1000 μg/L were not only at increased risk of cirrhosis, but also of non-specific signs and symptoms of haemochromatosis. This has implications for a cost-effectiveness analysis of population genetic screening for hereditary haemochromatosis. Other criticisms of such screening,14 including concerns over insurance implications and creating a cohort of “worried well” among those at genetic risk of haemochromatosis, have proved unfounded.15,16 It appears that cost is the last barrier to screening. The questions that remain regarding population screening include: Would it be more cost-effective to simply offer screening to men? What is the most cost-effective age to screen at? What is the most pragmatic way to access a population before an age at which disease is likely to develop? Hereditary haemochromotosis may yet offer a prototype for population genetic screening programs, but the journey of justification has offered unexpected challenges.

Katrina J Allen BMedSc, FRACP, PhD

A decade of research has led to more precise guidelines for a complex health problem It has long been considered that all patients with heart conditions that predispose to infective endocarditis should receive antibiotic prophylaxis when undergoing procedures that can lead to bacteraemia with organisms known to cause endocarditis. However, the evidence for such action is surprisingly poor.1 It is based on isolated case reports of endocarditis following dental or other procedures, and on theoretical considerations, rather than the results of randomised controlled trials. The American Heart Association (AHA) has published guidelines for endocarditis prophylaxis since 1955. In Australia, all editions of the Antibiotic guidelines (now Therapeutic guidelines: antibiotic, version 132) have also included recommendations for antibiotic prophylaxis against endocarditis. Of necessity, these guidelines have been complex, as three major variables were considered — the lifetime risk of endocarditis due to the underlying heart condition, the likelihood and nature of bacteraemia following the procedure, and the risk of adverse effects from antibiotic therapy.2 The lifetime risk associated with the cardiac condition was divided into three risk categories (high, medium and low), and the likelihood of bacteraemia from a procedure was similarly divided into risk categories. Thus, prophylaxis has been firmly recommended for patients with an underlying heart condition who are at high risk of endocarditis and are undergoing a procedure that has a high risk of leading to significant bacteraemia. Conversely, it has not been recommended for patients with conditions who are at low risk of endocarditis and are undergoing procedures with a low risk of leading to significant bacteraemia. Prophylaxis has been “possibly” and “probably” recommended for various intermediate-risk combinations. Over the past 10 years, thinking has changed for three main reasons. First, there is now strong evidence that bacteraemia with endocarditis-causing organisms frequently occurs following everyday activities, such as tooth brushing.3-6 Second, it has been recognised that very few cases of endocarditis can reasonably be attributed to a preceding procedure and are more likely to have resulted from everyday activities. Third, it has been realised that we should be more concerned about patients who are likely to have a poor outcome if they develop endocarditis than those who are at high risk of developing endocarditis at all.1 In the context of this change in thinking, organisations around the world (including the AHA) have published new guidelines for endocarditis prophylaxis that differ considerably from the previous versions.1,7,8 In Australasia, at the request of the Heart Foundation (formerly, the National Heart Foundation of Australia) and The Cardiac Society of Australia and New Zealand, Therapeutic Guidelines Limited convened an expert group to reconsider its guidelines. This expert group updated the Australian guidelines largely along the lines of the new AHA guidelines, continuing a trend to reduce the categories of patients for whom prophylaxis is recommended, while still specifying procedures for which it is required. In summary, the changes are: The list of heart conditions for which endocarditis prophylaxis is recommended is much shorter and is largely limited to conditions in which foreign material is implanted in the heart. In this setting, endocarditis is very difficult to eradicate, so an adverse outcome is more likely. Of note, the list does not include rheumatic valvular heart disease in non-Indigenous patients or mitral valve prolapse. The list of dental and respiratory procedures for which endocarditis prophylaxis should be given is more precise. For some dental procedures, the guidelines emphasise that the need for prophylaxis relates more to the circumstances of the procedure and the patient’s periodontal condition than to the procedure itself. The list of gastrointestinal and genitourinary procedures is similarly precise, and includes procedures that also have a requirement for surgical antibiotic prophylaxis, or which are being carried out in the presence of a related infection. The only significant difference between the new Australian guidelines and the AHA guidelines is that rheumatic valvular heart disease in Indigenous Australians has been retained in the list of cardiac conditions for which prophylaxis should be given. Experienced clinicians have the strong impression that the outcome of endocarditis in Indigenous Australians is poorer than in non-Indigenous Australians, possibly in part because of delays in diagnosis and therapy. Studies are currently being undertaken to determine whether this clinical impression is correct, but until the results are available, it was thought wise to retain this indication. These new guidelines might cause confusion at first, particularly when patients who previously received prophylaxis are advised that it is no longer necessary. To help ease this confusion, the new guidelines state that it is reasonable to give prophylaxis to patients who have previously received it and would prefer to be given it again. The new Australian guidelines are available free of charge on the Therapeutic Guidelines website (http://www.tg.com.au) and in its electronic publications (eTG complete and miniTG). The print versions of Therapeutic guidelines: antibiotic and Therapeutic guidelines: oral and dental will be updated as the new editions are published. We recommend these guidelines to Australian practitioners and trust they will find them useful and decide to follow them.

Robert F W Moulds BMedSc, PhD, FRACP · Melanie S Jeyasingham BPharm, MPS

Trials measuring major cardiovascular events as an endpoint are the best evidence to determine if an intervention such as ezetimibe conveys benefit At an American College of Cardiology meeting in Chicago earlier this year, the long-awaited results of the Ezetimibe and Simvastatin in Hypercholesterolemia Enhances Atherosclerosis Regression (ENHANCE) trial were finally presented, with simultaneous publication in the New England Journal of Medicine.1 ENHANCE was a double-blind, randomised controlled trial comparing 80 mg of simvastatin plus placebo daily with 80 mg of simvastatin plus 10 mg of ezetimibe daily in patients with familial hypercholesterolaemia. The primary trial endpoint was change in mean carotid and femoral intima-media thickness (IMT) over a 24-month period (Box). Although the trial finished in mid 2006, the results were not forthcoming from the United States sponsors (Merck and Schering-Plough) until a US Congressional Committee required the companies to reveal them, which they did in the form of a press release earlier this year.2,3 In the combined-therapy group, the benefit expected from a 17% lower level of low-density lipoprotein cholesterol (LDL-C) due to ezetimibe was not realised — mean IMT did not differ between the two groups. There was progression in mean carotid IMT (CIMT) in both groups (P = 0.02 for simvastatin-only group and P < 0.01 for combined-therapy group). Regression occurred in 44.4% of the simvastatin-only group and 45.3% of the combined-therapy group. New lesions (> 1.3 mm CIMT) occurred in 2.8% of the simvastatin-only group and 4.7% of the combined-therapy group (P = 0.20). Various possible explanations for these unexpected results were given by the study authors.1 The first was that ezetimibe is not protective for the vasculature, in spite of its significant lowering of LDL-C levels; the second was that the methodology used to measure IMT was insufficient to detect small changes in response to the therapy; and the third was that the population with familial hypercholesterolaemia had virtually normal baseline IMT due to their previous extensive treatment with statins, which may have rendered their arteries relatively unresponsive to further LDL-C reduction. The first explanation is unlikely because ezetimibe has shown no previous evidence of vascular toxicity, and a recent study in which statin–ezetimibe therapy was used as part of an aggressive management algorithm showed regression of CIMT (although this was not a randomised trial of ezetimibe use).4 The second explanation is also unlikely, although ENHANCE did not employ electrocardiogram gating of images to control for image variability during the cardiac cycle, and used single-frame technology rather than cine-loop technology to improve image quality.2 The third explanation seems the most likely, for several reasons. Previous studies of CIMT have shown either lack of progression (ie, stabilisation) or regression with lipid-modifying therapy, primarily related to changes in LDL-C levels.5 Unlike ENHANCE, these studies involved patients with increased baseline CIMT and had inclusion criteria for CIMT. Data also presented at the American College of Cardiology meeting, but yet to be published, showed that statin-naïve patients had no significant change in CIMT with either therapy.2 Baseline CIMT in this group was also near-normal — an unusual finding for true familial hypercholesterolaemia patients. However, no data were presented to confirm the presence of LDL receptor mutations. If this explanation is correct, perhaps ENHANCE could never have shown a positive result, because most patients had been treated with statins for decades before enrolment in the trial. Evidence for this theory comes from the Atorvastatin versus Simvastatin on Atherosclerosis Progression (ASAP) extension study, in which patients in the earlier ASAP trial were continued on 80 mg of atorvastatin daily for a further 2 years.6 Patients in the original atorvastatin group (in whom there had been regression of 0.031 mm) showed no further change in CIMT, while those originally in the simvastatin 40 mg group (in whom there had been progression of 0.036 mm) showed significant regression.6 The results of the ENHANCE trial are important because ezetimibe accounts for a significant proportion of lipid-lowering medication prescriptions around the world (3% in Canada, similar to use in Australia; and 15% in the US).7 Ezetimibe was approved for marketing in the US about 5 years ago, based on its efficacy in lowering LDL-C levels rather than efficacy in reducing major adverse cardiovascular events or improving surrogate endpoints such as CIMT. This situation is the opposite for newer drugs such as torcetrapib, which, in spite of increasing high-density lipoprotein cholesterol levels by more than 50%, was withdrawn from the market because of negative results in trials investigating its effects on CIMT and major adverse cardiovascular events.8,9 So, where do we go from here? The first caveat is not to abandon the modern cholesterol hypothesis (“the lower the LDL-C, the better”) after one negative trial. Only trials measuring major adverse cardiovascular events as an endpoint can definitively answer the question of whether a given intervention conveys benefit, regardless of changes in surrogate markers like CIMT or plaque size. We must therefore await the results of a clinical endpoint trial with ezetimibe, which adds a further 15%–20% reduction in LDL-C levels to that achieved by statin therapy, and which should reduce major adverse cardiovascular events by a similar percentage. IMPROVE-IT is a trial comparing cardiovascular death, major coronary events and stroke in 18 000 patients with recent acute coronary syndromes treated with 40 mg of simvastatin either alone or in combination with 10 mg of ezetimibe.2 It is due to be reported in 2012. Until then, it seems prudent to continue clinical practice on the basis that the cholesterol hypothesis is alive and well, and to continue using ezetimibe in statin-intolerant patients and those taking maximum-tolerated doses of statins who have not yet achieved LDL-C target levels.10 Ezetimibe and Simvastatin in Hypercholesterolemia Enhances Atherosclerosis Regression (ENHANCE) study1 720 patients with familial hypercholesterolaemia Baseline: low-density lipoprotein (LDL) cholesterol, 8.2 mmol/L; high-density lipoprotein (HDL) cholesterol, 1.2 mmol/L Compared simvastatin 80 mg + placebo daily with simvastatin 80 mg + ezetimibe 10 mg daily Primary endpoint was mean intima-media thickness (IMT) of carotid and femoral arteries with B-mode ultrasonography End of study: mean LDL cholesterol 16.5% lower in ezetimibe group (P < 0.01); no difference in HDL cholesterol No difference between treatment groups in carotid IMT after 2 years (P = 0.29): + 0.0058 mm in simvastatin–placebo group + 0.011 mm in simvastatin–ezetimibe group Side-effect and safety profiles similar in both groups

Ian R Hamilton-Craig MB BS, PhD, FRACP

Postmarketing surveillance of vaccine safety requires active input from vaccine providers and health care professionals Human papillomavirus (HPV) vaccines have now been licensed worldwide and at least 26 million doses have been distributed, including more than 3.7 million in Australia.1 Australia was one of the first countries to implement a universal HPV immunisation program for females aged 12–26 years, commencing in April 2007. Concerns over vaccine safety have the potential to derail immunisation programs. This may, in turn, cause considerable harm through resurgence of disease as vaccination coverage falls. For example, fears that the measles–mumps–rubella vaccine might cause autism resulted in a recent resurgence of measles in the United Kingdom.2 Thus, monitoring and ensuring vaccine safety is critical to the success of any immunisation program. When a new vaccine (such as the HPV vaccine) is first licensed, the majority of vaccine safety data are derived from Phase I, II and III clinical trials. Vaccine trials are powered to detect adverse reactions occurring at rates of up to 1 in 10 000, but cannot reliably detect rarer reactions. Australia monitors for such events using passive surveillance, whereby health care providers, parents or vaccinees are requested to report any adverse events following immunisation (AEFI) that they regard as serious and/or unexpected. In Australia, AEFI are reported to the Adverse Drug Reactions Unit of the Therapeutic Goods Administration (TGA), either directly (https://www.tgasime.health.gov.au/SIME/ADRS/ADRSRepo.nsf?OpenDatabase) or through state vaccine units. AEFI fall into a number of categories, including events that are causally related to the vaccine (caused by the vaccine antigen or excipients), coincidental (unrelated to the vaccine), the result of injection reactions (related to the process of vaccination and not to the vaccine itself), or the result of program errors (eg, errors in the vaccination schedule or route of administration). It is the role of public health authorities to collect all reports of AEFI, classify them according to these categories and then initiate appropriate action. In this issue of the Journal, Buttery et al3 report on a cluster of events described as a “mass psychogenic response” to HPV vaccination in the context of a school-based program (→ Mass psychogenic response to human papillomavirus vaccination). They identify the layout of the school as a possible precipitant. The key message for the public, vaccinators and parents is that the reported cluster of AEFI related to the process of vaccination rather than the vaccine itself. Despite the rapid public health response and reassuring outcome, the propensity for rapid dissemination of both information and misinformation about vaccination by the media and vaccine opponents/sceptics is clearly highlighted by this incident. Loss of parental confidence in the safety of HPV vaccination could undermine the impact of the entire program, given that achieving high vaccination coverage in adolescent girls is the most significant factor in reducing population rates of HPV infection, with very little population benefit to be gained by vaccinating women who are already sexually active.4 In a recent letter to the Journal, Das et al reported a case of acute pancreatitis following HPV vaccination.5 A 26-year-old woman presented 4 days after receiving the first dose of HPV vaccine. No other potential cause for the pancreatitis was identified, and it is unclear whether the “prodromal illness” between vaccination and the onset of pancreatitis was related to vaccination or coincidental. Every year in Australia about 180 women aged 25–29 years are hospitalised with a principal diagnosis of acute pancreatitis (ICD-10-AM code K85), with an average annual incidence of 25 per 100 000 from 1998–99 to 2004–05.6 In up to 90% of these cases, a cause is identified (chiefly gallstones or alcohol), but this still leaves 10% of cases with an undetermined cause. When a three-dose vaccination schedule is superimposed at the population level, incidents of pancreatitis shortly after HPV vaccination will inevitably occur. How then does one disentangle coincidence from causality? Differentiating these two categories of AEFI is beyond the capability of a passive AEFI system. Further epidemiological investigations, using large population-based health datasets such as hospitalisations or health insurance records, are required to determine the rates at which a reported event occurs in vaccinated and unvaccinated individuals, in order to determine relative risk. For example, using such methods, researchers were able to confirm an increased rate of intussusception following rotavirus vaccination in the United States.7,8 Data linkage is a promising tool for such investigations where vaccination registers or records exist, and an investigation into the use of data linkage for AEFI surveillance in Australia is underway. At this stage, it is impossible to draw any conclusions about whether the case of pancreatitis reported by Das et al5 was causally related to the HPV vaccine or was coincidental. In the US, where over 16 million doses of HPV vaccine have been distributed since 2006, only one case of acute pancreatitis in the age group 18–29 years had been reported to the Vaccine Adverse Event Reporting System as at July 2008.9 In Australia, two cases of pancreatitis, including the case described by Das et al, have been notified. These data are insufficient to warrant further investigation into a possible association between the vaccine and acute pancreatitis at present. In Australia, the ability to monitor the safety of a newly licensed vaccine is critically dependent on vaccine providers and health professionals reporting to the TGA any AEFI that they regard as serious and/or unexpected. Understanding that there are different types of AEFI is helpful in the interpretation of surveillance reports and in explanations to parents and vaccinees. When faced with media-driven public concerns about vaccine safety, the principles of risk communication may provide guidance. These include adequate preparation, establishment of communication networks for sharing information before an event receives media attention, and being responsive and open to the media once public attention is drawn to the possible adverse effects of a vaccine.10 The TGA provides updated information about HPV vaccine adverse event reports (http://www.tga.gov.au/alerts/medicines/gardasil.htm), and the National Centre for Immunisation Research and Surveillance has information to help immunisation providers address common HPV vaccine questions and “rumours” (http://www.ncirs.usyd.edu.au/facts/hpv_faq.pdf).

Julia M L Brotherton BMed(Hons), MPH(Hons), FAFPHM · Michael S Gold MD, FRACP, FCP

The effects of “appearance medicine” programs need closer scrutiny Recent data released by the British Association of Aesthetic Plastic Surgeons show that more people are having cosmetic and weight reduction surgery than ever before: the number of surgical procedures performed by members of the Association in 2007 was 12% greater than in the previous year.1 The increased demand for cosmetic surgery was not limited to women — 18% more procedures were performed on men compared with the previous year. The greatest increases were in anti-ageing procedures, such as facelifts and eyelid surgery, which both increased by over 36%. Data recently reported by the American Society of Plastic Surgeons show that almost 12 million cosmetic surgery procedures were performed in the United States during 2007, representing a 59% increase from the number performed in 2000.2 Current Australian figures are difficult to establish but seem to be rising.3 An important driving factor behind the increase in cosmetic and weight reduction surgery may well be the large number of “reality” television programs that focus on weight loss and appearance change. Recent data from patients seeking first-time cosmetic surgery reveal that many were regular viewers of “appearance medicine” programs, and that four out of five reported that plastic surgery reality television influenced their decision to undergo cosmetic surgery.4 Dentists also report that “extreme makeover” programs have recently increased the demand for cosmetic dental procedures.5 Two categories of programs are particularly relevant. In the first category are programs with a focus on weight reduction through drastic diet and lifestyle changes. Recent examples in Australia include The biggest loser Australia and Overhaul; in the United Kingdom, they include Supersize vs superskinny and Superslim me. Contestants in such programs compete to make the fastest or most dramatic changes in weight. In 2007, The biggest loser Australia averaged over a million viewers per episode, and the finale drew nearly two million viewers.6 The winner of this series lost 70 kg, which represented 47% of his starting weight. In the second category of programs, participants undergo extensive surgical and cosmetic procedures to improve their lives. In the UK, this category includes Supersize surgery and Make me perfect. In the US, popular examples are The swan and I want a famous face, where participants compete to make the most drastic changes in appearance through strict diet and exercise regimens, and cosmetic surgery procedures.7 The winner of the 2004 series of The swan underwent 13 cosmetic face, dental and body procedures, including brow, eye and mid-face lifts, liposuction, fat transfer to the lips, and abdominoplasty. The portrayal of cosmetic and weight loss procedures on television typically distorts the speed and difficulty of these changes. Most programs focus on the few individuals who have the most dramatic changes in appearance, thus exaggerating the likelihood of positive outcomes. Condensation of time, to fit a television program format, also makes the rate of weight loss and other appearance changes seem extremely rapid. Complications, infections and failed procedures are barely mentioned, giving the impression that negative outcomes are rare. Moreover, the environments in which appearance medicine programs are filmed are often highly artificial, as they provide time and resources (such as equipment, personal trainers and chefs) that are not readily available to the public at large. The recent increase in numbers and popularity of appearance medicine programs has heightened the potential for harm to both participants and viewers. Given the dissatisfaction that participants typically express about themselves and their lives at the programs’ commencement, the extreme psychological pressure that is created during filming, and the difficulty of maintaining rapid weight loss, it would be surprising if all participants and their families walked away unscathed. However, we have been unable to find any follow-up studies of program participants. Another concern is that viewers may be negatively affected by appearance medicine programs. A recent study demonstrated that women who felt societal pressure to be thin had significantly lower self-esteem scores after viewing an episode of The swan, compared with a home improvement program.8 Viewers may find it easier to identify with participants of reality shows than with actors in scripted television programs. This process may contribute to inflating viewers’ expectations of the transformations they themselves could achieve through surgical procedures, and the ease and speed with which these changes occur.9 The issue of the negative effects of appearance medicine television highlights the differences between public concern for the welfare of participants in medical research and television program participants. While researchers need to convince ethics committees that their participants will not be harmed, or induced by money to participate in risky experimental procedures, similar well developed constraints do not exist for television programs. Ethical safeguards for those who choose to participate in such programs are needed, as is research into the effects of these programs on both viewers and participants. Both would help improve participant selection procedures and ensure that vulnerable individuals are not placed in potentially damaging situations.

Keith J Petrie PhD · Kate E Faasse BSc · Sarah A I Fuhrmann BSc

Recent trials and meta-analyses have raised questions about choice of therapy and use of strict glycaemic targets In August 2006, representatives of the American Diabetes Association (ADA) and European Association for the Study of Diabetes (EASD) published a consensus algorithm for glycaemic management of type 2 diabetes.1 The algorithm provoked debate, but the authors defended their recommendations,2 including the introduction of metformin at diagnosis and the addition of insulin, sulfonylureas or glitazones as second-line therapy if satisfactory glycaemic control is not achieved. The glycaemic target at this and later stages of therapeutic intensification was a glycated haemoglobin (HbA1c) level less than 7.0%. However, based on epidemiological data from studies suggesting no threshold for microvascular or macrovascular benefit, including pooled results from the United Kingdom Prospective Diabetes Study (UKPDS),3 organisations such as the ADA suggested more stringent goals — including a normal HbA1c level (< 6.0%) — if the clinical situation allowed this.4 The first challenge to the applicability of the algorithm came when the results of A Diabetes Outcome Progression Trial (ADOPT) were published at the end of 2006.5 These confirmed the durable glycaemic efficacy of rosiglitazone monotherapy but showed an unexpected increase in distal fractures in women, which was subsequently also reported for pioglitazone,6 the other agent in the class. Then, in May 2007, a meta-analysis of published and unpublished trial data revealed a significant 43% increase in risk of myocardial infarction with rosiglitazone relative to other therapies for type 2 diabetes.7 Although the validity of this analysis is debated,8 pioglitazone appears to have no such deleterious cardiovascular effects and may reduce all-cause mortality.9 The ADA/EASD consensus algorithm was updated in early 2008 to include warnings about the association between rosiglitazone and myocardial infarction, as well as the risk of fracture with both glitazones (Box 1).10 Three recent large-scale randomised controlled trials investigated whether the 7.0% HbA1c threshold recommended in the ADA/EASD algorithm should be lowered. In the glycaemic control arms of the Action to Control Cardiovascular Risk in Diabetes (ACCORD)11 and Action in Diabetes and Vascular disease: preterAx and diamicroN modified release Controlled Evaluation (ADVANCE)12 trials, and in the Veterans Affairs Diabetes Trial (VADT),13 type 2 participants who were at high vascular risk were randomly assigned to either conventional or intensive therapy. The target HbA1c level in the intensive arm was < 6.0% in both ACCORD and VADT, and ≤ 6.5% in ADVANCE. Median HbA1c levels achieved at close of the trials were 6.4%, 6.9%, and 6.5%, respectively, compared with a median ≥ 0.7% greater HbA1c in the respective conventional therapy groups.11-13 Although ADVANCE used sulfonylurea-based intensive treatment,12 other therapies could be added as needed. In ACCORD and VADT, there was no uniform management strategy, but most intensively treated patients were prescribed rosiglitazone and insulin.11,13 Despite differences in the components of the primary endpoints between these trials, intensive therapy was not associated with significant macrovascular benefit. In addition, a 22% increase in all-cause mortality in the ACCORD intensive group, detected 18 months before close of the trial, resulted in all patients being transferred to less intensive glycaemic control for the remainder of the ongoing blood pressure and lipid treatment arms.11 Microvascular endpoint data are not yet available for ACCORD and VADT,11,13 but ADVANCE data show significant reduction in new or worsening nephropathy but no effect on retinopathy with intensive therapy.12 The lack of effect of intensive glycaemic control on cardiovascular disease in these trials appears to be at odds with epidemiological data, especially from the UKPDS.3 It is possible that better contemporary management of non-glycaemic cardiovascular risk factors, with increased use of statins, angiotensin-converting enzyme inhibitors, β-blockers and antiplatelet agents, attenuates the benefits of improved glycaemic control. For example, fewer than 2% of UKPDS patients took lipid-lowering therapy during the trial — which closed in 1997 — compared with more than 50% of ACCORD and ADVANCE patients at the end of these studies.11,12 Although overt hypoglycaemia was not implicated in the increased mortality in ACCORD,11 it was linked to later cardiovascular events in VADT13 and it is also possible that unrecognised low blood glucose concentrations contribute silently to a higher than expected cardiovascular event rate in intensively treated patients. In addition, as suggested by ACCORD subgroup analyses,11 established atherosclerosis may be refractory to glycaemic intervention. A further possibility is that, in contrast to statin studies, in which benefit is evident early, the cardiovascular effects of glycaemic improvement only manifest many years later. This “legacy effect” has been reported in type 1 diabetes14 and may not have been detected in ACCORD, ADVANCE and VADT as average duration of follow-up was ≤ 6 years. What are the lessons from what some might regard as an “annus horribilis” for research into type 2 diabetes management? One is the clear need for carefully designed and adequately powered studies that assess the long-term efficacy and safety of new treatments from both metabolic and cardiovascular standpoints. The Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes (RECORD) study might provide endpoint data that help overcome the limitations of rosiglitazone meta-analyses. However, despite an interim unblinded review of data from the study,15 and post-hoc ACCORD11 and VADT13 analyses that did not suggest increased risk in rosiglitazone-treated patients, it is likely that larger studies will be needed for a valid assessment of the cardiovascular effects of this drug. With new therapies now available in Australia — sitagliptin (a dipeptidyl peptidase-4 inhibitor) and exenatide (a glucagon-like peptide-1 mimetic) — it would be reassuring for prescribers to know that long-term, large-scale safety surveillance of these agents was in progress. It is hoped that such trials will not be viewed as too expensive or logistically difficult, and that the government, pharmaceutical industry, hospitals, academic institutions and consumer organisations will work together to ensure their viability. In the case of glycaemic targets, ACCORD, ADVANCE and VADT were necessary because the relative cost, inconvenience and rates of side effects (including hypoglycaemia) associated with intensive treatment needed to be weighed against cardiovascular and mortality benefit using “gold standard” randomised trial methodology. Their overall findings support the conservative glycaemic target (HbA1c < 7.0%) used in the consensus algorithm10 (Box 2). However, further analyses of their data — especially those relating to microangiopathy, together with post-trial follow-up — could allow a more complex treatment algorithm to be developed, with some well defined patient groups benefiting more from achieving HbA1c levels close to or below 6.0% than others. In the meantime, evidence is emerging of the importance of optimal management of non-glycaemic vascular risk factors in patients with diabetes. For example, the recently published Steno-2 study found short- and long-term morbidity and mortality benefits from multifactorial interventions including multiple drug combinations of renin-angiotensin system blockers, aspirin and lipid-lowering agents in addition to appropriate lifestyle modification.16 Indeed, at present the ADA recommends placing less emphasis on concerted efforts to achieve normal HbA1c levels, and more on optimal management of non-glycaemic vascular risk factors.17 1 Updated algorithm for the metabolic management of type 2 diabetes from the ADA and EASD (2008)10 Reinforce lifestyle intervention at every visit. a Check HbA1c every 3 months until HbA1c is < 7%, and then at least every 6 months. b Associated with increased risk of fluid retention, congestive heart failure and fractures. Rosiglitazone, but probably not pioglitazone, may be associated with an increased risk of myocardial infarction. c Although three oral agents can be used, initiation and intensification of insulin therapy is preferred based on effectiveness and lower expense. ADA = American Diabetes Association. EASD = European Association for the Study of Diabetes. HbA1c = glycated haemoglobin. Source: Nathan DM, Buse JB, Davidson MB, et al. Management of hyperglycaemia in type 2 diabetes mellitus: a consensus algorithm for the initiation and adjustment of therapy: update regarding the thiazolidinediones. Diabetologia 2008; 51: 9 (Figure 1). Reproduced with kind permission of Springer Science+Business Media. 2 Recommendations for glycaemic management of type 2 diabetes based on consensus guidelines and recent trial data A glycated haemoglobin (HbA1c) level < 7.0% remains an appropriate target when using established blood glucose-lowering therapies There are possible deleterious effects of attempting to achieve normoglycaemia (HbA1c level < 6.0%), which may include death due to cardiovascular causes associated with hypoglycaemia Prescribe metformin at diagnosis Add insulin, a sulfonylurea or a glitazone* as second-line therapy (see algorithm to aid choice, Box 1) Use triple therapy if necessary (ie, initiate insulin or add a second oral agent)* Intensify insulin therapy (continue metformin ± glitazone) as the final therapeutic option Use glitazones only when increased risks of osteoporosis, cardiac failure and myocardial infarction (rosiglitazone) have been considered carefully * Pharmaceutical Benefits Scheme restrictions to subsidised glitazone therapy may apply.

Timothy M E Davis DPhil, FRCP, FRACP

Australia should be improving, not abandoning, the collection of alcohol sales data Australians pay a substantial price for the pleasure they derive from alcohol. According to the latest estimate, on a net basis, alcohol accounts for 2.2% of the total disease burden in Australia.1 This is marginally more than illicit drugs (2.0%),1 but alcohol’s toll would be even higher if the 3430 deaths of young adults caused by alcohol-related road crashes, accidents, assaults, suicide and other causes were not partially offset by 2345 deaths from heart disease counted (some would argue erroneously)2,3 as having been averted by moderate drinking in adults over the age of 65.1 The health costs of risky alcohol use are not the only social costs. According to a National Drug Strategy study,4 in addition to $1.98 billion in health costs in the 2004–05 financial year, alcohol misuse cost the Australian economy $3.58 billion in lost productivity in the workplace, $1.57 billion in lost productivity in the home, $1.61 billion in crime-related costs, and $2.20 billion in road accidents, with a total social cost in excess of $15 billion. For the past decade, illicit drugs have overshadowed alcohol as a political and public health issue. Policies to reduce alcohol-related harms (such as taxation and reduced trading hours)5 have been effectively opposed by an alcohol industry that has had the ear of federal and state governments, both of which have major conflicts of interest in alcohol policy. The federal government derives substantial income from alcohol excise, while state and territory governments impose licensing fees and taxes on gambling in pubs and clubs. Governments are also aware that the alcohol industry plays an important role in the Australian economy, especially in regional areas (eg, the wine industry in South Australia). The recent change of federal government has brought a renewed policy interest in alcohol use. The alcohol industry claims that this interest is misplaced, citing data which suggest that per capita alcohol use and frequency of consumption, as indicated by household surveys, have been relatively stable for over a decade.6,7 However, there are doubts about the quality of these alcohol trend data, and the most recent survey data certainly indicate there is cause for concern. In 2007, one in five Australians over the age of 14, including nearly half (44%) of young men and around a third of young women aged 20–29 years, reported drinking in risky ways monthly or more often.7 The alcohol industry derives substantial profits from risky drinking, with — on conservative estimates — two-thirds of all alcohol, and 80% of alcohol used by young people aged 14–24 years, consumed in ways that put the drinker’s (and others’) health at risk.6 It is essential that debates about alcohol policy are informed by good data on alcohol use and alcohol-related harm in the Australian population.8 The World Health Organization has recommended that public health monitoring of alcohol use should include credible estimates of per capita alcohol consumption derived from alcohol sales data, in addition to well conducted population surveys of drinking patterns.8 Despite this, Australia is now in danger of failing to collect alcohol sales data at a time when community concern about alcohol is increasing and the quality of survey data may be declining. For many years, the Australian Bureau of Statistics (ABS) has published national estimates of per capita alcohol consumption9 based on import clearance, excise and domestic alcohol sales data. Until 1997, the ABS estimates were complemented by state and territory alcohol sales data collected by liquor licensing authorities. However, after a High Court ruling that state liquor licensing fees were unconstitutional, most jurisdictions stopped collecting these data; only Western Australia and the Northern Territory continue to do so.6 In its most recent report, the ABS has indicated that it may no longer report on national alcohol consumption estimates derived from sales data.9 If this were to happen, Australia would be the only OECD (Organisation for Economic Co-operation and Development) country to not collect national alcohol consumption data. The collection of alcohol sales data should be improved rather than abandoned. Without these data, policymakers, community action groups and public health researchers would lack essential information to monitor trends in per capita alcohol use, which is strongly related to adverse health outcomes such as liver cirrhosis, motor vehicle crashes, and suicide.5 National sales data are essential for monitoring trends in per capita consumption, and they facilitate studies of the relationships between changes in the level of per capita alcohol consumption and both population health outcomes and social harms (eg, arrests for assault and public disorder).5 Sales data also provide a benchmark to gauge the accuracy of national alcohol consumption surveys.10 Household surveys of self-reported alcohol use, such as the National Drug Strategy Household Surveys and the National Health Surveys, provide important information on drinking patterns among population subgroups, but, at best, they complement rather than substitute for sales-based data. For example, the National Drug Strategy surveys and the National Health Surveys are conducted every 3 years and 5 years, respectively, and the alcohol use they measure accounts for only about 60% of the alcohol that is sold.10 The response rates of the most recent National Drug Strategy surveys (in 2004 and 2007) have been less than 50%, raising concerns about the representativeness of survey data for population alcohol use. State and territory sales data should be collected in ways that enable the sales volumes of each beverage type to be estimated at local levels. These local-level sales data can be used to evaluate the effectiveness of community initiatives to reduce alcohol-related harm, such as those in northern and central Australia, and the effects of liquor licensing changes on alcohol consumption. State-level data could be used to evaluate the effect of new alcohol management strategies such as pub “lock outs”, restrictions on types of alcohol that can be sold in Aboriginal communities, and the tax increase on premixed spirits-based drinks. The collection and reporting of alcohol sales data would entail minimal cost to the alcohol industry, which already provides these data to commercial market research companies. Given that alcohol harms a substantial proportion of people who use it and can also adversely affect the safety and amenity of those who do not misuse it, the federal government should require alcohol sales data to be provided by those who are licensed to sell this intoxicating and addictive commodity.

Wayne D Hall BSc, PhD · Tanya N Chikritzhs BA(Hons), GradDipEpidBioStats, PhD · Peter H N d’Abbs BA, MA, PhD · Robin G W Room PhD

Volunteers and the Internet can provide education in public health where it is most needed The multiple health problems faced by low-income countries require urgent solutions. One solution, as articulated in the United Nations Millennium Development Goals, is to increase the health workforce.1 An editorial (and accompanying articles) in the Lancet highlighted the need for global health capacity building,2 and the first Global Forum on Human Resources for Health (in March 2008) produced the Kampala Declaration, which urged “. . . immediate action to resolve the accelerating crisis in the global health workforce . . .”.3 Part of this solution will involve boosting in-country public health capacity,4 and an educational initiative to do this was launched recently — the People’s Open Access Education Initiative, better known as the Peoples-uni (http://peoples-uni.org).5 The “open-source” movement describes collaborative software development, where products are shared and improved upon among developers and made freely available to others. It has transformed computer software. The movement to make open-source educational materials freely available on the Internet6 promises a mechanism to provide public health education at low cost. An ever-expanding range of high-quality open educational resources is freely available on the Internet, and a number of universities are providing open access to online educational material, but do not offer tuition or accreditation. The Peoples-uni aims to provide an educational context around these materials, using a competence-based approach and volunteers to develop and deliver an educational program. Through the Internet, health professionals can learn while they work, and local workforce is not depleted. Previous experience shows that distance and online learning in public health is feasible.7 The open-source approach is a new way for individuals and organisations to collaboratively develop and share the products of their work. The Peoples-uni offers involvement in the exciting and evolving field of the application of the open-source philosophy to education. A number of national and international partners have agreed to be part of the Peoples-uni, and momentum is building. A pilot of a course module on maternal mortality, run between October and December 2007, attracted a large interest and was well received. The draft of this module is available at <http://moodle.cawd.net/course/view.php?id=2>, and student evaluation is available on the Peoples-uni website. This draft is now being modified as part of the process of developing a set of new course modules covering some of the foundation sciences of public health and some major health problems facing low- to middle-income populations. The United Kingdom Royal Society for Public Health has agreed to oversee the assessment process and offer awards at certificate and diploma levels, and teams are currently being established for course development and online facilitation. Access to educational resources and teachers of high international quality will provide highly credible education at low cost. While Australia is committed to its responsibilities towards overseas development through its official development assistance, only 12% of this budget goes to health, and even this is not focused on the areas of greatest global health need.8 Australian universities, including their medical schools,9 contribute to global educational activities, but are constrained by the need to charge fees, which cannot be met by most people who would benefit from university education. In 2005, full-fee-paying students provided 15% of income within the higher-education sector, and education services were the third highest export-earnings generator for Australia.10 For these reasons, which are not confined to Australia, the Peoples-uni has been established outside the more traditional educational sector and will rely on volunteers to meet its goals. Is the volunteer approach sustainable? Will busy health professionals be willing to add to their activities, and in a way that may not help meet the goals of their employing institutions? To date, more than 80 people have agreed to take part in the development of course modules, and are working in 12 teams. Volunteers come from 24 different countries and range from established academics in senior positions to trainees and students. Some students from the pilot have joined the teams. The difficulties of maintaining a large volunteer workforce should not be underestimated, and it is a priority to develop a system that provides rewards, such as the opportunity to work with a diverse and interesting group of colleagues, and to keep up to date with advances in international public health issues and developments in information and educational technology, in addition to appealing to the altruism of those involved. Although the workload will vary according to the level of commitment of the volunteers, we have divided it into feasible amounts for busy people, such that even a small and short-term commitment of 2–3 hours a week for a 3-week period can be a valuable contribution. A similar approach to level of commitment has also been taken by the Clinical Toxicology Teaching Resource Project (http://wikitox.org), with which the Peoples-uni shares a number of philosophical ideals. The Peoples-uni provides a novel opportunity to contribute to-wards meeting global health workforce and public health needs. Australian health care professionals and academics have made, and continue to make, major contributions to international health. I hope that the Australian health professional community will be involved in contributing to and helping shape this initiative.

Richard F Heller FRCP, FRACP, FAFPHM

Obesity control in Australia is imperative, and has much to learn from tobacco-control strategies The increasing incidence of obesity in Australia is set to impose a major additional cancer burden at a time when population ageing alone is projected to cause unprecedented growth in cancer incidence. While obesity is frequently associated with type 2 diabetes, hypertension, lipid abnormalities and death from heart disease and stroke, there is growing evidence for its role in causing cancer. A systematic review and meta-analysis, which included the Million Women Study, investigated the link between body mass index (BMI; calculated by dividing weight in kilograms by height in metres squared) and types of cancer.1,2 In men, a 5 kg/m2 increase in BMI was strongly associated with adenocarcinoma of the oesophagus, and thyroid, colon and renal cancers, and in women with adenocarcinoma of the oesophagus, and endometrial, gallbladder and renal cancers. There were weaker associations for melanoma and rectal cancer in men, and postmenopausal breast, thyroid and colon cancer in women. Leukaemia, myeloma and Hodgkin disease were associated in both sexes. One postulated mechanism for the link between obesity and cancer is that chronic hyperinsulinaemia results in raised levels of free IGF-I (insulin-like growth factor), with higher mean concentrations in men compared with women. This alters the environment of cells to favour cancers developing.3 In adipocytes, androgens are converted to oestradiol, and chronic hyperinsulinaemia also reduces sex-hormone-binding globulin, leaving more oestrogen to impact on oestrogen-sensitive tissues. Further, adiponectin, a protein hormone secreted by adipocytes, is an insulin-sensitising agent that is anti-angiogenic and anti-inflammatory, inversely correlated with BMI, found in higher concentrations in men than in women and, in some studies, its level is inversely associated with cancer risk.4 Obesity is linked to 11% of colon cancers and 9% of post-menopausal breast cancers5 — both increasingly common tumour types in Australia as a result of population ageing. With high percentages of endometrial cancer (39%), oesophageal adenocarcinoma (37%), kidney cancer (25%) and gallbladder cancer (24%) attributed to obesity and overweight, these rarer cancers may become more common as Australia’s obese population ages.5 The risk of an obesity-related increase in cancer burden in this country is amplified, with the link between BMI and cancer compounded by a 50% increase in the number of obese or overweight Australians over the past 15 years. An estimated 7.4 million Australians are obese or overweight, including a quarter of children aged between 5 and 16 years.6 Multiple strategies are needed to control obesity. Decreasing the consumption of energy-dense, nutrient-poor foods and encouraging consumption of healthy foods and increased physical activity are clearly the keys. What is not so obvious is what works. The high risk of childhood obesity continuing into adulthood and the lag time before the development of cancer make children a critical target for obesity-control programs. A range of interventions have been introduced, such as regulating school canteens, eliminating soft drink sales in schools, physical activity programs and education, but there is no coherent national strategy. The debate on whether such a national strategy should include restricting junk-food advertising is likely to continue for a number of compelling reasons. Australian children are exposed to more food advertising than children in the United States, United Kingdom, New Zealand and 11 western European nations,7 much of it potentially misleading in its use of healthy imagery to promote products high in sugar, fats and salt.8 Governments in Sweden, Norway and Quebec have restricted junk-food advertising to children, with some encouraging results.9 Great Britain adopted a similar policy in 2007, so more data on the efficacy of this strategy will emerge. In the absence of empirical Australian data, modelling by the Victorian Government shows that restrictions on junk-food advertising would be the most cost-effective intervention for reducing adolescent obesity.8 The South Australian Government has announced a phase-out of junk-food advertising during children’s television viewing hours, using its sovereign authority to act independently of federal broadcasting laws. Other jurisdictions may follow, and this presents an opportunity for the federal government to show national leadership towards a uniform approach. Product labelling that informs consumers in making healthier choices is also pivotal to food marketing reform, while government assistance to make healthier foods more affordable and accessible, particularly to disadvantaged groups, should also be considered. A whole-of-government response to fostering healthier communities, including initiatives to support increased physical activity, must also be built into a national obesity strategy. Consideration of the options for reducing obesity draws historical comparisons with the experience of tobacco control in the early 1970s. While minimising the use of tobacco (which has no safe consumption level) differs in many ways from reducing junk-food consumption (which is low risk if consumed in moderation), there are compelling parallels. The disease burdens related to both tobacco and obesity are disproportionately prevalent among disadvantaged population groups. Tackling both smoking and obesity requires a combination of research, policy, social marketing and program-based interventions. And, of particular interest to the debate on food advertising, there are commercial interests with a clear stake in maximising junk-food consumption, just as there are in maximising tobacco consumption. Moreover, public health advocates cite “de-normalisation” as a key to Australia’s historical success in reducing tobacco consumption. It could be argued that excessive junk-food consumption is effectively “normalised” at an early age by the sheer volume of advertising pitched at children. An important lesson from tobacco control is that an array of modest government interventions to influence healthy behaviour will fall well short of their potential if they must compete with big-budget advertising from industry encouraging unhealthy choices; smoking rates in Australia dropped markedly when broadcast advertising of tobacco was phased out in the mid 1970s.10 With an increasing incidence of cancer, now is the time for a range of tough decisions that will modify dietary behaviour and put public health before corporate interests.

Ian N Olver MD, PhD, FRACP · Paul B Grogan

What is a reasonable approach to management of women with pelvic pain? Pelvic pain in women is as common as the common cold, it seems. Certainly that is the impression one is left with after reading the article by Pitts et al on the prevalence and correlates of pelvic pain in Australian women. Pitts and colleagues found that 72% of women experienced dysmenorrhoea and only one in four women did not report any kind of pelvic pain.1 A systematic review of international studies reported a similar prevalence of dysmenorrhoea and pelvic pain.2 Is the experience of pelvic pain, particularly dysmenorrhoea, just a normal part of life? If this is the case, then we need to ask how clinicians should most appropriately respond to the many women presenting for assistance with chronic pelvic pain. What proportion of women with pelvic pain will have underlying pathology? Most studies of women with dysmenorrhoea suggest that endometriosis is present in 30%–40% of cases.3 But the pain felt by women during menstruation may be no less severe than the pain experienced by women with pathology. Period pain can lead to lost days from school or the workplace and may have a considerable impact on daily living. Which women with pelvic pain should be referred for further investigation with laparoscopy? Common sense suggests that women who warrant further investigation are those for whom empirical approaches (such as suppression of the menstrual cycle) have failed and those who have symptoms at the severe end of the spectrum. The guidelines of the Royal College of Obstetrics and Gynaecology in the United Kingdom and the consensus statement of the American College of Obstetrics and Gynecology support the use of an empirical approach before laparoscopy.4-6 Such an approach has been justified on the basis of the risks of the procedure and the possibility that pain will not be relieved even if surgery is undertaken, and that ongoing medical therapy will be necessary.7 Additionally, there would be the potential for harm if even 20% of adolescents with dysmenorrhoea were to undergo laparoscopy. A laparoscopy is an invasive procedure that may have unexpected consequences: performing extensive biopsies or peritoneal stripping could potentially lead to adhesion formation and impaired fertility. Further considerations concern patients and doctors alike. Women have stated that they find diagnostic laparoscopy reassuring because is either confirms or rules out endometriosis.8 Surveys of women with established endometriosis have reported delays of up to 12 years between the onset of pain symptoms and the surgical diagnosis of endometriosis.9 Some women are frustrated about these delays, and there have been calls for such delays to be avoided through greater education of health professionals, changes in guidelines and increased access to diagnostic laparoscopic services.7,10 The assumption underlying these women’s frustration is the possibility that when they first experienced pain they already had pathology that was not diagnosed. However, there is no evidence for this, as there are few longitudinal studies of pelvic pain and it is not possible to perform laparoscopy on all women with pelvic pain symptoms. Then there is the concern that the delay in diagnosis of endometriosis may have an impact on future fertility. But it is possible that the experience of pain as an adolescent is unrelated to a later diagnosis of endometriosis. So, on the one hand, clinicians are increasingly being asked to investigate women with pelvic pain, yet, on the other hand, the likelihood of pathology is less than 50%, especially in the adolescent age group. Furthermore, treatment of dysmenorrhoea can be initiated without a firm diagnosis. Decision making is thus a trade-off between missing a pathological condition and overinvestigation. In the light of current evidence, what is a reasonable management approach to women who present with pelvic pain? In adolescents with dysmenorrhoea, the first-line strategy should be to prescribe non-steroidal anti-inflammatory drugs (NSAIDs) with the oral contraceptive pill. Both of these have been found to reduce the experience of pain and reduce days of absenteeism.11,12 Avoiding menstruation by skipping the non-hormonal pills and allowing bleeding only 3–4 times a year is another useful strategy, although some women will experience breakthrough bleeding. Reassurance should be given that the experience of dysmenorrhoea is normal and that serious pathology such as advanced endometriosis is unlikely to arise during the adolescent years. Women who fail to respond to first-line approaches may need to consult a gynaecologist for consideration of a laparoscopy. For women in their 30s and 40s with pelvic pain, doctors should be aware of the increasing likelihood of underlying pathology. New or worsening symptoms can initially be managed with simple strategies such as the use of NSAIDs and oral contraceptives, but women who fail to respond to these should be referred to a gynaecologist earlier rather than later, especially if they wish to conceive in the future. Finally, there is a small group of women with chronic pelvic pain who have had repeated surgery and may suffer from a form of neuropathic pain. Such patients generally require the help of a multidisciplinary team that should include gynaecologists, psychologists, pain specialists and physiotherapists.

Cynthia M Farquhar MB ChB, MD, FRANZCOG

Removing the protection of confidentiality will not help raise standards of care Governments confronting serious adverse health care events feel obliged to be seen to be doing something. They often set up an inquiry or, less commonly but peremptorily, amend legislation, attempting to avoid repetition of the events. The Davies Inquiry, “with particular reference to Dr Jayant Patel.”, was Queensland’s response to adverse incidents in that state.1 By contrast, New South Wales responded to adverse incidents relating to Dr Graeme Reeves2 by amending the Medical Practice Act 1992 (NSW) in the Medical Practice Amendment Act 2008 (NSW), obliging practitioners to notify the NSW Medical Board of “disruptive” or “wayward” colleagues (see Box). The amendments, welcomed by the Board, allow for generally speedier suspension or deregistration of professionally incompetent doctors. These actions can, however, still be delayed by doctors appealing to the Medical Tribunal (customarily, two medical practitioners in the same field of practice as the respondent, a lay person, and a District Court judge as chairman) or the Supreme Court (which has, on legal grounds, stayed the Board’s suspensions of two subsequently deregistered doctors), and by the inclusion of lay persons in these inquiries. In NSW, unlike in other Australian states, the Health Care Complaints Commission, not the Board, investigates and prosecutes breaches of the Act, and the Medical Tribunal, not the Board, strikes off and re-registers doctors. The Board’s jurisdiction covers registration, impairment, performance, and disciplinary breaches that would not warrant de-registration. The amendments to the Medical Practice Act allow the Tribunal to take into account, in a re-registration application, complaints received subsequent to deregistration. Further, the proceedings of the Medical Board’s professional standards committees (PSCs) will no longer be confidential, will be chaired by a legal practitioner, and their findings made public. The mandatory notification included in the amended Act overcomes some of the problems facing whistleblowers who, traditionally, are encouraged to voice their concerns locally — at their hospital or Area Board.5 Already, in many jurisdictions, doctors must report colleagues with health problems that could affect their practice of medicine. Mandatory reporting in the areas of professional standards and competence, however, is a first for Australia. Such reporting is mandated in seven of the United States of America (Arizona, Delaware, Montana, Nebraska, New Jersey, Oregon and Texas). The NSW Board’s much publicised standards of professional care expect doctors to make such notifications6 in accordance with section 86E of the Act: persons may notify the Board of “any matter that the person thinks indicates that the professional performance of a registered medical practitioner is unsatisfactory”. Failure to report concerns has led to serious consequences: the United Kingdom General Medical Council set a precedent when it found a senior anaesthetist guilty of serious professional misconduct for failing to pursue complaints that a locum was endangering patients.7 In 2005, it punished two doctors who had not reported their concerns about a patient of Harold Shipman,8 found guilty of murdering 15 patients and implicated in the deaths of many more. Despite longstanding obligations to report “impaired” colleagues, we know that there is a continuing reluctance among doctors to do so. Will they be any more forthcoming in reporting “incompetent” colleagues? Unless harm to patients is qualified to refer to serious, perhaps life-threatening, harm, as in New Jersey (“conduct which would present an imminent danger to an individual patient or to the public health, safety or welfare”9), the way could now be open for cross-complaints where “turf wars” exist between branches of the profession. Some plastic and reconstructive Fellows of the Royal Australasian College of Surgeons are dismayed by the work of “cosmetic physicians” who lack surgical training; and orthopaedic and neurosurgeons might dispute one another’s spinal surgery techniques. These areas of practice are bedevilled by patients’ complaints. With the amendments now effective, the effects of the “law of unintended consequences” (inevitable unanticipated consequences of the actions of people, and particularly of governments10) remain to be seen. How will the NSW Medical Board, Medical Tribunal and Supreme Court define a flagrant departure from accepted standards? Proof that a doctor ought reasonably to have believed that a colleague warranted being reported will, no doubt, trigger much legal disputation. Over the past two decades, the NSW Medical Board has moved away from seeing all breaches of standards as requiring punishment. Part 5 of the Medical Practice Act enables the Board to help doctors in difficulty continue in practice, with appropriate treatment and monitoring (provided they are no threat to the public). Under Part 5A, the Board has a well established system of performance appraisal. Both procedures are based on confidentiality. A balance needs to be struck between the public interest of raising standards through frank discussion (in confidence) among professional peers, and satisfying individual patients’ or relatives’ desire to know the facts of individual mistakes. Just as the confidentiality of meetings on maternal and perinatal mortality and morbidity and on anaesthetic deaths has led to improvements in standards, so too has the confidentiality of meetings of PSCs. From its inception in 1987, the PSC was understood, and accepted by the NSW Government, as a professional assessment of standards. Cabinet agreed to the trade-off of confidentiality to encourage respondents to be frank and truthful, thus assisting PSCs to improve standards. Respondents are, therefore, not legally represented at these professional hearings. By contrast, serious breaches go to the Medical Tribunal, where respondents have legal representation before a judge, with a right of appeal on points of law to the Supreme Court. Now that PSC findings are no longer confidential, respondents are faced with representing themselves in potentially career-damaging proceedings with publicly available findings. This might make them decline to appear, instead entrusting the defence of their reputation to a barrister before the Medical Tribunal. Such a change, from a discussion with colleagues about techniques or therapies, aimed at improving standards, to a courtroom with a barrister, trying to prove no wrongdoing, is inconsistent with raising standards of care. Are these proposals then simply another example of a government wishing to be seen to be doing something, or are the benefits likely to outweigh the disadvantages? In view of the established policies of the Medical Board, breaches of which are already sufficient to attract disciplinary action, the only gain would seem to be directing whistleblowers to the Board instead of to their local hospital or Area Board.11 This could avoid the futility experienced by nurse Toni Hoffman, in informing her hospital superiors of her concerns about Dr Patel.12 Regrettably, as agreed by complainants’ advocate Terry Stern,13 the abolition of the confidentiality of PSC hearings will hinder the Medical Board’s attempts to improve medical standards. The looming uncertainty, of course, is how these issues will be handled if, when and how the Council of Australian Governments’ proposals for national registration of health care professionals14 are implemented. Reportable misconduct under the Medical Practice Amendment Act 2008 (NSW) (Section 71A) NSW doctors must report if they reasonably believe or ought reasonably to believe that a colleague has: engaged in sexual misconduct in the practice of medicine; practised while intoxicated by drugs or alcohol; or flagrantly departed from accepted standards of professional practice or competence, risking harm to patients.

Peter C Arnold BSc, MB, BA

VTE prophylaxis is effective and safe, but grossly underused in Australian hospitals In this issue of the Journal, Ho and colleagues report their findings from a Perth community-based study of venous thromboembolism (VTE).1 They found an incidence of VTE, which includes deep vein thrombosis and pulmonary embolism, of 0.83 (95% CI, 0.69–0.97) per 1000 population per year. This figure is consistent with hospital discharge data from the Australian Institute of Health and Welfare, which predict an estimated 14 716 VTE cases in 20082 or an incidence of 0.74 per 1000. This incidence comes with high costs to Australian society in terms of deaths, morbidity and health care expenditure. VTE is a major cause of hospital deaths — Australian Institute of Health and Welfare data indicate that 7% of all deaths in Australian hospitals are due to VTE,2 and autopsy studies suggest the percentage may be as high as 10%.3 Thus, VTE causes more deaths than any common cancer (breast, lung, prostate or bowel) and is 40 times more deadly than HIV/AIDS in Australia. VTE also causes significant long-term morbidity from post-thrombotic syndrome (chronic leg swelling, pain and skin ulcers) and pulmonary hypertension. A report by Access Economics estimated that the cost to Australia of treating VTE is currently $1.72 billion annually (0.15% of gross domestic product).2 This estimate includes costs attributable to direct health system expenditure ($148 million), productivity loss ($1.38 billion) and efficiency loss ($162 million). If costs relating to premature mortality are included, then VTE represents the most costly disease burden among the 16 diseases (including cancer, dementia, osteoporosis, cardiovascular disease and schizophrenia) that have been studied and ranked by Access Economics in recent years. The key to saving lives, improving patient outcomes and reducing the huge financial cost to individuals and the nation lies in prevention of this disease. Evidence-based findings from well designed studies have clearly shown that prevention is possible.4,5 With a modest outlay, VTE incidence can be significantly reduced, effectively and safely, using anticoagulants such as unfractionated or low-molecular-weight heparins, or, particularly if a risk of bleeding exists, by mechanical means (compression stockings and intermittent calf compression). However, current data suggest that VTE prophylaxis is grossly underused in hospitals in Australia and overseas.6 The ENDORSE study (which enrolled over 68 000 medical and surgical patients in 32 countries, including Australia) showed that 51.8% of hospital inpatients were at risk of VTE, but only 58.5% of at-risk surgical patients and 39.5% of at-risk medical patients received VTE prophylaxis.6 This is consistent with the findings of a prospective audit carried out by the National Health and Medical Research Council (NHMRC) National Institute of Clinical Studies in Australian hospitals in 2005–2006 (Dr Sue Phillips, Director, Research Implementation Program, National Institute of Clinical Studies, NHMRC, Melbourne, personal communication). These studies show that many at-risk hospital patients in Australia and overseas, especially medical inpatients, are left unprotected against VTE. Adoption of clinical guidelines by hospitals can lead to increased levels of appropriate prescribing of VTE prophylaxis.7 However, the risk of thromboembolic events continues after hospital discharge, and far less research has been conducted into the use of VTE prophylaxis in the community. There is an increasing trend for at-risk medical patients (eg, patients with chronic lung disease or cardiac failure) to be managed in the community, especially through hospital-in-the-home and early discharge programs.8 With increasingly short hospital stays for both surgical and medical patients, it is important that community-based doctors are aware of the importance of VTE risk assessment and the continuation or commencement of VTE prophylaxis for their patients. The Australia & New Zealand Working Party on the Management and Prevention of Venous Thromboembolism has been convened to formulate a national strategy to promote the optimal use of VTE prophylaxis. Initiatives of the Working Party will include: Developing simple, user-friendly VTE prevention guidelines that will assist doctors to identify and treat at-risk patients. The fourth edition of the Working Party’s VTE prevention guidelines — based on the recommendations of the American College of Chest Physicians4 and the International Union of Angiology,5 but adapted to local conditions (see http://stgcs.med.unsw.edu.au/stgcsweb.nsf/page/TBD) — has recently been published.9 Promoting hospital and community education programs to create awareness of the VTE prevention guidelines and enhance understanding of VTE risk assessment. Researching and developing recommendations for reminder systems, including computer alerts10 or interventions by a VTE nurse or pharmacist, with the intention of reminding doctors to prescribe appropriate VTE prophylaxis. Establishing VTE centres of excellence that will act to promote optimal VTE patient care. Lobbying federal and state governments to initiate health policies that will lead to increased use of VTE prophylaxis in Australian hospitals, including designating VTE prophylaxis rate as a hospital performance indicator. This is particularly relevant now, while the federal government is working with state governments to reduce surgical waiting lists. If patients undergoing surgery do not receive appropriate VTE prophylaxis, this could lead to increases in adverse outcomes of VTE and fatal pulmonary embolism. Hosting a national VTE summit to generate new ideas for improving VTE prevention. VTE is a significant health issue internationally and in Australia. It is a common cause of hospital deaths and a considerable financial burden on governments and individuals. Doctors, nurses, health administrators and governments should work together to ensure all surgical and medically ill patients in hospital have their VTE and bleeding risk assessed, and to maximise appropriate use of VTE prophylaxis. Achieving this will improve patient outcomes, save lives and reduce health costs.

Beng H Chong MB BS, FRACP, PhD · Jeffrey Braithwaite MBA, PhD, FCHSE · Mark F Harris MB BS, FRACGP · John P Fletcher MD, MS, FRACS

GPs can play a crucial role in screening for problem gambling Problem gambling is a significant mental health problem in Australia. Estimates of the prevalence of serious gambling problems in Australia range from 1% to 2% of the general adult population, with higher rates in specific groups.1 An estimated 2.5%–5% of the Australian adult population display at-risk gambling behaviour (according to standard diagnostic criteria).1 The prevalence of problem gambling exceeds that of stroke and coronary heart disease, and is comparable with the estimated prevalence of type 2 diabetes in Australia.2 Further, problem gambling has been shown to be strongly comorbid with other health and mental health problems with high burdens of disease.3 A large-scale study in the United States found that 73% of pathological gamblers (as defined by the Diagnostic and statistical manual of mental disorders,4 fourth edition [DSM-IV]) had an alcohol use disorder, 38% had a drug use disorder, 60% had nicotine dependence, 50% had a mood disorder, 41% had an anxiety disorder, and 61% had a personality disorder.5 A recent Australian study found that, compared with non-gamblers, problem gamblers had a relative risk of 18.8 of having a severe mood disorder, and were over four times more likely to have hazardous alcohol use.6 The causal nexus between depression, excessive alcohol use and problem gambling is not known, but the associations are very strong. Thus, problem gambling is a significant clinical problem with high prevalence that is strongly associated with other high-burden health problems; it therefore warrants attention in primary care practice. In 1999, the Australian Medical Association released its pioneering position statement, Health effects of problem gambling.7 The statement noted that medical practitioners need to be aware of “the adverse impacts of problem gambling” and its comorbidities. It recommended that practitioners include gambling as part of lifestyle risk assessment. Despite this recommendation, many Australian general practitioners are not screening for gambling problems in their patients.8 This may be because they lack the requisite knowledge and tools to deal effectively with problem gambling when it is identified.8 How can this be remedied? Internationally, various medical associations have devised policy statements and toolkits to guide medical practitioners in the treatment of problem gamblers and their families. In 2007, the British Medical Association released protocols for the treatment of gambling addiction within the United Kingdom’s National Health Service.9 These protocols advise that practitioners develop an awareness of problem gambling, its prevalence within key population groups and its comorbidities, and recommend education and training for GPs. The American Medical Association has endorsed policies on problem gambling, emphasising the importance of patient education about the risks of gambling, and has published a patient information sheet in the Journal of the American Medical Association.10 Some jurisdictions in the US have released clinical protocols to help health professionals screen for and treat problem gambling. Essentially, there is international agreement that GPs routinely encounter problem gamblers and that an effective response is required. However, what should this response be? The first step must be effective screening. But how should patients be screened, and who should be screened? The most popular diagnostic tools for problem gambling are the Canadian Problem Gambling Index,11 the DSM-IV criteria for pathological gambling,4 and the South Oaks Gambling Screen.12 However, these tools are too time consuming for routine use in primary care practice. Recently, we developed a one-item screening test for use in primary care practice with beyondblue and Victorian Government funding. We have found that answers to the question “Have you ever had an issue with your gambling?” closely predict answers to the full Canadian Problem Gambling Index tool.6 We wish to extend the screen to include family members of problem gamblers, as they also experience serious difficulties as a result of their family member’s gambling.13 As for who should be screened for problem gambling, we recommend screening patients with anxiety and depressive symptoms or high drug or alcohol use, because of the high rates of comorbidity of these conditions. Those who screen positive to the question “Have you ever had an issue with your gambling?” should be referred for further assessment and treatment by appropriately trained specialist practitioners in problem gambling. There is a developing body of research on treatment for problem gambling.14 The major therapies include counselling, cognitive behaviour therapy and drug treatments. At present, there is limited evidence from randomised controlled trials for their effectiveness. It is recommended that problem gambling interventions be delivered by specialists. Family members may also require treatment for psychological problems because of the impact of their family member’s gambling. Most gambling treatment services accommodate both gamblers and their family members. All Australian jurisdictions have networks of publicly funded practitioners who specialise in the treatment of problem gambling, and a wide range of psychologists and psychiatrists provide treatment in mental health and private practices. However, GPs are well placed to detect and initiate treatment for this debilitating psychological problem.

Shane A Thomas PhD · Leon Piterman MMed(Primary Care), MEdSt, FRACGP · Alun C Jackson PhD

Australia’s GPs are meeting the challenges of change, while maintaining some constancies A few short years ago, the death of general practice as we knew it was reported.1 However, as suggested by our cover image of the mythical phoenix (Box), with its reference to Ovid’s poem Metamorphoses — “what is called birth is change from what we were, and death the shape of being left behind” — there is another explanation. This perceived “death” may, in fact, have been the preface to a significant cycle of change now manifesting in general practice in many countries around the world, including Australia. These changes, reflected in the articles in this general practice theme issue of the Journal, are many. They include already evolving pandemics of chronic illnesses, including cancer (see Weller and Harris, "Cancer care: what role for the general practitioner?"; Jiwa et al, "Timely cancer diagnosis and management as a chronic condition: opportunities for primary care"), accompanied by the increasing realisation that patients with chronic illness often have multiple morbidities (see Knox et al, "Estimating prevalence of common chronic morbidities in Australia"; Britt et al, "Prevalence and patterns of multimorbidity in Australia"). Parallel with changes in the epidemiology of disease, there have also been changes in health care policy and funding, including a wide array of systems for remunerating practices for their services, all of which need to be acknowledged and some of which could do with a degree of rethinking (see Ashworth and Jones, "Pay for performance systems in general practice: experience in the United Kingdom"; Kirby et al, "Sharing or shuffling — realities of chronic disease care in general practice"). Much discussion and debate about the possibilities for further change have followed the election of the Rudd federal Labor government, particularly the proposed introduction of GP Super Clinics2 (see Kidd, "What impact will the change of federal government have on Australian general practice?"). The announcement that a National Primary Health Care Strategy is to be developed, with strong general practice input into the committee formed to steer the process, is a welcome indication of government interest.3 On the other hand, recent budget cuts to general practice programs such as after-hours services and e-health, and changes to the immunisation incentives program, send a contradictory message.4 Undoubtedly, major challenges surround the issues of general practice workforce and changing roles for general practitioners in clinical practice (see Thistlethwaite et al, Addressing general practice workforce shortages: policy options; Willcock, "Getting back into the emergency department: diversifying general practice while relieving emergency medicine workforce shortages"). Interesting and challenging questions are being asked about what sort of clinician might be best equipped to provide health care for patients with several complex, chronic illnesses. In a world of increasing specialisation and subspecialisation, including within general practice, it is paradoxical that the role of the generalist will become more important in providing comprehensive, coordinated and accessible care for all (see Gunn et al, "The promise and pitfalls of generalism in achieving the Alma-Ata vision of health for all"). This same need underpinned an earlier rebirth of general practice in the 1950s.5 Though much has changed in the world and in general practice, some constancies remain. As highlighted by Professor Trisha Greenhalgh in her keynote address at this year’s General Practice and Primary Health Care Research Conference in Hobart (http://www.phcris.org.au/conference/browse.php?confID=758), people in the community continue to want a knowledgeable, skilled and altruistic family doctor who understands evidence, but who also knows how to apply it with understanding and humanity. We believe this to be an apt description of a typical Australian GP. The phoenix — “and all things change” “The themes of rebirth and renewal of the phoenix legend are universal; the fire can represent illness, death of course, or perhaps another kind of adversity from which, with courage, we might emerge changed by the experience, perhaps stronger.” Dr Kate Hansford, General Practitioner, Hobart, Tasmania. Artworks by other GPs are also featured in this issue.

Ann T Gregory MB BS, GradDipPopHealth · Nicholas A Zwar MPH, PhD, FRACGP

General practice is still somewhat adrift in the complex world of cancer services General practice has not traditionally had a central role in cancer care. Typically, general practitioners have had the task of identifying and referring patients to specialists in a timely manner, but have stayed on the periphery of cancer care until patients reach the palliative stage. But the climate is changing — driven partly by the growing burden of cancer and the need to expand and diversify the workforce. The prevalence of cancer has increased substantially in Western countries,1,2 largely due to the ageing of the population: in Australia, by the age of 75 years, the risk of cancer is 1 in 3 in men and 1 in 4 in women.1 There is now an explicit recognition that GPs should be involved in all stages of the cancer journey, from first presentation to palliative care, and that service reforms must incorporate more significant roles for primary care.3 This has found its way into policy and practice in the United Kingdom and Australia, where service guidance emphasises integration of services and urges all those involved in delivering cancer services to better connect the various stages of the cancer journey and to provide care that is accessible and convenient — all predicated upon significant primary care input.4,5 Management of cancer is complex. It requires specialised skills and knowledge, access to sophisticated diagnostic and treatment facilities, and often long-term management of symptoms and recurrences. Despite this complexity, when cancer patients are asked about how their care could be improved, their requests are often simple: they want to know who is in charge of their overall care, they want ready access to care that is convenient and non-threatening, and they want reassurance that they will have access to specialised services if needed.6 A diagnosis of cancer has a profound psychosocial impact, and those who care for cancer patients need to address a range of complex and often rapidly changing needs. Ideally, cancer care should be provided by teams, supported by a network of services. The concepts of multidisciplinary teams and managed clinical cancer networks have been widely advocated,7 but the place of primary care within these teams has remained poorly defined and highly variable.8 This variability is demonstrated by urban–rural differences: in Australia, rural GPs tend to play a more active role in treating cancer patients than their urban counterparts. General practice is still somewhat adrift in the complex world of cancer services. In this issue of the Journal, Jiwa and colleagues describe the many challenges faced by general practice in providing cancer care that is truly integrated with other parts of the health care sector.9 They emphasise that integrated care is required at all stages of the cancer journey. Just as cancer screening should link public health and clinical perspectives, post-diagnosis treatment needs a range of health care providers, including GPs, to be part of the team effort. Effective communication between specialist and primary care services is an essential component of this integration. There is growing emphasis on the concept of survivorship in cancer patients — rightly so, as cancer has taken on the characteristics of other chronic illnesses such as diabetes and coronary heart disease. Increasing numbers of patients have very prolonged periods of survival after cancer diagnosis, and die with their illness rather than of it. Survivorship is a very positive concept, and general practice, with its capacity for multidimensional care, is well placed to play a leading role in improving services for people living with cancer, providing follow-up that addresses patient priorities, and developing more personalised care for cancer survivors.10 This typically involves “survivorship care plans”, which include a range of tools for health care providers and users. It features heavily in the UK’s Cancer Reform Strategy.5 A challenge for primary care is to recognise its unrealised potential for promoting survivorship and to develop new models of care that allow it to do so.11 Primary care must be able to respond to rapidly changing health care needs of cancer patients in an appropriate and flexible manner. If we are to develop and test new models with enhanced roles for primary care, we need to better define and understand current patterns of care. Do GPs and primary care teams provide the kinds of services that cancer patients need? How well do they detect and manage recurrence of disease and toxicity from treatments? Do they provide the kinds of psychosocial support cancer patients need, and do they help or hinder truly integrated care? How well do they address issues of patient choice, and how good are they at providing education and support? The experiences and needs of cancer patients and their carers vary tremendously. We have perhaps been slow, in general practice, to respond to the needs expressed by our cancer patients. But if we take time to listen to our patients, from the time of diagnosis to death and bereavement, many ideas emerge about how the services we provide could be improved. Cancer patients have a range of illness and social trajectories, their patterns of wellbeing fluctuate, and they often perceive a lack of integration in the services they receive.12 GPs also need to maximise their contribution to primary prevention of cancer, especially in relation to smoking cessation and lifestyle risk factor management — despite the challenges of time constraints, practice systems and patients’ reluctance to change.13-15 To meet the challenges of the future and to adapt to changing health service environments, general practice must be prepared to evolve.16 A better understanding of the role of primary care in cancer management is vital if we are to improve outcomes and quality of life in our cancer patients.3,17 We need to know how primary care can contribute to new models of care. At present, there is little evidence on which to base service design and innovation. We need to develop new, genuinely integrated models of care that address important priorities for cancer patients, such as the availability of care close to home, timely management of symptoms, early detection of recurrences, and comprehensive psychosocial support. Until we have done so, GPs will remain at the periphery of cancer management, and there will be ongoing confusion over how we can make our most effective contribution.

David P Weller FRACGP, FAFPHM, PhD · Mark F Harris FRACGP, MD

P4P has raised the quality of primary care in the UK, but broader performance indicators are needed to accurately reflect the scope of general practice Pay for performance, or “P4P” as it is often known, is now centre-stage in primary care in the United Kingdom. P4P promotes change in clinical behaviour by offering financial rewards in return for achieving certain predefined targets. Both sides of the P4P “equation” are currently the subject of much debate: how generous should the financial reward be (the first “P”); and which performance indicators (the second “P”) should be used as the basis for calculating eligibility for the reward? From the foundation of the UK National Health Service (NHS) in 1948, general practitioners derived their income largely from capitation. Income was related more to the quantity than the quality of care. In 1990, and against much resistance from within the profession, the first performance targets were introduced into primary care. There were just two: rates of cervical smears and childhood vaccines. All this changed in 2004, when GPs accepted a new contract that radically promoted the role of P4P. This new contract tied about 25% of GP income to the achievement of a panoply of performance indicators. Large financial rewards were within reach for GPs able to achieve targets set for 147 performance indicators (subsequently revised to 135 indicators in 2006 and further revised to 128 in 2008). Details of the original 147 performance indicators and the mechanism for tying them to financial rewards have been well documented.1 The overall structure is known as the “Quality and Outcomes Framework” (QOF). In essence, the indicators are a mix of clinical indicators covering the management of 10 long-term conditions (eg, diabetes, coronary heart disease, hypothyroidism) and a series of indicators covering managerial, organisational, educational, prescribing and “patient experience” aspects (eg, undertaking an approved patient survey each year) of primary care. The clinical indicators are a mix of process indicators (such as creating a disease register or conducting a specific investigation), intermediate, or proxy, outcome measures (such as reduced cholesterol levels), and true outcome measures (such as improved epilepsy control). Achievement of an indicator is converted into “quality points”, which are weighted according to the perceived workload required to attain the target set for each indicator. Each quality point attracts a fee — currently set at £126 (A$260) for the average-sized general practice (5891 patients) — and the maximum attainable score is currently 1000 points. Since 2004, the components of the QOF have been revised twice. New indicators for an additional nine long-term conditions (eg, chronic kidney disease) were added in 2006, and in its latest 2008 incarnation, there are 80 clinical and 48 non-clinical indicators. What have been the positive consequences of P4P in UK primary care? The introduction of the QOF has demonstrated that GPs in the UK have achieved far higher quality standards than expected — at least, as budgeted for by government pay negotiators. In 2007, 5% of practices achieved the highest possible score, and the mean achievement of all practices in England was 95.5% of the available points.2 Such a demonstration of success has the potential to both affirm professional pride and to provide some evidence to the general public to justify the additional taxation that has been required to fund P4P. As with most systems of P4P, there is evidence that rewarded activity has increased. Substantial increases have been documented in some of the intermediate outcomes, such as blood pressure, cholesterol and glycosylated haemoglobin control, and also in the proportions of heart attack and stroke patients treated with aspirin.2 The overall rise in standards has been accompanied by a narrowing of the health inequality gap (as measured by the QOF) between least- and most-deprived neighbourhoods. Taken together, these achievements should translate into substantial national public health gains. What have been the unintended consequences of P4P in UK primary care? The success of P4P has been challenged from several perspectives. First, in the case of several QOF indicators, the achievement gains pre-dated the introduction of the QOF and, since then, the improvement rate has continued at a similar pace. For example, evidence has accumulated that overall cholesterol control was improving long before 2004.4 Second, high achievement may be interpreted as targets that were too easy to attain. For example, maximum QOF points are awarded for achieving target blood pressure control in just 60% of patients with diabetes, and the target blood pressure was set at 145/85 mmHg, which is above the value given in most guidelines. Third, GPs may indulge in “gaming” to boost their tally of QOF points — either by under-counting the number of patients on each disease register (only including those for whom target achievement is more readily accomplished) or by using the process of “exception reporting”, whereby GPs can decide whether it is “unsuitable” for a patient to be considered for a given clinical target on grounds such as “maximum tolerated therapy”, extreme frailty, or not responding to three letters inviting them to an appointment.5 More fundamentally, P4P has divided GPs on issues of professionalism. For some GPs, the electronic QOF prompts that accompany a consultation with a patient act as useful reminders and allow the GP to give more thought to deeper issues during the consultation. For others, these prompts represent the intrusion of a reductionist, points-driven approach to patient care that undermines professional autonomy.6 Furthermore, it is readily apparent that measures of patient satisfaction, patient enablement, listening skills, continuity of care, and many of the aspects of general practice that give GPs their greatest professional satisfaction lie outside the scope of any of the performance indicators. There are no measures of the psychosocial problems so common in primary care, nor of many medical conditions (such as any of the chronic gastrointestinal diseases). Indeed, even the advocates of the QOF would concede that probably only a quarter of all registered patients have any of the conditions for which QOF points are available. It is thus clear that P4P in its current form only rewards a small proportion of the overall work of a GP. Finally, the QOF has proven costly. Should such a large proportion of GP income be determined by these indicators, many of which lack a robust evidence base? Since its introduction, a vigorous debate has continued on balancing the “pay” component of P4P with the “performance” component. The higher than expected performance resulted in higher than expected costs, which contributed to NHS overspending in the early years of the new contract (although spending has now been reined in). What are the lessons for Australia? In the UK, the QOF was introduced as a “big bang” solution, without prior piloting. From our perspective as UK-based researchers and practising GPs, we think that perhaps the single greatest lesson from this experience is that piloting might have avoided many of the unintended consequences of P4P in primary care. Although P4P focuses attention on the quality of care, the definition of quality should be multifaceted and derived from evidence-based guidelines and the collective views of GPs, public health specialists and, importantly, patients. Performance indicators undoubtedly need to change over time, either because the evidence base has changed or because the original indicator has become redundant, and a transparent and robust system needs to be devised for regular updating of indicators and targets. An evolving QOF can act as a means to translate research evidence into practice. Simply put, the QOF has the capacity to “cut the implementation corner”. Although contentious, P4P represents a bold attempt to redefine the quality standards of primary care, such that best-practice targets quickly become the norm, expected by patients, health service planners and doctors alike. Beyond this, the next challenge is how P4P can evolve into rewarding a broader, more pluralist definition of quality and not merely the narrow focus of those things that are easy to measure.

Mark Ashworth DM, MRCP, MRCGP · Roger H Jones DM, FRCP, FRCGP

Policies need more than development — they need implementation, and continuous reform In his historic Gettysburg Address, President Abraham Lincoln described the core of democracy as “government of the people, by the people, for the people.”1 We were reminded of these words when we witnessed the Rudd Labor Government vigorously emulating this ideal during the recent Australia 2020 Summit.2 In April this year, a thousand Australians gathered in the Great Hall of Parliament House in Canberra to debate 10 national challenges. These included the future of the Australian economy; future directions for rural industries and rural communities; strengthening communities, supporting families and social inclusion; options for the future of Indigenous Australia; and a long-term national health strategy.2 In the challenging area of health, key ideas that were advanced included creating a Health Equalities Commission; creating a National Preventive Health Agency; initiatives for making healthy food choices easy in schools and regional areas; and, finally, the creation of a self-sufficient and flexible health workforce.3 In short, the Summit endorsed the expectation of healthy and long life for all Australians, and the equitable means to achieve this. Before the Summit, the Rudd Labor Government had already set in motion other consultative processes, such as the Preventative Health Taskforce to tackle the health challenges of tobacco, alcohol and obesity, and come up with a national preventative health strategy.4 This body was to be joined by the National Health and Hospitals Reform Commission (NHHRC), created to develop a long-term health reform plan for modern Australia.5 Its brief was to produce a blueprint for tackling future challenges in the Australian health system, such as the burden of chronic diseases and the ageing of the population as well as the rising costs of health care, which have been exacerbated by cost shifting and the “blame game”. In the recent federal budget, the Rudd Government included provisions for another national taskforce to address mental health. In this issue of the Journal, Bennett, Chair of the NHHRC, presents an outline of the Commission’s first report,6 Beyond the blame game: accountability and performance for the next Australian Health Care Agreements.7 At the heart of this report lies the need for the federal and state governments to stop playing the pernicious blame game, and the report advances a raft of relevant performance indicators to govern the Australian Health Care Agreement processes. Also in this issue of the Journal, Southby recounts the workings and achievements of the Hospitals and Health Services Commission, established by the Whitlam Labor Government in the 1970s.8 Its success as a harbinger of change lay in its dual responsibility for both comprehensive development and implementation of policy. In addition, its work was underpinned by an extensive analysis of relevant data, accompanied by consultation with all levels of government, professional bodies, universities and non-government organisations. And this highlights a significant danger for the efficacy of the current health taskforce and commissions — they are advisory only. A government can always ignore or merely cherrypick recommendations and, more worryingly, there need be no real political commitment to developing or implementing policy. Recommendations may well end up gathering dust in ministerial offices in Canberra, or being savaged by the leagues of advisors who prowl those offices. Witness the innumerable reports on health reform emanating from the Productivity Commission, the Council of Australian Governments, the Australian Healthcare Reform Alliance, the Australian Healthcare and Hospitals Association, Consumers’ Health Forum of Australia, and so on . . .9 Most seem to fall on deaf political ears. And yet, we continue to tolerate a health care system whose capacity to deliver is faltering in the face of increasing community demand. What Australia desperately needs is a continuous health reform agenda. We need to abandon the episodic and ad-hoc response to public disquiet and discontent, followed by the inevitable political quick fix. To ensure that this becomes a reality, the NHHRC needs to become a body with similar functions and status to those of the Whitlam era’s Hospitals and Health Services Commission, with a brief for wide involvement. Effectively, it needs to be responsible for driving reform, mirroring President Lincoln’s democratic dictum “by the people, for the people”. We also need to keep the government honest and up to the task of reform through an overarching body, perhaps the “Australian Health Council”, which would promote greater accountability of governments in driving reform effectively. The Council would also need to meet regularly in a different location each time, to have its members discuss health issues with Australian communities in open forums. The time has come to stop the reform rhetoric and political gamesmanship and acknowledge that good health is a right for all Australians. Indeed “the health of the people is the highest law”.10 But we can only achieve this most basic of human rights by making a sincere commitment to implementing meaningful reform of the health care systems we now have.

Martin B Van Der Weyden MD, FRACP, FRCPA